INVEGA Sustenna Prolonged Release Suspension for IM Injection 150mg1.5ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Paliperidone palmitate 234 mg eqv Paliperidone

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

N05AX13

Dosage:

150mg/1.5ml

Pharmaceutical form:

INJECTION, SUSPENSION, EXTENDED RELEASE

Composition:

Paliperidone palmitate 234 mg eqv Paliperidone 150mg/1.5ml

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Janssen Pharmaceutica N.V.,

Authorization status:

ACTIVE

Authorization date:

2011-06-13

Patient Information leaflet

1 
PRODUCT NAME 
INVEGA
®
  Sustenna
®
  (25  mg  paliperidone  as  39  mg  paliperidone  palmitate)  Prolonged-
Release Suspension for Intramuscular Injection. 
INVEGA
®
  Sustenna
®
  (50  mg  paliperidone  as  78  mg  paliperidone  palmitate)  Prolonged-
Release Suspension for Intramuscular Injection. 
INVEGA
®
  Sustenna
®
  (75  mg  paliperidone  as  117  mg  paliperidone  palmitate)  Prolonged-
Release Suspension for Intramuscular Injection. 
INVEGA
®
  Sustenna
®
  (100  mg  paliperidone  as  156  mg  paliperidone  palmitate)  Prolonged-
Release Suspension for Intramuscular Injection. 
INVEGA
®
  Sustenna
®
  (150  mg  paliperidone  as  234  mg  paliperidone  palmitate)  Prolonged-
Release Suspension for Intramuscular Injection. 

INTERNATIONAL NON-PROPRIETARY NAME 
Paliperidone palmitate 

DOSAGE FORMS AND STRENGTHS 
INVEGA
®
 Sustenna
®
 contains 25, 50, 75, 100, or 150 mg paliperidone (as 39, 78, 117, 156, 
or 234 mg of paliperidone palmitate, respectively). 
Prolonged-release suspension in prefilled syringes. The suspension
is white to off-white.

For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 
INDICATIONS 
INVEGA
®
 Sustenna
®
 is  indicated for the treatment  of schizophrenia and for the prevention 
of recurrence of symptoms of schizophrenia. 

DOSAGE AND ADMINISTRATION 
DOSAGE 
For  patients  who  have  never  taken  oral  paliperidone  or  oral  or  injectable  risperidone,  it  is 
recommended  to  establish  tolerability  with  oral  paliperidone  or  oral  risperidone  prior  to 
initiating treatment with INVEGA
®
 Sustenna
®
. 

Recommended initiation of INVEGA
®
 Sustenna
®
 is with a dose of 150 mg  on treatment day 
1  and  100  mg  one  week  later,  both  administ

Summary of Product characteristics

1
PRODUCT NAME
INVEGA
®
Sustenna
®
(25 mg paliperidone as 39 mg paliperidone palmitate) Prolonged-
Release Suspension for Intramuscular Injection.
INVEGA
®
Sustenna
®
(50 mg paliperidone as 78 mg paliperidone palmitate) Prolonged-
Release Suspension for Intramuscular Injection.
INVEGA
®
Sustenna
®
(75 mg paliperidone as 117 mg paliperidone palmitate) Prolonged-
Release Suspension for Intramuscular Injection.
INVEGA
®
Sustenna
®
(100 mg paliperidone as 156 mg paliperidone palmitate) Prolonged-
Release Suspension for Intramuscular Injection.
INVEGA
®
Sustenna
®
(150 mg paliperidone as 234 mg paliperidone palmitate) Prolonged-
Release Suspension for Intramuscular Injection.
INTERNATIONAL NON-PROPRIETARY NAME
Paliperidone palmitate
DOSAGE FORMS AND STRENGTHS
INVEGA
®
Sustenna
®
contains 25, 50, 75, 100, or 150 mg paliperidone (as 39, 78, 117, 156,
or 234 mg of paliperidone palmitate, respectively).
Prolonged-release suspension in prefilled syringes. The suspension is
white to off-white.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
INVEGA
®
Sustenna
®
is indicated for the treatment of schizophrenia and for the prevention
of
recurrence of symptoms of schizophrenia.
INVEGA
®
Sustenna
®
is indicated for the treatment of schizoaffective disorder as
monotherapy
and as an adjunct to mood stabilizers or antidepressants.
DOSAGE AND ADMINISTRATION
For patients who have never taken oral paliperidone or oral or
injectable risperidone, it is
recommended to establish tolerability with oral paliperidone or oral
risperidone prior to
initiating treatment with INVEGA
®
Sustenna
®
.
DOSAGE
_Schizophrenia: _
Recommended initiation of INVEGA
®
Sustenna
®
is with a dose of 150 mg on
treatment day 1 and 100 mg one week later, both administered in the
deltoid muscle. The
recommended monthly maintenance dose is 75 mg; some patients may
benefit from lower or
higher doses within the recommended range of 25 to 150 mg based on
individual patient
tolerability and/or efficacy. Following the second