OCTAPLASLG Solution for infusion Ref.[27958] Active ingredients: Human plasma protein fraction

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Octapharma Limited, The Zenith Building, 26 Spring Gardens, Manchester, M2 1AB

Product name and form

OctaplasLG, solution for infusion.

Pharmaceutical Form

Solution for infusion.

The frozen solution is (slightly) yellow.

Qualitative and quantitative composition

A 200 ml bag contains 9-14 g of ABO-blood group specific human plasma proteins (45-70 mg/mL). octaplasLG is supplied in separate presentations according to the following blood groups:

Blood group A
Blood group B
Blood group AB
Blood group O

For details about important coagulation factors and inhibitors, see section 5.1 and table 2.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Human plasma protein fraction
List of Excipients

Sodium citrate dihydrate
Sodium dihydrogenphosphate dihydrate
Glycine

Pack sizes and marketing

200 ml of ABO-blood group specific human plasma proteins in bag (polyvinyl chloride) over-wrapped with a film.

Pack size of 1 and 10.

Marketing authorization holder

Octapharma Limited, The Zenith Building, 26 Spring Gardens, Manchester, M2 1AB

Marketing authorization dates and numbers

PL 10673/0009

04/03/2008

Drugs

Drug Countries
OCTAPLASLG Ecuador, Estonia, Finland, France, Croatia, Malta, Poland, Romania, United Kingdom

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