CAMPTO 40 mg/2ml Concentrate for Soln for Inf
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
27-04-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
थमां उपलब्ध:
Pfizer Limited
INN (इंटरनेशनल नाम):
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
डोज़:
40 mg/2ml
फार्मास्यूटिकल फॉर्म:
Concentrate for Soln for Inf
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may not be renewed (A)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
0000-00-00
उत्पाद विशेषताएं
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CAMPTO 40 mg/2 ml, concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrate contains 20 mg/ml irinotecan hydrochloride, trihydrate (equivalent to 17.33 mg/ml irinotecan). Vials
of CAMPTO contain 40 mg or 100 mg of irinotecan hydrochloride, trihydrate.
_For excipients, see “6.1 List of excipients”._
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CAMPTO is indicated for the treatment of patients with advanced colorectal cancer:
○
in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease,
○
as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
CAMPTO in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor
receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy.
CAMPTO in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of
patients with metastatic carcinoma of the colon or rectum.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults only. CAMPTO solution for infusion should be infused into a peripheral or central vein.
RECOMMENDED DOSAGE:
In monotherapy (for previously treated patient):
The recommended dosage of CAMPTO is 350 mg/m² administered as an intravenous infusion over a 30- to 90- minute
period every three weeks _(see « Instructions for Use/Handling » and « Special Warnings and Special Precautions for_
_Use » sections )._
In combination therapy (for previously untreated patient):
Safety and efficacy of CAMPTO in combination with 5-fluorouraci
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