PREZISTA 400 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DARUNAVIR AS ETHANOLATE

Available from:

J-C HEALTH CARE LTD

ATC code:

J05AE10

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DARUNAVIR AS ETHANOLATE 400 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

JANSSEN CILAG S.P.A., ITALY

Therapeutic group:

DARUNAVIR

Therapeutic area:

DARUNAVIR

Therapeutic indications:

Prezista , co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection for over 18 years of age.

Authorization date:

2014-11-30

Patient Information leaflet

Prezista 600mg SPC 03-2022 SUB
1.
NAME OF THE MEDICINAL PRODUCT
PREZISTA 600 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of darunavir (as ethanolate).
Excipient with known effect: Each tablet contains a maximum of 1.375
mg sunset yellow FCF.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange oval shaped tablet, debossed with “600MG” on one side and
“TMC” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prezista, co-administered with 100 mg ritonavir (Prezista/rtv), and
with other antiretroviral
agents, is indicated for the treatment of human immunodeficiency virus
(HIV -1) infection for
patients over 18 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PREZISTA must be co-administered with ritonavir to exert its
therapeutic effect. Failure to
correctly co-administer PREZISTA with ritonavir will result in plasma
levels of darunavir that
will be insufficient to achieve the desired antiviral effect and will
alter some drug interactions.
_Treatment-Experienced Adult Patients _
Treatment-Experienced Adult Patients
With at least one darunavir resistance
associated
substitution*
600 mg PREZISTA twice daily taken with
ritonavir 100 mg
twice daily and with food
* V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V
For antiretroviral treatment-experienced patients genotypic testing is
recommended. However,
when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg
twice daily dosing is
recommended.
Prezista 600mg SPC 03-2022 SUB
_Advice on missed doses _
in case a dose of PREZISTA and/or ritonavir is missed within 6 hours
of the time it is usually
taken, patients should be instructed to take the prescribed dose of
PREZISTA and ritonavir
with food as soon as possible. If this is noticed later than 6 hours
after the time it is usually
taken, the missed dose should not be taken and the patient should
resume the usual dosing
schedule.
This guidance is based on the 15 hour ha

Summary of Product characteristics

Prezista 400mg_SPC_03-2022_ SUB
1.
NAME OF THE MEDICINAL PRODUCT
PREZISTA 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of darunavir (as ethanolate).
Excipient with known effect: Each tablet contains 0.834 mg sunset
yellow FCF (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light orange oval shaped tablet, debossed with “400MG” on one side
and “TMC” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prezista, co-administered with 100 mg ritonavir (Prezista/rtv), and
with other antiretroviral
agents, is indicated for the treatment of human immunodeficiency virus
(HIV -1) infection for
over 18 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PREZISTA must be co-administered with ritonavir to exert its
therapeutic effect. Failure to
correctly co-administer PREZISTA with ritonavir will result in plasma
levels of darunavir that
will be insufficient to achieve the desired antiviral effect and will
alter some drug interactions.
_Treatment-Naïve Adult Patients _
The recommended oral dose of PREZISTA tablets is 800 mg taken with
ritonavir 100 mg once
daily and with food.
_Treatment-Experienced Adult Patients _
Treatment-Experienced Adult Patients
With
no
darunavir
resistance
associated
substitutions*
800 mg PREZISTA once daily with ritonavir
100 mg once daily and with food
Prezista 400mg_SPC_03-2022_ SUB
* V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V
For antiretroviral treatment-experienced patients genotypic testing is
recommended. _Advice on missed doses _
If once daily dose of PREZISTA and/or ritonavir is missed within 12
hours of the time it is
usually taken, patients should be instructed to take the prescribed
dose of PREZISTA and
ritonavir with food as soon as possible. If this is noticed later than
12 hours after the time it is
usually taken, the missed dose should not be taken and the patient
should resume the usual
dosing schedule.
If a patient vomits within