HERZUMA trastuzumab (rch) 440 mg powder for injection for intravenous infusion vial with diluent

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Trastuzumab, Quantity: 440 mg

Saadav alates:

Celltrion Healthcare Australia Pty Ltd

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: histidine hydrochloride; histidine; polysorbate 20; trehalose dihydrate

Manustamisviis:

Intravenous Infusion

Ühikuid pakis:

1 x 50 mL

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Early Breast Cancer HERZUMA? is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,Locally Advanced Breast Cancer HERZUMA? is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERZUMA?.,Metastatic Breast Cancer HERZUMA? is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormonereceptor positive metastatic breast cancer.,Advanced Gastric Cancer HERZUMA? is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro- oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Toote kokkuvõte:

Visual Identification: Sterile, white to pale yellow lyophilized powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 72 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Registered

Loa andmise kuupäev:

2020-04-20

Infovoldik

Celltrion Healthcare Australia Pty Ltd
CONSUMER MEDICINE INFORMATION
HERZUMA
®
trastuzumab 150 mg, 440mg Powder for Injection for Intravenous (IV)
Infusion
HERZUMA
®
_POWDER FOR INJECTION FOR INTRAVENOUS (IV) INFUSION _
_ _
_Contains the active ingredient trastuzumab (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HERZUMA
®
. 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 being given
HERZUMA
®
against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE
.
You may need to read it again.
WHAT HERZUMA
® IS
GIVEN FOR
HERZUMA
®
contains the active
ingredient called trastuzumab.
HERZUMA
®
belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. HERZUMA
®
belongs to a class called
monoclonal antibodies.
Monoclonal antibodies are proteins
made in a laboratory. These proteins
are designed to recognise and bind
to other unique proteins in the body.
HERZUMA
®
binds selectively to a
protein called human epidermal
growth factor receptor 2 (HER2).
HER2 is found in large amounts on
the surface of some cancer cells.
When HERZUMA binds to HER2 it
stops the growth and spread of the
cancer cells.
HERZUMA
®
is used to treat breast
and gastric cancer. It is only used in
patients whose tumour has tested
positive to HER2.
HERZUMA
®
may be used alone or
with other medicines that treat
breast cancer, such as an aromatase
inhibitor (hormone receptor positive
breast cancer) or a taxane (e.g.
paclitaxel or docetaxel).
For the treatment of gastric cancer
HERZUMA
®
is used with
chemotherapy medicines cisplatin
and capecitabine (or 5FU).
For further information about the
other medicines you are receiving
with HERZUMA
®

Toote omadused

HERZUMA
®
(trastuzumab (rch))
2021-08 v7.0
Page 1 of 40
AUSTRALIAN PI – HERZUMA
®
(TRASTUZUMAB (RCH)) POWDER
FOR INJECTION FOR INTRAVENOUS (IV) INFUSION
1
NAME OF THE MEDICINE
HERZUMA
®
(trastuzumab (rch))
Trastuzumab 150 mg and 440 mg powder for injection for intravenous
(IV) infusion
HERZUMA
®
is a biosimilar medicine to the reference biological medicine
HERCEPTIN
®.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HERZUMA
®
150 mg vial contains 150 mg of trastuzumab.
HERZUMA
®
440 mg vial contains 440 mg of trastuzumab.
The reconstituted HERZUMA
®
solution contains 21 mg/mL of trastuzumab. For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for Injection for Intravenous (IV) Infusion.
HERZUMA
®
is a sterile, white to pale yellow lyophilised powder.
The solvent is a clear to slightly opalescent liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Early Breast Cancer
HERZUMA
®
is indicated for the treatment of HER2-positive early breast cancer
following
surgery, and in association with chemotherapy and, if applicable,
radiotherapy.
Locally Advanced Breast Cancer
HERZUMA
®
is indicated for the treatment of HER2-positive locally advanced
breast cancer in
combination with neoadjuvant chemotherapy followed by adjuvant HERZUMA
®.
Metastatic Breast Cancer
HERZUMA
®
is indicated for the treatment of patients with metastatic breast
cancer who have
tumours that overexpress HER2:
a)
as monotherapy for the treatment of those patients who have received
one or more
chemotherapy regimens for their metastatic disease;
b)
in combination with taxanes for the treatment of those patients who
have not received
chemotherapy for their metastatic disease; or
HERZUMA
®
(trastuzumab (rch))
2021-08 v7.0
Page 2 of 40
c)
in combination with an aromatase inhibitor for the treatment of
post-menopausal patients
with hormone-receptor positive metastatic breast cancer.
Advanced Gastric Cancer
HERZUMA
®
is indicated in combination with cisplatin and either capecitabine or
5-FU for th