INVEGA TRINZA paliperidone (as palmitate) 263 mg modified release suspension for injection pre-filled syringe

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

paliperidone palmitate, Quantity: 312 mg/mL (Equivalent: paliperidone, Qty 200 mg/mL)

Disponível em:

Janssen-Cilag Pty Ltd

DCI (Denominação Comum Internacional):

Paliperidone palmitate

Forma farmacêutica:

Injection, suspension

Composição:

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

Via de administração:

Intramuscular

Unidades em pacote:

1 assembled prefilled syringe

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

Resumo do produto:

Visual Identification: White to off-white suspension; Container Type: Syringe; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Licence status A

Data de autorização:

2016-09-23

Folheto informativo - Bula

INVEGA TRINZA™
1
INVEGA TRINZA™
_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
Trinza. 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 TRINZA, 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 TRINZA IS
USED FOR
Invega Trinza belongs to a group of
medicines called antipsychotic agents
which improve the symptoms of
certain type of mental illness.
It is used to treat symptoms of
schizophrenia, a mental illness with
disturbances in thinking, feelings and
behaviour. Invega Trinza 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)
•
a false belief or wrong judgment,
sometimes associated with
hallucinations, held with
conviction despite evidence to the
contrary (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
Trinza 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 TRINZA IF YOU
KNOW YOU ARE ALLERGIC TO ANY OF ITS
INGREDIENTS LISTED AT THE END OF T

Características técnicas

CCDS200612ver06
Page 1 of 35
INVEGATRINZA(200729)API
INVEGA TRINZA
®
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
TRINZA
contains a
racemic
mixture
of
(+)- and
(-)-
paliperidone palmitate. 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.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
INVEGA TRINZA is available as a white to off-white sterile modified
release aqueous suspension for
intramuscular injection in dose strengths of 175 mg, 263 mg, 350 mg
and 525 mg paliperidone (as
273 mg, 410 mg, 546 mg and 819 mg paliperidone palmitate,
respectively).
INVEGA TRINZA paliperidone (as palmitate) 175 mg suspension for
injection pre-filled syringe. Each
0.875 mL prefilled syringe contains 175 mg of paliperidone as 273 mg
paliperidone palmitate
INVEGA TRINZA paliperidone (as palmitate) 263 mg suspension for
injection pre-filled syringe. Each
1.315mL prefilled syringe contains 263 mg of paliperidone as 410 mg
paliperidone palmitate
INVEGA TRINZA paliperidone (as palmitate) 350 mg suspension for
injection pre-filled syringe. Each
1.75 mL prefilled syringe contains 350 mg of paliperidone as 546 mg
paliperidone palmitate
INVEGA TRINZA paliperidone (as palmitate) 525 mg suspension for
injection pre-filled syringe. Each
2.625 mL prefilled syringe contains 525 mg of paliperidone as 819 mg
paliperidone palmitate
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INVEGA TRINZA, a 3-month injection, is indicated for the maintenance
treatment of schizophrenia
in adult patients who have been adequately treated with the 1-month
paliperidone palmitate
injectable product for at least four months.
4.2 DOSE AND METHOD OF