EDURANT rilpivirine 25 mg (as hydrochloride) film-coated tablet bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

rilpivirine hydrochloride, Quantity: 27.5 mg (Equivalent: rilpivirine, Qty 25 mg)

可用日期:

Janssen-Cilag Pty Ltd

INN（国际名称）:

rilpivirine hydrochloride

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose

给药途径:

Oral

每包单位数:

30

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/mL at baseline. This indication is based on Week 48 safety and efficacy analyses from 2 randomised double-blind, controlled Phase III trials in treatment-naive adult patients and on Week 96 safety and efficacy analyses from the Phase IIb trial TMC278-C204 in treatment-naive adult patients (see CLINICAL TRIALS section).

產品總結:

Visual Identification: White to off-white, round, biconvex, film-coated tablet debossed with "TMC" on one side and "25" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

授权状态:

Licence status A

授权日期:

2011-12-23

资料单张

EDURANT
®
1
EDURANT
® TABLETS
_rilpivirine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EDURANT tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
EDURANT against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN EDURANT ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING EDURANT.
You may need to read it again.
WHAT EDURANT IS
USED FOR
EDURANT is a medicine used for
the treatment of Human
Immunodeficiency Virus (HIV)
infection. It belongs to a group of
anti-HIV medicines called non-
nucleoside reverse transcriptase
inhibitors (NNRTIs). EDURANT
works by reducing the amount of
HIV in your body. This will improve
your immune system and reduce the
risk of developing illnesses linked to
HIV infection.
EDURANT is used to treat adults
who are infected by HIV and who
have not used other anti-HIV
medicines before.
EDURANT must be taken in
combination with other anti-HIV
medicines. Your doctor will discuss
with you which combination of
medicines is best for you.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EDURANT
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
EDURANT
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE EDURANT:
•
if you are allergic
(hypersensitive) to rilpivirine, or
other ingredients of EDURANT.
See Product Description at the
end of this leaflet for a list of
ingredients.
DO NOT TAKE EDURANT:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the pack has
passed. If you take EDURANT
after the expiry date it may not
work.
DO NOT COMBINE EDURANT WITH
ANY OF THE FOLLOWING MEDICINES:
•
carbamazepine, oxcarbazepine,
phenobarbital, phenytoin (to treat
epilepsy or prevent seizures)
•
non-nucleoside reverse
transcri

产品特点

_ _
CCDS181016v011
Page 1
EDURANT (190130) API
EDURANT
®
RILPIVIRINE
AUSTRALIAN PRODUCT INFORMATION
1. NAME OF THE MEDICINE
Rilpivirine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EDURANT (rilpivirine) is available as 25 mg film-coated tablets. Each
tablet contains rilpivirine
hydrochloride equivalent to 25 mg rilpivirine. EDURANT tablets also
contain lactose
monohydrate. For a full list of excipients, see section 6.1 List of
Excipients.
3. PHARMACEUTICAL FORM
EDURANT 25 mg tablets are white to off-white, film coated, round,
biconvex, tablets of 6.4 mm,
debossed with “TMC” on one side and “25” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EDURANT, in combination with other antiretroviral medicinal products,
is indicated for the
treatment
of
human
immunodeficiency
virus
type
1
(HIV-1)
infection
in
antiretroviral
treatment-naïve adult patients with viral load ≤ 100,000 copies/mL
at baseline.
This indication is based on Week 48 safety and efficacy analyses from
2 randomised double-blind,
controlled Phase III trials in treatment-naïve adult patients and on
Week 96 safety and efficacy
analyses from the Phase IIb trial TMC278-C204 in treatment-naïve
adult patients (see section 5.1
Pharmacodynamic Properties, Clinical Trials).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The recommended dose of EDURANT in adults is one 25 mg tablet once
daily taken orally with
a meal (see section 5.2 Pharmacokinetic Properties).
_Timing of dosing _
If the patient misses a dose of EDURANT within 12 hours of the time it
is usually taken, the
patient should take EDURANT with a meal as soon as possible and then
take the next dose of
EDURANT at the regularly scheduled time. If a patient misses a dose of
EDURANT by more
than 12 hours, the patient should not take the missed dose, but resume
the usual dosing
schedule.
_Dose adjustment _
For patients concomitantly receiving rifabutin, the EDURANT dose
should be increased to 50 mg
(two tablets of 25 mg each) once daily, taken with a meal.