TELZIR fosamprenavir 700mg (as calcium) tablet

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

fosamprenavir calcium, Quantity: 853.2 mg (Equivalent: fosamprenavir, Qty 700 mg)

Доступно од:

ViiV Healthcare Pty Ltd

INN (Међународно име):

Fosamprenavir calcium

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: povidone; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; iron oxide red

Пут администрације:

Oral

Јединице у пакету:

1 x 60 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Telzir, in combination with low dose ritonavir, is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. In antiretroviral experienced adults Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir/ritonavir. No comparative studies have been undertaken in children or adolescents.

Резиме производа:

Visual Identification: Pink, film-coated, capsule-shaped, biconvex tablets, debossed GX LL7 on one face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус ауторизације:

Registered

Датум одобрења:

2004-05-27

Информативни летак

TELZIR TABLETS
_fosamprenavir_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start TELZIR tablets.
This leaflet answers some common
questions about TELZIR tablets. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking TELZIR in
combination with ritonavir against
the expected benefits it will have for
you.
As you will be taking TELZIR
together with low doses of ritonavir,
you should also carefully read the
Patient Leaflet for that product
before starting treatment with this
combination.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE TABLETS.
You may need to read it again.
WHAT TELZIR TABLETS
ARE USED FOR
TELZIR tablets contain
fosamprenavir which belongs to a
group of antiretroviral medicines
called protease inhibitors.
The low doses of ritonavir you take
together with TELZIR are designed
to increase the amount of the active
ingredient, amprenavir, available to
control your HIV infection.
TELZIR, taken with ritonavir, are
used together with other
antiretroviral medicines to slow
down the progression of human
immunodeficiency virus (HIV)
infection, which can lead to Acquired
Immune Deficiency Syndrome
(AIDS) and other related illnesses
(eg AIDS-related Complex or ARC).
TELZIR does not cure AIDS or kill
the HIV virus, but prevents further
damage to the immune system by
stopping production of new viruses.
TELZIR does not reduce the risk of
passing the infection to others. You
will still be able to pass on the HIV
virus by sexual activity or by
contamination with infected blood.
You should still use proper
precautions to prevent this.
While taking TELZIR and/or any
other therapy for HIV disease, you
may continue to develop other
infections and other complications of
HIV infection. You should keep in
regular contact with the doctor who
is looking aft

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION
TELZIR (FOSAMPRENAVIR CALCIUM) TABLETS
1
NAME OF THE MEDICINE
Fosamprenavir calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TELZIR tablet contains 700 mg of fosamprenavir, as fosamprenavir
calcium.
Fosamprenavir is converted in humans to amprenavir. Each TELZIR 700 mg
tablet is
equivalent to approximately 600 mg of amprenavir.
Fosamprenavir calcium is a white to cream coloured solid.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TELZIR are biconvex, capsules-shaped, pinked coloured tablets marked
with GXLL7 on one
face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TELZIR, in combination with low dose ritonavir, is indicated for the
treatment of Human
Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and
children of 6 years
and above in combination with other antiretroviral medicinal products.
In antiretroviral experienced adults TELZIR in combination with low
dose ritonavir has not
been shown to be as effective as lopinavir/ritonavir. No comparative
studies have been
undertaken in children or adolescents.
4.2
DOSE AND METHOD OF ADMINISTRATION
A physician experienced in the management of HIV infection should
initiate therapy.
Fosamprenavir is administered orally.
The tablet can be taken with or without food.
Higher than approved dose combinations of fosamprenavir with ritonavir
are not
recommended for use (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR
USE).
2
ADULTS (GREATER THAN OR EQUAL TO 18 YEARS OF AGE)
_ANTIRETROVIRAL NAÏVE PATIENTS._ The recommended dose is 1400 mg
fosamprenavir once
daily with 200 mg ritonavir once daily or 700 mg (one tablet)
fosamprenavir twice daily with
100 mg ritonavir twice daily. Both regimens must be administered in
combination with other
antiretroviral agents.
_PROTEASE INHIBITOR EXPERIENCED PATIENTS._ The recommended dose 700 mg
(one tablet)
fosamprenavir twice daily with 100 mg ritonavir twice daily. This
regimen must be
administered in combination with other anti