Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
amoxicillin trihydrate 100 g/Kg
LABORATORIOS MAYMÓ, S.A.
QJ01CA04
Medicated premix
amoxicillin
Pigs
2011-05-13
* M aymoxi 100 g/kg Premezcla // M aymoxi 10 Premix // M aymoxi 10 Pré-mistura medicamentosa para suínos ES/V/0125/001/IB/002 –SPC Date: 24/03/2011 1/8 I.B. SUMMARY OF PRODUCT CHARACTERISTICS, LABEL AND PACKAGE INSERT I.B.1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MAYMOXI 100 G/KG PREMEZCLA MAYMOXI 10 PREMIX MAYMOXI 10 PRÉ-MISTURA MEDICAMENTOSA PARA SUÍNOS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each kg of product contains: ACTIVE SUBSTANCE: Amoxicillin (trihydrate) 100 g For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Medicated premix 4. CLINICAL PARTICULARS 4.1. TARGET SPECIE S Porcine (weaned pigs). 4.2. INDICATIONS FOR USE Prevention and treatment of respiratory infections caused by _Streptococcus suis_ sensible to amoxicillin in weaned piglets. 4.3. CONTRAINDICATIONS Do not use in case of hypersensitivity to penicillins. Do not administer orally to rabbits, guinea pigs and hamsters, due to the fact that amoxicillin, as well as all other aminopenicillins, has an important action on the cecal bacterial population. Do not use in equine, due to the fact that amoxicillin, as well as all other aminopenicillins, has an important action on the cecal bacterial population. Do not administer orally to animals with functional rumen. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None. * M aymoxi 100 g/kg Premezcla // M aymoxi 10 Premix // M aymoxi 10 Pré-mistura medicamentosa para suínos ES/V/0125/001/IB/002 –SPC Date: 24/03/2011 2/8 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR U Read the complete document
ES/ V/0125/ 001/ R/001 – Final SPC 1/9 I.B. SUMMARY OF PRODUCT CHARACTERISTICS AND LABEL/LEAFLET I.B.1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Maymoxi 100 g/kg Premezcla medicamentosa (ES) Maymoxi 100g/kg Premiscela per suini (IT) Maymoxi 10 Pré-mistura medicamentosa para suínos (PT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each kg of product contains: ACTIVE SUBSTANCE: Amoxicillin (trihydrate) .................. 100 g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff. White powder. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Porcine (weaned piglets). 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Prevention and treatment of respiratory infections caused by _Streptococcus suis_ sensible to amoxicillin in weaned piglets. The presence of the disease in the herd should be established before the preventive treatment. 4.3. CONTRAINDICATIONS Do not use in case of hypersensitivity to penicillins_ _or cephalosporins or to any of the excipients. Do not use in case resistance to penicillins or cephalosporins occurs. Do not administer to rabbits, guinea pigs and hamsters, due to the fact that amoxicillin, as well as all other aminopenicillins, has an important action on the cecal bacterial population. Do not use in equine, due to the fact that amoxicillin, as well as all other aminopenicillins, has an important action on the cecal bacterial population. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES The inge Read the complete document