Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Irinotecan Hydrochloride Trihydrate
FRESENIUS KABI (SINGAPORE) PTE LTD
L01XX19
INJECTION, SOLUTION
Irinotecan Hydrochloride Trihydrate 20.0 mg/ml
INTRAVENOUS
Prescription Only
Fresenius Kabi Oncology Limited
ACTIVE
2021-07-07
- 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 Soma hati kamili