IRINOTECAN TEVA

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Boleh didapati daripada:

ABIC MARKETING LTD, ISRAEL

Kod ATC:

L01XX19

Borang farmaseutikal:

CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 MG/ML

Laluan pentadbiran:

I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

ACTAVIS GROUP PTC EHF, ICELAND

Kawasan terapeutik:

IRINOTECAN

Tanda-tanda terapeutik:

* 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.

Tarikh kebenaran:

2020-10-31

Ciri produk

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