PREZISTA 150 MG

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

DARUNAVIR AS ETHANOLATE

Beszerezhető a:

J-C HEALTH CARE LTD

ATC-kód:

J05AE10

Gyógyszerészeti forma:

FILM COATED TABLETS

Összetétel:

DARUNAVIR AS ETHANOLATE 150 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

JANSSEN CILAG S.P.A., ITALY

Terápiás csoport:

DARUNAVIR

Terápiás terület:

DARUNAVIR

Terápiás javallatok:

Adult Patients:Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV -1) infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .Pediatric patients:Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in treatment-experienced pediatric patients 6 years of age and older .This indication is based on 24 Week analyses of plasma HIV-1 RNA levels and CD4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with Prezista/rtv: - Treatment history and, when available, genotypic or phenotypic testing, should guide the use of Prezista/rtv. - The use of other active agents with Prezista/rtv is associated with a greater likelihood of treatment response.

Engedély dátuma:

2015-08-31

Betegtájékoztató

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_
4.8.15
_
םש
רישכת
תילגנאב
רפסמו
םושירה
75MG PREZISTA
םושיר רפסמ
144-22-32957-00
PREZISTA 150MG
םושיר רפסמ
144-32-32992-00
PREZISTA 400MG
םושיר רפסמ
142-12-31999-00
PREZISTA 600MG
םושיר רפסמ
142-13-32000-00
PREZISTA 800MG םושיר רפסמ
151-64-34005-00
םש
לעב
םושירה
_
J-C HEALTH CARE LTD
.
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שדח
Interactions
7.3
ESTABLISHED AND OTHER
POTENTIALLY SIGNIFICANT DRUG
INTERACTIONS
Darunavir and ritonavir are
both inhibitors of the CYP3A
isoform. Co-administration of
darunavir and ritonavir and
medicinal products primarily
metabolised by CYP3A may
result in increased systemic
exposure to such medicinal
products, which could increase
or prolong their therapeutic
effect and adverse reactions
.
PREZISTA co-administered
with low dose ritonavir must
not be combined with
medicinal products that are
highly dependent on CYP3A
for clearance and for which
increased systemic exposure
is associated with serious
and/or life-threatening
events (narrow therapeutic
index). These medicinal
products include
amiodarone, bepridil,
quinidine, systemic
lidocaine, astemizole,
alfuzosin, terfenadine,
sildenafil (when used for the
treatment of pulmonary
arterial hypertension),
7.3
ESTABLISHED AND OTHER POTENTIALLY
SIGNIFICANT DRUG INTERACTIONS
Darunavir and ritonavir are both inhibitors of
the CYP3A isoform. Co-administration of
darunavir and ritonavir and medicinal
products primarily metabolised by CYP3A
may result in increased systemic exposure to
such medicinal products, which could
increase or prolong their therapeutic effect
and adverse reactions
.
PREZISTA co-administered with low dose
ritonavir must not be combined w

Termékjellemzők

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