Enoxaparin Becat 20mg/0.2ml solution for injection pre-filled syringes

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Enoxaparin sodium

Disponible depuis:

ROVI Biotech Ltd

Code ATC:

B01AB05

DCI (Dénomination commune internationale):

Enoxaparin sodium

Dosage:

100mg/1ml

forme pharmaceutique:

Solution for injection

Mode d'administration:

Subcutaneous; Intraarterial; Intravenous

classe:

No Controlled Drug Status

Type d'ordonnance:

Caution - AMP level prescribing advised

Descriptif du produit:

BNF: 02080100; GTIN: 8437009577837

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENOXAPARIN BECAT 2,000 IU (20 MG)/0.2 ML SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Enoxaparin Becat is and what it is used for
2.
What you need to know before you use Enoxaparin Becat
3.
How to use Enoxaparin Becat
4.
Possible side effects
5.
How to store Enoxaparin Becat
6.
Contents of the pack and other information
1.
WHAT ENOXAPARIN BECAT IS AND WHAT IT IS USED FOR
Enoxaparin Becat contains the active substance called enoxaparin
sodium that is a low molecular weight
heparin (LMWH).
Enoxaparin Becat 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.
Enoxaparin Becat 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 seve

Résumé des caractéristiques du produit

OBJECT 1
ENOXAPARIN BECAT 2,000 IU (20MG/0.2ML) PRE-
FILLED SYRINGE WITH SAFETY DEVICE
Summary of Product Characteristics Updated 15-Feb-2018 | ROVI Biotech
Limited
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
Enoxaparin Becat 2,000 IU (20 mg)/0.2 mL solution for injection in
pre-filled syringe
2. Qualitative and quantitative composition
_2,000 IU (20 mg) /0.2 mL_
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 (Injection).
Clear, colourless to pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Enoxaparin Becat 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 in