Nefotek 100mg/ml solution for injection 100ml POM

Nefotek 100mg/ml solution for injection for cattle, horses and pigs.

Target species
Cattle, pigs and horses

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

Special warnings for each target species
None

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.

Adverse reactions (frequency and seriousness)
In very rare cases (less than 1 animal in 10,000 animals, including isolated reports) 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

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 effect 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 case according to the benefit/risk assessment by the responsible veterinarian.

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.

Amounts to be administered and administration route
Cattle: Intramuscular use or Intravenous use
3 mg ketoprofen/kg b.w/day (equivalent to 3 ml of the product /100 kg b.w/day) for up to 3 days.

Pigs: Intramuscular use
3 mg ketoprofen/kg b.w./day (equivalent to 3 ml of the product /100 kg b.w./day)administered once.

Horses: Intravenous use
2.2 mg ketoprofen/kg b.w./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.

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.

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.

Pharmaceutical particulars
List of excipients
L Arginine
Benzyl alcohol (E1519)
Citric acid monohydrate (for pH adjustment)
Water for injection

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

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.

Special precautions for storage
Keep the container in the outer carton. Protect from light.
Do not refrigerate or freeze.

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 1unit.
Not all pack sizes may be marketed.

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.