Evotaz
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
25-04-2023
Charakterystyka produktu
(SPC)
25-04-2023
Sprawozdanie z oceny publicznego
(PAR)
10-08-2015
Składnik aktywny:
cobicistat, atazanavir
Dostępny od:
Bristol-Myers Squibb Pharma EEIG
Kod ATC:
J05AR15
INN (International Nazwa):
atazanavir, cobicistat
Grupa terapeutyczna:
Antivirals for systemic use
Dziedzina terapeutyczna:
HIV Infections
Wskazania:
EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
Podsumowanie produktu:
Revision: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2015-07-13
Ulotka dla pacjenta
52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOTAZ 300 MG/150 MG FILM-COATED TABLETS
atazanavir/cobicistat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What EVOTAZ is and what it is used for
2.
What you need to know before you take EVOTAZ
3.
How to take EVOTAZ
4.
Possible side effects
5.
How to store EVOTAZ
6.
Contents of the pack and other information
1.
WHAT EVOTAZ IS AND WHAT IT IS USED FOR
EVOTAZ contains two active substances:
ATAZANAVIR, AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE.
It is one of a group called
_protease _
_inhibitors_
. These medicines control human immunodeficiency virus (HIV) infection
by stopping
production of a protein that HIV needs for its multiplication. They
work by reducing the amount
of HIV in your body and this in turn, strengthens your immune system.
In this way atazanavir
reduces the risk of developing illnesses linked to HIV infection.
COBICISTAT, A BOOSTER (PHARMACOKINETIC ENHANCER) TO HELP IMPROVE THE
EFFECTS OF ATAZANAVIR
.
Cobicistat, does not directly treat your HIV, but boosts the levels of
atazanavir in the blood. It
does this by slowing down the breakdown of atazanavir which will make
it stay in the body for
longer.
EVOTAZ may be used by adults and adolescents (aged 12 years and older
weighing at least 35 kg),
who are infected with HIV, the virus that causes acquired
immunodeficiency syndrome (AIDS). It is
used in combination with other anti-HIV medicines to help control your
HIV infection. Your doctor
will discuss wi
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EVOTAZ 300 mg/150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains atazanavir sulphate corresponding to
300 mg atazanavir and 150 mg
of cobicistat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pink, oval, biconvex, film-coated tablet of approximate dimensions of
19 mm x 10.4 mm, debossed
with "3641" on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EVOTAZ is indicated in combination with other antiretroviral medicinal
products for the treatment of
HIV-1 infected adults and adolescents (aged 12 years and older
weighing at least 35 kg) without
known mutations associated with resistance to atazanavir (see sections
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_ _
The recommended dose of EVOTAZ for adults and adolescents (aged 12
years and older weighing at
least 35 kg) is one tablet once daily taken orally with food (see
section 5.2).
_Advice on missed doses_
If EVOTAZ is missed within 12 hours of the time it is usually taken,
patients should be instructed to
take the prescribed dose of EVOTAZ with food as soon as possible. If
this is noticed later than
12 hours of the time it is usually taken, the missed dose should not
be taken and the patient should
resume the usual dosing schedule.
Special populations
_ _
_Renal impairment _
Based on the very limited renal elimination of cobicistat and
atazanavir, no special precautions or dose
adjustments of EVOTAZ are required for patients with renal impairment.
EVOTAZ is not recommended for patients undergoing haemodialysis (see
sections 4.4 and 5.2).
Cobicistat has been shown to decrease estimated creatinine clearance
due to inhibition of tubular
secretion of creatinine without affecting actual renal glomerular
function. EVOTAZ should not be
initiate
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