NOZINAN Tablets (2017)
Βιβλιογραφική αναφορά
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
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
Nozinan 25mg Tablets.
Qualitative and quantitative composition
Levomepromazine maleate 25mg per tablet. For excipients, see 6.1.
Pharmaceutical form
Tablets. Circular, greyish-white cream, biconvex uncoated tablet. One face with Nozinan around a central 25 and a breakline on the reverse.
Therapeutic indications
Nozinan is a neuroleptic with indications in psychiatry and general medicine, particularly in terminal illness. Clinically it is more sedative and more potent than chlorpromazine in the management of psychotic ...
Posology and method of administration
Dosage varies with the condition under treatment and the individual response of the patient. Terminal illness Nozinan tablets 25mg may be substituted for the injection if oral therapy is more convenient, ...
Contraindications
Safety in pregnancy has not been established. There are no absolute contraindications to the use of Nozinan in terminal care.
Special warnings and precautions for use
The drug should be avoided, or used with caution, in patients with liver dysfunction or cardiac disease. The hypotensive effects of Nozinan should be taken into account when it is administered to patients ...
Interaction with other medicinal products and other forms of interaction
Combinations requiring precaution Cytochrome P450 2D6 Metabolism: Levomepromazine and its non-hydroxylated metabolites are reported to be potent inhibitors of cytochrome P450 2D6 (CYP2D6). Co-administration ...
Fertility, pregnancy and lactation
Pregnancy Safety in pregnancy has not been established. Neonates exposed to antipsychotics (including Nozinan) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal ...
Effects on ability to drive and use machines
Nozinan can cause drowsiness, disorientation, confusion or excessive hypotension, which may affect the patients ability to drive or operate machinery.
Undesirable effects
Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000;<1/100); rare (≥1/10,000;<1/1,000); very rare ...
Overdose
Symptoms of levomepromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias hypothermia and convulsions. Severe extrapyramidal dyskinesias ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antipsychotics ATC Code: NO5AA02 Levomepromazine resembles chlorpromazine and promethazine in the pattern of its pharmacology. It possesses anti-emetic, antihistamine and anti-adrenaline ...
Pharmacokinetic properties
Maximum serum concentrations are achieved in 2 to 3 hours depending on the route of administration. Excretion is slow, with a half-life of about 30 hours. It is eliminated via urine and faeces.
Preclinical safety data
There are no pre-clinical safety data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
List of excipients
Potato starch Calcium hydrogen phosphate Magnesium stearate Sodium lauryl sulfate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months for blister pack. 60 months for polyethylene or polypropylene containers. Not all pack sizes may be marketed.
Special precautions for storage
Store below 25°C. Store in original container and protect from light.
Nature and contents of container
PVC/PVdC/aluminium foil blister pack containing 84 tablets. OR High density polyethylene bottle with flip cap or polypropylene tablet container. Each pack contains 500 tablets. Not all pack sizes may be ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Aventis Pharma Limited, One Onslow StreetGuildford, Surrey, GU1 4YS, UK or trading as Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 04425/0658
Date of first authorization / renewal of the authorization
19<sup>th</sup> June 2009
Date of revision of the text
06 January 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
