Ketink 100mg/ml solution for injection 100ml

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 Postpartum Dysgalactia
Syndrome -PDS- (Metritis Mastitis Agalactia Syndrome) and respiratory diseases.
Horses: Anti-inflammatory and analgesic treatment of diseases in the
musculoskeletal system and joints.
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.
Donot use in animals suffering from gastro-intestinal lesions, haemorrhagic diathesis,
blood dyscrasia, impaired hepatic, cardiac or renal function.
Do not use in foals in their first month of life.
Do not useother non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or
within 24 hours of each other.
4.4. Special warnings for each target species
None.
Revised: March 2017
AN: 00276/2016
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4.5. Special precautions for use
Special precautions for use in animals
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, hypovolemic or hypotensive animals as there is a
potential risk of increased renal toxicity. 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.
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.
4.6. Adverse reactions (frequency and seriousness)
In very rare cases these signs can be observed:
• temporary irritation after repeated intramuscular injections
• gastric and intestinal irritation or ulceration (due to ketoprofen mechanism of
action including inhibition of prostaglandin synthesis)
• reversible inappetence after repeated administration to swine.
• allergic reactions.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the
course of one treatment).
- Common (more than 1 but less than 10 animals in 100 animals).
- Uncommon (more than 1 but less than 10 animals in 1,000 animals).
- Rare (more than 1 but less than 10 animals in 10,000 animals).
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).
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.
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AN: 00276/2016
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4.8. Interaction with other medicinal products and other forms of interaction
The veterinary medicinal product must not be administered in conjunction with, or
within 24 hours of administration of other 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.
4.9. Amounts to be administered and administration route
Cattle: Intramuscular use or Intravenous use
3 mg ketoprofen/kg body weight/day(equivalent to 3 mlof the product/100 kg
b.w./day) for up to 3 days.
Pigs: Intramuscular use
3 mg ketoprofen/kg body weight/day(equivalent to 3 ml of the product/100 kg
b.w./day) administered once.
Horses: Intravenous use
2.2 mg ketoprofen/kg body weight/day(equivalent to 1 ml of the product/45 kg
b.w./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.
4.10. 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
(15mg/kg/day) the recommended dose for 5 days, or to pigs at 3 times (9mg/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.
4.11. Withdrawal periods
Cattle, horses, pigs:
Meat and offal: 4 days
Milk (bovine): Zero hours
Not authorised for use in mares producing milk for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, nonsteroids
ATCvet code: QM01AE03.
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AN: 00276/2016
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5.1 . Pharmacodynamic properties
Ketoprofen isa 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
partiallyby 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. PHARMACEUTICAL PARTICULARS
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.
Revised: March 2017
AN: 00276/2016
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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 productsor 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.