Inflacam Granules for Horses

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
MELOXICAM
Available from:
Virbac (Australia) Pty Ltd
Pharmaceutical form:
ORAL GRANULES, PELLETS
Composition:
MELOXICAM UNGROUPED Active 330.0 mg/Sa
Units in package:
100sachets; 20 sachets
Class:
VM - Veterinary Medicine
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Product summary:
Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [MUSCULOSKELETAL CONDITIONS]
Authorization status:
Registered
Authorization number:
87755
Authorization date:
2020-07-01

Product Name:

APVMA Approval No:

Inflacam Granules for Horses

87755/119164

Label Name:

Inflacam Granules for Horses

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

Each sachet contains 330 mg MELOXICAM

Claims:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in

horses.

Net Contents:

20 sachets

100 sachets

Directions for Use:

Restraints:

DO NOT USE in horses that may be used for human consumption.

Contraindications:

Contraindicated for use in pregnant or lactating mares as no data has been established.

Contraindicated for use in horses less than 6 weeks of age.

Contraindicated for use in animals suffering from gastrointestinal disorders, such as

irritation, haemorrhage and gastric ulceration. Contraindicated for use in animals suffering

from impaired hepatic, cardiac or renal function and haemorrhagic disorders or where there

is evidence of individual hypersensitivity to the active substance.

Contraindicated for concurrent administration with glucocorticoids or other NSAIDs, or with

anti-coagulant agents.

Precautions:

Avoid introduction of contamination during use.

Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk

of increased renal toxicity.

If adverse reactions occur, treatment should be discontinued and the advice of a

veterinarian should be sought.

RLP

APPROVED

Side Effects:

Reversible side effects consistent with the use of non-steroidal anti-inflammatory drugs

(NSAIDs) may be observed, e.g. slight urticaria and diarrhoea. In very rare cases loss of

appetite, lethargy, abdominal pain and colitis may occur. In very rare cases anaphylactoid

reactions which may be serious (including fatal) may occur and should be treated

symptomatically. If adverse reactions occur, treatment should be discontinued and the

advice of a veterinarian should be sought.

Overdose:

In the case of overdosing a symptomatic treatment should be initiated.

Dosage and

Administration:

For use in horses weighing between 500 and 600 kg.

Use immediately after adding to muesli feed.

In-feed use:

To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to

14 days. The product should be added to 250 g feed, prior to feeding.

Each sachet contains one dose for a horse weighing between 500 and 600 kg and the dose

must not be divided into smaller doses.

General Directions:

Withholding Periods:

DO NOT USE in horses that may be used for human consumption.

Trade Advice:

Safety Directions:

First Aid Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia

131126.

First Aid Warnings:

Additional User

Safety:

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)

should avoid contact with the product.

In case of accidental ingestion, seek medical advice immediately and show the label to the

physician.

Environmental

Statements:

Disposal:

Dispose of empty container by wrapping in paper and putting in garbage.

Storage:

Store below 25oC (air conditioning).

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