NOZINAN Solution for injection / infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Nozinan 25mg/ml Solution for Injection/Infusion.
Qualitative and quantitative composition
Levomepromazine hydrochloride 25mg per ml. For excipients, see 6.1.
Pharmaceutical form
Solution for injection/infusion. Clear, colourless solution contained in a clear glass ampoule.
Therapeutic indications
Management of the terminally ill patient. Levomepromazine resembles chlorpromazine and promethazine in the pattern of its pharmacology. It possesses anti-emetic, antihistamine and anti-adrenaline activity ...
Posology and method of administration
Intramuscular and intravenous injection Dosage varies with the condition and individual response of the patient. Nozinan injection may be administered by intramuscular injection or intravenous injection ...
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
Ascorbic acid Anhydrous sodium sulphite Sodium chloride Water for injections
Incompatibilities
Incompatible with alkaline solutions.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Protect from light.
Nature and contents of container
Colourless type I glass ampoule. Each pack contains 10 ampoules.
Special precautions for disposal and other handling
Nozinan may be administered by intramuscular injection or intravenous injection after dilution with an equal volume of normal saline, or by continuous subcutaneous infusion with an appropriate volume of ...
Marketing authorization holder
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 04425/0659
Date of first authorization / renewal of the authorization
12<sup>th</sup> June 2009
Date of revision of the text
30 August 2017
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