ZIEXTENZO pegfilgrastim 6mg/0.6mL solution for injection prefilled syringe with automatic needle guard

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

Pegfilgrastim, Quantity: 6 mg

から入手可能:

Sandoz Pty Ltd

医薬品形態:

Injection, solution

構図:

Excipient Ingredients: polysorbate 20; acetic acid; sodium hydroxide; water for injections; sorbitol

投与経路:

Subcutaneous

パッケージ内のユニット:

1 pre-filled syringe with automatic needle guard

処方タイプ:

(S4) Prescription Only Medicine

適応症:

For the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

製品概要:

Visual Identification: Clear, colourless to slightly yellowish solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2019-09-06

情報リーフレット

ZIEXTENZO
®
1
ZIEXTENZO
®
_pegfilgrastim _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ziextenzo.
It does not contain all the available
information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and benefits.
Your doctor has prescribed Ziextenzo
after considering its likely benefit to
you, as well as the potential risks.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read this information
again.
WHAT ZIEXTENZO IS USED
FOR
Ziextenzo is used following
chemotherapy to help fight infection.
Some chemotherapy will reduce the
number of neutrophils in your body.
Although Ziextenzo is not a treatment
for cancer, it does help the body to
make new neutrophils. This will
reduce your chance of developing
infections that might require
antibiotics and/or hospital stays. It
may even increase your chance of
receiving your chemotherapy on time
and at the right dose.
_HOW IT WORKS_
Ziextenzo is a long acting form of
Recombinant Human Granulocyte
Colony Stimulating Factor or G-
CSF. Using gene technology,
Ziextenzo is produced in a
specific type of bacteria, called E.
coli.
G-CSF is produced in the bone
marrow and assists in the
production of neutrophils, which
are a type of white blood cell.
Neutrophils help the body fight
infections by surrounding and
destroying the bacteria that cause
the infections.
G-CSF also helps neutrophils to
do this work better.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor's prescription.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT_
DO NOT HAVE ZIEXTENZO IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
pegfilgrastim or Filgrastim
•
any of the ingredients listed at
the end of this leaflet
•
any medicines or products that
are produced using the
bacteria E. coli.
Symptoms of an allergic

製品の特徴

211207-ziextenzo-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
ZIEXTENZO
®
(PEGFILGRASTIM)
1.
NAME OF THE MEDICINE
ZIEXTENZO
®
(pegfilgrastim) is a long-acting form of
recombinant human granulocyte
colony-stimulating factor (G-CSF).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.6 mL single use pre-filled syringe with an automatic needle
guard contains 6 mg of
pegfilgrastim.
ZIEXTENZO
®
(pegfilgrastim) is composed of filgrastim (recombinant methionyl human
G-
CSF) with an approximately 20,000 dalton polyethylene glycol (PEG)
molecule covalently
bound to the N-terminal methionine residue.
Filgrastim is a 175 amino acid protein manufactured by recombinant DNA
technology.
Filgrastim is produced by
_Escherichia coli _
(
_E. coli_
) bacteria into which has been inserted the
human G-CSF gene. Filgrastim is unglycosylated and contains an
N-terminal methionine
necessary for expression in
_E coli_
. Pegfilgrastim has a total molecular weight of approximately
39,000 daltons.
ZIEXTENZO
®
(pegfilgrastim) is a biosimilar medicine to Neulasta
®
.
The comparability of ZIEXTENZO
®
with Neulasta has been demonstrated with regard to
physicochemical
characteristics
and
efficacy
and
safety
outcomes
[see
Sections
5.1
Pharmacodynamic properties – Clinical trials and 4.8 Adverse effects
(Undesirable effects)].
The evidence for comparability supports the use of ZIEXTENZO
®
for the listed indication.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
ZIEXTENZO
®
is a sterile, clear, colourless to slightly yellowish,
preservative-free liquid for
subcutaneous (SC) administration.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
ZIEXTENZO
®
is indicated for the treatment of cancer patients following
chemotherapy, to
decrease the duration of severe neutropenia and so reduce the
incidence of infection, as
manifested by febrile neutropenia.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The recommended dosage of ZIEXTENZO
®
is a single SC injection of 6 mg admin