Neurobion Ampoules 3 ml Solution for Injection
PDF Leaflet Revision Date: 02 February 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Indicated for restoring Vitamin B1, B6, and B12 levels and managing neuropathies.
Dosage (summary)
Inject intramuscularly; specific dosage not provided.
Special Populations
- Children under 14 years
- Patients on Levodopa therapy
Pregnancy & Breastfeeding
Safety in pregnancy/lactation not established; may inhibit breast milk production.
Key Drug Interactions
- Vitamin B6 may decrease L-DOPA effect
- Pyridoxine antagonists may decrease Vitamin B6 efficacy
- Loop diuretics may decrease Vitamin B1 levels
- Acid-lowering agents may lead to Vitamin B12 deficiency
Contraindications
- Hypersensitivity to components
- Children under 14 years
- Patients on Levodopa therapy
Common side effects
- Hypersensitivity reactions
- Gastrointestinal complaints
- Injection site reactions
Counselling Points
- Report any adverse reactions
- Avoid breastfeeding while on treatment
Serious warnings
- May mask Vitamin B12 deficiency symptoms
- Regular monitoring recommended for long-term use
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
NEUROBION AMPOULES are indicated for:
- Restoring Vitamin B 1 , B 6 and/or B 12 levels.
- The prevention and treatment of deficiencies in vitamin B 1 , B 6 and B 12.
NEUROBION AMPOULES assist with the management of neuropathies.
4.2 Posology and method of administration
NEUROBION AMPOULES are preferably injected intramuscularly (deep intragluteal).
4.3 Contraindications
- Hypersensitivity to Vitamin B 1 , B 6 and/or B 12 or any of the excipients of NEUROBION AMPOULES (see section 6.1).
- Children below the age of 14 years (due to the high doses of the active ingredients).
- NEUROBION AMPOULES should not be used in patients on Levodopa therapy.
4.4 Special warnings and precautions for use
NEUROBION AMPOULES should not be given for Vitamin B 12 deficiency before a diagnosis has been fully established, because of the possibility of masking symptoms of subacute degeneration of the spinal cord. NEUROBION AMPOULES are not a suitable form of Vitamin B 12 for the treatment of optic neuropathies associated with raised plasma concentrations of Vitamin B 12. Neuropathies are described in the literature following long-term intake (6 - 12 months) of more than 50 mg mean daily dose of vitamin B 6. Therefore, regular monitoring is recommended if NEUROBION AMPOULES are given over longer periods of time.
4.5 Interactions with other medicines and other forms of interaction
- Vitamin B 6 (pyridoxine) may decrease the effect of L-DOPA.
- Pyridoxine antagonists such as isoniazide, cycloserine, penicillamine, or hydralazine may decrease the efficacy of Vitamin B 6 (pyridoxine).
- Long-term use of loop diuretics such as furosemide may accelerate the elimination and thus decrease the serum levels of Vitamin B 1 (thiamine).
- Long term use of acid-lowering agents may lead to Vitamin B 12 deficiency.
4.6 Fertility, pregnancy and lactation
The safety of this preparation in pregnancy and lactation has not been established. Vitamins B 1 , B 6 and B 12 (the components of NEUROBION AMPOULES) are secreted into human breast milk, but risks of overdose for the infant are not known. High doses of Vitamin B 6 , i.e. > 600 mg daily, may inhibit the production of breast milk. Mothers on NEUROBION AMPOULES should not breastfeed their infants.
4.7 Effects on ability to drive and use machines
No effects of the product on the ability to drive or use machines are known.
4.8 Undesirable effects
As most undesirable effects are based on post-marketing spontaneous reporting, frequency estimation is not possible.
Immune system disorders
Frequency not known: Hypersensitivity reactions, such as sweating, tachycardia, and skin reactions with itching and urticaria.
Gastrointestinal disorders
Less frequent: Gastrointestinal complaints, such as nausea, vomiting, diarrhoea and abdominal pain.
Skin and subcutaneous tissue disorders
Less frequent: Cases of acne or eczema have been reported after high doses of Vitamin B12.
General disorders and administration site conditions
Frequency not known: Injection site reactions.
Renal and urinary disorders
Less frequent: Chromaturia (u201creddish urineu201d, appeared during the first 8 hours after an administration and typically resolves within 48 hours).
4.9 Overdose
Sensorial neuropathy and other sensorial neuropathy syndromes which can be caused by long-term administration of high doses of pyridoxine improve gradually upon vitamin discontinuation.
