Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluphenazine decanoate
Sanofi
N05AB02
Fluphenazine decanoate
25mg/1ml
Solution for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020200; GTIN: 5012712000532
OBJECT 1 MODECATE INJECTION 25MG/ML Summary of Product Characteristics Updated 13-Jan-2014 | SANOFI 1. Name of the medicinal product Modecate Injection 25mg/ml. 2. Qualitative and quantitative composition Each ampoule contains 25mg/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. 3. Pharmaceutical form Solution for Injection Pale yellow clear, oily liquid. 4. Clinical particulars 4.1 Therapeutic indications For the treatment and maintenance of schizophrenic patients and those with paranoid psychoses. While Modecate injection has been shown to be effective in acute states, it is particularly useful in the maintenance treatment of chronic patients who are unreliable at taking their oral medication, and also of those who do not absorb their oral phenothiazine adequately. 4.2 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 fluphenazine formulation: Initially 0.5ml ie 12.5mg (0.25 ml ie 6.25mg for patients over 60) by deep intramuscular injection into the gluteal region. The onset of action generally appears between 24 and 72 hours after injection and the effects of the drug on psychotic symptoms become significant within 48 to 96 hours. Subsequent injections and the dosage interval are determined in accordance with the patient's response. When administered as maintenance therapy, a single injection may be effective in controlling schizophrenic symptoms for up to four weeks or longer. It is desirable to maintain as much flexibility in the dose as possible to achieve the best therapeutic response with the least side-effects; most patients are successfully maintained within the dose range 0.5ml (12.5mg) to 4.0ml (100mg) given at a dose interval of 2 to 5 weeks. Patients previously maintained on oral fluphenazine: It is not Przeczytaj cały dokument