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ZIBOR 2.500 IU Solution for injection (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Zibor 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringes.

2. Qualitative and quantitative composition

Bemiparin sodium: 2500 IU (anti Factor Xa*) per 0.2 ml pre-filled syringe (equivalent to 12500 IU (antiFactor Xa*) per millilitre solution for injection). Potency is described in International anti-Factor ...

3. Pharmaceutical form

Solution for injection in pre-filled syringes. Colourless or slightly yellowish, clear solution, free of visible particles.

4.1. Therapeutic indications

Prevention of thromboembolic disease in patients undergoing general 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 ...

4.3. Contraindications

Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Hypersensitivity to heparin or substances of porcine origin. History of confirmed or suspected immunologically ...

4.4. Special warnings and precautions for use

Do not administer by the intramuscular route. Due to the risk of haematoma during bemiparin administration, the intramuscular injection of other agents should be avoided. When using daily doses of bemiparin ...

4.5. Interaction with other medicinal products and other forms of interaction

Bemiparin interactions with other medicinal products have not been investigated and the information given on this section is derived from data available from other LMWHs. The concomitant administration ...

4.6. Pregnancy and lactation

Pregnancy Animal studies have not shown any evidence of teratogenic effects with the use of bemiparin (see section 5.3). For bemiparin, clinical data on exposed pregnancies are limited. However, caution ...

4.7. Effects on ability to drive and use machines

Zibor has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The most commonly reported adverse reaction is haematoma and/or ecchymosis at the injection site, occurring in approximately 15% of patients receiving Zibor. Osteoporosis has been associated with long-term ...

4.9. Overdose

Bleeding is the main symptom of overdosage. If bleeding occurs bemiparin should be discontinued depending on the severity of the haemorrhage and the risk of thrombosis. Minor haemorrhages rarely need specific ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antithrombotic agent, heparin group ATC code: B01AB12 Bemiparin sodium is a LMWH obtained by depolymerization of heparin sodium from porcine intestinal mucosa. Its mean molecular ...

5.2. Pharmacokinetic properties

The pharmacokinetic properties of bemiparin have been determined by measuring the plasma anti-Xa activity using the amydolitic method; it is based on reference to the W.H.O. First International Low Molecular ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction. Acute and repeated dose toxicity ...

6.1. List of excipients

Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

2 years. After first opening, Zibor should be used immediately.

6.4. Special precautions for storage

Do not store above 30°C. Do not freeze.

6.5. Nature and contents of container

0.2 ml solution in pre-filled syringe (Type I glass) with a plunger rod (polypropylene), rubber plunger stopper (chlorobutyl) and injection needle (stainless steel). Packs of 2, 6, 10, 30 and 100 syringes. ...

6.6. Special precautions for disposal and other handling

Single-dose container. Discard any unused content. Do not use if the protective package is opened or damaged. Only clear colourless or slightly yellowish solutions, free of visible particles, should be ...

7. Marketing authorization holder

Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain

8. Marketing authorization number(s)

PA1769/001/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 03 May 2002 Date of last renewal: 09 March 2010

10. Date of revision of the text

April 2021

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