REZOLSTA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

COBICISTATE; DARUNAVIR AS ETHANOLATE

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

J05AE10

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

COBICISTATE 150 MG; DARUNAVIR AS ETHANOLATE 800 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JANSSEN CILAG S.P.A., ITALY

المجال العلاجي:

DARUNAVIR

الخصائص العلاجية:

REZOLSTA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11i, V32i, L33F, i47V, i50V, i54L, i54M, T74P, L76V, i84V, L89V).שינוי משטר מינון 2/4/2019Pregnancy and postpartumTreatment with REZOLSTA during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). Therefore, therapy with REZOLSTA should not be initiated during pregnancy, and women who become pregnant during therapy with REZOLSTA should be switched to an alternative regimen, see section 4.4 and 4.6. Darunavir/ritonavir may be considered as an alternative.

تاريخ الترخيص:

2020-09-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
NAME AND FORM OF THE PREPARATION:
REZOLSTA
®
FILM-COATED TABLETS
ACTIVE INGREDIENTS AND THEIR QUANTITY:
darunavir 800 mg (as ethanolate), cobicistat 150 mg.
Inactive and allergenic ingredients: See “Further Information” in
section 6 and “Important information about some of the ingredients
of the medicine” in section 2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. The leaflet contains concise information about the medicine.
If you have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It may harm them even if it seems to you that their
ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Rezolsta is an antiretroviral medicine used to treat infection caused
by the human immunodeficiency virus (HIV), in combination with
other antiretroviral medicines, in adult patients who have not
received
treatment or who received treatment in the past, on the condition that
they did not develop resistance to darunavir.
THERAPEUTIC GROUP: Darunavir is an anti-HIV agent of the protease
inhibitor group.
Cobicistat is a cytochrome P450 inhibitor.
The medicine contains the active ingredients: darunavir, which acts by
reducing the level of HIV in the blood to a very low level, and
cobicistat,
which increases the amount of the active ingredient darunavir in the
blood.
Treatment with Rezolsta will improve your immune system (your body’s
natural defence) and will reduce the risk of developing illnesses
linked
to HIV infection; however, Rezolsta does not cure HIV infection.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to any of the active ingredients or
to
any of the other ingredients contained in the medicine (listed in
section 6).
• You are suffering from SEVERE LIVER PROBLEMS. Ask the doctor
if you are u

خصائص المنتج

Page 1 of 33
REZOLSTA_800_150-TABLETS_SPC_02_2023
1.
NAME OF THE MEDICINAL PRODUCT
REZOLSTA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg of darunavir (as ethanolate)
and 150 mg of cobicistat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on
one side and “TG” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REZOLSTA is indicated in combination with other antiretroviral agents
for the treatment of human
immunodeficiency virus (HIV 1) infection in treatment-naïve and
treatment-experienced adults with
no darunavir resistance-associated substitutions (V11I, V32I, L33F,
I47V, I50V, I54L, I54M, T74P,
L76V, I84V, L89V).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a healthcare provider experienced in
the management of HIV infection.
Posology
After therapy with REZOLSTA has been initiated, patients should not
alter the dosage or discontinue
therapy without the instruction of their healthcare provider.
_ART-naïve patients _
The recommended dose regimen is one film-coated tablet of REZOLSTA
once daily taken with food.
_ _
_ART-experienced patients _
One film-coated tablet of REZOLSTA once daily taken with food may be
used in patients with prior
exposure to antiretroviral medicinal products but without darunavir
resistance associated mutations
(DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+
cell count
≥ 100 cells x 10
6
/l (see section 4.1).
*
DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V,
L89V.
In all other ART-experienced patients or if HIV-1 genotype testing is
not available, the use of
REZOLSTA is not appropriate and another antiretroviral regimen should
be used. Refer to the
Summary of Product Characteristics of other antiretroviral medicinal
products for dosing information.
_Advice on missed doses _
If REZOLSTA is missed within 12 hours of the time it is us