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

Страна: Вірменія

мова: англійська

Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активний інгредієнт:

oxaliplatin

Доступна з:

Accord Healthcare Polska Sp. z o.o.

Код атс:

L01XA03

ІПН (Міжнародна Ім'я):

oxaliplatin

Дозування:

5mg/ml

Фармацевтична форма:

concentrate for solution for infusion

Одиниць в упаковці:

20ml glass vial

Тип рецепту:

Prescription

Статус Авторизація:

Registered

Дата Авторизація:

2021-03-17

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
OXALIPLATIN
Read all of this leaflet carefully before you start using this
medicine

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor , pharmacist or
nurse.

If you get any side effects talk to your doctor ,pharmacist or nurse.
This includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Oxaliplatin Concentrate for solution for infusion is and what
it is used for
2. What you need to know before you use Oxaliplatin Concentrate for
solution for infusion
3. How to use Oxaliplatin Concentrate for solution for infusion
4. Possible side effects
5. How to store Oxaliplatin Concentrate for solution for infusion
6. Contents of the pack and other information
1. WHAT OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION
IS AND WHAT IT IS USED FOR
The name of your medicine is Oxaliplatin 5 mg/ml Concentrate for
Solution for Infusion but in the rest of the leaflet it
will be called ‘Oxaliplatin concentrate for solution for
infusion’.
The active ingredient of Oxaliplatin concentrate for solution for
infusion is oxaliplatin.
Oxaliplatin concentrate for solution for infusion is used to treat
cancer of the large bowel (treatment of stage III colon
cancer after complete resection of primary tumour, metastatic cancer
of colon and rectum). Oxaliplatin concentrate for
solution for infusion is used in combination with other anticancer
medicines called 5 fluorouracil and folinic acid.
Oxaliplatin concentrate for solution for infusion has to be dissolved
and made into a solution before it can be injected into
a vein. Oxaliplatin concentrate for solution for infusion is an
antineoplastic or anticancer drug and contains platinum.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN CONCENTRATE FOR
SOLUTION FOR INFUSION
YOU SHOULD NOT BE GIVEN OXALIPLATIN CONCENTRATE FOR SOLUTION FOR
INFUSION IF:
- You are allergic to oxaliplatin

Характеристики продукта

1/18/2021
Oxaliplatin 5mg/ml concentrate for Solution for Infusion - Summary of
Product Characteristics (SmPC) - print friendly - (emc)
https://www.medicines.org.uk/emc/product/6088/smpc/print
1/16
OXALIPLATIN 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 25-Oct-2019 | Accord
Healthcare Limited
1. NAME OF THE MEDICINAL PRODUCT
Oxaliplatin 5mg/ml concentrate for Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 5 mg Oxaliplatin.
10 ml of concentrate for solution for infusion contains 50 mg of
Oxaliplatin.
20 ml of concentrate for solution for infusion contains 100 mg of
Oxaliplatin.
40 ml of concentrate for solution for infusion contains 200 mg of
Oxaliplatin.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless solution, free from visible particles a pH in the
range of 3.5 and 6.5 and 125 m Osm/Ltr. to 175 m Osm/
Ltr. osmolarity.
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 (Duke's C) colon cancer after
complete resection of primary tumour
• Treatment of metastatic colorectal cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
FOR ADULTS ONLY
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m
2
intravenously repeated every two weeks for 12
cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic
colorectal cancer is 85 mg/m
2
intravenously repeated
every 2 weeks until disease progression or unacceptable toxicity.
Dosage given should be adjusted according to tolerability (see section
4.4).
OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES –
I.E. 5 FLUOROURACIL.
Oxaliplatin concentrate for solution for infusion is administered as a
2 to 6-hour intravenous infusion in 250 to 500 ml of
5% glucose solution to give a concentration bet