Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Iron(iii) ion, toltrazuril
Bayer Animal Health GmbH
QP51AJ51
toltrazuril, iron (III) ion
Pigs (piglets)
toltrazuril, combinations
For the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by Cystoisospora suis, and prevention of iron deficiency anaemia.
Authorised
2019-05-20
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: BAYCOX IRON 36 MG/ML + 182 MG/ML SUSPENSION FOR INJECTION FOR PIGLETS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen Germany Manufacturer responsible for batch release: Produlab Pharma BV Raamsdonksveer 4941 SJ Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: ACTIVE SUBSTANCES: Toltrazuril 36.4 mg Iron (III) 182 mg (as gleptoferron 484.7 mg) EXCIPIENTS: Phenol 5 mg Slightly viscous dark brown suspension. 4. INDICATION(S) For the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by _Cystoisospora suis_ , and prevention of iron deficiency anaemia. 5. CONTRAINDICATIONS Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 18 6. ADVERSE REACTIONS Transient discolouration of the tissue and/or slight swelling may be observed commonly at the site of injection. Anaphylactic reactions may occur rarely. Deaths have been reported rarely in piglets following the administration of parenteral iron injections. These deaths have been associated with genetic factors or deficiencies of vitamin E and/or selenium. Piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 anim Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: Toltrazuril 36.4 mg Iron (III) 182 mg (as gleptoferron 484.7 mg) EXCIPIENTS: Phenol 5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Slightly viscous dark brown suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (piglets 48 to 72 hours after birth). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by _Cystoisospora suis,_ and prevention of iron deficiency anaemia. 4.3 CONTRAINDICATIONS Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Neonatal piglets may experience clinical signs similar to those due to coccidiosis (such as diarrhoea) for numerous reasons (e.g. other pathogens, stress). Should clinical signs be observed in the two weeks following administration of the product, the responsible veterinarian should be informed. Frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance. It is recommended to administer the product to all the piglets in a litter. 3 Once clinical signs of coccidiosis are evident, damage to the small intestine will have already occurred. Therefore, the product should be administered to all animals before the expected onset of clinical signs, that is, in the prepatent period. Hygienic measures may reduce the risk of porcine coccidiosis. It is therefore recommended to concomitantly improve the hygiene conditions in the farm concerned, particularly by increasing dryness and cleanliness. The product Read the complete document