Removab
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
12-07-2017
Fachinformation
(SPC)
12-07-2017
Öffentlichen Beurteilungsberichts
(PAR)
12-07-2017
Wirkstoff:
Catumaxomab
Verfügbar ab:
Neovii Biotech GmbH
ATC-Code:
L01XC09
INN (Internationale Bezeichnung):
catumaxomab
Therapiegruppe:
Other antineoplastic agents
Therapiebereich:
Ascites; Cancer
Anwendungsgebiete:
Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.,
Produktbesonderheiten:
Revision: 5
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2009-04-20
Gebrauchsinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Removab 10 micrograms concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1
ml solution, corresponding to
0.1 mg/ml.
*rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse
hybrid-hybridoma cell line
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Removab is indicated for the intraperitoneal treatment of malignant
ascites in adults with
EpCAM-positive carcinomas where standard therapy is not available or
no longer feasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Removab must be administered under the supervision of a physician
experienced in the use of
anti-neoplastic medicinal products.
Posology
Prior to the intraperitoneal infusion, pre-medication with analgesic /
antipyretic / non-steroidal
antiphlogistic medicinal products is recommended (see section 4.4).
Removab dosing schedule comprises the following four intraperitoneal
infusions:
1
st
dose
10 micrograms on day 0
2
nd
dose
20 micrograms on day 3
3
rd
dose
50 micrograms on day 7
4
th
dose
150 micrograms on day 10
Removab has to be administered as constant rate intraperitoneal
infusion with an infusion time of at
least 3 hours. In clinical studies infusion times of 3 hours and 6
hours were investigated. For the first
of the four doses an infusion time of 6 hours may be considered
depending on the patient’s health
condition.
An interval of at least two infusion free calendar days must elapse
between infusion days. The interval
between the infusion days can be prolonged in case of relevant adverse
reactions. The overall
treatment period should not exceed 20 days.
_ _
_Monitoring _
Adequate monitoring of the patient after end of Removab infusion is
recommended. In the pivotal
study patien
Lesen Sie das vollständige Dokument
Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Removab 10 micrograms concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1
ml solution, corresponding to
0.1 mg/ml.
*rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse
hybrid-hybridoma cell line
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Removab is indicated for the intraperitoneal treatment of malignant
ascites in adults with
EpCAM-positive carcinomas where standard therapy is not available or
no longer feasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Removab must be administered under the supervision of a physician
experienced in the use of
anti-neoplastic medicinal products.
Posology
Prior to the intraperitoneal infusion, pre-medication with analgesic /
antipyretic / non-steroidal
antiphlogistic medicinal products is recommended (see section 4.4).
Removab dosing schedule comprises the following four intraperitoneal
infusions:
1
st
dose
10 micrograms on day 0
2
nd
dose
20 micrograms on day 3
3
rd
dose
50 micrograms on day 7
4
th
dose
150 micrograms on day 10
Removab has to be administered as constant rate intraperitoneal
infusion with an infusion time of at
least 3 hours. In clinical studies infusion times of 3 hours and 6
hours were investigated. For the first
of the four doses an infusion time of 6 hours may be considered
depending on the patient’s health
condition.
An interval of at least two infusion free calendar days must elapse
between infusion days. The interval
between the infusion days can be prolonged in case of relevant adverse
reactions. The overall
treatment period should not exceed 20 days.
_ _
_Monitoring _
Adequate monitoring of the patient after end of Removab infusion is
recommended. In the pivotal
study patien
Lesen Sie das vollständige Dokument
