New drug indication approval - July 2022

Product Name

FRAGMIN INJECTION 2500 IU/ML

Active Ingredient

Dalteparin

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

06/07/2022

Dosing regimen:

Prevention of Clotting in the Extracorporeal System During Hemodialysis and Hemofiltration

Administer dalteparin into the arterial side of the dialyzer or intravenously, selecting the appropriate regimen from those described below.

· Patients with chronic renal insufficiency or patients with no known risk of bleeding - These patients normally require few dose adjustments and, therefore, frequent monitoring of anti-Xa levels is not necessary for most patients.

o Hemodialysis and hemofiltration up to a maximum of 4 hours - A single bolus injection of 5000 IU can be administered, either intravenously or into the arterial side of the extracorporeal system, at the start of the procedure. Alternatively, administer 30 to 40 IU/kg total body weight IV bolus injection, followed by 10 to 15 IU/kg/h IV infusion.

o The 5000 IU starting dose for the single bolus dosing regimen can be adjusted, session-to-session, based on the outcome of the previous dialysis; the dose may be increased or decreased in steps of 500 or 1000 anti-Xa IU until a satisfactory outcome is obtained (see section 5.1. Pharmacodynamic properties).

Product Name

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML

Active Ingredient

Risankizumab

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

18/07/2022

Indications:

SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults who have an inadequate response or who have been intolerant to at least one prior disease-modifying antirheumatic drug (DMARD) therapy.

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals