REKAMBYS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RILPIVIRINE

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

J05AG05

الشكل الصيدلاني:

SUSPENSION FOR INJECTION PROLONGED RELEASE

تركيب:

RILPIVIRINE 300 MG / 1 ML

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CILAG AG, SWITZERLAND

المجال العلاجي:

RILPIVIRINE

الخصائص العلاجية:

REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

تاريخ الترخيص:

2022-07-17

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
REKAMBYS
®
PROLONGED-RELEASE SUSPENSION FOR INJECTION
ACTIVE INGREDIENT:
Each 1 ml suspension for injection contains:
rilpivirine 300 mg
The 2 ml Rekambys vial contains rilpivirine 600 mg.
The 3 ml Rekambys vial contains rilpivirine 900 mg.
Inactive and allergenic ingredients in the preparation: see chapter 2
section “Important information
about some of the ingredients in the medicine” and chapter 6
“Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This 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?
Rekambys is indicated for the treatment of human immunodeficiency
virus type 1 (HIV-1) infection
in adults. Rekambys is always given together with another HIV-1
medicine called cabotegravir. The
two medicines are used together in adults from the age of 18 years and
over, whose HIV-1 infection
is already under control.
THERAPEUTIC GROUP:
Rekambys belongs to a group of medicines called non-nucleoside reverse
transcriptase inhibitors (NNRTIs), which are used to treat human
immunodeficiency virus type 1
(HIV-1) infection.
Rekambys is indicated together with cabotegravir injection to treat
HIV-1 infection in adults whose
HIV-1 infection is under control with antiretroviral therapy, with no
evidence of resistance to, or
treatment failure with medicines of the NNRI and INI group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to rilpivirine or to any of the
additional ingredients contained in the
medicine (see chapter 6).
•
you are taking one of the following medicines, since they may affect
the way Rekamb

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
REKAMBYS
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mL vial
Each vial contains 600 mg rilpivirine
3 mL vial
Each vial contains 900 mg rilpivirine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release suspension for injection.
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
REKAMBYS is indicated, in combination with cabotegravir injection, for
the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in adults who are
virologically suppressed (HIV-1
RNA < 50 copies/mL) on a stable antiretroviral regimen without present
or past evidence of viral
resistance to, and no prior virological failure with, agents of the
NNRTI and INI class (see sections 4.2,
4.4 and 5.1).
4.2
Posology and method of administration
Therapy should be prescribed by a physician experienced in the
management of HIV infection. Each
injection should be administered by a healthcare professional.
Prior to starting REKAMBYS, the healthcare professional should
carefully select patients who
agree to the required injection schedule and counsel patients about
the importance of adherence
to scheduled dosing visits to help maintain viral suppression and
reduce the risk of viral
rebound and potential development of resistance associated with missed
doses.
Following discontinuation of REKAMBYS in combination with cabotegravir
injection, it is
essential to adopt an alternative, fully suppressive antiretroviral
regimen no later than one
month after the last every 1 month injection of REKAMBYS or two months
after the last every
2 months injection of REKAMBYS (see section 4.4).
The prescribing information for cabotegravir injection should be
consulted for recommended dosing.
Posology
REKAMBYS may be initiated with oral lead-in or without (direct to
injection).
The healthcare professional and patient may decide to use rilpivirine
tablets as an oral lead-in prior to the
initiation of REKAMBYS injections to