IRINOTEL INJECTION 20 MGML

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Irinotecan Hydrochloride Trihydrate

可用日期:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC代码:

L01XX19

药物剂型:

INJECTION, SOLUTION

组成:

Irinotecan Hydrochloride Trihydrate 20.0 mg/ml

给药途径:

INTRAVENOUS

处方类型:

Prescription Only

厂商:

Fresenius Kabi Oncology Limited

授权状态:

ACTIVE

授权日期:

2021-07-07

产品特点

-
1 -
_ _
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
_ _
IRINOTECAN HYDROCHLORIDE INJECTION USP
IRINOTEL
DESCRIPTION
Irinotecan is a semisynthetic derivative of the plant alkaloid
camptothecin extracted from the
Chinese tree
_Camptotheca accuminata_
. It inhibits topoisomerase I function by binding to the
topoisomerase I / DNA-cleavable complex.
COMPOSITION
Each mL contains:
Irinotecan Hydrochloride Trihydrate
20.0 mg
Sorbitol USNF
45.0 mg
Lactic Acid USP
0.9 mg
Water for injection USP
q.s.
CHEMICAL STRUCTURE
Irinotecan hydrochloride is a pale yellow-to-yellow crystalline
powder. Chemically it is (
_(S)_
-4,11-
diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1
H
pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-
9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride,
trihydrate. It is slightly soluble in water
and organic solvents. It has an empirical formula of C
33
H
38
N
4
O
6
.HCl.3H
2
O and a molecular weight
of 677.19.
SAFETY WARNINGS
Irinotecan Injection should be administered only under the supervision
of a physician who is experienced
in the use of cancer chemotherapeutic agents. Appropriate management
of complications is possible only
when adequate diagnostic and treatment facilities are readily
available. Irinotecan Injection can induce
both early and late forms o
f diarrhea that appear to be mediated by different mechanisms. Both
forms of
diarrhea may be severe. Early diarrhea (occurring during or shortly
after infusion of Irinotecan may be
accompanied by cholinergic symptoms of rhinitis, increased salivation,
miosis, lacrimation, diaphoresis,
flushing, and intestinal hyper peristalsis that can cause abdominal
cramping. Early diarrhea and other
cholinergic symptoms may be prevented or ameliorated by atropine. Late
diarrhea (generally occurring
more than 24 hours after administration of Irinotecan can be life
threatening since it may be prolonged and
may lead to dehydration, electrolyte imbalance, or sepsis. Late
diarrhea should be treated promptly with
lo