Nadroparin calcium Aspen Forte 15,200 I.U. anti-Xa/0.8ml solution for injection in a pre-filled syringe.

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Nadroparin calcium

Fáanlegur frá:

Aspen Pharma Trading Limited

ATC númer:

B01AB; B01AB06

INN (Alþjóðlegt nafn):

Nadroparin calcium

Skammtar:

15,200 I.U.anti-Xa/0.8 millilitre(s)

Lyfjaform:

Solution for injection in pre-filled syringe

Gerð lyfseðils:

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

Lækningarsvæði:

Heparin group; nadroparin

Leyfisstaða:

Not marketed

Leyfisdagur:

2018-05-04

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
NADROPARIN CALCIUM ASPEN FORTE 19,000 I.U. ANTI-XA/ML SOLUTION FOR
INJECTION in a pre-filled
syringeNADROPARIN 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 nadroparin calcium, to heparin 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 may have a tendency to bleed, such as:
o
acute gastro-intestinal ulcers
o
ce

Vara einkenni

Health Products Regulatory Authority
09 November 2018
CRN008QHX
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nadroparin calcium Aspen Forte 15,200 I.U. anti-Xa/0.8ml solution for
injection in a
pre-filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 Pre-filled syringe with 0.8 ml solution for injection contains
15,200 I.U. anti-Xa
nadroparin calcium derived from porcine intestinal mucosa.
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 calcium Aspen Forte 15,200 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 calcium Aspen Forte 15,200 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
Health Products Regulatory Authority
09 November 2018
CRN008QHX
Page 2 of 18
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.