IRINOTECAN TEVA

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

可用日期:

ABIC MARKETING LTD, ISRAEL

ATC代码:

L01XX19

药物剂型:

CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 MG/ML

给药途径:

I.V

处方类型:

Required

厂商:

ACTAVIS GROUP PTC EHF, ICELAND

治疗领域:

IRINOTECAN

疗效迹象:

* For the treatment of patients with metastatic colorectal cancer: - In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. - As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. * For the treatment of patients with small cell lung cancer.* For the treatment of patients with gastric cancer.* Irinotecan in combination with leucovorin, Oxaliplatin and 5-fluorouracil, for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.

授权日期:

2020-10-31

产品特点

Irinotecan Teva 20 mg/ml, N.A 07/2022 Notification
IRINOTECAN TEVA
1.
NAME OF THE MEDICINAL PRODUCT
Irinotecan Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrate contains 20 mg/ml irinotecan hydrochloride trihydrate
(equivalent to 17.33 mg/ml irinotecan).
One vial of 5 ml contains 100 mg of irinotecan hydrochloride
trihydrate (100 mg/5 ml).
One vial of 15 ml contains 300 mg of irinotecan hydrochloride
trihydrate (300 mg/15 ml).
One vial of 25 ml contains 500 mg of irinotecan hydrochloride
trihydrate (500 mg/25 ml).
For the full list of excipients, see section 6.1.
Excipients with known effect:
Sorbitol
Sodium
Irinotecan Teva 20 mg/ml concentrate for solution contains 225 mg of
sorbitol in each 5 ml of solution, which is
equivalent to 225mg/5ml.
Irinotecan Teva 20 mg/ml concentrate for solution contains 675 mg of
sorbitol in each 15 ml of solution, which is
equivalent to 675mg/15ml.
Irinotecan Teva 20 mg/ml concentrate for solution contains 1125 mg of
sorbitol in each 25 ml of solution, which is
equivalent to 1125mg/25ml.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion:
A clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Irinotecan Teva is indicated for the treatment of patients with
metastatic colorectal cancer:

In combination with 5-fluorouracil and folinic acid in patients
without prior chemotherapy for metastatic
disease.

As a single agent in patients who have failed an established
5-fluorouracil containing treatment regimen.

For the treatment of patients with small cell lung cancer.

For the treatment of patients with gastric cancer.

Irinotecan in combination with leucovorin, Oxaliplatin and
5-fluorouracil for the first-line treatment of patients
with metastatic pancreatic adenocarcinoma (based on NCCN guidelines,
version 2.2015).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults only. Irinotecan Teva solution for infusion should be
infused into a peripheral or central vein.
Irinotecan Teva 20 mg/ml, N.A 07/2022 N