国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Nandrolone laurate
CP-Pharma Handelsgesellschaft mbH
QA14AB01
Nandrolone laurate
25 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
nandrolone
Authorised
2019-09-27
Health Products Regulatory Authority 02 October 2019 CRN0098LM Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nandrosol 25 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Nandrolone laurate 25 mg (equivalent to nandrolone 15 mg) EXCIPIENT(S): Benzyl alcohol (E1519) 104 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear yellowish oily solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Indicated for use in dogs and cats as an adjunctive treatment for conditions in which anabolic therapy is considered to be beneficial. 4.3 CONTRAINDICATIONS Do not use in pregnant animals. Do not use in animals with hypercalcaemia. Do not use in animals with androgenic dependent tumours. Do not use in breeding animals. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Anabolic therapy is to induce an improvement in clinical signs rather than a cure. The animal should therefore be carefully examined for potential pre-existing disease and the anabolic therapy should be combined with treatment of this underlying disease, if present. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals This product contains benzyl alcohol, which has been documented to cause adverse reactions in neonates. For this reason, use of the product is not recommended in very young animals. Special care (particularly in geriatric patients) should be taken when administering the product to animals with compromised cardiac or renal function because of the potential of anabolic steroids to increase sodium and water retention. The product should be administered with caution to animals with severe hepatic dysfunction. The liver function of treat 完全なドキュメントを読む