Product Description
INDICATIONS:
Used for neurological diseases caused by severe vitamin B1, B6 and B12 deficiencies that cannot be remedied by means of oral therapy.
DOSAGE AND MODE OF ADMINISTRATION:
Vitamin B1 + B6 + B12 Injection 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.
CONTRAINDICATIONS:
Hypersensitivity to the active substances or to any of the excipients.
WARNINGS AND PRECAUTIONS:
Vitamin B1 + B6 + B12 Injection 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.
PREGNANCY AND LACTATION:
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 Vitamin B1 + B6 + B12 Injection.
STORAGE CONDITIONS:
Store at temperatures not exceeding 30°C.
DOSAGE FORMS AND PACKAGING AVAILABLE:
Dosage form: Solution for Injection (I.M)
Packaging available: 3 mL Type I amber glass ampoule in a plastic tray (Box of 10's)
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