EDURANT

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

RILPIVIRINE AS HYDROCHLORIDE

Tilgjengelig fra:

J-C HEALTH CARE LTD

ATC-kode:

J05AG05

Legemiddelform:

TABLETS

Sammensetning:

RILPIVIRINE AS HYDROCHLORIDE 25 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

JANSSEN CILAG S.P.A., ITALY

Terapeutisk gruppe:

RILPIVIRINE

Terapeutisk område:

RILPIVIRINE

Indikasjoner:

EDURANT™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

Autorisasjon dato:

2017-08-31

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed
with a doctor’s prescription only
EDURANT
®
, FILM-COATED TABLETS, 25 MG
Active ingredient and its quantity per dosage unit:
RILPIVIRINE )AS HYDROCHLORIDE( 25 MG PER TABLET
Inactive and allergenic ingredients in the medicine – see
section 6 “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even
if it seems to you that their ailment is similar.
The medicine is intended for adults )above the age of
18 years(.
1. WHAT IS THE MEDICINE INTENDED FOR?
Edurant is a medicine intended for the treatment of HIV
infection in adults. Edurant works by reducing the amount
of HIV in your body. This reduction will lead to an improved
immune system and to a reduction in the risk of developing
diseases that are associated with HIV.
Edurant is intended for adults who were not treated in the
past with other HIV medicines and whose viral load does
not exceed 100,000 copies per ml. The doctor will measure
your viral load.
Edurant is always given in combination with other HIV
medicines. Your doctor will explain to you which combination
of medicines is best for you.
THERAPEUTIC GROUP: HIV treatment from the non-nucleoside
reverse transcriptase inhibitors )NNRTIs( group.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to the active ingredient
rilpivirine or to any of the other ingredients contained
in Edurant. For a list of the additional ingredients, see
section 6 “Further information”.
• DO NOT TAKE EDURANT IN COMBINATION WITH ANY OF THE
FOLLOWING MEDICINES, as they may affect the activity of
Edurant or alternatively, Edurant may affect the activity
of the medicines:
∘ carbamaz

Preparatomtale

1
1.
NAME OF THE MEDICINAL PRODUCT
EDURANT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains rilpivirine hydrochloride equivalent
to 25 mg rilpivirine.
Excipient with known effect
Each film-coated tablet contains 56 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex tablet 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 agents, is
indicated for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in antiretroviral
treatment-naïve adult patients with
HIV-1 RNA less than or equal to 100,000 copies/mL at the start of
therapy.
EDURANT is not recommended for patients less than 18 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of EDURANT is one 25 mg tablet once daily.
EDURANT
MUST BE
taken orally
with a meal [
_see section 5.2 Pharmacokinetic properties_
].
_Dose adjustment_
For patients concomitantly receiving rifabutin, the EDURANT dose
should be increased to 50 mg (two
tablets of 25 mg each) taken once daily, taken with a meal. When
rifabutin co-administration is stopped,
the EDURANT dose should be decreased to 25 mg once daily, taken with a
meal
_[see section 4.5 _
_Interaction with other medicinal products and other forms of
interaction ]. _
_ _
_Missed dose_
If the patient misses a dose of EDURANT within 12 hours of the time it
is usually taken, the patient
must take the medicine with a meal as soon as possible and resume the
normal dosing schedule. 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.
If a patient vomits within 4 hours of taking the medicine, another
EDURANT tablet should be taken
with a meal. If a patient vomits more than 4 hours after taking the
medicine, the patient does not need
to take another dose of EDU