Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, Greece: NEUROBION Sol. (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Α.Ε.
Διεύθυνση :
41-45 Kifisias ave. (Building B'), 15123, Marousi, Athens, Greece
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Neurobion ampoules.

Qualitative and quantitative composition

3 ml of aqueous solution (1 ampoule) contains: Thiamine chloride hydrochloride (vitamin B1): 100 mg Pyridoxine hydrochloride (vitamin B6): 100 mg Cyanocobalamin (vitamin B12): 1 mg Excipients: Contains ...

Pharmaceutical form

Solution for injection Red, clear solution.

Therapeutic indications

Neurological diseases caused by severe vitamin B1, B6 and B12 deficiencies that cannot be remedied by means of oral therapy.

Posology and method of administration

For intramuscular administration. Neurobion ampoules are to be administered intramuscularly (by deep intragluteal injection). In severe (acute) cases: One ampoule daily until the acute symptoms subside. ...

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Special warnings and precautions for use

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. ...

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 B1 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 B6 The ...

Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ATC Code: A11DB Neurobion ampoules contain a combination of neurotropic active substances of the vitamin B complex. ...

Pharmacokinetic properties

Thiamine The elimination half-life is approx. 4 hours. The human body can store approx. 30 mg thiamine. On account of the rapid metabolisation, the reserve capacity, at 4-10 days, is very limited. Pyridoxine ...

Preclinical safety data

The toxicity of vitamins B1, B6 and B12 is very low. The data available to date do not suggest any potential risk for humans. The literature available on the subject does not contain any findings indicating ...

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 B1 is completely degraded by sulphite-containing infusion solutions. Other vitamins, ...

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

No specific notes.

Marketing authorization holder

Merck A.E. 41-45 Kifisias ave. (Building B') 15123 Marousi Athens Greece

Marketing authorization number(s)

795

Date of first authorization / renewal of the authorization

05/04/1971

Date of revision of the text

07/08/2012

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 78,6 KB