Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany
Neurological diseases caused by severe vitamin B1, B6 and B12 deficiencies that cannot be remedied by means of oral therapy.
In severe (acute) cases: One ampoule daily until the acute symptoms subside.
After improvement of symptoms: One ampoule 1-3 times per week.
Neurobion ampoules are contraindicated in children below 14 years (see section 4.3).
For intramuscular administration.
Neurobion ampoules are to be administered intramuscularly (by deep intragluteal injection).
Neurobion coated tablets are recommended for supporting or continuing ongoing injection therapy and for relapse prophylaxis.
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.
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. These symptoms improve gradually upon vitamin discontinuation.
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.
Allergic reactions, eczematous skin alterations and a benign form of acne have been observed after high-dose parenteral administration.
3 years.
Store in the refrigerator (at 2°C to 8°C). Store the ampoules in the original carton to protect them from light.
Amber glass ampoules (Type I) with 3 ml injection solution.
Package sizes: 3 Ampules.
Not all pack sizes may be marketed.
Do not re-use syringes and needles. Syringes and needles must be disposed immediately after use.
Used syringes and needles must not be disposed in waste bins or toilets, but they must be disposed in a special sharps container.
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