国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
THIAMINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN
Merck Serono Limited
100mg, 1mg
Solution for Injection
1998-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neurobion Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear red sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjuvant therapy in the management of peripheral neuropathy related to vitamin B complex deficiency. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For administration by slow, deep intramuscular injection. One ampoule daily until the acute symptoms resolve. One ampoule two or three times a week as treatment maintenance. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the active ingredients. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE The content of pyridoxine may interfere with the effects of concurrent levodopa therapy. Very rarely hypersensitivity reactions to vitamin B injection have been reported. These reactions are usually associated with intravenous administration and, unless otherwise indicated the intramuscular route is to be preferred. Mild allergic reactions such as sneezing or mild asthma are warning signs that further injections may give rise to anaphylactic shock. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Patients treated with L-dopa should not take high doses of pyridoxine and thus Neurobion, as pyridoxine attenuates the effect of L-dopa. Thiamine hydrochloride 100 mg Pyridoxine hydrochloride 100 mg Cyanocobalamin 1 mg For excipients, see 6.1 1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 01/12/2005_ _CRN 2017419_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Neurobion should not be used during pregnancy unless considered essential by a physician. There is no information on whether the administration of these vitamins leads 完全なドキュメントを読む