Pegasys RBV

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Peginterferon alfa-2a 270 µg/mL; Ribavirin 200mg;  ;  

Tilgængelig fra:

Roche Products (NZ) Ltd

INN (International Name):

Peginterferon alfa-2a 270 µg/mL

Dosering:

135µg/0.5mL + 200mg

Lægemiddelform:

Combination

Sammensætning:

Active: Peginterferon alfa-2a 270 µg/mL Excipient: Benzyl alcohol Glacial acetic acid Polysorbate 80 Sodium acetate trihydrate Sodium chloride Water for injection Active: Ribavirin 200mg     Excipient: Ethylcellulose Hypromellose as a component of Opadry 03A14309 Iron oxide red as a component of Opadry 03A14309 Iron oxide yellow as a component of Opadry 03A14309 Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified talc as a component of Opadry 03A14309 Sodium starch glycolate Titanium dioxide as a component of Opadry 03A14309 Triacetin

Enheder i pakken:

Bottle, plastic, HDPE Copegus tablets, 112 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Roche Diagnostics GmbH

Terapeutiske indikationer:

Pegasys RBV is indicated for the treatment of chronic hepatitis C (CHC) in: · non-cirrhotic patients · cirrhotic patients with compensated liver disease

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, plastic, HDPE Copegus tablets - 112 tablets - 48 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE Copegus tablets - 168 tablets - 48 months from date of manufacture stored at or below 30°C - Combination pack, 4 Pegasys Syringes + 168 Copegus Tablets - 4 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 4 Pegasys Syringes + 112 Copegus Tablets - 4 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, 4 x Pegasys pre-filled syringes - 2 mL - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisation dato:

2004-02-17

Indlægsseddel

_ _

Pegasys RBV
®
CMI 141013
1
CONSUMER MEDICINE INFORMATION
PEGASYS
RBV
®
PEGINTERFERON ALFA-2A
135 MCG AND 180 MCG IN 0.5 ML SOLUTION FOR INJECTION IN PREFILLED
SYRINGES
RIBAVIRIN
200 MG FILM COATED TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PEGASYS RBV
combination pack.
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
RBV 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 RBV IS USED FOR
PEGASYS RBV is a combination pack product that contains two medicines.
One is called PEGASYS
®
(peginterferon alfa-2a, solution for injection) and the other is
called COPEGUS
®
(ribavirin, film coated
tablets).
PEGASYS RBV is used to treat chronic hepatitis C, which is a viral
infection of the liver.
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.
COPEGUS belongs to a group of medicines called antivirals. These
medicines work by preventing the
activity of some viruses.
PEGASYS RBV is more effective in chronic hepatitis C than treatment
with PEGASYS alone.
People who get 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. If this viral infection is not managed, in some
people, the liver becomes badly
damaged and scarred. This is called cirrhosis. Cirrhosis can cause the
liver to stop working properly.
Cirrhosis can also be caused by caused by things other than viral
infections such as long-term
alcoholism.
_ _

Pegasys RBV
®
CMI 141013
2
It is not know

Produktets egenskaber

_ _
Pegasys RBV

160525
1
DATA SHEET
PEGASYS RBV
®
_Peginterferon alfa-2a (40 kD) solution for injection 135 and 180 mcg
in 0.5 mL + _
_ribavirin film-coated tablets 200 mg _
IMMUNOSTIMULATING AGENT/CYTOKINE + DIRECT ACTING ANTIVIRAL
PHARMACEUTICAL FORM
Pegasys RBV is a combination therapy, containing Pegasys
®
solution for injection and Copegus
®
film-coated tablets.
Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous
injection as prefilled syringes:
•
Pegasys 180 mcg prefilled syringe: each single use syringe contains
180 mcg peginterferon
alfa-2a in 0.5 mL solution for injection.
•
Pegasys 135 mcg prefilled syringe: each single use syringe contains
135 mcg peginterferon
alfa-2a in 0.5 mL solution for injection.
_ _
A stainless steel needle is also supplied with the syringe to allow
for subcutaneous injection.
Copegus is supplied as a 200 mg oval shaped film-coated tablet for
oral administration.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_PEGASYS _
ACTIVE INGREDIENT
Peginterferon alfa-2a
EXCIPIENTS
Sodium chloride, benzyl alcohol, sodium acetate, acetic acid,
polysorbate 80, water for injections.
APPEARANCE
Clear, colourless light
yellow solution practically free of particles supplied
in disposable glass
syringes.
_COPEGUS _
ACTIVE INGREDIENT
Each Copegus film-coated tablet contains 200 mg of ribavirin.
Pegasys RBV

160525
2
EXCIPIENTS
_Kernel: _
pregelatinised
starch,
sodium
starch
glycolate,
microcrystalline
cellulose,
maize
starch,
magnesium stearate.
_Film-coat: _ethyl cellulose, hydroxypropyl methylcellulose, titanium
dioxide, talc, iron oxide yellow, iron
oxide red, triacetin.
APPEARANCE
Copegus 200 mg tablets are light pink to pink, flat, oval, film-coated
tablets with RIB and 200
engraved on one side and ROCHE on the other side.
CLINICAL PARTICULARS
_THERAPEUTIC INDICATIONS_
_ _
Pegasys RBV is indicated for the treatment of chronic hepatitis C
(CHC) in:
•
non-cirrhotic patients
•
cirrhotic patients with compensated liver disease_ _
_DOSAGE AND ADMINISTRATION _
Before b