Vitamin B Complex solution for injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

vitamin B1, vitamin B2, vitamin B6, dexpanthenol, nicotinamide

Disponibil de la:

Arpimed LLC

Codul ATC:

A11BA

INN (nume internaţional):

vitamin B1, vitamin B2, vitamin B6, dexpanthenol, nicotinamide

Dozare:

5mg/ml+ 2mg/ml+ 2mg/ml+ 3mg/ml+ 20mg/ml

Forma farmaceutică:

solution for injection

Unități în pachet:

(10/2x5/) ampoules 2ml, in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-03-26

Caracteristicilor produsului

SUMMARY PRODUCT CHARACTERISTIC (SPC)
VITAMIN B COMPLEX
SOLUTION FOR INJECTION
FOR I/M INJECTION
1.1. NAME OF THE MEDICINAL PRODUCT– VITAMIN B
COMPLEX
1.2.INTERNATIONAL NONPROPRIETARY OR GENERIC NAME – Pyridoxine
hydrochloride, Riboflavin,
Thiamine hydrochloride, Dexpanthenol, Nicotinamide.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule (2 ml) contains:
pyridoxine hydrochloride (vitamin B
6
) - 4mg, riboflavin (vitamin B
2
), - 4mg, thiamine
hydrochloride (vitamin B
1
), – 10mg, dexpanthenol (vitamin B
5
) - 6mg, nicotinamide (vitamin
PP). – 40mg.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
A transparent yellow solution with a specific odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of clinical and sub-clinical vitamin B deficiency
states (manifestations of
which include glossitis, stomatitis, cheilosis, the heart
manifestations of beriberi, the skin
manifestations of pellagra, corneal vascularisation and polyneuritis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Vitamin B complex injection is usually well tolerated. It must be
slowly injected. (See SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
_ADULTS _
A therapeutic dose of (1 ampoule) 2 mL daily
is recommended by
slowly intramuscular
injection. Once daily for up to 7 days.
_ELDERLY:_ As for adults.
_PATIENTS WITH RENAL IMPAIRMENT_: no limitations.
4.3 CONTRAINDICATIONS
-
Sensitivity to the ingredients listed.
-
Haemophilia, intestinal mechanical obstruction (dexpanthenol)
-
Sever cases of hepatic insufficiency
-
Pernicious or other forms of anemia
-
Pediatric age (0-12 years)
-
Stage 2 and stage 3 hypertension
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The usual precautions for parenteral administration should be
observed. Do not inject if
precipitation occurs.
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