Modecate 25mg/1ml solution for injection ampoules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Fluphenazine decanoate

Dostępny od:

Sanofi

Kod ATC:

N05AB02

INN (International Nazwa):

Fluphenazine decanoate

Dawkowanie:

25mg/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intramuscular

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04020200; GTIN: 5012712000525

Charakterystyka produktu

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