Erbitux 5mgml

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Cetuximab, chimeric antibody

Fáanlegur frá:

MERCK PTE. LTD.

ATC númer:

L01FE01

Skammtar:

5mg/ml

Lyfjaform:

INFUSION, SOLUTION

Samsetning:

Cetuximab, chimeric antibody 5mg/ml

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

Merck Healthcare KGaA

Leyfisstaða:

ACTIVE

Leyfisdagur:

2009-04-14

Upplýsingar fylgiseðill

ERBITUX
®
5 MG/ML
Active ingredient: Cetuximab
1. NAME OF THE MEDICINAL PRODUCT
Erbitux 5 mg/ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg cetuximab. Each vial
contains 20 ml or 100 ml.
Cetuximab is a chimeric monoclonal IgG
1
antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA
technology.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
Erbitux 5 mg/ml is a colourless solution.
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 irinotecan-based
_ _
chemotherapy or continuous infusional 5-fluorouracil/folinic acid plus
oxaliplatin (for details,
see section Properties)
• as a single agent in patients who have failed oxaliplatin- and
irinotecan-based therapy and who are intolerant to irinotecan.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Erbitux must be administered under the supervision of a physician
experienced in the use of antineoplastic medicinal products. Close
monitoring is required during the infusion and for at least 1 hour
after the end of the infusion. Resuscitation equipment must be
available.
Posology
Prior to the first infusion, patients must receive premedication with
an antihistamine and a corticosteroid at least 1 hour prior to
administration of cetuximab. This premedication is recommended prior
to all subsequent infusions.
In all indications, Erbitux is administered once a week. The initial
dose is 400 mg cetuximab per m
2
body surface area. All subsequent
weekly doses are 250 mg/m
2
each.
_Colorectal cancer _
In patients with metasta

Vara einkenni

ERBITUX
®
5 MG/ML
Active ingredient: Cetuximab
1. NAME OF THE MEDICINAL PRODUCT
Erbitux 5 mg/ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg cetuximab. Each vial
contains 20 ml or 100 ml.
Cetuximab is a chimeric monoclonal IgG1 antibody produced in a
mammalian cell line (Sp2/0) by
recombinant DNA technology. For a full list of excipients, see section
6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
Erbitux 5 mg/ml is a colourless solution.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Erbitux is indicated for the treatment of patients with RAS wild-type
metastatic colorectal cancer
•
in combination with irinotecan-based chemotherapy or continuous
infusional 5-fluorouracil/folinic
acid plus oxaliplatin (for details, see section Properties)
•
as a single agent in patients who have failed oxaliplatin- and
irinotecan-based therapy and who are
intolerant to irinotecan.
Erbitux is indicated in combination with encorafenib, for the
treatment of adult patients with metastatic
colorectal cancer (CRC) with a BRAF V600E mutation, who have received
prior systemic therapy.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Erbitux must be administered under the supervision of a physician
experienced in the use of antineoplastic
medicinal products. Close monitoring is required during the infusion
and for at least 1 hour after the end of
the infusion. Resuscitation equipment must be available.
Posology
Prior to the first infusion, patients must receive premedication with
an antihistamine and a corticosteroid at
least 1 hour prior to administration of cetuximab. This premedication
is recommended prior to all
subsequent infusions.
_Colorectal cancer _
As a single-agent or in combination with chemothera