Target species
Pigs (weaned pigs).
Indications for use, specifying the target species
Symptomatic treatment for reduction of pyrexia, in the context of acute infectious respiratory diseases, in combination with appropriate anti-infective therapy.
Contraindications
Do not use in animals with known hypersensitivity to paracetamol.
Do not use the product if there are animals with hepatic or renal impairment, or hypovolaemic animals.
Also see Interactions with other medicinal products.
Special warnings for each target species
Animals with reduced appetite and/or disturbed general condition have to be treated parenterally.
Special precautions for use
Special precautions for use in animals
The product is a premix that must not be given to pigs before it has been mixed with solid feed at the minimum rate of 5 kg/ton.
Special precautions to be taken by the person administering the medicinal product to animals
Persons with known hypersensitivity to paracetamol should avoid any contact with the medicated feed. In order to avoid contact with skin, mucous membranes and/or eyes use gloves, CE-approved anti-dust mask and protecting spectacles when handling the medicated feed. In case of contact with skin and/or eyes rinse generously with clean water. Seek medical advice if, following exposure, signs such as skin rash or persistent eye irritation develop.
Adverse reactions (frequency and seriousness)
No side effects have been seen following administration of the medicinal product at the therapeutic dose.
Use during pregnancy, lactation or lay
The safety has been shown in studies with pregnant and lactating sows when using the product in 3 times of the recommended dose.
Interactions with other medicinal products and other forms of interaction
Concurrent administration of nephrotoxic drugs should be avoided.
No interactions described with commonly used antibiotics. Concomitant treatment should be considered case by case.
The safety of the co-administration of the product and feed supplemented with vitamin E or polyunsatured fatty acids has not been established. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Amounts to be administered and administration route
The daily dose is 30 mg per kg bodyweight for 5 consecutive days to be administered in feed.
The dose can be administered in dry feed supplied in two meals.
The product may be administered in pellets as well as non-pelleted feed.
For the preparation of medicated feed:
30 mg paracetamol per kg bodyweight daily corresponds to 300 mg “Pracetam 10% premix” per kg bodyweight daily.
For the preparation of the medicated feed the bodyweight of the animals to be treated and their actual daily intake of feed should be taken into due account. To provide the required amount of active substance per kg medicated feed the premix has to be incorporated into the feed according to the following formula:
300 mg "Pracetam 10% premix" per kg bodyweight daily | x | average bodyweight (kg) of animals to be treated | |
______________________________________________________________________________________ | = mg "Pracetam 10% premix" per kg of feed |
average daily feed intake per animal (kg) | |
The mixing should be performed in an (authorised) feeding stuff manufacture with adequate mixing apparatus.
Overdose (symptoms, emergency procedures, antidotes) if necessary
No adverse effects have been demonstrated in pigs administered up to 10x the recommended dose.
Acetylcysteine can be used in case of accidental overdosage
Withdrawal periods
Meat and offal: 1 Day