Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
trastuzumab
F. Hoffmann-La Roche Ltd.
L01XC03
trastuzumab
440mg
powder for concentrate for solution for infusion
glass vial and solvent in vial 20ml
Prescription
Registered
2021-07-29
10238528_NP9357.indd 1 3/18/21 1:35 PM Artwork Creator Date Version Signature Proofreader Date Signature Perigord / MAH 18 Mar 2021 1 Genisys-No. 10238528 make-up code: FE Type size: 8 pt Printing colour: Pantone Black Format: 450x500 mm folded: 47x60 mm Drawing Norm: NP9357 17.08.10 10.114 - 3 HERCEPTIN ® Trastuzumab These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine. Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists and corticosteroids. In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome. The majority of the LVEF decreases noted in BO18255 study were asymptomatic, with the exception of one patient in the Herceptin- containing arm whose LVEF decrease coincided with cardiac failure. TABLE 2 SUMMARY OF LVEF CHANGE FROM BASELINE (BO18255 STUDY) Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy or co-morbidities may be at increased risk of a fatal infusion reaction. Therefore, these patients should not be treated with Herceptin. ANTINEOPLASTIC AGENT 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Antineoplastic agent. ATC code: L01 XC03. 1.2 TYPE OF DOSAGE FORM Powder for concentrate for solution for infusion. Herceptin is a white to pale yellow lyophilized powder. 1.3 ROUTE OF ADMINISTRATION Intravenous infusion. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile product. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _ trastuzumab. _Dosage preparations: _ 150 mg single-dose vials, and 440 mg multidose vials containing powder for concentrate for solution for infusion. Reconstituted Herceptin concentrate contains 21 mg/ml of trastuzumab. _Excipients: _ As registered locally. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATIONS BREAST CANCER _Metastatic Breast Cancer (MBC)_ _ _ Herceptin is indicated for the treatment of patients with metastatic breast cancer who have Pročitajte cijeli dokument
December 2020 Ro 45-2317 Summary of Product Characteristics FE/English Herceptin 1 December 2020 Summary of Product Characteristics FE HERCEPTIN ® Trastuzumab ANTINEOPLASTIC AGENT 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Antineoplastic agent. ATC code: L01 XC03. 1.2 TYPE OF DOSAGE FORM Powder for concentrate for solution for infusion. Herceptin is a white to pale yellow lyophilized powder. 1.3 ROUTE OF ADMINISTRATION Intravenous infusion. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile product. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _trastuzumab. _Dosage preparations: _150 mg single-dose vials, and 440 mg multidose vials containing powder for concentrate for solution for infusion. Reconstituted Herceptin concentrate contains 21 mg/ml of trastuzumab. _Excipients: _As registered locally. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATIONS BREAST CANCER _Metastatic Breast Cancer (MBC) _ Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease. b) in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. December 2020 Ro 45-2317 Summary of Product Characteristics FE/English Herceptin 2 December 2020 Summary of Product Characteristics FE c) in combination with an aromatase inhibitor for the treatment of patients with hormone- receptor-positive metastatic breast cancer. _Early Breast Cancer (EBC) _ _ _ Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. i Pročitajte cijeli dokument