EVOTAZ atazanavir/cobicistat 300 mg/150 mg film coated tablets bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

cobicistat, Quantity: 150 mg; atazanavir, Quantity: 300 mg

제공처:

Bristol-Myers Squibb Australia Pty Ltd

INN (국제 이름):

atazanavir,Cobicistat

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: stearic acid; croscarmellose sodium; hyprolose; crospovidone; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide red

관리 경로:

Oral

패키지 단위:

30 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

EVOTAZ is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

제품 요약:

Visual Identification: Oval, biconvex, pink film-coated tablets, debossed with "3641" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

승인 상태:

Licence status A

승인 날짜:

2015-09-23

환자 정보 전단

EVOTAZ
® TABLETS
(EV-OH-TAZ)
_Atazanavir (Ata-zan-a-vir) and Cobicistat (Co-bi-ci-stat)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking EVOTAZ. This leaflet
answers some common questions
about EVOTAZ.
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 EVOTAZ
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 EVOTAZ IS USED
FOR
EVOTAZ contains two active
ingredients, atazanavir and cobicistat.
Atazanavir belongs to a group of
medicines called protease inhibitors.
Cobicistat is a type of medicine
called a pharmacokinetic enhancer
(or "booster"). Cobicistat is included
to improve the effect of atazanavir by
increasing the level of atazanavir in
your body.
EVOTAZ is for adults. EVOTAZ is
used in combination with other anti-
HIV agents to treat adults 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 EVOTAZ 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.
EVOTAZ helps to block HIV
protease, an enzyme that is needed
for the HIV virus to multiply.
EVOTAZ 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

제품 특성 요약

AU_PI_Evotaz_V7.0
1
AUSTRALIAN PRODUCT INFORMATION - EVOTAZ ®
(ATAZANAVIR/COBICISTAT)
1
NAME OF THE MEDICINE
EVOTAZ (atazanavir/cobicistat)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EVOTAZ is a fixed-dose combination tablet for oral administration
containing 300 mg atazanavir as
atazanavir sulfate and 150 mg cobicistat.
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
EVOTAZ tablets are oval, biconvex, pink film-coated, debossed with
“3641” on one side and plain on
the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
EVOTAZ is indicated in combination with other antiretroviral agents
for the treatment of HIV-1
infection in adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended adult dosage of EVOTAZ is one tablet once daily taken
orally with food. Administer
EVOTAZ in conjunction with other antiretroviral agents. When
co-administered with H
2
-receptor
antagonists or proton-pump inhibitors, dose separation may be required
(see 4.5 Interactions with other
medicines and other forms of interactions).
EVOTAZ tablets should be taken whole and not broken, cut, or crushed.
If a dose of EVOTAZ is missed by 12 hours or less, the missed dose of
EVOTAZ should be taken right
away. The next dose of EVOTAZ should be taken at the usual time. If a
dose of EVOTAZ is missed by
more than 12 hours, the patient should wait and take the next dose at
the usual time. If a dose of
EVOTAZ is missed, the patient should not double the next dose.
RENAL IMPAIRMENT
EVOTAZ should not be administered to HIV treatment-experienced
patients with severe renal disease
managed with haemodialysis. Cobicistat, a component of EVOTAZ, has
been shown to decrease
estimated creatinine clearance due to inhibition of tubular secretion
of creatinine without affecting
actual glomerular function. Consider this effect when EVOTAZ is
coadministered with a drug that has
dosing adjustment recommendations guided by estimated creatinine
clearance (see 4.4 Special warnings
and precautions for use).
LABOR