ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Flexicam 5 mg/ml solution for injection for dogs and cats
2.
One ml contains
Active substance:
Meloxicam 5 mg
Excipients:
Ethanol, anhydrous 150 mg
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear yellow solution
4.
Dogs and cats.
Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for
repeated oral administration has been established.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
anaesthesia.
2
If side effects occur, treatment should be discontinued.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of
increased renal toxicity.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self-injection may give rise to pain.
People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal
product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood and apathy have occasionally been reported. In dogs, these side effects occur generally within
the first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Flexicam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia
and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such drugs should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg
body weight).
Reduction of post-operative pain (over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
3
Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.
In the case of over dosage symptomatic treatment should be initiated.
4.11 Withdrawalperiods
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption:
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean
plasma concentrations of 0.73 µg/ml in dogs and 1.1 µg/ml in cats were reached approximately
2.5 hours and 1.5 hours post administration, respectively.
Distribution:
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range in dogs. More than 97% of meloxicam is bound to plasma proteins. The volume
of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.
Metabolism:
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol,
an acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination:
Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats. Approximately 75%
of the administered dose is eliminated via faeces and the remainder via urine.
4
6.
6.1 List of excipients
Ethanol anhydrous
Poloxamer 188
Glycofurol
Meglumine
Glycine
Sodium Chloride
Sodium Hydroxide
Water for injection
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: 28 days.
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
Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed
with a flip-off aluminium violet seal.
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.
Dechra Veterinary Products A/S
Mekuvej 9
DK-7171 Uldum
Denmark
8.
EU/2/06/058/004
5
9.
10/04/2006 / 10/03/2011
10/03/2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (European Medicines Agency) http://www.ema.europa.eu/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDERS 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
7
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturers responsible for batch release
Accord Healthcare Limited
Sage House 1
st
Floor, 319 Pinner Road
North Harrow, Middlesex HA1 4HF
United Kingdom
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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 ml glass vial
1.
Flexicam 5 mg/ml solution for injection for dogs and cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 5 mg/ml
Ethanol 150 mg/ml
3.
Solution for injection
4.
PACKAGE SIZE
10 ml
5.
6.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
8.
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
11
10. EXPIRY DATE
EXP: {MM/YYYY}
Shelf-life after first opening the container: 28 days.
Once broached, use by:
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose 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.
Dechra Veterinary Products A/S
Mekuvej 9
DK-7171 Uldum
Denmark
16. MARKETING AUTHORISATION NUMBER
EU/2/06/058/004
17. MANUFACTURER’S BATCH NUMBER
Lot: {number}
12
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
10 ml glass vial
1.
Flexicam 5 mg/ml solution for injection for dogs and cats
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 5 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
4.
ROUTES OF ADMINISTRATION
Dogs: i.v. or s.c.
Cats: s.c.
5.
6.
BATCH NUMBER
Lot: {number}
7.
EXPIRY DATE
EXP: {MM/YYYY}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET
Flexicam 5 mg/ml solution for injection for dogs and cats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Dechra Veterinary Products A/S
Mekuvej 9
DK-7171 Uldum
Denmark
Manufacturer for the batch release
Accord Healthcare Limited
Sage House 1
st
Floor, 319 Pinner Road
North Harrow, Middlesex HA1 4HF
United Kingdom
2.
Flexicam 5 mg/ml solution for injection for dogs and cats
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 ml of solution for injection contains 5 mg of meloxicam.
Other substances: Ethanol anhydrous 150 mg/ml.
4.
INDICATIONS
Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
5.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for
repeated oral administration has been established.
15
6.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood and apathy have occasionally been reported. In dogs, these side effects occur generally within
the first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs and cats.
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Dogs:
single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Cats:
single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Dogs:
Musculo-skeletal disorders: single subcutaneous injection.
Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous
injection before surgery, for example at the time of induction of anaesthesia.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single
subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Avoid introduction of contamination during use.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing.
10. WITHDRAWAL PERIOD
Not applicable.
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 carton and the vial after EXP.
Shelf-life after first opening the container: 28 days.
12. SPECIAL WARNINGS
If side effects occur, treatment should be discontinued. Avoid use in any dehydrated, hypovolaemic or
hypotensive animal, as there is a potential risk of increased renal toxicity.
16
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Flexicam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia
and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such drugs should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
In the case of over dosage symptomatic treatment should be initiated.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
anaesthesia.
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
User warnings
Accidental self-injection may give rise to pain. People with known hypersensitivity to meloxicam
should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show this package insert or
the label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste material 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
10/03/2011
Detailed information on this product is available on the website of the European Medicines Agency
(European Medicines Agency)
http://www.ema.europa.eu
/
.
15. OTHER INFORMATION
Pack sizes:
Single 10 ml injection vial.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
17
Source: European Medicines Agency
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