Ontruzant

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Trastuzumab 150mg

Saadav alates:

Samsung Bioepis NZ Limited

Annus:

150 mg

Ravimvorm:

Powder for infusion concentrate

Koostis:

Active: Trastuzumab 150mg Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 20 Trehalose dihydrate

Retsepti tüüp:

Prescription

Näidustused:

Metastatic breast cancer Ontruzant 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.

Toote kokkuvõte:

Package - Contents - Shelf Life: Vial, glass, single dose, Type 1, bromobutyl rubber stopper, aluminium and polypropylene flip-off cap - 150 mg - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Loa andmise kuupäev:

2021-08-23

Infovoldik

CONSUMER MEDICINE INFORMATION
ONTRUZANT
®
TRASTUZUMAB
150 MG POWDER FOR CONCENTRATE, SOLUTION FOR INTRAVENOUS INFUSION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Ontruzant infusion.
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
ONTRUZANT against the benefits expected 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 ONTRUZANT IS USED FOR
ONTRUZANT contains the active ingredient trastuzumab.
ONTRUZANT belongs to a group of medicines known as antineoplastic (or
anti-cancer) agents.
There are many different classes of antineoplastic agents. ONTRUZANT
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.
ONTRUZANT 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 ONTRUZANT
binds to HER2 it stops the growth and spread of the cancer cells.
ONTRUZANT is used to treat breast and gastric cancer. It is only used
in patients whose tumours
has tested positive to HER2.
ONTRUZANT 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, ONTRUZANT is used with the
chemotherapy medicines
cisplatin and capecitabine (or 5FU).
For further information about other medicines you are receiving with
ONTRUZANT, please ask
your doctor, nurse or pharmacist for the Consumer medicine Information
(CMI) leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY ONTRUZANT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only

Toote omadused

1
NEW ZEALAND DATA SHEET
ONTRUZANT (TRASTUZUMAB)
1.
PRODUCT NAME
Ontruzant 150 mg powder for concentrate for solution for infusion
Ontruzant is a biosimilar medicine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 150
mg trastuzumab, a humanised IgG1 monoclonal antibody produced by
mammalian
(Chinese hamster ovary) cell suspension culture and purified by
several chromatography steps including
specific viral inactivation and removal procedures.
The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab.
For the full list of excipients, see section 6.1.
The prescribing physician should be involved in any decision regarding
interchangeability (unless the product
is known to be non-interchangeable), and a reference to this webpage
for further information
(www.medsafe.govt.nz/profs/RIss/Biosimilars.asp)
Comparability of Ontruzant with reference product (Herceptin
®
) is stated in “5. Pharmacological Properties”
section of this datasheet.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to pale yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
METASTATIC BREAST CANCER
Ontruzant 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
Ontruzant is indicated for the treatment of patients with:
•
HER2-positive locally advanced breast cancer in combination with
neoadjuvant chemotherapy,
followed by adjuvant Ontruzant; or
•
HER2-positive early breast cancer following surgery, sequentially or
concurrently with chemotherapy
and, if applicable