Apo-Thiamine

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

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Hent Produktets egenskaber (SPC)
30-05-2008

Aktiv bestanddel:

Thiamine hydrochloride 10mg;  

Tilgængelig fra:

Apotex NZ Ltd

INN (International Name):

Thiamine hydrochloride 10 mg

Dosering:

10 mg

Lægemiddelform:

Tablet

Sammensætning:

Active: Thiamine hydrochloride 10mg  

Enheder i pakken:

Bottle, plastic, HDPE, 100 tablets

Klasse:

General sale

Recept type:

General sale

Fremstillet af:

Shanghai Yuansen Medicine Raw Material Co Ltd

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE (500 tablet) - 500 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisation dato:

1969-12-31

Produktets egenskaber

                                NEW ZEALAND DATA SHEET
THIAMINE MULTICHEM
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Thiamine multichem, 50mg, tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50mg tablet contains 50mg of thiamine hydrochloride.
Excipients with known effect
Thiamine multichem contains Lactose. If you have been told by your
doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Thiamine multichem 50mg tablets are white, round, 8mm in diameter,
biconvex, engraved with
“APO’ on one side and “THI” over “50”on the other side.
Each tablet contains 50mg thiamine
hydrochloride.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Prophylaxis and treatment of vitamin B1 deficiency states including
beriberi and Wernicke’s
encephalopathy.
4.2
Dose and Method of administration
Dose
In preventing vitamin deficiencies adequate dietary intake is
preferred over supplementation
whenever possible. An adequate human diet in most circumstances is one
containing between
0.8 and 1.5mg vitamin B
1
daily.
The usual adult dose to treat deficiency is 5-30mg either as a single
or in divided doses. In severe
thiamine deficiency including treatment of beriberi doses of up to
300mg daily in three divided
doses may be given.
Method of administration
In severe thiamine deficiency including treatment of beriberi doses of
up to 300mg daily in
three divided doses may be given. Even higher daily
doses may be given in Wernicke’s
encephalopathy although the intravenous route is usually chosen under
these circumstances.
4.3
Contraindications
Hypersensitivity to vitamin B
1
.
4.4
Special warnings and precautions for use
Serious sensitivity reactions can occur with deaths having resulted
from I.V. use.
NEW ZEALAND DATA SHEET
THIAMINE MULTICHEM
Page 2 of 5
Simple vitamin B1 deficiency is rare. Multiple vitamin deficiencies
should be suspected in any
case of dietary inadequacy.
4.5
Interaction with other medicines and oth
                                
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