Zibor 25,000 IU anti-Xa/ml solution for injection in pre-filled syringes

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bemiparin sodium

Available from:

Rovi Pharma Industrial Services S.A.

ATC code:

B01AB; B01AB12

INN (International Name):

Bemiparin sodium

Dosage:

25,000 international unit(s)

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

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

Therapeutic area:

Heparin group; bemiparin

Authorization status:

Marketed

Authorization date:

2007-01-26

Patient Information leaflet

1
Package leaflet: Information for the user
ZIBOR 25,000 TU ANTI-XA/ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGES
Bemiparin sodium
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zibor is and what is it used for
2.
What you need to know before you use Zibor
3.
How to use Zibor
4.
Possible side effects
5.
How to store Zibor
6.
Contents of the pack and other information
1.
WHAT ZIBOR IS AND WHAT IT IS USED FOR
The active ingredient in Zibor is bemiparin sodium, which belongs to a
group of medicines called
anticoagulants. These help to stop blood from clotting in the blood
vessels.
Zibor is used to treat dangerous blood clots, which have formed in,
for example, the veins of the
legs and/or the lungs (deep vein thrombosis and/or pulmonary
embolism).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZIBOR
DO NOT USE ZIBOR:
-
if you are allergic to bemiparin sodium,
heparin or a similar product (such as enoxaparin,
dalteparin, nadroparin) or any other ingredients of this medicine
(listed in section 6).
-
if you have had an allergic reaction after being given any medicine
containing heparin.
-
if you are allergic to any substance derived from pigs.
-
if you suffer from Heparin Induced Thrombocytopenia (HIT), a condition
that produces a
severe decrease in your number of blood-clotting cells (platelets),
(or, as a result of HIT,
you suffer from another condition called, Disseminated Intravascular
Coagulation (DIC),
where your blood-clotting cells would clump together if Zibor is used.
-
if you suffer from

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2023
CRN00DKL2
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zibor 25,000 IU anti-Xa/ml solution for injection in pre-filled
syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bemiparin sodium: 25,000 IU (anti-Factor Xa*) per millilitre solution
for injection.
Equivalent to: 5,000 IU (anti-Factor Xa) per 0.2 ml pre-filled syringe
7,500 IU (anti-Factor Xa) per 0.3 ml pre-filled syringe
10,000 IU (anti-Factor Xa) per 0.4 ml pre-filled syringe
*Potency is described in International anti-Factor Xa activity units
(IU) of the 1
st
International Low Molecular Weight Heparin
Reference Standard.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringes.
(Colourless or slightly yellowish, clear solution, free of visible
particles).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of established deep vein thrombosis, with or without
pulmonary embolism, during the acute phase.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
WARNING: The different low molecular weight heparins are different and
are not necessarily equivalent. Therefore it is
important to comply with the dosage regimen and the specific method of
use specified for each of these medicinal products.
Posology
_Adults_
_Treatment of deep vein thrombosis:_
_Zibor 25,000 IU should be administered by the subcutaneous route at a
dose of 115 IU anti-Xa/kg weight, once daily. The _
_recommended duration of treatment is 7 ± 2 days. The daily dose
generally corresponds - depending on the body weight range- _
_to the following doses and volumes of the product in prefilled
syringes: < 50 kg, 0.2 ml (5,000 IU anti-Xa); 50-70 kg, 0.3 ml (7,500
_
_IU anti-Xa), > 70 kg, 0.4 ml (10,000 IU anti-Xa). In patients
weighing more than 100 kg body-weight, the dose should be _
_calculated on the basis of 115 IU anti-Xa/kg/day, where the
concentration of anti-Xa is 25,000 IU/ml._
In the absence of any contra-indication, oral anticoagulation