TRAZIMERA trastuzumab 60 mg powder for injection vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

Trastuzumab, Quantity: 60 mg

Доступна с:

Pfizer Australia Pty Ltd

Фармацевтическая форма:

Injection, powder for

состав:

Excipient Ingredients: histidine hydrochloride monohydrate; histidine; polysorbate 20; sucrose

Администрация маршрут:

Intravenous

Штук в упаковке:

1

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

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

Обзор продуктов:

Visual Identification: a sterile, white, preservative-free lyophilized powder or cake for IV infusion.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Registered

Дата Авторизация:

2019-08-19

тонкая брошюра

TRAZIMERA™
T
R
A
Z
I
M
E
R
A
™
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TRAZIMERA?
TRAZIMERA contains the active ingredient trastuzumab. TRAZIMERA is
used to treat breast and gastric cancer. It is only used in
patients whose tumour has tested positive to HER2.
For more information, see Section 1. Why am I using TRAZIMERA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TRAZIMERA?
Do not use if you have ever had an allergic reaction to any medicine
containing trastuzumab, any protein of Chinese hamster origin
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TRAZIMERA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TRAZIMERA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TRAZIMERA?
TRAZIMERA must be prepared by a healthcare professional and will be
given in a hospital or clinic by a doctor or nurse.
TRAZIMERA is given by "drip" into a vein (intravenous (IV) infusion).
The first TRAZIMERA infusion is given over 90 minutes. If the
first infusion is well tolerated, your drip time may be shortened to
30 minutes.
For the treatment of breast cancer, TRAZIMERA is given either once a
week or once every three weeks. It may be given alone or in
combination with other medicines used to treat breast cancer.
For the treatment of gastric cancer TRAZIMERA is given every three
weeks in combination with other medicines used to treat gastric
cancer.
More instructions can be found in Section 4. How do I use TRAZIMERA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TRAZIMERA?
THINGS YOU
SHOULD DO
•
Remind any doctor

Характеристики продукта

Version: pfptrazv11121
Supersedes: pfptrazv10720
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION –
TRAZIMERA
TM
(TRASTUZUMAB)
1
NAME OF THE MEDICINE
Trastuzumab
TRAZIMERA is a biosimilar medicine to the reference biological
medicine HERCEPTIN
®
.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 60 mg or 150 mg trastuzumab.
The humanized antibody against HER2 is produced by recombinant
mammalian cells (Chinese
hamster ovary (rch)) in suspension culture in a nutrient medium and
purified by affinity
chromatography
and
ion
exchange,
including
specific
viral
inactivation
and
removal
procedures.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection for infusion.
TRAZIMERA is a sterile, white preservative-free lyophilized powder or
cake for IV infusion.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
TRAZIMERA 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
TRAZIMERA is indicated for the treatment of HER2-positive locally
advanced breast cancer
in combination with neoadjuvant chemotherapy followed by adjuvant
TRAZIMERA.
METASTATIC BREAST CANCER
TRAZIMERA 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
Version: pfptrazv11121
Supersedes: pfptrazv10720
Page 2 of 36
c) in combination with an aromatase inhibitor for the treatment of
post-menopausal patients
with hormone-receptor positive metastatic breast cancer.
ADVANCED GASTRIC CANCER
TRAZIMERA is indicated in combination with cisplatin and either
capecitabine or 5-FU for
the treatment of patients with HER2 positi