CAMPTO

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

IRINOTECAN HYDROCHLORIDE

Dostępny od:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Kod ATC:

L01XX19

Forma farmaceutyczna:

SOLUTION FOR INFUSION

Skład:

IRINOTECAN HYDROCHLORIDE 20 MG/ML

Droga podania:

I.V

Typ recepty:

Required

Wyprodukowano przez:

PFIZER INC, USA

Grupa terapeutyczna:

IRINOTECAN

Dziedzina terapeutyczna:

IRINOTECAN

Wskazania:

Campto 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.

Data autoryzacji:

2021-12-31

Ulotka dla pacjenta

1
רזייפ
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
רקנש 'חר
9
.ד.ת ,
12133
לארשי ,חותיפ הילצרה
46725
:לט
972-9-9700500
:סקפ
972-9-9700501
ינוי
2018
,ה/דבכנ ת/חקור ,ה/אפור
ולעב ןוכדע לע ךעידוהל וננוצרב
ן
אפורל
לש
רישכתה
CAMPTO
:ליעפה ביכרמה
IRINOTECAN HYDROCHLORIDE 20MG/ML
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..
:אפורל ןולעב םיירקיעה םינוכדעה ןלהל
4.8.
UNDESIRABLE EFFECTS
....
POST-MARKETING SURVEILLANCE
MEDDRA SYSTEM ORGAN
CLASS
PREFERRED TERM
Infections and infestations

Pseudomembranous colitis one of which has been
documented bacteriologically (_Clostridium _
_difficile_)

Sepsis

Fungal infections
*

Viral infections
†
....
....
e.g. Pneumocystis jirovecii pneumonia, bronchopulmonary aspergillosis,
systemic candida.
*
enza, hepatitis B reactivation, cytomegalovirus colitis.
e.g. Herpes zoster, influ
†
....
.הרמחה םיווהמ בוהצ עקרב םישגדומה
םייונישה
ינוכדעו עדימ תטמשה ,עדימ תפסות םיללוכה
םיפסונ םייוניש ועצוב ,ןכ ומכ
.הרמחה םיווהמ םניאש חסונ
ולעה
םינ
כדועמה
םי
חלשנ
ו
ךרוצל תואירבה דרשמל
מוסרפ
ם
:תואירבה דרשמ רתאבש תופורתה רגאמב
https://www.old.health.gov.il/units/pharmacy/trufot/index.asp?safa=h
ולע תלבקל ,ןיפוליחל
םינ
אלמ
םי
ספדומ
ם

Charakterystyka produktu

Campto LPD CC 060522
2021-0069540, 2021-0074031 Page 1 of 20
CAMPTO
®
1.
NAME OF THE MEDICINAL PRODUCT
CAMPTO
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrate contains 20 mg/mL irinotecan hydrochloride, trihydrate
(equivalent to 17.33 mg/ml
irinotecan).
One vial of 2 mL contains 34.66 mg of irinotecan as 40 mg of
irinotecan hydrochloride, trihydrate (40
mg/2 mL).
One vial of 5 mL contains 86.65 mg of irinotecan as 100 mg of
irinotecan hydrochloride, trihydrate
(100 mg/5 mL).
One vial of 15 mL contains 259.95 mg of irinotecan as 300 mg of
irinotecan hydrochloride, trihydrate
(300 mg/15 mL).
For the full list of excipients, see section 6.1.
Excipient(s) with known effect
Sorbitol
CAMPTO 20 mg/mL concentrate for solution for infusion contains 90 mg
of sorbitol in each 2 mL of
solution, which is equivalent to 90 mg/2 mL.
CAMPTO 20 mg/mL concentrate for solution for infusion contains 225 mg
of sorbitol in each 5 mL of
solution, which is equivalent to 225 mg/5 mL.
CAMPTO 20 mg/mL concentrate for solution for infusion contains 675 mg
of sorbitol in each 15 mL
of solution, which is equivalent to 675 mg/15 mL.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATION
CAMPTO
®
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).
Campto LPD CC 060522
2021-0069540, 2021-0074031 Page 2 of 20
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For adults only. CAMPTO
®
solution for infusion should