Atazanavir Medicopharm 150 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATAZANAVIRSULFAAT 170,9 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 150 mg/stuk

Beschikbaar vanaf:

Medicopharm AG Stangenreiterstraße 4 83131 NUßDORF AM INN (DUITSLAND)

ATC-code:

J05AE08

INN (Algemene Internationale Benaming):

ATAZANAVIRSULFAAT 170,9 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 150 mg/stuk

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) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atazanavir

Autorisatie datum:

2019-07-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATAZANAVIR MEDICOPHARM 150 MG, HARDE CAPSULES
ATAZANAVIR MEDICOPHARM 200 MG, HARDE CAPSULES
ATAZANAVIR MEDICOPHARM 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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[INVENTED 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
[Invented name] reduces the risk
of developing illnesses linked to HIV infection.
[Invented name] capsules may be used by adults and children 6 years of
age and older. Your doctor
has prescribed [Invented 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-HIV
medicines. Your doctor will discuss with you which combination of
these medicines with [Invented
name] is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]:
▪
IF YOU ARE ALLERGIC
to atazanavir or any of the other ingre

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Medicopharm 150 mg, harde capsules
Atazanavir Medicopharm 200 mg, harde capsules
Atazanavir Medicopharm 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Invented name] 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
[Invented name] 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
[Invented name] 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.
[Invented name] 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.
[Invented name] 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.
[Invented name] 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
[Invented name] 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 medic