Atazanavir Hetero 200 mg, harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ATAZANAVIRSULFAAT SAMENSTELLING overeenkomend met ; ATAZANAVIR

Beschikbaar vanaf:

Hetero Europe S.L.

ATC-code:

J05AE08

INN (Algemene Internationale Benaming):

ATAZANAVIRSULFAAT COMPOSITION corresponding to ; ATAZANAVIR

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atazanavir

Autorisatie datum:

2019-07-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATAZANAVIR HETERO 150 MG, HARDE CAPSULES
ATAZANAVIR HETERO 200 MG, HARDE CAPSULES
ATAZANAVIR HETERO 300 MG, HARDE CAPSULES
Atazanavir
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 Atazanavir Hetero is and what it is used for
2.
What you need to know before you take Atazanavir Hetero
3.
How to take Atazanavir Hetero
4.
Possible side effects
5.
How to store Atazanavir Hetero
6.
Contents of the pack and other information
1.
WHAT ATAZANAVIR HETERO IS AND WHAT IT IS USED FOR
ATAZANAVIR HETERO IS AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE. It is
one of a group called protease
inhibitors. These medicines control Human Immunodeficiency Virus (HIV)
infection by stopping a
protein that the 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 Hetero reduces the risk
of developing illnesses linked to HIV infection.
Atazanavir Hetero capsules may be used by adults and children 6 years
of age and older. Your doctor
has prescribed Atazanavir Hetero for you because you are infected by
the HIV that causes Acquired
Immunodeficiency Syndrome (AIDS). It is normally used in combination
with other anti-HIV
medicines. Your doctor will discuss with you which combination of
these medicines with Atazanavir
Hetero is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR HETERO
DO NOT TAKE ATAZANAVIR HETERO:

IF YOU ARE ALLERGIC to atazanavir or any of the ot

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Hetero 150 mg, harde capsules
Atazanavir Hetero 200 mg, harde capsules
Atazanavir Hetero 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atazanavir Hetero 150 mg hard capsules
Each capsule contains atazanavir sulphate corresponding to 150 mg of
atazanavir.
Excipient(s) with known effect: 81.45 mg of lactose per capsule
Atazanavir Hetero 200 mg hard capsules
Each capsule contains atazanavir sulphate corresponding to 200 mg of
atazanavir.
Excipient(s) with known effect:
109 mg of lactose per capsule
0.0007 mg of sunset yellow FCF (E110) per capsule
Atazanavir Hetero 300 mg hard capsules
Each capsule contains atazanavir sulphate corresponding to 300 mg of
atazanavir.
Excipient(s) with known effect:
163 mg of lactose per capsule
0.41 mg of sunset yellow FCF (E110) per capsule
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Atazanavir Hetero 150 mg hard capsules
Off white to pale yellow coloured granular powder filled in hard
gelatin capsules of approx. 19.3 mm
in length with green opaque cap imprinted with “H” in black colour
and light green opaque body
imprinted with “A6” in black colour.
Atazanavir Hetero 200 mg hard capsules
Off white to pale yellow coloured granular powder filled in hard
gelatin capsules of approx. 21.4 mm
in length with green opaque cap imprinted with “H” in black colour
and light green opaque body
imprinted with “A7” in black colour.
Atazanavir Hetero 300 mg hard capsules
Off white to pale yellow coloured granular powder filled in hard
gelatin capsules of approx. 23.5 mm
in length with orange opaque cap imprinted with “H” in black
colour and green opaque body
imprinted with “A8” in black colour.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir Hetero capsules, co-administered with low dose ritonavir,
are indicated for the treatment
of HIV-1 infected adults and paediatric patients 6 years of age and
older in combinati