IRINOTECAN TEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L01XX19

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ACTAVIS GROUP PTC EHF, ICELAND

Therapeutic area:

IRINOTECAN

Therapeutic indications:

* 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.

Authorization date:

2020-10-31

Summary of Product characteristics

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