Arixtra
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
27-03-2024
Karatteristiċi tal-prodott
(SPC)
27-03-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
08-10-2010
Ingredjent attiv:
fondaparinux sodium
Disponibbli minn:
Mylan IRE Healthcare Limited
Kodiċi ATC:
B01AX05
INN (Isem Internazzjonali):
fondaparinux sodium
Grupp terapewtiku:
Antithrombotic agents
Żona terapewtika:
Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
Indikazzjonijiet terapewtiċi:
1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injectionPrevention 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 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 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 adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.2.5-mg/0.5-ml solution for injectionTreatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated.infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injectionTreatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Sommarju tal-prodott:
Revision: 35
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2002-03-20
Fuljett ta 'informazzjoni
84
B. PACKAGE LEAFLET
85
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIXTRA 1.5 MG/0.3 ML SOLUTION FOR INJECTION
fondaparinux sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT ARIXTRA IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARIXTRA
3.
HOW TO USE ARIXTRA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ARIXTRA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ARIXTRA IS AND WHAT IT IS USED FOR
ARIXTRA IS A MEDICINE THAT HELPS PREVENT BLOOD CLOTS FROM FORMING IN
THE BLOOD VESSELS (
_an _
_antithrombotic agent_
).
Arixtra contains a synthetic substance called fondaparinux sodium.
This stops a clotting factor Xa
(“ten-A”) from working in the blood, and so prevents unwanted
blood clots (
_thromboses_
) from
forming in the blood vessels.
ARIXTRA IS USED TO:
•
prevent the formation of blood clots in the blood vessels of the legs
or lungs after orthopaedic
surgery (such as hip or knee surgery) or abdominal surgery
•
prevent the formation of blood clots during and shortly after a period
of restricted mobility due to
acute illness
_. _
•
treat blood clots in blood vessels that are near the surface of the
skin of the legs (
_superficial-vein _
_thrombosis_
).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARIXTRA
DO NOT USE ARIXTRA:
•
IF YOU ARE ALLERGIC to fondaparinux sodium or to any of the other
ingredients of this medicine
(listed in section 6)
•
IF YOU ARE BLEEDING EXCESSIVELY
•
IF YOU HAVE A BACTERIAL HEART INFECTION
•
IF YOU HAVE VERY SEVERE KIDNEY DISE
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each pre-filled syringe (0.3 ml) contains 1.5 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 adults with acute symptomatic spontaneous
superficial-vein thrombosis of the lower
limbs without concomitant deep-vein thrombosis (see sections 4.2 and
5.1).
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.
Treatment should be continued until the risk of venous
thrombo-embolism has diminished, usually
until the patient is ambulant, at least 5 to 9 days after surgery.
Experience shows that in patients
undergoing hip fracture surgery, the risk of VTE cont
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