Abevmy

Country: ইউরোপীয় ইউনিয়ন

ভাষা: বুলগেরিয়

সূত্র: EMA (European Medicines Agency)

এখন এটা কিনুন

সক্রিয় উপাদান:

бевацизумаб

থেকে পাওয়া:

Biosimilar Collaborations Ireland Limited

এটিসি কোড:

L01XC07

INN (International Name):

bevacizumab

Therapeutic group:

Антинеопластични средства

Therapeutic area:

Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms

থেরাপিউটিক ইঙ্গিত:

Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Abevmy in combination with capecitabine. За допълнителна информация относно статуса на HER2, моля, вижте раздел 5. Abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5. Abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. Abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5. Abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

পণ্য সারাংশ:

Revision: 7

অনুমোদন অবস্থা:

упълномощен

অনুমোদন তারিখ:

2021-04-21

তথ্য লিফলেট

                                71
Б. ЛИСТОВКА
72
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
ABEVMY 25 MG/ML КОНЦЕНТРАТ ЗА ИНФУЗИОНЕН
РАЗТВОР
бевацизумаб (bevacizumab)
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. Можете да
дадете своя принос като
съобщите всяка нежелана реакция,
която сте получили. За начина на
съобщаване на нежелани
реакции вижте края на точка 4.
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ИЗПОЛЗВАТЕ ТОВА
ЛЕКАРСТВО, ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА
ЗА ВАС ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар,
фармацевт или
медицинска сестра.
-
Ако получите някакви нежелани
лекарствени реакции, уведомете Вашия
лекар,
фармацевт или медицинска сестра. Това
включва всички възможни неописани в
тази
листовка нежелани реакции. Вижте
точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Abevmy и за какво се
използва
2.
Какво трябва да знаете, преди да Ви
бъде приложен Abevmy
3.
Как се прилага Abevmy
4.
Възможни нежелани реакции
5.
Как да съхранявате Abevmy
6.
Съдържание на
                                
                                সম্পূর্ণ নথি পড়ুন
                                
                            

পণ্য বৈশিষ্ট্য

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. От
медицинските специалисти се
изисква да съобщават всяка подозирана
нежелана реакция. За начина на
съобщаване на
нежелани реакции вижте точка 4.8.
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Abevmy 25 mg/ml концентрат за инфузионен
разтвор.
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки ml от концентрата съдържа 25 mg
бевацизумаб (bevacizumab)*.
Всеки флакон от 4 ml съдържа 100 mg
бевацизумаб.
Всеки флакон от 16 ml съдържа 400 mg
бевацизумаб.
За разреждане и други препоръки за
работа вижте точка 6.6.
*Бевацизумаб е рекомбинантно
хуманизирано моноклонално антитяло,
получено чрез ДНК
технология в клетъчни линии от яйчник
на китайски хамстер.
Помощно(и) вещество(а) с известно
действие
Всеки флакон от 4 ml съдържа 4,196 mg
натрий.
Всеки флакон от 16 ml съдържа 16,784 mg
натрий.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Концентрат за инфузионен разтвор
(стерилен концентрат).
Бистра до леко опалесцентна,
безцветна до светлокафява течност с pH
от 5,70 до 6,4
                                
                                সম্পূর্ণ নথি পড়ুন
                                
                            

অন্যান্য ভাষায় নথি

তথ্য লিফলেট তথ্য লিফলেট স্পেনীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য স্পেনীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট চেক 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ডেনিশ 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য ডেনিশ 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট জার্মান 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য জার্মান 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট এস্তোনীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য এস্তোনীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট গ্রিক 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য গ্রিক 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ইংরেজি 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য ইংরেজি 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ফরাসি 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য ফরাসি 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ইতালীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য ইতালীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট লাত্‌ভীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য লাত্‌ভীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট লিথুয়েনীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য লিথুয়েনীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট হাঙ্গেরীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য হাঙ্গেরীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট মল্টিয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য মল্টিয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ডাচ 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট পোলিশ 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য পোলিশ 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট পর্তুগীজ 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য পর্তুগীজ 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট রোমানীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য রোমানীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট স্লোভাক 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য স্লোভাক 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট স্লোভেনীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য স্লোভেনীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ফিনিশ 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য ফিনিশ 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট সুইডিশ 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য সুইডিশ 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট নরওয়েজীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য নরওয়েজীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট আইসল্যান্ডীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য আইসল্যান্ডীয় 01-02-2024
তথ্য লিফলেট তথ্য লিফলেট ক্রোয়েশীয় 01-02-2024
পণ্য বৈশিষ্ট্য পণ্য বৈশিষ্ট্য ক্রোয়েশীয় 01-02-2024

এই পণ্য সম্পর্কিত সতর্কতা অনুসন্ধান করুন

দস্তাবেজ ইতিহাস দেখুন