NITOMAN Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Nitoman 25 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 25 mg of Tetrabenazine. <u>Excipients:</u> Contains Lactose Monohydrate 64 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Yellowish-buff, circular, bevel-edged tablets having CL25 imprinted on one face and a single scoreline on the other. The tablet can be divided into equal halves.
4.1. Therapeutic indications
In the control of disorders of movement associated with organic disease of the central nervous system, such as Huntingtons chorea, hemiballismus and senile chorea.
4.2. Posology and method of administration
Posology Adults Proper dosing of tetrabenazine involves careful titration of therapy to determine an individualised dose for each patient. When first prescribed, tetrabenazine therapy should be titrated ...
4.3. Contraindications
Tetrabenazine is contraindicated in patients: With hypersensitivity to the active substance (tetrabenazine) or to any of the excipients listed in section 6.1 Who are actively suicidal With untreated or ...
4.4. Special warnings and precautions for use
The dose of tetrabenazine should be titrated to determine the most appropriate dose for each patient. In vitro and in vivo studies indicate that the tetrabenazine metabolites α- HTBZ and β- HTBZ are substrates ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed in vivo. The metabolising enzymes of tetrabenazine are partly unknown. In vitro-studies indicate that tetrabenazine may be an inhibitor of CYP2D6 and therefore ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no adequate and well controlled studies for the use of tetrabenazine in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. ...
4.7. Effects on ability to drive and use machines
Tetrabenazine may cause drowsiness and therefore may impair the ability to drive and use machines.
4.8. Undesirable effects
Blood & lymphatic system disorders <u>Very rare (≤1/10,000):<u> Leukopaenia, Neutropenia Immune system disorders <u>Very rare (≤1/10,000):<u> Hypersensitivity Metabolism and nutrition disorders <u>Common ...
4.9. Overdose
Symptoms associated with overdoses of tetrabenazine may include acute dystonia, oculogyric crisis, nausea, vomiting, diarrhoea, sweating, hypotension, confusion, hallucinations, hypothermia, sedation, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other nervous system drugs <b>ATC Code:</b> N07XX06 Tetrabenazine is a synthetic derivative of benzylquinolizine that causes depletion of dopamine and other monoamines ...
5.2. Pharmacokinetic properties
Absorption and Distribution Tetrabenazine is quickly and mostly absorbed after oral administration. Its absorption is not affected by the taking of food. Clinical testing has shown that a single oral dose ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and ...
6.1. List of excipients
Lactose monohydrate Maize starch Talc Magnesium stearate Iron oxide yellow, (E172)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Five years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
A white HDPE bottle containing 112 tablets with a white HDPE cap.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA2280/003/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 1 April 1994 Date of last renewal: 1 April 2009
10. Date of revision of the text
May 2019
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