OGIVRI trastuzumab (rch) 150 mg powder for injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Trastuzumab, Quantity: 150 mg

Sẵn có từ:

Maxx Pharma Pty Ltd

Dạng dược phẩm:

Powder

Thành phần:

Excipient Ingredients: histidine; sorbitol; histidine hydrochloride monohydrate; macrogol 3350; sodium hydroxide; hydrochloric acid

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

1 vial

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

? Early Breast Cancer,OGIVRI 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,OGIVRI is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant OGIVRI.,? Metastatic Breast Cancer,OGIVRI 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,OGIVRI 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.

Tóm tắt sản phẩm:

Visual Identification: Lyophilized powder, off-white to pale yellow in colour. Reconstituted solution - colourless to pale yellow clear to slightly opalescent solution practically free of visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2018-12-11

Tờ rơi thông tin

OGIVRI
_contains the active ingredient trastuzumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OGIVRI. 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 OGIVRI
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 OGIVRI IS USED
FOR
OGIVRI contains an active
ingredient called trastuzumab.
OGIVRI belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of
antineoplastic agents. OGIVRI
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.
OGIVRI 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 OGIVRI binds to HER2 it
stops the growth and spread of the
cancer cells.
OGIVRI is used to treat breast and
gastric cancer. It is only used in
patients whose tumor has tested
positive to HER2.
OGIVRI 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
OGIVRI is used with chemotherapy
medicines cisplatin and capecitabine
(or 5FU).
For further information about the
other medicines you are receiving
with OGIVRI, please ask your
doctor, nurse or pharmacist for the
Consumer Medicine Information
(CMI) leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY OGIVRI HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
OGIVRI

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
OGIVRI
_trastuzumab (rch) powder for injection _
1
NAME OF THE MEDICINE
Trastuzumab.
OGIVRI is a biosimilar medicine to Herceptin. The evidence for
comparability supports the use of OGIVRI
for the listed indications.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OGIVRI contains trastuzumab as the active ingredient.
Each OGIVRI 150 mg single-dose vial contains 150 mg of trastuzumab.
Each OGIVRI 440 mg Pharmacy Bulk Pack contains 440 mg of trastuzumab.
Excipients with known effect: Sorbitol
OGIVRI contains 0.77 mg sorbitol/ 1.00 mg trastuzumab. There is 115.2
mg of sorbitol in the 150 mg vial
and 337.9 mg of sorbitol in the 440 mg Pharmacy Bulk Pack.
Reconstitution of the 150 mg vial with 7.2 mL of sterile water for
injection yields 7.4 mL of a single-dose
solution containing approximately 21 mg/mL trastuzumab, at a pH of
approximately 6.0. A volume overage
of 4% ensures that the labelled dose can be withdrawn from each vial.
Reconstitution of the 440 mg vial with 20 mL of bacteriostatic water
for injection yields a multiple-dose
solution containing approximately 21 mg/mL trastuzumab, at a pH of
approximately 6.0.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for IV infusion.
OGIVRI is a sterile, white to pale yellow, preservative-free
lyophilized powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
OGIVRI 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
OGIVRI is indicated for the treatment of HER2-positive locally
advanced breast cancer in combination with
neoadjuvant chemotherapy followed by adjuvant OGIVRI.
METASTATIC BREAST CANCER
OGIVRI 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 metast