Atazanavir Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atazanavir sulfate 227.8mg equivalent to Atazanavir 200mg; Atazanavir sulfate 227.8mg equivalent to Atazanavir 200mg

Available from:

Viatris Limited

INN (International Name):

Atazanavir sulfate 227.8 mg (equivalent to Atazanavir 200mg)

Dosage:

200 mg

Pharmaceutical form:

Capsule

Composition:

Active: Atazanavir sulfate 227.8mg equivalent to Atazanavir 200mg Excipient: Brilliant blue FCF   Crospovidone Erythrosine Gelatin   Lactose monohydrate Magnesium stearate Purified water   Titanium dioxide   Active: Atazanavir sulfate 227.8mg equivalent to Atazanavir 200mg Excipient: Crospovidone Gelatin   Indigo carmine Iron oxide yellow Lactose monohydrate Magnesium stearate Patent blue V Purified water   TekPrint black SW-9008 Titanium dioxide  

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Atazanavir Viatris is indicated for the treatment of HIV 1 infection, in combination with other antiretroviral agents, in adult patients and in paediatric patients 6 to 18 years of age. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC-Al blister pack - 60 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with CRC cap - 60 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2016-12-12

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ATAZANAVIR VIATRIS
_ATAZANAVIR (AS SULFATE) CAPSULES 150 MG & 200 MG _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Atazanavir
Viatris.
This leaflet answers some common
questions about Atazanavir Viatris.
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
Viatris 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
VIATRIS IS USED FOR
Atazanavir Viatris 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).
This medicine belongs to a group of
medicines called protease
inhibitors.
Atazanavir Viatris contains the
active ingredient atazanavir sulfate.
It belongs to a group of medicines
called protease inhibitors.
_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 VIATRIS _
_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 Viatris helps to block
HIV protease, an enzyme that is
needed for the HIV virus to multiply.
Atazanavir Viatris 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

Summary of Product characteristics

Page 1 of 50
NEW ZEALAND DATA SHEET
ATAZANAVIR VIATRIS
1. PRODUCT NAME
Atazanavir Viatris 150 mg capsules
Atazanavir Viatris 200 mg capsules
Atazanavir Viatris 300 mg capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Atazanavir Viatris 150 mg: each capsule contains 150 mg of atazanavir
(as sulfate).
Atazanavir Viatris 200 mg: each capsule contains 200 mg of atazanavir
(as sulfate).
Atazanavir Viatris 300 mg: each capsule contains 300 mg of atazanavir
(as sulfate).
Excipient with known effect: Lactose
Allergen declaration: Sugars as lactose.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Hard gelatin capsules.
Atazanavir Viatris 150 mg capsules: 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 Viatris 200 mg capsules: 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 Viatris 300 mg capsules: 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 Viatris is indicated for the treatment of HIV 1 infection,
in combination with other
antiretroviral agents in adult patients and in paediatric patients 6
to 18 years of age.
This indication is based on analyses of plasma HIV-1 RNA levels and
CD4 cell counts from controlled
studies (see section 5.1).
Page 2 of 50
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
GENERAL DOSING RECOMMENDATIONS
Atazanavir Viatris capsules must be taken with food.
Atazanavir
Viatris
capsules
should
be
taken
WHOLE.
The
recommended
doses
are
to
be
administered using combinations of registered capsule strengths;