Zaltrap 25mgml Concentrate for Solution for Infusion

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

AFLIBERCEPT

제공처:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (국제 이름):

AFLIBERCEPT

패키지 단위:

4ml mL; 8ml mL

Manufactured by:

Sanofi-Aventis Deutschland GmbH

환자 정보 전단

Not Applicable

제품 특성 요약

1
NAME OF THE MEDICINAL PRODUCT
ZALTRAP 25 mg/ml Concentrate for Solution for Infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate for solution for infusion contains 25 mg aflibercept*
One vial of 4 ml of concentrate contains 100 mg of aflibercept
One vial of 8 ml of concentrate contains 200 mg of aflibercept
* Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system
by recombinant DNA technology.
For the full list of excipients, see section List of Excipients.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
The concentrate is a clear colourless to pale yellow solution
CLINICAL PARTICULARS
Therapeutic Indications
ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy
is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has
progressed after an oxaliplatin-containing regimen.
Posology and Method of Administration
ZALTRAP should be administered under the supervision of a physician experienced in the use of
antineoplastic medicinal products.
Posology
The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4
mg/kg of body weight, followed by the FOLFIRI regimen. This is considered as one treatment
cycle.
The FOLFIRI regimen to be used is irinotecan 180 mg/m
2 intravenous infusion over 90 minutes
and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on
day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg/m² intravenous bolus, followed
by 5-FU 2400 mg/m² continuous intravenous infusion over 46 hours.
The treatment cycle is repeated every 2 weeks.
ZALTRAP treatment should be continued until disease progression or unacceptable toxicity
occurs.
Dose Modification
ZALTRAP should be discontinued for (see section Special Warnings and Precautions for Use):
 Severe haemorrhage