ATAZANAVIR MYL atazanavir (as sulfate) 300 mg capsule bottle

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

atazanavir sulfate

MAH:

Alphapharm Pty Ltd

authorization_status:

Registered

PIL

ATAZANAVIR MYL
_atazanavir (as sulfate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ATAZANAVIR
MYL. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ATAZANAVIR MYL against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ATAZANAVIR
MYL IS USED FOR
ATAZANAVIR MYL belongs to a
group of medicines called protease
inhibitors.
ATAZANAVIR MYL is used in
combination with other anti-HIV
agents to treat adults and children
aged between 6 and 18 years of age
who are infected with Human
Immunodeficiency Virus (HIV).
WHAT IS HIV
HIV is a virus that kills important
cells in the immune system over time
(e.g. CD4 cells). When HIV has
killed enough of the immune cells,
your body becomes prone to certain
types of infections. Some infections
are the cause of "AIDS-defining"
illnesses. This is when someone is
said to have developed Acquired
Immunodeficiency Syndrome or
AIDS. AIDS is a serious condition
and can lead to death.
_HOW ATAZANAVIR MYL_
_WORKS_
When HIV infects cells in the
immune system, it takes over part of
the cell's internal workings and uses
the contents of the cell to produce
new viruses.
ATAZANAVIR MYL helps to block
HIV protease, an enzyme that is
needed for the HIV virus to multiply.
ATAZANAVIR MYL may lower the
amount of HIV in your blood and
help your body keep its supply of
CD4 and T-cells. Interfering with the
production of new viruses helps to
reduce the total amount of HIV in the
body and slows down the damage to
the immune system.
ATAZANAVIR MYL is not a cure
for HIV infection. Taking it will not
necessarily prevent the illnesses that
commonly occur in people with HIV
infection or AIDS. You can still
infect other people with HIV while
you are

SPC

AUSTRALIAN PRODUCT INFORMATION
ATAZANAVIR MYL
_atazanavir (as sulfate) capsule _
1
NAME OF THE MEDICINE
Atazanavir (as sulfate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains either 150 mg, 200 mg or 300 mg of atazanavir
(as sulfate) as the active ingredient.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ATAZANAVIR MYL 150 mg capsule: a.No.1, greenish-blue opaque cap and
blue opaque body, hard-shell
gelatin capsule filled with white to pale yellow powder. The capsule
is axially printed with MYLAN over AR150
in black ink on both the cap and body.
ATAZANAVIR MYL 200 mg capsule: a.No.0, blue opaque cap and
greenish-blue opaque body, hard-shell
gelatin capsule filled with white to pale yellow powder. The capsule
is axially printed with MYLAN over AR200
in black ink on both the cap and body.
ATAZANAVIR MYL 300 mg capsule: a.No.00, red opaque cap and
greenish-blue opaque body, hard-shell
gelatin capsule filled with white to pale yellow powder. The capsule
is axially printed with MYLAN over AR300
in black ink on both the cap and body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir is indicated for the treatment of HIV-1 infection, in
combination with other antiretroviral agents.
This indication is based on analyses of plasma HIV-1 RNA levels and
CD4 cell counts from controlled studies
(see section 5.1 Pharmacodynamic Properties – Clinical Trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL DOSING RECOMMENDATIONS
ATAZANAVIR MYL capsules must be taken with food.
ATAZANAVIR MYL capsules should be taken WHOLE. The recommended doses
are to be administered using
combinations of registered capsule strengths; e.g. a dose of 300 mg
may be administered as one 300 mg capsule
or two 150 mg capsules.
The recommended oral dosage of atazanavir depends on the treatment
history of the patient and the use of other
co-administered drugs. When co-administered with H
2
-receptor antagonists, or proton-pump in