Instruction for use of Ketoprofen 10%

I. General information

1. Trade name of the veterinary medicinal product: Ketoprofen 10%.

International Nonproprietary Name: ketoprofen.

2. Dosage form: solution for injection.

Ketoprofen 10% in 1 mL contains ketoprofen - 100 mg as an active ingredient, and excipients: L-arginine hydrochloride, sodium hydroxide, benzyl alcohol, citric acid, water for injection.

3. In appearance, the drug is a clear light yellow or green yellow liquid. The shelf life of the drug under the storage conditions in a sealed package is 3 years from the manufacturing date, in-use shelf life is no more than 28 days.

The use of Ketoprofen 10% after the expiry date is prohibited.

4. Ketoprofen 10% is produced packaged in 20, 50, 100 and 250 mL glass bottles, sealed with rubber stoppers, reinforced with aluminum temper-evident caps. Each consumer package is provided with the instructions for use.

5. The drug is stored in the manufacturer’s sealed package, separately from food and feed, in a light-proof place at a temperature of 5 °C to 25 °C. In-use storage of the drug is at a temperature of 5 °C to 8 °C.

6. Ketoprofen 10% should be stored out of the reach of children.

7. Unused drug should be disposed in accordance with legal requirements.

8. Ketoprofen 10% is available without a prescription from a veterinarian.

II. Pharmacological properties

9. Ketoprofen 10% belongs to non-steroidal anti-inflammatory drugs.

10. Ketoprofen, which is included in the drug composition, is a derivative of propionic acid, has a pronounced anti-inflammatory, analgesic and antipyretic effect, inhibits platelet aggregation. The mechanism of action of ketoprofen is based on an inhibition of prostaglandin synthesis as a result of its effect on cyclooxygenase and lipoxygenase mediated arachidonic acid metabolism. The substance stabilizes lysosomal membranes and inhibits neutrophils in animals with arthritis.

Ketoprofen is rapidly absorbed from the administration site, enters the bloodstream and most organs and tissues, reaching a plasma maximum concentration after 30-40 minutes; more than 98% of ketoprofen binds to plasma proteins and concentrates in the focus of inflammation. Excreted mainly in the urine.

Ketoprofen 10% in terms of health effect belongs to low-hazardous substances (class 4 hazard according to GOST 12.1.007-76); if administered at the recommended doses, it does not have a local irritant, sensitizing and embryotoxic effect. The drug is non-cumulative.

III. Usage procedure

11. Ketoprofen 10% is prescribed to cattle and pigs as anti-inflammatory, analgesic and antipyretic drug in the combination therapy of acute and chronic diseases, accompanied by inflammatory processes, pain syndromes and hyperthermia of various etiologies (obstetric, gynecological, gastrointestinal, respiratory and musculoskeletal diseases).

12. Contraindications include animal hypersensitivity to the drug components, pronounced renal/liver failure, gastric and duodenal ulcer, hemorrhagic syndrome. The drug is used with caution in animals in dehydration, hypovolemia and hypotension due to the possible toxic effects of ketoprofen on the kidneys.

13. When working with Ketoprofen 10%, observe the general hygiene and safety rules provided for the work with medicinal products.

In case of hypersensitivity to the drug components, avoid direct contact with the drug. Do not drink, smoke or eat while working with the drug. After working with the drug, wash your hands with soap. Empty drug packages should not be used for domestic purposes and should be disposed in the household waste.

If the drug enters the skin or eye mucosa, wash immediately with plenty of water. In case of allergic reactions or accidental ingestion, immediately contact a medical facility (bring the instructions for use or drug label).

14. Use of the drug in pregnant and newborn animals is possible pro re nata if the expected benefit exceeds the potential risk. No special features of the drug administration in lactating animals detected.

15. Ketoprofen 10% is administered to animals parenterally at a dose of 3 mL per 100 kg of animal weight (equivalent to 3 mg of ketoprofen per 1 kg of animal weight) daily, once a day for 1-3 days;

— to cattle – intravenously or intramuscularly;

— to pigs – intramuscularly.

The therapy duration depends on the animal condition and is determined by a veterinarian.

16. No side effects and complications in the use of Ketoprofen 10% in accordance with the instructions for use have been detected. Some animals may experience irritation of the stomach and vomiting after the drug administration. These symptoms disappear spontaneously and usually do not require additional medicinal products. In case of allergic reactions, the drug therapy should be withdrawn and the symptomatic treatment should be prescribed.

17. In case of a drug overdose, the animal experiences a decreased appetite, an inflammatory reaction at the administration site, gastric and duodenal ulcer. The drug therapy should be withdrawn and the symptomatic treatment should be prescribed.

18. Ketoprofen 10% should not be co-administered with other non-steroidal anti-inflammatory drugs, diuretics, glucocorticoids and anticoagulants and mixed in the same syringe with other drugs.

19. No special features of the drug action after the first use and withdrawal have been detected.

20. If a dose is missed, resume the normal dosing on the same schedule.

21. Cattle slaughter in meat processing after Ketoprofen administration is allowed no earlier than 5 days, and pig slaughter - 4 days, after the last drug injection. The meat of animals compulsorily slaughtered before the periods specified expire can be used as feed for fur-bearing animals.

Milk of dairy animals during and after the drug therapy is allowed without restrictions.

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