Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Oxytetracycline
Chem-Pharm Limited
QJ01AA06
Oxytetracycline
200 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
oxytetracycline
Antibacterial
Authorised
1998-10-01
Chem-Pharm Limited Maxoject LA 200 mg/ml Solution for Injection Part 1b-spc-pl Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Maxoject LA 200mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Oxytetracycline (as Oxytetracycline Dihydrate) 200 mg Excipient Sodium Formaldehyde Sulphoxylate 2 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear amber solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep, pigs and piglets. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Oxytetracycline is active against a wide range of Gram-positive and Gram-negative pathogenic bacteria, certain rickettsia and the larger viruses. Maxoject LA is indicated in the treatment of a wide range of common systemic, respiratory and local infections caused by or associated with organisms sensitive to oxytetracycline in cattle, sheep and pigs. 4.3 CONTRAINDICATIONS Do not use in animals suffering from hepatic or renal damage. Do not use in animals with known hypersensitivity to Oxytetracycline. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Chem-Pharm Limited Maxoject LA 200 mg/ml Solution for Injection Part 1b-spc-pl Page 2 of 12 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not dilute Maxoject LA. If concurrent treatment is administered, use a separate injection site. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS In case of contact with eyes or skin, wash immediately with water as irritation may occur. Wash hands after use. Take care to avoid accidental injection. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Although well tolerated, occasionally a slight local reaction of a transient nature has been observed. Hypersensitivity reactions, including anaphylaxis (sometimes fatal), have been reported very rarely. 4.7 USE DURING PREGNANCY, LACTATION OR LAY The use of tetracycline during the period of Lesen Sie das vollständige Dokument