PegIntron

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

peginterferon alfa-2b

Commercializzato da:

Schering-Plough Labo N.V.

INN (Nome Internazionale):

peginterferon alfa-2b

Dosaggio:

120mcg/0,5ml

Forma farmaceutica:

powder lyophilized for solution for injection

Tipo di ricetta:

Prescription

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS IN ARMENIA
1.
NAME OF THE MEDICINAL PRODUCT
PEGINTRON
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of PegIntron contains:
_active ingredient_: a sufficient amount of powder of peginterferon
alfa-2b to provide after
reconstitution of vial (with the solvent provided) 0.7 ml of solution
with peginterferon alfa-2b
concentrations
50 mcg/0.5 ml,
80 mcg/0.5 ml,
100 mcg/0.5 ml,
120 mcg/0.5 ml,
150 mcg/0.5 ml respectively.
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 nonpegylated 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.
3. PHARMACEUTICAL FORM
Lyophilized powder for solution for injection in vial and the solvent.
White to off-white liophilized powder free of particulate matter;
prepared solution – clear and colorless solution free of visible
matter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults (tritherapy) _
PegIntron in combination with ribavirin and boceprevir (tritherapy) is
indicated for the
treatment of chronic hepatitis C (CHC) genotype 1 infection in adult
patients (18 years of age
and older) with compensated liver disease who are previously untreated
or who have failed
previous therapy.
Please refer to the ribavirin and boceprevir instructions for medical
use when PegIntron is to
be used in combination with these medicines.
_Adults (bitherapy and monotherapy) _
PegIntron is indicated for the treatment of adult patients (18 years
of age and older) with CHC
who are positive for hepatitis C virus RNA (HCV-RNA), including
patients with compensated
cirrhosis and/or co-infected with clinically stable HIV.
Peg