Volume: 100 ml
 
Withdrawal periods:
Cattle:
 
Slaughter for meat: 2 days
 
Milk marketing: No withdrawal period
 
For veterinary use only
 
After initial opening, store below 25°C can be used for 28 days.
 
Store at a temperature up to 30°C in the original packaging. Protect from light. Do not refrigerate or freeze. Keep out of the reach and sight of children.
 
Instructions: Consult the package leaflet before use.
 
1. Name of the veterinary medicinal product, its form and strength
Kelprofen 10% Veterinary, solution for injection.
 
2. Active substance and its quantity per unit dose
Ketoprofen 100 mg/ml
Ketoprofen 100 mg/ml
Inactive ingredients: Benzyl alcohol (E1519) 10 mg/ml. For the full list of inactive ingredients, see section 13 later in the leaflet.
 
3. Therapeutic indications

In horses:

- Relief of inflammation and pain associated with musculoskeletal disorders.

- Relief of abdominal pain associated with colic.

In cattle:

- Supportive treatment for paresis (partial paralysis) associated with calving.

- Relief of fever and pain associated with bacterial respiratory tract diseases, when used in conjunction with appropriate antimicrobial therapy.

- Improvement of recovery rates in acute clinical mastitis including acute endotoxin mastitis caused by Gram-negative microorganisms when used in conjunction with appropriate antimicrobial therapy.

- Reduction of udder edema associated with calving.
 
Therapeutic group: Non-steroidal anti-inflammatory drug (NSAID).
 
4. Contraindications
Do not use in animals with hypersensitivity to the active substance or to any of the other ingredients of the product.
Do not administer other non steroidal anti inflammatory drugs (NSAIDs), corticosteroids, diuretics, or anticoagulants concurrently or within 24 hours of administering this product.
Do not use in animals suffering from heart, liver, or kidney disease, in cases where there is a risk of gastrointestinal damage or bleeding, or where there is evidence of circulatory disorders.
 
5. Adverse reactions
In very rare cases (less than 1 animal in 10,000), gastric or renal intolerance may occur, due to the inhibition of prostaglandin synthesis.
In very rare cases (less than 1 animal in 10,000), allergic reactions may occur.
 
6. Target species: Horses, cattle
 
7. Dosage and administration
In horses
Intravenous administration.
For musculoskeletal disorders: 2.2 mg ketoprofen/kg—equivalent to 1 ml of the product per 45 kg of body weight—administered intravenously once daily for 3–5 days.
For colic (spasmodic abdominal pain): 2.2 mg/kg (equivalent to 1 ml/45 kg) of body weight, administered intravenously for an immediate effect. A second injection may be given if the colic recurs.
In cattle
Intravenous or intramuscular administration.
3 mg ketoprofen/kg of body weight—equivalent to 1 ml of the product per 33 kg of body weight—administered intravenously or by deep intramuscular injection once daily for up to 3 days.
 
8. Method of administration
The use of a draw-off needle is recommended when treating large groups of animals.
Do not puncture the vial more than 33 times.

9. Withdrawal period in cattle
For meat – 2 days.
For milk – no withdrawal period.
 
10. Warnings
Special warnings regarding the use of the medicinal product and treatment of the animal
The use of ketoprofen is not recommended in foals at increased risk of adverse effects (up to 15 days of age).
Use in animals under 6 weeks of age or in elderly animals may pose an additional risk. If use in such animals cannot be avoided, a reduced dosage and careful monitoring may be required.
Avoid treating animals that are dehydrated, hypovolemic, or hypotensive, as there is an increased risk of renal toxicity in these cases.
Avoid intra-arterial injection.
Do not exceed the recommended dose or the recommended duration of treatment.
Special warnings regarding the safety of the person
administering the product
Individuals with a known sensitivity to the active ingredient and/or to benzyl alcohol should avoid contact with the product. In the event of accidental self-injection, seek medical attention and show the product leaflet or packaging to the physician.
Wash hands after use.
Avoid spraying the product onto the skin or into the eyes. In case of contact, rinse the exposed area thoroughly with water. If irritation persists, seek medical advice.
Adverse reactions in the treated animal
The safety of ketoprofen has been evaluated in laboratory animals (rats, mice, and rabbits) as well as in cattle; no teratogenic or embryotoxic effects were observed. The product may be administered to pregnant and lactating cows. Since the effects of ketoprofen on fertility, pregnancy, and fetal health in horses have not been established, the product should not be administered to pregnant mares.
Interactions with other medicinal products or other forms of interaction 
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, diuretics, or anticoagulants concurrently or within 24 hours of administering this product.
Some NSAIDs bind extensively to plasma proteins and compete with other drugs that also exhibit high plasma protein binding; this may lead to toxic effects.
Do not administer in combination with nephrotoxic drugs (drugs that are toxic to the kidneys).
Overdose – No clinical signs are expected when ketoprofen is administered to horses at 5 times the recommended dose for 15 days, or to cattle at 5 times the recommended dose for 5 days.
Incompatibility – In the absence of compatibility studies, this product must not be mixed with other substances in the same syringe.
 
11. Storage Instructions
- Prevent poisoning! This medicine, and all other medicines, must be kept in a closed place, out of the reach of children and/or infants, to prevent poisoning.
- Do not use the medicine after the expiry date (exp. date) appearing on the packaging. The expiry date refers to the last day of that month.
- Storage conditions: Store in the original packaging, below 30°C, and protect from light. Do not freeze; do not refrigerate.
- After first opening, store below 25°C; the product may be used for 28 days.
 
12. Instructions for Disposal of the Product/Residual Product After Use
Any unused veterinary medicinal product, or waste material derived from the use of such a product, must be disposed of as toxic waste; do not dispose of it in the sewage system.
 
13. Additional Information
In addition to the active ingredients, the medicine also contains:
L-Arginine, Benzyl Alcohol (E1519), Citric Acid Monohydrate (for pH adjustment)
Water for Injection