Pegasys

Pegasys 135 or 180 micrograms solution for injection, pre-filled syringe.

Pegylated interferon alfa-2a (Pegasys) is prepared by conjugating interferon alfa-2a with PEG reagent (bis-monomethoxypolyethylene glycol). Pegasys has the same characteristic antiviral and antiproliferative activity in vitro as interferon alfa-2a.

Interferon alfa-2a is conjugated to bis- [monomethoxypolyethylene glycol] with a degree of substitution of one mole polymer / mole protein. The average molecular weight is about 60,000, of which the protein part consists of about 20,000.

QUALITATIVE AND QUANTITATIVE COMPOSITIONPegasys 135 micrograms solution for injection in a pre-filled syringe. Each syringe with 0.5 ml solution contains 135 micrograms peginterferon alfa-2a *
Pegasys 180 micrograms solution for injection in a pre-filled syringe. Each syringe with 0.5 ml solution contains 180 micrograms peginterferon alfa-2a *
The strength indicates the amount of interferon alfa-2a without regard to the pegylation.

PHARMACEUTICAL FORMSolution for injection
The solution is clear and colourless to light yellow.

Nature and contents of container
0.5 ml solution for injection in a pre-filled syringe (siliconized type I glass) with a rubber plunger and rubber seal (butyl rubber laminated with a fluoropolymer on the side in contact with the product). A needle is included.

Pegasys 135 micrograms solution for injection in a pre-filled syringe
The syringe is labeled with graduations corresponding to doses of 135 micrograms, 90 micrograms and 45 micrograms. Supplied in packs of 1, 4 or in multipacks with 12 (2 packs of 6) pre-filled syringes. Not all pack sizes may be marketed.

Pegasys 180 micrograms solution for injection in a pre-filled syringe
The syringe is labeled with graduations corresponding to doses of 180 micrograms, 135 micrograms and 90 micrograms. Supplied in packs of 1, 4 or in multipacks with 12 (2 packs of 6) pre-filled syringes. Not all pack sizes may be marketed.
For more information

SE: https://www.fass.se/LIF/startpage
NO: https://www.felleskatalogen.no
DK: http://www.produktresume.dk
FI: https://www.fimea.fi

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