PREZISTA darunavir 600mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

darunavir, Quantity: 600 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

Darunavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; purified talc; polyvinyl alcohol; macrogol 3350; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; sunset yellow FCF aluminium lake; titanium dioxide

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adult Patients,PREZISTA ( with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.,Paediatric Patients,PREZISTA (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

Product summary:

Visual Identification: Orange, oval-shaped, film-coated tablet debossed with '600MG' on one side and 'TMC' on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-07-30

Patient Information leaflet

PREZISTA (211105) ACMI
1
PREZISTA
® TABLETS
_darunavir (da-ROO-nuh-veer) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PREZISTA (pre-
ZIS-ta) tablets. 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 being given
PREZISTA against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN PREZISTA ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING PREZISTA.
You may need to read it again.
WHAT PREZISTA IS
USED FOR
PREZISTA is an antiretroviral
medicine. It belongs to a group of
medicines called protease (PRO-tee-
ase) inhibitors. PREZISTA works by
reducing the amount of HIV in your
body. Reducing the amount of HIV
in your blood improves your immune
system, and reduces the risk of
developing illnesses as a result of
HIV infection.
PREZISTA is used to treat adults,
and children 6 years of age or above
weighing more than 20 kg, who are
infected by HIV (Human
Immunodeficiency Virus).
In adults, PREZISTA must be taken
in combination with cobicistat or
with a low dose of ritonavir, and with
other anti-HIV medicines.
In children, PREZISTA must be
taken in combination with a low dose
of ritonavir, and with other anti-HIV
medicines.
Your doctor will discuss with you
which combination of medicines will
work best with PREZISTA.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREZISTA
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
PREZISTA
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE PREZISTA:
•
if you are allergic
(hypersensitive) to darunavir,
other ingredients of PREZISTA
or to ritonavir or to cobicistat.
Symptoms of an allergic reaction
may include rash, itching or hives
on the skin, shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue
or other parts of the body.
DO NOT TAKE P

Summary of Product characteristics

_ _
CCDS210601
Page 1
PREZISTA (211102) API
AUSTRALIAN PRODUCT INFORMATION
PREZISTA
®
DARUNAVIR
FILM-COATED TABLET
1.
NAME OF THE MEDICINE
Darunavir
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREZISTA darunavir is available as 75 mg, 400 mg, 600 mg and 800 mg
film-coated tablets
(the 75 mg and 400 mg tablets are not currently marketed). Each
film-coated tablet contains
75 mg, 400 mg, 600 mg or 800 mg of darunavir, as 81.31 mg, 433.64 mg,
650.46 mg or 867.28
mg of darunavir ethanolate, respectively.
For a full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
PREZISTA 75 mg film-coated tablets are white caplet-shaped tablets,
debossed with 75 on one
side and TMC on the other side (currently not marketed).
PREZISTA 400 mg film-coated tablets are light orange oval shaped
tablets, debossed with
400MG on one side and TMC on the other side (currently not marketed).
PREZISTA 600 mg film-coated tablets are orange oval shaped tablets,
debossed with 600MG
on one side and TMC on the other side.
PREZISTA 800 mg film-coated tablets are dark red oval-shaped tablets,
debossed with 800 on
one side and T on the other side.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
ADULT PATIENTS
PREZISTA (with low dose ritonavir as a pharmacokinetic enhancer) is
indicated in combination
with other antiretroviral agents for the treatment of human
immunodeficiency virus-1 (HIV-1)
infection in adult patients.
_ _
CCDS210601
Page 2
PREZISTA (211102) API
PAEDIATRIC PATIENTS
PREZISTA (with low dose ritonavir as a pharmacokinetic enhancer) is
indicated in combination
with other antiretroviral agents for the treatment of human
immunodeficiency virus (HIV)
infection in treatment-experienced paediatric patients aged 6 years
and older, weighing at least
20 kg.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
_Adults: _
For antiretroviral treatment-experienced patients, HIV-1 genotype
testing is recommended_. _
_Once Daily Dose _
The recommended dose of PREZISTA is 800 mg once daily with ritonavir
10