PEGASYS PRE-FILLED SYRINGE FOR INJECTION 180 mcg0.5 ml

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

PEGINTERFERON ALFA-2A

Saadav alates:

DKSH SINGAPORE PTE. LTD.

ATC kood:

L03AB11

Annus:

180 mcg/0.5 ml

Ravimvorm:

INJECTION

Koostis:

PEGINTERFERON ALFA-2A 180 mcg/0.5 ml

Manustamisviis:

SUBCUTANEOUS

Retsepti tüüp:

Prescription Only

Valmistatud:

F HOFFMANN-LA ROCHE LTD

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2003-06-05

Infovoldik

 
1
PEGASYS
®   

Peginterferon alfa-2a  
___________________________________________________________________________________________ 

1. DESCRIPTION 
1.1 
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG 
Immunostimulants/ Interferons ATC code: L03A B11 

1.2 
TYPE OF DOSAGE FORM 
Pegasys is supplied as a sterile,
ready-to-use liquid for subcutaneous injection as prefilled
syringes and vials: 
• 
180 mcg Pegasys prefilled syringe: each single use syringe contains
0.5 mL with 180 mcg peginterferon alfa-2a. 
• 
135 mcg Pegasys prefilled 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. 

2 
C
LINICAL 
P
ARTICULARS

2.1 
THERAPEUTIC INDICATIONS 
Pegasys is indicated for the treatment of chronic hepatitis C in
adult patients who are positive for serum HCV-RNA,
including patients with 
compensated cirrhosis and patients with HIV
disease that is clinically stable (e.g. antiretroviral
therapy not required or receiving stable antiretroviral 
therapy). 

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 naive patients and patients_ _who have failed previous
treatment with interferon alpha (pegylated or non-pegylated) alone
or in combination 
therapy with ribavirin. 

Monotherapy is indicated mainly in case of intolerance
or contraindication to ribavirin. 
Chronic Hepatitis B: Pegasys is indicated for the treatment o

Toote omadused

PFS-PEG-2021 12-0
PEGASYS®
Peginterferon alfa-2a
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Immunostimulants/ Interferons
ATC code: L03A B11
1.2
TYPE OF DOSAGE FORM
Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous
(SC) injection as prefilled syringes and vials:
•
180 mcg Pegasys prefilled syringe: each single use syringe contains
0.5 mL with 180 mcg peginterferon alfa-2a.
•
135 mcg Pegasys prefilled 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.
Excipients:
As registered locally.
2
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Pegasys is indicated in combination with other medicinal products,
for the treatment of chronic hepatitis C (CHC) in patients with
compensated liver disease. This includes patients with compensated
cirrhosis and patients with HIV disease that is clinically stable
(e.g.
antiretroviral therapy not required or receiving stable antiretroviral
therapy).
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 naive patients and patients
_ _
who have failed
previous treatment with interferon alpha (pegylated or non-pegylated)
alone or in combination therapy with ribavirin.
Monotherapy is indicated mainly in case of intolerance or
contraindication to ribavirin.
Chronic Hepatitis B (CHB): Pegasys is indicated for the treatment of
both HBeAg-positive and HBeAg-negative chronic hepatitis B in
adult patients with compensated liver disease and evidence of viral
replication and liver inflammation.
2.2
DOSAGE AND METHOD OF ADMINISTRATION
GENERAL
The safet