SUMMARY OF PRODUCT CHARACTERISTICS

Ketink 100 mg/ml solution for injection for cattle, horses and pigs [Austria, Bulgaria, Cyprus, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom]

Ainil 100 mg/ml solution for injection for cattle, horses and pigs [Denmark]

Aristal 100 mg/ml solution for injection for cattle, horses and pigs [Belgium]

One ml contains:

Active substance

Ketoprofen 100 mg

Excipients:

Benzyl alcohol (E1519) 10 mg

For a full list of excipients, see section 6.1.

Solution for injection

A clear, colourless to yellow solution. Free from visible particles.

4.1 Target species

Cattle, pigs and horses.

4.2 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 Mastitis Metritis Agalactia Syndrome and respiratory diseases.

Horses: Anti-inflammatory and analgesic treatment of diseases in the musculature, joints and the skeleton.

Symptomatic analgesic treatment for colic. Postoperative pain and swelling.

4.3 Contraindications

Do not use in case 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.

Not to be used in foals in their first month of life.

Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.

4.4 Special warnings

None.

4.5 Special precautions for use

Special precautions for use in animals

The use of ketoprofen is not recommended in foals under the age of 1 month. 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 animals and animals with low blood pressure. 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.

4.6 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.

4.7 Adverse reactions (frequency and seriousness)

Repeated intramuscular injections can cause temporary irritation.

Due to its mechanism of action including inhibition of prostaglandin synthesis, ketoprofen can cause gastric and intestinal irritation or ulceration.

Repeated administration to swine may result in reversible inappetence.

Allergic reactions may occur very rarely.

4.8 Use during pregnancy, lactation or lay

Studies of the effect of ketoprofen in pregnant laboratory animals and cattle have not produced any evidence of adverse effects. As the safety of ketoprofen has not been assessed in pregnant mares or sows, the product should be used in this case only according to the benefit/risk assessment by the responsible veterinarian.

4.9 Interaction with other medicinal products and other forms of interaction

The product must not be administered in conjunction with, or within 24 hours of administration ofother 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.

4.10 Amounts to be administered and administration route

Cattle: Intramuscular use or Intravenous use

3 mg ketoprofen/kg b.w., equivalent to 3 ml of the product/100 kg b.w. once a day for up to 3 days.

Pigs: Intramuscular use

3 mg ketoprofen/kg b.w., equivalent to 3 ml of the product/100 kg b.w., administered once.

Horses: Intravenous use

2.2 mg ketoprofen/kg b.w., equivalent to 1 ml of the product/45 kg b.w. once per 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.

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

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.

4.12 Withdrawal periods

Meat and offal: 4 days

Milk (bovine): Zero hours

Not authorised for use in mares producing milk for human consumption.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Non-steroidal anti-inflammatory/antirheumatic agents (NSAIDs)

ATCvet code: QM01AE03.

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.

5.2 Pharmacokinetic particulars

After intravenous injection to horses the half-life is approx. 1 hour. The distribution volume is approx. 0.17 l/kg and the clearance approx. 0.3 l/kg. After intramuscular injection to cattle and pigs ketoprofen is quickly absorbed and the maximum plasma concentration of approx. 11 micrograms/ml is obtained within ½ to 1 hour. The mean absorption time is approx. 1 hour. The plasma half-life is 2 – 2 ½ hours. The bioavailability after intramuscular injection is 90 – 100% in cattle and pigs. In the case of repeated injections at 24 hour intervals ketoprofen exhibits linear and stationary kinetics since the above parameters remain unchanged. Ketoprofen is approx. 95% bound to plasma proteins.

Ketoprofen is metabolised mainly by the reduction of the ketone group to a main metabolite. Ketoprofen is quickly excreted; approx. 80% is eliminated within 12 hours after administration. 90% of the elimination takes place via the kidneys, mainly in metabolised form.

6.1 List of excipients

L Arginine

Benzyl alcohol (E1519)

Citric acid monohydrate (for pH adjustment)

Nitrogen

Water for injection

6.2 Incompatibilities

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

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Keep the container in the outer carton.

Protect from light.

Do not refrigerate or freeze.

6.5 Nature and composition of immediate packaging

The product is packaged in amber type II glass vials of 100 ml and 250 ml.

The vials are closed with a type I rubber bromobutyl stopper oversealed with an aluminium cap. Vials are packaged in cardboard boxes containing 1, 6, 10 or 12 units.

Not all pack sizes may be marketed.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Industrial Veterinaria, S.A.

Esmeralda 19

E-08950 Esplugues de Llobregat

Barcelona

Spain

Tel: +34 934 706 270

Fax: +34 933 727 556

e-mail: invesa@invesagroup.com

Vm 36547/4001

2 February 2012

February 2012

Prohibition of sale, supply and/or use

To be supplied only on veterinary prescription