Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Paracetamol
SP Veterinaria, S.A.
QN02BE01
Paracetamol
300 milligram(s)/millilitre
Solution for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
paracetamol
Authorised
2019-08-02
_[Version 9,03/2022] corr. 11/2022 _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PIRESOL 300 mg/ml solution for use in drinking water for pigs DK: APIRETAM 300 mg/ml solution for use in drinking water for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Paracetamol 300.00 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t Benzyl alcohol (E 1519) 0.01 ml Azorubine (E 122) 0.025 mg Macrogol 300 Dimethylacetamide Saccharin Sodium Purified water Red, clear solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Symptomatic treatment of fever in the context of respiratory diseases in combination with an appropriate anti infective therapy, if necessary. 3.3 CONTRAINDICATIONS - Do not use in cases of hypersensitivity to the active substance or to any of the excipients. - Do not use in animals with severe hepatic impairment. - Do not use in animals with severe renal impairment. See also section 3.8. - Do not use in animals suffering from dehydration or hypovolaemia. 3.4 SPECIAL WARNINGS The anti-pyretic effect of the veterinary medicinal product is expected at 12 - 24 hours after the onset of treatment. The intake of medicated water by animals may be altered as a consequence of illness. In case of insufficient water intake, animals should be treated parenterally instead. In case of combined viral and bacterial aetiology of the disease, an appropriate anti infective therapy should be given concomitantly. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals This veterinary medicinal product may cause hypersensitivity (allergy). People with known hypersensitivity to paracetamol or any of the excipients Prečítajte si celý dokument