B-PLEX 100- thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, dexpanthenol, niacinamide injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Merit Pharmaceutical

INN (International Name):

THIAMINE HYDROCHLORIDE

Sammensætning:

THIAMINE HYDROCHLORIDE 100 mg in 1 mL

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

HOW SUPPLIED:   Vitamin B-Complex 100 Injection is available in a 30mL multiple dose vial individually boxed. 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.

Autorisation status:

unapproved drug other

Produktets egenskaber

B-PLEX 100- THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM,
PYRIDOXINE HYDROCHLORIDE,
DEXPANTHENOL, NIACINAMIDE INJECTION, SOLUTION
MERIT PHARMACEUTICAL
_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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B PLEX 100
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 100mg, Riboflavin 5'
Phosphate Sodium 2mg, Pyridoxine
Hydrochloride 2mg, Dexpanthenol 2mg, 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 my occur (See WARNINGS). Use
should be discontinued upon
observa