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SPC: CLIVARIN Solution for injection

Αναφορές

Βιβλιογραφική αναφορά

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Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Clivarin 5726 IU anti-Xa/ml, solution for injection, in prefilled syringe. Clivarin 1432 IU anti-Xa/0.25ml, solution for injection, in prefilled syringe.

Qualitative and quantitative composition

1 ml solution contains: reviparin sodium 5726 IU anti-Xa. 0.25 ml contains: reviparin-sodium 1432 IU anti-Xa. 0.6 ml contains: reviparin-sodium 3436 IU anti-Xa. 0.9 ml contains: reviparin-sodium 5153 IU ...

Pharmaceutical form

Solution for injection in prefilled syringe. Clear, colourless to slightly yellowish, solution.

Therapeutic indications

Prevention of venous thromboembolism in general surgery and in orthopaedic surgery. Treatment of venous thrombosis.

Posology and method of administration

For subcutaneous use only. The prefilled syringe is intended for single use of Clivarin only. It is ready for use once the needle shield has been removed. The residual volume of the prefilled syringe has ...

Contraindications

Hypersensitivity to reviparin or to any of the excipients of Clivarin (see section 6.1), or other low molecular heparin preparations and/or heparin, e.g., history of known or suspected immunological mediated ...

Special warnings and precautions for use

Warnings Haemorrhage: Reviparin, like other anticoagulants should be used with extreme caution in patients treated concomitantly with other anticoagulants or platelet inhibitors. Reviparin should be used ...

Interaction with other medicinal products and other forms of interaction

Caution must be used when reviparin is administered concomitantly with oral anticoagulants, cephalosporin-type antibiotics or medicinal products that raise serum potassium levels. Caution must be used ...

Pregnancy and lactation

Pregnancy Controlled clinical studies on the use of low molecular weight heparin in pregnancy have not been performed. In studies during the second and third trimesters, passage of low molecular weight ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Adverse reactions with this or other formulations of reviparin which occurred in more than 1% of 1273 patients receiving reviparin injection in the two phase III studies (COLUMBUS and/or CORTES), other ...

Overdose

Overdosage of low molecular weight heparin results in hypocoagulability and thus in an increased risk of bleeding. Slight bleeding or haematoma at the injection site may occur with normal doses but should ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anticoagulantia, heparin group. ATC code: B01AB08 Clivarin (reviparin) Solution for Injection is composed of fragmented heparin sodium extracted from porcine intestinal mucosa ...

Pharmacokinetic properties

With subcutaneous injection of reviparin the plasma levels peak after 3 hours then plateau and start to decline at 4-6 h after administration. Pharmacokinetic studies in 24 healthy subjects performed with ...

Preclinical safety data

Toxicity, especially bleeding, occurs at dose levels considerably higher than the recommended dose and is related to the exaggerated pharmacodynamic effects of overdosing. Studies with heparin and other ...

List of excipients

Sodium chloride Sodium hydroxide Water for injection

Incompatibilities

Clivarin must not be mixed with other medicinal products.

Shelf life

Shelf-life: 3 years.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

Available in the following pack sizes: Clivarin 1432 IU anti-Xa/0.25 ml, solution for injection in prefilled syringe: 2 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe 5 0.25 ml (0.25 ml = ...

Special precautions for disposal and other handling

For single use only any unused solution should be discarded.

Marketing authorization number(s)

Clivarin 5726 IU anti-Xa/ml (0.6ml/0.9ml): DE/H/2865/002 Clivarin 1432 IU anti-Xa/0.25ml: DE/H/2865/001

Date of first authorization / renewal of the authorization

Clivarin 5726 IU anti-Xa/ml: 2005-02-17/2010-02-17 Clivarin 1432 IU anti-Xa/0.25ml: 1995-03-15//2010/03-15

Πηγαίο έγγραφο

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