Atazanavir Medicopharm 300 mg, harde capsules

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

ATAZANAVIRSULFAAT 341,7 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 300 mg/stuk

Verfügbar ab:

Medicopharm AG Stangenreiterstraße 4 83131 NUßDORF AM INN (DUITSLAND)

ATC-Code:

J05AE08

INN (Internationale Bezeichnung):

ATAZANAVIRSULFAAT 341,7 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 300 mg/stuk

Darreichungsform:

Capsule, hard

Zusammensetzung:

AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; CROSPOVIDON (E 1202) ; ERYTHROSINE (E 127) ; 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

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Atazanavir

Berechtigungsdatum:

1900-01-01

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 ingredients of
this medicine (listed in section
6).
▪
IF YOU HAVE MODERATE TO SEVERE LIVER PROB

Fachinformation

1
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Medicopharm 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atazanavir Medicopharm 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 Medicopharm 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 Medicopharm 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 Medicopharm 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults_
The recommended dose of Atazanavir Medicopharm capsules is 300 mg once
daily taken with ritonavir 100
mg once daily and with food. Ritonavir is used as a booster of
atazanavir pharmacokinetics (see sections
4.5 and 5.1). (See also section 4.4 Withdrawal of ritonavir only under
restrictive conditions).
_Paediatric population (6 years to less than 18 years of age and
weighing at least 15 kg)_
The dose of atazanavir capsules for paediatric patients is based on
bo