PREZISTA darunavir 300mg tablets bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

darunavir

可用日期:

Janssen-Cilag Pty Ltd

INN（国际名称）:

Darunavir

授权状态:

Registered

产品特点

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CCDS200226
Page 1
PREZISTA (200722) API
PREZISTA
®
DARUNAVIR
AUSTRALIAN PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Darunavir
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREZISTA darunavir is available as 75 mg, 150 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, 150 mg, 400 mg, 600 mg or 800 mg of darunavir, as
81.31 mg, 162.62 mg,
325.23 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 150 mg film-coated tablets are white oval-shaped tablets,
debossed with 150 on one
side and TMC on the other side.
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.
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CCDS200226
Page 2
PREZISTA (200722) 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