DOXORUBICIN HYDROCHLORIDE 50MG POWDER FOR INJECTION

Active substance: DOXORUBICIN HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Doxorubicin Hydrochloride 10 mg and 50 mg
Powder for Injection
read direction

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.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.
In this leaflet:
1. What Doxorubicin Hydrochloride Powder for Injection is and
what it is used for
2. Before you use Doxorubicin Hydrochloride Powder for Injection
3. How to use Doxorubicin Hydrochloride Powder for Injection
4. Possible side effects
5. How to store Doxorubicin Hydrochloride Powder for Injection
6. Further information

1. What Doxorubicin Hydrochloride Powder for Injection is and
what it is used for
Doxorubicin Hydrochloride Powder for Injection is an anti-cancer
medicine. Treatment with an anti-cancer medicine is sometimes
called cancer chemotherapy.
Doxorubicin is used in the treatment of certain types of cancer,
for example, cancers of the blood (leukaemia), breast, soft
tissue, bone, lung and bladder. It is also used in the treatment of
some cancers in children. Doxorubicin is often given with other
anti-cancer medicines.

2. Before you use Doxorubicin Hydrochloride Powder for Injection
Do not use Doxorubicin Hydrochloride Powder for Injection
• if you have shown signs of hypersensitivity (severe allergy)
to doxorubicin or any of the other ingredients mentioned in
section 6, in the past
• if your bone marrow is not making enough blood cells (your
doctor will check for this using blood tests)
• if after your last dose you had a burning sensation in your mouth
or mouth ulcers
Tell your doctor if any of the above applies to you before this
medicine is used.

Take special care with Doxorubicin Hydrochloride Powder for
Injection
• if you have any heart problems
• if you have liver problems
• if the levels of cells in your blood become low (your doctor will
check this)
• if you have received or are going to have radiation therapy
Tell your doctor if any of the above applies to you before this
medicine is used.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as
some could interact with doxorubicin; for example:
• the toxicity of other anti-cancer medicines may be increased
by the use of doxorubicin e.g. blood in the urine with
cyclophosphamide and liver damage with 6-mercaptopurine
• the combination of ciclosporin (a medicine used to reduce the
activity of the body’s immune system) and doxorubicin may
increase the risk of nervous system side effects
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. Your doctor will decide if you should receive this
medicine.
Due to the risk of birth defects, women of childbearing potential
should use appropriate contraception methods during treatment
with doxorubicin.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
Do not drive or use machines if you experience any side effect (e.g.
drowsiness) which may lessen your ability to do so.

3. How to Use Doxorubicin Hydrochloride Powder for Injection
This medicine is given by injection into a vein, by infusion (drip) into
an artery or by instillation (using a catheter) into the bladder.

Dose
Your doctor will work out the correct dose of Doxorubicin
Hydrochloride Powder for Injection for you and how often it must be
given.
The dose of medicine given to you will depend upon your medical
condition, your age, size, blood cell levels, how well your liver
is working and whether you are receiving any other anti-cancer
medicines. Your doctor will check your blood cell levels and tell
how well your liver is working using blood tests.
If you are to be given an instillation of this medicine directly into the
bladder, you may be told by your doctor not to drink any fluids for
12 hours before treatment. After the installation you may be asked
to change your position frequently to ensure that the medicine
comes into contact with all areas of the bladder.

If you are given too much or too little Doxorubicin Hydrochloride
Powder for Injection
This medicine will be given to you in a hospital, under the
supervision of a doctor. It is unlikely that you will be given too
much or too little, however, tell your doctor or nurse if you have any
concerns.

Doxorubicin Hydrochloride 10 mg and 50 mg
Powder for Injection
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on
the preparation/handling of the medicinal product is provided here.

Incompatibilities
Doxorubicin should not be mixed with heparin since it has been
reported that these drugs are incompatible to the extent that a
precipitate may form. Until specific compatibility data are available, it is
not recommended that doxorubicin be mixed with other drugs.

Reconstitution and dilution
Single use only
Discard any unused contents
The contents of the vial should be reconstituted with Water for
Injection, sodium chloride 0.9%, or dextrose 5% to a solution
concentration of 2 mg doxorubicin hydrochloride per ml.
Chemical and physical in-use stability following reconstitution in either
sodium chloride 0.9% or Water for Injections in glass or polypropylene
containers has been demonstrated for up to 21 days at 2-8°C. From
a microbiological point of view, however, the product should be
used immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would
Q73797

Component Specification

Requester

Item number:

Q73797

Request number:

AS2119

Country:

United Kingdom

Inventory code(s):

M2326AGB20

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed to
the printing stage.
Previous Item Number:

OI template:
Amalia version:
Mulgrave version:

ZHI001
4
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 570 mm
Standard vial leaflet
ZHOPL
tbc
35.5 x 118 mm
Yes
No

Pharma code:
Max pharma code:
Pharma code length:
Supplier Code:

720 (122121112)
16.5 mm
16.5 mm
n/a

Colours
Black:

N/A

Signed:
Date:

Version 1
Technician:
Date:

JL
16/Jul/12

Version 2
Technician:
Date:

BJ
16/May/13

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

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dd/mmm/yy

Version 5
Technician:
Date:

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dd/mmm/yy

Version 6
Technician:
Date:

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dd/mmm/yy

Version 7
Technician:
Date:

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Version 8
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Version 9
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Version 10
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4. Possible Side Effects
Like all medicines, Doxorubicin Hydrochloride Powder for Injection
can have side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:
• severe allergic reaction – you may experience a sudden itchy
rash (hives), swelling of the hands, feet, ankles, face, lips, mouth
or throat (which may cause difficulty in swallowing or breathing),
and you may feel you are going to faint
• chest pain
• pain at the injection site during or immediately after the injection
These are serious side effects. You may need urgent medical
attention.

If any of the following happen, tell your doctor as soon as
possible:
The following side effects are more common:
• unexpected bruises or bleeding, or symptoms of an infection
e.g. fever, chills or achiness (these problems may occur up to
3 weeks after your last treatment)
• painful burning sensation in the mouth, throat or oesophagus
(food-pipe). It often develops 5 to 10 days after treatment. The
vagina and back passage may also be affected. Ulcers may form
which can become infected. It normally gets better after 10 days.
It is often worse if you have had radiation treatment to these
areas before.
• abnormally fast heart beat
• skin problems (possibly a skin infection affecting the face, neck
or legs; the affected area may be hot, tender and red)
• pain or redness of the blood vessels
• inflammation of a vein or red streaking along a vein near the
injection site
• reddening of the face (if the injection has been given too quickly)
• hair loss
• dehydration (feeling thirsty)
• feeling or being sick
• diarrhoea
• red coloured urine
The following side effects are less common:
• itchy skin rash (hives)
• paleness due to anaemia
• conjunctivitis (red, sore and itchy eyes)
• drowsiness
• loss of appetite
• unusual colouration of the nail beds and skin creases (seen in
children)
As doxorubicin may affect your heart, your doctor may do tests to
monitor your heart function before starting treatment and during or
after treatment. Problems with your heart may occur even years
after stopping doxorubicin treatment.
Doxorubicin may lead to changes in your blood cells. Your doctor
will take blood samples to monitor for these and also to check how
well your liver and kidneys are working. Leukaemia (abnormalities
of the white blood cells) has been reported when doxorubicin has
been given together with some other cancer treatments.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

Effects on fertility
Men and women taking this medicine may become infertile. In
women, ovulation and menstruation (periods) should return once
treatment is stopped. If you have any questions about the effects of
this medicine on the chances of you having a baby, ask your doctor.

5. How to store Doxorubicin Hydrochloride Powder for Injection
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is
stated on the vial label and carton after ‘EXP’. Where only a month
and year is stated, the expiry date refers to the last day of that
month.

Storage
Keep the vial in the outer carton, in order to protect from light, and
store at or below 25°C.
Unused portions of opened vials must not be stored for later use.
Prepared infusions should be used immediately, however, if this
is not possible they can be stored for up to 21 days provided they
have been prepared in a way to exclude microbial contamination.

6. Further Information
What Doxorubicin Hydrochloride Powder for Injection contains
The active ingredient is doxorubicin hydrochloride. After
reconstitution, each millilitre (ml) of solution contains 2 milligrams
(mg) of doxorubicin hydrochloride.
The other ingredient is lactose monohydrate.

What Doxorubicin Hydrochloride Powder for Injection looks
like and contents of the pack
Doxorubicin Hydrochloride Powder for Injection is an orange-red
powder for solution for injection (a powder which is made into a
solution before being injected). It comes in glass containers called
vials.
It may be supplied in packs containing:
• 1 x 10 mg vial
• 1 x 50 mg vial
Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible
for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa,
Warwickshire, CV31 3RW, UK

Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170,
Australia
This leaflet was last approved in 05/2013

not normally be longer than 24 hours when stored at 2-8°C, unless
reconstitution has taken place in controlled and validated aseptic
conditions.

Cytotoxic Handling Guidelines
Doxorubicin is a potent cytotoxic agent which should only be
prescribed, prepared and administered by professionals who have
been trained in the safe use of the preparation. The following
guidelines should be followed when handling, preparing and disposing
of doxorubicin.
Preparation: Reconstitution of powder, transfer to syringes or infusion
bags should be carried out in designated areas, preferably a laminar
flow station.
Personnel must be adequately protected with suitable clothing, gloves,
mask and eye shield.
Pregnant women should be excluded from handling cytotoxic agents.
Contamination: In the event of contact with the skin or eyes, the
affected area should be washed with copious amounts of water or
normal saline. A bland cream may be used to treat transient stinging of
skin. Medical advice should be sought if the eyes are affected.
In the event of spillage treat with 1% sodium hypochlorite solution
using a cloth/sponge kept in the designate area. Rinse twice with
water. Put all cloths into a plastic bag and seal for incineration.
Disposal: All items used during preparation or administration including
syringes, containers, absorbent materials, residual solutions should all
be placed in a thick plastic bag and incinerated at 700°C.
Q73797

Component Specification

Requester

Item number:

Q73797

Request number:

AS2119

Country:

United Kingdom

Inventory code(s):

M2326AGB20

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed to
the printing stage.
Previous Item Number:

OI template:
Amalia version:
Mulgrave version:

ZHI001
4
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 570 mm
Standard vial leaflet
ZHOPL
tbc
35.5 x 118 mm
Yes
No

Pharma code:
Max pharma code:
Pharma code length:
Supplier Code:

720 (122121112)
16.5 mm
16.5 mm
n/a

Colours
Black:

N/A

Signed:
Date:

Version 1
Technician:
Date:

JL
16/Jul/12

Version 2
Technician:
Date:

BJ
16/May/13

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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