RESCUEFLOW

RescueFlow is administered as a single 250 ml dose intravenously, as the initial treatment after primary stabilisation of respiration and bleeding. v. infusion (a full dose in two to five minutes). Treatment with RescueFlow should be followed by immediate administration of isotonic fluids, dosed according to the needs of the patient.

No undesirable effects have been attributed to RescueFlow in the clinical trauma trials. Local pain close to the site of infusion has been observed in healthy volunteers. It was attenuated by gentle massage distal to the infusion site.

4 regarding the risk for anaphylactic reactions to dextrans and the use of hapten dextran

Attention should be paid to haemostatic competence in patients on concomitant treatment with drugs known to affect coagulation. 5 g dextran /kg bodyweight. Aggressive fluid resuscitation can, however, dilute blood clotting factors to such an extent that a bleeding diathesis occurs.

As RescueFlow is a potent volume expander, caution should be exercised in patients with compromised cardiac function. In patients with diabetes mellitus having severe hyperglycaemia with hyperosmolality, hypertonic solutions should be used with caution.

If this condition is known or suspected other forms of fluid treatment should be considered. Infusion of hypertonic sodium chloride without colloid in patients with chronic renal failure has been observed to cause clinically relevant hyperkalemia.

Pretreatment with hapten dextran (Promit, Promiten) has been shown to reduce the risk of hypersensitivity reactions during dextran usage. In the clinical trials performed to document RescueFlow for the initial treatment of trauma induced hypotension, no such pretreatment was given.

Depending on the acuteness of the shock state preinjection of hapten dextran, when available, should be considered and the potentially higher risk for anaphylactic reactions in case hapten dextran is not used should be weighed against the benefit to the patient.

Known hypersensitivity to the active substances or to any of the excipients. 6).