Reyataz

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

atazanavir (as sulfate)

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

J05AE08

INN (International Name):

atazanavir sulfate

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Reyataz 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 Reyataz 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).Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (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 Reyataz 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).

Product summary:

Revision: 54

Authorization status:

Authorised

Authorization date:

2004-03-01

Patient Information leaflet

100
B. PACKAGE LEAFLET
101
PACKAGE LEAFLET: INFORMATION FOR THE USER
REYATAZ 100 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 REYATAZ is and what it is used for
2.
What you need to know before you take REYATAZ
3.
How to take REYATAZ
4.
Possible side effects
5.
How to store REYATAZ
6.
Contents of the pack and other information
1.
WHAT REYATAZ IS AND WHAT IT IS USED FOR
REYATAZ 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
REYATAZ reduces the risk of
developing illnesses linked to HIV infection.
REYATAZ capsules may be used by adults and children 6 years of age and
older. Your doctor has
prescribed REYATAZ 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 REYATAZ
is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REYATAZ
DO NOT TAKE REYATAZ

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 PROBLEMS.
Your doctor will evaluate how severe your
liver disease is before

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
REYATAZ 100 mg hard capsules
REYATAZ 150 mg hard capsules
REYATAZ 200 mg hard capsules
REYATAZ 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
REYATAZ 100 mg hard capsules
Each capsule contains 100 mg of atazanavir (as sulphate).
Excipient with known effect: 54.79 mg of lactose per capsule.
REYATAZ 150 mg hard capsules
Each capsule contains 150 mg of atazanavir (as sulphate).
Excipient with known effect: 82.18 mg of lactose per capsule.
REYATAZ 200 mg hard capsules
Each capsule contains 200 mg of atazanavir (as sulphate).
Excipient with known effect: 109.57 mg of lactose per capsule.
REYATAZ 300 mg hard capsules
Each capsule contains 300 mg of atazanavir (as sulphate).
Excipient with known effect: 164.36 mg of lactose per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
REYATAZ 100 mg hard capsules
Opaque blue and white capsule printed with white and blue inks, with
"BMS 100 mg" on one half and
with "3623" on the other half.
REYATAZ 150 mg hard capsules
Opaque blue and powder blue capsule printed with white and blue inks,
with "BMS 150 mg" on one
half and with "3624" on the other half.
REYATAZ 200 mg hard capsules
Opaque blue capsule printed with white ink, with "BMS 200 mg" on one
half and with "3631" on the
other half.
3
REYATAZ 300 mg hard capsules
Opaque red and blue capsule printed with white ink, with "BMS 300 mg"
on one half and with "3622"
on the other half.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REYATAZ 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 REYATAZ in treatment-exp