18 September 2020 · Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Antifibrinolytics & haemostatics Etamsylate is a…
Powder and solvent for solution for injection 5ml water (250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU)
During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. The end of the 6 months storage at room temperature should be recorded on the product carton. The product may not be returned to refrigerated storage again. Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Yes reduce to 6 months if exposed to temperature excursions described above. The revised expiry date must not exceed the expiry date stated on the product.
Please contact Shire for products exposed to conditions other than described above. Refer to the current BNF for company contact details.
Iblias (EU), Kovaltry (EU,US), Kogenate PF · Haemophilia A in children and adults
Iblias (EU), Kovaltry (EU,US), Kogenate PF
Development and Regulatory status
Licensed but not launched
Licensed but not launched
Feb 20 · Bayer has no plans to launch in the UK .
Sep 19 · Has been available in the US since March 2016 .
Mar 18 · Bayer has no immediate plans to launch in UK .
Mar 16 · Approved in the US .
Feb 16 · Approved in EU .
Dec 15 · EU positive opinion for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Iblias can be used for all age groups .
Dec 14 · Filed in the EU and US, for the treatment of hemophilia A in children and adults. The submission was based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials. 
Dec 14 · Global filings planned before end 2014 .
Plasma protein-free recombinant factor VIII formulated with sucrose.
Haemophilia affects 1 in 5,000 to 1 in 10,000 male live births .
Haemophilia A in children and adults
Trial or other data
Dec 14 · Bayer is conducting a PIII trial of BAY 818973, a plasma protein-free formulation of recombinant octocog alfa formulated with sucrose, for treatment of haemophilia A (NCT01029340). The trial has enrolled 68 patients at multiple sites worldwide and is expected to be completed by April 2012 .
Sep 13 · Results from PIII NCT01029340 (Leopold) study reported. The study assessed the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study also compared 2 different assays for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients received the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose was measured based on the Chromogenic Substrate Adjusted assay CS/ADJ) .