HERCEPTIN SC trastuzumab (rch) 600mg/5mL solution for injection

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Trastuzumab, Quantity: 600 mg

Предлага се от:

Roche Products Pty Ltd

INN (Международно Name):

Trastuzumab

Лекарствена форма:

Injection, solution

Композиция:

Excipient Ingredients: vorhyaluronidase alfa; histidine hydrochloride monohydrate; histidine; trehalose dihydrate; methionine; polysorbate 20; water for injections

Начин на приложение:

Subcutaneous

Броя в опаковка:

1 x vial

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

EARLY BREAST CANCER: HERCEPTIN SC is indicated for the treatment of HER2-positive localised breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,LOCALLY ADVANCED BREAST CANCER: HERCEPTIN SC is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN.,METASTATIC BREAST CANCER: HERCEPTIN SC is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:,- as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,- in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,- in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Каталог на резюме:

Visual Identification: Colourless to yellowish, clear to opalescent liquid solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 21 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2015-03-19

Листовка

HERCEPTIN SC
®
_SUBCUTANEOUS INJECTION_
_Contains the active ingredient trastuzumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Herceptin SC. 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
Herceptin SC 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.
HERCEPTIN IS ALSO AVAILABLE AS AN
INTRAVENOUS (IV) INJECTION. FOR
MORE INFORMATION ON HERCEPTIN IV
PRODUCT PLEASE REFER TO THE
SEPARATE CONSUMER MEDICINE
INFORMATION (CMI) FOR HERCEPTIN
IV OR SPEAK WITH YOUR DOCTOR OR
PHARMACIST.
WHAT HERCEPTIN SC IS
GIVEN FOR
Herceptin SC contains an active
ingredient called trastuzumab.
Herceptin SC belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. Herceptin SC
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.
Herceptin SC 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 Herceptin SC binds to HER2
receptors it stops the growth and
spread of the cancer cells.
Herceptin SC is used to treat breast
cancer whose tumour has tested
positive to HER2.
Herceptin may be used alone or in
combination 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 further information about the
other medicines you are receiving
with Herceptin SC, please ask your
doctor, nurse or pharmacist for the
CMI leaflet.
ASK YO

Данни за продукта

herceptinsc20220407
1
AUSTRALIAN PRODUCT INFORMATION
HERCEPTIN SC (TRASTUZUMAB) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Trastuzumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Herceptin SC vial contains 600mg/5mL of trastuzumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear to opalescent solution, colourless to yellowish.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
Herceptin SC 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
Herceptin SC is indicated for the treatment of HER2-positive locally
advanced breast cancer in combination
with neoadjuvant chemotherapy followed by adjuvant Herceptin.
METASTATIC BREAST CANCER
Herceptin SC 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
post-menopausal patients with hormone-
receptor positive metastatic breast cancer.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
In order to prevent medication errors, it is important to check the
vial labels to ensure the medicine being
prepared and administered is Herceptin SC (trastuzumab) and not
Kadcyla
®
(trastuzumab emtansine).
It is important to check the labels to ensure the correct formulation
(intravenous or subcutaneous) is being
administered to the patient as was prescribed
.
Switching treatment between Herceptin IV and Herceptin SC
and vice versa, using a three-weekly (q3w) dosing regimen, was
investigated in study MO22982 (PrefHER)
(see section 4.8 Adverse Effects (Undesirable Effects)).
In order to