Kraj: Hiszpania
Język: angielski
Źródło: HMA (Heads of Medicines Agencies)
ivermectin 10 mg/ml
Virbac de Portugal Laboratorio Lda
QP54AA1
Solution for injection
Ivermectin
Pigs
2010-12-20
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VIRBAMEC 10 mg/ml injectable solution for swine solution for injection for swine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCE: Ivermectin 10.00 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection White or yellowish-white, crystalline powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Swine. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of GASTRO-INTESTINAL ROUNDWORMS (ADULT AND FOURTH-STAGE LARVAE) : Ascaris suum (adult and L4) Hyostrongylus rubidus (adult and L4) Oesophagostomum spp. (adult and L4) Strongyloides ransomi (adult) LUNGWORMS Metastrongylus spp. (adult) SUCKING LICES Haematopinus suis MANGE MITES Sarcoptes scabiei var. suis 4.3 CONTRAINDICATIONS Do not use by the intramuscular or intravenous route. Do not use in case of known hypersensitivity to the active ingredient. See also section 4.7. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken to avoid the following practices because they increase the risk of development of resistence and could ultimately result in ineffective therapy: - Too frequent and repeated usse of anthelmintics from the same class, over an e xtended period of time. - Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device. Suspected clinical cases of resistance to anthelmint Przeczytaj cały dokument