Pharmorubicin 10mg/5ml solution for injection Cytosafe vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Epirubicin hydrochloride

Available from:

Pfizer Ltd

ATC code:

L01DB03

INN (International Name):

Epirubicin hydrochloride

Dosage:

2mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intravesical

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010200; GTIN: 5013457026672

Patient Information leaflet

Page 1 of 16
PATIENT LEAFLET: INFORMATION FOR THE USER
PHARMORUBICIN® 2 MG/ML SOLUTION FOR INJECTION OR INFUSION
Epirubicin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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 PHARMORUBICIN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USEPHARMORUBICIN
3.
HOW TO USE PHARMORUBICIN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PHARMORUBICIN
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PHARMORUBICIN IS AND WHAT IT IS USED FOR
•
Pharmorubicin is an injection that contains epirubicin hydrochloride.
It belongs to a
group of medicines called cytotoxics used for chemotherapy.
Pharmorubicin causes cells
that are actively growing, such as cancer cells, to slow or stop their
growth and increases
the likelihood that they die. This medicine helps to selectively kill
the cancer tissue rather
than normal, healthy tissue.
•
Pharmorubicin 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,
ovaries, stomach, bowel and lung. In addition, this medicine can be
given to treat cancers
of the blood forming tissues such as malignant lymphomas, leukaemias
and multiple
myeloma.
•
Pharmorubicin can also be put directly into the bladder through a
tube. This is sometimes
used to treat abnormal cells or cancers of the bladder wall. It can be
used after

Summary of Product characteristics

OBJECT 1
PHARMORUBICIN
Summary of Product Characteristics Updated 05-Sep-2016 | Pfizer
Limited
1. Name of the medicinal product
Pharmorubicin 2 mg/ml Solution for Injection
2. Qualitative and quantitative composition
Epirubicin hydrochloride 2 mg per ml
5 ml vials contain 10 mg of epirubicin hydrochloride
10 ml vials contain 20 mg of epirubicin hydrochloride
25 ml vials contain 50 mg of epirubicin hydrochloride
100 ml vials contain 200 mg epirubicin hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection or infusion.
Red, sterile, preservative-free, aqueous solution.
4. Clinical particulars
4.1 Therapeutic indications
Pharmorubicin has produced responses in a wide range of neoplastic
conditions, including breast, ovarian,
gastric, lung and colorectal carcinomas, malignant lymphomas,
leukaemias and multiple myeloma.
Intravesical administration of Pharmorubicin has been found to be
beneficial in the treatment of
superficial bladder cancer, carcinoma-in-situ and in the prophylaxis
of recurrences after transurethral
resection.
4.2 Posology and method of administration
Pharmorubicin is not active when given orally and should not be
injected intramuscularly or intrathecally.
It is advisable to give the drug via the tubing of a freely-running IV
saline infusion after checking that the
needle is well placed in the vein. This method minimises the risk of
drug extravasation and makes sure
that the vein is flushed with saline after the administration of the
drug. Extravasation of Pharmorubicin
from the vein during injection may give rise to severe tissue lesions,
even necrosis. Venous sclerosis may
result from injection into small vessels or repeated injections into
the same vein.
_Conventional doses:_
When Pharmorubicin is used as a single agent, the recommended dosage
in adults is 60-90 mg/m
2
body
area; the drug should be injected I.V. over 3-5 minutes and, depending
on the patient's haematomedullary
status, the dose should be repeated at 21-day intervals.
_High dose