Oxaliplatin Ebewe concentrate for solution for infusion 5mg/ml concentrate for solution for infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

oxaliplatin

Доступна с:

EBEWE Pharma Ges. m.b.H. Nfg. KG

код АТС:

L01XA03

ИНН (Международная Имя):

oxaliplatin

дозировка:

5mg/ml

Фармацевтическая форма:

concentrate for solution for infusion

Штук в упаковке:

20ml glass vial

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2019-12-26

Характеристики продукта

1
m12 - en-spc-w - 859
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Oxaliplatin Ebewe® concentrate for solution for infusion (5 mg/ml)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance: _oxaliplatin.
1 ml contains 5 mg oxaliplatin.
10 ml vial contains 50 mg of oxaliplatin
20 ml vial contains 100 mg of oxaliplatin
40 ml vial contains 200 mg of oxaliplatin
For the list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colorless to light yellow solution
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Oxaliplatin in combination with 5-fluorouracil (5 FU) and folinic acid
(FA) is indicated for:
- adjuvant treatment of stage III (Dukes C) colon cancer after
complete resection of primary
tumour,
- treatment of metastatic colorectal cancer
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The preparation of injectable solutions of cytotoxic agents must be
carried out by trained
specialist personnel with knowledge of the medicinal products used,
under conditions that
guarantee integrity of the medicinal product, protection of the
environment and in particular
protection of the personnel handling the medicinal products, according
to hospital policy. It
requires a preparation area reserved for this purpose. It is forbidden
to smoke, eat or drink in
this area (see section 6.5 for detailed information).
Posology
FOR ADULTS ONLY
The recommended dose of oxaliplatin used in adjuvant treatment is
85mg/m
2
body surface
area, administered intravenously every 2 weeks for 12 cycles (6
months).
The recommended dose of oxaliplatin for the treatment of metastatic
colorectal cancer is
en-spc-w
Pg. 1
2
m12 - en-spc-w - 859
85mg/m
2
body surface area, administered intravenously every 2 weeks until
disease
progression or unacceptable toxicity.
Dosage given should be adjusted according to tolerability (see section
4.4).
THE ADMINISTRATION OF OXALIPLATIN SHOULD ALWAYS PRECEDE THAT OF
FLUOROPYRIMIDINES, I.E.
5-FLUOROURACIL (5-FU).
Oxaliplatin is administered as