HERCEPTIN trastuzumab (rch) 60mg powder for injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Trastuzumab, Quantity: 60 mg

Commercializzato da:

Roche Products Pty Ltd

INN (Nome Internazionale):

Trastuzumab

Forma farmaceutica:

Injection, powder for

Composizione:

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

Via di somministrazione:

Intravenous

Confezione:

1 vial

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Early Breast Cancer. HERCEPTIN is indicated for the treatment of patients with HER2 positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. Locally Advanced Breast Cancer.Herceptin 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 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. Advanced Gastric Cancer. HERCEPTIN 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.

Dettagli prodotto:

Visual Identification: Lyophilised powder: white to pale yellow in colour. Reconstituted solution: colourless to pale yellow, clear to slightly opalescent liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2010-12-03

Foglio illustrativo

HERCEPTIN
®
_INTRAVENOUS INFUSION_
_Contains the active ingredient trastuzumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Herceptin. 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 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.
HERCEPTIN IS ALSO AVAILABLE AS A
SUBCUTANEOUS (SC) INJECTION. FOR
MORE INFORMATION ON HERCEPTIN SC
PRODUCT PLEASE REFER TO THE
SEPARATE CMI FOR HERCEPTIN SC OR
SPEAK WITH YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT HERCEPTIN IS
GIVEN FOR
Herceptin contains an active
ingredient called trastuzumab.
Herceptin belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. Herceptin 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 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 binds to HER2 it
stops the growth and spread of the
cancer cells.
Herceptin is used to treat breast and
gastric cancer It is only used in
patients whose tumour has tested
positive to HER2.
Herceptin 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
Herceptin is used with chemotherapy
medicines cisplatin and capecitabine
(or 5FU).
For further information about the
other medicines you are receiving
with Herceptin, plea

Scheda tecnica

herceptin20210507
1
AUSTRALIAN PRODUCT INFORMATION
HERCEPTIN (TRASTUZUMAB) POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Trastuzumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Herceptin 150 mg vial contains 150mg of trastuzumab
Herceptin 60mg vial contains 60 mg trastuzumab
The reconstituted Herceptin 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 IV infusion.
Sterile, preservative-free lyophilized white to pale yellow powder.
_Herceptin solution for subcutaneous (SC) injection (Herceptin SC) is
a colourless to yellowish, clear to _
_opalescent and contains 600 mg/5mL of trastuzumab (see separate
Herceptin SC Product Information). _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
Herceptin 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 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 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.
ADVANCED GASTRIC CANCER
Herceptin 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