Complex Vitamin B Injection,USP
Contents of the pack and other information
What VB-PLEX 100 contains
• Each ampoule of this medicine contains Vitamin B1 (thiamine hydrochloride) 100mg, Vitamin B6 (pyridoxol hydrochloride) 100mg, Vitamin B12 ( cyanocobalamin) 1mg as the active ingredient.
• There’s no excipient used in the product.
What VB-PLEX 100 looks like and contents of the pack
VB-PLEX 100 is a clear red solution which comes in a brown glass ampoule. Each box contains 5 ampoules of the injection in a plastic tray.
DESCRIPTION
1.What VB-PLEX 100 is and what it is used for
VB-PLEX 100 is a combination of the essentiak-essential neurotropic factors of the vitamin B complex of the following compositions in 3ml solution for injection per ampoule :
Vitamin B1 (thiamine hydrochloride) 100mg Vitamin B6 (pyridoxol hydrochloride) 100mg Vitamin B12 ( cyanocobalamin) 1mg
VB-PLEX 100 is used for neurological diseases caused by severe vitamin B1, B6 and B12 deficiencies that cannot be remedied by means of oral therapy.
The favourable effect of these components of the vitamin B complex is an established of the B factors often shows a considerably increased therapeutic effect as compared to that of single factors, which is especially advantageous in severe disorders.
The promoters of this nutritional formulation are of the opinion that it is more effective in providing vitamin B to the body than other modes of administration (tablets and gels). According to them, the body enzymes and acids alter the molecular structure of the vitamins once they are ingested. In recent times, many weight conscious people are relying on vitamin B12 injections for weight loss.
2. What you need to know before you take VB-PLEX 100
Do not use VB-PLEX 100 if you are hypersensitivity to any ingredients in this product.
Take special care before taking VB-PLEX 100:
• VB-PLEX 100 must not be administered by intravenous injection. Short-term parenteral vitamin B12 administration may temporarily impair the diagnosis of funicular myelosis or pernicious anemia.
• If symptoms of peripheral sensory neuropathy (paraesthesia) occur, the dosage should be reviewed and treatment with the medicinal product discontinued, if necessary. Neuropathies have been observed under long-term administration (over 6-12 months) of daily dosages exceeding 50 mg vitamin B6 as well as in short-term administration (over 2 months) of more than 1 g vitamin B6 per day.
• VB-PLEX 100 may be used in children and adolescents only in the case of compelling reasons.
Pregnancy, breast-feeding and fertility
Do not recommended in pregnancy and breast-feeding women. Large amount of Vitamin B6 administered by pregnancy may result in vitamin B6 dependency of new born babies.
DIRECTION
1.How to take VB-PLEX 100
For intramuscular administration.
VB-PLEX 100 is to be administered intramuscularly (by deep intragluteal injection).
In severe (acute) cases: One ampoule daily until the acute symptoms subside.
After improvement of symptoms: One ampoule 1-3 times per week. There is only limited experience with therapy in children and adolescents.
Complex Vitamin B coated tablets are recommended for supporting or continuing ongoing injection therapy and for relapse prophylaxis.
2. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the following, the undesirable effects are classified by organ system and frequency. The assessment of undesirable effects is based on the following frequency grouping:
Very common (1/10) Common (1/100, <1/10) Uncommon (1/1,000, <1/100) Rare (1/10,000, < 1/1,000) Very rare (< 1/10,000)
Unknown (frequency not estimatable on the basis of the data available) Nervous system disorders:
Unknown: Long-term intake (> 6-12 months) of a daily dosage > 50 mg vitamin B6 may cause peripheral sensory neuropathy.
Gastrointestinal disorders:
Unknown: Gastrointestinal complaints such as nausea, vomiting, diarrhoea and abdominal pain.
Immune system disorders:
Very rare: Hypersensitivity reactions such as sweating, tachycardia and skin reactions like itching and urticaria, as well as anaphylaxis.
Skin and subcutaneous tissue disorders:
Unknown: Allergic reactions, eczematous skin alterations and a benign form of acne have been observed after high-dose vitamin B12.
General disorders and administration site conditions: Unknown: Injection-site reactions.
INGREDIENTS
Contents of the pack and other information
What VB-PLEX 100 contains
• Each ampoule of this medicine contains Vitamin B1 (thiamine hydrochloride) 100mg, Vitamin B6 (pyridoxol hydrochloride) 100mg, Vitamin B12 ( cyanocobalamin) 1mg as the active ingredient.
• There’s no excipient used in the product.
What VB-PLEX 100 looks like and contents of the pack
VB-PLEX 100 is a clear red solution which comes in a brown glass ampoule. Each box contains 5 ampoules of the injection in a plastic tray.
STORE
How to store VB-PLEX 100
VB-PLEX 100 must not be used after the expiry date ‘EXP’ shown on the container. Keep out of the reach and sight of children.
Store in sealed containers, protected from light.
