PEGASYS peginterferon alfa-2a 180 micrograms/0.5mL injection pre-filled syringe

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Peginterferon alfa-2a, Quantity: 180 microgram

Disponibbli minn:

Echo Therapeutics Pty Ltd

Għamla farmaċewtika:

Injection, solution

Kompożizzjoni:

Excipient Ingredients: acetic acid; water for injections; sodium acetate; sodium chloride; polysorbate 80; benzyl alcohol

Rotta amministrattiva:

Subcutaneous

Unitajiet fil-pakkett:

4 pre-filled syringes with needles

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Chronic Hepatitis C (CHC): The combination of PEGASYS and COPEGUS is indicated for the treatment of chronic heptitis C in patients who have received no prior interferon therapy (treatment naive patients) and patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. The combination of PEGASYS and COPEGUS is also indicated for the treatment of chronic hepatitis C in patients with clinically stable human immunodeficiency virus (HIV) co-infection who have previously not received interferon therapy. PEGASYS monotherapy is indicated for the for the treatment of chronic heptitis C in treatment naive patients (see Dosage and Administration; Chronic Hepatitis C: Treatment naive patients). Patients must be 18 years of age or older and have compensated liver disease. Chronic Hepatitis B (CHB): PEGASYS is indicated for the treatment of chronic heptitis B in adult patients with evidence of viral replication and liver inflammation and compensated liver disease.

Sommarju tal-prodott:

Visual Identification: Clear, colourless to light yellow solution, practically free from particles.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2003-05-28

Fuljett ta 'informazzjoni

PEGASYS® CMI 1.00
1
PEGASYS
®
pronounced peg-ah-sis
contains the active ingredient peginterferon alfa-2a
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Pegasys pre-filled
syringes.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Pegasys
against the benefits they expect it
will have for you.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Pegasys is used
for
Pegasys contains the active
ingredient peginterferon alfa-2a.
Pegasys belongs to a group of
medicines called interferons. Pegasys
is a long-acting interferon.
Interferons are proteins that modify
the response of the body's immune
system to help fight infections and
severe diseases.
Pegasys is used to treat chronic
hepatitis B or C, which are viral
infections of the liver.
If these viral infections are not
managed, in some people, the liver
becomes badly damaged and scarred.
This is called cirrhosis. Cirrhosis can
cause the liver to stop working.
Cirrhosis can also be caused by
things other than viral infections such
as long-term alcoholism.
It is not known if Pegasys can
prevent liver failure or liver cancer
that is caused by hepatitis infection.
Most people who get hepatitis B or C
carry the virus in their blood for the
rest of their lives, unless successfully
treated. Most of these people will
have some liver damage, but not all
feel sick from the disease.
For chronic hepatitis B, Pegasys is
usually used alone.
For chronic hepatitis C, Pegasys is
best used in combination with
ribavirin tablets.
If you are given Pegasys in
combination therapy, you should also
read the ribavirin Consumer
Medicine Information leaflet before
use.
Pegasys is used alone for chronic
hepatitis C only if you cannot take
ribavirin tablets for any reason.
Pegasys treat

Karatteristiċi tal-prodott

Pegasys (peginterferon alfa-2a) solution for injection PI 1.00
1
AUSTRALIAN PRODUCT INFORMATION
Pegasys (peginterferon alfa-2a)
1.
NAME OF THE MEDICINE
Peginterferon alfa-2a
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pegasys 135micrograms solution for injection in pre-filled syringe.
Each syringe of 0.5mL solution contains
135 micrograms of peginterferon alfa-2a.
Pegasys 180 micrograms solution for injection in pre-filled syringe.
Each syringe of 0.5mL solution contains
180 micrograms of peginterferon alfa-2a.
Excipient with known effect
Benzyl alcohol (10 mg/ 1 ml)
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear and colourless to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic Hepatitis C (CHC)
The combination of Pegasys and ribavirin is indicated for the
treatment of chronic hepatitis C in
patients who have received no prior interferon therapy
(treatment-naïve patients) and patients who
have failed previous treatment with interferon alfa (pegylated or
non-pegylated) alone or in
combination therapy with ribavirin.
The combination of Pegasys and ribavirin is also indicated for the
treatment of chronic hepatitis C
patients with clinically stable human immunodeficiency virus (HIV)
co-infection who have
previously not received interferon therapy.
Pegasys monotherapy is indicated for the treatment of chronic
hepatitis C in treatment-naïve patients
(see section 4.2 Dose and Method of Administration).
Patients must be 18 years of age or older and have compensated liver
disease.
Chronic Hepatitis B (CHB)
PEGASYS is indicated for the treatment of chronic hepatitis B in adult
patients with evidence of
viral replication and liver inflammation and compensated liver
disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Before beginning Pegasys, standard haematological and biochemical
laboratory tests are
recommended for all patients (see section 4.4 Special Warnings and
Precautions for Use).
When used in combi