Modecate

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Fluphenazine decanoate 25 mg/mL (26.88mg added to provide 25mg/ml plus a 7.5% excess.)

Tilgængelig fra:

Bristol-Myers Squibb (NZ) Limited

INN (International Name):

Fluphenazine decanoate 25 mg/mL (26.88mg added to provide 25mg/ml plus a 7.5% excess.)

Dosering:

25 mg/mL

Lægemiddelform:

Injection (depot)

Sammensætning:

Active: Fluphenazine decanoate 25 mg/mL (26.88mg added to provide 25mg/ml plus a 7.5% excess.) Excipient: Benzyl alcohol Nitrogen Sesame oil

Enheder i pakken:

Ampoule, glass, 1ml One Point Cut ampoule, 5 dose units

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Fine Chemicals Corporation (Pty) Limited

Terapeutiske indikationer:

Fluphenazine decanoate is indicated in the long-term management of psychotic disorders including schizophrenia, mania and organic brain syndrome. It is of particular value in the treatment of chronic schizophrenia and for patients who are unreliable at taking oral medication. The drug often alleviates such target symptoms as hallucinations, delusions, confusion and withdrawal. It is not only useful in the hospital milieu but is unparalleled, because of its long duration of action in the long-term maintenance therapy of chronically psychotic patients who are amenable to out-patient therapy. Fluphenazine decanoate has not been shown to be effective in the management of behavioural complications in patients with mental retardation.

Produkt oversigt:

Package - Contents - Shelf Life: Ampoule, glass, 1ml One Point Cut ampoule - 5 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate or freeze - Ampoule, glass, 0.5ml One Point Cut ampoule - 5 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate or freeze

Autorisation dato:

1971-01-14

Produktets egenskaber

 NZ_Modecate__ V8.0 27 February 2013 
1 
DATA SHEET 

NAME OF MEDICINE 

Modecate 
Modecate Concentrate 
Fluphenazine decanoate 

PRESENTATION 

Injection: Straw-coloured viscous liquid containing fluphenazine
decanoate  12.5mg/0.5mL 
and  25mg/mL; 100mg/mL (Concentrate); in a sesame
oil vehicle, with benzyl alcohol as 
preservative. 

USES 

ACTIONS 

Fluphenazine decanoate is an esterified trifluoromethyl
phenothiazine derivative. Chemically, 
fluphenazine  is
4-(3-[2-(Trifluoromethyl) phenothiazin-10-y1]propyl)-1 piperazine.
 It is a 
highly potent antipsychotic agent with a markedly extended
duration of action, available for 
intramuscular administration. 

The basic effects of fluphenazine decanoate  appear to be no
different from those of 
fluphenazine hydrochloride.  The only exception to
this is a prolonged duration of action. The 
esterification of fluphenazine  with decanoic acid
markedly prolongs the drug's duration of 
effect without reducing its activity. 

Like all phenothiazine  derivatives,  fluphenazine decanoate  appears to
act on the 
hypothalamus,
depressing various components of the mesodiencephalic activating system 
which is involved in the control of basal metabolism and
body temperature, wakefulness, 
vasomotor tone, emesis,  and hormonal balance.  In addition,
the phenothiazines exert a 
peripheral autonomic affect to varying degrees. However,
the site and mode of action of the 
phenothiazines have not been completely elucidated. 

 NZ_Modecate__ V8.0 27 February 2013 
2 
Fluphenazine  and its ester derivatives differ from other phenothiazines in several respects; 
fluphenazine and its esters are more potent on a
milligram basis, appear to be less sedating, 
and have
less potentiating effect on central nervous system depressants and anaesthetics than 
do
some of the other