NOVOSEVEN RT
FACTOR VIIa RECOMBINANT (EPTACOGALFA) · by NOVO NORDISK
Composition
Inj:1 mg/1.2 mg/2 mg/2.4 mg/4.8 mg/5mg: Per Vial: Factor VIIa Recombinant (Eptacog alfa) 1 mg/1.2 mg/2 mg/2.4mg/4.8 mg/5 mg.
Indications & Dosage
Haemophilia A or B with inhibitors or acquired haemophilia: BY IV BOLUS: Adults: 90 mcg/kg body weight, initially 2-3 hourly, may increase dosing frequency to 4, 6, 8 or 12 hourly Congenital Factor VII deficiency: BY IV BOLUS: Adults: 15-30 mcg/kgbody wt 4-6 hourly. Glanzmanns thrombasthenia with antibodies to GP Iib-Iiia or HLA, with past or present refractory platelet transfusions: Adults: IV bolus.90 mcg/kg body wt (80-120 mcg/kg body wt) 2 hourly(1.5-2.5 hr) at least 3 doses. Children: See Literature.
Administration
IV administration only. Bolus over 2-5 min. Administer within 3 Hours after reconstitution Reconstitute each vial to a final concentration of 1 mg/ml. In 1 mg vial, 1.1 ml histidine diluent is reconstituted. In 2 mg vial, 2.1 ml histidine diluent is reconstituted. In 5 mg vial, 5.2 ml histidine diluent is reconstituted. In 8 mg vial, 8.1ml histidine diluent is reconstituted.
Stability
Prior to reconstitution, store under refrigeration or between 2C-25C (36F77F). Do not freeze. Protect from light. Prior to reconstitution bring vial to room temperature at recommended diluent along wall of the vial; do not inject directly on to powder. Gently swirl until dissolved. Reconstituted solutions may be stored at room temperature or under refrigeration, but must be infused within 3 hours of reconstitution. Do not freeze reconstituted solutions. Do not store reconstituted solutions in syringes.
Precautions
Patients undergone surgery, crush injury, thrombotic complications, advanced atherosclerotic disease, septicaernia/toxaemia,
Interactions
Simultaneous use of activated/non-activated prothrombin complex concentrates.
Pregnancy
Caution advised
Lactation
Caution advised
Side Effects
Fever, pain on inj site, nausea, skin rash, increased D-dimer, thrombophlebitis, MI.