- Metabolic disorders.
- Different types of anemia including; sideroblastic, megaloblastic and pernicious anemia.
- Peripheral neuritis.
- Demyelination and other neurological disorders.
- Chronic and acute beri-beri.
- To improve fat, carbohydrate and amino acid metabolism.
- Depletion or increased demands of vitamins B1, B6, and B12.
- Neuralgic pain of various origins such as Herpes zoster and/or nerve damage due to diabetes
or chronic alcoholism.

For intramuscular administration.
Neurovit ampoules are 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.
Neurovit coated tablets are recommended for supporting or continuing ongoing injection therapy and for relapse prophylaxis.

Neurovit ampoules 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.
Neurovit ampoules may be used in children and adolescents only in the case of compelling reasons.
Each ampoule contains traces of potassium.

Thiamine is inactivated by 5-fluorouracil as the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.
Loop diuretics, e.g. furosemide that inhibit tubular reabsorption may cause increased excretion of thiamine in long-term therapy and, thus, lowering of the thiamine level.
If taken simultaneously with L-dopa, vitamin B6 can lessen the dopa effect.

The simultaneous administration of pyridoxine antagonists (e.g. isoniazide (INH), hydralazine, D-penicillamine or cycloserine) may increase the vitamin B6 requirement.
Beverages containing sulphite (e.g. wine) enhance thiamine degradation.

Pregnancy:
There are only insufficient animal studies on the effect of this medicinal product on pregnancy, embryo-foetal, prenatal and postnatal development. The possible risk for human beings is not known. The treating physician should decide about the use of this product during pregnancy after carefully weighing the risk-to-benefit ratio.
Lactation:
Vitamins B1, B6 and B12 are secreted into human breast milk. High concentrations of vitamin B6 can inhibit the production of breast milk. Data on the extent of secretion into breast milk from animal studies are not available. Therefore, the advantages of breast-feeding for the infant should be carefully weighed against the therapeutic benefit for the women in order to decide to either discontinue breast-feeding or therapy with Neurovit.

Neurovit ampoules do not affect the capability to drive a vehicle or to operate machinery.

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.

Vitamin B1:
Thiamine has a broad therapeutic range. Very high doses (over 10 g) have a ganglion-blocking effect, similar to that of curare, and suppress the conduction of nerve impulses.
Vitamin B6:
The toxic potential of vitamin B6 can be considered as very low. Long-term treatment (> 6-12 months) of a daily dosage > 50 mg vitamin B6 may, however, cause peripheral sensory neuropathy.
Continuous intake of vitamin B6 at a daily dosage of more than 1 g over more than two months may produce neurotoxic effects.

Neuropathies with ataxia and sensitivity disorders, cerebral convulsions with EEG changes as well as, in individual cases, hypochromic anaemia and seborrhoeic dermatitis have been described after administration of more than 2 g daily.
Vitamin B12:
Allergic reactions, eczematous skin alterations and a benign form of acne have been observed after high-dose parenteral administration.

Pharmacotherapeutic group: Vitamin B1 in combination with vitamin B6 and/or vitamin B12
Neurovit ampoules contain a combination of neurotropic active substances of the vitamin B complex. The vitamins thiamine (B1), pyridoxine (B6) and cyanocobalamin (B12) contained play a particular role as coenzymes in the intermediary metabolism of the central and peripheral nervous system.
Like all other vitamins, they are essential nutrients which the body cannot synthesize itself.
Therapeutic supply of vitamins B1, B6 and B12 balances deficiencies due to inadequate nutritive vitamin intake and thus ensures the availability of the required quantities of coenzymes.
Animal and clinical studies have indicated antinociceptive activity of vitamin B1, B6 and B12.

Thiamine:
The elimination half-life is approx. 4 hours.
The human body can store approx. 30 mg thiamine. On account of the rapid metabolisation, the reserve capacity, at 4-10 days, is very limited.
Pyridoxine:
Approx. 40 to 150 mg can be stored; 1.7 to 3.6 mg is excreted in the urine per day.

Cyanocobalamin:
Vitamin B12 is stored predominantly in the liver; the daily requirement is 1 μg. The turnover rate is 2.5 μg B12 per day, or 0.05% of the stored quantity.
Vitamin B12 is mainly secreted into bile and largely reabsorbed during the enterohepatic circulation.

The toxicity of vitamins B1, B6 and B12 is very low. The data available to date do not suggest any potential risk for humans.
The literature available on the subject does not contain any findings indicating that vitamins B1, B6 and B12 have carcinogenic, mutagenic or teratogenic properties.
Chronic toxicity: In animals, very high doses of vitamin B1 cause bradycardia. Other symptoms are blockade of vegetative ganglia and motor end plates. The oral administration of 150–200 mg of vitamin B6/kg body weight/day over a period of 100-107 days caused ataxia, muscular asthenia, disorders of balance, as well as degenerative changes of axons and myelin sheaths in dogs. Animal studies also showed incidences of convulsions and impaired coordination after high doses of vitamin B6.
Mutagenic and tumorigenic potential: Mutagenic effects of vitamin B1 and vitamin B6 are not to be expected under the conditions of clinical use.
There are no long-term animal studies available on the tumorigenic potential of thiamine and vitamin B6. Reproduction toxicity: Thiamine is transported actively to the foetus. Concentrations in the foetus and the newborn exceed maternal concentrations of vitamin B1.
Systematic investigations on human embryonal and foetal development in connection with the use of vitamin B1 at doses exceeding the stated daily requirements are not available.
Vitamin B6 is insufficiently investigated in animal studies. An embryotoxicity study in rats gave no indications of a teratogenic potential. In male rats the administration of very high doses of vitamin B6 induced damage to spermatogenesis.

Sodium Acetate Trihydrate.
Benzyl Alcohol.
Disodium Edetate.
Ferric Ammonium Citrate.
Water for injection.

It is not recommended to use Neurovit ampoules together with other drugs in a 'mixed injection' or infusion.
Vitamin B1 is completely degraded by sulphite-containing infusion solutions.
Other vitamins, especially cyanocobalamin, may be inactivated in the presence of vitamin B1 degradation products.

Store below 25°C.

A chromo-duplex carton box containing a pamphlet and a plastic anti-shock tray (containing 3 brown glass ampoules, each of 3 ml).

No special requirements.