INVEGA SUSTENNA paliperidone (as palmitate) 100 mg modified release suspension for injection pre-filled syringe

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

paliperidone palmitate, Quantity: 156 mg (Equivalent: paliperidone, Qty 100 mg)

Dostupné z:

Janssen-Cilag Pty Ltd

INN (Medzinárodný Name):

Paliperidone palmitate

Forma lieku:

Injection

Zloženie:

Excipient Ingredients: dibasic sodium phosphate; water for injections; macrogol 4000; monobasic sodium phosphate monohydrate; polysorbate 20; citric acid monohydrate; sodium hydroxide

Spôsob podávania:

Intramuscular

Počet v balení:

one syringe per carton

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

Visual Identification: A white to off-white aqueous suspension in a syringe.; Container Type: Syringe; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2010-07-28

Príbalový leták

INVEGA SUSTENNA
®
1
INVEGA SUSTENNA
®
_MODIFIED RELEASE AQUEOUS SUSPENSION FOR INTRAMUSCULAR 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

Súhrn charakteristických

CCDS200407ver16
Page 1 of 34
INVEGASUSTENNA(200729)API
INVEGA SUSTENNA
®
PALIPERIDONE PALMITATE
AUSTRALIAN PRODUCT INFORMATION
1. NAME OF THE MEDICINE
Paliperidone palmitate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient, paliperidone palmitate, is a psychotropic agent
belonging to the chemical class
of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic
mixture of (+)- and (-)-
paliperidone palmitate. INVEGA SUSTENNA is available in dose strengths
of 25 mg, 50 mg, 75 mg,
100 mg and 150 mg paliperidone (as palmitate).
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
INVEGA SUSTENNA is available as a white to off-white sterile modified
release aqueous suspension
for intramuscular injection.
INVEGA SUSTENNA paliperidone (as palmitate) 25 mg modified release
injection pre-filled syringe:
Each 0.25 mL prefilled syringe contains 25 mg of paliperidone as 39 mg
paliperidone palmitate.
INVEGA SUSTENNA paliperidone (as palmitate) 50 mg modified release
injection pre-filled syringe:
Each 0.5 mL prefilled syringe contains 50 mg of paliperidone as 78 mg
paliperidone palmitate.
INVEGA SUSTENNA paliperidone (as palmitate) 75 mg modified release
injection pre-filled syringe:
Each 0.75 mL prefilled syringe contains 75 mg of paliperidone as 117
mg paliperidone palmitate.
INVEGA SUSTENNA paliperidone (as palmitate) 100 mg modified release
injection pre-filled
syringe: Each 1.0 mL prefilled syringe contains 100 mg of paliperidone
as 156 mg paliperidone
palmitate.
INVEGA SUSTENNA paliperidone (as palmitate) 150 mg modified release
injection pre-filled
syringe: Each 1.5 mL prefilled syringe contains 150 mg of paliperidone
as 234 mg paliperidone
palmitate.
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
patients
wit