Nadroparin calcium Aspen 9,500 I.U. anti-Xa/ 1.0 ml solution for injection in a vial

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nadroparin calcium

Available from:

Mylan IRE Healthcare Limited

ATC code:

B01AB; B01AB06

INN (International Name):

Nadroparin calcium

Dosage:

9,500 I.U. anti-Xa/1.0 millilitre(s)

Pharmaceutical form:

Solution for injection in vial

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
9,500 I.U. ANTI-XA/ 1.0 ML SOLUTION FOR INJECTION IN A VIAL
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.
-
- 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:
o
Peri- and postoperative primary prophylaxis of deep vein thrombosis in
patients with low,
moderate or high thromboembolic risk.
o
Peri- and postoperative primary prophylaxis of deep vein thrombosis in
patients undergoing
larger orthopaedic 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NADROPARIN CALCIUM ASPEN
DO NOT USE NADROPARIN CALCIUM ASPEN
-
If you are allergic to the active substance nadroparin, heparin or a
similar product (such as enoxaparin,
bemiparin, dalteparin), or any of the other ingredients of this
medicine (listed in section 6)
-
In case of current or history of heparin-related drop in the platelet
count (type II thrombocyt

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2022
CRN00CW67
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nadroparin calcium Aspen 9,500 I.U. anti-Xa/ 1.0 ml solution for
injection in a vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 9,500 I.U. anti-Xa
Nadroparin-Calcium derived 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. Each vial contains 5ml or
15ml of Nadroparin Calcium.
Excipient(s) with known effect:
Nadroparin calcium Aspen contains 9 mg benzyl alcohol per 1 ml.
For the full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Solution for injection in a vial. The solution is sterile and clear,
pH 5.0 to 7.5 and contains a preservative.
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 undergoing 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 and hemofiltration.
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.