Pegasys

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

peginterferon alfa-2a

Available from:

F.Hoffmann-La Roche Ltd.

INN (International Name):

peginterferon alfa-2a

Dosage:

180mcg/0,5ml

Pharmaceutical form:

solution for injection

Prescription type:

Prescription

Patient Information leaflet

PEGASYS
®
Peginterferon alfa-2a
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Immunostimulating Agent/Cytokine ATC code: L03A B11
1.2
TYPE OF DOSAGE FORM
Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous
injection
as autoinjectors, pre-fi lled syringes and vials:
–
180 mcg Pegasys autoinjector: each single use autoinjector contains
0.5 ml with 180 mcg peginterferon alfa-2a
–
135 mcg Pegasys autoinjector: each single use autoinjector contains
0.5 ml with 135 mcg peginterferon alfa-2a
–
180 mcg Pegasys pre-fi lled syringe: ea ch single-use syringe contains
0.5 ml with 180 mcg peginterferon alfa-2a
–
135 mcg Pegasys pre-fi lled syringe: each single-use syringe contains
0.5 ml with 135 mcg peginterferon alfa-2a
–
Single-dose vials: each vial contains 1.0 ml with 180 mcg of
peginterferon alfa-2a
–
Single-dose vials: each vial contains 1.0 ml with 135 mcg of
peginterferon alfa-2a
1.3
ROUTE OF ADMINISTRATION
Subcutaneous injection
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
Peginterferon alfa-2a.
_Other excipients:_
Sodium chloride, polysorbate 80, benzyl alcohol,
sodium acetate, acetic acid, water for injections.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
CHRONIC HEPATITIS B:
Pegasys is indicated for the treatment of both
HBeAg-positive and HBeAg-negative chronic hepatitis B in non-cirrhotic
and cirrhotic patients with compensated liver disease and evidence of
viral
replication and liver infl ammation.
CHRONIC HEPATITIS C:
Pegasys alone or in combination with Copegus
(ribavirin) is indicated for the treatment of chronic hepatitis C in
non-cirrhotic
and cirrhotic patients with compensated liver disease. The combination
of
Pegasys and Copegus is indicated in naive patients and patients
_ _
who have
failed previous treatment with interferon alfa (pegylated or
non-pegylated)
alone or in combination therapy with ribavirin. Demonstrated effi cacy
included HCV patients co-infected with clinicall

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
Pegasys 180 micrograms solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each syringe of 0.5 ml solution contains 180 micrograms peginterferon
alfa-2a*. The strength
indicates the quantity of the interferon alfa-2a moiety of
peginterferon alfa-2a without consideration of
the pegylation.
*The active substance, peginterferon alfa-2a, is a covalent conjugate
of the protein interferon alfa-2a
produced by recombinant DNA technology in _Escherichia coli _with
bis-[monomethoxy polyethylene
glycol].
The potency of this medicinal product should not be compared to the
one of another pegylated or non-
pegylated protein of the same therapeutic class. For more information,
see section 5.1.
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear and colourless to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic hepatitis B
Pegasys is indicated for the treatment of hepatitis B envelope antigen
(HBeAg)-positive or HBeAg-
negative chronic hepatitis B (CHB) in adult patients with compensated
liver disease and evidence of
viral replication, increased ALT and histologically verified liver
inflammation and/or fibrosis (see
sections 4.4 and 5.1).
Chronic hepatitis C
Pegasys is indicated for the treatment of chronic hepatitis C (CHC) in
adult patients who are positive
for serum hepatitis C virus ribonucleic acid (HCV-RNA). This includes
patients with compensated
cirrhosis and/or co-infected with clinically stable HIV (see section
4.4).
The optimal way to use Pegasys in patients with chronic hepatitis C is
in combination with ribavirin.
The combination of Pegasys and ribavirin is indicated in
treatment-naïve patients and in adult patients_ _
who have failed previous treatment with interferon alpha (pegylated or
non-pegylated) alone or in
combination therapy with rib