Herceptin SC

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Trastuzumab 120 mg/mL

متاح من:

Roche Products (NZ) Ltd

INN (الاسم الدولي):

Trastuzumab 120 mg/mL

جرعة:

600 mg/5mL

الشكل الصيدلاني:

Solution for injection

تركيب:

Active: Trastuzumab 120 mg/mL Excipient: Histidine Histidine hydrochloride monohydrate Hyaluronidase Methionine Polysorbate 20 Trehalose dihydrate Water for injection

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Roche Diagnostics GmbH

الخصائص العلاجية:

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; or 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.

ملخص المنتج:

Package - Contents - Shelf Life: Vial, glass, single dose, - 5 mL - 21 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours not refrigerated stored at or below 30°C. in diffuse daylight, do not freeze.

تاريخ الترخيص:

2012-10-02

نشرة المعلومات

Herceptin SC 200131
1
CONSUMER MEDICINE INFORMATION
HERCEPTIN
® SC
TRASTUZUMAB
600 MG/5 ML SOLUTION FOR SUBCUTANEOUS INJECTION
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 USED FOR
HERCEPTIN SC contains the active ingredient trastuzumab.
HERCEPTIN SC belongs to a group of medicines known as anti-neoplastic
(or anti-cancer) agents.
There are many different classes of antineoplastic 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 SC 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 further information about the other medicines you are receiving
with HERCEPTIN SC, please ask
your doctor, nurse or pharmacist for the CMI leaflet.
ASK YOUR DOCTOR IF YO

خصائص المنتج

Herceptin SC 200131
1
NEW ZEALAND DATA SHEET
HERCEPTIN SC (TRASTUZUMAB)
1.
PRODUCT NAME
Herceptin SC 600mg/5mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Herceptin SC vial contains 600mg/5mL of trastuzumab.
For the full list of excipients, see section 6.1.
_Herceptin is also available as a powder for concentrate solution, for
intravenous infusion containing _
_150 mg (single-dose vial) or 440mg (multi-dose vial) of trastuzumab
(See separate Herceptin _
_Powder for Intravenous (IV) Infusion Data Sheet). _
3.
PHARMACEUTICAL FORM
Solution for subcutaneous (SC) injection
Colourless to yellowish, clear to opalescent liquid solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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; or

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.
EARLY BREAST CANCER
Herceptin SC is indicated for the treatment of patients with:

HER2-positive locally advanced breast cancer in combination with
neoadjuvant chemotherapy,
followed by adjuvant Herceptin; or

HER2-positive early breast cancer following surgery, sequentially or
concurrently with
chemotherapy and, if applicable, radiotherapy.
Herceptin SC should only be used in early breast cancer patients with
a normal left ventricular
ejection fraction.
Herceptin SC 200131
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
HER2 testing is mandatory prior to initiation of Herceptin SC therapy
(see Dosage and
Administration, Detection of HER2 Overexpression or Gene
Amplification).
IN ORDER TO PREVENT MEDICATION ERRORS, IT IS IMPORTANT TO CHECK THE
VIAL LABELS TO ENSURE THE