SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ketodolor 100 mg/ml solution for injection for horses, cattle, pigs (AT, BE, CZ, EE, FR, HU, IE, IT, LT, LU, LV, MT, PL, RO, SK, UK)

Ketosan 100 mg/ml solution for injection for horses, cattle, pigs

(ES, PT)

Ketodolor vet. 100 mg/ml solution for injection for horses, cattle, pigs

(FI)

Ketodine vet. 100 mg/ml solution for injection for horses, cattle, pigs (DK, NO, SE, IS)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Ketoprofen 100 mg

Excipients:

Benzyl alcohol (E1519) 10 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Horses, cattle, pigs

4.2 Indications for use,specifying the target species

Horses:

- alleviation of inflammation and pain associated with musculoskeletal disorders

- alleviation of visceral pain associated with colic.

Cattle:

- alleviation of pain (e.g. from pressure trauma) resulting from parturient paresis;

- reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate;

- improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative micro-organisms, in conjunction with antimicrobial therapy;

- alleviation of pain associated with udder oedema following calving.

- reducing pain associated with lameness.

Pigs:

- reducing the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate.

- the supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate.

4.3 Contraindications

Do not use in horses, cattle or pigs that have previously shown a hypersensitivity to ketoprofen.

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

Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.

Please refer to section 4.7.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

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.

The use of ketoprofen is not recommended in foals under the age of 15 days.

Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.

Avoid intra-arterial injection.

Do not exceed the stated dose or duration of treatment.

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

In case of accidental self-injection seek medical advice and show the package leaflet or the label to the physician.

People with known hypersensitivity to the active substance and/or benzyl alcohol should avoid contact with the product.

Avoid splashes on the skin and eyes. Wash the affected area thoroughly with water should this occur. If irritation persists seek medical advice.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

In common with all NSAIDs, due to their action of inhibition of prostaglandin synthesis, there can be the possibility in certain individuals of gastric or renal intolerance.

4.7 Use during pregnancy, lactation or lay

The safety of ketoprofen has been investigated in pregnant laboratory animals, (rats, mice and rabbits) and in cattle, and showed no teratogenic or embryotoxic effects.

The product may be given to pregnant and to lactating cattle, and to lactating sows.

As the effects of ketoprofen on the fertility, pregnancy or foetal health of horses have not been determined, the product should not be administered to pregnant horses.

As the safety of ketoprofen has not been assessed in pregnant sows, the product should be used in these cases according to a benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

Concurrent administration with nephrotoxic drugs should be avoided.

Concurrent administration of other steroidal or non-steroidal anti-inflammatory drugs, diuretics or anticoagulant agents may lead to potentiating adverse effects. A treatment free period, dependent on the product administered, should be observed between such treatments.”

4.9 Amounts to be administered and administration route

Horse:

For use in musculo-skeletal conditions, the recommended dosage is 2.2 mg ketoprofen/kg i.e. 1ml of the product /45kg body weight, administered by intravenous injection once daily for up to 3 to 5 days.

For use in equine colic, the recommended dosage is 2.2mg/kg (1ml/45kg) body weight, given by intravenous injection for immediate effect. A second injection may be given if colic recurs.

Cattle:

The recommended dose is 3mg ketoprofen/kg body weight, i.e. 1ml of the product/33kg body weight, administered by intravenous or deep intramuscular injection once daily for up to 3 days.

Pigs:

The recommended dose is 3mg ketoprofen/kg body weight, i.e. 1ml of the product /33kg body weight, administered once by deep intramuscular injection

The stopper cannot be punctured more than 20 times.

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

No clinical signs were observed when ketoprofen was administered to horses at 5 times the recommended dose for 15 days, to cattle at 5 times the recommended dose for 5 days, or to pigs at 3 times the recommended dose for 3 days.

4.11 Withdrawal period(s)

Cattle

meat & offal: following intravenous administration - 1 day

following intramuscular administration - 4 days

milk: zero hours

Pigs

meat & offal: 4 days

Horses

meat & offal: 1 day

milk: not authorized for use in lactating animals producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids

ATCvet code: QM01AE03

5.1 Pharmacodynamic properties

Ketoprofen is a derivative of phenylpropionic acid, and belongs to the non steroidal anti-inflammatory group of drugs. Like all such substances, its principal pharmacological actions are anti-inflammatory, analgesic and anti pyretic. The mechanism of action is related to the ability of ketoprofen to interfere with the synthesis of prostaglandins from precursors such as arachidonic acid.

Following intravenous injection in the horse, the onset of musculo-skeletal anti-inflammatory activity occurs by 2 hours, and reaches a peak at about 12 hours. It is still measurable 24 hours after each dose.

5.2 Pharmacokinetic particulars

Ketoprofen binds 95% to plasma proteins.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (E1519)

L-arginine

Citric acid monohydrate (for pH adjustment)

Water for injections

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

Do not refrigerate or freeze.

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

6.5 Nature and composition of immediate packaging

The product is packed in amber type II glass vials of 50 ml or 100 ml, fitted with red chlorobutyl stoppers and aluminium caps.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product 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.

7. MARKETING AUTHORISATION HOLDER

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 41821/4004

9. DATE OF FIRST AUTHORISATION

Date:27 June 2013

10. DATE OF REVISION OF THE TEXT

Date:January 2015

PROHIBITION OF SALE, SUPPLY AND/OR USE

Only on veterinary prescription

Approved: 24 March 2015