INTRONA Solution for injection or infusion Ref.[8706] Active ingredients: Interferon, alfa-2b

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

IntronA 10 million IU/mL solution for injection or infusion.

Pharmaceutical Form

Solution for injection or infusion.

Clear and colourless solution.

Qualitative and quantitative composition

One vial of solution for injection or infusion contains 10 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1 mL of solution.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Interferon, alfa-2b

Recombinant interferon alfa-2b is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface. Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals. It has demonstrated significant immunomodulatory activity in vitro.
List of Excipients

Disodium phosphate anhydrous
Sodium dihydrogen phosphate monohydrate
Edetate disodium
Sodium chloride
M-cresol
Polysorbate 80
Water for injections

Pack sizes and marketing

1 mL of solution (corresponding to 10 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).

IntronA is supplied as:

  • Pack of 1 vial.
  • Pack of 1 vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab.
  • Pack of 6 vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs.
  • Pack of 12 vials, 12 injection syringes of 2 mL, 12 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

EU/1/99/127/019
EU/1/99/127/020
EU/1/99/127/021
EU/1/99/127/022

Date of first authorisation: 9 March 2000
Date of latest renewal: 9 March 2010

Drugs

Drug Countries
INTRONA Austria, Canada, Cyprus, Estonia, Ireland, Lithuania, Netherlands, Poland, Singapore, United States
 
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