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Naxcel

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Summary for the public


What is Naxcel?

Naxcel is an antibiotic suspension that contains ceftiofur (as crystalline free acid) as the active substance. It is available as a suspension for injection for pigs (injection into the muscle) and for cattle (injection under the skin at the base of the ear).


What is Naxcel used for?

Naxcel is used to treat pigs and cattle that have an infection caused by specific groups of bacteria. In pigs, these infections can be respiratory tract infections (such as lung infections), infections of the joints and infections affecting the general health of the pigs (septicaemia). In cattle, Naxcel is used to treat foot rot, an infection of the feet.


How does Naxcel work?

The active substance in Naxcel is ceftiofur, which belongs to a class of antibiotics called “third generation cephalosporins”. All these cephalosporin antibiotics, including ceftiofur, kill bacteria by disrupting the building of the bacterial cell walls. Like other antibiotics, ceftiofur is only effective against certain types of bacteria.


How has Naxcel been studied?

Data from laboratory studies with different bacteria showed that ceftiofur is effective against bacteria involved in causing the pig and cattle diseases listed above.

Naxcel has been investigated in pigs with respiratory diseases caused by various bacteria or in pigs suffering from severe lameness, fever or other clinical signs of septicaemia (blood infection), polyarthritis (inflammation of the joints) or polyserositis (inflammation of the internal body membranes) associated with Streptococcus suis infections. In these trials, Naxcel was either used on its own or compared with another authorised antibiotic (ceftiofur sodium) or a placebo (a dummy treatment without any active substance).

In cattle, Naxcel was given under the skin at the base of the ear, to treat animals with foot rot. In this trial, Naxcel was compared with another authorised antibiotic (ceftiofur sodium).


What benefit has Naxcel shown during the studies?

In all studies, Naxcel was as effective in curing the infection as the comparator antibiotic.


What is the risk associated with Naxcel?

The most common side effects noted during the studies were local swelling and other mild reactions at the injection site (skin discoloration or small cysts). These effects disappeared after a few weeks and did not require any further treatment.

Ceftiofur (like other cephalosporins or penicillins) may cause allergic reaction in humans or in animals, which may occasionally be serious. It should, therefore, not be used in animals that have previously shown an allergy to any cephalosporin or penicillin-type antibiotics.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious. Naxcel should therefore not be handled by anyone who is hypersensitive (allergic) to these antibiotics, or by anyone who has been advised not to work with them.

Naxcel should be handled with care and all of the recommended precautions be taken to avoid exposure to the product. If any symptoms occur after accidental exposure to Naxcel, for example a skin rash, then the advice of a doctor should be sought immediately. Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

In pigs, the withdrawal period in meat and offal is 71 days.

In cattle, the withdrawal period in meat and offal is nine days, and in milk it is zero days.

However, these withdrawal periods in cattle are only valid when Naxcel has been injected in non-edible tissue at the recommended location (the base of the ear).


Why has Naxcel been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Naxcel were greater than any risks when used as recommended. The Committee, therefore, recommended that Naxcel should be given a marketing authorisation.

The benefit risk balance may be found in module 6 of this EPAR.


Other information about Naxcel

The European Commission granted a marketing authorisation valid throughout the European Union for Naxcel to Pfizer Ltd on 19 May 2005. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Naxcel
EMEA Product number: EMEA/V/C/000079
Active substance: ceftiofur
INN or common name: Ceftiofur
Species: PigsCattle
ATCvet Code: QJ01DD90
Marketing Authorisation Holder: Pfizer Limited
Revision: 5
Date of issue of Market Authorisation valid throughout the European Union: 19/05/2005
Contact address:
Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom



Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 100 mg/ml suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance(s):
Ceftiofur (as crystalline free acid)
100 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opaque white to light brown suspension.
4.
CLINICAL PARTICULARS
4.1
Target species
Pigs
4.2
Indications for use, specifying the target species
Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae ,
Pasteurella multocida , Haemophilus parasuis and Streptococcus suis .
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis
infection.
4.3
Contraindications
Do not use in cases of hypersensitivity to ceftiofur or other
β
-lactam antibiotics, or to any of the excipients.
4.4
Special warnings
None.
4.5
Special precautions for use
Special precautions for use in animals
For systemically administered broad spectrum cephalosporins (3 rd and 4 th generation, such as ceftiofur), it
should be reflected that these are to be reserved for the treatment of clinical conditions which have
responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials. Increased
use, including use of the product deviating from the instructions given in the SPC, may increase the
prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be
taken into account when the product is used.
2
Whenever possible, cephalosporins should only be used based on susceptibility testing. When considering
the treatment strategy, it is appropriate to consider improvement of the herd management practice and use
supporting treatment with suitable local products (e.g. disinfectants).
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals
following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross
reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be
serious.
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this
veterinary medicinal product.
Avoid contact with skin or eyes. In the event of contact, wash with clean water.
If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should
seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips or
eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
4.6
Adverse reactions (frequency and seriousness)
Occasionally, transient local swelling may occur following intramuscular injection.
Mild tissue reactions at the injection site, such as small areas (less than 6 cm²) of discolouration and small
cysts have been observed for up to 42 days after injection. Resolution has been observed at 56 days post-
injection. In very rare cases anaphylactic type reactions may occur following administration of the product.
4.7 Use during pregnancy, lactation or lay
Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic
effects. Laboratory studies in rats revealed no teratogenic effects but maternotoxic (soft faeces) and
foetotoxic (reduced fetal weight) effects were observed. No effects on the reproductive performance were
observed in both species. No studies have been conducted in pregnant or lactating sows, or in breeding
pigs. Use only according to the benefit/risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9
Amounts to be administered and administration route
Intramuscular use.
5 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 20 kg body weight) administered once
in the neck by intramuscular injection. Shake bottle vigorously for 30 seconds, or until all visual
settlement has been resuspended.
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
It is recommended to limit injection volumes to a maximum of 4 ml.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other
than transient local swellings as described in section 5.4 (undesirable effects).
4.11 Withdrawalperiod(s)
Meat and offal: 71 days
3
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: third generation cephalosporins.
ATCvet code: QJ01DD90.
5.1 Pharmacodynamic properties
Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and
Gram-negative pathogens. Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal
properties.
Ceftiofur is particularly active against the following target pathogens causing respiratory and other
diseases in pigs: Actinobacillus pleuropneumoniae , Pasteurella multocida , Haemophilus parasuis and
Streptococcus suis . Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro .
Desfuroylceftiofur is the principal active metabolite. It has an antimicrobial activity similar to that of
ceftiofur against the target pathogens.
At the recommended therapeutic dose, concentrations in plasma were higher than the MIC 90 values
(<0.2 µg/ml) for the target bacteria isolated in clinical studies for at least 158 hours.
5.2
Pharmacokinetic particulars
After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite.
Protein binding of ceftiofur and its major metabolite is approximately 70 %. One hour after a single
administration, plasma concentrations are above 1 µg/ml. Maximum concentrations in plasma (4.2 ± 0.9
µg/ml) are reached at approximately 22 hours after administration. Plasma concentrations above 0.2 µg/ml
of ceftiofur and its metabolite are maintained for an appropriate period of time.
Approximately 60 % and 15 % of the dose are excreted in the urine and faeces, respectively, within 10
days after administration.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Oily vehicle (vegetable origin):
Triglycerides, medium chain
Cottonseed oil.
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 opening the container: 28 days.
6.4. Special precautions for storage
Do not store above 25
°
C.
4
6.5 Nature and composition of immediate packaging
Cardboard box with one Type I glass vial of 50 ml or 100 ml with a chlorobutyl-isoprene 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
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
MARKETING AUTHORISATION NUMBER (S)
EU/2/05/053/001
EU/2/05/053/002
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19 May 2005
10.
DATE OF REVISION OF THE TEXT
26 May 2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
5
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 200 mg/ml suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Ceftiofur (as crystalline free acid)
200 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opaque white to light brown suspension.
4.
CLINICAL PARTICULARS
4.1
Target species
Cattle
4.2
Indications for use, specifying the target species
Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
4.3
Contraindications
Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the
excipients.
4.4
Special warnings
None.
4.5
Special precautions for use
Special precautions for use in animals
For systemically administered broad spectrum cephalosporins (3 rd and 4 th generation, such as ceftiofur), it
should be reflected that these are to be reserved for the treatment of clinical conditions which have
responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials. Increased
use, including use of the product deviating from the instructions given in the SPC, may increase the
prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be
taken into account when the product is used.
Whenever possible, cephalosporins should only be used based on susceptibility testing. When considering
the treatment strategy, it is appropriate to consider improvement of the herd management practice and use
supporting treatment with suitable local products (e.g. disinfectants).
6
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals
following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross
reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be
serious.
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this
veterinary medicinal product.
Avoid contact with skin or eyes. In the event of contact, wash with clean water.
If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should
seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips or
eyes or difficulty with breathing are serious reactions and require urgent medical attention.
4.6 Adverse reactions (frequency and seriousness)
Visible swellings have been noted at the injection site in about two thirds of treated animals, two days
after injection in field conditions. These reactions will resolve within a maximum of 23 days. Injection site
swellings may result in mild to moderate pain in some animals in the initial days following injection.
In very rare cases (i.e. in less than 1 out of 10,000 animals), sudden death has been reported following
administration of the product. In such cases, death has been attributed to intra-vascular administration of
the product or anaphylaxis.
4.7 Use during pregnancy, lactation or lay
Pregnancy:
Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic
effects. Laboratory studies in rats have shown no evidence of teratogenic effects but maternotoxic (soft
faeces) and foetotoxic (reduced foetal weight) effects were observed. No effects on the reproductive
performance were observed in both species. No specific studies have been conducted in pregnant cows.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Lactation:
This veterinary medicinal product can be used during lactation.
Fertility:
No specific studies have been conducted in breeding cattle. Use only according to the benefit/risk
assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9
Amounts to be administered and administration route
Single subcutaneous injection of 6.6 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 30
kg body weight) administered at the base of the ear.
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
It is recommended to limit injection volumes to a maximum of 30 ml per injection site.
Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
7
Base of the ear administration:
• Administer in the posterior part of the ear base (see Figure 2).
• Hold the syringe and insert the needle behind the animal’s ear so the needle and syringe point in the
direction of an imaginary line that would pass through the head toward the animal’s opposite eye (see
Figure 1).
• Take appropriate precautions to avoid intra-arterial or intravenous injection.
Figure 1. Subcutaneous administration
of NAXCEL at the posterior aspect of
the ear where it attaches to the head
(base of ear)
Figure 2. Injection location for the
subcutaneous administration of
NAXCEL at the posterior aspect of the
ear where it attaches to the head (base
of ear)
If the clinical signs of necrobacillosis have not improved 48 hours after treatment, the diagnosis and
treatment of the condition should be re-evaluated.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In cattle, although NAXCEL has not been specifically tested for overdoses, no signs of systemic toxicity
related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium
for five days.
4.11 Withdrawalperiod(s)
Meat and offal: 9 days.
Milk: zero days.
It is essential that NAXCEL is only administered subcutaneously at the base of ear location in non-edible
tissue, as described in section 4.9, in order to comply with the meat withdrawal period.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: third generation cephalosporins, ATCvet code: QJ01DD90.
5.1 Pharmacodynamic properties
Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and
Gram-negative pathogens. Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal
properties.
Ceftiofur is active against the following target pathogens causing interdigital necrobacillosis in cattle:
Bacteroides spp., Fusobacterium necrophorum , Porphyromonas spp. and Prevotella spp.
8
 
Desfuroylceftiofur is the principal active metabolite. It has an antimicrobial activity similar to that of
ceftiofur against the target pathogens.
5.2 Pharmacokinetic particulars
Ceftiofur is well absorbed in cattle following base of the ear injection. After administration, ceftiofur is
quickly metabolised to desfuroylceftiofur, the principal active metabolite. Protein binding of ceftiofur and
its major metabolite is approximately 70–90 %. One hour after a single administration, plasma
concentrations are greater than 1 µg/ml. Maximum concentrations in plasma (about 5 µg/ml) occurred
from 12 hours following administration. Plasma concentrations above 0.2 µg/ml of ceftiofur and its
metabolite are maintained for at least 7 days.
At the recommended therapeutic dose, concentrations in plasma were higher than the Minimum Inhibitory
Concentrations (MIC) values (<0.2 µg/ml) for the majority of target bacteria isolated in clinical studies for
at least 7 days.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Oily vehicle (vegetable origin):
Triglycerides, medium chain
Cottonseed oil.
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 opening the vial: 28 days.
6.4. Special precautions for storage
Do not store above 25
°
C.
6.5 Nature and composition of immediate packaging
Cardboard box with one Type I glass vial of 100 ml with a chlorobutyl-isoprene rubber stopper and an
aluminium cap.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products
should be disposed of in accordance with local requirements.
9
7.
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/05/053/003
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08.10.2009
10.
DATE OF REVISION OF THE TEXT
26 May 2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA) http://www.ema.europa.eu/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
10
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
11
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Pfizer N.V/S.A
Rijksweg 12
B-2870 Puurs
Belgium
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable.
D. STATEMENT OF THE MRLs
The following constituents of Naxcel are included in Table 1 of the annex to Commission Regulation (EU)
No 37/2010 as follows:
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRLs
Target
tissues
Other
provisions
Therapeutic
classification
Ceftiofur
Sum of all
residues
retaining the
betalactam
structure
expressed as
desfuroyl-
ceftiofur
All
mammalia
n food
producing
species
1,000
µg/kg
Muscle
For porcine
species the fat
MRL relates
to ‘skin and
fat in natural
proportions’.
Anti-infectious
agents/Antibiot
ics
2,000
µg/kg
Fat
2,000
µg/kg
Liver
6,000
µg/kg
Kidney
100
µg/kg
Milk
Triglycerides,
medium chain
(myglyol)
NOT
APPLICABL
E
All food
producing
species
No MRL
required
NOT
APPLICA
BLE
NO ENTRY NO ENTRY
In addition to the above constituents the product contains the following excipient: cottonseed oil. This
excipient is considered as not falling within the scope of Regulation (EC) No 470/2009.
12
 
ANNEX III
LABELLING AND PACKAGE INSERT
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 100 mg/ml suspension for injection for pigs
Ceftiofur
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Active substance:
Ceftiofur (as crystalline free acid)
100 mg/ml.
Excipient:
Oily vehicle (vegetable origin).
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
100 ml
50 ml
5.
TARGET SPECIES
Pigs
6.
INDICATION(S)
Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella
multocida , Haemophilus parasuis and Streptococcus suis .
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
5 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 20 kg body weight) administered once
in the neck by intramuscular injection. Shake bottle vigorously for 30 seconds, or until all visual
settlement has been resuspended.
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
It is recommended to limit injection volumes to a maximum of 4 ml.
14
 
8
WITHDRAWAL PERIOD
Meat and offal: 71 days.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package insert before use.
10.
EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days.
11.
SPECIAL STORAGE CONDITIONS
Do not store above 25
°
C.
12 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/05/053/001 (100 ml)
EU/2/05/053/002 (50 ml)
15
 
17.
MANUFACTURER’S BATCH NUMBER
Lot {number}
16
 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
VIAL – 100 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 100 mg/ml suspension for injection for pigs
Ceftiofur
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Ceftiofur (as crystalline free acid)
100 mg/ml,
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
100 ml
5.
TARGET SPECIES
Pigs
6.
INDICATION(S)
Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella
multocida , Haemophilus parasuis and Streptococcus suis .
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
5 mg ceftiofur/kg body weight (1 ml / 20 kg body weight).
Shake bottle vigorously.
It is recommended to limit injection volumes to a maximum of 4 ml.
8.
WITHDRAWAL PERIOD
Meat and offal: 71 days.
17
Oily vehicle (vegetable origin).
 
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10.
EXPIRY DATE
EXP {month/year}
Once broached, use by …..< leave space for the date to be inserted>
11.
SPECIAL STORAGE CONDITIONS
Do not store above 25
°
C.
12 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/05/053/001
17.
MANUFACTURER’S BATCH NUMBER
Lot {number}
18
 
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE
VIAL – 50 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 100 mg/ml suspension for injection for pigs
Ceftiofur
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Ceftiofur 100 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
50 ml
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular use.
5 mg ceftiofur/kg (1 ml / 20 kg).
Shake bottle vigorously.
It is recommended to limit injection volumes to a maximum of 4 ml.
Read the package leaflet before use.
5
WITHDRAWAL PERIOD
Meat and offal: 71 days.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use by …..<leave space for the date to be inserted>
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
19
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard box
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 200 mg/ml suspension for injection for cattle
Ceftiofur
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Active substance:
Ceftiofur (as crystalline free acid)
200 mg/ml.
Excipient:
Oily vehicle (vegetable origin).
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
100 ml
5.
TARGET SPECIES
Cattle
6.
INDICATION(S)
Treatment of acute interdigital necrobacillosis ( Panaritium , foot rot) in cattle.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Single subcutaneous injection of 6.6 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 30
kg body weight) administered at the base of the ear.
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
It is recommended to limit injection volumes to a maximum of 30 ml per injection site.
Take appropriate precautions to avoid intra-arterial or intravenous injection.
Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
20
 
8.
WITHDRAWAL PERIOD
Meat and offal: 9 days.
Milk: zero days.
It is essential that NAXCEL is only administered subcutaneously at the base of ear location in non-edible
tissue, as described in section 9 of the package leaflet, in order to comply with the meat withdrawal period.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use .
10. EXPIRY DATE
EXP {month/year}
Once broached, use by…..
11. SPECIAL STORAGE CONDITIONS
Do not store above 25
°
C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
21
 
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/05/053/003
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
22
 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Vial of 100 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 200 mg/ml suspension for injection for cattle
Ceftiofur
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Ceftiofur (as crystalline free acid)
200 mg/ml,
Oily vehicle (vegetable origin).
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
100 ml
5.
TARGET SPECIES
Cattle
6.
METHOD AND ROUTE(S) OF ADMINISTRATION
Single subcutaneous injection of 6.6 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 30
kg body weight) administered at the base of the ear.
Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
7.
WITHDRAWAL PERIOD
Meat and offal: 9 days.
Milk: zero days.
Read the package leaflet before use.
8.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
23
 
9.
EXPIRY DATE
EXP
Once broached, use by…
10. SPECIAL STORAGE CONDITIONS
Do not store above 25
°
C.
11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Disposal: read package leaflet.
12. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
13. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
14. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
15. MARKETING AUTHORISATION NUMBER(S)
EU/2/05/053/003
16. MANUFACTURER’S BATCH NUMBER
Lot {number}
24
 
B. PACKAGE LEAFLET
25
PACKAGE INSERT
NAXCEL 100 mg/ml suspension for injection for pigs
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Pfizer NV/SA
Rijksweg 12
B-2870 Puurs
Belgium
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 100 mg/ml suspension for injection for pigs
Ceftiofur
3.
STATEMENT OF THE ACTIVE AND OTHER INGREDIENT (S) (S)
1 ml contains:
Active substance:
Ceftiofur (as crystalline free acid)
100 mg,
Excipients:
Oily vehicle (vegetable oil).
4.
INDICATION(S)
Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella
multocida , Haemophilus parasuis and Streptococcus suis .
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ceftiofur or other ß-lactam antibiotics, or to any of the excipients.
26
6.
ADVERSE REACTIONS
Occasionally, transient local swelling may occur following intramuscular injection.
Mild tissue reactions at the injection site, such as small areas (less than 6 cm²) of discolouration and small
cysts have been observed for up to 42 days after injection. Resolution has been observed at 56 days post-
injection.
In very rare cases anaphylactic type reactions may occur following administration of the product.
If you notice any other side effects, please inform your veterinary surgeon.
7.
TARGET SPECIES
Pigs
8.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
5 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 20 kg body weight) administered once
in the neck by intramuscular injection.
9.
ADVICE ON CORRECT ADMINISTRATION
Shake bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
It is recommended to limit injection volumes to a maximum of 4 ml.
Use of the product should be based on susceptibility testing and take into account official and local
antimicrobial policies.
10.
WITHDRAWAL PERIOD
Meat and offal: 71 days.
11.
SPECIAL STORAGE PRECAUTIONS
C.
Shelf-life after first opening the container: 28 days.
Do not use after the expiry date stated on the label after EXP.
°
12.
SPECIAL WARNING(S)
Special precautions for the animal:
Whenever possible, cephalosporins should only be used based on susceptibility testing.
For systemically administered broad spectrum cephalosporins (3 rd and 4 th generation, such as ceftiofur), it
should be reflected that these are to be reserved for the treatment of clinical conditions which have
responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials. Increased
use, including use of the product deviating from the instructions given above, may increase the prevalence
27
Keep out of the reach and sight of children.
Do not store above 25
of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into
account when the product is used.
When considering the treatment strategy, it is appropriate to consider improvement of the herd
management practice and use supporting treatment with suitable local products (e.g. disinfectants).
No specific studies have been conducted in pregnant cows or in breeding cattle. Use only according to the
benefit/risk assessment by the responsible veterinarian.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
Special precautions for people:
Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals
following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross
reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be
serious.
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this
veterinary medicinal product.
Avoid contact with skin or eyes. In the event of contact, wash with clean water. If you develop symptoms
following exposure such as a skin rash or persistent eye irritation, you should seek medical advice.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require
urgent medical attention.
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 APPROVED
26 May 2010
15.
OTHER INFORMATION
Naxcel is available in 50 ml or 100 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.
28
België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tel./Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
Република България
Pfizer H.C.P. Corporation
Tel: + 359 2 970 43 21
Magyarország
Pfizer KFT
Tel: +361 488 3695
Česká Republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
Danmark
Orion Pharma
Animal Health
Tlf: +45 49 12 67 65
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH,
Tel: +49 30 5500 5501
Norge
Orion Pharma
Animal Health
Tlf: +47 40 00 41 90
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria G.m.b.H,
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 2 10 67 85 800
Polska
Pfizer Trading Polska sp. z.o.o.
Tel: +48 22 335 62 00
España
Pfizer S. A.,
Portugal
Laboratórios Pfizer, Lda.
Telefone: +351 21 423 55 00
Teléfono: +34 91 4909900
France
Pfizer
Téléphone: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Telephone: +353 (0) 1 467 6500
Slovenija
Pfizer Luxemburg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Icepharma Ltd
Tel: +354 540 80 00
Slovenská Republika
Pfizer Luxembourg SARL o.z.
Pfizer AH
Tel: +421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Telefono: +39 06 3318 2933
Suomi/Finland
Pfizer Oy Animal Health,
Telephone: +358 (0)9 4300 40
29
Kύπροσ
Pfizer Hellas A.E.
Τηλ.: +30 2 10 67 85 800
Sverige
Orion Pharma Animal Health
Tel: +46 8 623 64 40
Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Telephone: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel.: +370 5 269 17 96
30
PACKAGE LEAFLET
NAXCEL 200 mg/ml suspension for injection for cattle
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder :
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Pfizer N.V/S.A
Rijksweg 12
B-2870 Puurs
Belgium
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAXCEL 200 mg/ml suspension for injection for cattle
Ceftiofur
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
Active substance:
Ceftiofur (as crystalline free acid)
200 mg,
Excipient(s):
Oily vehicle (vegetable origin).
4.
INDICATION(S)
Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the
excipients.
31
6.
ADVERSE REACTIONS
Visible swellings have been noted at the injection site in about two thirds of treated animals, two days
after injection in field conditions. These reactions will resolve within a maximum of 23 days. Injection site
swellings may result in mild to moderate pain in some animals in the initial days following injection.
In very rare cases (i.e. in less than 1 out of 10,000 animals), sudden death has been reported following
administration of the product. In such cases, death has been attributed to intra-vascular administration of
the product or anaphylaxis.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Cattle.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Single subcutaneous injection of 6.6 mg ceftiofur/kg body weight (equivalent to 1 ml of NAXCEL per 30
kg body weight) administered at the base of the ear.
9.
ADVICE ON CORRECT ADMINISTRATION
To ensure a correct dosage, body weight should be accurately determined to avoid under-dosing.
It is recommended to limit injection volumes to a maximum of 30 ml per injection site.
Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.
Base of the ear administration:
• Administer in the posterior part of the ear base (see Figure 2).
• Hold the syringe and insert the needle behind the animal’s ear so the needle and syringe point in the
direction of an imaginary line that would pass through the head toward the animal’s opposite eye (see
Figure 1).
• Take appropriate precautions to avoid intra-arterial or intravenous injection.
Figure 1. Subcutaneous administration
of NAXCEL at the posterior aspect of
the ear where it attaches to the head
(base of ear)
Figure 2. Injection location for the
subcutaneous administration of
NAXCEL at the posterior aspect of the
ear where it attaches to the head (base
of ear)
32
 
If the clinical signs of necrobacillosis have not improved 48 hours after treatment, the diagnosis and
treatment of the condition should be re-evaluated.
10. WITHDRAWAL PERIOD
Meat and offal: 9 days.
Milk: zero days.
It is essential that NAXCEL is only administered subcutaneously at the base of ear location in non-edible
tissue, as described in section 9, in order to comply with the meat withdrawal period.
11. SPECIAL STORAGE PRECAUTIONS
C.
Do not use after the expiry date stated on the label after EXP.
Shelf-life after first opening the container: 28 days.
12. SPECIAL WARNING(S)
Special precautions for the animal:
Whenever possible, cephalosporins should only be used based on susceptibility testing.
For systemically administered broad spectrum cephalosporins (3 rd and 4 th generation, such as ceftiofur), it
should be reflected that these are to be reserved for the treatment of clinical conditions which have
responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials. Increased
use, including use of the product deviating from the instructions given above, may increase the prevalence
of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into
account when the product is used.
When considering the treatment strategy, it is appropriate to consider improvement of the herd
management practice and use supporting treatment with suitable local products (e.g. disinfectants).
No specific studies have been conducted in pregnant cows or in breeding cattle. Use only according to the
benefit/risk assessment by the responsible veterinarian.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
Special precautions for people:
Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals
following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross
reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be
serious.
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this
veterinary medicinal product.
Avoid contact with skin or eyes. In the event of contact, wash with clean water. If you develop symptoms
following exposure such as a skin rash or persistent eye irritation, you should seek medical advice.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require
urgent medical attention.
33
Keep out of the reach and sight of children.
Do not store above 25
°
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 APPROVED
26 May 2010
Detailed information on this product is available on the website of the European Medicines Agency (EMA)
http://www.ema.europa.eu/.
15. OTHER INFORMATION
For any information about this veterinary medicinal product, please contact the local representative of the
marketing authorisation holder.
België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tel./Tél.: +32 (0)2 554 62 11
Luxembourg/Luxemburg
Pfizer Animal Health s.a.,
Tél/Tel: + 32 (0)2 554 62 11
Република България
Pfizer H.C.P. Corporation
Tel: + 359 2 970 43 21
Magyarország
Pfizer Kft.
Tel: +361 488 3695
Česká republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
Danmark
Orion Pharma
Animal Health
Tlf: +45 49 12 67 65
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH
Tel: + 49 30-5500 5501
Norge
Orion Pharma Animal Health
Tlf: +47 40 00 41 90
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria G.m.b.H,
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o.
Tel: +48 22 335 62 00
España
Pfizer S.A.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 55 00
34
France
Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Tel: + 353 (0) 1 467 6500
Slovenija
Pfizer Luxemburg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Icepharma hf,
Tel: +354 540 80 00
Slovenská republika
Pfizer Luxembourg SARL o.z.
Pfizer AH
Tel: + 421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Suomi/Finland
Pfizer Oy Animal Health,
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Orion Pharma Animal Health
Tel: +46 (0)8 623 64 40
Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel.: +370 5 269 17 96
35


Source: European Medicines Agency



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