PREZISTA 400 mg TABLET

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

Janssen Pharmaceutica (Pty) Ltd

Annos:

See ingredients

Lääkemuoto:

TABLET

Koostumus:

EACH TABLET CONTAINS DARUNAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 400,0 mg

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2017-02-06

Pakkausseloste

Page 1 of 10
1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL DOSAGE FORM
PREZISTA
®
400 mg
Film-coated tablet
Read all of this 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 of PREZISTA 400 mg contains 400 mg of
darunavir (as darunavir
ethanolate).
The other ingredients are colloidal silicon dioxide, crospovidone,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
FD&C Yellow #6 Aluminium
Lake, talc, titanium dioxide.
Sugar free
WHAT PREZISTA IS USED FOR
Page 2 of 10
PREZISTA is an antiretroviral medicine. It belongs to a group called
protease inihibitors.
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 by 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) (phenobarbitone or
phenytoin)
-
medicines to treat allergy symptoms (astemizole)
-
medicines to treat tuberculosis (rifampicin, rifabutin)
-
medicines to treat high blood pressure as a result of problems with
your lungs (sildenafil,
bosentan)
-
medicines to treat gout if you have liver or kidney problems
(colchicine)
-

Valmisteyhteenveto

Page 1 of 36
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
PREZISTA
®
400 mg (film-coated tablet)
COMPOSITION
Each film-coated tablet of PREZISTA 400 mg contains 400 mg of
darunavir (as darunavir
ethanolate).
Excipients:
Colloidal silicon dioxide, crospovidone, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol, FD&C Yellow #6 Aluminium Lake,
talc, titanium dioxide
Sugar free
CATERGORY AND CLASS
A.20.2.8 Antiviral agents.
PHARMACOLOGICAL ACTION
Pharmacodynamic Properties
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.
Antiviral activity in vitro
S4
Page 2 of 36
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).
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 etravirine, nevirapine, delavirdine, or
efavirenz and the fusion inhibitor
enfuvirtide. No antagonism was observed between darunavir and any of
those antiretrovirals.
Resistance in vitro
In vitro darunavir-resistant virus isolates from wildtype HIV-1
selected viruses showing decreased
susceptibility to darunavir (range: 6-21-fold) harboure