EPREX 2000

البلد: أندونيسيا

اللغة: الإندونيسية

المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

العنصر النشط:

EPOETIN ALFA

متاح من:

INTEGRATED HEALTHCARE INDONESIA - Indonesia

INN (الاسم الدولي):

EPOETIN ALFA

جرعة:

2000 IU

الشكل الصيدلاني:

INJEKSI

الوحدات في الحزمة:

DUS, 6 PRE-FILLED SYRINGE @ 0,5 ML

المصنعة من قبل:

CILAG AG SWITZERLAND - Switzerland

تاريخ الترخيص:

2021-11-28

خصائص المنتج

ERBITUX
TM
CETUXIMAB
MERCK
For intravenous use only.
WARNING
INFUSION REACTIONS: Severe infusion reaction occurred with the
administration of ERBITUX in approximately 3% of patients,
rarely with fatal outcome (< in 1000). Approximately 90% of severe
infusion reactions were associated with first infusion of
ERBITUX.
Severe
infusion
reactions are
characteristized
by
rapid
onset
of
airway
obstruction
(bronchspasm,
stridor,hoarseness), urticaria, hypotension and/or cardiac arrest (see
WARNINGS
and ADVERSE REACTIONS). Severe
infusion reactions required immediate interupption of ERBITUX infusion
and permanent discontinuation from further treatment.
(See WARNINGS: INFUSION REACTIONS and DOSAGE AND ADMINISTRATION: DOSE
MODIFICATIONS.)
CARDIOPULMONARY ARREST: Cardipulmonary Arrest and/or sudden death
accured in 2% (4/208) of patients with squamous cell
carcinoma of the head and neck treated with radiation therapy and
ERBITUX as compared to none of 212 patients treated with
radiation therapy alone. Fatal events occurred within 1 to 43 days
after the last ERBITUX treatment. ERBITUX in combination
with radiation therapy should be used with caution in head and neck
cancer patients with known coronary artery disease,
congestive heart failure, and errhytmias. Although the etiology of
these events is unknown, close monitoring of serum
electrocytes, including serum magnesium, potassium, and calcium,
during and after ERBITUX therapy is recommended. (See
WARNINGS: CARDIOPULMARY ARREST, PRECAUTIONS: LABORATORY TEST:
ELECTROLYTE MONITORING, AND ADVERSE
REACTIONS: ELECTROLYTE DEPLETION.)
DESCRIPTION
ERBITUX
®
(Cetuximab) is a recombinant, human/mouse a chimeric monochlonal
antibody that binds specifically to the extracelluler domain of the
human
epidermal growth factor reseptor (EGFR). Cetuximab is composed of the
Fv regions of a murine anti-EGFR antibody with human IgGI heavy and
kappa light
chain constant regions and has an approximate molecular weight of 152
kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.
ER