INVEGA 3 MG EXTENDED RELEASE TABLETS

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

সক্রিয় উপাদান:

PALIPERIDONE

থেকে পাওয়া:

JOHNSON & JOHNSON SDN BHD

INN (International Name):

PALIPERIDONE

প্যাকেজ ইউনিট:

28 Tablets; 30 Tablets

Manufactured by:

JANSSEN CILAG MANUFACTURING L.L.C

তথ্য লিফলেট

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
INVEGA
® EXTENDED RELEASE TABLETS
Paliperidone (3mg, 6mg, 9mg)
WHAT IS IN THIS LEAFLET
1.
What INVEGA
®
is used for
2.
How INVEGA
®
works
3.
Before you use INVEGA
®
4.
How to use INVEGA
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
INVEGA
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT INVEGA
® IS USED FOR
_SCHIZOPHRENIA _
INVEGA
®
belongs to the class of
antipsychotic medicines and is used to
treat schizophrenia in adults (18 years
of age and older). In addition, after
symptoms have been relieved,
INVEGA
®
is used to keep the disorder
under control, i.e. to prevent its
recurrence.
Schizophrenia is a disorder with
symptoms such as hearing things,
seeing or sensing things that are not
there, mistaken beliefs, unusual
suspiciousness, becoming withdrawn,
incoherent speech, and reduced
behavioral/emotional responses.
People with this disorder may also feel
depressed, anxious, guilty, or tense.
_SCHIZOAFFECTIVE DISORDER _
INVEGA
®
belongs to the class of
antipsychotic medicines and is used to
treat schizoaffective disorder in adults
(18 years of age and older), used
either alone or with other medicines
that are also used to treat depression
and/or other mood disorders.
INVEGA
®
is not for treating people
with schizoaffective disorder who are
younger than 18 years old.
Schizoaffective disorder is a mental
condition in which a person
experiences a combination of
schizophrenia symptoms (as listed
above) in addition to mood disorder
symptoms (feeling very high, feeling
sad, feeling agitated, distracted,
sleeplessness, talkativeness, losing
interest in everyday activities, sleeping
too much or too little, eating too much
or too little, and recurrent thoughts of
suicide).
HOW INVEGA
® WORKS
INVEGA
®
can help alleviate the
symptoms of your disease and stop
your symptoms from coming back.
BEFORE YOU USE INVEGA
®
-
_When you must not use it _
Do not take INVEGA
®
if you know
that you a

পণ্য বৈশিষ্ট্য

1
PRODUCT NAME
INVEGA
®
Extended-Release Tablets
INTERNATIONAL NON-PROPRIETARY NAME
Paliperidone
DOSAGE FORMS AND STRENGTHS
Each extended-release tablet contains 3, 6, or 9 mg of paliperidone.
For excipients, see List of Excipients.
•
3 mg: white capsule-shaped tablet imprinted with “PAL 3”
•
6 mg: beige capsule-shaped tablet imprinted with “PAL 6”
•
9 mg: pink capsule-shaped tablet imprinted with “PAL 9”
The
chemical
name
is
(±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-
tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2 a]pyrimidin-4-one.
For excipients, see List of Excipients.
INVEGA
®
utilizes 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 color overcoat and
print markings. In an aqueous environment,
such as the gastrointestinal tract, the water-dispersible color
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, along with insoluble core components.
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
INVEGA
®
is indicated for the treatment of schizophrenia in adolescents 15
years and older, including acute
treatment and recurren