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Date: Thursday, May 30, 2024 10:51

Description: Ceva logo
Release 2.208
Ketofen® 10% solution for injection
 
Species: Cattle, Horses and other equidae, Pigs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Injections: NSAIDs, Pharmaceuticals: Locomotor (including navicular and osteoarthritis), Pharmaceuticals: Neurological preparations: Analgesics
Active ingredient: Ketoprofen
Product:Ketofen® 10% solution for injection
Product index: Ketofen 10%
Cattle - milk: Zero hours
Cattle - meat: See note
Pig - meat: 4 days
Withdrawal notes: Cattle: Meat: IV: 1 day, IM: 4 days. Horses: Meat: 1 day
Incorporating:
Qualitative and quantitative composition
Active substance:
Ketoprofen 100 mg/ml
Preservative:
Benzyl alcohol 10 mg/ml
Excipients:
For the full list of excipients, see Pharmaceutical particulars
Pharmaceutical form
Solution for injection.
Clinical particulars
Target species
Horses, cattle, pigs.
Indications for use, specifying the target species
In the horse, Ketofen 10% is indicated for:
- The alleviation of inflammation and pain associated with musculoskeletal disorders;
- The alleviation of visceral pain associated with colic.
In cattle, Ketofen 10% is indicated for:
- 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;
- Reducing pain associated with lameness
In pigs, Ketofen 10% is indicated for:
- 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.
Contraindications
Do not administer to horses, cattle or pigs that have previously shown a hypersensitivity to ketoprofen. Do not administer 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 gastrointestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.
Special warnings for each target species
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.
Special precautions for use
Special precautions for use in animals
Avoid intra-arterial injection. Do not exceed the stated dose or duration of treatment.
Special precautions to be taken by the person administering the medicinal product to animals
In case of accidental self-injection seek medical advice. Wash hands after use.
Avoid splashes on the skin and eyes. Irrigate 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.
Use during pregnancy, lactation or lay
As the effects of ketoprofen on fertility, pregnancy or foetal health of horses have not been determined, KETOFEN 10% should not be administered to pregnant mares. KETOFEN 10% may be given to pregnant and lactating cattle. It is indicated for use in lactating sows.
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.
Amounts to be administered and administration route
For use in musculo-skeletal conditions, the recommended dosage is 2.2mg ketoprofen/kg i.e. 1ml of KETOFEN 10%/45kg bodyweight, 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) bodyweight, given by intravenous injection for immediate effect. A second injection may be given if colic recurs.
Cattle:
The recommended dose is 3mg ketoprofen/kg bodyweight, i.e. 1ml of KETOFEN 10%/33kg bodyweight, administered by intravenous or deep intramuscular injection once daily for up to 3 days.
Pigs:
The recommended dose is 3mg ketoprofen/kg bodyweight, i.e. 1ml of KETOFEN 10%/33kg bodyweight, administered once by deep intramuscular injection. The stopper cannot be broached more than 45 times. When treating large groups of animals at one time, use an automatic dosing device.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No clinical signs were observed when KETOFEN 10% 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.
Horses have been found to tolerate intravenous dosages of ketoprofen of 2.2, 6.6 and 11.0 mg/kg once daily for 15 consecutive days (i.e. up to 5 times the recommended dose for three times the recommended duration) with no evidence of toxic effects.
Ketoprofen is similarly well-tolerated in cattle, where doses of up to 15mg/kg/day (5 times recommended dose) for 5 consecutive days have been given without significant adverse effects. The product has been safely given to calves as young as 3 days of age, and to pregnant and lactating cattle. Ketoprofen is well tolerated in pigs. Doses of 9mg/kg/day (3 times the recommended dose) for 3 consecutive days have been given with no significant adverse effects.
Withdrawal periods
Horses, cattle and pigs must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after the following periods from the last treatment:
Horses – 1 day
Cattle – following intravenous administration: 1 day
– following intramuscular administration: 4 days
Pigs – 4 days
There is no withholding period necessary for the milk of treated cattle.
Pharmacological particulars
ATCvet code: QM01AE03
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.
Pharmaceutical particulars
List of excipients
L Arginine, Benzyl Alcohol, Citric Acid Monohydrate, Water for injections.
Major incompatibilities
None known.
Shelf life
Shelf life of the product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25 °C.
Keep the multilayer plastic vial in the outer carton in order to protect from light.
Discard unused material safely.
Nature and composition of immediate packaging
50, 100 or 250 mL type II brown glass vials with chlorobutyl stopper
50, 100 or 250 mL amber multilayer plastic (Polypropylene/ Adhesive/ Ethylene vinyl alcohol layer/ Adhesive/ Polypropylene)vials with bromobutyl stopper
Cardboard box of 1 vial
Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 15052/4146
Significant changes
Date of the first authorisation or date of renewal
12 February 1992
Date of revision of the text
October 2022
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Ketofen 10% 50 ml
GTIN:03411112999729
GTIN description:Ketofen 10% 100 ml
GTIN:03411112999712
GTIN description:Ketofen 10% 250 ml
GTIN:03411112999828