Erbitux

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Cetuximab 2 mg/mL;  

Inapatikana kutoka:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Jina la Kimataifa):

Cetuximab 2 mg/mL

Kipimo:

2 mg/mL

Dawa fomu:

Solution for infusion

Tungo:

Active: Cetuximab 2 mg/mL   Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection

Vitengo katika mfuko:

Vial, glass, Type I clear with teflon coated bromobutyl stopper and aluminium seal, 50 mL

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Imclone LLC

Bidhaa muhtasari:

Package - Contents - Shelf Life: Vial, glass, Type I clear with teflon coated bromobutyl stopper and aluminium seal - 50 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Idhini ya tarehe:

2006-01-10

Taarifa za kipeperushi

ERBITUX
®
1
ERBITUX
®
_cetuximab (rmc) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ERBITUX.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of treating you with ERBITUX
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, TALK TO
YOUR DOCTOR, NURSE OR THE HOSPITAL
PHARMACIST.
KEEP THIS LEAFLET WHILE YOU ARE
BEING TREATED WITH ERBITUX.
You may need to read it again.
WHAT ERBITUX IS
USED FOR
ERBITUX is used to treat certain
cancers that have a protein on their
cell surface called epidermal growth
factor receptor (EGFR). When a
growth factor called EGF attaches to
EGFR it turns on signals within the
cell causing it to grow and divide to
form more cells. In many human
tumours, there is an over-activation
of these receptors, which leads to
increased uncontrolled growth of
cancer cells and development into a
tumour.
_HOW ERBITUX WORKS _
The active substance in ERBITUX is
cetuximab. It belongs to a group of
medicines called monoclonal
antibodies. Monoclonal antibodies
are proteins that specifically
recognise and attach to other unique
proteins. ERBITUX attaches to the
EGFR more tightly than EGF and
thereby interferes with the growth of
cancer cells.
_WHAT ERBITUX DOES _
ERBITUX is used to treat metastatic
colorectal cancer (cancer of the colon
or large intestine and rectum that has
spread to other parts of the body). It
may be used alone or in combination
with certain types of medicines
called chemotherapy to treat
metastatic colorectal cancer.
Before you are prescribed
ERBITUX, your doctor will test your
cancer cells to see if they contain
either the normal (wild-type) or
mutant forms of genes called RAS.
ERBITUX is used to treat patients
who express normal RAS genes.
ERBITUX is used to treat locally
advanced head and neck cancer, in
combination with radiation therapy.
It is

Tabia za bidhaa

ERBITUX Data Sheet
Version: A016-0918
Page 1 of 21
Supersedes: A015-0415
NEW ZEALAND DATA SHEET
1.
ERBITUX
®
Erbitux 100 mg/20 mL solution for infusion
Erbitux 500 mg/100 mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial contains 100 mg cetuximab.
Each 100 mL vial contains 500 mg cetuximab.
Each mL solution contains 5 mg cetuximab.
Cetuximab is a chimaeric monoclonal antibody of the immunoglobulin G
1
(IgG
1
) subclass,
produced in mammalian cell culture by mouse myeloma cells (Sp2/0). It
is obtained by
attaching the variable regions of the murine monoclonal antibody M225
against epidermal
growth factor receptor (EGFR) to constant regions of the human IgG
1
.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Erbitux is a sterile, preservative-free, colourless solution that is
intended for intravenous
infusion.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Erbitux is indicated for the treatment of patients with epidermal
growth factor receptor
(EGFR)-expressing, _RAS_ wild-type metastatic colorectal cancer
•
in combination with infusional 5-fluorouracil/folinic acid plus
irinotecan
•
in combination with irinotecan in patients who are refractory to
first-line chemotherapy
•
in first-line in combination with FOLFOX
•
as a single agent in patients who have failed or are intolerant to
oxaliplatin-based
therapy and irinotecan-based therapy.
(See Clinical trials)
Erbitux is indicated for the treatment of patients with squamous cell
cancer of the head and
neck
•
in combination with radiation therapy for locally advanced disease
•
in combination with platinum-based chemotherapy for recurrent and/or
metastatic
disease.
ERBITUX Data Sheet
Version: A016-0918
Page 2 of 21
Supersedes: A015-0415
4.2. DOSE AND METHOD OF ADMINISTRATION
Erbitux must be administered under the supervision of a physician
experienced in the use of
antineoplastic agents. Close monitoring is required during the
infusion and for at least 1 hour
after the end of the infusion. Av