Atazanavir betapharm 150 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATAZANAVIRSULFAAT SAMENSTELLING overeenkomend met ; ATAZANAVIR

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

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

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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir betapharm 150 mg, harde capsules
Atazanavir betapharm 200 mg, harde capsules
Atazanavir betapharm 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Atazanavir betapharm 150 mg, harde capsules:_
Each capsule contains 150 mg of atazanavir (as sulfate).
Excipient with known effect
69.00 mg of lactose monohydrate per capsule.
_Atazanavir betapharm 200 mg, harde capsules:_
Each capsule contains 200 mg of atazanavir (as sulfate).
Excipient with known effect
92.00 mg of lactose monohydrate per capsule.
_Atazanavir betapharm 300 mg, harde 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
_Atazanavir betapharm 150 mg, harde capsules:_
Opaque, blue and powder blue capsule of size 1 printed with white ink,
with “150 mg” on the
cap.
_Atazanavir betapharm 200 mg, harde capsules:_
Opaque, blue capsule of size 0 printed with white ink, with “200
mg” on the cap.
_Atazanavir betapharm 300 mg, harde 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
Atazanavir betapharm 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).
The choice of Atazanavir betapharm in treatment experienced adult and
paediatric patients
should be based on
individual viral resistance testing and the patient’s treatment
history (see
sections 4.4 and 5.1).
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be