Company name: Alstoe Ltd
Address: The Industrial Park
Sheriff Hutton
York
YO60 6RZ
Telephone: 01347 878606
Fax: 01347 878333
Email: info@alstoe.co.uk
Website: www.alstoe.co.uk
Pracetam 200 mg/mL Solution for use in drinking water for Pigs
Company name: Alstoe Ltd
Address: The Industrial Park
Sheriff Hutton
York
YO60 6RZ
Telephone: 01347 878606
Fax: 01347 878333
Email: info@alstoe.co.uk
Website: www.alstoe.co.uk
Solution for use in-drinking water. Clear viscous solution, slightly pink to pinkish. Colour may intensify over time.
Target species
Pigs.
Indications for use
Symptomatic treatment of fever in the context of respiratory diseases in combination with an appropriate anti infective therapy, if necessary.
Contra-indications
Do not use in animals with known hypersensitivity to paracetamol and to any other ingredients of the product,
Do not use in animal with severe hepatic impairment,
Do not use in animal with severe renal impairment.
Do not use in animal suffering from dehydration or hypovolaemia
Special warnings for each target species
Animals with reduced water intake and/or disturbed general condition have to be treated parenterally.
In case of combined viral and bacterial aetiology of the disease, an appropriate anti infective therapy should be given concomitantly.
Special precautions for use
None
Adverse reactions
In rare cases, at therapeutic doses, transient soft faeces can occur and can persist up to 8 days after the withdrawal of administration. It does not have any effect on general condition of animals, and resolve without any specific treatment
Use during pregnancy or lactation
Studies in laboratory animals have not detected any teratogenic nor foetotoxic effects at therapeutic doses. The administration of the product up to three times the recommended dose, during pregnancy or lactation, didn't result in adverse effects. So the product may be administered during pregnancy and lactation.
Interactions
Concurrent administration of nephrotoxic drugs should be avoided.
Amounts to be administered and administration route
In drinking water use 30 mg of paracetamol per kg body weight and per day, for 5 days, orally, administered in the drinking water, equivalent to 1.5 ml of Pracetam Solution per 10 kg body weight and per day for 5 days. The intake of medicated drinking water depends on the clinical condition of the animals. In order to obtain a correct dosage, the concentration in the drinking water must be adjusted accordingly.
Recommendation for dissolution: The product is easily dissolved in ambient temperature water (20°C to 25°C). When using the product through a water proportioner, adjust the proportioner from 5% to 3%. Do not set proportioners under 3%.
Overdose
After administration of 5 times the recommended dose of paracetamol, liquid faeces with solid particles may occasionnally occur. It does not have any effect on general body condition of animals.
Acetylcysteine can be used in case of accidental overdosage.
Withdrawal periods
Zero Days
Pharmacodynamic properties
Paracetamol or acetaminophen or N-acetyl-p-aminophenol is a paraminophenol derivative with analgesic and antipyretic properties.
Pharmacokinetic properties
Absorption: Paracetamol is rapidly and almost completely absorbed after oral administration (bioavailability of about 90% after administration in the drinking water). Peak concentrations are reached in a little less than 2 hours after ingestion.
Metabolism: Paracetamol is mainly metabolised in the liver. The two major metabolic pathways are conjugation to glucuronate and conjugation to sulphate. The latter route is rapidly saturable at dosages higher than therapeutic doses. A minor pathway, catalysed by cytochrome P450 (CYP), leads to the formation of the intermediary reagent, N-acetyl-benzoquinoneimine which, under normal conditions of use, is rapidly detoxified by reduced glutathione and removed in urine after conjugation with cystein and mercapturic acid. On the contrary, after massive intoxication, the quantity of this toxic metabolite is increased.
Elimination: Paracetamol is mainly eliminated in the urine. In the pig, 63% of the ingested dose is eliminated by the kidneys in 24 hours mainly conjugated to glucuronate and suphate. Less than 5% is eliminated in unchanged form. The elimination half-life is approximately 5 hours.
Excipients
Macrogol 300
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
After first opening: 1 year.
After dilution in the drinking water: 24 hours.
Special precautions for storage
Store below 25 °C
Do not Freeze
Immediate packaging
High density polyethylene bottle
High density polyethylene screwcap
Polyethylene-aluminium-wax-paper-low density polyethylene seal(1 Litre bottle)
Polyethylene-PET-aluminium-wax-cardboard seal (2 Litre, 5 Litre and 10 Litre bottles)
Not all pack sizes will be marketed
Disposal
Any unused veterinary medicinal product or waste material from such veterinary medicinal product should be disposed of in accordance with local requirements.
Wear appropriate protective clothing, gloves and a mask and goggles to protect the face and eyes. If the product comes in contact with the skin or eyes, flush immediately with a large amount of water. If symptoms persist, seek medical advice. To rule out any risk of ingestion it is recommended not to eat, or drink while using Pracetam and to wash the hands after use. In the case of ingestion of the product, consult a doctor.