VITAMIN B COMPLEX- thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Mylan Institutional LLC

INN (Tarptautinis Pavadinimas):

THIAMINE HYDROCHLORIDE

Sudėtis:

THIAMINE 100 mg in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Vitamin B-Complex 100 Injection is available in a 30 mL 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. 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: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 0415L107 Revised: 9/2021 MI:VITBIJ:R4

Autorizacija statusas:

unapproved drug other

Prekės savybės

VITAMIN B COMPLEX- THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE
SODIUM,
DEXPANTHENOL AND NIACINAMIDE INJECTION
MYLAN INSTITUTIONAL LLC
_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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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.
transitory exanthema, feeling of swelling of entire body, anaphylactic
shock and death.
Sensitivity to the ingredients listed may occ