PegIntron powder lyophilized for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

peginterferon alfa-2b

Available from:

Schering-Plough Labo N.V.

ATC code:

L03AB10

INN (International Name):

peginterferon alfa-2b

Dosage:

80mcg/0,5ml

Pharmaceutical form:

powder lyophilized for solution for injection

Units in package:

(1) glass vial and solvent in ampoule 0.7ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-07-10

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
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
2.
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 sectio