FULPHILA pegfilgrastim 6 mg/0.6 mL pre-filled syringe

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Pegfilgrastim, Quantity: 6 mg

Beszerezhető a:

Maxx Pharma Pty Ltd

Gyógyszerészeti forma:

Injection, solution

Összetétel:

Excipient Ingredients: sorbitol; sodium; water for injections; polysorbate 20; acetate

Az alkalmazás módja:

Subcutaneous

db csomag:

1

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

FULPHILA is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia.

Termék összefoglaló:

Visual Identification: Clear, colourless, preservative-free, sterile solution for subcutaneous injection.; 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

Engedélyezési státusz:

Registered

Engedély dátuma:

2018-08-17

Betegtájékoztató

FULPHILA
1
FULPHILA
_contains the active ingredient pegfilgrastim (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FULPHILA.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has prescribed
FULPHILA 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 THIS MEDICINE IS
USED FOR
FULPHILA is used following
chemotherapy to help fight infection.
Some chemotherapy will reduce the
number of neutrophils in your body.
Although FULPHILA 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 _
Fulphila is a long acting form of
Recombinant Human Granulocyte
Colony Stimulating Factor or G-CSF.
Using gene technology, Fulphila 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 FULPHILA 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 products that are produced
using the bacteria

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION
FULPHILA
®
_Pegfilgrastim (rbe) _
1
NAME OF THE MEDICINE
FULPHILA
®
is a Mylan company trade mark for pegfilgrastim (rbe), a long-acting
form of recombinant
human granulocyte colony-stimulating factor (G-CSF).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FULPHILA
®
is composed of filgrastim (recombinant methionyl human G-CSF) with a
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 39,000 daltons.
Each single-use pre-filled syringe with automatic needle guard
contains 6 mg of pegfilgrastim (based on
protein mass only) as the active ingredient.
FULPHILA
®
(pegfilgrastim) is a biosimilar medicine to Neulasta (pegfilgrastim).
The comparability of FULPHILA
®
with Neulasta has been demonstrated with regard to physiochemical
characteristics
and
efficacy
and
safety
outcomes
(see
SECTION
5.1
PHARMACODYNAMIC
PROPERTIES, CLINICAL TRIALS
and
SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)
).
The evidence for comparability supports the use of FULPHILA
®
for the listed indication.
Excipients with known effect: Sorbitol
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FULPHILA
®
is a sterile, clear, colourless, preservative-free liquid for
subcutaneous (SC) administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FULPHILA
®
is indicated for the treatment of cancer patients following
chemotherapy, to decrease the
duration of severe neutropenia and so reduce the incidence of
infections, as manifested by febrile
neutropenia.
FULPHILA
®
– PRODUCT INFORMATION
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The recommended dos