Praxbind

Praxbind

idarucizumab

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Idarucizumab
Indications/Uses
Specific reversal agent for dabigatran & in adult patients treated w/ Pradaxa when rapid reversal of the anticoagulant effects of dabigatran is required for emergency surgery/urgent procedures, or life-threatening or uncontrolled bleeding.
Dosage/Direction for Use
IV 5 g (2 x 2.5 g/50 mL) as 2 consecutive infusions over 5-10 min each or as bolus inj. Flush IV line w/ sterile NaCL 9 mg/mL (0.9%) soln prior to & at the end of infusion. Recurrent bleeding/potential life-threatening re-bleeding/2nd emergency surgery/urgent procedure w/ prolonged clotting time Consider 2nd 5-g dose. Restarting antithrombotic therapy: After administration, Pradaxa may be reinitiated after 24 hr, & other antithrombotic therapy (eg, LMWH) may be started at any time if clinically stable & adequate hemostasis has been achieved.
Special Precautions
Hypersensitivity. Discontinue treatment if anaphylactic reaction or other serious allergic reaction occurs. Underlying disease predisposing to thromboembolic events, in patients on dabigatran therapy. Hereditary fructose intolerance. May cause transient proteinuria. Patients on controlled Na diet. Pregnancy & lactation. Childn <18 yr.
Drug Interactions
Do not mix w/ other medicinal drugs & no other infusion should be administered in parallel via same IV access.
MIMS Class
Antidotes & Detoxifying Agents / Haemostatics
ATC Classification
V03AB37 - idarucizumab ; Belongs to the class of antidotes. Used to reverse anticoagulant effects of dabigatran.
Presentation/Packing
Form
Praxbind soln for inj/infusion 50 mg/mL
Packing/Price
2's
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