Arixtra 2.5mg0.5ml solution for injection pre-filled syringes

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Fondaparinux sodium

Sẵn có từ:

Aspen Pharma Trading Ltd

Mã ATC:

B01AX05

INN (Tên quốc tế):

Fondaparinux sodium

Liều dùng:

5mg/1ml

Dạng dược phẩm:

Solution for injection

Tuyến hành chính:

Intravenous; Subcutaneous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02080100; GTIN: 5000283630258

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIXTRA 2.5 MG/0.5 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 some types of heart attack and severe angina (pain caused by
narrowing of the arteries in
the heart).
•
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 EXCESSIVE

Đặc tính sản phẩm

OBJECT 1
ARIXTRA FONDAPARINUX SODIUM SOLUTION FOR
INJECTION 2,5 MG/ 0,5 ML
Summary of Product Characteristics Updated 14-Oct-2016 | Aspen
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
adultsfor 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.
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