REOPRO 2 Mg/Ml Solution for Inj/Inf

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

ABCIXIMAB

Pieejams no:

Janssen Biologics B.V.

ATĶ kods:

B01AC13

SNN (starptautisko nepatentēto nosaukumu):

ABCIXIMAB

Deva:

2 Mg/Ml

Zāļu forma:

Solution for Inj/Inf

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Platelet aggregation inhibitors excl. Heparin

Autorizācija statuss:

Authorised

Autorizācija datums:

1995-07-12

Lietošanas instrukcija

 
PACKAGE LEAFL ET: INFORMATION FOR THE USER
REOPRO
®
 2 MG/ML SOLUTION 
FOR INJECTION OR INFUSION
abciximab
READ ALL OF THIS LEAFL ET CAREFULLY 
BEFORE YOU START USING THIS MEDICINE 
BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
-  Keep this leafl et. You may need to read it 
again.
-  If you have further questions, ask your 
doctor.
-  If you get any of side eff ects, talk to your 
doctor. This includes any possible side 
eff ects not listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET
1.
 WHAT REOPRO IS AND WHAT IT IS USED FOR
2.
 WHAT YOU NEED TO KNOW BEFORE YOU ARE 
GIVEN REOPRO
3.
 HOW TO USE REOPRO
4.
 POSSIBLE SIDE EFF ECTS
5.
 HOW TO STORE REOPRO
6.
 CONTENTS OF THE PACK AND OTHER 
INFORMATION
1. 
WHAT REOPRO IS AND WHAT IT IS 
USED FOR
WHAT REOPRO IS?
The active ingredient, abciximab, is a ‘murine 
monoclonal antibody’. Monoclonal antibodies 
are proteins that recognise and bind to other 
unique proteins. ReoPro belongs to a group 
of medicines known as antithrombotics and 
binds to proteins in your blood to help to 
prevent blood clots.
WHAT IS REOPRO USED FOR?
ReoPro is used when you undergo an 
operation known as angioplasty (see “What 
is an angioplasty operation?” below) for the 
following purposes:
• ReoPro is used (together with heparin and 
acetylsalicylic acid) to prevent the formation 
of blood clots in the heart during or after an 
angioplasty operation.
• ReoPro is also used (together with heparin 
and acetylsalicylic acid) to lower the short 
term risk of getting a heart attack before an 
angioplasty operation, which is planned to 
take place within the next 1-month. This is 
for patients who have chest pain due to low 
blood supply to the heart (unstable angina) 
and have not responded to the usual therapy.
WHAT IS AN ANGIOPLASTY OPERATION?
An angioplasty operation aims to open 
blocked arteries around the heart. A doctor will 
carefully guide a special instrument through an 
artery (whi

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ReoPro 2 mg/mL solution for injection or infusion.
2 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 perfusion.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
ReoPro is a colourless and clear liquid.
4 CLINICAL PARTICULARS
4.1 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 coronary intervention (balloon
angioplasty, atherectomy and stent) (see section 5.1)
• Unstable angina
The short-term (1-month) reduction of the risk of myocardial infarction, in patients with unstable angina, not
responding to full conventional therapy who have been scheduled for percutaneous coronary intervention.
4.2 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 of unstable angina patients, the bolus dose followed by the infusion should be started up to 24
hours prior to the possible intervention and concluded 12 hours after the intervention.
For the prevention of ischemic cardiac complications in patients undergoing percutaneous coronary intervention, and
who are not currently receiving a ReoPro infusion, the bolus should be administered 10 to 60 minutes prior to the
intervention followed by the infusion for 12�