Pharmaceutical Form
Concentrate for solution for infusion. Clear colourless to pale yellow solution. 

 

Indications
Anticoagulation in adult patients with heparin-induced thrombocytopenia type II who require parenteral antithrombotic therapy. The diagnosis should be confirmed by the HIPAA (heparin induced platelet activation assay) or an equivalent test. However, such confirmation must not delay the start of treatment.

 

Product Information
Novastan 100 mg/ml concentrate for solution for infusion.

Name of the medicinal product: Novastan 100 mg/ml concentrate for solution for infusion.
 

Qualitative and quantitative composition: One ml concentrate for solution for infusion contains 100 mg argatroban monohydrate. One vial with 2.5 ml concentrate for solution for infusion contains 250 mg argatroban monohydrate. Final concentration after dilution as recommended is 1 mg/ml.
 

Excipients: 1 ml solution contains 400 mg ethanol (50% by volume) and 300 mg sorbitol. For a full list of excipients, see SmPC.

 

Novastan is contraindicated in patients with uncontrolled bleeding, Hypersensitivity to argatroban or to any of the excipients and in patients with Severe hepatic impairment.

 

Article Number
021624

 

ATC Code
B01AE03