may be impaired.
Do not use unless solution is clear and seal is intact.
Do not add supplementary medication or withdraw solution directly from the bag with a syringe.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Preparation for administration
1. Suspend container from eyelet support.
2. Remove plastic protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.
Use according to the dosage table above.
AGGRASTAT CONCENTRATE
Instructions for use
Aggrastat Concentrate must be diluted before use:
1. Draw 50 ml from a 250 ml container of sterile 0.9% saline or 5% glucose in water and replace with 50 ml Aggrastat (from one 50 ml puncture vial) to make up a concentration of 50 microgram/ml. Mix well before use.
2. Use according to the dosage table above.
FOR BOTH FORMULATIONS
Where the solution and container permit, parenteral drugs should be inspected for visible particles or discoloration before use.
Aggrastat should only be given intravenously and may be administered with unfractionated heparin through the same infusion tube.
It is recommended that Aggrastat be administered with a calibrated infusion set using sterile equipment.
Care should be taken to ensure that no prolongation of the infusion of the initial dose occurs and that miscalculation of the infusion rates for the maintenance dose on the basis of the patient's weight is avoided.
† IntraVia is the tradename for the infusion bag used for Aggrastat Solution. Trademark of Baxter International Inc.
Aggrastat is contra-indicated in patients who are hypersensitive to the active substance or to any of the excipients of the preparation listed in section 6.1 or who developed thrombocytopenia during earlier use of a GP IIb/IIIa receptor antagonist.
Since inhibition of platelet aggregation increases the bleeding risk, Aggrastat is contra-indicated in patients with:
• History of stroke within 30 days or any history of haemorrhagic stroke.
• Known history of intracranial disease (e.g. neoplasm, arteriovenous malformation, aneurysm).
• Active or recent (within the previous 30 days of treatment) clinically relevant bleeding (e.g. gastro-intestinal bleeding).
• Malignant hypertension.
• Relevant trauma or major surgical intervention within the past six weeks.
• Thrombocytopenia (platelet count <100,000/mm3), disorders of platelet function.
• Clotting disturbances (e.g. prothrombin time >1.3 times normal or INR [International Normalised Ratio] >1.5).
• Severe liver failure.
The administration of Aggrastat alone without unfractionated heparin is not recommended.
There is limited experience with concomitant administration of Aggrastat with enoxaparin (see sections 5.1 and 5.2). The concomitant administration of Aggrastat with enoxaparin is associated with a higher frequency of cutaneous and oral bleeding events, but not in TIMI bleeds**, when compared with the conc
