INVEGA SUSTENNA

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paliperidone palmitate 117mg equivalent to 75 mg paliperidone base;  

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Paliperidone palmitate 117 mg (equivalent to 75 mg paliperidone base)

Dosage:

75 mg

Pharmaceutical form:

Suspension for injection

Composition:

Active: Paliperidone palmitate 117mg equivalent to 75 mg paliperidone base   Excipient: Citric acid monohydrate Dibasic sodium phosphate Macrogol 4000 Monobasic sodium phosphate monohydrate Polysorbate 20 Sodium hydroxide Water for injection

Units in package:

Syringe, cyclic-olefin-copolymer with plunger stopper and tip cap (bromobutyl rubber), 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

Therapeutic indications:

INVEGA SUSTENNA® is indicated for the acute and maintenance treatment of schizophrenia in adults.

Product summary:

Package - Contents - Shelf Life: Syringe, cyclic-olefin-copolymer with plunger stopper and tip cap (bromobutyl rubber) with backstop - 1 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2009-04-22

Patient Information leaflet

INVEGA SUSTENNA
®
1
INVEGA SUSTENNA
®
_MODIFIED RELEASE SUSPENSION FOR INJECTION _
_Paliperidone palmitate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about INVEGA
SUSTENNA. It does not contain all
of the available information. It does
not take the place of talking to your
doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING INVEGA SUSTENNA, ASK
YOUR DOCTOR OR PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS INFORMATION HANDY.
You can refer to it later if you have
any questions.
WHAT INVEGA
SUSTENNA IS USED
FOR
INVEGA SUSTENNA belongs to a
group of medicines called
antipsychotic agents which improve
the symptoms of certain types of
mental illness.
It is used to treat symptoms of
schizophrenia, a mental illness with
disturbances in thinking, feelings and
behaviour. INVEGA SUSTENNA
helps to correct a chemical imbalance
in the brain associated with this
condition. It can also be used to
lessen the chance of your
schizophrenia symptoms from
coming back.
Some of the most common
symptoms of schizophrenia may
include:
•
Seeing, hearing, or sensing things
that are not there (hallucinations)
•
Believing that what other people
say is not true (delusions)
•
Not trusting others and feeling
very suspicious (paranoia)
•
Avoiding family and friends and
wanting to be alone
It may take some time before your
symptoms of schizophrenia start to
improve. Remember that INVEGA
SUSTENNA is one part of your
overall treatment plan. It is important
to keep all your appointments, so you
can get your treatments on time and
your doctor can check your progress.
Your doctor, however, may prescribe
this medicine for another use.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED TO YOU.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE INVEGA SUSTENNA
IF YOU KNOW YOU ARE ALLERGIC TO ANY
OF ITS INGREDIENTS LISTED AT THE END
OF THIS LEAFLET OR MEDICINES
CONTAINING PALIPERIDONE (E.G.
INVEGA) OR RISPERIDONE (E.G.

Summary of Product characteristics

18.221205
1
INVEGA SUSTENNA(230327)ADS
INVEGA SUSTENNA
®
PALIPERIDONE PALMITATE
NEW ZEALAND DATASHEET
1. PRODUCT NAME
INVEGA SUSTENNA 25 mg Suspension for injection
INVEGA SUSTENNA 50 mg Suspension for injection
INVEGA SUSTENNA 75 mg Suspension for injection
INVEGA SUSTENNA 100 mg Suspension for injection
INVEGA SUSTENNA 150 mg Suspension for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Paliperidone palmitate
INVEGA SUSTENNA contains 25 mg, 50 mg, 75 mg, 100 mg and 150 mg
paliperidone (as
palmitate).
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection
INVEGA SUSTENNA is available as a white to off-white sterile modified
release suspension for
intramuscular injection.
Paliperidone palmitate is very slightly soluble in ethanol and
methanol, practically insoluble in water,
polyethylene glycol 400 and propylene glycol, and slightly soluble in
ethyl acetate.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INVEGA SUSTENNA is indicated for the acute and maintenance treatment
of schizophrenia in
adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
SWITCHING FROM OTHER ANTIPSYCHOTICS
There are no systematically collected data to specifically address
switching schizophrenic patients
from other antipsychotics to INVEGA SUSTENNA, or concerning
concomitant administration with
other antipsychotics.
SWITCHING FROM ORAL ANTIPSYCHOTICS:
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. Previous oral antipsychotics can be
gradually discontinued at
18.221205
2
INVEGA SUSTENNA(230327)ADS
the time of initiation of treatment with INVEGA SUSTENNA. INVEGA
SUSTENNA should be initiated
as described under RECOMMENDED DOSING.
SWITCHING FROM LONG-ACTING INJECTABLE ANTIPSYCHOTICS:
When switching patients currently at steady-state on a long-acting
injectable antipsychotic, initiate
INVEGA SUSTENNA therapy in place of t