Doxorubicin 2 mg/ml solution for injection

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

DOXORUBICIN HYDROCHLORIDE

Доступна з:

Cell Pharm GmbH

Код атс:

L01DB; L01DB01

ІПН (Міжнародна Ім'я):

DOXORUBICIN HYDROCHLORIDE

Дозування:

2 milligram(s)/millilitre

Фармацевтична форма:

Solution for injection

Тип рецепту:

Product subject to prescription which may not be renewed (A)

Терапевтична области:

Anthracyclines and related substances; doxorubicin

Статус Авторизація:

Not marketed

Дата Авторизація:

2004-03-19

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION
Doxorubicin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Doxorubicin 2 mg/ml Solution for Injection is and what it is
used for
2. What you need to know before you use Doxorubicin 2 mg/ml Solution
for Injection
3. How to use Doxorubicin 2 mg/ml Solution for Injection
4. Possible side effects
5. How to store Doxorubicin 2 mg/ml Solution for Injection
6. Contents of the pack and other information
1.
WHAT DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION
IS AND WHAT IT IS USED FOR
Doxorubicin 2 mg/ml Solution for Injection
is an anti-cancer medicine. Often, Doxorubicin 2
mg/ml Solution for Injection
is used in combination with other anti-cancer medicines.
Doxorubicin 2 mg/ml Solution for Injection
is used to treat the following forms of cancer:
-
breast cancer
-
cancer of the connective tissue, ligaments, bone, muscle (sarcoma )
-
lung cancer
-
cancer of the lymphnodes (Hodgkin’s disease or non-Hodgkin’s
lymphoma )
-
blood cancer (acute leukaemia)
-
cancer of the thyroid gland
-
cancer of the ovaries
-
bladder cancer
-
tumours in children such as neuroblastoma
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOXORUBICIN 2 MG/ML SOLUTION
FOR INJECTION
DO NOT USE DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION
-
if you are allergic to doxorubicin, other medicines of the
anthracycline or anthracenedione
groups (e. g. daunorubicin, mitoxantrone and epirubicin) or any of the
other ingredients of
this medicine (list

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin 2 mg/ml solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg doxorubicin hydrochloride.
Excipient with know effect:
9 mg/ml sodium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear red solution for injection. pH = 2.5 – 3.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast cancer, sarcoma, small-cell carcinoma of the lung, Hodgkin
disease or non-Hodgkin lymphoma, acute
leukaemia, cancer of the thyroid, bladder, ovaries, Paediatric
tumours, such as neuroblastom.
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytotoxic drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Doxorubicin 2 mg/ml solution for injection should be
started by or after consultation with a doctor with
extensive experience from cytostatic treatment.
The solution is injected via the tubing of a freely-running
intravenous infusion over 2-15 minutes. This technique
minimizes the risk of thrombophlebitis or perivenous extravasation
which can lead to severe cellulitis and vesication.
Intravenous administration:
The dosage of doxorubicin depends on dosage regimen, general status
and previous treatment of the patient.
Several dosage regimens exist:
The recommended dose is 60-75 mg/m² body surface i.v. as a single
dose or in divided doses on 2-3 consecutive days
administered with 21 day’s intervals. The lower dose should be given
to patients with bone marrow depression.
When Doxorubicin 2 mg/ml solution for injection is administered in
combination with other cytostatics, the dosage
should be reduced to 30-60 mg/m².
In patients, who cannot receive the full dose (eg. in case of
immunosuppression, old age), an alternative dosage is 15-
20 mg/m² body surface per week_._
In order to avoid cardiomyopathy, it is recommended that the
cumulative total lifetime dose of doxorubicin (including
related drugs such as daunorubicin) should