Atazanavir Mylan

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

atazanavir (as sulfate)

Beschikbaar vanaf:

Mylan Pharmaceuticals Limited

ATC-code:

J05AE08

INN (Algemene Internationale Benaming):

atazanavir

Therapeutische categorie:

Antivirals for systemic use

Therapeutisch gebied:

HIV Infections

therapeutische indicaties:

Atazanavir Mylan, co-administered with low dose ritonavir, is 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). There are very limited data available from children aged 6 to less than 18 years.The choice of Atazanavir Mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Product samenvatting:

Revision: 14

Autorisatie-status:

Authorised

Autorisatie datum:

2016-08-22

Bijsluiter

69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATAZANAVIR MYLAN 150 MG HARD CAPSULES
ATAZANAVIR MYLAN 200 MG HARD CAPSULES
ATAZANAVIR MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Atazanavir Mylan
3.
How to take Atazanavir Mylan
4.
Possible side effects
5.
How to store Atazanavir Mylan
6.
Contents of the pack and other information
1.
WHAT ATAZANAVIR MYLAN IS AND WHAT IT IS USED FOR
ATAZANAVIR MYLAN
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 Mylan
reduces the risk of developing illnesses
linked to HIV infection.
Atazanavir Mylan capsules may be used by adults and children 6 years
of age and older. Your doctor has
prescribed Atazanavir Mylan 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 Mylan is best for
you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR MYLAN
_ _
DO NOT TAKE ATAZANAVIR MYLAN
•
IF YOU ARE ALLERGIC
to atazanavir or any of

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atazanavir Mylan 150 mg hard capsules
Atazanavir Mylan 200 mg hard capsules
Atazanavir Mylan 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
150 mg capsules
Each capsule contains 150 mg atazanavir (as sulphate)
200 mg capsules
Each capsule contains 200 mg atazanavir (as sulphate)
300 mg capsules
Each capsule contains 300 mg atazanavir (as sulphate)
Excipient(s) with known effect
150 mg capsules
Each capsule contains 84 mg lactose monohydrate
200 mg capsules
Each capsule contains 112 mg lactose monohydrate
300 mg capsules
Each capsule contains 168 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
150 mg capsules
Atazanavir Mylan 150 mg capsules are greenish-blue and blue opaque
hard shell gelatin capsules filled with
white to pale yellow powder and approximately 19.3 mm in length. The
capsules are axially printed with
‘MYLAN’ over ‘AR150’ in black ink on cap and body.
200 mg capsules
Atazanavir Mylan 200 mg capsules are blue and greenish-blue opaque
hard shell gelatin capsules filled with
white to pale yellow powder and approximately 21.4 mm in length. The
capsules are axially printed with
‘MYLAN’ over ‘AR200’ in black ink on cap and body.
3
300 mg capsules
Atazanavir Mylan 300 mg capsules are red and greenish-blue opaque hard
shell gelatine capsules filled with
white to pale yellow powder and approximately 23.5 mm in length. The
capsules are axially printed with
‘MYLAN’ over ‘AR300’ in black ink on cap and body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir Mylan, co-administered with low dose ritonavir, is
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 multip