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DOXORUBICIN HYDROCHLORIDE 2 MG/ML SOLUTION FOR INFUSION

Active substance(s): DOXORUBICIN HYDROCHLORIDE

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Doxorubicin hydrochloride 2 mg/ml · 82411-VP1GB · BA · 02.14 · Pharma-Code: 93
Format: 592 x 150 mm · HKS 44 · Corrective action: KV01_osc_10.02.14

Package leaflet:
Information for the patient

Doxorubicin hydrochloride
2 mg/ml
solution for infusion
Doxorubicin hydrochloride
Read all of this leaflet carefully before you receive
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 side effects
not listed in this leaflet. See section 4.

1. What Doxorubicin hydrochloride is and what it is
used for
Doxorubicin is one of a group of medicines known as
anthracyclines. It works by killing tumour and blood
cancer cells. Your doctor will be able to explain how
doxorubicin might help in your particular condition.
This medication is used to treat:
• breast cancer
• ovarian cancer
• uterine cancer
• cancer of the bladder
• lung cancer
• thyroid cancer
• soft tissue and bone cancer (sarcoma)
• neuroblastoma (cancer of the nerve cells)
• Wilms’ tumour
• malignant lymphoma (Hodgkin’s and non-Hodgkin’s)
• leukaemias (cancer cause abnormal production of
blood cells)
• cancer of white blood cells (multiple myeloma)

You should avoid contact to persons recently
vaccinated against polio when you are under treatment
with Doxorubicin hydrochloride.

• Cardioactive medicines (medications for heart
diseases), e.g. calcium channel blockers, verapamil,
digoxin
• Inhibitors of cytochrome P-450 (medicines that stop
the substance cytochrome P-450, which is important
for the detoxification of your body, from working;
e.g. cimetidine)
• Medicine inducing cytochrome P-450
(e.g. rifampicin, barbiturates)
• Antiepileptic medicines (e.g. carbamazepine,
phenytoin, valproate)
• Heparin (prevents the clotting of the blood)
• Amidopyrine derivatives (pain-killers)
• Antiretroviral medicines (medications against special
forms of viruses, e.g. ritonavir against AIDS)
• Chloramphenicol
• Sulphonamides (medications against bacteria)
• Progesterone (e.g. at threatening miscarriage)
• Amphotericin (used to treat fungal infections)
• Live vaccines (e.g. against polio myelitis, malaria)
• Trastuzumab (used in the treatment of breast cancer)
• Clozapine (antipsychotic medicine)
• Dose adjustment of uric acid lowering agents may be
necessary

Other medicines and Doxorubicin hydrochloride
Tell your doctor if you are taking, have recently taken
or might take any other medicines.

Please note that these statements may also apply to
products used some time ago or at some time in the
future.

The following medications can interact with Doxorubicin
hydrochloride:
• Other cytostatics (medication against cancer) e.g.
anthracyclines (daunorubicin, epirubicin, idarubicin),
cisplatin, cyclophosphamide, cyclosporin, cytarabine,
dacarbazine, dactinomycin, fluorouracil, mitomycin C,
taxanes (e.g. paclitaxel), mercaptopurine,
methotrexate, streptozocin

Pregnancy, breast-feeding and fertility
If you are a woman, you should not get pregnant during
treatment with doxorubicin or up to 6 months after
treatment.







if you tend to bleed easily.
if you suffer from any kind of infection.
if you suffer from mouth ulcers.
if your liver is not working well.
if you suffer from an infection of the bladder or if
you have blood in your urine (in case the medicine is
given to you by an administration into your bladder)
• if you are breast-feeding.
Take special care with Doxorubicin hydrochloride
and tell your doctor
• if you have had any radiotherapy before.
• if you are pregnant, trying to become pregnant,
likely to want to try to become pregnant in the future
or if you want to father a child.
• if you are on a controlled sodium diet.
If there is a burning sensation in the area of the infusion,
this can be a sign of an injection error and the infusion
must be stopped immediately.

after treatment. If you are considering becoming parents
after the treatment please discuss with your doctor.
Because doxorubicin may cause permanent infertility, it
is advised to discuss with your doctor the possibility of
freezing sperm before treatment start (cryo-preservation
or cryo-conservation).
Doxorubicin is not recommended if you are pregnant.
Breast-feeding must be discontinued for the
duration of Doxorubicin hydrochloride therapy.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Due to the frequent occurrence of drowsiness, nausea
and vomiting, you are not advised to drive cars and
operate machinery.
Doxorubicin hydrochloride contains sodium
Please tell your doctor if you are on a low-sodium diet.
He/she will take into account that 1 ml of Doxorubicin
hydrochloride contains 3.5 mg sodium.

2. Before you receive Doxorubicin hydrochloride
What is in this leaflet
1. What Doxorubicin hydrochloride is and what it is
used for
2. What you need to know before you receive
Doxorubicin hydrochloride
3. How Doxorubicin hydrochloride is administered
4. Possible side effects
5. How to store Doxorubicin hydrochloride
6. Contents of the pack and other information

You must not receive Doxorubicin hydrochloride
in the following cases. Please tell your doctor
• if you are allergic to doxorubicin or any of the other
ingredients of this medicine (listed in section 6) or
to other anthracyclines.
• if you have been told that your blood is thin
(your bone marrow is not working well).
• if you have, or ever have had, any heart problems.
• if you have received doxorubicin, other
anthracyclines, other anti-tumour medicines
or immunosuppressive medicines before.

If you are a man, you should take adequate precautions
to ensure that your partner does not become pregnant
during your treatment with doxorubicin or up to 6 months

3. How Doxorubicin hydrochloride is administered
Method and routes of administration
Do not administer the medicine yourself. Your medicine
will be given to you as part of an intravenous infusion,
into a blood vessel, under the direction of specialists.
You will be monitored regularly both during and after
your treatment.
If you suffer from superficial bladder cancer it is
possible that you may receive your medicine into
your bladder (intravesical use).

Dosage
The dosage is usually calculated on the basis of your
body surface area. 60 – 75 mg per square metre of body
surface area may be given every three weeks when
used alone. The dosage may need to be reduced to
30 – 40 mg per square metre of body surface area when
given in combination with other anti-tumour medicines.
The dosage may be given as either a single dose every
three weeks or divided over three consecutive days
(20 – 25 mg per square metre of body surface area on
each day). If given weekly the recommended dose is
20 mg per square metre of body surface area.
Your doctor will advise you of how much you will need.

The following information is intended for healthcare
professionals only:

Patients with reduced liver or kidney function
If your liver or kidney function is reduced, the dosage
should be decreased. Your doctor will advise you of
how much you need.

Opened vials
The product should be used immediately after opening
the vial.

Use in children/obese patients/elderly/patients after
radiotherapy
The dosage may need to be reduced in children, in
obese patients and the elderly or if you have received
any radiotherapy. Your doctor will advise you of how
much you need.
If you received more Doxorubicin hydrochloride
than you should
During and after treatment you will be carefully
monitored by your doctor or nurse. The symptoms of
an overdose are an extension of doxorubicin‘s possible
side effects, particularly the blood changes and heart
problems. Heart disorders may even occur up to six
months after you received the overdose.
In case of an overdose your doctor will take appropriate
measures, such as a blood transfusion and/or treatment
with antibiotics.

Incompatibilities
Doxorubicin should not be mixed with heparin as a
precipitate may form and it should not be mixed with
5-fluorouracil as degradation may occur. Prolonged
contact with any solution of an alkaline pH should be
avoided as it will result in hydrolysis of the medicine.
In the absence of compatibility studies, this medicinal
product must not be mixed with other medicinal
products.

Prepared infusion solutions
Chemical and physical in-use stability at a
concentration of 0.5 mg/ml has been demonstrated
in sodium chloride 0.9 % and glucose 5 % for
up to 7 days at 2 °C to 8 °C or room temperature
(20 °C to 25 °C) when prepared in PE-bags and
protected from light.
From a microbiological point of view, 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 normally not
be longer than 24 hours at 2 °C to 8 °C, unless dilution
has taken place in controlled and validated aseptic
conditions.
Special precautions for disposal and other handling
For single use only.
Any unused product or waste material should be
disposed of in accordance with local requirements.

Doxorubicin hydrochloride 2 mg/ml · 82411-VP1GB · BA · 02.14 · Pharma-Code: 93
Format: 592 x 150 mm · HKS 44 · Corrective action: KV01_osc_10.02.14

Observe guidelines for handling cytotoxic medicines.

Please tell your doctor if any of the symptoms occur.

The following protective recommendations are given
due to the toxic nature of this substance:
• Personnel should be trained in good technique
for handling.
• Pregnant staff should be excluded from working
with this medicine.
• Personnel handling doxorubicin should wear
protective clothing: goggles, gowns, disposable
gloves and masks.
• A designated area should be defined for
reconstitution (preferably under a laminar flow
system). The work surface should be protected by
disposable, plastic-backed and absorbent paper.
• All items used for administration or cleaning,
including gloves, should be placed in high risk
waste disposal bags for high temperature (700 °C)
incineration.
• In case of skin contact, thoroughly wash the affected
area with soap and water or sodium bicarbonate
solution. However, do not graze the skin by using
a scrubbing brush.
• In case of contact with eye(s), hold back the eyelid(s)
and flush the affected eyes with copious amounts
of water for at least 15 minutes. Then seek medical
evaluation by a physician.
• Spillage or leakage should be treated with dilute
sodium hypochlorite (1 % available chlorine) solution,
preferably soaking overnight and then rinse with
water.
• All cleaning materials should be disposed of as
indicated previously.
• Always wash hands after removing gloves.

Effects when treatment with Doxorubicin
hydrochloride is interrupted or stopped early
Your doctor will decide on the duration of your
treatment with Doxorubicin hydrochloride. If the
treatment is stopped before the advised course of
treatment is finished, the effects of the doxorubicin
therapy might be reduced.
Ask your doctor for advice if you wish to stop the
treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor straight away if you notice any
of the following serious side effects:
They have been ranked according to their potential
seriousness.
• You may develop hives, fever, chills, severe
hypersensitivity. This type of allergic reaction can be
life-threatening.
• Heart problems – for example you may notice your
heart beating abnormally quickly, with an increase
in pulse rate. In case of heart problems, routine ECG
monitoring is commonly applied. If you have suffered
from heart problems (even a long time ago) before
treatment with Doxorubicin hydrochloride make sure
to tell your doctor about this.
• Blood changes – e.g. your vulnerability for infections
may increase, you may suffer from unusual
bleedings and you may observe signs of anaemia
(weakness, tiredness, laboured breathing with a
feeling of apprehension).

Your urine may be coloured red, particularly the
first time that you pass urine after each injection of
Doxorubicin hydrochloride. This is nothing to worry
about and your urine will soon return to its normal
colour.
Common (may affect up to 1 in 10 people):
• decreased activity in bone marrow leads to reduced
blood cells
• cardiomyopathy (heart disease in which your heart
muscle does not work properly)
• ECG changes (includes irregular heartbeat)
• deficiency in blood cells causing infection
• nausea and/or vomiting (feeling and /or being sick)
• mucositis (inflammation of membranes in digestive
tract, starts with burning sensations in mouth or
pharynx)
• anorexia (eating disorder)
• diarrhoea – may result in dehydration
• bladder inflammation sometimes with painful
urination, need to urinate more often or during night
or blood in urine (following administration into the
bladder)
• alopecia (hair loss)
• sepsis (serious infection of the whole body)
• septicaemia (bacterial infection of the blood)
Uncommon (may affect up to 1 in 100 people):
• dehydration
• phlebitis (vein inflammation)
• local hypersensitivity reaction of the field of radiation
• bleeding in stomach or bowel
• abdominal pain
• ulceration and necrosis (death of cells of the tissue)
of the digestive tract
• inflammation of voice box and throat

Rare (may affect up to 1 in 1,000 people):
• secondary leukaemia (blood cancer arisen from
combined treatment with a special kind of other
anti-cancer medicines)
• tumour lysis syndrome (complications of having
chemotherapy)
• severe allergic reactions including skin rash, itching,
fever, chills and breathing difficulties
• abnormal reduction of white blood cells when given
with other cancer medicines
• conjunctivitis (usually causing red watery eyes)
• hives
• rash
• erythematous reactions (rash-like symptoms) along
the vein used for the injection
• skin and nails may appear darker than usual.
• separation of nail plates may also occur after being
treated with doxorubicin
• shivering
• fever
• dizziness
Not known (cannot be estimated from the
available data):
• severe reducing in blood cells may cause
spontaneous bleeding or anaemia
• hot flushes
• severe heart failure (loss of cardiac function)
• inflammation of the veins
• clot formation in a blood vessel
• irregular heart beat
• bronchospasm (coughing or difficulty in breathing)
• inflammation of the lung after radiation
• increase of liver enzymes
• hand-foot syndrome
• local death of cells of tissue
• loss of renal function may lead to renal failure

• high uric acid level in blood
• absence of menstruation
• infertility in men, low sperm volume or lack of sperm
Burning, redness and swelling at the administration
site may occur. If this is the case during an infusion
you should inform the doctor or nurse, because the
injection should be stopped immediately and restarted
at another site.

Remnants of the medicinal product as well as all
materials that have been used for dilution and
administration must be destroyed according to hospital
standard procedures applicable to cytotoxic agents
with due regard to current laws related to the disposal
of hazardous waste.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

6. Contents of the pack and other information
This leaflet was last revised in February 2014.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Doxorubicin hydrochloride
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the label and carton.
The expiry date refers to the last day of that month.
Store the unopened vials in a refrigerator (2 – 8 °C).
Keep the vial in the outer carton in order to protect
from light.
The product should be used immediately after opening
the vial.
For single dose use only. Any unused solution should
be discarded immediately after initial use.
Do not use this medicine if you notice that the solution
is not clear, red and free of particles.

What Doxorubicin hydrochloride contains
1 ml contains 2 mg doxorubicin hydrochloride.
Each 5 ml vial contains a total content
of doxorubicin hydrochloride of 10 mg.
Each 10 ml vial contains a total content
of doxorubicin hydrochloride of 20 mg.
Each 25 ml vial contains a total content
of doxorubicin hydrochloride of 50 mg.
Each 75 ml vial contains a total content
of doxorubicin hydrochloride of 150 mg.
Each 100 ml vial contains a total content
of doxorubicin hydrochloride of 200 mg.
The other ingredients are sodium chloride, hydrochloric
acid (for pH adjustment) and water for injections.
What Doxorubicin hydrochloride looks like and
contents of the pack
Doxorubicin hydrochloride is a clear, red solution
which is practically free of particles.
Pack sizes:
The solution is available in packs of 1 or 5 vials
containing 5/10/25/75 or 100 ml solution.
This corresponds to 10/20/50/150 or 200 mg of the
active substance, doxorubicin hydrochloride, per vial.

82411-VP1GB
BA

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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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