inApitant aprepitant 125mg hard capsules

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

APREPITANT

Commercializzato da:

Intega Sdn. Bhd.

INN (Nome Internazionale):

APREPITANT

Confezione:

3 Capsules; 3 Capsules

Prodotto da:

Pharmathen International S.A.

Foglio illustrativo

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INAPITANT APREPITANT 80MG HARD CAPSULES
INAPITANT APREPITANT 125MG HARD CAPSULES
Aprepitant (80mg, 125mg)
1
WHAT IS IN THIS LEAFLET
1.
What inApitant is used for
2.
How inApitant works
3.
Before you use inApitant
4.
How to use inApitant
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
inApitant
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT INAPITANT IS USED FOR
InApitant is taken along with
other medicines to prevent and
control nausea (sick feeling) and
vomiting caused by your cancer
chemotherapy treatment.
HOW INAPITANT WORKS
InApitant belongs to a class of
medicines called neurokinin 1
(NK1) receptor antagonists
which works by blocking signals
to the area of the brain that
controls nausea and vomiting.
BEFORE YOU USE INAPITANT
_-When you must not use it _
Do not take inApitant if you are
allergic to any of the ingredients
of this medicine (listed in
Product Description).
_-Before you start to use it _
Talk to your doctor before
taking inApitant
•
If you have any past or
present medical problems.
•
If you have any allergies.
•
If you are taking or plan to
take any medicine, even
those you can get without a
prescription or herbal
products.
•
If you have intolerance to
some sugars as this medicine
contains sucrose.
_Pregnancy and Breastfeeding _
If you are pregnant or breast-
feeding, think you may be
pregnant or are planning to have
a baby, ask your doctor for
advice before taking this
medicine.
_ _
_Use in Children _
Usage of aprepitant has not been
adequately studied in children.
Therefore, inApitant should not
be given to children under 18
years old.
_Use in the elderly _
Aprepitant works equally well
in and is equally well-tolerated
by elderly and younger adults.
No dosage adjustment is
necessary in the elderly.
_-Taking other medicines _
Do not take inApitant with
medicines containing pimozide
(used to treat psychiatric
illness), terfenadine and
astemizole (used for hay fever
an

Scheda tecnica

INAPITANT APREPITANT 80MG HARD CAPSULES
INAPITANT APREPITANT 125MG HARD CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
inApitant Aprepitant 80mg hard capsules
inApitant Aprepitant 125mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 125 mg capsule contains 125 mg of aprepitant.
Each 80 mg capsule contains 80 mg of aprepitant.
Excipient with known effect
Each 125 mg capsule contains 125 mg of sucrose and 0.00026 mmol (0.006
mg) of sodium.
Each 80 mg capsule contains 80 mg of sucrose and 0.00022 mmol (0.005
mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The 125 mg hard capsules are presented as opaque hard gelatin No 1
capsules with a pink cap and white body, printed with “125mg” on
the body with black ink.
The 80 mg hard capsules are presented as opaque hard gelatin No 2
capsules with a white cap and white body, printed with “80mg” on
the body with black ink.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INAPITANT, in combination with other antiemetic agents, is indicated
for the prevention of acute and delayed nausea and vomiting associated
with initial
and repeat courses of:
•
Highly emetogenic cancer chemotherapy, including high-dose cisplatin
•
Moderately emetogenic cancer chemotherapy
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
INAPITANT is given for 3 days as part of a regimen that includes a
corticosteroid and a 5-HT
3
antagonist. The recommended dose of INAPITANT is 125
mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg
orally once daily in the morning on Days 2 and 3. The package insert
for the co-
administered 5-HT
3
antagonist must be consulted prior to initiation of treatment with
INAPITANT.
Recommended dosing for the prevention of nausea and vomiting
associated with highly emetogenic cancer chemotherapy:
Day 1
Day 2
Day 3
Day 4
INAPITANT
125 mg
80 mg
80 mg
none
Dexamethasone**
12 mg orally
8 mg orally
8 mg orally
8 mg orally
5-HT
3
antagonist
See the package insert for
the selected 5-HT
3
antagonist for a