Herzuma 150mg powder for concentrate for solution for infusion vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Trastuzumab

זמין מ:

Napp Pharmaceuticals Ltd

קוד ATC:

L01XC03

INN (שם בינלאומי):

Trastuzumab

כמות:

150mg

טופס פרצבטיות:

Powder for solution for infusion

מסלול נתינה (של תרופות):

Intravenous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 08010500; GTIN: 8806238000315

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HERZUMA 150 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
trastuzumab
This medicine 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 Herzuma is and what it is used for
2.
What you need to know before you use Herzuma
3.
How to use Herzuma
4.
Possible side effects
5.
How to store Herzuma
6.
Contents of the pack and other information
1.
WHAT HERZUMA IS AND WHAT IT IS USED FOR
Herzuma 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 Herzuma binds to HER2 it
stops the growth of such cells and causes them to die.
Your doctor may prescribe Herzuma 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. Herzuma may be prescribed in combination
with the chemotherapy
medicine paclitaxel or docetaxel as first treatment for metastatic
breast cancer or it may be
prescribed alone if other treatments have proved unsuccessful. It is
also used in combination
with medicines called aromatase inhi

מאפייני מוצר

OBJECT 1
HERZUMA 150 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 10-Apr-2018 | Napp
Pharmaceuticals Limited
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
Herzuma 150 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
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.
The reconstituted Herzuma 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 _
Herzuma 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 pat