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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Nadroparin calcium

Inapatikana kutoka:

Aspen Pharma Trading Limited

ATC kanuni:

B01AB; B01AB06

INN (Jina la Kimataifa):

Nadroparin calcium

Kipimo:

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

Dawa fomu:

Solution for injection

Dawa ya aina:

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

Eneo la matibabu:

Heparin group; nadroparin

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2018-05-04

Taarifa za kipeperushi

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 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
1.
-
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 calcium,
heparin or any of the other ingredients
of this medicine Nadroparin Calcium Aspen(listed in section 6)
-
In case of current or history of heparin-related drop in the platelet
count (type II thrombocytopenia

Tabia za bidhaa

Health Products Regulatory Authority
22 January 2020
CRN009275
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 d