Invega

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Paliperidone 9mg (Drug Layer 1: 2.7 mg, Drug Layer 2: 6.3 mg)

থেকে পাওয়া:

Janssen-Cilag (New Zealand) Ltd

INN (আন্তর্জাতিক নাম):

Paliperidone 9 mg (Drug Layer 1: 2.7 mg, Drug Layer 2: 6.3 mg)

ডোজ:

9 mg

ফার্মাসিউটিকাল ফর্ম:

Modified release tablet

রচনা:

Active: Paliperidone 9mg (Drug Layer 1: 2.7 mg, Drug Layer 2: 6.3 mg) Excipient: Butylated hydroxytoluene Carnauba wax Cellulose acetate Hyetellose Hypromellose Iron oxide black Iron oxide red Macrogol 3350 Macrogol 400 Opacode black NS-78-17821 Polyethylene oxide Povidone Sodium chloride Stearic acid Titanium dioxide

প্যাকেজ ইউনিট:

Blister pack, PVC-PCTFE/Paper-Al, 28 tablets

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)

থেরাপিউটিক ইঙ্গিত:

INVEGA prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Blister pack, OPA-Al-PVC/Al-paper (Child resistant) - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, OPA-Al-PVC/Al-paper (Child resistant) - 56 tablets - 24 months from date of manufacture stored at or below 25°C

অনুমোদন তারিখ:

2006-08-17

তথ্য লিফলেট

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.

পণ্য বৈশিষ্ট্য

CCDS180507
Page 1 of 26
INVEGA TABS(180723)ADS
INVEGA
®
PALIPERIDONE
NEW ZEALAND DATASHEET
1. PRODUCT NAME
INVEGA 3 mg modified release tablets
INVEGA 6 mg modified release tablets
INVEGA 9 mg modified release tablets
INVEGA 12 mg modified release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Paliperidone
INVEGA (paliperidone) is a novel antipsychotic agent belonging to the
benzisoxazole-derivatives
class.
Excipient(s) with known effect
The 3 mg tablet contains 13.2 mg lactose
For a full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Modified release tablet
3 mg
White, capsule shaped tablets imprinted with “PAL 3”.
6 mg
Beige, capsule shaped tablets imprinted with “PAL 6”.
9 mg
Pink, capsule shaped tablets imprinted with “PAL 9”.
12 mg Dark yellow, capsule shaped tablets imprinted with “PAL 12”.
INVEGA utilises osmotic drug-release technology, whereby osmotic
pressure delivers paliperidone
from the dosage form at a controlled rate. The system, which resembles
a capsule-shaped tablet in
appearance,
comprises
an
osmotically
active
trilayer
core
surrounded
by
a
subcoat
and
semipermeable membrane. The trilayer core is composed of two drug
layers containing the drug and
excipients, and a push layer containing osmotically active components.
There are two precision
laser-drilled orifices on the drug-layer dome of the tablet. Each
strength is identified by a unique
colour overcoat and print markings. In an aqueous environment, such as
the gastrointestinal tract,
the
water-dispersible
colour
overcoat
erodes
quickly.
Water
is
then
imbibed
through
the
semipermeable, rate-controlling membrane. The membrane controls the
rate at which water enters
the tablet core, which, in turn, controls drug delivery. The
hydrophilic polymers of the core hydrate
and swell, creating a gel containing paliperidone that is then pushed
out through the tablet orifices.
The biologically inert components of the tablet remain intact during
gastrointestinal transit and are
eliminated in the stool as a tablet shell,