ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
EQUIOXX 8.2 mg/g oral paste for horses.
2.
Each syringe contains 7.32 g of paste and delivers:
Firocoxib 8.2 mg/g
For a full list of excipients, see section 6.1.
3.
Oral paste.
White to off-white paste.
4.
Horses.
4.2 Indications for use specifying the target species
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other NSAIDs.
None.
Do not use in animals less than 10 weeks. If side effects occur, treatment should be discontinued and
the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or
hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent
administration of potentially nephrotoxic drugs should be avoided.
The recommended treatment dose and duration should not be exceeded.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
2
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water.
Wash hands after use of the product.
Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive
should avoid contact with, or wear disposable gloves, when administering the product.
4.6 Adverse reactions (
frequency
and seriousness)
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals. Typically, these lesions are mild and resolve without treatment, but oral
lesions may be associated with salivation and labial and tongue oedema.
No data is available in horses. However, studies with laboratory animals have shown embryo-
foetotoxicity, malformations, delayed parturition and decreased pup survival. Therefore, do not use in
breeding, pregnant or lactating animals.
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to
toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects and a treatment-free period with such products should therefore be observed. The treatment-
free period should take into account the pharmacological properties of the products used previously.
Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be
subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be
avoided as there might be an increased risk of renal toxicity.
Oral use.
Administer 0.1 mg firocoxib per kg bodyweight, once daily. Duration of treatment will be dependent
on the response observed, but should not exceed 14 days
.
To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate
dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient
firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to
600 kg. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid
overdosing.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by
rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’s
weight. Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the
syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the
tongue.
3
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals when administered the recommended treatment dose. Typically, these
lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and
labial and tongue oedema. The incidence of oral/skin lesions increases with increasing dose.
At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and
2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate
renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic
treatment initiated.
4.11 Withdrawalperiod
Meat and offal: 26 days
Do not use in mares producing milk for human consumption.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, ATC vet
code: QM01AH90.
5.1 Pharmacodynamic properties
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which
acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Cyclooxygenase is responsible for generation of prostaglandins. COX-2 is the isoform of the enzyme
that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be
primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Coxibs therefore display analgesic, anti-inflammatory, and antipyretic properties. COX-2 is also
thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central
nervous system functions (fever induction, pain perception, and cognitive function). “In “
in vitro
”
equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1. The
concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to
0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
5.2 Pharmacokinetic particulars
Following oral administration in horses at the recommended dose of 0.1 mg per kg of bodyweight,
firocoxib is rapidly absorbed, and the time to maximal concentration (T
max
) is 3.9 (± 4.4) hours. The
peak concentration (C
max
) is 0.075 (± 0.033) µg/ml (equivalent to approximately 0.223 µM), area
under the curve (AUC
0-24
) is 0.96 (± 0.26) µg x hr/ml, and oral bioavailability is 79 (± 31) percent.
The elimination half-life (t
½
) after a single dose is 29.6 (± 7.5) hours and 50.6 hours after 14 days of
dosing. Firocoxib is approximately 97% bound to plasma proteins. Following multiple oral
administrations, the steady state is reached by approximately the eighth daily dose. Firocoxib is
metabolised predominantly by dealkylation and glucuronidation in the liver. Elimination is principally
in the excreta (primarily the urine), with some biliary excretion also observed.
6.
6.1 List of excipients
Titanium dioxide (E 171)
Glycerol triacetate
4
Silica, colloidal anhydrous
Magnesium carbonate, heavy
Macrogol 300
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the syringe: 3 months
6.4 Special precautions for storage
Replace cap after use.
This medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Pre-filled oral syringes made of polypropylene, with a polyethylene cap, a rubber rod tip, and a
polypropylene plunger rod.
Each syringe contains a net weight of 7.32 g of oral paste and is labelled in 100 kg dosing increments.
The oral paste is available in the following pack sizes:
-
1 carton box containing 7 syringes
-
1 carton box containing 14 syringes
Not all pack sizes may be marketed
6.6
Special precautions for the disposal of unused veterinary medicinal products 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.
MERIAL
29 avenue Tony Garnier
FR-69007 Lyon
France.
8.
EU/2/08/083/001
EU/2/08/083/004
EU/2/08/083/005
5
-
1 carton box containing 1 syringe
9.
25.06.2008
12/03/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu/
6
1.
EQUIOXX 20 mg/ml solution for injection for horses
2.
One ml of the solution contains:
Active substance:
Firocoxib 20 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection
Clear colourless solution
4.
Horses
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs
(NSAIDs).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
None.
Do not use in animals less than 10 weeks of age. Avoid use in any dehydrated, hypovolaemic or
hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration
of potentially nephrotoxic medicinal product should be avoided. Do not exceed the recommended dose or
duration of treatment.
7
Special precautions to be taken by the person administering the veterinary medicinal product
to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Avoid contact with eyes and skin. If this occurs, rinse affected area immediately with water.
Wash hands after use of the product.
Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive
should avoid contact with, or wear disposable gloves, when administering the product.
Mild reactions at the injection site characterised by swelling and associated with perivascular
inflammation have been reported in clinical studies following administration of the product at the
recommended dose. There is potential for the injection site reaction to be associated with pain.
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals. Typically, these lesions are mild and resolve without treatment, but oral
lesions may be associated with salivation and labial and tongue oedema.
The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated
.
However, studies with laboratory animals have shown embryo-foetotoxicity, malformations, delayed
parturition and decreased pup survival. Therefore, do not use in breeding, pregnant or lactating
animals.
Other NSAIDs, diuretics and substances that have a high degree of protein binding may compete for
binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
reactions and a treatment-free period with such products should therefore be observed. The treatment-
free period should take into account the pharmacological properties of the products used previously.
Concurrent administration of potentially nephrotoxic medicinal products should be avoided as there
might be an increased risk of renal toxicity. Concomitant treatment with molecules displaying action
on renal flow (e.g. diuretics) should be subject to clinical monitoring.
The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1ml of the solution per
225 kg bodyweight) once daily by intravenous injection.
EQUIOXX 8.2 mg/g Oral Paste may be used for continuation of treatment at a dosage of 0.1 mg
firocoxib per kg bodyweight once daily.
The overall duration of treatment with EQUIOXX solution for injection or EQUIOXX oral paste will
be dependent on the response observed, but should not exceed 14 days
.
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals when administered the recommended treatment dose. Typically, these
lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and
labial and tongue oedema. The incidence of oral/skin lesions increases with increasing dose.
8
At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and
2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate
renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic
treatment initiated.
Meat and offal: 26 days
Do not use in mares producing milk for human consumption.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
ATCvet code: QM01AH90
5.1 Pharmacodynamic properties
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which
acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Cyclooxygenase is responsible for generation of prostaglandins. COX-2 is the isoform of the enzyme
that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be
primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Coxibs therefore display analgesic, anti-inflammatory, and antipyretic properties. COX-2 is also
thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central
nervous system functions (fever induction, pain perception, and cognitive function). In “
in vitro
”
equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1. The
concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to
0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
5.2 Pharmacokinetic particulars
The peak plasma levels observed one minute following firocoxib intravenous administration was
approximately 3.7 fold greater than the observed peak plasma concentrations reached after
administration of the oral paste (oral T
max
= 2.02 hours). The terminal elimination half-life (T ½ el)
values were not significantly different (p>0.05), with mean values of 31.5 hours and 33.0 hours for the
oral paste and the intravenous solution, respectively. Firocoxib is approximately 97% bound to
plasma proteins. Drug accumulation occurs with repeated dose administrations and steady state
concentrations are achieved after 6-8 days of treatment in the horse. Firocoxib is metabolised
predominantly by dealkylation and glucuronidation in the liver. Elimination is principally in the
excreta (primarily the urine), with some biliary excretion also observed.
6.
6.1 List of excipients
Glycerol formal
Disodium edetate
n-Propyl gallate
Thiodipropionic acid
Macrogol 400
9
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: 3 years.
Shelf life after first opening the immediate packaging: 1 month.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Multi-dose amber-coloured glass injection vials closed with rubber stopper and sealed with an
aluminium crimped top.
The injection vials are available in the following pack sizes:
-
carton containing one vial of 25 ml.
-
carton containing 6 vials of 25 ml
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.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France
8.
EU/2/08/083/002-003
9.
25.06.2008
{MM/YYYY}
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
10
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11
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
12
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Merial Toulouse
4 Chemin du Calquet
31057 Toulouse
France
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
In accordance with Council Regulation (EEC) No 2377/90, as amended and in accordance with Article
34.4b of Regulation (EC) No 726/2004 of 31 March 2004 Firocoxib is included in Annex I of Council
Regulation (EEC) No 2377/90 in accordance with the following table:
Pharmacologically
active substance(s)
Marker
residue
Animal
species
MRLs
Target
tissues
Other provisions
Firocoxib
Firocoxib
Equidae
10 μg/kg
15 μg/kg
60 μg/kg
10 μg/kg
Muscle
Fat
Liver
Kidney
13
ANNEX III
LABELLING AND PACKAGE LEAFLET
14
LABELLING
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box labelling
1.
EQUIOXX 8.2 mg/g oral paste for horses.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Firocoxib 8.2 mg/g
3.
Oral paste.
4.
PACKAGE SIZE
1 syringe.
7 syringes.
14 syringes.
5.
Horses.
6.
INDICATION(S)
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
Non-steroidal anti-inflammatory of the coxib class
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
8.
Withdrawal period: Meat and offal: 26 days.
Do not use in mares producing milk for human consumption.
9.
SPECIAL WARNING(S), IF NECESSARY
16
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 3 months.
11. SPECIAL STORAGE CONDITIONS
This medicinal product does not require any special storage conditions. Replace cap after use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
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.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France.
EU/2/08/083/001
EU/2/08/083/004
EU/2/08/083/005
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Syringe labelling
1.
EQUIOXX 8.2 mg/g oral paste for horses
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Firocoxib 8.2 mg/g
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
7.32 g of oral paste
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
5.
Withdrawal period: Meat and offal: 26 days.
Do not use in mares producing milk for human consumption.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use within 3 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
18
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton Box labelling
1.
EQUIOXX 20 mg/ml solution for injection for horses
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Firocoxib 20 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
25 ml
6 x 25 ml
5.
Horses
6.
Alleviation of pain and inflammation associated with osteoarthritis, reduction of associated lameness
Non-steroidal anti-inflammatory of the coxib class.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intravenous use
Read the package leaflet before use.
8.
Withdrawal period: Meat and offal: 26 days
Do not use in mares producing milk for human consumption.
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
19
EXP {month/year}
Once broached use by 1 month
11. SPECIAL STORAGE CONDITIONS
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use
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.
MERIAL
29, Avenue Tony Garnier
FR-69007 LYON
France
EU/2/08/083/002
EU/2/08/083/003
17. MANUFACTURER’S BATCH NUMBER
Lot
20
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial labelling – 25 ml
1.
EQUIOXX 20 mg/ml solution for injection for horses
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Firocoxib 20 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
25 ml
4.
ROUTE(S) OF ADMINISTRATION
Intravenous use
5.
Withdrawal period : Meat and offal: 26 days
Do not use in mares producing milk for human consumption.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP
Once broached use by 1 month
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
21
PACKAGE LEAFLET
22
PACKAGE LEAFLET
EQUIOXX 8.2 mg/g oral paste for horses
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder
:
MERIAL, 29 avenue Tony Garnier, 69007 Lyon, France.
Manufacturer for the batch release
:
MERIAL, 4 chemin du Calquet, FR-31300 Toulouse, France.
2.
EQUIOXX 8.2 mg/g oral paste for horses.
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Firocoxib 8.2 mg/g
4.
INDICATIONS
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
5.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other NSAIDs.
6.
ADVERSE REACTIONS
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals. Typically, these lesions are mild and resolve without treatment, but oral
lesions may be associated with salivation and labial and tongue oedema.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Horses.
23
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days.
Oral use.
9.
ADVICE ON CORRECT ADMINISTRATION
To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate
dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient
firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to
600 kg.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by
rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’s
weight. Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert
the syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the
tongue.
10. WITHDRAWAL PERIOD
Withdrawal period: Meat and offal: 26 days.
Do not use in mares producing milk for human consumption.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Replace cap after use.
Do not use after the expiry date stated on the label.
Shelf-life after first opening the syringe: 3 months.
12. SPECIAL WARNINGS
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential
risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be
avoided.
Do not use in animals less than 10 weeks.
The recommended treatment dose and duration should not be exceeded.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water.
Wash hands after use of the product.
Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive
should avoid contact with, or wear disposable gloves, when administering the product.
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to
toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.
24
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects and a treatment-free period with such products should therefore be observed. The treatment-
free period should take into account the pharmacological properties of the products used previously.
Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be
subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be
avoided as there might be an increased risk of renal toxicity.
No data on use during pregnancy is available in horses. Therefore, do not use in breeding, pregnant or
lactating animals.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12/03/2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which
acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
The oral paste is available in the following pack sizes:
-
1 carton box containing 1 syringe
-
1 carton box containing 7 syringes
-
1 carton box containing 14 syringes
Not all pack sizes may be marketed
25
PACKAGE LEAFLET
EQUIOXX 20 mg/ml solution for injection for horses
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder :
MERIAL
29, Avenue Tony Garnier
FR-69007 LYON
France
Manufacturer for the batch release
:
MERIAL
4, Chemin du Calquet
FR-31057 Toulouse Cedex
France
2.
EQUIOXX 20 mg/ml solution for injection for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Firocoxib 20 mg/ml
4.
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
5.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs
(NSAIDs).
Do not use in case of hypersensitivity to the active substance or to any of the excipients
.
6.
ADVERSE REACTIONS
Mild injection site swellings associated with perivascular inflammation and pain.
Occasional lesions of the oral mucosa and of the skin around the mouth associated with salivation and
labial and tongue oedema. These lesions are mild and resolve without treatment.The incidence of
oral/skin lesions increases with increasing dose.
26
At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and
2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate
renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic
treatment initiated.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Horses
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1 ml of the solution per
225 kg bodyweight) once daily by intravenous injection.
EQUIOXX 8.2 mg/g Oral Paste may be used for continuation of treatment at a dosage of 0.1 mg
firocoxib per kg bodyweight once daily.
The overall duration of treatment with EQUIOXX solution for injection or EQUIOXX oral paste will
be dependent on the response observed, but should not exceed 14 days
9.
ADVICE ON CORRECT ADMINISTRATION
Avoid the introduction of contamination during use.
10. WITHDRAWAL PERIOD
Meat and offal: 26 days
Do not use in mares producing milk for human consumption
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions
Do not use after the expiry date stated on the label after EXP
Shelflife after first opening the container : 1 month.
12. SPECIAL WARNING(S)
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of
increased renal toxicity. Concurrent administration of potentially nephrotoxic medicinal drugs should be
avoided.
Do not use in animals less than 10 weeks of age.
Do not exceed the recommended dose or duration of treatment.
Other NSAIDs, diuretics and substances that have a high degree of protein binding may compete for
binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.
27
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
reactions and a treatment-free period with such products should therefore be observed. The treatment-
free period should take into account the pharmacological properties of the products used previously.
Concurrent administration of potentially nephrotoxic drugs should be avoided, as there might be an
increased risk of renal toxicity. Concomitant treatment with molecules displaying action on renal flow
(e.g. diuretics) should be subject to clinical monitoring.
The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated.
Therefore, do not use in breeding, pregnant or lactating animals.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Avoid contact with eyes and skin. If this occurs, rinse affected area immediately with water.
Wash hands after use of the product.
Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive
should avoid contact with, or wear disposable gloves, when administering the product.
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
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
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Mode of action:
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of
cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis. COX-2 is the isoform of the enzyme
that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain,
inflammation, and fever. In
in-vitro
equine whole blood assays, firocoxib exhibited 222 to 643 fold
selectivity for COX-2 over COX-1.
The injection vials are available in the following pack sizes:
-
carton containing one vial of 25 ml.
Not all pack sizes may be marketed.
28
-
carton containing 6 vials of 25 ml
Source: European Medicines Agency
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