PREZISTA darunavir 75mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

darunavir, Quantity: 75 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

Darunavir

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

480 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: White, caplet-shaped, film-coated tablet debossed with '75' and 'TMC'; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-02-04

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