Boehringer Ingelheim Metacam® 15 Mg / Ml Suspension For Horses

METACAM® 15 MG / ML SUSPENSION FOR HORSES

Non-steroidal anti-inflammatory drug for horses
Metacam ®, the modern NSAID for the treatment of inflammation and pain, for diseases of the musculoskeletal system in the horse. With the strong anti-inflammatory and the very good tolerance.

For quick and sustainable treatment of inflammation and pain, you have the solution for injection Metacam ® 20 mg / ml solution for injection for initial therapy and the tasty suspension 15 mg / ml Metacam® for further treatment.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active ingredient:

Meloxicam 15 mg

Excipient:

sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM
Oral suspension.
Yellowish viscous suspension with a green tinge.

CLINICAL PARTICULARS

Target species
horses

Areas of application stating the target species
Relief of inflammation and pain in acute and chronic musculoskeletal disorders in horses.

Contraindications
Do not use in pregnant or lactating mares.
Do not use in horses with gastrointestinal disorders such as irritation or hemorrhage. Do not use in case of liver, heart or kidney dysfunction. Other contraindications are blood clotting disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use on horses younger than 6 weeks.

Special warnings for each target species
No.

Special precautions for use
Special precautions for use in animals
Do not use in dehydrated, hypovolemic or hypotensive animals as there is a potential risk of renal toxicity.

Special precautions for user
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In the event of accidental ingestion, a doctor should be consulted immediately and the leaflet or label shown to him.

Side effects (frequency and seriousness)

In individual cases, the side effects typical of NSAIDs (mild urticaria, diarrhea) were observed during the clinical studies. The symptoms were reversible.
In very rare cases, loss of appetite, lethargy, abdominal pain and colitis have been reported.
In very rare cases, anaphylactoid reactions, which can be serious (even fatal), may occur and should be treated symptomatically.

If side effects occur, treatment should be discontinued and veterinarian advice sought.

The frequency of side effects is defined as follows:
- Very common (more than 1 in 10 animals treated have side effects)
- Common (more than 1 but less than 10 in 100 animals treated)
- Uncommon (more than 1 but less than 10 in) 1000 animals treated)
- Rare (more than 1 but less than 10 animals in 10,000 animals treated)
- Very rare (less than 1 in 10,000 animals treated, including individual reports).

Use during pregnancy, lactation or lay
Laboratory studies in cattle have provided no evidence of teratogenic, foetotoxic or maternotoxic effects. However, no data were collected for the horse. Therefore use in this species during pregnancy and lactation is not recommended

Interaction with other medicinal products and other forms of interaction
Do not co-administer with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulants.

Dosage and route of administration
Administration once a day for up to 14 days either mixed with the feed or directly into the mouth at a dose of 0.6 mg / kg body weight.
When administered with the feed, a small amount of feed should be given before the actual feeding.

The suspension should be administered using the dosing syringe provided. The syringe fits on the bottle and has a scale based on kg body weight.

Shake well before use.

After administration of the medication, the bottle must be closed by putting on the lid.
The dosing syringe must be cleaned with warm water and then left to dry.

Contamination during removal must be avoided.

Overdose (symptoms, emergency measures, antidotes) if necessary
In the event of an overdose, symptomatic treatment should be initiated.

Waiting time (s)
Edible tissues: 3 days.

PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Non-steroidal anti-inflammatory and
anti-rheumatic products ( Oxicame ) ATCvet code: QM 01AC06

Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) from the Oxicam group that inhibits prostaglandin synthesis and is therefore anti-inflammatory, analgesic, anti-exudative and anti-pyretic. It reduces leukocyte infiltration into the inflamed tissue. There is also a weak inhibition of collagen-induced platelet aggregation. Meloxicam also has anti-endotoxic properties. It was shown that thromboxane B2 production in calves and pigs was inhibited by intravenous E. coli endotoxin administration by meloxicam.

Pharmacokinetic particulars

Absorption:
If the product is administered according to the dosage instructions, the oral bioavailability is approximately 98%. Maximum plasma concentrations are reached after approximately 2-3 hours. The accumulation factor of 1.08 indicates that meloxicam does not accumulate when administered daily.

Distribution:
Meloxicam is approximately 98% bound to plasma proteins. The volume of distribution is 0.12 l / kg.

Metabolism:
The metabolism in rats, mini-pigs, humans, cattle and pigs is qualitatively similar, but differs quantitatively. The main metabolites found in all species are 5 hydroxy and 5 carboxy metabolites as well as oxalyl metabolites. The metabolism in horses has not been studied. All major metabolites have been shown to be pharmacologically inactive.

Elimination:
Meloxicam is eliminated with an elimination half-life of 7.7 hours.

PHARMACEUTICAL PARTICULARS

List of excipients
Sodium benzoate
sorbitol
glycerin
saccharin sodium
xylitol
sodium dihydrogen phosphate dihydrate
colloidal silicon dioxide
hydroxyethyl cellulose
citric acid
honey aroma
purified water

Significant incompatibilities
Not applicable.

Shelf life
Shelf life of the veterinary medicinal product in the intact container: 3 years.
Shelf life after opening the container: 6 months

Special storage instructions
No special storage conditions are required for this veterinary medicinal product.