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Λογότυπο Γαληνού

SPC, UK: Reopro 2mg/ml solution for injection or infusion (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Eli Lilly and Company Limited
Διεύθυνση :
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL
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Δωρεάν εγγραφή

Name of the medicinal product

ReoPro 2mg/mL solution for injection or infusion.

Qualitative and quantitative composition

ReoPro 2 mg/mL contains 10 mg abciximab in 5 mL water for injection. Abciximab is the Fab fragment of a chimeric IgG1 monoclonal antibody manufactured from a recombinant cell line cultured by continuous ...

Pharmaceutical form

Solution for injection or infusion. ReoPro is a colourless and clear liquid.

Therapeutic indications

ReoPro is indicated as an adjunct to heparin and acetylsalicylic acid for: 1. Percutaneous Coronary Intervention The prevention of ischaemic cardiac complications in patients undergoing percutaneous coronary ...

Posology and method of administration

ReoPro is for intravenous (IV) administration in adults. ReoPro should only be administered in conjunction with extensive specialist medical and nursing care. In addition, there must be availability of ...

Contraindications

ReoPro should not be administered to patients with known hypersensitivity to abciximab, to any component of the product, to murine monoclonal antibodies or to papain. Trace amounts of papain resulting ...

Special warnings and precautions for use

Careful assessment of risk: benefit should be made in individual patients before commencing therapy with ReoPro. A favourable risk: benefit has not been established in low risk patients >65 years of age. ...

Interaction with other medicinal products and other forms of interaction

ReoPro has been formally studied as an adjunct to heparin and acetylsalicylic acid treatment. In the presence of ReoPro, heparin is associated with an increase in the incidence of bleeding. Limited experience ...

Pregnancy and lactation

Animal reproduction studies have not been conducted with ReoPro. It is also not known whether abciximab can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The most frequent adverse events are bleeding, back pain, hypotension, nausea, chest pain, vomiting, headache, bradycardia, fever (pyrexia), puncture site pain and thrombocytopenia. Cardiac tamponade, ...

Overdose

There has been no experience of adverse events associated with overdose. However, in the event of acute allergic reactions, thrombocytopenia or uncontrolled bleeding the administration of ReoPro should ...

Pharmacodynamic properties

Pharmacotherapeutic group: antithrombotic agents, platelet aggregation inhibitors excl. heparin ATC code: B01AC13 ReoPro is the Fab fragment of the chimeric monoclonal antibody 7E3. It is directed against ...

Pharmacokinetic properties

Following intravenous bolus administration of ReoPro, free plasma concentrations decrease very rapidly, with an initial half-life of less than 10 minutes and a second phase half-life of about 30 minutes, ...

Preclinical safety data

No remarkable findings.

List of excipients

Water for injection Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium chloride Polysorbate 80

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

3 years. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...

Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Do not shake. For storage conditions of the diluted medicinal product, see section 6.3.

Nature and contents of container

ReoPro is supplied as a 5 mL solution in a type I borosilicate glass vial with a Teflon-coated rubber stopper and an aluminium crimp protected by a plastic cap in a pack size of one.

Special precautions for disposal and other handling

Do not shake vials. ReoPro does not contain a preservative and is for single use only. For administration instructions see section 4.2. ReoPro is for intravenous (IV) administration in adults. Adults ...

Marketing authorization holder

Janssen Biologics B.V. Einsteinweg 101 2333 CB Leiden The Netherlands Distributor: Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL England

Marketing authorization number(s)

PL 08563/0015

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 March 1995 Date of last renewal of the authorisation: 22 March 2010

Date of revision of the text

24 October 2011
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