Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate
Interchem Ireland Ltd
QJ01CA04
Amoxicillin trihydrate
150 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
amoxicillin
Antibacterial
Authorised
2012-06-08
Health Products Regulatory Authority 30 January 2018 CRN000V5N Page 1 of 4 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Promox LA 150 mg/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Amoxicillin (as Amoxicillin Trihydrate) 150 mg For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM A white to off white suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of diseases caused by a wide range of Gram-positive and Gram-negative organisms including: _Clostridium spp._ _Corynebacterium spp._ _Erysipelas spp._ _Fusiformis spp._ _Haemophilus spp._ _Pasteurella spp._ _Salmonella spp._ _Streptococci_ _Staphylococci_. SPECIFIC INDICATIONS Pneumonia, skin and soft tissue infections, abscesses, wounds, joint/navel ill. 4.3 CONTRAINDICATIONS Not for intravenous administration. Health Products Regulatory Authority 30 January 2018 CRN000V5N Page 2 of 4 Do not use in animals with known hypersensitivity to the active ingredients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Massage the injection site after administration. In adult cattle, the volume should be divided between two injection sites. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. Allergic reaction to these substances can occasionally be serious. 1. Do not handle this product if you know you are Lestu allt skjalið