NOAH Compendium

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Date: Monday, September 20, 2021 20:02

Release 5.168
Metacam 0.5 mg/ml oral suspension for cats and guinea pigs
 
Species: Cats, Small mammals
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics, Other NSAIDs, Locomotor (including navicular and osteoarthritis)
Active ingredient: Meloxicam
Product:Metacam® 0.5 mg/ml oral suspension for cats and guinea pigs
Product index: Metacam 0.5 mg/ml oral suspension for cats and guinea pigs
Presentation
Yellowish viscous oral suspension with a green tinge. One ml contains 0.5 mg meloxicam as active ingredient (equivalent to 0.017 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).
Uses
Cats
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery. For alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.
Guinea pigs:
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.
Dosage and administration
Cats:
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.
Acute musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.
Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.
Route and method of administration
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.
Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.
To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight. Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the package can be used.
Particular care should be taken with regard to the accuracy of dosing.
The recommended dose should not be exceeded.
Guinea pigs:
Dosage
Post-operative pain associated with soft tissue surgery:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery). Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg meloxicam/kg body weight on day 2 to day 3 (post-surgery).
The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.
Route and method of administration
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.
Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight
Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next use.
Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.
Advice on correct administration
Shake well before use.
Avoid introduction of contamination during use.
Contra-indications, warnings, etc
Contraindications
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
Do not use in guinea pigs less than 4 weeks of age.
Special precautions for use
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Post-operative use in cats and guinea pigs:
In case additional pain relief is required, multimodal pain therapy should be considered.
Chronic musculoskeletal disorders in cats:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Adverse reactions (frequency and seriousness)
In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases from post-marketing safety experience.
These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Overdose (symptoms, emergency procedures, antidotes), if necessary
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.
In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3).
Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided.
In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Pharmaceutical precautions
Shelf life of the veterinary medicinal product as packaged for sale:
3 ml bottle: 2 years
10 ml, 15 ml and 30 ml bottle: 3 years.
Shelf life after first opening the immediate packaging:
3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottle: 6 months.
This veterinary medicinal product does not require any special storage conditions.
Keep out of the sight and reach of children. For animal treatment only.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant closure.
Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-resistant closure.
Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.
Further information
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).
Pharmacokinetic properties
Cats:
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).
Guinea pigs:
No data available.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
EU/2/97/004/034 – 3 ml
EU/2/97/004/033 – 10 ml
EU/2/97/004/026 – 15 ml
EU/2/97/004/049 – 30 ml
Significant changes
GTIN
GTIN description:Metacam 0.5 mg/ml Oral Suspension for Cats - 3ml
GTIN:5012917010152
GTIN description:Metacam 0.5 mg/ml Oral Suspension for Cats - 15ml
GTIN:5012917010176
GTIN description:Metacam 0.5 mg/ml Oral Suspension for Cats - 30ml
GTIN:5012917010367