देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
PANITUMUMAB
AMGEN EUROPE B.V.
L01XC08
CONCENTRATE FOR SOLUTION FOR INFUSION
PANITUMUMAB 20 MG / 1 ML
I.V. INFUSION
Required
AMGEN EUROPE B.V., NETHERLANDS
PANITUMUMAB
In combination with chemotherapy for the treatment of unresectable, advanced or recurrent colorectal cancer (mCRC) with wild-type RAS.Monotherapy for the treatment of patients with metastatic colorectal carcinoma with wild-type RAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
2015-02-28
לירפא 8 201 ML MG/ 20 ) ANITUMUMAB P ( VECTIBIX CONCENTRATE FOR SOLUTION FOR INFUSION ,ה/דבכנ ת/חקור ,ה/דבכנ ה/אפור לע ךעידוהל תשקבמ ,םושירה תלעב ,יו יב הפוריא ן'גמא ולעב םינוכדע אפורל ן רישכתל סקיביטקו . דבלב הרמחה םיווהמה םייונישה םיניוצמ וז העדוהב . :תורשואמה תויוותהה In combination with chemotherapy for the treatment of unresectable, advanced or recurrent colorectal cancer (mCRC) with wild-type RAS. Monotherapy for the treatment of patients with metastatic colorectal carcinoma with wild-type RAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. :אפורל ןולעב תורמחה 4.8 UNDESIRABLE EFFECTS …. Tabulated summary of adverse reactions The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2,224) and spontaneous reporting. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. ADVERSE REACTIONS MEDDRA SYSTEM ORGAN CLASS VERY COMMON (≥ 1/10) COMMON (≥ 1/100 TO < 1/10) UNCOMMON (≥ 1/1,000 TO< 1/100) Infections and infestations Conjunctivitis Paronychia 1 Rash pustular Cellulitis 1 Urinary tract infection Folliculitis Localized infection Eye infection Eyelid infection Blood and lymphatic system disorders Anemia Leukopenia Immune system disorders Hypersensitivity 1 Anaphylactic reaction 2 Metabolism and nutrition disorders Hypokalemia Hypomagnesemia Decreased appetite Hypocalcemia Dehydration Hyperglycemia Hypophosphatemia Psychiatric disorders Insomnia Anxiety ADVERSE REACTIONS MEDDRA SYSTEM ORGAN CLASS VERY COMMON (≥ 1/10) COMMON (≥ 1/100 TO < 1/10) UNCOMMON (≥ 1/1,000 TO< 1/100) Nervous system disorders Headache Dizziness Eye disorders Blepharitis Growth of eyelashes Lacrimation increased Ocular hyperemia Dry eye पूरा दस्तावेज़ पढ़ें
1 _Revised in November 2021 according to MoHs guidelines._ 1. NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg panitumumab. Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL. When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/mL. Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology. Excipient with known effect Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Colorless, pH 5.6 to 6.0 solution that may contain translucent-to-white, visible amorphous, proteinaceous panitumumab particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In combination with chemotherapy for the treatment of unresectable, advanced or recurrent colorectal cancer (mCRC) with wild-type RAS. Monotherapy for the treatment of patients with metastatic colorectal carcinoma with wild-type RAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Evidence of wild-type _RAS_ ( _KRAS_ and _NRAS_ ) status is required before initiating treatment with Vectibix. Mutational status should be determined by an experienced laboratory using validated test methods for detection of _KRAS_ (exons 2, 3, and 4) and _NRAS_ (exons 2, 3, and 4) mutations. Posology The recommended dose of Vectibix is 6 mg/kg of body weight given once every two weeks. Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows: 2 OCCURRENCE OF SKIN SYMPTOM(S): ≥ GRADE 3 1 पूरा दस्तावेज़ पढ़ें