Inhixa
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
13-12-2023
Summary of Product characteristics
(SPC)
13-12-2023
Public Assessment Report
(PAR)
06-09-2022
Active ingredient:
enoxaparin sodium
Available from:
Techdow Pharma Netherlands B.V.
ATC code:
B01AB05
INN (International Name):
enoxaparin sodium
Therapeutic group:
Antithrombotic agents
Therapeutic area:
Venous Thromboembolism
Therapeutic indications:
Inhixa 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.
Product summary:
Revision: 25
Authorization status:
Authorised
Authorization date:
2016-09-15
Patient Information leaflet
320
B. PACKAGE LEAFLET
321
PACKAGE LEAFLET: INFORMATION FOR THE USER
INHIXA 2,000 IU (20 MG)/0.2 ML SOLUTION FOR INJECTION
INHIXA 4,000 IU (40 MG)/0.4 ML SOLUTION FOR INJECTION
INHIXA 6,000 IU (60 MG)/0.6 ML SOLUTION FOR INJECTION
INHIXA 8,000 IU (80 MG)/0.8 ML SOLUTION FOR INJECTION
INHIXA 10,000 IU (100 MG)/1 ML SOLUTION FOR INJECTION
enoxaparin 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, 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 Inhixa is and what it is used for
2.
What you need to know before you use Inhixa
3.
How to use Inhixa
4.
Possible side effects
5.
How to store Inhixa
6.
Contents of the pack and other information
1.
WHAT INHIXA IS AND WHAT IT IS USED FOR
Inhixa contains the active substance called enoxaparin sodium that is
a low molecular weight heparin
(LMWH).
Inhixa works in two ways:
1)
Stopping existing blood clots from getting bigger. This helps your
body to break them down and stop
them causing you harm.
2)
Stopping blood clots forming in your blood.
Inhixa 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
If you have experienced a blood clot due to cancer to prevent further
clots from forming.
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
probl
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10,000 IU/mL (100 mg/mL) solution for injection
Each pre-filled 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
depolymerisation of heparin benzyl ester
derived from porcine intestinal mucosa.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe (injection).
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inhixa 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.
Extended treatment of deep vein thrombosis (DVT) and pulmonary
embolism (PE) and prevention of its
recurrence in patients with active cancer.
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
intervention (PCI).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prophylaxis of venous thromboembolic disease in moderate and high
risk s
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