PegIntron powder lyophilized for solution for injection

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

peginterferon alfa-2b

Mevcut itibaren:

Schering-Plough Labo N.V.

ATC kodu:

L03AB10

INN (International Adı):

peginterferon alfa-2b

Doz:

80mcg/0,5ml

Farmasötik formu:

powder lyophilized for solution for injection

Paketteki üniteler:

(1) glass vial and solvent in ampoule 0.7ml

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2017-07-10

Ürün özellikleri

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