Pegasys

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Peginterferon alfa-2a 135 µg/mL

Dostupno od:

Roche Products (NZ) Ltd

INN (International ime):

Peginterferon alfa-2a 135 µg/mL

Doziranje:

135 mcg/mL

Farmaceutski oblik:

Solution for injection

Sastav:

Active: Peginterferon alfa-2a 135 µg/mL Excipient: Acetic acid Benzyl alcohol Glacial acetic acid Sodium acetate 10% soln Polysorbate 80 Sodium acetate trihydrate Sodium chloride Water for injection

Jedinice u paketu:

Vial, glass, single dose, 1 vial, 1 dose unit

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Hoffmann-La Roche Inc

Proizvod sažetak:

Package - Contents - Shelf Life: Vial, glass, single dose, 1 vial - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, 4 vials - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Datum autorizacije:

2001-02-15

Uputa o lijeku

Pegasys
®
220530-1.00
1
CONSUMER MEDICINE INFORMATION
PEGASYS
®
PEGINTERFERON ALFA-2A
180 MCG IN 0.5 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGES
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Pegasys solution for
injection.
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 expected 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 change how the body’s immune system
fights infections and
severe disease.
Pegasys is used to treat chronic hepatitis B and chronic hepatitis 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 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.
People who get hepatitis B or hepatitis C will usually carry the virus
in their blood for the rest
of their lives, unless successfully treated. Most will end up with
some liver damage, but not
all will feel sick in the earlier stages of the disease. In some
people, the liver becomes badly
damaged and scarred. This is called cirrhosis. Cirrhosis can cause the
liver to stop working
properly.
Pegasys
®
220530-1.00
2
CHRONIC HEPATITIS B:
Pegasys is usually used alone.
CHRONIC HEPATITIS C:
Pegasys is best used for this treatment in combination with ribavirin
tablets.
IF YOU RECEIVE THE COMBINA

Svojstava lijeka

Pegasys 220530
-1.00
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Pegasys (peginterferon alfa-2a) 180mcg/0.5mLsolution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pegasys 180 micrograms solution for injection in pre-filled syringe.
Each syringe of 0.5mL
solution contains 180 micrograms of peginterferon alfa-2a.
Excipients 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, practically free
of particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic hepatitis B (CHB)
Pegasys is indicated for the treatment of both HBeAg-positive and
HBeAg-negative CHB in
non-cirrhotic and cirrhotic patients with compensated liver disease
and evidence of viral
replication and liver inflammation.
Chronic hepatitis C (CHC)
Pegasys alone or in combination with ribavirin is indicated for the
treatment of CHC in non-
cirrhotic and cirrhotic patients with compensated liver disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Before beginning Pegasys, standard haematological and biochemical
laboratory tests are
recommended for all patients (see section 4.4 Special warnings and
precautions for use).
Dose
Chronic hepatitis B
The recommended dosage of Pegasys for both HBeAg-positive and
HBeAg-negative CHB is
180 mcg once weekly by subcutaneous administration in the abdomen or
thigh. The
recommended duration of therapy is 48 weeks.
Chronic hepatitis C: treatment-naïve, prior treatment non-responder
and relapser patients
The recommended dosage of Pegasys, alone or in combination with
ribavirin, is 180 mcg
once a week by subcutaneous administration in the abdomen or thigh.
Ribavirin should be administered in divided doses (morning and
evening) with food.
The recommended duration of Pegasys monotherapy is 48 weeks.
The duration of combination therapy and the daily dose of ribavirin
given in combination
with Pegasys should be individualised based on the patient’s v