Atazanavir Sandoz 150 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATAZANAVIRSULFAAT 171 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 150 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J05AE08

INN (Algemene Internationale Benaming):

ATAZANAVIRSULFAAT 171 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 150 mg/stuk

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:

2018-11-12

Bijsluiter

Sandoz B.V.
Page 1/10
Atazanavir Sandoz 100, 150, 200, 300 mg, harde capsules
RVG 121563-6
1313-V5
1.3.1.3 Bijsluiter
maart 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATAZANAVIR SANDOZ 100 MG, HARDE CAPSULES
ATAZANAVIR SANDOZ 150 MG, HARDE CAPSULES
ATAZANAVIR SANDOZ 200 MG, HARDE CAPSULES
ATAZANAVIR SANDOZ 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] 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 [Nationally completed name] reduces the risk of
developing illnesses linked to
HIV infection.
[Nationally completed name] capsules may be used by adults and
children 6 years of age and
older. Your doctor has
prescribed [Nationally completed name] for you because you are
infected by the HIV that causes Acquired
Immunodeficiency Syndrome (AIDS). It is normally
used in combination with other anti-H

Productkenmerken

Sandoz B.V.
Page 1/42
Atazanavir Sandoz 100, 150, 200, 300 mg, harde capsules
RVG 121563-6
1311-V9
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Sandoz 100 mg, harde capsules
Atazanavir Sandoz 150 mg, harde capsules
Atazanavir Sandoz 200 mg, harde capsules
Atazanavir Sandoz 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_100 mg hard capsules_
Each hard capsule contains 100 mg of atazanavir (as sulfate).
Excipient with known effect
Each hard capsule contains 43.7 mg of lactose (as monohydrate).
_150 mg hard capsules_
Each hard capsule contains 150 mg of atazanavir (as sulfate).
Excipient with known effect
Each hard capsule contains 65.6 mg of lactose (as monohydrate).
_200 mg hard capsules_
Each hard capsule contains 200 mg of atazanavir (as sulfate).
Excipient with known effect
Each hard capsule contains 87.4 mg of lactose (as monohydrate).
_ _
_ _
_300 mg hard capsules_
Each hard capsule contains 300 mg of atazanavir (as sulfate).
Excipient with known effect
Each hard capsule contains 131.1 mg of lactose (as monohydrate).
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.
Sandoz B.V.
Page 2/42
Atazanavir Sandoz 100, 150, 200, 300 mg, harde capsules
RVG 121563-6
1311-V9
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
_ _
_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
[Nationally completed name] capsules, co-administered with low dose
ritonavir, are indicated
for the treatment of HIV-1 infected adu