FLUANXOL DEPOT INJECTION 20 mgml

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

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Hent Indlægsseddel (PIL)
09-06-2014
Hent Produktets egenskaber (SPC)
09-06-2014

Aktiv bestanddel:

CIS(Z)-FLUPENTHIXOL DECANOATE

Tilgængelig fra:

LUNDBECK SINGAPORE PTE. LTD.

ATC-kode:

N05AF01

Dosering:

20 mg/ml

Lægemiddelform:

INJECTION

Sammensætning:

CIS(Z)-FLUPENTHIXOL DECANOATE 20 mg/ml

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

Prescription Only

Fremstillet af:

H LUNDBECK A/S

Autorisation status:

ACTIVE

Autorisation dato:

1988-05-18

Indlægsseddel

                                FLUANXOL DEPOT 
FLUPENTIXOL DECANOATE) 
 
A POTENT NON-SEDATING NEUROLEPTIC FOR LONG-TERM THERAPY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fluanxol Depot 20mg/ml solution for injection. 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
flupentixol decanoate 20mg/ml 
 
3. PHARMACEUTICAL FORM 
Solution for injection (injection). 
20mg/ml: Clear, colourless to slightly yellowish oil, practically
free from particles. 
 
4. CLINICAL PARTICULARS 
 
4.1 THERAPEUTIC INDICATIONS 
Maintenance treatment of schizophrenia and other psychoses,
especially with symptoms such as 
hallucinations, delusions and thought disturbances along with apathy,
lack of energy, and 
withdrawal. 
 
4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
 
Posology 
Adults: 
Dosage and interval between injections should be adjusted for each
individual patient so as to 
achieve a maximum suppression of psychotic symptoms with a minimum
of side effects. 
 
Flupentixol decanoate 20mg/ml 
In the maintenance treatment the dosage range would normally be
20-40mg (1-2ml) at intervals 
of 2 to 4 weeks depending on the response. Some patients may need
larger doses or need them at 
shorter intervals. 
 
Flupentixol decanoate 20mg/ml is unsuitable for patients in
whom sedation is required. Injection 
volumes larger than 2ml should be distributed between two injection
sites. 
 
If volumes larger than 2-3ml of the 20mg/ml solution are required the
more concentrated 
solution (flupentixol decanotae 100mg/ml or 200mg/ml) should be
preferred. 
 
During an exacerbation or acute relapse of the illness single
injections of as much as 400mg 
fortnightly (or in the occasional cases weekly for a short period) may
be required. 
 
Adequate control of severe psychotic symptoms by the concentrated
injection fluids is usually 
achieved within 4 to 6 months and may justify gradual return to lower
dose maintenance 
 
When changing the medication from oral flupentixol to maintenance
treatment with flupentixol 
decanoate the follo
                                
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Produktets egenskaber

                                FLUANXOL DEPOT
FLUPENTIXOL DECANOATE)
A POTENT NON-SEDATING NEUROLEPTIC FOR LONG-TERM THERAPY
1. NAME OF THE MEDICINAL PRODUCT
Fluanxol Depot 20mg/ml solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
flupentixol decanoate 20mg/ml
3. PHARMACEUTICAL FORM
Solution for injection (injection).
20mg/ml: Clear, colourless to slightly yellowish oil, practically free
from particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maintenance treatment of schizophrenia and other psychoses, especially
with symptoms such as
hallucinations, delusions and thought disturbances along with apathy,
lack of energy, and
withdrawal.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Dosage and interval between injections should be adjusted for each
individual patient so as to
achieve a maximum suppression of psychotic symptoms with a minimum of
side effects.
Flupentixol decanoate 20mg/ml
In the maintenance treatment the dosage range would normally be
20-40mg (1-2ml) at intervals
of 2 to 4 weeks depending on the response. Some patients may need
larger doses or need them at
shorter intervals.
Flupentixol decanoate 20mg/ml is unsuitable for patients in whom
sedation is required. Injection
volumes larger than 2ml should be distributed between two injection
sites.
If volumes larger than 2-3ml of the 20mg/ml solution are required the
more concentrated
solution (flupentixol decanotae 100mg/ml or 200mg/ml) should be
preferred.
During an exacerbation or acute relapse of the illness single
injections of as much as 400mg
fortnightly (or in the occasional cases weekly for a short period) may
be required.
Adequate control of severe psychotic symptoms by the concentrated
injection fluids is usually
achieved within 4 to 6 months and may justify gradual return to lower
dose maintenance
When changing the medication from oral flupentixol to maintenance
treatment with flupentixol
decanoate the following guidelines should be used:
x mg p.o. daily corresponds to 4x mg decanoate every 2 weeks.
x mg p.o. daily corresponds to 8x
                                
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