Prezista

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Darunavir ethanolate 867.28mg equivalent to darunavir 800 mg

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Darunavir ethanolate 867.28 mg (equivalent to darunavir 800 mg)

Dosage:

800 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Darunavir ethanolate 867.28mg equivalent to darunavir 800 mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Opadry red 85F150004 Purified water Silicified microcrystalline cellulose

Prescription type:

Prescription

Manufactured by:

Cilag AG

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.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP child resistant closure - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2012-10-08

Patient Information leaflet

PREZISTA (230831) NZ CMI
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).
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
(listed in ingredients section
below) or to ritonavir.
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 PREZISTA:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the p

Summary of Product characteristics

36.220704
1
PREZISTA (230831) ADS
PREZISTA
®
DARUNAVIR
DATA SHEET
1. PRODUCT NAME
PREZISTA 75 mg film-coated tablets
PREZISTA 150 mg film-coated tablets
PREZISTA 300 mg film-coated tablets
PREZISTA 400 mg film-coated tablets
PREZISTA 600 mg film-coated tablets
PREZISTA 800 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg, 150 mg, 300 mg, 400 mg, 600 mg
or 800 mg darunavir,
as 81.31 mg, 162.62 mg, 325.23 mg, 433.64 mg, 650.46 or 867.28 mg
darunavir ethanolate,
respectively.
Excipient(s) with known effect:
The 300 mg, 400 mg and 600 mg tablets contains 1.375 mg, 0.834 mg and
2.750 mg sunset
yellow FCF (E110), respectively.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
PREZISTA 75 mg film-coated tablet: White caplet-shaped tablet,
debossed with 75 on one side
and TMC on the other side.
PREZISTA 150 mg film-coated tablet: White oval-shaped tablet, debossed
with 150 on one side
and TMC on the other side.
PREZISTA 300 mg film-coated tablet: Orange oval shaped tablet,
debossed with 300MG on one
side and TMC114 on the other side.
PREZISTA 400 mg film-coated tablet: Light orange oval shaped tablet,
debossed with 400MG on
one side and TMC on the other side.
PREZISTA 600 mg film-coated tablet: Orange oval shaped tablet,
debossed with 600MG on one
side and TMC on the other side.
PREZISTA 800 mg film-coated tablet: Dark red oval-shaped tablet,
debossed with 800 on one
side and T on the other side.
36.220704
2
PREZISTA (230831) ADS
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.
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 trea