SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Comforion Vet 100 Mg/Ml Solution for Injection For Horse, Cattle And Swine

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:

1 Ml Contains Ketoprofen 100 Mg

Excipients:

1 Ml Contains Benzyl Alcohol 10 Mg

For A Full List of Excipients, See Section 6.1.

3. PHARMACEUTICAL FORM

Solution For Injection

Clear, Colourless Or Yellowish Solution

4. CLINICAL PARTICULARS

4.1 Target species

Horse, Cattle, Swine

4.2 Indications for use, specifying the target species

Horse: anti-inflammatory and analgesic treatment of musculosceletal disorders. Alleviation of visceral pain associated with colic.

Cattle: anti-inflammatory and analgesic treatment of mammary gland disorders. Reduction of pyrexia associated with respiratory disease in conjunction with antimicrobial treatment.

Swine: reduction of pyrexia in respiratory tract disorders. Supportive treatment of post partum dysgalactiae syndrome, pds (mma-syndrome) in conjunction with antibiotic therapy.

4.3 Contraindications

Hypersensitivity to ketoprofen or any of the excipients in the product. Severe hepatic, renal or cardiac insufficiency, gastro-intestinal ulceration, heavy bleeding or evidence of blood dyscrasia.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Avoid intra-arterial injections. Do not exceed the recommended dose or the duration of treatment. Use with precaution in dehydrated or hypotensive animals. In colic, a subsequent dose may be given only after a thorough re-examination. The use of ketoprofen is not recommended in foals under the age of 15 days. Use in any animal 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. See point 4.7 regarding the use of the product in pregnant mares and sows.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid splashes to the skin and eyes. Wash hands after use. If accidental skin or eye contact occurs, irrigate thoroughly with water. In case of accidental self injection, seek medical advice.

4.6 Adverse reactions (frequency and seriousness)

Repeated intramuscular injections may cause mild transient irritation. Due to the mechanism of action of ketoprofen (inhibition of the prostaglandin synthesis), gastric and intestinal irritation or ulceration or renal intolerance may occur.

4.7 Use during pregnancy, lactation or lay

The safety of ketoprofen has been investigated in pregnant laboratory animals (rats, mice, rabbits) and cattle. No adverse effects were noted. As the safety of ketoprofen has not been assessed in pregnant mares or sows, the product should be used in these cases only accordingly to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Other non-steroidal anti-inflammatory drugs should not be used concomitantly or within 24 hours from administration of the product. Competition on plasma protein binding sites may lead to intoxication. Concurrent administration with diuretics, anticoagulant therapy and nephrotoxic drugs should be avoided.

4.9 Amounts to be administered and administration route

Horse: 2.2 mg ketoprofen/kg bodyweight/day intravenously. For example, 11 ml/500 kg/day by intravenous injection for up to 3 days. In colic, see point 4.5, special precautions for use.

Cattle: 3 mg ketoprofen/kg bodyweight/day intravenously or intramuscularly. For example, 3 ml/100 kg/day by intravenous ordeep intramuscular injection for up to 3 days.

Swine: 3 mg ketoprofen/kg bodyweight/day intramuscularly. For example, 3 ml/100 kg/day by deep intramuscular injection for up to 3 days.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The signs of overdose are listed in point 4.6. Treatment is symptomatic.

4.11 Withdrawal periods

Meat and offal: 4 days

Milk: zero days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: NSAID
ATCVET code: QM01AE03

5.1 Pharmacodynamic properties

Ketoprofen is a non-steroidal anti-inflammatory drug belonging to the 2-arylpropionic acid group of nsaids. In addition to the anti-inflammatory effect, it also has an anti-pyretic and analgesic effect. The pharmacological mechanism of action of ketoprofen is based on the inhibition of the cyclo-oxygenase and lipoxygenase. Ketoprofen also prevents the formation of bradykinin and stabilises the cell membranes of lysosomes, which inhibits the release of lysosomal enzymes that mediate tissue destruction.

5.2 Pharmacokinetic particulars

Ketoprofen is rapidly absorbed after intramuscular administration. The measured maximum plasma concentration at 30 minutes from a single dose injection is 16.3 mg/l in swine and 9.7 mg/l in cattle.

Ketoprofen binds approximately 95% to plasma proteins and its bioavailability after intramuscular administration is 80-100%. The plasma half life is approximately 1 hour in horses, approximately 2.5 hours in cattle, and 2-3 hours in swine. Only minor quantities of ketoprofen are transferred to milk. Ninety per cent of the dose is eliminated in the urine primarily as metabolites. Elimination from synovial fluid is delayed.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Arginine

Benzyl alcohol

Citric acid monohydrate (e330)

Water for injections

6.2 Incompatibilities

In the absence of incompatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf life

3 years

After first opening, the product should be used within 10 days.

6.4. Special precautions for storage

Do not store above 30 °c.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging

100 ml amber glass vial, type i;

Chlorobutyl or bromobutyl rubber stopper coated with fluorine polymer; aluminium cap equipped with polypropylene flip off seal

Package size:

1x100 ml (1 vial of 100 ml in a cardboard box)

10x100 ml (a shrink-wrapped package containing 10 cardboard boxes)

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused product or waste materials should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

8. MARKETING AUTHORISATION NUMBER(S)

Vm06043/4000

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date: 21 March2005

10. DATE OF REVISION OF THE TEXT

May2012