Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
KetoProPig 100mg/ml Oral Solution For Pigs
Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Presentation
Each ml contains:
Active substance: Ketoprofen: 100 mg
Excipients: Benzyl Alcohol: 20 mg
Uses
Symptomatic treatment for reduction of pyrexia in cases of acute infectious respiratory disease in fattening pigs in combination with an appropriate anti-infective therapy.
Dosage and administration
The veterinary medicinal product is administered by oral route, diluted in drinking water. Administration over a 24 hour period is recommended.
The recommended daily dose is 3mg of ketoprofen/kg bodyweight equivalent to 0.03ml of KetoProPig 10% Oral Solution per kg bodyweight.
Duration of treatment: 1 day. Based on the risk-benefit assessment of the veterinarian additional administration for another 1-2 days at the most can be considered.
Correct administration:
Medicated water should be the only water supply during the period of treatment. Medicated water should be refreshed every 24 hours. The product may be put directly into the header tank or introduced via a water proportioner pump. Once the treatment period has finished, the pigs should be given unmedicated water.
The water intake of the pigs to be treated should be measured before calculating the total amount of product to be administered each day.
The following calculation should be made to determine the quantity of KetoProPig 100mg/ml Oral Solution in ml to be added to the daily consumption of drinking water.
0.03 ml product/ | Average body weight (kg) | |
kg bodyweight/day | x | of the animals to be treated |
Average amount of drinking water/animal (l) | ||
| ||
= ml product / l of drinking water | ||
To prevent overdosing, pigs should be grouped according to bodyweight and an average bodyweight estimated as accurately as possible.
Contra-indications, warnings, etc
For Animal Treatment Only.
Do not use in case of hypersensitivity to ketoprofen.
Do not use in animals known to be allergic to aspirin.
Do not use in gestating animals.
Do not use in pigs already suffering from gastric ulcers in order not to aggravate their situation.
Adverse Reactions:
Feed intake may decrease due to the treatment and the gastric ulcers induced by the treatment. In tolerance studies ulcers have been observed in up to 70% of the treated animals.
When administration is performed over a 24 hour period, no severe ulcers were identified. In a punctuated administration of the product (maximal 3 hours for administration), at least 12% of severe ulcers were identified. Three days after the cessation of dosing, gastric ulcers generally recover (with some residual scarring) or are in the process of recovery/cicatrisation.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Special warnings:
Avoid use in dehydrated, hypovolaemic or hypotensive pigs, as there is a potential risk of increased renal toxicity. Use in very young animals may involve additional risks; however, if used, animals require careful clinical management.
As ketoprofen is ulcerogenic, the use is not recommended in case PMWS (Post-weaning multisystemic wasting syndrome) because ulcers are already frequently associated with this pathology. Do not exceed the recommended dose to reduce the risk of adverse reactions. To limit the appearance of ulcers, administration over a 24 hour period is recommended. For safety reasons the administration of the product must not exceed a maximum treatment period of three days.
Do not use in pigs suffering from cardiac, hepatic or renal disease or gastrointestinal problems, where there is the possibility of gastro-intestinal ulceration or bleeding or where there is evidence of a blood dyscrasia.
Do not use in case of hypersensitivity to ketoprofen or to any of the excipients. Do not use in animals known to be allergic to aspirin. If serious adverse events such as signs of ulcers or gastrointestinal haemorrhage occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects. Do not administer corticosteroids or other NSAIDs concurrently or within 24 hours of each other. The treatment-free period, however, should take into account the pharmacological properties of the products used previously. KetoProPig 100mg/ml must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs. The concomitant administration of active substances that are highly plasma protein bound may demonstrate a competitive effect with the ketoprofen with the possibility of consequent toxic effects due to the unbound fraction of the drug.
Avoid combining with anticoagulant drugs, particularly coumarin derivatives such as warfarin.
User warnings:
Personal protective equipment consisting of rubber gloves and safety glasses should be worn when mixing the veterinary medicinal product.
In the case of accidental spillage onto skin, the affected area should be washed immediately with soap and water. In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. Seek medical advice if irritation persists.
Contaminated clothing should be removed and any splashes on to the skin should be washed off immediately. Wash hands after use. Hypersensitivity reactions (skin rash, urticaria) could occur. People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product.
Pharmaceutical precautions
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 4 months
Shelf-life after dilution: 24 hours
Legal category
POM-V
Packaging Quantities
1 litre white HDPE containers coated with fluorinated polymers, provided with white polypropylene caps with screw top and sealed with a three layer-seal.
Each container is provided with a polypropylene cup measuring device graduated from 10 up to 75 ml.
Further information
Ketoprofen, 2-(phenyl 3benzoyl) propionic acid, is a nonsteroidal anti-inflammatory drug belonging to the arylpropionic acid group. Ketoprofen inhibits the biosynthesis of PGE2 and PGF2 alpha without affecting the ratio of PGE2/PGF2 alpha and thromboxanes. Ketoprofen possesses anti-inflammatory, analgesic and antipyrectic activity. The anti-inflammatory activity is increased by an enantiomer conversion from the (R) to the (S) form. Indeed, the (S) form is known to support the major anti-inflammatory activity of ketoprofen.
Disposal:
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Marketing authorisation number
Vm 01596/4361.
Significant Changes
New product | 25/07/2008 |