Trazimera

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Trastuzumab 440mg (No overfill, only 420 mg deliverable);  

Saadav alates:

Pfizer New Zealand Limited

Annus:

440 mg

Ravimvorm:

Powder for infusion concentrate

Koostis:

Active: Trastuzumab 440mg (No overfill, only 420 mg deliverable)   Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 20 Sucrose Benzyl alcohol Water for injection

Retsepti tüüp:

Prescription

Näidustused:

Metastatic breast cancer Trazimera 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: Combination pack, 1 vial 440 mg Trazimera, 1 vial of BWFI diluent - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. This shelf-life applies if reconstituted in supplied diluent. - Vial, glass, (Type I) of diluent, closed with a bromobutyl stopper, aluminium seal and polypropylene cap - 20 mL - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). or stored at 2 to 30°C. - Vial, glass, multi-dose, (Type I) of active, closed with a chlorobutyl stopper, aluminium seal and polypropylene cap - 440 mg - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Loa andmise kuupäev:

2019-08-20

Toote omadused

Version: pfdtrazv10921
Supersedes: pfdtrazv10620
Page 1 of 32
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
TRAZIMERA™ 150 mg powder for concentrate for solution for infusion
TRAZIMERA™ 440 mg powder for concentrate for solution for infusion
TRAZIMERA is a biosimilar medicine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRAZIMERA 150 mg vial contains 150 mg trastuzumab.
TRAZIMERA 440 mg vial contains 440 mg trastuzumab and delivers 420 mg
of trastuzumab; each vial
of solvent contains 20 mL of bacteriostatic water for injection.
The reconstituted TRAZIMERA solution contains 21 mg/mL of trastuzumab.
The humanized antibody against human epidermal growth factor receptor
2 protein (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.
TRAZIMERA is a biosimilar medicine to HERCEPTIN
®
. The prescribing physician should be involved
in any decision regarding interchangeability with other products.
Additional information is available at
www.medsafe.govt.nz/profs/RIss/Biosimilars.asp
For information on comparative studies, see sections 5.1 and 5.2.
EXCIPIENT WITH KNOWN EFFECT
Each vial of solvent (bacteriostatic water for injection) contains
benzyl alcohol 1.1% (220 mg) as
preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White lyophilised powder or cake.
TRAZIMERA 440mg solvent is a clear to slightly opalescent liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS_ _
METASTATIC BREAST CANCER
TRAZIMERA 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
Version: pfdtrazv10921
Supersedes: pfdtrazv10620
Page 2 of 32
•
in
combination
with
taxanes
for