Thiamine multichem

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Thiamine hydrochloride 50mg (+5% manufacturing overage);  ;  ;  

Available from:

Multichem NZ Limited

INN (International Name):

Thiamine hydrochloride 50 mg (+5% manufacturing overage)

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Thiamine hydrochloride 50mg (+5% manufacturing overage)       Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Units in package:

Bottle, plastic, HDPE bottle with polypropylene cap (100 tablets), 100 tablets

Class:

General sale

Prescription type:

General sale

Manufactured by:

DSM Nutritional Products GmbH

Product summary:

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

Authorization date:

1969-12-31

Summary of Product characteristics

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