LUCENTIS

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

RANIBIZUMAB

Dostupné z:

NOVARTIS ISRAEL LTD

ATC kód:

S01LA04

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

RANIBIZUMAB 10 MG/ML

Spôsob podávania:

INTRAVITREAL

Typ predpisu:

Required

Výrobca:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Terapeutické skupiny:

RANIBIZUMAB

Terapeutické oblasti:

RANIBIZUMAB

Terapeutické indikácie:

Treatment of patients with neovascular (wet) age-related macular degeneration (AMD). Treatment of adult patients with visual impairment due to diabetic macular oedema (DME) . The treatment of visual impairement due to macular oedema secondary to retinal vein occlusion (RVO). The treatment of visual impaiment due to choroidal neovascularization (CNV) . Lucentis is indicated in preterm infants for: the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.The treatment of proliferative diabetic retinopathy (PDR)

Dátum Autorizácia:

2022-05-31

Príbalový leták

ةيبناجلا ضارعلأا )4
ً
اضارعأ ببسي دق سيتنيسول لامعتسإ نإ
،ءاود لكب امك
ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا
ضعب دنع ةيبناج
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
نم سيتنيسول لامعتسإب قلعتت يتلا
ةيبناجلا ضارعلأا
ىلعو نقحلا ةيلمع نع وأ هتاذ ءاودلا نع
مجنت نأ اهنأش
.نيعلا ىلع رثؤت بلغلأا
رابكلا نيجلاعتملا ىدل
:يلي اميف ةلصف
ُ
م ةروطخ رثكلأا ةيبناجلا ضارعلأا
1 - 10 ىدل رهظت ضارعأ( ةعئاش ةريطخ ةيبناج
ضارعأ
ءزجلا يف ةقبطلا قزمت وأ لاصفنإ :)100 نيب
نم نيلمعتسم
كلذل ةجيتنو )ةيكبشلا قزمت وأ لاصفنإ(
نيعلا نم يفلخلا
روطتت يتلا ،ةمئاع ءايشأ عم ءوضلا نم
تاضمو ثودح
.)تكاراتاك( ةسدعلا ةيبابض وأ ةيؤرلا يف
تقؤم نادقف ةجردل
ىدل رهظت ضارعأ( ةعئاش ريغ ةريطخ ةيبناج
ضارعأ
نيعلا ةلقم ثولت ،ىمع :)1,000 نيب نم
نيلمعتسم 1-10
.نيعلل يلخادلا ءزجلا باهتلإ عم )ةلقملا
نطاب باهتلإ(
،نيعلا يف دئاز جاعزنإ وأ ملأ يه اهنم
يناعت دق يتلا ضارعلأا
ددع ةدايز ،ةيؤرلا يندت وأ شوشت ،نيعلا
رارمحإ يف مقافت
.ءوضلل ةدئاز ةيساسح وأ ةيؤرلا لاجم يف
ةريغصلا تائيزجلا نم
ً
ايأ كيدل روطت اذإ بيبطلا ىلإ
ً
لااح هجوتلا بجي
.ةيبناجلا ضارعلأا كلت اهنع غيلبتلا مت يتلا
ً
اعويش رثكلأا ةيبناجلا ضارعلأا
:يلي اميف ةلصف
ُ
م
نم رثكأ ىدل رهظت ضارعأ(
ً
ادج ةعئاش ةيبناج ضارعأ
)ةرشع نيب نم دحاو لمعت

Súhrn charakteristických

LUC API MAY23 V13
1
1.
NAME OF THE MEDICINAL PRODUCT
Lucentis, 10 mg/ml solution for injection in pre-filled syringe.
Lucentis, 10 mg/ml solution for injection in a vial.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRE-FILLED SYRINGE
One ml contains 10 mg ranibizumab*. One pre-filled syringe contains
0.165 ml, equivalent to 1.65 mg
ranibizumab. The extractable volume of one pre-filled syringe is 0.1
ml. This provides a usable amount to
deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab.
VIAL
One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of
ranibizumab in 0.23 ml solution. This
provides a usable amount to deliver a single dose of 0.05 ml
containing 0.5 mg ranibizumab
to adult
patients and a single dose of 0.02 ml containing 0.2 mg ranibizumab to
preterm infants.
*Ranibizumab is a humanised monoclonal antibody fragment produced in
_Escherichia coli_
cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale brownish-yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of patients with neovascular (wet) age-related macular
degeneration (AMD)
•
Treatment of adult patients with visual impairment due to diabetic
macular oedema (DME)
•
The treatment of visual impairment due to macular oedema secondary to
retinal vein occlusion
(RVO)
•
The treatment of visual impairment due to choroidal neovascularisation
(CNV)
•
The treatment of proliferative diabetic retinopathy (PDR)
Lucentis is indicated in preterm infants for:
•
The treatment of retinopathy of prematurity (ROP) with zone I (stage
1+, 2+, 3 or 3+), zone II (stage
3+) or AP-ROP (aggressive posterior ROP) disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lucentis must be administered by a qualified ophthalmologist
experienced in intravitreal injections.
LUC API MAY23 V13
2
Posology
_Adults _
The recommended dose for Lucentis in adults is 0.5 mg given as a
single intravitreal injection. This
cor