Atazanavir Krka

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

atazanavir (as sulfate)

Available from:

Krka, d.d., Novo mesto

ATC code:

J05AE08

INN (International Name):

atazanavir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Atazanavir Krka 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.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 Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2019-03-25

Patient Information leaflet

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATAZANAVIR KRKA 150 MG HARD CAPSULES
ATAZANAVIR KRKA 200 MG HARD CAPSULES
ATAZANAVIR KRKA 300 MG HARD 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 Krka is and what it is used for
2.
What you need to know before you take Atazanavir Krka
3.
How to take Atazanavir Krka
4.
Possible side effects
5.
How to store Atazanavir Krka
6.
Contents of the pack and other information
1.
WHAT ATAZANAVIR KRKA IS AND WHAT IT IS USED FOR
ATAZANAVIR KRKA 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 Krka reduces the risk
of developing illnesses linked to HIV infection.
Atazanavir Krka capsules may be used by adults and children 6 years of
age and older. Your doctor
has prescribed Atazanavir Krka 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
Krka is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR KRKA
DO NOT TAKE ATAZANAVIR KRKA
-
IF YOU ARE ALLERGIC to atazanavir or any of the other ingr

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Krka 150 mg hard capsules
Atazanavir Krka 200 mg hard capsules
Atazanavir Krka 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Atazanavir Krka 150 mg hard capsules_
Each hard capsule contains 150 mg atazanavir (as sulphate).
Excipient with known effect
Each hard capsule contains 79.43 mg lactose monohydrate.
_Atazanavir Krka 200 mg hard capsules_
Each hard capsule contains 200 mg atazanavir (as sulphate).
Excipient with known effect
Each hard capsule contains 105.91 mg lactose monohydrate.
_Atazanavir Krka 300 mg hard capsules_
Each hard capsule contains 300 mg atazanavir (as sulphate).
Excipient with known effect
Each hard capsule contains 158.86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
_Atazanavir Krka 150 mg hard capsules_
Hard gelatine capsule, size no. 1. The body of the capsule is white or
almost white colour, the cap of
the capsule is brownish-orange colour. The capsule cap is imprinted
with black mark A150. The
content of the capsule is yellowish-white to yellow-white powder.
_Atazanavir Krka 200 mg hard capsules_
Hard gelatine capsule, size no. 0. The body and the cap of the capsule
are brownish-orange colour.
The capsule cap is imprinted with black mark A200. The content of the
capsule is yellowish-white to
yellow-white powder.
_Atazanavir Krka 300 mg hard capsules_
Hard gelatine capsule, size no. 00. The body of the capsule is white
or almost white colour, the cap of
the capsule is dark brown colour. The capsule cap is imprinted with
white mark A300. The content of
the capsule is yellowish-white to yellow-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir Krka 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).