REYATAZ atazanavir (as sulfate) 300mg capsule bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

atazanavir sulfate, Quantity: 341.69 mg (Equivalent: atazanavir, Qty 300 mg)

Boleh didapati daripada:

Bristol-Myers Squibb Australia Pty Ltd

INN (Nama Antarabangsa):

Atazanavir sulfate

Borang farmaseutikal:

Capsule, hard

Komposisi:

Excipient Ingredients: crospovidone; magnesium stearate; lactose monohydrate; titanium dioxide; indigo carmine; iron oxide yellow; sorbitan monolaurate; iron oxide red; potable water; Gelatin; iron oxide black; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; Pharmaceutical glaze; dimeticone

Laluan pentadbiran:

Oral

Unit dalam pakej:

30 capsules

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Reyataz 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 5.1 Pharmacodynamic properties: Clinical trials).

Ringkasan produk:

Visual Identification: Size 00, hard gelatin capsule with red opaque cap and blue opaque body; printed in white with "BMS 300mg" on the cap, and "3622" on the body.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status kebenaran:

Licence status A

Tarikh kebenaran:

2007-08-14

Risalah maklumat

REYATAZ
® CAPSULES
(RAY-UH-TAZ)
_Atazanavir (Ata-zan-a-vir)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking REYATAZ. This leaflet
answers some common questions
about REYATAZ.
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 REYATAZ
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 REYATAZ IS
USED FOR
REYATAZ is a trade name
(manufacturer's name) for the
medicine, atazanavir. REYATAZ
belongs to a group of medicines
called protease inhibitors.
REYATAZ 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 the Acquired
Immunodeficiency Syndrome or
AIDS. AIDS is a serious condition
and can lead to death.
_HOW REYATAZ WORKS_
When HIV infects cells in the
immune system, it takes over part of
the cell's internal workings and uses
contents of the cells to produce new
viruses.
REYATAZ helps to block HIV
protease, an enzyme that is needed
for the HIV virus to multiply.
REYATAZ 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.
REYATAZ is not a cure for HIV
infection. Taking it will not
necessarily prevent the illnesses that
commonly occur in peopl

Ciri produk

REYATAZ PI v23.0
1
AUSTRALIAN PRODUCT INFORMATION – REYATAZ
®
(ATAZANAVIR)
1
NAME OF THE MEDICINE
REYATAZ (atazanavir)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
REYATAZ 200 mg hard capsules
Each capsule contains 200 mg of atazanavir (as sulfate).
Excipient with known effect: 109.57 mg of lactose monohydrate per
capsule.
REYATAZ 300 mg hard capsules
Each capsule contains 300 mg of atazanavir (as sulfate).
Excipient with known effect: 164.36 mg of lactose monohydrate per
capsule.
Atazanavir sulfate is an off-white to pale yellow crystalline powder.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
REYATAZ 200 mg hard capsules
Blue capsule printed with white ink, with "BMS 200 mg" on one half and
with "3631" on the other half.
REYATAZ 300 mg hard capsules
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
T
HERAPEUTIC INDICATIONS
REYATAZ 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 5.1 Pharmacodynamic properties: Clinical trials).
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL DOSING RECOMMENDATIONS
REYATAZ capsules must be taken with food.
REYATAZ capsules should be taken WHOLE.
The recommended oral dosage of REYATAZ depends on the treatment
history of the patient and the
use of other coadministered drugs. When coadministered with H
2
-receptor antagonists, or proton-pump
inhibitors, dose separation may be required (see recommendations
below).
When coadministered with didanosine buffered or enteric-coated
formulations REYATAZ should be
given (with food) 2 hours before or 1 hour after didanosine.
REYATAZ without ritonavir is not recommended for treatment-experienced
patients with prior
virologic failure.
REYATAZ PI v23.0
2
Efficacy and safety of REYATAZ with ritonavir in doses greater than
100 mg once daily have not been
e