VITAMIN B COMPLEX 100- vitamin b complex injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)

Available from:

Fisiopharma SRL

INN (International Name):

THIAMINE HYDROCHLORIDE

Composition:

THIAMINE HYDROCHLORIDE 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist. Sensitivity to the ingredients listed

Product summary:

Vitamin B-Complex 100 Injection NDC 71414-225-01 30 mL Multi-Dose Vial, individually boxed. Rx Only. Phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. Do not use product if these do not redissolve on warming to body temperature and shaking well. Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The colour does not affect the safety or efficacy of the product. PROTECT FROM LIGHT: Store in carton until contents are used . Store under refrigeration 2° to 8°C (36° to 46°F). Do not permit to freeze. Manufactured for: FLON LABORATORIES LLC Elkhorn, NE 68022 U.S.A www.flonlabs.com 225PI REV: 06/17

Authorization status:

unapproved drug other

Summary of Product characteristics

VITAMIN B COMPLEX 100- VITAMIN B COMPLEX INJECTION
FISIOPHARMA SRL
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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VITAMIN B-COMPLEX 100 INJECTION
DESCRIPTION:
Vitamin B-Complex 100 Injection is a sterile solution for
intramuscular or slow intravenous injection
comprised of vitamins which may be categorized as belonging to the
vitamin B complex group. Each
mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate
Sodium 2 mg, Pyridoxine
Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl
Alcohol 2% as
preservative, in Water for Injection. Sodium Hydroxide and/or
Hydrochloric Acid may have been used
to adjust pH.
INDICATIONS AND USAGE:
In disorders requiring parenteral administration of vitamins, i.e.
pre- and post-operative treatment, when
requirements are increased as in fever, severe burns, increased
metabolism, pregnancy, gastrointestinal
disorders interfering with intake or absorption of vitamins, prolonged
or wasting diseases, alcoholism
and where other deficiencies exist.
CONTRAINDICATIONS:
Sensitivity to the ingredients listed
WARNINGS:
Anaphylactogenesis may occur with parenteral thiamine. Use with
caution. An intradermal test dose is
recommended prior to administration in patients suspected of being
sensitive to the drug.
PRECAUTIONS:
The usual precautions for parenteral administration should be
observed. Do not inject if precipitation
occurs. Inject slowly by the intravenous route. High concentrations
should be diluted using Normal
Saline Injection when given intravenously.
ADVERSE REACTIONS:
Mild transient diarrhea, polycythemia vera, peripheral vascular
thrombosis, itching transitory
exanthema, feeling of swelling of entire body, anaphylactic shock and
death. Sensitivity to the
ingredients listed may occur (see WARNINGS). Use should be
discontinued upon observance of any
untoward reaction. Pain upon intramuscular injection m