Arovi 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enoxaparin sodium

Available from:

Laboratorios Farmacéuticos ROVI, S.A.

ATC code:

B01AB; B01AB05

INN (International Name):

Enoxaparin sodium

Dosage:

2000 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Heparin group; enoxaparin

Authorization status:

Not marketed

Authorization date:

2018-07-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AROVI 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 Arovi is and what it is used for
2.
What you need to know before you use Arovi
3.
How to use Arovi
4.
Possible side effects
5.
How to store Arovi
6.
Contents of the pack and other information
1.
WHAT AROVI IS AND WHAT IT IS USED FOR
Arovi contains the active substance called enoxaparin sodium that is a
low molecular weight heparin
(LMWH).
Arovi 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.
Arovi 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 kidne

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2023
CRN00D7PP
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
▼ 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
Arovi 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
Arovi 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 acetylsal