HERTUZU trastuzumab (rch) 440 mg powder for injection for intravenous infusion vial with diluent

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Trastuzumab, Quantity: 440 mg

Disponibil de la:

Celltrion Healthcare Australia Pty Ltd

Forma farmaceutică:

Injection, powder for

Compoziție:

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

Calea de administrare:

Intravenous Infusion

Unități în pachet:

1 x 50 mL

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Early Breast Cancer HERTUZU? 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 HERTUZU? is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERTUZU?.,Metastatic Breast Cancer HERTUZU? 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 postmenopausal patients with hormonereceptor positive metastatic breast cancer.,Advanced Gastric Cancer HERTUZU? is indicated in combination with cisplatin a

Rezumat produs:

Visual Identification: Sterile, white to pale yellow lyophilized powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 72 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-04-20

Caracteristicilor produsului

HERTUZU
®
(trastuzumab (rch))
2021-08 v7.0
Page 1 of 40
AUSTRALIAN PI – HERTUZU
® (TRASTUZUMAB (RCH)) POWDER FOR
INJECTION FOR INTRAVENOUS (IV) INFUSION
1
NAME OF THE MEDICINE
HERTUZU
®
(trastuzumab (rch))
Trastuzumab 150 mg and 440 mg powder for injection for intravenous
(IV) infusion
HERTUZU
®
is a biosimilar medicine to the reference biological medicine
HERCEPTIN
®.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HERTUZU
®
150 mg vial contains 150 mg of trastuzumab.
HERTUZU
®
440 mg vial contains 440 mg of trastuzumab.
The reconstituted HERTUZU
®
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 Injection for Intravenous (IV) Infusion.
HERTUZU
®
is a sterile, white to pale yellow lyophilised powder.
The solvent is a clear to slightly opalescent liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Early Breast Cancer
HERTUZU
®
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
HERTUZU
®
is indicated for the treatment of HER2-positive locally advanced
breast cancer in
combination with neoadjuvant chemotherapy followed by adjuvant HERTUZU
®.
Metastatic Breast Cancer
HERTUZU
®
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.
HERTUZU
®
(trastuzumab (rch))
2021-08 v7.0
Page 2 of 40
Advanced Gastric Cancer
HERTUZU
®
is indicated in combination with cisplatin and either capecitabine or
5-FU for th