Zercepac

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

trastuzumab

Saadav alates:

Accord Healthcare S.L.U.

ATC kood:

L01FD01

INN (Rahvusvaheline Nimetus):

trastuzumab

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Breast Neoplasms; Stomach Neoplasms

Näidustused:

Breast cancerMetastatic breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.                     in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.Early breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant Zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.Zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.Metastatic gastric cancer Zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Zercepac should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

Toote kokkuvõte:

Revision: 9

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-07-27

Infovoldik

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZERCEPAC 60 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ZERCEPAC 150 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ZERCEPAC 420 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
trastuzumab
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. You can help by reporting any side-effects you
may get. See the end of
section 4 for how to report side-effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zercepac is and what it is used for
2.
What you need to know before you are given Zercepac
3.
How Zercepac is given
4.
Possible side effects
5.
How to store Zercepac
6.
Contents of the pack and other information
1.
WHAT ZERCEPAC IS AND WHAT IT IS USED FOR
Zercepac contains the active substance trastuzumab, which is a
monoclonal antibody. Monoclonal
antibodies attach to specific proteins or antigens. Trastuzumab is
designed to bind selectively to an
antigen called human epidermal growth factor receptor 2 (HER2). HER2
is found in large amounts on
the surface of some cancer cells where it stimulates their growth.
When Zercepac binds to HER2 it
stops the growth of such cells and causes them to die.
Your doctor may prescribe Zercepac for the treatment of breast and
gastric cancer when:
•
You have early breast cancer, with high levels of a protein called
HER2.
•
You have metastatic breast cancer (breast cancer that has spread
beyond the original tumour)
with high levels of HER2. Zercepac may be prescribed in combination
with the chemotherapy
medicine paclitaxel or docetaxel as first treatment

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zercepac 60 mg powder for concentrate for solution for infusion
Zercepac 150 mg powder for concentrate for solution for infusion
Zercepac 420 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zercepac 60 mg powder for concentrate for solution for infusion
One vial contains 60 mg of trastuzumab, a humanised IgG1 monoclonal
antibody produced by
mammalian (Chinese hamster ovary) cell suspension culture and purified
by affinity and ion exchange
chromatography including specific viral inactivation and removal
procedures.
Zercepac 150 mg powder for concentrate for solution for infusion
One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal
antibody produced by
mammalian (Chinese hamster ovary) cell suspension culture and purified
by affinity and ion exchange
chromatography including specific viral inactivation and removal
procedures.
Zercepac 420 mg powder for concentrate for solution for infusion
One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal
antibody produced by
mammalian (Chinese hamster ovary) cell suspension culture and purified
by affinity and ion exchange
chromatography including specific viral inactivation and removal
procedures.
The reconstituted Zercepac solution contains 21 mg/mL of trastuzumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to pale yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
_Metastatic breast cancer _
Zercepac is indicated for the treatment of adult patients with HER2
positive metastatic breast cancer
(MBC):
3
-
as monotherapy for the treatment of thos