RISPERDAL CONSTA FOR INJECTION 37.5 mgvial

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

RISPERIDONE

Tersedia dari:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Kode ATC:

N05AX08

Dosis:

37.5 mg/vial

Bentuk farmasi:

INJECTION, POWDER, FOR SOLUTION

Komposisi:

RISPERIDONE 37.5 mg/vial

Rute administrasi :

INTRAMUSCULAR

Jenis Resep:

Prescription Only

Diproduksi oleh:

Cilag AG

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2003-07-21

Selebaran informasi

1

NAME OF THE MEDICINAL PRODUCT 
RISPERDAL

 CONSTA

 25 MG PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR 
INJECTION 
RISPERDAL

 CONSTA

 37.5 MG PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR 
INJECTION 
RISPERDAL

 CONSTA
 
50 MG PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR 
INJECTION 
INTERNATIONAL NON-PROPRIETARY NAME 
RISPERIDONE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
RISPERDAL

 CONSTA

 contains 25 mg, 37.5 mg or 50 mg risperidone. RISPERDAL


CONSTA

 is an extended release microspheres formulation of risperidone,
composed of 
risperidone drug substance micro-encapsulated in
polylactide-co-glycolide, at a 
concentration of 381 mg risperidone per gram of microspheres. 
For excipients, see List of Excipients.. 
PHARMACEUTICAL FORM 
Prolonged-release powder and diluent for suspension for injection. 
_Vial with powder_. 
White to off-white free flowing powder. 
_Pre-filled syringe of diluent for reconstitution_. 
Clear, colorless aqueous solution. 

2
CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
RISPERDAL

 CONSTA

 IS INDICATED FOR THE TREATMENT OF ACUTE 
AND CHRONIC SCHIZOPHRENIC PSYCHOSES, AND OTHER PSYCHOTIC 
CONDITION, IN WHICH POSITIVE SYMPTOMS (SUCH AS HALLUCINATIONS, 
DELUSIONS, THOUGH DISTURBANCES, HOSTILITY, SUSPICIOUSNESS), AND 
/OR NEGATIVE SYMPTOMS (SUCH AS BLUNTED AFFECT, EMOTIONAL AND 
SOCIAL WITHDRAWAL, POVERTY OF SPEECH) ARE PROMINENT. 
RISPERDAL® CONSTA® ALSO ALLEVIATES AFFECTIVE SYMPTOMS 
(SUCH AS DEPRESSION, GUILT FEELINGS, ANXIETY) ASSOCIATED WITH 
SCHIZOPHRENIAPOSOLOGY AND METHOD OF ADMINISTRATION 
For risperidone naive patients, it is recommended to establish
tolerability with oral 
risperidone prior to initiating treatment with RISPERDAL

 CONSTA

. 
RISPERDAL

 CONSTA

 should be administered every two weeks by deep 
intramuscular deltoid or gluteal injection using the appropriate
safety needle. For deltoid 
administration, use the 1-inch needle alte

Karakteristik produk

1
PRODUCT NAME
RISPERDAL

CONSTA

25 mg Prolonged Release Suspension for Intramuscular Injection
RISPERDAL

CONSTA

37.5 mg Prolonged Release Suspension for Intramuscular Injection
(risperidone)
DOSAGE FORMS AND STRENGTHS
RISPERDAL

CONSTA

contains 25 mg or 37.5 mg risperidone.
RISPERDAL

CONSTA

is
an extended
release microspheres
formulation of risperidone,
composed of risperidone drug substance micro-encapsulated in
polylactide-co-glycolide, at a
concentration of 381 mg risperidone per gram of microspheres.
Prolonged-release powder and diluent for suspension for injection.
_ _
VIAL WITH POWDER
White to off-white free flowing powder.
PRE-FILLED SYRINGE OF DILUENT FOR RECONSTITUTION
Clear, colorless aqueous solution.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
RISPERDAL

CONSTA

is indicated for the treatment of acute and chronic schizophrenic
psychoses, hallucinations and delusions.
RISPERDAL
®
CONSTA
®
also alleviates affective symptoms (such as depression, guilt
feelings,
anxiety) associated with schizophrenia
DOSAGE AND ADMINISTRATION
For risperidone naive patients, it is recommended to establish
tolerability with oral risperidone
prior to initiating treatment with RISPERDAL

CONSTA

.
_ _
ADULTS (OLDER THAN 18 YEARS OF AGE)
The recommended dose is 25 mg intramuscular every two weeks. Some
patients may benefit
from the higher doses of 37.5 mg or 50 mg. Doses higher than 50 mg
every 2 weeks are not
recommended.
Where
patients
are
not
stabilized
on
oral
risperidone
the
recommended
dose
is
25
mg
RISPERDAL
®
CONSTA
®
every two weeks. Should a dosage adjustment be required, see two
paragraphs down for guidance on dose increments. Patients who have no
previous history of
risperidone use should be pretreated with oral RISPERDAL
®
for several days as clinically
feasible, to assess tolerability before the first injection.
2
For those patients stabilized on a fixed dose of oral risperidone for
two weeks or more, the
following conversion schemes