Reg. No. 83/2.6/63  Act 36/1947

Contains:
Each ml contains flunixin meglumine equivalent to 50 mg flunixin.
Preservative:   phenol 0,5 % m/v.
Anti-oxidants: edetate disodium  0,01%
sodium formaldehyde sulphoxylate  0,25% m/v 

Pharmacological classification:
C.2.6. Non-narcotic analgesics, antipyretics.

Pharmacological action:
Flunixin, similar to other non-steroidal anti-inflammatory drugs (NSAIDs) has analgesic, antipyretic and peripheral anti-inflammatory activity. NSAIDs act mainly by inhibiting cyclo-oxygenase resulting in reduced synthesis of prostaglandins and related compounds.  Flunixin is rapidly and relatively completely absorbed from the gastro-intestinal tract of the horse.  Rapid absorption following parenteral administration to cattle has also been shown.

Indications:

Treatment:

• Acute inflammation, including musculoskeletal inflammatory conditions.

• Pain – Flunixin is particularly useful in alleviating pain associated with colic in horses.

• Fever. Flunixin is useful for the control of fever in the treatment of respiratory disease in pigs.

• Sepsis and endotoxaemia.

• Acute coliform mastitis.

Prophylaxis:

• Acute bovine pulmonary emphysema and oedema (ABPE).

• Acute inflammation – Flunixin is used prior to ophthalmic surgery to prevent inflammatory response.

Contraindications:
NSAIDs should not be used when the following exists:

• Blood dyscrasia.

• Gastro-intestinal ulceration and/or haemorrhage.

Intra-arterial injection should be avoided.

Warnings:
An animal with cardiac, hepatic or renal impairment should be carefully monitored.  Rehydrate animals before administering NSAIDs as renal papillary necrosis may occur in the dehydrated state.

Cattle: In cattle intended for human consumption, a five day withdrawal period is required. Milk from lactating cattle should not be used for human consumption within 36 hours after administration of FINADYNE Injection. A withdrawal period has not been established for FINADYNE in pre-ruminating calves.
Do not use in calves to be processed for veal.
Non-steroidal anti-inflammatory drugs are known to delay parturition by inhibiting Prostaglandin F_2a synthesis and should therefore not be used in healthy pregnant cows.

Horses: The effect in pregnant horses is unknown.

Swine: In swine intended for human consumption, a twenty-eight (28) day withdrawal period is required.

Dosage and directions for use:

Do not exceed the recommended dosage.

Horses: The recommended dose for musculoskeletal disorders is 1 ml per 45 kg (1,1 mg/kg) of live weight, once daily.  Treatment may be given by intravenous or intramuscular injection and repeated for up to five days.  Studies show onset of activity is within two hours.  Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.  Administration of flunixin should not exceed five consecutive days.

The recommended dose for the alleviation of pain associated with equine colic is 1 ml per 45 kg (1,1 mg/kg) of live weight.  Intravenous administration is recommended for prompt relief.  Clinical studies show pain is alleviated in less than 15 minutes in many cases.  During clinical studies, approximately 10 % of the horses required one to two additional treatments.  The cause of colic should be determined and treated with concomitant therapy.

Do not treat foals younger than 72 hours.

Cattle:  For use in bovine acute inflammatory conditions associated with respiratory disease, the recommended dosage is 2 ml Finadyne Injection per 45 kg live weight (equivalent to 2,2 mg flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for no more than five consecutive days.  The cause of the acute inflammatory conditions should be determined and treated with concomitant therapy.

Avoid rapid intravenous administration.

Swine:  2,2 mg/kg bodyweight administered as a single intramuscular injection

once daily for 3 consecutive days in conjunction with antimicrobial treatment.

Dogs:  Intramuscular or intravenous: 0,5 to 1 mg/kg body weight as a single dose or daily for not more than 3 days.

Side effects and special precautions:

• Prolonged use or higher than recommended dose rates may cause gastro-intestinal ulceration and may lead to a life-threatening plasma protein-losing enteropathy.

• Lesions may occur after parenteral dosing.

• Nephrotoxicity in the form of papillary necrosis.

• Bone marrow suppression resulting in blood dyscrasia.

• Impaired hepatic function.

• Cats and young animals (less than 30 days of age) are more susceptible to toxicity due to a deficiency in the enzyme glucuronyl transferase, an important conjugation mechanism.

• Avoid intra-arterial administration of flunixin (may cause excitement and death).

• Isolated reports of local reactions following intramuscular injection in the horse, particularly in the neck have been reported. These include swelling, sweating, induration and stiffness.

In rare instances in horses, fatal or non-fatal clostridial infections or other infections have been reported in association with intramuscular use of FINADYNE Injection.

In horses and cattle, rare instances of anaphylatic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use.

Do not use in bulls intended for breeding, as reproductive effects of FINADYNE Injection in this class of cattle have not been investigated.

Swine:   Do not use in swine intended for breeding. 

Do not mix FINADYNE Injection with other medication prior to administration. 

Drug interactions
Concurrent use with other non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids may increase the risk of severe gastro-intestinal side-effects, including ulceration or haemorrhage, provide no additional improvement, and is generally not recommended.  NSAIDs may displace other drugs from their protein-binding sites, leading to increased action of displaced drugs.  Inhibition of prostaglandin synthesis by NSAIDs during treatment with aminoglycoside antibiotics (e.g. gentamicin) leads to nephrotoxicity. 

Known signs of overdosage and treatment particulars

See side-effects.  With very high doses or long-term use of flunixin in horses clinical signs include: anorexia, listlessness, depression, gastric ulceration and a decrease in plasma protein concentration.  When overdosed withdraw medication immediately.  Treatment is symptomatic and supportive. 

Identification
A clear, colourless to light yellow solution, free from foreign matter. 

Presentation
Finadyne Injection 50 mg/ml is available in individual 50 ml and 250 ml multidose vials. 

Storage instructions
Store between 2 °C and 30 °C.
The contents should be used within 4 weeks of broaching the vial.
Keep out of reach of children and uninformed persons.

Registration holder:

Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07