NAM PHUC THINH TRADING CO., LTD

KETINK 100 mg/ml
 

Composition: 1 ml contains: Ketoprofen 100 mg; excipient q.s 1 ml.

Dosage form: Solution for injection
Properties: Ketoprofen is a substance belonging to the group non-steroidal anti-inflammatory drugs (NSAIDs). Ketoprofen has anti-inflammatory, analgesic and antipyretic properties. Not all aspects of its mechanism of action are known. Effects are obtained partially by the inhibition of prostaglandin and leukotriene synthesis by ketoprofen, acting on cyclooxygenase and lipoxygenase respectively. The formation of bradykinin is also inhibited. Ketoprofen inhibits thrombocyte aggregation.

Target species: Cattle, pigs and horses

Indications for use, specifying the target species:

Cattle: Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and the udder.
Pigs: Anti-inflammatory and antipyretic treatment of Postpartum Dysgalactia Syndrome -PDS- (Mastitis Metritis Agalactia Syndrome) and respiratory diseases.
Horses: Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and joints. Symptomatic analgesic treatment for colic. Postoperative pain and swelling.

Dosage for each species, routes and method of administration:

Cattle: Intramuscular use or Intravenous use. 3 mg ketoprofen/kg body weight/day (equivalent to 3 ml of the product/100 kg b.w./day) for up to 3 days.
Pigs: Intramuscular use. 3 mg ketoprofen/kg body weight/day (equivalent to 3 ml of the product/100 kg b.w./day), administered once.
Horses: Intravenous use. 2.2 mg ketoprofen/kg body weight/day (equivalent to 1 ml of the product/45 kg b.w./day) for 3 to 5 days. In the case of colic, treatment should not be repeated until a clinical re-examination has been carried out.
Not more than 5 ml should be administered at one intramuscular injection site.
The stoppers must not be punctured more than 166 times.

Contraindications: Do not use in cases of hypersensitivity to the active substance, or to any of the excipients. Do not use in animals suffering from gastro-intestinal lesions, haemorrhagic diathesis, blood dyscrasia, impaired hepatic, cardiac or renal function. Do not use in foals in their first month of life. Do not use other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.

Adverse reactions: In very rare cases these signs can be observed: Temporary irritation after repeated intramuscular injections; Gastric and intestinal irritation or ulceration due to ketoprofen mechanism of action including inhibiton of prostaglandin synthesis; Reversible inappetence after repeated administration to swine; Allergic reactions.
The frequency of adverse reactions is defined using the following convention:
Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).
Common (more than 1 but less than 10 animals in 100 animals).
Uncommon (more than 1 but less than 10 animals in 1,000 animals).
Rare (more than 1 but less than 10 animals in 10,000 animals).
Very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Special warnings:
Special precautions for use in animals: 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 management. Avoid intra-arterial injection. Do not exceed the stated
dose or duration of treatment. Use with caution in dehydrated, hypovolemic or hypotensive
animals as there is a potential risk of increased renal toxicity. In the case of colic a supplementary dose may only be given after a thorough clinical examination. Sufficient drinking water must be supplied at all times during treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to
the physician. People with known hypersensitivity to ketoprofen or benzyl alcohol should avoid contact with the veterinary medicinal product. Avoid splashes on the skin and eyes. Rinse thoroughly with water should this occur. If irritation persists seek medical advice. Wash hands after use.

Pregnancy and lactation: The safety of ketoprofen has been investigated in pregnant laboratory animals, (rats, mice and rabbits) and in cattle, and showed no teratogenic or embryotoxic effects. The product may be given to pregnant and to lactating cattle, and to lactating sows. As the effects of ketoprofen on the fertility, pregnancy or foetal health of horses have not been determined, the product should not be administered to pregnant horses. As the safety of ketoprofen has not been assessed in pregnant sows, the product should be used in these cases according to a benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction: The veterinary medicinal product must not be administered in conjunction with, or within 24 hours of administration of other NSAIDs and glucocorticoids. Concurrent administration of diuretics, nephrotoxic drugs and anticoagulative drugs should be avoided. Ketoprofen is highly bound to plasma proteins, and may displace or be displaced by other highly protein bound medicines, such as anticoagulants. Due to the fact that ketoprofen may inhibit platelet aggregation and cause
gastrointestinal ulceration, it should not be used with other medicines that have the same profile of adverse drug reactions.

Overdose (symptoms, emergency procedures, antidotes): No clinical signs were observed when the product was administered to horses at 5 times (11 mg/kg) the recommended dose for 15 days, to cattle at 5 times (15 mg/kg/day) the recommended dose for 5 days, or to pigs at 3 times (9 mg/kg/day) the recommended dose for 3 days. Ketoprofen can lead to hypersensitivity reactions and moreover might have a detrimental effect on the gastric mucosa. This may require cessation of ketoprofen treatment and introduction of symptomatic therapy.

Other information: Ketoprofen is a substance belonging to the group nonsteroidal anti-inflammatory drugs (NSAIDs). Ketoprofen has anti-inflammatory, analgesic and antipyretic
properties. Not all aspects of its mechanism of action are known. Effects are obtained partially by the inhibition of prostaglandin and leukotriene synthesis by ketoprofen, acting on cyclooxygenase and lipoxygenase respectively. The formation of bradykinin is also inhibited. Ketoprofen inhibits thrombocyte aggregation.

Withdrawal period: Cattle, horses, pigs: Meat and offal: 4 days; Milk (bovine): Zero hours.
Not authorized for use in mares producing milk for human consumption

Storage conditions: Keep the container in the outer carton. Protect from light. Do not refrigerate or freeze.

Presentations: Vials of 10, 50, 100, 250 and 500 ml.

Shelf-life: 2 years from the manufacturing date; 28 days from the first opening.

FOR VETERINARY USE ONLY

Keep out of the reach of children

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona, Spain