Adenoscan 30mg/10ml solution for infusion vials

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Adenosine

Sẵn có từ:

Sanofi

Mã ATC:

C01EB10

INN (Tên quốc tế):

Adenosine

Liều dùng:

3mg/1ml

Dạng dược phẩm:

Solution for infusion

Tuyến hành chính:

Intravenous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02030200; GTIN: 5000283600787

Tờ rơi thông tin

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ADENOSCAN® 30 MG/10 ML SOLUTION
FOR INFUSION
Adenosine
If this leaflet is hard to see or read
Phone [phone] for help
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN
THIS MEDICINE.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or
nurse.
•
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or nurse.
IN THIS LEAFLET:
1. What Adenoscan is and what it is used for
2. Before you are given Adenoscan
3. How Adenoscan is given
4. Possible side effects
5. How to store Adenoscan
6. Further information
1. WHAT ADENOSCAN IS AND WHAT IT IS USED FOR
Adenoscan contains a medicine called adenosine. This
belongs to a group of medicines called ‘coronary
vasodilatators’.
This medicine is for diagnostic use only.
Adenoscan is used before a test called “myocardial
perfusion imaging” to look at your heart. During this test
you are given a medicine called a
“radiopharmaceutical”.
Adenoscan works by opening up your heart’s blood
vessels and allowing blood to flow more freely. This
allows the “radiopharmaceutical” medicine to get into
your heart. The doctor can see your heart and assess
your heart condition. This procedure is used if you are
not capable of exercise or if an exercise stress test is not
possible.
2. BEFORE YOU ARE GIVEN ADENOSCAN
DO NOT HAVE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
 You are allergic (hypersensitive) to adenosine or any
of the other ingredients of Adenoscan (listed in
section 6 below).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
 You have very low blood pressure (severe
hypotension)
 You have unstable angina which is not controlled by
treatment with medicine
 You have asthma or any other severe breathing
problem
 You are taking a medicine called dipyridamole used
to thin the blood.
 You have a ty

Đặc tính sản phẩm

OBJECT 1
ADENOSCAN
Summary of Product Characteristics Updated 06-Feb-2014 | SANOFI
1. Name of the medicinal product
ADENOSCAN
®
30 mg/10 ml, solution for infusion
2. Qualitative and quantitative composition
Each 10 ml vial of Adenoscan
®
contains 30 mg of adenosine (3 mg/ml)
Excipient: each vial contains 90 mg of sodium chloride (9 mg/ml).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Adenoscan® is a sterile clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Intravenous (IV) Adenoscan
®
is a coronary vasodilator for use in conjunction with radionuclide
myocardial perfusion imaging in patients who cannot exercise
adequately or for whom exercise is
inappropriate
4.2 Posology and method of administration
Adenoscan
®
is intended for use in hospitals with monitoring and
cardio-respiratory resuscitation
equipment available for immediate use if necessary.
It should be administered following the same procedure as for exercise
testing where facilities for cardiac
monitoring and cardio-respiratory resuscitation are available. During
administration of Adenoscan
®
continuous ECG control is necessary as life-threatening arrhythmia
might occur. Heart rate and blood
pressure should be monitored every minute.
ADULTS :
1. Adenoscan
®
should be administered undiluted as a continuous peripheral
intravenous infusion at a dose
of 140 µg/kg/min for six minutes using an infusion pump. Separate
venous sites for Adenoscan
®
and
radionuclide administration are recommended to avoid an adenosine
bolus effect.
2. After three minutes of Adenoscan
®
infusion, the radionuclide is injected to ensure sufficient time for
peak coronary blood flow to occur. The optimal vasodilator protocol is
achieved with six minutes of
Adenoscan
®
infusion.
3. To avoid an adenosine bolus effect, blood pressure should be
measured in the arm opposite to the
Adenoscan
®
infusion.
The table below is given as a guide for adjustment of the infusion
rate of undiluted Adenoscan
®
, i