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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Eli Lilly and Company Limited
Διεύθυνση Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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 ...

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 ...

Posology and method of administration

ReoPro is for intravenous (IV) administration in adults. ReoPro should only be administered in conjunction ...

Contraindications

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

Not relevant.

Undesirable effects

The most frequent adverse events are bleeding, back pain, hypotension, nausea, chest pain, vomiting, ...

Overdose

There has been no experience of adverse events associated with overdose. However, in the event of acute ...

Pharmacodynamic properties

Pharmacotherapeutic group: antithrombotic agents, platelet aggregation inhibitors excl. heparin ATC code: ...

Pharmacokinetic properties

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 ...

Incompatibilities

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

Shelf life

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)

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
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.