NEUROBION Solution for injection Ref.[4436] Active ingredients: Pyridoxine Vitamin B1 Vitamin B12

Neurobion 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. Therefore, regular monitoring is recommended under long-term treatment.

Neurobion ampoules must not be used in children below the age of 14 years (due to their high active substance content).

Each ampoule contains 42 mg sodium. This is to be taken into account in persons under sodium-restricted diet (low in table salt/sodium).

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 serum 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 decrease the efficacy of vitamin B₆ (pyridoxine).

Long term use of acid-lowering agents may lead to vitamin B₁₂ deficiency.

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.

Breast-feeding

Vitamins B₁, B₆ and B₁₂ are secreted into human breast milk. High concentrations of vitamin B₆, i.e. >600 mg daily, 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 Neurobion.

Neurobion 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 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data).

Nervous system disorders

Not known: Long-term intake (>6-12 months) of a daily dosage >50 mg vitamin B6 may cause peripheral sensory neuropathy.

Gastrointestinal disorders

Not known: 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

Not known: Allergic reactions, eczematous skin alterations and a benign form of acne have been observed after high-dose vitamin B₁₂.

Renal and urinary disorders

Not known: Chromaturia (“reddish urine”, appeared during the first 8 hours after an administration and typically resolves within 48 hours).

General disorders and administration site conditions

Not known: Injection-site reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Pharmaceutical Services, Ministry of Health, CY-1475, website: www.moh.gov.cy/phs, Fax: +357 22608649.

It is not recommended to use Neurobion 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.