Nadroparin calcium Aspen Forte 19,000 I.U. anti-Xa/ml solution for injection in a pre-filled syringe

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Nadroparin calcium

Prieinama:

Aspen Pharma Trading Limited

ATC kodas:

B01AB; B01AB06

INN (Tarptautinis Pavadinimas):

Nadroparin calcium

Dozė:

19,000 international unit(s)/millilitre

Vaisto forma:

Solution for injection in pre-filled syringe

Recepto tipas:

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

Gydymo sritis:

Heparin group; nadroparin

Autorizacija statusas:

Not marketed

Leidimo data:

2018-05-04

Pakuotės lapelis

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

Prekės savybės

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 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).
Health Products Regulatory Authority
09 November 2018
CRN008QHX
Page 2 of 18
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