Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CEFALEXIN (AS CEFALEXIN SODIUM)
Norbrook Laboratories Limited
QJ01DB01
CEFALEXIN (AS CEFALEXIN SODIUM)
180 Mg/Ml
Suspension for Injection
POM
Bovine, Canine
Cefalexin
Antibacterial
Authorised
2002-06-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Solvasol Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Cefalexin 180 mg (as cefalexin sodium) Base to 1 ml For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. An off-white to cream oily suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections caused by, or associated with organisms sensitive to cefalexin in cattle and dogs. When susceptible organisms are present, Solvasol Injection is indicated in the treatment of infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissues in dogs. In dogs it may also be effective in the treatment of infections of the gastrointestinal tract. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to cephalosporins. Do not inject intravenously or intrathecally. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 14/11/2016_ _CRN 7023649_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Accumulation may occur when renal function is impaired. Use with caution in cases of known renal insufficiency. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle thi Read the complete document