NEOFLUNIXIN

Description

NEOFLUNIXIN (CURRENTLY IN REGISTRATION PROCESS)

 

COMPOSITION:
Active substance
Flunixin 50 miligrams

Excipients:
Phenol
Sodium formaldehyde sulfoxylate
Propylene glycol
Disodium edetate
Trisodium phosphate dodecahydrate
Sodium hydroxide
Water for injection

 

INDICATION

In Cattle:
For the control of acute inflammation associated with respiratory disease.
NEOFLUNIXIN has also been shown to have some benefit in the treatment of experimental acute bovine pulmonary emphysema (Fog Fever).
NEOFLUNIXIN may be used as adjunctive therapy in the treatment of acute mastitis.

In Horses:
For the alleviation of inflammation and pain associated with musculo-skeletal disorders.
For the alleviation of visceral pain associated with colic in the horse.

In Pigs:
For use as an adjunctive therapy in the treatment of swine respiratory diseases.

CONTRAINDICATION
Do not exceed the stated dose or the duration of treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is hypersensitivity to the product.
Do not use the product within 48 hours before expected parturition in cows.
Do not administer to pregnant mares.
Do not administer to pregnant sows, gilts at mating and in breeding boars.

TARGET SPECIES
Cattle, horses and pigs

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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.

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 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: 0.25mg/kg every 6-8 hours, by intravenous injection.

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.

In order to prevent excessive broaching of the rubber stopper, it is not recommended that the stopper is broached more than 25 times.

ADVICE ON CORRECT ADMINISTRATION
In order to prevent excessive broaching of the rubber stopper, it is not recommended that the stopper is broached more than 25 times.

WITHDRAWAL PERIOD
Animals must not be slaughtered for human consumption during treatment.
Cattle: 5 days from the last treatment.
Horses: 7 days from the last treatment.
Pigs: 22 days from the last treatment.
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 24 hours from the last treatment.

SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not freeze.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first broaching the immediate packaging: 28 days.

SPECIAL WARNING(S)

Special precautions for use in animals
Non-steroidal, anti-inflammatory drugs are not permitted under the rules of Racing and under rules covering other competitive events. These drugs should be discontinued at least 8 days before the competition.
Avoid intra-arterial injection.
NSAIDS are known to have the potential to delay parturition through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition. The use of the product in the immediate post-partum period may interfere with uterine involution and expulsion of foetal membranes resulting in retained placentae. See also section “Use during pregnancy and lactation”.
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.
The product should not be used in piglets weighing less than 6 kg.

Use during pregnancy/ lactation
The product may be used in pregnant and lactating cattle.
The product should only be administered within the first 36 hours post-partum following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placentae.
Do not use in pregnant mares or pregnant sows.
Safety studies in pregnant mares and pregnant sows have not been conducted.

Interaction with other medicinal products and other forms of interaction
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.
Concurrent administration of potentially nephrotoxic drugs should be avoided.

Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage studies in the target species have shown the product to be well-tolerated. Flunixin meglumine is a non-steroidal anti-inflammatory drug. Overdosage is associated with gastrointestinal toxicity. Concurrent use of nephrotoxic drugs should be avoided.

Incompatibilites
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.
Concurrent administration of potential nephrotoxic drugs should be avoided.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Nature and composition of packaging: Type II glass vial with a fluoropolymer coated chlorobutyl stopper and an aluminium overseal.

Conditions or restrictions regarding supply and use: On veterinary prescription only.

ATC-vet code: QM01AG90