País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
vitamin B1, vitamin B2, vitamin B6, dexpanthenol, nicotinamide
Arpimed LLC
A11BA
vitamin B1, vitamin B2, vitamin B6, dexpanthenol, nicotinamide
5mg/ml+ 2mg/ml+ 2mg/ml+ 3mg/ml+ 20mg/ml
solution for injection
(10/2x5/) ampoules 2ml, in blister
Prescription
Registered
2018-03-26
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 Leia o documento completo