NEUROBION Solution for Injection 100mg, 1mg

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

即購入

ダウンロード 製品の特徴 (SPC)
08-06-2024

有効成分:

THIAMINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN

から入手可能:

Merck Serono Limited

投薬量:

100mg, 1mg

医薬品形態:

Solution for Injection

承認日:

1998-04-01

製品の特徴

                                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
                                
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