Nadroparin calcium Aspen 2,850 I.U. anti-Xa/ 0.3 ml solution for injection in a pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nadroparin calcium

Available from:

Aspen Pharma Trading Limited

ATC code:

B01AB; B01AB06

INN (International Name):

Nadroparin calcium

Dosage:

2,850 I.U. anti-Xa/ 0.3 millilitre(s)

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; nadroparin

Authorization status:

Not marketed

Authorization date:

2018-05-04

Patient Information leaflet

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
NADROPARIN CALCIUM ASPEN
2,850 I.U. anti-Xa/ 0.3 ml solution for injection in a pre-filled
syringe.
Nadroparin calcium
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 or pharmacist.
-
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 Nadroparin Calcium Aspen is and what it is used for
2.
What you need to know before you take Nadroparin Calcium Aspen
3.
How to use Nadroparin Calcium Aspen
4.
Possible side effects
5.
How to store Nadroparin Calcium Aspen
6.
Contents of the pack and other information
1.
WHAT NADROPARIN CALCIUM ASPEN IS AND WHAT IT IS USED FOR
Nadroparin Calcium Aspen is an antithrombotic agent. It is a
low-molecular weight heparin.
NADROPARIN CALCIUM ASPEN IS USED FOR
-
Perioperative thrombosis prophylaxis,
-
Peri- and postoperative primary prophylaxis of deep vein thrombosis in
patients with
○
low, moderate or high thromboembolic risk,
○
larger orthopedic surgeries (e.g. elective hip surgeries),
- Prophylaxis to stop blood clots from forming in your blood when you
have an acute
illness and face period of limited mobility.
-
Treatment of deep vein thrombosis,
-
Thrombosis prophylaxis and anticoagulation with extracorporeal
circulation during haemodialysis
and hemofiltration.
Note:
The medicinal product is available in different strengths which are
not suitable for all therapeutic
indications (see section 3. How to use Nadroparin Calcium Aspen).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NADROPARIN CALCIUM ASPEN
DO NOT USE NADROPARIN CALCIUM ASPEN
-
If you are allergic to the calcium, heparin o

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2020
CRN009271
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nadroparin calcium Aspen 2,850 I.U. anti-Xa/ 0.3 ml solution for
injection in a pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 9,500 I.U. anti-Xa
Nadroparin-Calciumderived from porcine intestinal mucosa, equal to 95
to 130 I.U.
anti-Xa/mg, a low molecular weight heparin with a mean molecular
weight of 4,500 Dalton.
1 Pre-filled syringe with 0.3 ml solution for injection contains 2,850
I.U. anti-Xa Nadroparin-Calcium.
For the full list of the excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
The solution is sterile and clear, pH 5.0 to 7.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Perioperative thrombosis prophylaxis:

Peri- and postoperative primary prophylaxis of deep vein thrombosis in
patients with low, moderate or high
thromboembolic risk.

Peri- and postoperative primary prophylaxis of deep vein thrombosis in
patients with larger orthopaedic surgeries
(e.g. elective hip surgeries)
- 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.
- Thrombosis prophylaxis and anticoagulation with extracorporeal
circulation during haemodialysis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Perioperative thrombosis prophylaxis_
Peri- and postoperative primary prophylaxis of deep vein thrombosis
- In patients with low, moderate or high thromboembolic risk
0.3 ml (2,850 I.U. anti-Xa) subcutaneously 2 hours before surgery,
afterwards 0.3 ml (2,850 I.U. anti-Xa) subcutaneously every
morning until the patient is fully mobilized, but at least for the
duration of 7 days.
- In patients with larger orthopaedic surgeries (e.g. elective