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Date: Friday, April 19, 2024 21:44

Description: MSD-AH
Release 2.58
Finadyne® 50 mg/g Oral paste
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Horse NSAIDs, Pharmaceuticals: Locomotor (including navicular and osteoarthritis)
Active ingredient: Flunixin Meglumine
Product:Finadyne® 50 mg/g Oral paste
Product index: Finadyne® 50 mg/g Oral paste
Withdrawal notes: Not for use in horses intended for human consumption.
Incorporating:
Qualitative and quantitative composition
Each gram contains:
Active substance:
Flunixin 50 mg as as flunixin meglumine 83 mg
Excipients:
For the full list of excipients, see “Pharmaceutical Particulars”.
Pharmaceutical form
Oral paste.
White to off-white paste.
Clinical particulars
Target species
Horse
Indications for use
For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Contraindications
Do not exceed the stated dose or duration of treatment.
Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is the possibility of gastrointestinal ulceration or bleeding.
Do not use in cases of hypersensitivity to the active substance.
Do not administer steroidal or other non-steroidal anti-inflammatory drugs concurrently or within 24 hours of each other.
Do not use in hypovolaemic animals except in the case of endotoxaemia or septic shock.
Special warnings for each target species
Non-steroidal anti-inflammatory drugs are not permitted substances under the rules of racing and under rules covering other competitive events. The Royal College of Veterinary Surgeons has given guidance to the Veterinary profession regarding the use of anti-inflammatory drugs in competing horses. It states that if a veterinarian recommends the discontinuation of any such drug not less than eight days before racing he should feel sure he has catered for all but the most exceptional case.
Special precautions for use
Use in animals 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.
In animals undergoing general anaesthesia it is preferable to wait until they are fully recovered before the veterinary medicinal product is administered.
NSAIDs can cause inhibition of phagocytosis. During use in the treatment of inflammatory conditions associated with bacterial infections, appropriate concurrent antimicrobial therapy should be administered.
Avoid use in dehydrated, hypovolaemic or hypersensitive animals as there is a potential risk of increased renal toxicity.
Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.
Operator warnings
Avoid contact with eyes and direct contact with skin. Gloves should be worn during application.
In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.
The product may cause reactions in sensitive individuals. If you have known hypersensitivity to non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious.
Wash hands and exposed skin after use.
Adverse reactions
Allergic reactions (allergic skin reactions, anaphylaxis) may occur after administration of the veterinary medicinal product in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy.
Interactions
Concurrent administration of potentially nephrotoxic drugs should be avoided.
Some NSAIDs may be highly bound to plasma proteins and may compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations which can lead to toxic effects.
Amounts to be administered and administration route
Oral use. 1.1 mg flunixin per kg bodyweight once daily for up to 5 days according to clinical response.
Each 10 g syringe is sufficient for one day’s treatment for a 454 kg (1000 lb.) horse. The syringe is calibrated in 100 kg increments to facilitate dosing of horses of different weights.
Prior to first use, the syringe must be primed. Set the ring on the graduated syringe plunger to the zero (0) position. Remove the cap and press the plunger to remove air. Discard any small volume of paste that may be expelled. The syringe is now ready for use.
Overdose
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.
Withdrawal periods
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
Pharmacological particulars
ATC Code: QM01AG90
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids
Flunixin meglumine is a potent non-steroidal, non-narcotic analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic activities.
Pharmacokinetic properties
None known.
Environmental properties
Flunixin is toxic to avian scavengers although foreseen low exposure leads to low risk.
Pharmaceutical particulars
Excipients
Propylene glycol, Carmellose sodium, Maize starch and Purified water.
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25 °C. Do not freeze. Replace cap after use.
Keep syringes in the outer box.
Store syringes in an upright position.
Immediate packaging
White low density polyethylene syringes with white linear polyethylene graduated plungers and white low density polyethylene caps.
Pack size: Carboard box with 6 x 10 g syringes.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4599
Significant changes
Date of the first authorisation or date of renewal
2 February 1989
Date of revision of the text
18 October 2022.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Finadyne Paste 6x10gr :
GTIN:8713184150783