ARIXTRA 2.5 MG0.5 ML

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

FONDAPARINUX SODIUM

Tillgänglig från:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-kod:

B01AX05

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

FONDAPARINUX SODIUM 5 MG / 1 ML

Administreringssätt:

I.V, S.C

Receptbelagda typ:

Required

Tillverkad av:

ASPEN NOTRE DAME DE BONDEVILLE, FRANCE

Terapeutisk grupp:

FONDAPARINUX

Terapiområde:

FONDAPARINUX

Terapeutiska indikationer:

Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications such as patients undergoing abdominal cancer surgery. Prevention of Venous Thromboembolic Events (VTE) in adults medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders and/or acute infectious or inflammatory disease. Treatment of unstable angina or non-ST segment elevation myocardial infarcton (UA/NSTEMI) in adults for whom urgent ( < 120 mins) invasive management (PCI) is not indicated . Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.

Tillstånd datum:

2023-04-30

Bipacksedel

ارتسكيرا لامعتسلإ لصفم ليلد لامعتسلإا تاميلعت
:ةنقحملا ءازجأ
ةربلإا يقاو
سبكم
عبصلإل ضبقم
نامأ م
ُ
ك ةربلإا ةيامحل يلآ زاهج عم ةنقحم .1
ةروصلا
.1
نوباصلاو ءاملاب ا
ً
ديج كيدي لسغإ
.ةفشنملا ةطساوب امهففجو
أ ةروص
2
. :نأ دكأتو ةبلعلا نم ةنقحملا جرخأ
ةيحلاصلا ءاهتنا خيرات يضقني مل
تائيزج يوحي لاو نوللا ميدعو قئار
لولحملا
ررضتت وأ حتفت مل ةنقحملا
3
.
.ةحيرم ةيعضوب يقلتسا وأ سلجا
ىلع ,نطبلا لفسأ ةقطنم يف ا
ً
ناكم رتخا
)أ ةروصلا( ةرسلا تحت نم مس 5 لقلأا نم رخآ بناجب نقحلاب مق ةنقح لك يف يف ةرمو نيميلا يف ةرم ,نطبلا لفسأ
فيفخت يف دعاسي اذه .راسيلا
.نقحلا ناكمب جاعزنلإا
,نطبلا لفسأ يف نقحلا ناكملإاب نكي مل
اذإ
.بيبطلا وأ ةضرمملا رشتسا
1 ب ةروص
4
. .يلوحك دامضب نقحلا ةقطنم فظن
5
.
ً
لاوأ هريودتب مق .ةربلإا يقاو عزنإ
(1ب ةروصلا(
مسج نم ميقتسم طخب هبحسا مث نمو
.)2ب ةروصلا( ةنقحملا
.ةربلإا يقاو يمرا
2ب ةروصلا
ةماه ةظحلام .نقحلا لبق حطسم يأ سملات اهعدت لاو
ةربلإا سلمت لا ءاوهلا ةعاقف جارخإ لواحت لا .ميلس رمأ
وه .ةنقحملا لخاد ءاوهلا نم ةريغص ةعاقف
ةظحلام نإ
.كلذ تلعف اذإ ءاودلا نم ءزج نادقف ببست
دق تنأف -نقحلا لبق هذه
6
. مت يتلا دلجلا ةقطنم فطلب صرقأ
.ةيط ليكشتل كلذو اهفيظنت
ةليط ةبابسلاو ماهبلإا نيب دلجلا ةيط
كسما
نقحلا ةريسم
.(ج ةروصلا(
ج ةروصلا
7
. .عباص�

Produktens egenskaper

Page 1 of 15
1.
NAME OF THE MEDICINAL PRODUCT
Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux
sodium.
Excipient(s) with known effect: Contains less than 1 mmol of sodium
(23 mg) per dose, and therefore
is essentially sodium free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is a clear and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing
major orthopaedic surgery
of the lower limbs such as hip fracture, major knee surgery or hip
replacement surgery.
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing
abdominal surgery who
are judged to be at high risk of thromboembolic complications, such as
patients undergoing abdominal
cancer surgery (see section 5.1).
Prevention of Venous Thromboembolic Events (VTE) in adult medical
patients who are judged to be
at high risk for VTE and who are immobilised due to acute illness such
as cardiac insufficiency and/or
acute respiratory disorders, and/or acute infectious or inflammatory
disease.
Treatment of unstable angina or non-ST segment elevation myocardial
infarction (UA/NSTEMI) in
adults for whom urgent (< 120 mins) invasive management (PCI) is not
indicated (see sections 4.4
and 5.1).
Treatment of ST segment elevation myocardial infarction (STEMI) in
adults who are managed with
thrombolytics or who initially are to receive no other form of
reperfusion therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients undergoing major orthopaedic or abdominal surgery _
The recommended dose of fondaparinux
is 2.5 mg once daily administered post-operatively by
subcutaneous injection.
The initial dose should be given
_ _
6 hours following surgical closure provided that haemostasis has been
established.
Page 2 of 15
Treatment should be continued until the risk of venous
thrombo