PegIntron powder lyophilized for solution for injection

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

peginterferon alfa-2b

Sẵn có từ:

Schering-Plough Labo N.V.

Mã ATC:

L03AB10

INN (Tên quốc tế):

peginterferon alfa-2b

Liều dùng:

80mcg/0,5ml

Dạng dược phẩm:

powder lyophilized for solution for injection

Các đơn vị trong gói:

(1) glass vial and solvent in ampoule 0.7ml

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2017-07-10

Đặc tính sản phẩm

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