ERBITUX 5 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CETUXIMAB

Available from:

MERCK SERONO LTD

ATC code:

L01XC06

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

CETUXIMAB 5 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

MERCK HEALTHCARE KGAA, GERMANY

Therapeutic group:

CETUXIMAB

Therapeutic area:

CETUXIMAB

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• In first-line in combination with FOLFOX• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecanErbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck (SCCHN)• in combination with radiation therapy for locally advanced disease• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease• as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease

Authorization date:

2014-07-31

Patient Information leaflet

1 of 2
Merck Serono Ltd.
www.merckserono.co.il
18 Kishon St.
Yavne, Israel 81220
Tel: [phone]
Fax: [phone]
[e-mail]
רבמצד
2018
ERBITUX 5MG/ML, SOLUTION FOR INFUSION סקוטיברא
5
ג"מ
/
הסימת ,ל"מ
ל
יוריע
CETUXIMAB 5 MG/ML
ת/חקור ,ה/אפור
,םידבכנ יאופר תווצו
רישכתה לש אפורל ןולעה יכ םכעידוהל
םישקבמ ונא
ERBITUX 5MG/ML
ןכדוע
.
:תורשואמה תויוותהה
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
•
In first-line in combination with FOLFOX
•
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 (SCCHN)
•
in combination with radiation therapy for locally advanced disease
•
in combination with platinum-based chemotherapy for recurrent and/or
metastatic disease
•
as a single agent after failure of platinum-based chemotherapy for
recurrent
and/or metastatic disease
ל ןולעב םייונישה אפור
םניה
ףיעסב
4.4
Special warnings and precautions for use –
Respiratory disorders
Cases of interstitial lung disease (ILD), including fatal cases, have
been reported, with
the majority of patients from the Japanese population.
Confounding or contributing factors, such as concomitant chemotherapy
known to be
associated with ILD, and pre-existing pulmonary diseases were frequent
in fatal cases.
Such patients should be closely monitored. In the event of symptoms
(such as
dyspnoea, cough, fever) or radiographic findings suggestive of ILD,
prompt diagnostic
investigation should occur.
If interstitial lung disease is diagnosed, cetuximab must be
discontinued and the
patient be treated appropriately.
ףיעס
4.8
–
Undesirable effects
Respiratory,

Summary of Product characteristics

1
PRESCRIBING INFORMATION
ERBITUX
®
5 MG/ML
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 of 20 mL contains 100 mg cetuximab.
Each vial of 100 mL contains 500 mg cetuximab.
Cetuximab is a chimeric monoclonal IgG
1
antibody produced in a mammalian cell line (Sp2/0) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
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,
•
in first-line in combination with FOLFOX,
•
as a single agent in patients who have failed oxaliplatin- and
irinotecan-based therapy and
who are intolerant to irinotecan.
_For details, see section 5.1._
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
,
•
as a single agent after failure of 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. Availability of
resuscitation equipment must be
ensured.
2
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 c