REOPRO Solution for injection or infusion Ref.[2442] Active ingredients: Abciximab

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 hours.

Paediatric population

The safety and efficacy of ReoPro in children aged less than 18 years have not been established.

No data are available.

Method of administration

ReoPro is for intravenous administration in adults.

ReoPro should only be administered in conjunction with extensive specialist medical and nursing care. In addition, there must be availability of laboratory tests of haematology function and facilities for administration of blood products.

For instructions on dilution of the medicinal product before administration, see section 6.6.

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 be immediately discontinued (see section 4.4, paragraphs on Hypersensitivity and Thrombocytopenia). In the event of thrombocytopenia or uncontrolled bleeding, platelet transfusion is recommended (see section 4.4, paragraph on Transfusion to restore platelet function).

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 not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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.

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.

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

The recommended dose of ReoPro is a 0.25mg/kg intravenous bolus immediately followed by a 0.125µg/kg/min (to a maximum of 10µg/min) continuous intravenous infusion.

Instructions for Dilution

1. Parenteral medicinal products should be inspected visually for particulate matter prior to administration. Preparations of ReoPro containing visibly opaque particles should NOT be used.
2. As with all parenteral medicinal products, aseptic procedures should be used during the administration of ReoPro.
3. Preparation of bolus injection: Withdraw the necessary amount of ReoPro for the bolus injection into a syringe. Filter the bolus injection using a sterile, non-pyrogenic, low protein-binding 0.2µm/0.22µm or 5.0µm syringe filter. The bolus should be administered over one (1) minute.
4. Preparation of IV infusion: Withdraw the necessary amount of ReoPro for the continuous infusion into a syringe. Inject into an appropriate container of sterile sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose solution and infuse at the calculated rate via a continuous infusion pump. The continuous infusion should be filtered either upon admixture, using a sterile, non-pyrogenic, low protein-binding 0.2µm/0.22µm or 5.0µm syringe filter, or upon administration, using an in-line, sterile, non-pyrogenic, low protein-binding 0.2µm or 0.22µm filter. Discard the unused portion at the end of the infusion period.
5. No incompatibilities have been shown with intravenous infusion fluids or commonly used cardiovascular medicinal products. Nevertheless, it is recommended that ReoPro be administered in a separate intravenous line whenever possible and not mixed with other medicinal products.
6. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags or administration sets.
7. Any unused product or waste material should be disposed of in accordance with local requirements.