Thorinane
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
24-10-2019
Produktets egenskaber
(SPC)
24-10-2019
Offentlige vurderingsrapport
(PAR)
24-10-2019
Aktiv bestanddel:
enoxaparin sodium
Tilgængelig fra:
Pharmathen S.A.
ATC-kode:
B01AB05
INN (International Name):
enoxaparin sodium
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Venous Thromboembolism
Terapeutiske indikationer:
Thorinane is indicated for adults for: - Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. - Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). - Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. - Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). - Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). - Blood clot prevention in the extracorporeal circulation during haemodialysis. Prevention and treatment of various disorders related to blood clots in adults.,
Produkt oversigt:
Revision: 2
Autorisation status:
Withdrawn
Autorisation dato:
2016-09-14
Indlægsseddel
131
B. PACKAGE LEAFLET
Medicinal product no longer authorised
132
PACKAGE LEAFLET: INFORMATION FOR THE USER
THORINANE 2,000 IU (20 MG)/0.2 ML SOLUTION FOR INJECTION
enoxaparin sodium
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Thorinane is and what it is used for
2.
What you need to know before you use Thorinane
3.
How to use Thorinane
4.
Possible side effects
5.
How to store Thorinane
6.
Contents of the pack and other information
1.
WHAT THORINANE IS AND WHAT IT IS USED FOR
Thorinane contains the active substance called enoxaparin sodium that
is a low molecular weight heparin
(LMWH).
Thorinane works in two ways.
1)
Stopping existing blood clots from getting any bigger. This helps your
body to break them down and
stops them from causing you harm.
2)
Stopping blood clots from forming in your blood.
Thorinane can be used to:
Treat blood clots that are in your blood
Stop blood clots from forming in your blood in the following
situations:
o
Before and after an operation
o
When you have an acute illness and face period of limited mobility
o
When you have unstable angina (a condition when not enough blood gets
to your heart)
o
After a heart attack
Stop blood clots forming in the tubes of your dialysis machine (used
for people with severe kidney
prob
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Thorinane 2,000 IU (20 mg)/0.2 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10,000 IU/mL (100 mg/mL) solution for injection
Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa
activity (equivalent to 20 mg) in 0.2 mL
water for injections.
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin benzyl ester
derived from porcine intestinal mucosa.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thorinane is indicated in adults for:
Prophylaxis of venous thromboembolic disease in moderate and high risk
surgical patients, in particular
those undergoing orthopaedic or general surgery including cancer
surgery.
Prophylaxis of venous thromboembolic disease in medical patients with
an acute illness (such as acute
heart failure, respiratory insufficiency, severe infections or
rheumatic diseases) and reduced mobility at
increased risk of venous thromboembolism.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
excluding PE likely to require
thrombolytic therapy or surgery.
Prevention of thrombus formation in extra corporeal circulation during
haemodialysis.
Acute coronary syndrome:
-
Treatment of unstable angina and Non ST-segment elevation myocardial
infarction (NSTEMI), in
combination with oral acetylsalicylic acid.
-
Treatment of acute ST-segment elevation myocardial infarction (STEMI)
including patients to be
managed medically or with subsequent percutaneous coronary
intervent
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