Arovi 150mg/1ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Enoxaparin sodium

Available from:

ROVI Biotech Ltd

ATC code:

B01AB05

INN (International Name):

Enoxaparin sodium

Dosage:

150mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Subcutaneous; Intraarterial

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 02080100; GTIN: 8437009577905

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AROVI 15,000 IU (150 MG)/1 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
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
problems).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AROVI
DO NOT USE AROVI
•
If you are

Summary of Product characteristics

AROVI 15,000 IU (150mg/1ml) pre-filled syringe with safety device
Summary of Product Characteristics Updated 09-May-2019 | 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
Arovi 15,000 IU (150 mg)/1 mL solution for injection in pre-filled
syringe
2. Qualitative and quantitative composition
15,000 IU (150 mg) /1 mL
Each prefilled syringe contains enoxaparin sodium 15,000 IU anti-Xa
activity (equivalent to 150 mg) in 1.0 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.
• 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 manag