BEVITINE 100 mg/2 ml

Thiamin hydrochloride
Solution for injection

Treatment of vitamin B1 deficiency when oral therapy is not possible.
FORMS and PRESENTATIONS
Solution for injection 100 mg/2 ml: Ampoules of 2 ml, pack of 5.
COMPOSITION
Solution for injection : per amp
Thiamin (INN) hydrochloride, anhydrous 100 mg
(as thiamin hydrochloride: 104 mg/amp)
Excipients: thiomalic acid, sodium hydroxide, disodium phosphate dodecahydrate, water for injections.
INDICATIONS
Solution for injection:
Treatment of vitamin B1 deficiency when oral therapy is not possible.
DOSAGE AND ADMINISTRATION
Solution for injection:
IM/IV route.
One to two 100-mg ampoules daily. In some cases, a higher intravenous dose may be necessary (up to 1000 mg/day).
If the dosage exceeds 2 ampoules per day, the dose should be fractionated over 24 hours.
In case of intravenous administration, the product must be injected slowly over more than 10 minutes (cf Warnings
and Precautions for Use).
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients
WARNINGS and PRECAUTIONS FOR USE
Solution for injection: thiamin may cause reactions of the type anaphylactic shock. The prescriber must have suitable
resuscitation equipment available.
PREGNANCY and LACTATION
Pregnancy:
There are no teratogenicity studies available in animals.
In exposed pregnancies, no fetal malformation or toxicity has been reported to date. However, the follow-up of
pregnancies exposed to this medicinal product is insufficient to rule out a risk.
Therefore, as a precaution, this medicinal product should preferably not be used during pregnancy.
Lactation:
As thiamin is excreted in breast milk and in the absence of data on the effects of this excretion, this treatment should
be avoided during lactation.
UNDESIRABLE EFFECTS
Solution for injection:
Fleeting hypotension.
Isolated cases: anaphylactic shock.
PHARMACODYNAMICS
Vitamin B1 (A: alimentary tract and metabolism).
PHARMACOKINETICS
Thiamin is absorbed from the small intestine. It diffuses into all tissues. It is not stored, even after excessive intake. It
is eliminated in the urine as metabolites.
Thiamin is excreted in breast milk.
PRESCRIPTION/SUPPLY/REIMBURSEMENT
Marketing Authorization No. 301 111.6 (1948/96 revised 1997) sol inj.
Price: 2.81 (5 ampoules for inj).
65% reimbursement by national health insurance. Healthcare establishments.