Zibor 3,500 IU anti Xa/0.2 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:

B01AB12

INN (International Name):

Bemiparin sodium

Dosage:

3,500 IU 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:

bemiparin

Authorization status:

Marketed

Authorization date:

2002-05-03

Patient Information leaflet

Zibor3500 PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIBOR 3,500 IU ANTI-XA/0.2 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 prevent dangerous blood clots, which have formed in,
for example, the veins of the
legs and/or the lungs, which can occur if you are undergoing
orthopaedic
surgery (hip, knee or
other bone surgery), and it is also used to prevent blood clots
forming in the tubing of the dialysis
machine.
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 cond

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2023
CRN00DKL2
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zibor 3,500 IU anti Xa/0.2 ml solution for injection in pre-filled
syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bemiparin sodium: 3500 IU (anti Factor Xa*) per 0.2 ml pre-filled
syringe (equivalent to 17500 IU (antiFactor Xa*) per millilitre
solution for injection).
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
Prevention of thromboembolic disease in patients undergoing
orthopaedic surgery.
Prevention of clotting in the extracorporeal circuit during
haemodialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
WARNING: The different low molecular weight heparins are not
necessarily equivalent. Therefore compliance with the dosage
regimen and the specific method of use for each of these medicinal
products is required.
Posology
_Adults_
_Orthopaedic surgery with high risk of venous thromboembolism:_
On the day of the surgical procedure, 3,500 IU anti-Xa is to be
administered by subcutaneous route (sc), 2 hours before or 6
hours after surgery. On subsequent days, 3,500 IU anti-Xa sc is to be
administered every 24 hours.
Prophylactic treatment must be followed in accordance with the
physician’s opinion during the period of risk or until the
patient is mobilised. As a general rule, it is considered necessary to
maintain prophylactic treatment for at least 7 – 10 days
after the surgical procedure and until the risk of thromboembolic
disease has decreased.
_Prevention of clotting in the extracorporeal circuit during
haemodialysis:_
For patients undergoing repeated haemodialysis of no longer than 4
hours in duration and with no risk of