1. GENERAL INFORMATION
1.1 Ketoprofol 1% and 10% (Ketoprofol 1%, 10%).
1.2 Ketoprofol 1% and 10% is a colorless or slightly yellow, transparent solution. Each ml of the drug contains 10 to 100 mg ketoprofen respectively.
1.3 Ketoprofol 1% and 10% is pre-packed by 5, 10, 20, 50, 100, 200 and 250 ml in amber glass vials of suitable capacity.
1.4 Ketoprofol 1% and 10% should be stored with caution (see list B) in dry place protected from direct sunlight within the temperature range +4°C to +25°C. Shelf life of Ketoprofol 1% and 10% is 3 years from date of manufacture under specified storage conditions.
2. PHARMACOLOGICAL PROPERTIES
2.1 Ketoprofen as an ingredient of the drug is effective for treatment of acute, subacute and chronic inflammations accompanied by pain symptoms. Mechanism of the ketoprofen action is in inhibition of the prostaglandins synthesis (cyclo-oxygenase-2 and partially cyclo-oxygenase-1) by disruption of the arachidonic acid metabolism. In therapeutic doses ketoprofen ensures anti-inflammatory, analgesic, antipyretic and antiendotoxic effect.
2.2 After intramuscular administration of the drug maximum concentration of ketoprofen shall be observed in blood plasma after 30 minutes. Bioavailability of ketoprofen ranges between 85% and 100% depending on species. Ketoprofen is eliminated from the body mainly through kidneys.
2.3 In compliance with GOST 12.1.007-76 according to the impact degree on body Ketoprofol 1% and 10% refers to Hazard Category 4 (low- hazard substance); its does not have sensitizing effect in the body at recommended doses.
3. DRUG USAGE PROCEDURE
3.1 The drug is administered as follows:
- as symptomatic treatment in complex therapy against inflammatory responses in acute and chronic diseases of locomotor system (arthritis, tendovaginitis, injuries, herniated discs, infections of hooves);
- as pain relief of any origin (perioperative and postoperative therapy, colic);
- as an aid in treatment of the respiratory tract diseases, MMA syndrome, acute and chronic forms of mastitis;
- as antipyretic agent in cases involving hyperthermia and depression.
Ketoprofol 1% is recommended for dogs and cats.
Ketoprofol 10% is recommended for use in cattle, horses and pigs.
3.2 Dosage and administration:
In dogs and cats: subcutaneously, intramuscularly, intravenously based on 2 mg / kg animal weight (by ketoprofen), once a day for 1-5 days.
In horses: intravenously based on 2.2 mg / kg animal weight (by ketoprofen) for treatment of functional disorders of locomotor and osteoarticular systems - every day, once a day for 3 - 5 days. For symptomatic treatment of colic in horses Ketoprofol 10% shall be administered once. In general, a single dose shall be sufficient; any additional administration should only be done after preliminary clinical examination of the animal.
In cattle: intravenously or intramuscularly based on 3 mg / kg animal weight (by ketoprofen), once per day for 1-5 days.
3.3 Adverse effect. Ketoprofol 1% and 10% usually does not cause complications in animals at recommended doses. Caution should be used in dehydrated animals and animals with low blood pressure, because in such case the risk of renal complications (nephrotoxicity) is increasing.
3.4 Contraindications: allergy to ketoprofen and other components of the drug, peptic ulcer, hemorrhagic syndrome, severe liver and kidney failure, pregnancy. Do not use the drug in foals aged under 15 days.
3.5 Specific indications. Ketoprofol 1% and 10% is not recommended for use in combination with other non-steroidal anti-inflammatory drugs, glucocorticoids, anticoagulants and diuretins. Do not mix with other drugs in the same syringe. Avoid intra-arterial injection of the drug. Whereas to date there are no studies about ketoprofen effect on pregnancy in horses - the drug is not recommended to use in pregnant mares.
3.6 Slaughter of animals for meat after intramuscular injection shall be allowed not earlier than 4 days and after intravenous administration - not earlier than one day after the last drug administration. Meat of animal slaughtered prior expiry of specified period shall be used for animal feed or for production of meat and bone meal. Milk during treatment can be used without restrictions.
4. INDIVIDUAL PREVENTION MEASURES
4.1 All works with the drug should be carried out with use of uniforms (coat, hat, rubber gloves). In case of accidental contact of the drug with skin or mucous membranes it should be immediately rinsed with plenty of water.
4.2 Do not drink, smoke or eat during handling the drug.
4.3 After finishing work wash your hands with warm water and soap; Wash and dry your gloves.
4.4 It is restricted to use containers under drug for food purposes.
5. CLAIMS PROCEDURE
5.1 In case of complications after drug administration its use should be discontinued and reported to the Uzbek State Scientific and Veterinary Drugs Control Laboratory at: (700178, Tashkent, Karakamysh 2/4, No.1a,Yunusov str.) and to the drug manufacturer. Simultaneously samples of drug’s lot should be sent to the Uzbek State Scientific and Veterinary Drugs Control Laboratory samples expelled Series drug that caused complications in animals, with detailed description of complications.