Fresh frozen plasma (FFP)

SOURCE: UK SPC via MHRA Products (OCTAPLASLG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION, PLGB106730057). VERBATIM §4.2: 'The dosage depends upon the clinical situation and underlying disorder, but 12-15 ml octaplasLG/kg body weight is a generally accepted starting dose. This should increase the patient's plasma coagulation factor levels by approximately 25%. It is important to monitor the response, both clinically and with measurement of e.g. activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factor assays. Dosage for coagulation factor deficiencies: An adequate haemostatic effect in minor and moderate haemorrhages or surgery in coagulation factor deficient patients is normally achieved after the infusion of 5-20 ml octaplasLG /kg body weight. This should increase the patient's plasma coagulation factor levels by approximately 10-33 %. In the event of major haemorrhage or surgery, the expert advice of a haematologist should be sought. Dosage for TTP and haemorrhages in intensive plasma exchange: For therapeutic plasma exchange procedures, the expert advice of a haematologist should be sought. In TTP patients the whole plasma volume exchanged should be replaced with octaplasLG.' §4.1 indications: complex deficiencies of coagulation factors (severe hepatic failure, massive transfusion); substitution in coagulation factor deficiencies when a specific concentrate is not available or in emergencies without a precise diagnosis; rapid reversal of coumarin/indanedione oral anticoagulants when prothrombin complex concentrate is unavailable or vitamin K is insufficient; dangerous haemorrhage during fibrinolytic therapy not responding to conventional measures; therapeutic plasma exchange including TTP. No maximum dose is printed (the 1 ml/kg/minute figure is an infusion-RATE limit, not a dose ceiling), so none is given. Paediatric: 'There is limited data in children and adolescents (0-16 years)' — no paediatric dose is printed. SCOPE — THIS IS AN UMBRELLA PAGE: it is titled 'Fresh frozen plasma (FFP)', category 'Blood component', and names 'Octaplas (solvent-detergent)' as its brand. ONLY octaplasLG is dosed here. The blood-service FFP component has no SPC; the SPC itself distinguishes the two (§4.4 lists 'Previous reactions to fresh-frozen plasma (FFP) or solvent/detergent treated plasma (including octaplasLG)' as cautions and warns of 'the reduced protein S activity of octaplasLG compared to normal plasma'), so these volumes, the rate limit and every contraindication/caution on this card are octaplasLG's and must not be read across to blood-service FFP or to other plasma products, which differ and are not covered. The earlier-fetched eMC entry was the frozen-bag solution presentation (thawed); the dose figures there are identical but the route here follows the MHRA powder-and-solvent SPC (reconstitution).