Pegasys 180micrograms0.5ml solution for injection pre-filled pen

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Peginterferon alfa-2a

Available from:

Roche Products Ltd

ATC code:

L03AB11

INN (International Name):

Peginterferon alfa-2a

Dosage:

360microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5000471007176

Patient Information leaflet

1
uk-ie-mt-pil-pegasys-clean-171101-PEN
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEGASYS 135 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
PEGASYS 180 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
Peginterferon alfa-2a
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor, pharmacist or
nurse.
●
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
●
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pegasys is and what it is used for
2.
What you need to know before you use Pegasys
3.
How to use Pegasys
4.
Possible side effects
5.
How to store Pegasys
6.
Contents of the pack and other information
1.
WHAT PEGASYS IS AND WHAT IT IS USED FOR
Pegasys contains the active substance peginterferon alfa-2a, which is
a long-acting interferon.
Interferon is a protein that modifies the response of the body's
immune system to help fight infections
and severe diseases. Pegasys is used to treat chronic hepatitis B or
chronic hepatitis C in adults. It is
also used to treat chronic hepatitis B in children and adolescents
aged 3 years and older and chronic
hepatitis C in children and adolescents aged 5 years and older, who
have not been treated before. Both
chronic hepatitis B and C are viral infections of the liver.
CHRONIC HEPATITIS B: Pegasys is usually used alone.
CHRONIC HEPATITIS C: Pegasys is used in combination with other
medicines, for the treatment of
chronic hepatitis C (CHC).
Refer also to the package leaflets of any other medicines that are
used in combination with Pegasys.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PEGASYS
DO NOT USE PEGASYS
●
if you are allergic to peginterferonalfa-2a, to any interf

Summary of Product characteristics

PEGASYS 135 MCG AND 180 MCG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
Summary of Product Characteristics Updated 17-Nov-2017 | Roche
Products Limited
1. Name of the medicinal product
Pegasys 135 micrograms solution for injection in pre-filled pen
Pegasys 180 micrograms solution for injection in pre-filled pen
2. Qualitative and quantitative composition
Pegasys 135 micrograms solution for injection in pre-filled pen
Each pre-filled pen of 0.5 ml solution contains 135 micrograms
peginterferon alfa-2a*.
Pegasys 180 micrograms solution for injection in pre-filled pen
Each pre-filled pen 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
_Adult patients_
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 alanine aminotransferase (ALT) and
histologically verified liver inflammation
and/or fibrosis (see sections 4.4 and 5.1).
_Paediatric patients 3 years of age and older_
Pegasys is indicated for the treatment of HBeAg-positive CHB in
non-cirrhotic children and adolescents 3
years of age and older with evidence of viral re