Kelaprofen 100mg/ml Solution for Injection

Kelaprofen 100 mg/ml, Solution for Injection for Cattle, Horses and Pigs.

Presentation

KELAPROFEN is a clear, colourless or yellowish solution for injection containing 100 mg ketoprofen per ml.

Uses

Horse

-the alleviation of inflammation and pain associated with musculoskeletal disorders

-the alleviation of visceral pain associated with colic.

Cattle

-the supportive treatment of parturient paresis associated with calving

-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

-reducing oedema of the udder associated with calving.

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.

Dosage and administration

Use of a draw-off needle is recommended when treating large groups of animals.

Do not broach the container more than 33 times.

Horse:

Intravenous administration.

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

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

Cattle:

Intravenous or intramuscular administration.

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

Pigs:

Intramuscular administration.

3 mg ketoprofen/kg body weight, i.e. 1ml of product per 33 kg body weight, administered once by deep intramuscular injection.

Contra-indications, warnings, etc

Do not use in animals with known hypersensitivity to the active substances or to any of the excipients.

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

Do not use in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is evidence of blood dyscrasia.

Special warnings for each target species

None.

Special precautions for use

(i) Special precautions for use in animals

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.

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.

(ii) Special precautions to be taken by the person administering the medicinal product to the animals

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

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

Wash hands after use.

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

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. Allergic reactions may occur very rarely.

Use during pregnancy, lactation or lay

The safety of Ketoprofen has been investigated in pregnant laboratory animals (rats, mice and rabbits) and cattle. Ketoprofen showed no teratogenic or embryotoxic effects. Ketoprofen may be given to pregnant and lactating cattle. As the safety of ketoprofen has not been assessed in pregnant sows, the product should be used in these cases only accordingly to the benefit/risk assessment by the responsible veterinarian. Do not use in pregnant mares.

Interaction with other medicinal products and other forms of interaction

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

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.

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.

Withdrawal periods

Cattle:

Meat and offal:

- IV: 1 day

- IM: 2 days

Milk: zero hours

Horses:

Meat and offal: 1 day

Milk: Not authorised for use in lactating animals producing milk for human consumption

Pigs:

Meat and offal: 2 days

Pharmaceutical precautions

In the absence of compatibility studies, this product should not be mixed with other substances in the same syringe.

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

Do not refrigerate or freeze. Protect from light.

Legal category

POM-V

Packaging Quantities

Vials of 50, 100 and 250 ml.

Clinical containers of 6, 10 and 12 units of 50ml, 100ml and 250 ml.