Nadroparin calcium Aspen Forte 19,000 I.U. anti-Xa/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:

Mylan IRE Healthcare Limited

ATC code:

B01AB; B01AB06

INN (International Name):

Nadroparin calcium

Dosage:

19,000 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Therapeutic area:

Heparin group; nadroparin

Authorization status:

Not marketed

Authorization date:

2018-05-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NADROPARIN CALCIUM ASPEN FORTE 19,000 I.U. ANTI-XA/ML SOLUTION
FOR INJECTION IN A PRE-FILLED SYRINGE
NADROPARIN CALCIUM ASPEN FORTE 15,200 I.U. ANTI-XA/0.8ML SOLUTION
FOR INJECTION IN A PRE-FILLED SYRINGE
NADROPARIN CALCIUM ASPEN FORTE 11,400 I.U. ANTI-XA/0.6ML 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 Forte is and what it is used for
2.
What you need to know before you use Nadroparin Calcium Aspen Forte
3.
How to use Nadroparin Calcium Aspen Forte
4.
Possible side effects
5.
How to store Nadroparin Calcium Aspen Forte
6.
Contents of the pack and other information
1.
WHAT NADROPARIN CALCIUM ASPEN FORTE IS AND WHAT IT IS USED FOR
Nadroparin Calcium Aspen Forte is an antithrombotic medicine belonging
to the class of low-
molecular weight heparins.
NADROPARIN CALCIUM ASPEN FORTE IS USED FOR:
Treatment of deep venous thrombosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NADROPARIN CALCIUM ASPEN FORTE
DO NOT USE NADROPARIN CALCIUM ASPEN FORTE:
-
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)
-
with existing or a history of known heparin-induced decrease in the
number of blood platelets
(thrombocytopenia Type II) or a history of decrease in the number of
platelets due to nadroparin
calcium.
-
with organ lesions that

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2022
CRN00CW67
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nadroparin calcium Aspen Forte 19,000 I.U. anti-Xa/ml solution for
injection in a pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1.0 ml solution for injection contains 19,000 I.U. nadroparin
calciumderived from porcine intestinal mucosa, equivalent to 95 -
130 I.U. anti-Xa/mg, a low-molecular heparin with a mean molecular
weight of 4,500 Daltons.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injectionin pre-filled syringe. The solution is sterile
and clear, pH 4.5 to 7.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of deep venous thrombosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treatment of deep venous thrombosis._
Nadroparin 19,000 I.U. should be injected subcutaneously once daily
for the duration of 10 days in a dosage appropriately
adjusted for the patient’s body weight (see Table below).
The administration of oral anticoagulants should be started on the
first day. The duration of treatment with Nadroparin 19,000
I.U. is at least 5 days and should be continued until sufficient oral
anticoagulation has been achieved.
In patients with thrombophilia or complicated deep venous thrombosis,
or in patients with increased risk of bleeding
complications, a twice-daily administration of nadroparin calcium
should be considered (see Fraxiparine).
The prefilled syringes are graduated in 0.1 ml increments. For
patients needing dosages of 0.4 ml, 0.5 ml, 0.7 ml or 0.9 ml, in
accordance with their individual body weight, the correct dosage can
be obtained by using the respective higher-dose prefilled
syringe and discarding the excess amount of 0.1 or 0.2 ml before use.
_Treatment of deep venous thrombosis_
Weight in kg Treatment of deep venous thrombosis
ml subcutaneous injection once daily
< 50
50 to 59
60 to 69
70 to 79
80 to 89
≥ 90
0.4 ml
0.5 ml
0.6 ml
0.7 ml
0.8 ml
0,9 ml
Monitoring during treatm