SPC, UK: Reopro 2mg/ml solution for injection or infusion
||Eli Lilly and Company Limited
||Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL
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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 ...
Solution for injection or infusion. ReoPro is a colourless and clear liquid.
ReoPro is indicated as an adjunct to heparin and acetylsalicylic acid for: 1. Percutaneous Coronary Intervention ...
Posology and method of administration
ReoPro is for intravenous (IV) administration in adults. ReoPro should only be administered in conjunction ...
ReoPro should not be administered to patients with known hypersensitivity to abciximab, to any component ...
Special warnings and precautions for use
Careful assessment of risk: benefit should be made in individual patients before commencing therapy with ...
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 ...
Pregnancy and lactation
Animal reproduction studies have not been conducted with ReoPro. It is also not known whether abciximab ...
Effects on ability to drive and use machines
The most frequent adverse events are bleeding, back pain, hypotension, nausea, chest pain, vomiting, ...
There has been no experience of adverse events associated with overdose. However, in the event of acute ...
Pharmacotherapeutic group: antithrombotic agents, platelet aggregation inhibitors excl. heparin ATC code: ...
Following intravenous bolus administration of ReoPro, free plasma concentrations decrease very rapidly, ...
Preclinical safety data
No remarkable findings.
List of excipients
Water for injection Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium chloride ...
This medicinal product must not be mixed with other medicinal products except those mentioned in section ...
3 years. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature ...
Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not shake. For storage conditions of the diluted ...
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 ...
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 ...
Marketing authorization holder
Janssen Biologics B.V. Einsteinweg 101 2333 CB Leiden The Netherlands Distributor: Eli Lilly and Company ...
Marketing authorization number(s)
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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.