Doxorubicin 50mg/25ml solution for injection Cytosafe vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxorubicin hydrochloride

Available from:

Pfizer Ltd

ATC code:

L01DB01

INN (International Name):

Doxorubicin hydrochloride

Dosage:

2mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010200; GTIN: 5012882003661

Patient Information leaflet

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOXORUBICIN 2 MG/ML SOLUTION FOR INJECTION
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, please ask your doctor, pharmacist
or nurse.
•
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, tell 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 Doxorubicin is and what it is used for
2. What you need to know before you are given Doxorubicin
3. How Doxorubicin is given to you
4. Possible side effects
5. How to store Doxorubicin
6. Contents of the pack and other information
1. WHAT DOXORUBICIN IS AND WHAT IT IS USED FOR
•
This medicine contains doxorubicin hydrochloride, which belongs to a
group of medicines
called cytotoxics used for chemotherapy. This medicine causes cells
such as cancer cells that
are actively growing, to slow or stop their growth and increases the
likelihood that they die.
Doxorubicin treatment helps to selectively kill the cancer tissue
rather than normal, healthy
tissue. It can be used in both adults and children.
•
Doxorubicin is used to treat a variety of cancers, either alone or in
combination with other
drugs. The way in which it is used depends upon the type of cancer
that is being treated.
•
It has been found to be particularly useful in the treatment of
cancers of the breast and lung. In
addition, this medicine can be given to treat cancers of the blood
forming tissues such as
malignant lymphomas and leukaemia.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOXORUBICIN
DO NOT USE DOXORUBICIN IF YOU HAVE:
•
IF YOU HAVE AN ALLERGY (HYPERSENSITIVITY)
to dox

Summary of Product characteristics

OBJECT 1
DOXORUBICIN SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 03-Mar-2016 | Pfizer
Limited
1. Name of the medicinal product
Doxorubicin 2mg/ml Solution for Injection.
2. Qualitative and quantitative composition
Doxorubicin hydrochloride 2mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for intravenous use.
4. Clinical particulars
4.1 Therapeutic indications
Antimitotic and cytotoxic. Doxorubicin has been used successfully to
produce regression in a wide range
of neoplastic conditions including acute leukaemia, lymphomas,
soft-tissue and osteogenic sarcomas,
paediatric malignancies and adult solid tumours; in particular breast
and lung carcinomas.
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytotoxic drugs.
Doxorubicin cannot be used as an antibacterial agent.
4.2 Posology and method of administration
The total doxorubicin dose per cycle may differ according to its use
within a specific treatment regimen
(e.g. given as a single agent or in combination with other cytotoxic
drugs) and according to the indication.
The solution is given via the tubing of a freely running intravenous
infusion, taking not less than 3
minutes and not more than 10 minutes over the injection. This
technique minimises the risk of thrombosis
or perivenous extravasation which can lead to severe cellulitis,
vesication and necrosis. A direct push
injection is not recommended due to the risk of extravasation, which
may occur even in the presence of
adequate blood return upon needle aspiration (see section 4.4).
Dosage is usually calculated on the basis of body surface area. As a
single agent, the recommended
standard starting dose of doxorubicin per cycle in adults is 60-75mg/m
2
of body surface area. The total
starting dose per cycle may be given as a single dose or divided over
3 successive days or in divided
doses given on days 1 and 8. Under conditions of normal recovery from
drug-induced toxicity
(particularly bone marrow depression and stoma