RUCONEST - POWDER FOR SOLUTION FOR INJECTION

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

CONESTAT ALFA

Sẵn có từ:

KAMADA LTD, ISRAEL

Mã ATC:

B06AC04

Dạng dược phẩm:

POWDER FOR SOLUTION FOR INJECTION

Thành phần:

CONESTAT ALFA 2100 U/VIAL

Tuyến hành chính:

I.V

Loại thuốc theo toa:

Required

Sản xuất bởi:

PHARMING TECHNOLOGIES B.V., THE NETHERLANDS

Khu trị liệu:

CONESTAT ALFA

Chỉ dẫn điều trị:

Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents aged 12 years and above with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.

Ngày ủy quyền:

2018-12-31

Tờ rơi thông tin

tis ue type plasminogen( يجيسنلا نيچونيمزلاپ
طشنم ىقلتت تنك اذإ ●
تسنوكور يقلت زوجي لاف ةيومدلا تارثخلل
داحلا جلاعلل )activator, tPA
.ةيودلأا هذهب جلاعلا ءانثأ ةبوصخلاو عاضرلإا ،لمحلا
.تاعضرملا وأ لماوحلا ءاسنلا ىدل ءاودلا
لامعتسإ يف ةربخ دجوت لا
.ةعضرم وأ
ً
لاماح تنك اذإ ءاودلا لامعتسإب ىصوي لا
.ءاودلا لامعتسإ يف ءدبلا لبق بيبطلا
ةراشتسإ بجي ،لمحلل نيططخت تنك اذإ
تانكاملا لامعتساو ةقايسلا
عادصلا نم يناعت تنك وأ راودب ترعش اذإ
ةرطخ تانكام ليغشت وأ ةقايسلا زوجي لا
.تسنوكور ـب جلاعلا دعب
:ءاودلا تابكرم ضعب نع ةماه تامولعم
.ةريغص ةنينق لكل غلم 19.5 يلاوح ،)sodium(
مويدوصلا ىلع ءاودلا يوتحي
.حلملا ليلق يئاذغ ماظن ىلع ظفاحت تنك
اذإ رابتعلإا يف كلذ ذخأ بجي
؟ءاودلا لامعتسإ ةيفيك )3
.بيبطلا تاميلعت بسح
ً
امئاد رضحتسملا لامعتسإ بجي
رادقملا صوصخب
ً
اقثاو نكت مل اذإ يلديصلا نم وأ بيبطلا
نم حاضيتسلإا كيلع
.رضحتسملاب جلاعلا ةقيرطو يئاودلا
.طقف بيبطلا لبق نم ناددحي جلاعلا
ةقيرطو يئاودلا رادقملا
ةمذولا جلاعو صيخشت يف صصختم بيبط لبق
نم رضحتسملاب جلاعلا ءدب متي
.ةيثارولا ةيئاعولا
.كنزو بسح هباسح متي ،نيتريغص نيتنينق
ىتح :وه يدايتعلإا يئاودلا رادقملا
نأ بيبطلا ررقي نأ زئاجلا نم نكل ،دحاو
يئاود رادقم يفكي ،تلااحلا مظعم يف
.يفاضإ يئاود رادقمل ةجاح كانه
.ةع

Đặc tính sản phẩm

1.
NAME OF THE MEDICINAL PRODUCT
Ruconest - powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 2100 units of conestat alfa, corresponding to 2100
units per 14 ml after
reconstitution, or a concentration of 150 units/ml.
Conestat alfa is a recombinant analogue of the human C1 esterase
inhibitor (rhC1-INH)
produced by recombinant DNA technology in the milk of transgenic
rabbits.
1 unit of conestat alfa activity is defined as the equivalent of C1
esterase inhibiting activity
present in 1 ml of pooled normal plasma.
Excipient with known effect:
Each vial contains approximately 19.5 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ruconest is indicated for treatment of acute angioedema attacks in
adults and adolescents
aged 12 years and above with hereditary angioedema (HAE) due to C1
esterase inhibitor
deficiency.
4.2
Posology and method of administration
Ruconest should be initiated under the guidance and supervision of a
physician experienced in
the diagnosis and treatment of hereditary angioedema.
Posology in adults and adolescents aged 12 years and above
_ _
_- Body weight up to 84 kg _
One intravenous injection of 50 U/kg body weight.
_ _
_- Body weight of 84 kg or greater _
One intravenous injection of 4200 U (2 vials).
In the majority of cases a single dose of Ruconest is sufficient to
treat an acute angioedema
attack.
-
In case of an insufficient clinical response, an additional dose (50
U/kg body weight up to
4200 U) can be administered at the discretion of the physician (see
section 5.1).
Not more than two doses should be administered within 24 hours.
_Dose calculation _
Determine the patient’s body weight.
_ _
_- Body weight up to 84 kg _
For patients up to 84 kg calculate the volume required to be
administered according to the
formula below:
Volume to be
administered (ml)
=
body weight (kg) times 50 (U/kg)
150 (