PREZISTA 600 mg TABLET

国: 南アフリカ

言語: 英語

ソース: South African Health Products Regulatory Authority (SAHPRA)

から入手可能:

Janssen Pharmaceutica (Pty) Ltd

投薬量:

See ingredients

医薬品形態:

TABLET

構図:

EACH TABLET CONTAINS DARUNAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 600,0 mg

認証ステータス:

Registered

承認日:

2013-01-03

情報リーフレット

Page 1 of 10
1.3.2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
PREZISTA
®
600 mg (film-coated tablet)
Read this entire leaflet carefully before you start taking PREZISTA.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

PREZISTA has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT PREZISTA CONTAINS
Each film-coated tablet contains 600 mg of darunavir as ethanolate
salt.
The other ingredients are:
Colloidal silicon dioxide, crospovidone, macrogol, magnesium stearate,
microcrystalline
cellulose, polyvinyl alcohol (partially hydrolysed), talc and titanium
dioxide (C.I. no. 77891).
Sugar free
WHAT PREZISTA IS USED FOR
PREZISTA is an antiretroviral medicine. It belongs to a group called
protease inhibitors.
Page 2 of 10
PREZISTA works by reducing the amount of human immunodeficiency virus
(HIV) in your
body. This will improve your immune system and reduce the risk of
developing illnesses linked
to HIV infection.
PREZISTA is used in combination with ritonavir and other
antiretroviral medicines to treat
adults who are infected with HIV and who have developed resistance to
other antiretroviral
medicines.
Your doctor will discuss with you which combination of medicines is
best for you.
BEFORE YOU TAKE PREZISTA
Do not take PREZISTA:

if you are allergic (hypersensitive) to darunavir, other ingredients
of PREZISTA or to
ritonavir.
Do not take PREZISTA with any of the following medicines:

medicines to treat convulsions (epilepsy) (carbamazepine,
phenobarbital or phenytoin).

medicines to treat allergy symptoms (astemizole).

medicines to treat tuberculosis (rifampicin).

medicines to treat high blood pressure as a result of problems with
your lungs (sildenafil).

medicines to treat prostate problems (alfuzosin).

medicines to treat migraine and headaches (dihydroergota

製品の特徴

Page 1 of 35
1.3.1.1
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
PREZISTA
®
600 mg (film-coated tablet)
COMPOSITION
Each film-coated tablet contains 600 mg of darunavir as ethanolate
salt.
Excipients:
Colloidal silicon dioxide, crospovidone, macrogol, magnesium stearate,
microcrystalline
cellulose, polyvinyl alcohol (partially hydrolysed), talc and titanium
dioxide (C.I. no. 77891)
Sugar free
CATEGORY AND CLASS
A 20.2.8 Antiviral agents
PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Mechanism of action
Darunavir is an inhibitor of the HIV-1 protease. It selectively
inhibits the cleavage of HIV
encoded Gag-Pol polyproteins in virus infected cells, thereby
preventing the formation of
mature infectious virus particles. Darunavir tightly binds to the
HIV-1 protease.
Page 2 of 35
Antiviral activity in vitro
Darunavir exhibited activity against laboratory strains and clinical
isolates of HIV-1 and
laboratory strains of HIV-2 in acutely infected T-cell lines, human
peripheral blood
mononuclear cells and human monocytes/macrophages in vitro with median
EC
50
values
ranging from 1,2 to 8,5 nM; (0,7 to 5,0 ng/ml). Darunavir demonstrated
antiviral activity in vitro
against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group
O primary isolates with
EC
50
values ranging from < 0,1 to 4,3 nM. These EC
50
values are well below the 50 % cellular
toxicity concentration range of 87 µM to > 100 µM.
The EC
50
value of darunavir increases by a median factor of 5,4 in the presence
of human
serum. Darunavir showed synergistic antiviral activity when studied in
combination with the
protease inhibitors ritonavir, nelfinavir or amprenavir and additive
antiviral activity when studied
in combination with the protease inhibitors indinavir, saquinavir,
lopinavir, atazanavir or
tipranavir, the N(t)RTIs zidovudine, lamivudine, zalcitabine,
didanosine, stavudine, abacavir,
emtricitabine or tenofovir, the NNRTIs nevirapine, delavirdine or
efavirenz and the fusion
inhi