Atazanavir Alvogen 200 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATAZANAVIRSULFAAT SAMENSTELLING overeenkomend met ; ATAZANAVIR

Beschikbaar vanaf:

Alvogen Malta Operations (ROW) Ltd. Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings SGN 3000 SAN GW

ATC-code:

J05AE08

INN (Algemene Internationale Benaming):

ATAZANAVIRSULFAAT COMPOSITION corresponding to ; ATAZANAVIR

farmaceutische vorm:

Capsule, hard

Samenstelling:

CROSPOVIDON (E 1202) ; GELATINE (E 441) ; INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; WITTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atazanavir

Autorisatie datum:

2018-11-09

Bijsluiter

39
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATAZANAVIR ALVOGEN 150 MG HARDE CAPSULES
ATAZANAVIR ALVOGEN 200 MG HARDE CAPSULES
ATAZANAVIR ALVOGEN 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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
reduces the risk of
developing illnesses linked to HIV infection.
capsules may be used by adults and children 6 years of
age and older. Your doctor has
prescribed 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
is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE

-
IF YOU ARE ALLERGIC
to atazanavir or any of the other ingredients of this medici

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Alvogen 150 mg, harde capsules
Atazanavir Alvogen 200 mg, harde capsules
Atazanavir Alvogen 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ 100 mg hard capsules: _
Each capsule contains 100 mg of atazanavir (as sulfate).
Excipient with known effect
46.00 mg of lactose monohydrate per capsule.
_ 150 mg hard capsules: _
Each capsule contains 150 mg of atazanavir (as sulfate).
Excipient with known effect
69.00 mg of lactose monohydrate per capsule.
_ 200 mg hard capsules: _
Each capsule contains 200 mg of atazanavir (as sulfate).
Excipient with known effect
92.00 mg of lactose monohydrate per capsule.
_ 300 mg hard capsules: _
Each capsule contains 300 mg of atazanavir (as sulfate).
Excipient with known effect
138.00 mg of lactose monohydrate per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
_ 100 mg hard capsules: _
Opaque, blue and white capsule of size 2 printed with white ink, with
“100 mg” on the cap.
_ 150 mg hard capsules: _
Opaque, blue and powder blue capsule of size 1 printed with white ink,
with “150 mg” on the cap.
_ 200 mg hard capsules: _
Opaque, blue capsule of size 0 printed with white ink, with “200
mg” on the cap.
_ 300 mg hard capsules: _
Opaque red and blue capsule of size 00 printed with white ink, with
“300 mg” on the cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 combination with other
antiretroviral medicinal products (see section 4.2).
Based on available virological and clinical data from adult patients,
no benefit is expected in patients
with strains resistant to multiple protease inhibitors (≥ 4 PI
mutations).
2
The choice of

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