ATAZANAVIR TEVA 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ATAZANAVIR AS SULFATE

Available from:

TEVA ISRAEL LTD

ATC code:

J05AE08

Pharmaceutical form:

CAPSULES

Composition:

ATAZANAVIR AS SULFATE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic area:

ATAZANAVIR

Therapeutic indications:

Atazanavir Teva ® is indicated in combination with other antiretroviral agents for for the treatment of HIV-1 infection.

Authorization date:

2023-10-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's
prescription only
ATAZANAVIR TEVA 150 MG
CAPSULES
_Composition:_
Each capsule contains:
Atazanavir (as sulfate) 150 mg
ATAZANAVIR TEVA 200 MG
CAPSULES
_Composition:_
Each capsule contains:
Atazanavir (as sulfate) 200 mg
ATAZANAVIR TEVA 300 MG
CAPSULES
_Composition:_
Each capsule contains:
Atazanavir (as sulfate) 300 mg
For information regarding inactive ingredients and
allergens, see section 2 - “Important information
about
some
ingredients
of
the
medicine”
and
section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine. If you have additional questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them even if it
seems to you that their medical condition is similar.
THIS
MEDICINE
IS
INTENDED
FOR
ADULTS
AND
CHILDREN ABOVE 6 YEARS OF AGE. THIS MEDICINE IS
NOT INTENDED FOR BABIES UNDER THREE MONTHS OF
AGE.
1. WHAT IS THE MEDICINE INTENDED FOR?
Atazanavir
Teva
is
intended
for
treatment
of
HIV-1
(Human
Immunodeficiency
Virus
type
1)
and is given in combination with other antiretroviral
medicines intended to treat HIV-1 (antiretroviral
agents) in adults and children above 6 years of age.
Atazanavir Teva is not intended for babies under
three months of age.
THERAPEUTIC CLASS: Protease inhibitors.
Atazanavir Teva is a prescription medicine against
HIV-1 (Human Immunodeficiency Virus type 1),
which is given in combination with other antiretroviral
medicines intended to treat HIV-1 infections.
HIV-1 is the virus that causes AIDS (Acquired
Immunodeficiency Syndrome).
When used with other antiretroviral medicines to
treat HIV-1 infection, Atazanavir Teva may help
reduce the amount of the HIV-1 virus in the blood
(also called viral load), and to increase the number
of CD4+ (T) cells in the blood that help fight o

Summary of Product characteristics

Atazanavir Teva 150/200/300mg KL SPC Notification
2023
-
12
Atazanavir Teva 150 mg
Atazanavir Teva 200 mg
Atazanavir Teva 300 mg
(ATAZANAVIR as SULFATE) CAPSULES
_Per os _
1.
INDICATIONS AND USAGE
Atazanavir Teva (atazanavir as sulfate) is indicated in combination
with other antiretroviral agents for the
treatment of HIV-1 infection.
This indication is based on analyses of plasma HIV-1 RNA levels and
CD4+ cell counts from controlled
studies of 96 weeks duration in antiretroviral-naive and 48 weeks
duration in antiretroviral-treatment-
experienced adult and pediatric patients at least 6 years of age.
The following points should be considered when initiating therapy with
Atazanavir Teva:

In Study AI424-045, atazanavir /ritonavir and lopinavir/ritonavir were
similar for the primary
efficacy outcome measure of time-averaged difference in change from
baseline in HIV RNA level.
This study was not large enough to reach a definitive conclusion that
atazanavir /ritonavir and
lopinavir/ritonavir are equivalent on the secondary efficacy outcome
measure of proportions
below the HIV RNA lower limit of detection [see Clinical Studies
(13.2)].
The number of baseline primary protease inhibitor mutations affects
the virologic response to atazanavir
/ritonavir [see Clinical Pharmacology (11.4)].
2.
DOSAGE AND ADMINISTRATION
2.1.
overview

Atazanavir Teva Capsules must be taken with food.

Do not open the capsules.

The recommended oral dosage of Atazanavir Teva depends on the
treatment history of the patient
and the use of other coadministered drugs. When coadministered with
H2-receptor antagonists or
proton-pump inhibitors, dose separation may be required [see Dosage
and Administration
(2.3,2.4,2.5 and 2.6) and drug interactions (7)].

When coadministered with didanosine buffered or enteric-coated
formulations, Atazanavir Teva
should be given (with food) 2 hours before or 1 hour after didanosine.

Atazanavir Teva without ritonavir is not recommended for
treatment-experienced adult or
pediatric patients with pri