PEGINTRON Powder and solvent for solution for injection Ref.[9681] Active ingredients: Peginterferon alpha-2b

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The Netherlands

Product name and form

PegIntron 50 micrograms powder and solvent for solution for injection.
PegIntron 80 micrograms powder and solvent for solution for injection.
PegIntron 100 micrograms powder and solvent for solution for injection.
PegIntron 120 micrograms powder and solvent for solution for injection.
PegIntron 150 micrograms powder and solvent for solution for injection.

Pharmaceutical Form

Powder and solvent for solution for injection.

White powder.

Clear and colourless solvent.

Qualitative and quantitative composition

PegIntron 50 micrograms powder and solvent for solution for injection: Each vial contains 50 micrograms of peginterferon alfa-2b as measured on a protein basis. Each vial provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

PegIntron 80 micrograms powder and solvent for solution for injection: Each vial contains 80 micrograms of peginterferon alfa-2b as measured on a protein basis. Each vial provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

PegIntron 100 micrograms powder and solvent for solution for injection: Each vial contains 100 micrograms of peginterferon alfa-2b as measured on a protein basis. Each vial provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

PegIntron 120 micrograms powder and solvent for solution for injection: Each vial contains 120 micrograms of peginterferon alfa-2b as measured on a protein basis. Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

PegIntron 150 micrograms powder and solvent for solution for injection: Each vial contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis. Each vial provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol. The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class (see section 5.1).

* produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.

Excipients with known effect: Each vial contains 40 mg of sucrose per 0.5 ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Peginterferon alpha-2b

Peginterferon alpha-2b is a covalent conjugate of recombinant interferon alfa-2b with monomethoxy polyethylene glycol. Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism. This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
List of Excipients

Powder:

Disodium phosphate, anhydrous
Sodium dihydrogen phosphate dihydrate
Sucrose
Polysorbate 80

Solvent:

Water for injections

Pack sizes and marketing

The powder is contained in a 2 ml vial (Type I flint glass) with a butyl rubber stopper in an aluminium flip-off seal with a polypropylene bonnet. The solvent is presented in a 2 ml ampoule (Type I flint glass).

PegIntron is supplied as:

  • 1 vial of powder for solution for injection and 1 ampoule of solvent for parenteral use;
  • 1 vial of powder for solution for injection, 1 ampoule of solvent for parenteral use, 1 injection syringe, 2 injection needles and 1 cleansing swab;
  • 4 vials of powder for solution for injection and 4 ampoules of solvent for parenteral use;
  • 4 vials of powder for solution for injection, 4 ampoules of solvent for parenteral use, 4 injection syringes, 8 injection needles and 4 cleansing swabs;
  • 6 vials of powder for solution for injection and 6 ampoules of solvent for parenteral use.
  • 12 vials of powder for solution for injection, 12 ampoules of solvent for parenteral use, 12 injection syringes, 24 injection needles and 12 cleansing swabs.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The Netherlands

Marketing authorization dates and numbers

PegIntron 50 micrograms powder and solvent for solution for injection:

EU/1/00/131/001
EU/1/00/131/002
EU/1/00/131/003
EU/1/00/131/004
EU/1/00/131/005
EU/1/00/131/026

PegIntron 80 micrograms powder and solvent for solution for injection:

EU/1/00/131/006
EU/1/00/131/007
EU/1/00/131/008
EU/1/00/131/009
EU/1/00/131/010
EU/1/00/131/027

PegIntron 100 micrograms powder and solvent for solution for injection:

EU/1/00/131/011
EU/1/00/131/012
EU/1/00/131/013
EU/1/00/131/014
EU/1/00/131/015
EU/1/00/131/028

PegIntron 120 micrograms powder and solvent for solution for injection:

EU/1/00/131/016
EU/1/00/131/017
EU/1/00/131/018
EU/1/00/131/019
EU/1/00/131/020
EU/1/00/131/029

PegIntron 150 micrograms powder and solvent for solution for injection:

EU/1/00/131/021
EU/1/00/131/022
EU/1/00/131/023
EU/1/00/131/024
EU/1/00/131/025
EU/1/00/131/030

Date of first authorisation: 25 May 2000
Date of latest renewal: 25 May 2010

Drugs

Drug Countries
PEGINTRON Austria, Brazil, Cyprus, Estonia, Lithuania, Poland, Singapore, United States
 
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