Quixidar
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
16-05-2008
Karatteristiċi tal-prodott
(SPC)
16-05-2008
Rapport ta 'Valutazzjoni Pubblika
(PAR)
16-05-2008
Ingredjent attiv:
fondaparinux sodium
Disponibbli minn:
Glaxo Group Ltd.
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 injection:, Prevention of Venous Thromboembolic Events (VTE) in patients 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 patients 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 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., , 2.5 mg/0.5 ml, solution for injection:, Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients 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 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 injection:, Treatment of 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: 10
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2002-03-21
Fuljett ta 'informazzjoni
Medicinal Product no longer authorised
70
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
71
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUIXIDAR 1.5 MG/0.3 ML SOLUTION FOR INJECTION
fondaparinux sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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 personally. Do not pass it
on to others. It may harm
them, even if their symptoms seem to be the same as yours.
•
If any of the side effects get serious or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
WHAT QUIXIDAR IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE QUIXIDAR
3.
HOW TO USE QUIXIDAR
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE QUIXIDAR
6.
FURTHER INFORMATION
1.
WHAT QUIXIDAR IS AND WHAT IT IS USED FOR
QUIXIDAR IS A MEDICINE THAT HELPS PREVENT BLOOD CLOTS FROM FORMING IN
THE BLOOD VESSELS
(
_an _
_antithrombotic agent_
).
Quixidar 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.
QUIXIDAR 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
_. _
2.
BEFORE YOU USE QUIXIDAR
DO NOT USE QUIXIDAR:
•
IF YOU ARE ALLERGIC
(
_hypersensitive_
) to fondaparinux sodium or to any of the other ingredients of
Quixidar
•
IF YOU ARE BLEEDING EXCESSIVELY
•
IF YOU HAVE A BACTERIAL HEART INFECTION
•
IF YOU HAVE VERY SEVERE KIDNEY DISEASE.
→
TELL YOUR DOCTOR
if you think any of these applies to you. If they do, you must
NOT
use Quixidar.
TAKE SPECIAL CARE WITH QUIXIDAR:
Your doctor needs to know befo
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
Medicinal Product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Quixidar 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): Contains less than 1 mmol of sodium (23 mg) per dose,
and therefore is essentially
sodium free.
For a 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 patients
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 patients
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 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_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 continues beyond 9
days after surgery. In these
patients the use of prolonged prophylaxis with fondaparinux should be
considere
Aqra d-dokument sħiħ
