CELSENTRI 150 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

MARAVIROC

Dostupné z:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kód:

J05AX09

Forma lieku:

FILM COATED TABLETS

Zloženie:

MARAVIROC 150 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Terapeutické skupiny:

MARAVIROC

Terapeutické oblasti:

MARAVIROC

Terapeutické indikácie:

Celsentri is a CCR5 co-receptor antagonist indicated for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1.• In treatment-naïve subjects, more subjects treated with Celsentri experienced virologic failure and developed lamivudine resistance compared to efavirenz.• Tropism testing with a highly sensitive tropism assay is required for the appropriate use of Celsentri.

Dátum Autorizácia:

2013-10-31

Príbalový leták

.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
أرط ولو ىتح بيبطلا ةراشتسإ نودب
ءاودلاب جلاعلا نع فقوتلا زوجي لا
.ةيحصلا كتلاح ىلع نسحت
ديدجت كبيبط نم بلطأ ،ذافنلا ىلع كب
صاخلا يرتنسلس نوزخم كشوي امدنع
حبصي ثيح عفترت دق كمد يف سوريڤلا ةيمك
نلأ
ً
ادج ماه رملأا اذه .نوزخملا
.بعصأ هجلاع نم دكأتلاو ءاودلا عباط صيخشت بجي
!ةمتعلا يف ةيودأ لوانت زوجي لا اذإ ةيبطلا تاراظنلا عض .ءاود اهيف
لوانتت ةرم لك يف يئاودلا رادقملا
.كلذ رملأا مزل بيبطلا رشتسإ ،ءاودلا لامعتسإ لوح
ةيفاضإ ةلئسأ كيدل ترفوت اذإ
.يلديصلا وأ
ةيبناجلا ضارعلأا )4
ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق يرتنسلس لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا
:لمشت ةريطخ ةيبناج
ً
اضارعأ يرتنسلس ببسي نأ نكمي
."ءاودلا لامعتسإب قلعتت ةصاخ تاريذحت" :2
ةرقفلا رظنأ
-
ثودح نع غيلبتلا مت .ةيسسحت لعف دودرو
دلجلا يف ديدش حفط
-
ىلع
ً
ارطخ لكشت دق لب لا ،ةديدش ةيسسحت لعف
دودرو ةيدلج لعف دودر
روطت اذإ .يرتنسلس اولوانت نيذلا
صاخشلأا نم ددع ىدل كلذو ،ةايحلا
لصتإو يرتنسلس لامعتسإ نع فقوت
،ةيلاتلا ضارعلأا دحأ عم حفط كيدل
:كبيبطب ةرشابم
ةنوخس ●
ةماع ةكعوب روعشلا
●
ةيلضع ملاآ
●
كمف يف تاحرقت وأ تلاصيوح ●
دلجلا رشقت وأ تلاصيوح ●
نينيعلا خافتنإ وأ

Súhrn charakteristických

1
CELSENTRI 150 MG
CELSENTRI 300 MG
CELSENTRI 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of maraviroc.
CELSENTRI 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of maraviroc.
WARNING: HEPATOTOXICITY
HEPATOTOXICITY HAS BEEN REPORTED WITH USE OF CELSENTRI. SEVERE RASH OR E
VIDENCE OF A
SYSTEMIC ALLERGIC REACTION (E.G., FEVER, EOSINOPHILIA, OR ELEVATED
IGE) PRIOR TO THE
DEVELOPMENT OF HEPATOTOXICITY MAY OCCUR. PATIENTS WITH SIGNS OR
SYMPTOMS OF HEPATITIS OR
ALLERGIC REACTION FOLLOWING USE OF CELSENTRI SHOULD BE EVALUATED
IMMEDIATELY _[SEE _
_WARNINGS AND PRECAUTIONS (5.1)]_.
1
INDICATIONS AND USAGE
Celsentri is a CCR5 co-receptor antagonist indicated for combination
antiretroviral treatment of
adults infected with only CCR5-tropic HIV-1.
• In treatment-naïve subjects, more subjects treated with Celsentri
experienced virologic failure
and developed lamivudine resistance compared to efavirenz.
• Tropism testing with a highly sensitive tropism assay is required
for the appropriate use of
Celsentri.
2
DOSAGE AND ADMINISTRATION
2.1
TESTING PRIOR TO INITIATION OF SELZENTRY
Prior to initiation of CELSENTRI for treatment of HIV-1 infection,
test all patients for CCR5
tropism using a highly sensitive tropism assay. CELSENTRI is
recommended for patients with
only CCR5-tropic HIV-1 infection. Outgrowth of pre-existing low-level
CXCR4- or
dual/mixed-tropic HIV-1 not detected by tropism testing at screening
has been associated with
virologic failure on CELSENTRI
_[see Microbiology (12.4), Clinical Studies (14.1)]_
.
Monitor patients for ALT, AST, and bilirubin prior to initiation of
CELSENTRI and at other
time points during treatment as clinically indicated
_[see Warnings and Precautions (5.1)]_
.
_ _
2.2
GENERAL DOSING RECOMMENDATIONS
•
CELSENTRI tablets are taken twice daily by mouth and may be taken with
or without food.
•
CELSENTRI must be given in combination with other antiretroviral
medications.
2
•
The recommended dosage of CELSENTRI differs based on concomitant
medic