Modecate Concentrate 50mg/0.5ml solution for injection ampoules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Fluphenazine decanoate

Verfügbar ab:

Sanofi

ATC-Code:

N05AB02

INN (Internationale Bezeichnung):

Fluphenazine decanoate

Dosierung:

100mg/1ml

Darreichungsform:

Solution for injection

Verabreichungsweg:

Intramuscular

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04020200; GTIN: 5012712000495

Fachinformation

OBJECT 1
MODECATE CONCENTRATE INJECTION 100MG/ML
Summary of Product Characteristics Updated 25-Mar-2015 | SANOFI
1. Name of the medicinal product
Modecate Concentrate Injection 100mg/ml.
2. 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.
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 concentrate 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 0.125ml ie. 12.5mg (0.0625ml 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
0.125ml (12.5mg) to 1ml (100mg) given at a dose interval of 2 to 5
weeks.
Patients previously