ReoPro

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Abciximab 2 mg/mL

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Abciximab 2 mg/mL

Dosage:

2 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Abciximab 2 mg/mL Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection

Units in package:

Vial, glass, vial 10mg/5ml, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Janssen Biologics BV

Therapeutic indications:

REOPRO is indicated as an adjunct to heparin and aspirin for: Percutaneous coronary intervention: The prevention of ischaemic cardiac complications (death, myocardial infarction or need for urgent intervention) in patients during or following percutaneous coronary intervention (balloon angioplasty, atherectomy and stent placement).

Product summary:

Package - Contents - Shelf Life: Vial, glass, vial 10mg/5ml - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 14 days from date of manufacture stored between -12°C to 5°C or 5°C to 22°C but not a combination of both, during shipping distribution only

Authorization date:

1994-03-11

Summary of Product characteristics

CCDS181029V10
1
REOPRO(190208)ADS
REOPRO
®
ABCIXIMAB (RMC)
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
REOPRO
®
abciximab (rmc) 2 mg/mL solution for injection vials.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
REOPRO vial 5 mL contains 10 mg abciximab (rmc).
Excipient(s) with known effect
The total sodium content is approximately 3.45 mg/mL.
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
REOPRO is a clear, colourless, sterile solution for intravenous use.
REOPRO is formulated in a buffered aqueous solution (pH 7.2).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REOPRO is indicated as an adjunct to heparin and aspirin for:
1. Percutaneous coronary intervention: The prevention of ischaemic
cardiac complications
(death, myocardial infarction or need for urgent intervention) in
patients during or following
percutaneous coronary intervention (balloon angioplasty, atherectomy
and stent placement).
2.
Unstable
angina:
The
stabilisation
of
unstable
angina
patients
not
responding
to
conventional medical therapy who may be candidates for percutaneous
coronary intervention.
4.2 DOSE AND METHOD OF ADMINISTRATION
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.
For the prevention of ischaemic 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 hours.
CHILDREN OR PATIENTS AGED OVER 80 YEARS
There is no experience on the use of REOPRO in children or in patients
aged over 80 years.
New Zealand Datasheet
CCDS181029v10
2
REOPRO(190208)ADS
ADMINISTRATION INSTRUCTIONS
DO NOT SHAKE VIALS.
1.
Parenteral medicine produc