REOPRO Solution for injection or infusion (2016)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Eli Lilly and Company Limited |
|---|---|
| Διεύθυνση | Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL |
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Περιεχόμενα
Name of the medicinal product
ReoPro 2 mg/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 in adults as an adjunct to heparin and acetylsalicylic acid for: Percutaneous coronary intervention: The prevention of ischemic cardiac complications in patients undergoing percutaneous ...
Posology and method of administration
Posology Adults The recommended dose of ReoPro is a 0.25 mg/kg intravenous bolus immediately followed by a 0.125 µg/kg/min (to a maximum of 10 µg/min) continuous intravenous infusion. For the stabilisation ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to murine monoclonal antibodies or to papain. Trace amounts of papain resulting from the production process ...
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 ...
Fertility, pregnancy and lactation
Pregnancy It is also not known whether abciximab can cause foetal harm when administered to a pregnant woman. ReoPro should not be used during pregnancy unless clearly necessary. Breastfeeding Breastfeeding ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile The most frequent adverse reactions are bleeding, back pain, hypotension, nausea, chest pain, vomiting, headache, bradycardia, fever (pyrexia), puncture site pain and thrombocytopenia. ...
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 Mechanism of action ReoPro is the Fab fragment of the chimeric monoclonal antibody 7E3. ...
Pharmacokinetic properties
Distribution / Elimination 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 ...
Preclinical safety data
Available non-clinical data reveal no special hazard for humans.
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
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 ...
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
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
December 2016
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