ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Dicural 100 mg/ml oral solution for chickens and turkeys
2.
Each ml contains:
Active substance:
Difloxacin (as hydrochloride)
100 mg
Excipients:
Benzyl alcohol
100 mg
For a full list of excipients, see section 6.1
3.
Oral solution
4.
Chickens (broilers and future breeders)
Turkeys (young turkeys up to 2 kg body weight).
In chickens and turkeys:
Dicural oral solution is indicated for treatment of chronic respiratory
infections caused by sensitive strains of
Escherichia coli
and
Mycoplasma gallisepticum
.
In turkeys
: Dicural oral solution is also indicated for the treatment of infections caused by
Pasteurella
multocida
.
Since no studies were performed in clinically lame birds, Dicural
should not be used in birds with
existing leg-weakness or in birds suffering from osteoporosis.
None.
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Official and local antimicrobial policies should be taken into account when the product is used
.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
2
Use of the product deviating from the instructions given in the SPC may increase the prevalence of
bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other
quinolones due to the potential of cross resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to quinolones should avoid any contact with the product.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling
this product.
None known.
Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.
None known.
Dicural oral solution must be administrated daily via the drinking water in such a concentration that
the dose is 10 mg/kg bodyweight. The administration must be continued for 5 days.
Taking into account the content of difloxacin in the oral solution (10%w/v), the following calculation
should be made to determine the volume (ml) to be added for each 1000 litres of water:
number of animals in the house X mean weight of individual animal(kg) X 100
-----------------------------------------------------------------------------------------------------
total water consumption of the house at the previous day (litres)
The medicated drinking water should be prepared freshly each day.
No other source of drinking water should be available during the medication period.
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys
may be affected.
Target animal safety studies in chickens and turkeys demonstrated that, when administered in drinking
water at 30 mg/kg (chickens) or 22 mg/kg (turkeys) for three times the recommended duration (15
consecutive days), difloxacin hydrochloride appeared to be safe for the birds.
4.11 Withdrawalperiods
Meat and offal (chickens and turkeys): 24 hours.
Not permitted for use in laying birds producing eggs for human consumption.
3
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use,
quinolone antibacterials.
ATC vet code: QJ01MA94
The fluoroquinolones exert their antibacterial effect against both replicating and non-replicating
micro-organisms. Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial
DNA gyrase.
Strains of
Escherichia coli
,
Pasteurella multocida
,
Mycoplasma gallisepticum
isolated from broilers
and turkeys have been shown to be sensitive to difloxacin.
5.2 Pharmacokinetic properties
Difloxacin is rapidly absorbed after oral administration to reach steady state plasma concentrations in
a few hours after initiation of medication. Difloxacin is well distributed throughout the animal body,
as was demonstrated by the tissue to plasma ratios. Difloxacin concentrations equal to or greater than
the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as
medication is continued.
Chickens
:
In chickens difloxacin is nearly completely absorbed after oral administration (approx. 96%). It is well
distributed in the body (V
d
= 4.7 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Following continuous oral dosing with Dicural oral solution at 10 mg/kg/day for five consecutive days
the mean difloxacin steady state plasma concentrations are approximately 200 ng/ml. Tissue to plasma
ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver).
Turkeys
:
In turkeys difloxacin has a moderate oral bioavailability (approx. 58%). It is very well distributed in
the body (V
d
= 9.9 l/kg) and has a plasma elimination half-life of approximately 7 hours. Following
continuous oral dosing of Dicural oral solution at 10 mg/kg/day for five consecutive days the mean
difloxacin steady state plasma concentrations are approximately 60 ng/ml. Tissue to plasma ratios
range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver).
In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into
sarafloxacin or oxidised into N-oxide-difloxacin. The main metabolites are hydrolysable conjugates of
difloxacin, the other metabolites are proportionally minor ones.
6.
6.1
List of excipients
Edetic acid
Potassium hydroxide
Propylene glycol
Benzyl alcohol
Purified water
4
6.2 Incompatibilities
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should
be added to the drinking water used with this product.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Medicated water must be freshly prepared daily.
Shelf life after first opening the container: 1 month.
6.4 Special precautions for storage
Do not store above 25 °C. Protect from light. Do not freeze.
6.5 Nature and composition of immediate packaging
White HDPE bottles with a screw cap containing 250ml or 1litre of Dicural oral solution.
The screw cap on the 1 litre bottle can be used as measuring device. If filled to the brim the measuring
device provides 50ml. For the 250ml bottle a separate measuring device is placed on the screw cap.
Measuring lines indicate the volume supplied.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products, if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
EU/2/97/003/001-003
9.
DATE OF RENEWAL OF THE AUTHORISATION
15.01.2008
5
21.01.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
1.
Dicural 15 mg coated tablets for dogs
Dicural 50 mg coated tablets for dogs
Dicural 100 mg coated tablets for dogs
Dicural 150 mg coated tablets for dogs
2.
Active substance:
Each tablet contains:
Dicural 15 mg
difloxacin (as the hydrochloride)
15 mg
Dicural 50 mg
difloxacin (as the hydrochloride)
50 mg
Dicural 100 mg
difloxacin (as the hydrochloride)
100 mg
Dicural 150 mg
difloxacin (as the hydrochloride)
150 mg
For a full list of excipients, see section 6.1
3.
Coated tablets
4.
Dogs
For the treatment of:
Acute uncomplicated urinary tract infections caused by
Escherichia coli
or
Staphylococcus spp
Superficial pyoderma caused by
Staphylococcus intermedius.
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing
joints difloxacin should not be used during the rapid growth phase, that is, do not use in small and
medium-sized breeds of dogs up to and including 8 months of age, in large breeds up to 1 year of age
and in giant breeds up to 18 months of age.
Do not use in epileptic dogs.
None known.
7
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals.
People with known hypersensitivity to quinolones should avoid any contact with the product.
Adverse reactions were rare in dogs treated with difloxacin. The observed reactions were inappetence,
emesis, diarrhoea, and anal irritation. These adverse reactions were self-limiting within one or two
days and did not require additional treatment.
The reproductive safety of the veterinary medicinal product has only been evaluated in laboratory
animals, the use of difloxacin in pregnant or lactating bitches or male stud dogs is therefore not
recommended.
4.8 Interaction with other veterinary medicinal products and other forms of interaction
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may
cause seizures.
Antacids may interfere with gastro-intestinal absorption.
Nitrofurantoin may impair quinolone efficacy if used concurrently in the treatment of urinary tract
infections.
The recommended dose of difloxacin is 5 mg/kg bodyweight per day. Dicural coated tablets should be
given once a day for at least 5 days.
Superficial pyoderma may require treatment for up to a maximum of
21 days. The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
Therapy should be re-evaluated if no improvement is seen within 5 days,
or 10 days in the case of
superficial pyoderma.
Dogs treated orally with difloxacin (as hydrochloride) at 10 times the recommended dose for 10 days
occasionally showed mild adverse reactions such as orange/yellowing discoloration of the faeces,
emesis and hypersalivation.
Histopathological changes were noted in the articular cartilage of weight bearing joints of young (3.5
months old) beagle dogs after the oral administration of difloxacin at doses of greater than 5 mg/kg/day
(as the hydrochloride) for 90 days.
No specific antidotes for difloxacin (or other quinolones) are known, therefore, in case of overdose
symptomatic treatment should be given.
8
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use,
quinolone antibacterials.
ATC vet code: QJ01MA94
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity. Difloxacin can be
bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive micro-
organisms.
5.1 Pharmacodynamic properties
The fluoroquinolones exert their antibacterial effects against both replicating and dormant micro-
organisms. Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
The following organisms were tested and found to be susceptible to difloxacin
in vitro
:
Escherichia coli
Klebsiella spp.
Pasteurella spp.
Pseudomonas spp.
Staphylococcus intermedius
The following organisms were found to be of intermediate susceptibility:
Proteus spp.
Staphylococcus spp.
Streptococcus canis (beta)
Streptococcus spp.
5.2 Pharmacokinetic properties
Following an oral dose (a plain tablet) in dogs of 5 mg/kg bodyweight, difloxacin reached its average
peak plasma concentration of 1.8 µg/ml in approximately 3 hours. Approximately 95 % of the oral dose
was absorbed. The elimination half-life averaged 9.3 hours.
Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin
kinetics, neither by accumulation nor by increased drug metabolism.
6.
6.1
List of excipients
Sodium starch glycollate
Microcrystalline cellulose
Magnesium stearate
Colloidal silicon dioxide
Sodium lauryl sulphate
9
Lactose
Sodium croscarmellose
Micronised brewer’s yeast
Aromatic liver flavour
6.2 Incompatibilities
Not applicable.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
6.4 Special precautions for storage
Do not store above 25°C. Store in a dry place.
6.5 Nature and contents of container
PVC/aluminium blisters with 10 tablets per blister. Cardboard boxes of 1, 2 or 10 blisters.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products, if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
EU/2/97/003/004-015
9.
DATE OF RENEWAL OF THE AUTHORISATION
15.01.2008
10
21.01.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11
1.
Dicural 50 mg/ml solution for injection for cattle and dogs.
2.
Active substance:
Difloxacin (as hydrochloride)
50 mg/ml
Excipients:
Benzyl alcohol
50 mg/ml
For a full list of excipients, see section 6.1
3.
Solution for injection.
4.
Cattle (calves and young cattle)
Dogs.
In cattle:
Dicural 50 mg/ml solution for injection is indicated for the treatment of bovine respiratory
disease (shipping fever, calf pneumonia) caused by single or mixed infections with
Pasteurella
haemolytica
,
Pasteurella multocida
, and/or
Mycoplasma
spp
.
In dogs
: Dicural 50 mg/ml solution for injection is indicated for the treatment of:
Acute uncomplicated urinary tract infections caused by
Escherichia coli
or
Staphylococcus spp
Superficial pyoderma caused by
Staphylococcus intermedius.
Cattle:
None.
Dogs:
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing
joints difloxacin should not be used during the rapid growth phase. Therefore, do not use in small and
medium-sized breeds of dogs up to and including 8 months of age, in large breeds up to 1year of age
and in giant breeds up to 18 months of age.
Do not use in epileptic dogs.
None known.
12
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Official and local antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of
bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other
quinolones due to the potential of cross resistance
.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with a known hypersensitivity to quinolones should avoid any contact with the product.
Cattle:
In target animal safety studies, subcutaneous administration was generally well tolerated. Transient
swelling at the injection site following administration may occur.
Dogs:
In target animal safety studies, subcutaneous administration was generally well tolerated. Pruritis
and/or local swellings and occasionally a slight pain reaction on injection have been observed. In
general the pruritis disappears within a few minutes and the local swelling within a few days.
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
4.8 Interaction with other veterinary medicinal products and other forms of interaction
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs)
may cause seizures.
Antagonism may be observed with nitrofurantoin.
Subcutaneous use
Cattle:
The recommended dose is 2.5mg difloxacin/kg bodyweight/day for 3 days (i.e. 5ml/100 kg
bodyweight/day). If there is insufficient improvement after 3 days, the treatment can be continued for
another 2 days.
For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight/ day.
The volume administered per injection site in cattle should not exceed 7 ml. A new injection site
should be used each day
13
Dogs:
The recommended dose is a single injection of 5.0 mg difloxacin/kg bodyweight Treatment must be
continued with Dicural coated tablets (see that SPC)
The volume administered per injection site in dogs should not exceed 5 ml.
Cattle:
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors,
convulsions, etc) may occur in cattle. Overdosage may also give rise to oedema and swelling in the
knee joints.
Dogs:
The oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not
result in any adverse reactions.
In another study, dogs treated orally with difloxacin at 10 times the recommended dose for 10 days
showed occasionally mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis
and hypersalivation.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage
symptomatic treatment should be given.
4.11 Withdrawalperiod
Cattle
:
Meat and offal: 46 days
Dogs:
Not applicable
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use,
quinolone antibacterials.
ATC vet code: QJ01MA94
The fluoroquinolones exert their antibacterial effect against both replicating and dormant micro-
organisms. Difloxacin hydrochloride can be bactericidal in activity and acts primarily through
inhibition of bacterial DNA gyrase.
The following organisms were tested and found to be susceptible to difloxacin
in vitro
:
Pasteurella
spp
.
Mycoplasma
spp
.
Escherichia coli
Staphylococcus intermedius
The following organism was found to be of intermediate susceptibility:
Staphylococcus
spp.
14
Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and
by changes in cell permeability towards quinolones
5.2 Pharmacokinetic properties
Cattle:
After subcutaneous administration of difloxacin peak plasma levels of 1.7 g/ml are achieved at 6
hours post dosing. After subcutaneous administration the bioavailability is 88% and the volume of
distribution is 2.5 l/kg.
The parent compound difloxacin is the major component in the faeces and tissues. In the urine, liver,
fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small
amounts in addition to the major (parent) compound.
The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg. A half-life time
of 7.7 hours has been observed. The majority of difloxacin (i.e. 68 - 82%) is excreted via the faeces. A
fraction of difloxacin (i.e. 7 - 18%) is eliminated via the urine.
Dogs:
After subcutaneous administration of difloxacin peak plasma levels of 1.4 -1.9 g/ml are achieved in
3.1 hours post dosing. After subcutaneous administration the bioavailability is 96%. The volume of
distribution is 2.6 l/kg. A half-life time of 5.8 hours has been observed. The majority of difloxacin is
excreted via the faeces. A fraction of difloxacin is eliminated by the urine.
6.
6.1
List of excipients
Ethanol
Benzyl alcohol
Propylene glycol
Arginine
Water for injections
6.2
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first use of the product: 28 days
6.4 Special precautions for storage
Do not store above 25 C.
Do not freeze.
Keep the container in the outer carton.
6.5 Nature and composition of immediate packaging
Dogs:
Cardboard box with one glass vial of 50ml with a rubber stopper and aluminium cap.
15
Cattle:
Cardboard box with one glass vial of 50ml, 100ml or 250 ml with a rubber stopper and aluminium cap.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products, if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
EU/2/97/003/016-018
9.
DATE OF RENEWAL OF THE AUTHORISATION
15.01.2008
21.01.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
16
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY AND USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
17
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturers responsible for batch release:
For all three pharmaceutical forms:
Fort Dodge Veterinaria S.A.
Ctra. Camprodón, s/n “La Riba”
E-17813 Vall de Bianya (Girona)
Spain
Manufacturing Authorisation issued on 4 March 1997 by Ministerio de Agricultura, Spain.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY AND USE
To be supplied only on veterinary prescription.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable.
D. STATEMENT OF THE MRLs
which are accepted in accordance with Council Regulation (EEC) No 2377/90 and in accordance with
Article 31 (3b) of Council Regulation (EEC) No 2309/93 of 22 July 1993, as amended.
18
Annex I of Council Regulation (EEC) No 2377/90
Pharmacologically
active substance
Marker
residue
Animal
Species
MRLs
Target
tissues
Other
provisions
Difloxacin
Difloxacin
300 µg/kg
400 µg/kg
1900 µg/kg
600 µg/kg
Muscle
Skin + fat
Liver
Kidney
Not for use in
animals from
which eggs are
produced for
human
consumption
Difloxacin
Difloxacin
400 µg/kg
100 µg/kg
1400 µg/kg
800 µg/kg
Muscle
Fat
Liver
Kidney
Not for use in
animals from
which milk is
produced for
human
consumption
Annex II of Council Regulation (EEC) No 2377/90
Oral solution:
Pharmacologically active
substance
Animal Species
Other provisions
All food-producing species
Propylene glycol
5
For use as excipient
For use as excipient
Solution for injection:
Pharmacologically active
substance
Animal Species
Other provisions
All food-producing species
For use as excipient
Propylene glycol
9
Benzyl alcohol
10
Arginine
11
1 OJ No. L 172 of 02.07.02
2 OJ No. L 172 of 02.07.02
3 OJ No. L 290 of 5.12.95
4 OJ No. L 272 of 25.10.96
5 OJ No. L 45 of 15.02.97
6 OJ No. L 143 of 27.06.95
7 OJ No. L 143 of 27.06.95
8 OJ No. L 143 of 26.06.95
9 OJ No. L 45 of 15.02.97
10 OJ No L 143 of 26.06.95
11 OJ No. L 240 of 10.09.99
19
ANNEX III
LABELLING AND PACKAGE LEAFLET
20
A. LABELLING
21
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Dicural oral solution
CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE
VIAL LABEL 250 ml bottle / 1000 ml bottle
1.
Dicural 100 mg/ml oral solution for chickens and turkeys
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride) 100 mg/ml
Benzyl alcohol 100 mg/ml
3.
Oral solution
4.
PACKAGE SIZE
1 x 250 ml
1 x 1000 ml
6 x 1000 ml
5.
Chickens (broilers and future breeders) and turkeys (young turkeys up to 2 kg body weight).
6.
INDICATIONS
Chickens and turkeys - for treatment of chronic respiratory infections caused by sensitive strains of
Escherichia coli
and
Mycoplasma gallisepticum
.
Turkeys only - for the treatment of infections caused by
Pasteurella multocida
.
Dicural oral solution should be used based on susceptibility testing
7.
METHOD AND ROUTE OF ADMINISTRATION
For oral administration in drinking water.
Read the package leaflet before use.
8.
Withdrawal periods - Meat and offal (chickens and turkeys): 24 hours.
22
Not permitted for use in laying birds producing eggs for human consumption.
9.
SPECIAL WARNINGS
People with known hypersensitivity to quinolones should avoid any contact with the product.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling
this product.
10. EXPIRY DATE
EXP {month/year}
Medicated water must be freshly prepared daily.
Shelf life after first opening the container: 1 month.
11. SPECIAL STORAGE CONDITIONS
Do not store above 25 °C. Protect from light. Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
[Not requested on the immediate label]
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only- to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
[Not requested on the immediate label]
Keep out of the reach and sight of children.
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
23
EU/2/97/003/001 – 1 x 250 ml
EU/2/97/003/002 – 1 x 1000 ml
EU/2/97/003/003 – 6 x 1000 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
24
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Dicural 15 mg Coated tablets
CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
1.
Dicural 15 mg coated tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride)
15 mg
3.
Coated tablets
4.
PACKAGE SIZE
10 tablets
20 tablets
100 tablets
5.
Dogs
6.
INDICATIONS
7.
METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
8.
[Not applicable.]
9.
SPECIAL WARNINGS, IF NECESSARY
People with known hypersensitivity to quinolones should avoid any contact with the product.
25
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25-C. Store in a dry place.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only -to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/97/003/004 – 10 tablets
EU/2/97/003/005 – 20 tablets
EU/2/97/003/006 – 100 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
26
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Dicural 50 mg Coated tablets
CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
1.
Dicural 50 mg coated tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride)
50 mg
3.
Coated tablets
4.
PACKAGE SIZE
10 tablets
20 tablets
100 tablets
5.
Dogs
6.
INDICATIONS
7.
METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
8.
[Not applicable.]
9.
SPECIAL WARNINGS, IF NECESSARY
People with known hypersensitivity to quinolones should avoid any contact with the product.
27
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25-C. Store in a dry place.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only -to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/97/003/007 – 10 tablets
EU/2/97/003/008 – 20 tablets
EU/2/97/003/009 – 100 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
28
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Dicural 100 mg Coated tablets
CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
1.
Dicural 100 mg coated tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride)
100 mg
3.
Coated tablets
4.
PACKAGE SIZE
10 tablets
20 tablets
100 tablets
5.
Dogs
6.
INDICATIONS
7.
METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
8.
[Not applicable.]
29
9.
SPECIAL WARNINGS, IF NECESSARY
People with known hypersensitivity to quinolones should avoid any contact with the product.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25-C. Store in a dry place.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only -to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/97/003/010 – 10 tablets
EU/2/97/003/011 – 20 tablets
EU/2/97/003/012 – 100 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
30
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Dicural 150 mg Coated tablets
CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
1.
Dicural 150 mg coated tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride)
150 mg
3.
Coated tablets
4.
PACKAGE SIZE
10 tablets
20 tablets
100 tablets
5.
Dogs
6.
INDICATIONS
7.
METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
8.
[Not applicable.]
9.
SPECIAL WARNINGS, IF NECESSARY
People with known hypersensitivity to quinolones should avoid any contact with the product.
31
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25-C. Store in a dry place.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/97/003/013 – 10 tablets
EU/2/97/003/014 – 20 tablets
EU/2/97/003/015 – 100 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
32
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Dicural 15 mg coated tablets
Blister label
1.
Dicural 15 mg coated tablets for dogs
Difloxacin
2.
Pfizer Limited
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
33
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Dicural 50 mg coated tablets
Blister label
1.
Dicural 50 mg coated tablets for dogs
Difloxacin
2.
Pfizer Limited
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
34
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Dicural 100 mg coated tablets
Blister label
1.
Dicural 100 mg coated tablets for dogs
Difloxacin
2.
Pfizer Limited
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
35
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Dicural 150 mg coated tablets
Blister label
1.
Dicural 150 mg coated tablets for dogs
Difloxacin
2.
Pfizer Limited
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
36
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Dicural 50 mg/ml, solution for injection for cattle and dogs
CARTON for 50 ml vial
1.
Dicural 50 mg/ml solution for injection for cattle and dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride)
50 mg/ml
Benzyl alcohol
50 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
50 ml
5.
Cattle (calves and young cattle) and dogs
6.
Cattle:
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed
infections with
Pasteurella haemolytica
,
Pasteurella multocida
, and/or
Mycoplasma
spp
.
Dogs:
Treatment of:
Acute uncomplicated urinary tract infections caused by
Escherichia coli
or
Staphylococcus spp
Superficial pyoderma caused by
Staphylococcus intermedius.
7.
METHOD AND ROUTE OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
8.
Withdrawal period:
Cattle
- meat and offal 46 days
37
9.
SPECIAL WARNING(S), IF NECESSARY
People with a known hypersensitivity to quinolones should avoid any contact with the product.
10. EXPIRY DATE
EXP
{month/year}
Shelf life after first use of the product: 28 days
11. SPECIAL STORAGE CONDITIONS
Do not store above 25C. Do not freeze.
Keep the container in the outer carton.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription..
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/97/003/016
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
38
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Dicural 50 mg/ml, solution for injection for cattle and dogs
50 ml vial label
1.
Dicural 50 mg/ml solution for injection for cattle and dogs
2.
ACTIVE SUBSTANCES
Difloxacin (as hydrochloride) 50 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
50 ml
4.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
5.
Withdrawal period:
Cattle
- meat and offal 46 days
6.
MANUFACTURER’S BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP
{month/year}
Shelf-life after first use of the product: 28 days
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
[MA Number recommended, but not required on the immediate label]
EU/2/97/003/016
39
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE
Dicural 50 mg/ml solution for injection for cattle
OUTER CARTON for 100 ml vial / 250 ml vial / VIAL LABEL 100 ml vial / 250 ml vial
1.
Dicural 50 mg/ml solution for injection for cattle
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Difloxacin (as hydrochloride)
50 mg/ml
Benzyl alcohol
50 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
100 ml
250 ml
5.
Cattle (calves and young cattle)
6.
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed
infections with
Pasteurella haemolytica
,
Pasteurella multocida
, and/or
Mycoplasma
spp
.
7.
METHOD AND ROUTE OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
8.
Withdrawal period: Meat and offal 46 days
9.
SPECIAL WARNING(S), IF NECESSARY
People with a known hypersensitivity to quinolones should avoid any contact with the product.
40
10. EXPIRY DATE
EXP
{month/year}
Shelf-life after first use of the product: 28 days
11. SPECIAL STORAGE CONDITIONS
Do not store above 25C. Do not freeze.
Keep the container in the outer carton.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
[Not required on the immediate label]
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only. To be supplied only on veterinary prescription..
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
[Not required on the immediate label]
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
[Recommended, but not required on the immediate label]
EU/2/97/003/017 – 100 ml
EU/2/97/003/018 – 250 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET FOR
Dicural 100 mg/ml oral solution for chickens and turkeys
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release
Fort Dodge Veterinaria S.A.
Ctra. Camprodón, s/n “La Riba”
E-17813 Vall de Bianya (Girona)
Spain
2.
Dicural 100 mg/ml oral solution for chickens and turkeys
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Each ml contains:
Active substance
Difloxacin (as hydrochloride)
100 mg
Excipients
Other excipients, including benzyl alcohol, in an aqueous formulation to 1 ml
4.
INDICATIONS
In chickens and turkeys:
Dicural oral solution is indicated for treatment of chronic respiratory
infections caused by sensitive strains of
Escherichia coli
and
Mycoplasma gallisepticum
.
In turkeys:
Dicural oral solution is also indicated for the treatment of infections caused by
Pasteurella
multocida.
Dicural oral solution should only be used based on susceptibility testing
5.
Since no studies were performed in clinically lame birds, Dicural
oral solution should not be used in
birds with existing leg-weakness or in birds suffering from osteoporosis.
43
6.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Chickens (broilers and future breeders)
Turkeys (young turkeys up to 2 kg body weight).
8.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION
Dicural oral solution must be administrated daily via the drinking water in such a concentration that
the dose is 10 mg/kg bodyweight. The administration must be continued for 5 days.
For oral administration in drinking water.
Taking into account the content of difloxacin in the oral solution (10%w/v), the following calculation
should be made to determine the volume (ml) to be added for each 1000 litres of water:
number of animals in the house X mean weight of individual animal(kg) X 100
-----------------------------------------------------------------------------------------------------
total water consumption of the house at the previous day (litres)
9.
ADVICE ON CORRECT ADMINISTRATION
The screw cap on the 1 litre bottle can be used as measuring device. If filled to the brim the measuring
device provides 50 ml. For the 250 ml bottle a separate measuring device is placed on the screw cap.
Measuring lines indicate the volume supplied.
The medicated drinking water should be prepared freshly each day.
No other source of drinking water should be available during the medication period.
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should
be added to the drinking water used with this product.
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys
may be affected.
10. WITHDRAWAL PERIODS
Meat and offal (chicken and turkeys): 24 hours.
Not permitted for use in laying birds producing eggs for human consumption.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
44
Do not store above 25 °C.
Protect from light.
Do not freeze.
Shelf-life after first opening the container: 1 month.
Do not use after the expiry date stated on the label after EXP
12. SPECIAL WARNING(S)
Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.>
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
People with known hypersensitivity to quinolones should avoid any contact with the product.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device, when handling
this product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
21.01.2011
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/
15. OTHER INFORMATION
For animal treatment only. To be supplied only on veterinary prescription.
Dicural oral solution is a yellowish clear aqueous solution and is supplied in plastic white bottles with
a screw cap containing 250 or 1000 ml oral solution. Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
45
België/Belgique/Belgien
Luxembourg
Pfizer Animal Health s.a.,
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Tél.: + 32 (0)2 554 62 11
Република България
Magyarország
Pfizer Luxembourg SARL
Pfizer Kft.
Tel: + 359 2 970 43 21
Tel: +361 488 3695
Česká republika
Malta
Pfizer Animal Health
Agrimed Limited
Tel: +420 283 004 111
Tel: +356 21 465 797
Danmark
Nederland
Pfizer Oy Animal Health
Pfizer Animal Health B.V.,
Tlf: +358 (0)9 4300 40
Tel: +31 (0)10 4064 600
Deutschland
Norge
Pfizer GmbH
Pfizer Oy Animal Health
Tel: +49 30-5500 5501
Tlf: +358 (0)9 4300 40
Eesti
Österreich
Pfizer Animal Health
Pfizer Corporation Austria Ges.m.b.H.
Tel: +370 5 269 17 96
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Polska
Pfizer Hellas A.E.
Pfizer Trading Polska Sp. z.o.o.
Τηλ.: +30 210 6785800
Tel: +48 22 335 61 00
España
Portugal
Pfizer S.A.
Laboratórios Pfizer, Lda.
Tel: +34 91 4909900
Tel: +351 21 423 55 00
46
France
Romania
Pfizer
Pfizer Romania SRL
Tél: +33 (0)1 58 07 46 00
Tel: + 0040 21 207 28 93
Ireland
Slovenija
Pfizer Healthcare Ireland, trading as:
Pfizer Luxembourg SARL
Pfizer Animal Health
Tel: +386 (0) 1 52 11 670
Tel: +353 (0) 1 467 6500
Ìsland
Slovenská republika
Pfizer Oy Animal Health
Pfizer Luxembourg SARL o.z.
Tel: +358 (0)9 4300 40
Tel: + 421 2 3355 5500
Italia
Suomi/Finland
Pfizer Italia S.r.l.,
Pfizer Oy Animal Health,
Tel: +39 06 3318 2933
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Sverige
Pfizer Hellas A.E.
Pfizer Oy Animal Health
Τηλ.: +30 210 6785800
Tel: +358 (0)9 4300 40
Latvija
United Kingdom
Pfizer Animal Health
Pfizer Ltd
Tel: +370 5 269 17 96
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
47
PACKAGE LEAFLET FOR
Dicural coated tablets for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Fort Dodge Veterinaria S.A.
Carretera Camprodón, s/n - La Riba
E-17813-Vall de Bianya (Girona)
Spain
2.
Dicural 15 mg coated tablets for dogs
Dicural 50 mg coated tablets for dogs
Dicural 100 mg coated tablets for dogs
Dicural 150 mg coated tablets for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains:
Dicural 15 mg
difloxacin (as hydrochloride)
15 mg
Dicural 50 mg
difloxacin (as hydrochloride)
50 mg
Dicural 100 mg
difloxacin (as hydrochloride)
100 mg
Dicural 150 mg
difloxacin (as hydrochloride)
150 mg
4.
Dicural coated tablets are indicated for the following clinical conditions in dogs:
Acute uncomplicated urinary tract infections caused by
Escherichia coli
or
Staphylococcus spp.
Superficial pyoderma caused by
Staphylococcus intermedius.
Dicural Coated Tablets should only be used based on susceptibility testing.
5.
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing
joints, difloxacin should not be used during the rapid growth phase, that is, do not use in small-and
medium breed dogs up to and including 8 months of age, in large breeds up to 1 year of age and in
giant breeds up to 18 months of age.
48
Do not use in epileptic dogs.
6.
Adverse reactions were rare in dogs treated with difloxacin. The observed reactions were inappetence,
emesis, diarrhoea, and anal irritation. These adverse reactions were self-limiting within one or two
days and did not require additional treatment.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
The recommended dose of difloxacin is 5 mg/kg bodyweight per day. Dicural coated tablets should be
given once a day for at least 5 days. Superficial pyoderma may require treatment for up to a maximum of
21 days. The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of
superficial pyoderma.
Bodyweight
(kg)
Dicural
15 mg
Dicural
50 mg
Dicural
100 mg
Dicural
150 mg
Small
0 - 3
4 - 6
1
2
7 - 10
11 - 20
21 - 30
(3)
1
2
3
(1)
Medium
(1)
Large
31 - 40
41 - 60
2
3
(2)
For oral use.
9.
ADVICE ON CORRECT ADMINISTRATION
10. WITHDRAWAL PERIOD
Not applicable.
49
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in a dry place.
Do not use after the expiry date stated on the carton after EXP.
12. SPECIAL WARNING(S)
People with known hypersensitivity to quinolones should avoid any contact with the product.
The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended.
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
21.01.2011
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/
15. OTHER INFORMATION
For animal treatment only - to be supplied only on veterinary prescription.
Dicural coated tablets consist of a core tablet containing difloxacin hydrochloride and a highly
palatable coating. Each strength of the product is available in packs of 10, 20 and 100 tablets. Not all
pack sizes may be marketed.
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity. Difloxacin can be
bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive micro-
organisms.
The fluoroquinolones exert their antibacterial effects against both replicating and dormant micro-
organisms. Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
The following organisms were tested and found to be susceptible to difloxacin
in vitro
:
Escherichia coli
Klebsiella spp.
Pasteurella spp.
Pseudomonas spp.
Staphylococcus intermedius
50
The following organisms were found to be of intermediate susceptibility:
Proteus spp.
Staphylococcus spp.
Streptococcus canis (beta)
Streptococcus spp.
Following an oral dose (a plain tablet) in dogs of 5 mg/kg bodyweight, difloxacin reached its average
peak plasma concentration of 1.8 µg/ml in approximately 3 hours. Approximately 95 % of the oral dose
was absorbed. The elimination half-life averaged 9.3 hours.
Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin
kinetics, neither by accumulation nor by increased drug metabolism.
For any information about this veterinary medicinal product, please contact the local representative of
the Marketing Authorisation Holder.
51
België/Belgique/Belgien
Luxembourg
Pfizer Animal Health s.a.,
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Tél.: + 32 (0)2 554 62 11
Република България
Magyarország
Pfizer Luxembourg SARL
Pfizer Kft.
Tel: + 359 2 970 43 21
Tel: +361 488 3695
Česká republika
Malta
Pfizer Animal Health
Agrimed Limited
Tel: +420 283 004 111
Tel: +356 21 465 797
Danmark
Nederland
Pfizer Oy Animal Health
Pfizer Animal Health B.V.,
Tlf: +358 (0)9 4300 40
Tel: +31 (0)10 4064 600
Deutschland
Norge
Pfizer GmbH
Pfizer Oy Animal Health
Tel: +49 30-5500 5501
Tlf: +358 (0)9 4300 40
Eesti
Österreich
Pfizer Animal Health
Pfizer Corporation Austria Ges.m.b.H.
Tel: +370 5 269 17 96
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Polska
Pfizer Hellas A.E.
Pfizer Trading Polska Sp. z.o.o.
Τηλ.: +30 210 6785800
Tel: +48 22 335 61 00
España
Portugal
Pfizer S.A.
Laboratórios Pfizer, Lda.
Tel: +34 91 4909900
Tel: +351 21 423 55 00
52
France
Romania
Pfizer
Pfizer Romania SRL
Tél: +33 (0)1 58 07 46 00
Tel: + 0040 21 207 28 93
Ireland
Slovenija
Pfizer Healthcare Ireland, trading as:
Pfizer Luxembourg SARL
Pfizer Animal Health
Tel: +386 (0) 1 52 11 670
Tel: +353 (0) 1 467 6500
Ìsland
Slovenská republika
Pfizer Oy Animal Health
Pfizer Luxembourg SARL o.z.
Tel: +358 (0)9 4300 40
Tel: + 421 2 3355 5500
Italia
Suomi/Finland
Pfizer Italia S.r.l.,
Pfizer Oy Animal Health,
Tel: +39 06 3318 2933
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Sverige
Pfizer Hellas A.E.
Pfizer Oy Animal Health
Τηλ.: +30 210 6785800
Tel: +358 (0)9 4300 40
Latvija
United Kingdom
Pfizer Animal Health
Pfizer Ltd
Tel: +370 5 269 17 96
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
53
PACKAGE LEAFLET FOR:
Dicural 50 mg/ml solution for injection for cattle and dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Fort Dodge Veterinaria S.A.
Carretera Camprodón, s/n - La Riba
E-17813-Vall de Bianya (Girona)
Spain
2.
Dicural 50 mg/ml solution for injection for cattle and dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance
Difloxacin (as hydrochloride) 50 mg/ml
Excipients
Benzyl alcohol
50 mg/ml
4.
Cattle:
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or
mixed infections with
Pasteurella haemolytica
,
Pasteurella multocida
, and/or
Mycoplasma
spp
.
Dogs:
treatment of:
Acute uncomplicated urinary tract infections caused by
Escherichia coli
or
Staphylococcus spp
Superficial pyoderma caused by
Staphylococcus intermedius.
5.
Cattle:
None.
Dogs:
As for other quinolones, due to possible adverse effects on the articular cartilage of weight
bearing joints difloxacin should not be used during the rapid growth phase, that is,. do not use in
small and medium-sized breeds of dogs up to and including 8 months of age, in large breeds up
to 1 year of age and in giant breeds up to 18 months of age.
54
Do not use in epileptic dogs.
6.
Cattle:
In target animal safety studies, subcutaneous administration was generally well tolerated. Transient
swelling at the injection site following administration may occur.
Dogs:
In target animal safety studies, subcutaneous administration was generally well tolerated. Pruritis
and/or local swellings and occasionally a slight pain reaction on injection have been observed. In
general the pruritis disappears within a few minutes and the local swelling within a few days.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cattle (calves and young cattle)\
Dogs
8.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
Cattle:
The recommended dose is 2.5 mg difloxacin/kg bodyweight/day for 3 days (that is, 5ml/100 kg
bodyweight/day). If there is insufficient improvement after 3 days, the treatment can be continued for
another 2 days. For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight /
day.
Dogs:
The recommended dose is 5.0 mg difloxacin/kg body weight in a single injection Treatment should be
continued with Dicural coated tablets (read the package leaflet of this product)
9.
ADVICE ON CORRECT ADMINISTRATION
In
cattle
, the volume administered per injection site should not exceed 7 ml. A new injection site
should be used each day.
In
dogs
, the volume administered per injection site should not exceed 5 ml.
In the absence of incompatibility studies, this veterinary medicinal product must not be mixed with
other veterinary medicinal products.
10. WITHDRAWAL PERIOD
Cattle
: Meat and offal: 46 days
55
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25-C.
Do not freeze.
Keep the container in the outer carton.
Shelf-life after first use of the product: 28 days.
Do not use after the expiry date stated on the vial after EXP.
12. SPECIAL WARNING(S)
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Dicural 50 mg/ml solution for injection should only be used based on susceptibility testing.
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs)
may cause seizures.
Antagonism may be observed with nitrofurantoin.
People with a known hypersensitivity to quinolones should avoid any contact with the product.
Cattle:
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors,
convulsions, etc.) may occur in cattle. Overdosage may also give rise to oedema and swelling in the
knee joints.
Dogs:
In dogs the oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did
not result in any adverse reactions.
In another study dogs treated orally with difloxacin at 10 times the recommended dose for 10 days
showed occasionally mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis
and hypersalivation.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage
symptomatic treatment should be given
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
56
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
21.01.2011
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/
15. OTHER INFORMATION
For animal treatment only. To be supplied only on veterinary prescription.
Dicural 50 mg/ml, solution for injection for cattle and dogs is available in the following presentations:
Dogs:
50 ml vial.
Cattle: 50, 100 and 250 ml vials.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the Marketing Authorisation Holder.
57
België/Belgique/Belgien
Luxembourg
Pfizer Animal Health s.a.,
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Tél.: + 32 (0)2 554 62 11
Република България
Magyarország
Pfizer Luxembourg SARL
Pfizer Kft.
Tel: + 359 2 970 43 21
Tel: +361 488 3695
Česká republika
Malta
Pfizer Animal Health
Agrimed Limited
Tel: +420 283 004 111
Tel: +356 21 465 797
Danmark
Nederland
Pfizer Oy Animal Health
Pfizer Animal Health B.V.,
Tlf: +358 (0)9 4300 40
Tel: +31 (0)10 4064 600
Deutschland
Norge
Pfizer GmbH
Pfizer Oy Animal Health
Tel: +49 30-5500 5501
Tlf: +358 (0)9 4300 40
Eesti
Österreich
Pfizer Animal Health
Pfizer Corporation Austria Ges.m.b.H.
Tel: +370 5 269 17 96
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Polska
Pfizer Hellas A.E.
Pfizer Trading Polska Sp. z.o.o.
Τηλ.: +30 210 6785800
Tel: +48 22 335 61 00
España
Portugal
Pfizer S.A.
Laboratórios Pfizer, Lda.
Tel: +34 91 4909900
Tel: +351 21 423 55 00
58
France
Romania
Pfizer
Pfizer Romania SRL
Tél: +33 (0)1 58 07 46 00
Tel: + 0040 21 207 28 93
Ireland
Slovenija
Pfizer Healthcare Ireland, trading as:
Pfizer Luxembourg SARL
Pfizer Animal Health
Tel: +386 (0) 1 52 11 670
Tel: +353 (0) 1 467 6500
Ìsland
Slovenská republika
Pfizer Oy Animal Health
Pfizer Luxembourg SARL o.z.
Tel: +358 (0)9 4300 40
Tel: + 421 2 3355 5500
Italia
Suomi/Finland
Pfizer Italia S.r.l.,
Pfizer Oy Animal Health,
Tel: +39 06 3318 2933
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Sverige
Pfizer Hellas A.E.
Pfizer Oy Animal Health
Τηλ.: +30 210 6785800
Tel: +358 (0)9 4300 40
Latvija
United Kingdom
Pfizer Animal Health
Pfizer Ltd
Tel: +370 5 269 17 96
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
59
PACKAGE LEAFLET FOR:
Dicural 50 mg/ml solution for injection for cattle
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Fort Dodge Veterinaria S.A.
Carretera Camprodón, s/n - La Riba
17813-Vall de Bianya (Girona)
Spain
2.
Dicural 50 mg/ml solution for injection for cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance
Difloxacin (as hydrochloride) 50 mg/ml
Excipients
Benzyl alcohol
50 mg/ml
4.
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed
infections with
Pasteurella haemolytica
,
Pasteurella multocida
, and/or
Mycoplasma
spp
.
5.
None.
6.
In target animal safety studies, subcutaneous administration in cattle was generally well tolerated.
Transient swelling at the injection site following administration may occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
60
7.
Cattle (calves and young cattle)
8.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
The recommended dose is 2.5 mg difloxacin/kg bodyweight /day for 3 days (that is, 5ml/100 kg
bodyweight/day). If there is no sufficient improvement after 3 days, the treatment can be continued for
another 2 days. For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight/
day.
9.
ADVICE ON CORRECT ADMINISTRATION
In cattle, the volume administered per injection site should not exceed 7 ml. A new injection site
should be used each day.
In the absence of incompatibility studies, this veterinary medicinal product must not be mixed with
other veterinary medicinal products.
10. WITHDRAWAL PERIOD
Meat and offal: 46 days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25-C.
Do not freeze.
Keep the container in the outer carton.
Shelf-life after first use of the product: 28 days.
Do not use after the expiry date stated on the vial.after EXP.
12. SPECIAL WARNING(S)
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Dicural 50 mg/ml solution for injection should only be used based on susceptibility testing.
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs)
may cause seizures. Antagonism may be observed with nitrofurantoin.
61
People with a known hypersensitivity to quinolones should avoid any contact with the product.
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors,
convulsions, etc.) may occur in cattle. Overdosage may also give rise to oedema and swelling in the
knee joints.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage
symptomatic treatment should be given
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
21.01.2011
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/
15. OTHER INFORMATION
For animal treatment only. To be supplied only on veterinary prescription.
Dicural 50 mg/ml, solution for injection for cattle is available in 50, 100 and 250 ml vials. Not all pack
sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the Marketing Authorisation Holder.
62
België/Belgique/Belgien
Luxembourg
Pfizer Animal Health s.a.,
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Tél.: + 32 (0)2 554 62 11
Република България
Magyarország
Pfizer Luxembourg SARL
Pfizer Kft.
Tel: + 359 2 970 43 21
Tel: +361 488 3695
Česká republika
Malta
Pfizer Animal Health
Agrimed Limited
Tel: +420 283 004 111
Tel: +356 21 465 797
Danmark
Nederland
Pfizer Oy Animal Health
Pfizer Animal Health B.V.,
Tlf: +358 (0)9 4300 40
Tel: +31 (0)10 4064 600
Deutschland
Norge
Pfizer GmbH
Pfizer Oy Animal Health
Tel: +49 30-5500 5501
Tlf: +358 (0)9 4300 40
Eesti
Österreich
Pfizer Animal Health
Pfizer Corporation Austria Ges.m.b.H.
Tel: +370 5 269 17 96
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Polska
Pfizer Hellas A.E.
Pfizer Trading Polska Sp. z.o.o.
Τηλ.: +30 210 6785800
Tel: +48 22 335 61 00
España
Portugal
Pfizer S.A.
Laboratórios Pfizer, Lda.
Tel: +34 91 4909900
Tel: +351 21 423 55 00
63
France
Romania
Pfizer
Pfizer Romania SRL
Tél: +33 (0)1 58 07 46 00
Tel: + 0040 21 207 28 93
Ireland
Slovenija
Pfizer Healthcare Ireland, trading as:
Pfizer Luxembourg SARL
Pfizer Animal Health
Tel: +386 (0) 1 52 11 670
Tel: +353 (0) 1 467 6500
Ìsland
Slovenská republika
Pfizer Oy Animal Health
Pfizer Luxembourg SARL o.z.
Tel: +358 (0)9 4300 40
Tel: + 421 2 3355 5500
Italia
Suomi/Finland
Pfizer Italia S.r.l.,
Pfizer Oy Animal Health,
Tel: +39 06 3318 2933
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Sverige
Pfizer Hellas A.E.
Pfizer Oy Animal Health
Τηλ.: +30 210 6785800
Tel: +358 (0)9 4300 40
Latvija
United Kingdom
Pfizer Animal Health
Pfizer Ltd
Tel: +370 5 269 17 96
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
64
Source: European Medicines Agency
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