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MEFLOSYL 5% Solution for Injection for Horses, Cattle and Pigs

Description

Meflosyl 5% is a clear, colourless to faintly yellow solution for injection containing by ml:

Active substance:
Flunixin (meglumene) 50 mg
Excipients:
Phenol (preservative) 5.0 mg

INDICATIONS

In Horse:
Indicated for the alleviation of inflammation and pain associated in musculo-skeletal disorders and for the alleviation of visceral pain associated with colic.
In Cattle:
Indicated for the control of acute inflammation associated with respiratory disease. The product has also been known to have some benefit in the treatment of experimental acute bovine pulmonary emphysema (Fog Fever). It may also be used as an adjunctive therapy in the treatment of acute mastitis.
In Pigs:
For use as an adjunctive therapy in the treatment of swine respiratory diseases. Aid for the treatment of MMA-syndrome.

CONTRAINDICATIONS

Do not exceed the recommended dose or duration of treatment.
Do not administer to pregnant mares.
Do not administer to pregnant sows, gilts at mating and in breeding boars.
Do not use in animals showing hypersensitivity to flunixin meglumine.
Do not use in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding.
Do not administer other NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

ADVERSE REACTIONS

Flunixin meglumine is a non-steroidal anti-inflammatory drug (NSAID). Untoward effects include gastro-intestinal irritation, ulceration and in dehydrated or hypovolaemic animals, potential for renal damage.
Overdosage is associated with gastrointestinal toxicity.
In pigs transient irritation may occur at the injection site, this resolves spontaneously within 14 days.

TARGET SPECIES

Horses, Cattle and Pigs

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

Horses
By intravenous injection for musculo-skeletal disorders at the following rate:
1ml per 45kg bodyweight (1.1mg flunixin/kg) once daily for up to 5 days according to clinical response.
By intravenous injection for equine colic at the following rate:
1ml per 45kg bodyweight (1.1 mg flunixin/kg) repeated once or twice if colic recurs.
For the treatment of endotoxaemia or septic shock-associated with gastric torsion and with other conditions in which the circulation of blood to the gastro-intestinal tract is compromised: 0.25 mg/kg (= 1 ml per 200 kg bodyweight) administered every 6-8 hours by intravenous injection.
Cattle
2ml per 45kg bodyweight (equivalent to 2.2mg flunixin per kg) administered intravenously.
Repeat as necessary at 24 hour intervals for up to 5 consecutive days.
Pigs
2 ml per 45 kg bodyweight (equivalent to 2.2 mg flunixin/kg) once by intramuscular injection, in the neck, in conjunction with appropriate antimicrobial therapy. The injection volume should be limited to a maximum of 5 ml per injection site.
An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.
When intramuscular injection is used, the dose should be divided between two injection sites on either side of the neck

WITHDRAWAL PERIOD

Milk for human consumption must not be taken during treatment.
Withdrawal periods for milk and meet of treated species should be according to label conditions in each country.

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.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25 °C.
Protect from light.
Do not freeze.

SPECIAL WARNINGS

Special precautions for use in animals
Avoid intra-arterial injection.
Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management.
Do not use in hypovolaemic animals except in the case of endotoxaemia or septic shock.
It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.
The cause of colic should be determined and treated with concurrent therapy.
Concurrent use of nephrotoxic drugs should be avoided.
The product should not be used in piglets weighing less than 6 kg.
The product may be used in pregnant and lactating cattle.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid direct contact with skin or eyes.
In case of skin contact, wash exposed area with water.
In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
Avoid accidental self-injection.
The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious.
Wash hands after use.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

OTHER INFORMATION

ATCvet Code QM01AG90
Nature and composition of immediate packaging
Colourless type I glass vials of 50 and 100 ml. The vials are closed with rubber stoppers and sealed with aluminium caps.
National label conditions must be observed by country.

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