MODECATE Solution for injection (2015)
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Περιεχόμενα
Name of the medicinal product
Modecate Concentrate Injection 100mg/ml.
Qualitative and quantitative composition
Each ampoule contains 100mg/ml of the active substance Fluphenazine Decanoate. Also contains sesame oil (q.s.). Benzyl alcohol 15 mg/ml. For full list of excipients, see section 6.1.
Pharmaceutical form
Solution for Injection. Pale yellow clear, oily liquid.
Therapeutic indications
For the treatment and maintenance of schizophrenic patients and those with paranoid psychoses. While Modecate concentrate injection has been shown to be effective in acute states, it is particularly useful ...
Posology and method of administration
Dosage and Administration Adults It is recommended that patients be stabilised on the injection in hospital. Recommended dosage regimes for all indications: A. Patients without previous exposure to a depot ...
Contraindications
The product is contraindicated in the following cases: Comatose states Marked cerebral atherosclerosis Phaeochromocytoma Renal failure Liver failure Severe cardiac insufficiency Severely depressed states ...
Special warnings and precautions for use
Caution should be exercised with the following: Liver disease Renal impairment Cardiac arrhythmias, cardiac disease Thyrotoxicosis Severe respiratory disease Epilepsy, conditions predisposing to epilepsy ...
Interaction with other medicinal products and other forms of interaction
The possibility should be borne in mind that phenothiazines may: Increase the central nervous system depression produced by drugs such as alcohol, general anaesthetics, hypnotics, sedatives or strong analgesics. ...
Pregnancy and lactation
Use in pregnancy The safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighed against the potential benefits when administering this ...
Effects on ability to drive and use machines
The use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery.
Undesirable effects
Side effects Acute dystonic reactions occur infrequently, as a rule within the first 24-48 hours, although delayed reactions may occur. In susceptible individuals they may occur after only small doses. ...
Overdose
Overdosage should be treated symptomatically and supportively, extrapyramidal reactions will respond to oral or parenteral anti-parkinsonian drugs such as procyclidine or benzatropine. In cases of severe ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics; Phenothiazines with piperazine structure ATC code: N05AB02 Fluphenazine decanoate is an ester of the potent neuroleptic fluphenazine, a phenothiazine derivative ...
Pharmacokinetic properties
Plasma level profiles of fluphenazine following intramuscular injection have shown half-lives of plasma clearance ranging from 2.5-16 weeks, emphasising the importance of adjusting dose and interval to ...
Preclinical safety data
Not applicable.
List of excipients
Benzyl alcohol Sesame oil
Incompatibilities
None.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store below 25°C. Keep the ampoules in the outer carton in order to protect from light.
Nature and contents of container
Colourless type I glass ampoules with an OPC (one point cut) breaking system containing 0.5ml (packs of 10) and 1ml (packs of 5). Prefilled syringe with neoprene or pharma-gummi rubber plunger and stopper ...
Special precautions for disposal and other handling
No special requirements.
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 04425/0575
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 March 1996 Date of latest renewal: 23 September 2002
Date of revision of the text
23 March 2015
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