NEUROBION Solution for injection (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | P&G Health Germany GmbH |
|---|---|
| Διεύθυνση | Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany |
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Περιεχόμενα
Name of the medicinal product
Neurobion ampoules.
Qualitative and quantitative composition
<u>3 ml of aqueous solution (1 ampoule) contains:</u> Thiamine chloride hydrochloride (vitamin B<sub>1</sub>) 100 mg. Pyridoxine hydrochloride (vitamin B<sub>6</sub>) 100 mg. Cyanocobalamin (vitamin B ...
Pharmaceutical form
Solution for injection. Red, clear solution.
Therapeutic indications
Neurological diseases caused by severe vitamin B<sub>1</sub>, B<sub>6</sub> and B<sub>12</sub> deficiencies that cannot be remedied by means of oral therapy.
Posology and method of administration
Posology In severe (acute) cases: One ampoule daily until the acute symptoms subside. After improvement of symptoms: One ampoule 1-3 times per week. Paediatric population Neurobion ampoules are contraindicated ...
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Children below the age of 14 years (due to the high doses of the active ingredients).
Special warnings and precautions for use
Neurobion ampoules must not be administered by intravenous injection. Short-term parenteral vitamin B<sub>12</sub> administration may temporarily impair the diagnosis of funicular myelosis or pernicious ...
Interaction with other medicinal products and other forms of interaction
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 ...
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. ...
Effects on ability to drive and use machines
Neurobion ampoules do not affect the capability to drive a vehicle or to operate machinery.
Undesirable effects
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 ...
Overdose
Vitamin B<sub>1</sub> 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 ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vitamin B<sub>1</sub> in combination with vitamin B<sub>6</sub> and/or vitamin B<sub>12</sub> <b>ATC Code:</b> A11DB Neurobion ampoules contain a combination of neurotropic ...
Pharmacokinetic properties
Combined administration of vitamins B<sub>1</sub>, B<sub>6</sub> and B<sub>12</sub> is not expected to have a negative effect on the pharmacokinetics of the individual vitamins. Thiamine (vitamin B<sub> ...
Preclinical safety data
The toxicity of vitamins B<sub>1</sub>, B<sub>6</sub> and B<sub>12</sub> is very low. The data available to date do not suggest any potential risk for humans. The literature available on the subject does ...
List of excipients
Sodium hydroxide (for pH adjustment) Potassium cyanide Water for injection
Incompatibilities
It is not recommended to use Neurobion ampoules together with other drugs in a mixed injection or infusion. Vitamin B<sub>1</sub> is completely degraded by sulphite-containing infusion solutions. Other ...
Shelf life
3 years.
Special precautions for storage
Store in the refrigerator (at 2°C to 8°C). Store the ampoules in the original carton to protect them from light.
Nature and contents of container
Amber glass ampoules (Type I) with 3 ml injection solution. Package sizes: 3 Ampules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany
Marketing authorization number(s)
795
Date of first authorization / renewal of the authorization
05/04/1971
Date of revision of the text
10/04/2020
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