EPIRUBICIN HYDROCHLORIDE 50 MG POWDER FOR SOLUTION FOR INJECTION

Active substance: EPIRUBICIN HYDROCHLORIDE

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Epirubicin Hydrochloride 50mg
Powder for Solution for
Injection or Infusion
Read all of this leaflet carefully before you start
using this medicine.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your doctor.
I
•  his medicine has been prescribed for you. Do
T
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• f any of the side effects gets serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor.

In this leaflet:
1. What Epirubicin Hydrochloride
Powder for Solution for Injection
or Infusion is and what it is used
for
2. Before you use Epirubicin
Hydrochloride Powder for
Solution for Injection or Infusion
3. How to use Epirubicin
Hydrochloride Powder for
Solution for Injection or Infusion
4. Possible side effects
5. How to store Epirubicin
Hydrochloride Powder for
Solution for Injection or Infusion
6. Further information
1. What Epirubicin Hydrochloride
Powder for Solution for Injection
or Infusion is and what it is used
for
Epirubicin is an anti-cancer medicine. Treatment
with an anti-cancer medicine is sometimes
called cancer chemotherapy. Epirubicin is part
of a group of medicines called anthracyclines.
These act upon cells that are actively growing,
to slow or stop their growth and increase the
chance that the cells die.
Epirubicin is used to treat a variety of cancers.
The way in which it is used depends upon the
type of cancer that is being treated.
When injected into the bloodstream, Epirubicin
is used to treat cancers of the breast, stomach
and lung as well as advanced ovarian cancer.
When injected into the bladder through a tube,
Epirubicin is used to treat cancers of the bladder
wall. It can also be used after other treatments
for prevention of such cells from growing again.

2. Before you use Epirubicin
Hydrochloride Powder for
Solution for Injection or Infusion
Do not use Epirubicin Hydrochloride
Powder for Solution for Injection or
Infusion if you:
•  re allergic (hypersensitive) to epirubicin
a
hydrochloride, any of the other ingredients
of Epirubicin Hydrochloride Powder for
Solution for Injection or Infusion (see list in
chapter 6, ‘Further Information’) or other
similar drugs (belonging to a group of drugs
called anthracyclines, which among others
include doxorubicin or daunorubicin)
•  re allergic (hypersensitive) to drugs
a
belonging to the group anthracenediones
(including drugs used to treat cancer)
•  re breast-feeding.
a
Epirubicin should not be injected into a vein
(intravenous use) if you:
•  re aware your blood counts are low,
a
caused by previous treatment with
other anti-tumour drugs or by previous
radiotherapy
•  ave been treated with other
h
chemotherapy at maximum dose such
as epirubicin and/or other anthracyclines
(such as doxorubicin or daunorubicin), and
anthracenediones, which can increase the
risk of side effects
•  uffer with or have suffered with problems
s
with your heart
•  uffer from an acute severe infection
s
•  ave severe liver problems
h

Epirubicin should not be injected into the
bladder if:
•  ou suffer from urinary tract infection
y
(including your kidneys, bladder and
urethra)
•  here are tumours which penetrate the
t
bladder
•  here are problems placing the tube into
t
the bladder
•  ou have an inflammation of the bladder
y
•  ou have blood in the urine (hematuria)
y

Take special care with Epirubicin
Hydrochloride Powder for Solution
for Injection or Infusion if you:
•  ave some kidney or liver problems. You
h
should inform your doctor before treatment
as he/she needs to take special care.
Your doctor will also be making regular checks
•  o that your blood cell counts will not be too
s
low
•  o control the levels of uric acid and other
t
factors in the blood
•  o see that your heart and liver are working
t
normally
• f you have or are to have radiotherapy to
i
the area around the heart.
You should inform your doctor in case you
experience swelling and pain in your mouth or
mucous membrane.
You should tell your doctor if you are about to
have a vaccination, as it may cause side effects if
used with epirubicin.
It is possible that the urine will have a red colour
for one or two days after administration.

Using other medicines
Tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Especially:
•  imetidine (used to reduce the acid in the
C
stomach).
•  rastuzumab (used to treat cancer).
T
•  aclitaxel and docetaxel (used in some
P
cancers).
• nterferon alfa-2b (used in some cancers and
I
lymphoma and for some yellow fever).
•  uinine (used for treatment of malaria and
Q
for leg cramps).
•  exverapamil (used to treat some heart
D
conditions).
•  edicines that may affect your heart,
M
such as 5-fluorouracil, cyclophosphamide,
cisplatin, taxanes (used to treat cancer) or
calcium channel blockers (used to treat high
blood pressure or some heart conditions).
•  edicines that may affect your liver.
M
•  ive vaccines.
L
•  ther medicines that may affect the
O
bone marrow (such as other medicines
to treat cancer, sulphonamide and
chloramphenicol (antibacterial medicines),
diphenylhydantoin (antiepileptic),
amidopyrine derivatives (some medicines to
treat e.g. pain and fever) and some antiviral
medicines).

Pregnancy and breast-feeding
Fertility
There is a risk of sterility due to therapy with
Epirubicin. Male patients should consider
storage of sperm before treatment.
Epirubicin may cause absence of menstruation
or premature menopause in premenopausal
women.
Pregnancy
Epirubicin may cause birth defects when used
during pregnancy, it is important to tell your
doctor if you are pregnant or if you become
pregnant during treatment. You must not use
Epirubicin during pregnancy unless clearly
indicated by your doctor.
If you or your partner are being teated with
Epirubicin, effective birth control to prevent
pregnancy is advised. If pregnancy occurs
during treatment or if you desire to have
children after completion of therapy, genetic
counselling is recommended.
Breast-feeding
Epirubicin may be harmful to nursing infants,
therefore women must stop breast-feeding
before starting treatment with this product.

AAAE5945

The following information is intended for
medical or healthcare professionals only:
Epirubicin Hydrochloride Powder
for Solution for Injection or Infusion
Instructions for use

ANTINEOPLASTIC AGENT
Incompatibilities
Prolonged contact with any solution of an
alkaline pH (including sodium bicarbonate
containing solutions) should be avoided as
it will result in hydrolysis of the drug. Only
the diluents detailed in “Instructions for use”
should be used.
Epirubicin Hydrochloride Powder for Solution
for Injection or Infusion should not be mixed
with heparin due to chemical incompatibility
which may lead to precipitation when the
drugs are in certain proportions.
Epirubicin Hydrochloride Powder for Solution
for Injection or Infusion can be used in
combination with other antitumour agents,
but it is not recommended that it be mixed
with other drugs.
Instructions for use
Epirubicin Hydrochloride Powder for Solution
for Injection or Infusion is for intravenous or
intravesical use only.

Intravenous administration: It is advisable
to administer the reconstituted epirubicin
hydrochloride solution via the tubing of a
freely flowing intravenous infusion (0.9%
sodium chloride). To minimize the risk of
thrombosis or perivenous extravasation, the
usual infusion times range between 3 and
20 minutes depending upon dosage and
volume of the infusion solution. 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.
Intravesical administration: The reconstituted
solution should be diluted in sterile water
for injection or 0.9% sterile saline solution
before administration. Epirubicin should
be instilled using a catheter and retained
intravesically for 1-2 hours. During instillation,
the patient should be rotated to ensure that
the vesical mucosa of the pelvis receives the
most extensive contact with the solution. To
avoid undue dilution with urine, the patient
should be instructed not to drink any fluid in
the 12 hours prior to instillation. The patient
should be instructed to void at the end of the
instillation.
The injection solution contains no preservative
and any unused portion of the vial should be
discarded immediately.

The freeze dried powder may be reconstituted
with 0.9% sodium chloride for injection or
water for injection.

AAAE5945

Epirubicin Hydrochloride 50mg Powder PIL - UK
item no:

AAAE5945

dimensions: 130 x 600

print proof no: 8
origination date: 22-11-12
approved for print/date

pharmacode:
min pt size:

originated by:

BW

revision date:

17.06.13

Technical Approval

revised by:

SA

date sent: 22-11-12

supplier: Sindan

technically app. date: 23-11-12

colours/plates:
1. Black
2.
3.
4.
5.
6.
Non Printing Colours
1.
2.
3.

Driving and using machines
Epirubicin may cause episodes of nausea
and vomiting, which can temporarily lead to
an impairment of the ability to drive or use
machines.

Important information about some
of the ingredients of Epirubicin
Hydrochloride Powder for Solution for
Injection or Infusion
This medicinal product contains methyl
parahydroxybenzoate which may cause allergic
reactions (possibly delayed), and exceptionally,
bronchospasm.

3. How to use Epirubicin
Hydrochloride Powder for
Solution for Injection or Infusion
Epirubicin will be given to you by a doctor or
nurse, either into a vein or directly into your
bladder. Your doctor will decide the correct dose
and the number of days treatment you receive.
The dose will depend on the type of cancer you
have, your health, height, weight, how well your
liver is working and any other treatment you may
receive.
By injection or infusion into a vein
Epirubicin Hydrochloride Powder for Solution
for Injection or Infusion may be given as an
injection into a vein over 3-5 minutes. It may also
be diluted before it is infused slowly, usually via a
drip into a vein over 30 minutes.
By being put into the bladder
If the injection is given into the bladder, you
should not drink any fluids for 12 hours before
treatment so that your urine will not dilute the
drug too much. The solution should be kept in
your bladder for 1‑2 hours after installation. You
will need to turn occasionally to make sure all
parts of the bladder are exposed to the drug.
Care should be taken to ensure that the contents
of the bladder, when emptied, do not come into
contact with the skin. In case of skin contact,
thoroughly wash the affected area with soap and
water but do not scrub.
Your doctor will regularly check your blood for
any unwanted effects. To detect any possible
heart damage your doctor will also monitor your
heart for several weeks after the treatment.

If you receive more Epirubicin than
you should:
It may affect your heart, lower your blood cell
count and cause gastrointestinal toxic effects
(mainly mucositis). You may notice sores in your
mouth. However, as this medicine will be given
to you whilst you are in hospital it is unlikely that
you will be given too little or too much. Please tell
your doctor if you have any concerns.

4. Possible side effects
Like all medicines, Epirubicin Hydrochloride
Powder for Solution for Injection or Infusion can
cause side effects, although not everybody gets
them.
If any of the following side effects happen when
epirubicin is given by infusion into a vein tell your
doctor immediately, as these are very serious side
effects. You may need urgent medical attention:
•  edness, pain or swelling at the injection site;
r
tissue damage may occur after accidental
injection outside a vein
•  ymptoms of heart problems such as
s
chest pain, shortness of breath, swelling of
your ankles (these effects may occur up to
several weeks after finishing treatment with
epirubicin)
•  evere allergic reaction, symptoms include
s
faintness, skin rash, swelling of the face and
difficulty in breathing or wheeze . In some
cases collapse may occur.
If you experience any of the following tell your
doctor as soon as possible:
Very common (occur in more than 1 in 10 people):
Bone marrow suppression (which leads to low
blood cell count), hair loss (usually reversible),
reduced growth of beard hair, red coloured urine
for 1 to 2 days after being given the medicine.
Common (occur in less than 1 in 10 people):
Severe loss of appetite leading to weight
loss (anorexia), loss of fluid from the body
(dehydration), feeling or being sick (nausea
or vomiting), diarrhoea (which can result in
dehydration), loss of appetite, abdominal pain,
inflammation of the gullet (oesophagitis), high
levels of pigments in the mouth, swelling and
pain in your mouth, ulcers involving the lips
and/or tongue and/or under the tongue, hot
flushes, fever or infections, redness, pain or
swelling at the injection site; tissue damage may
occur after accidental injection outside a vein,
allergic reactions or inflammation of the bladder
(sometimes with bleeding) after injection of the
medicine into the bladder.

Uncommon (occur in less than 1 in 100 people):
Low levels of blood platelets (thrombocytopenia)
often causing unusual bruising or bleeding,
headache, high levels of pigments in the skin
and nails, skin redness, sensitivity of the skin to
light (in case of radiotherapy), vein inflammation
including blood clotting (thrombophlebitis).
Rare (occur in less than 1 in every 1,000 people):
Leukaemia (cancer of the blood), severe, wholebody allergic reaction (anaphylaxis), hives
(urticaria), increased blood levels of uric acid
(hyperuricaemia) possibly leading to gout, fever
and/or chills, dizziness, absence of menstrual
periods (amenorrhea), lack of sperm, changes in
liver function (changes in transaminase levels),
heart failure (shortness of breath, oedema,
enlargement of the liver , pulmonary oedema
which can cause respiratory failure and swelling
of the abdomen), abnormal heart rhythm,
weaker heart with lower pumping rate which can
result in feeling generally unwell and feeling of
weakness.
Not known (frequency cannot be estimated from
the available data)
Infection of the lungs (pneumonia), infection
of the blood (sepsis), septic shock (severe
complication of sepsis), bleeding and lack of
oxygen in body tissues, redness, dryness and
swelling of the eyes, shock, blockage of a blood
vessel by a clot (e.g., in the lungs), skin rash,
itching, skin changes, flushes (reddening of the
skin). Infected area of the skin can become sore,
swollen, red and hot, caused by severe cellulitis.
Decreased ability of the heart to pump blood
(asymptomatic drops in left ventricular ejection
fraction). Colour changes, bleeding, pain, sores,
ulcers or burning sensation inside the mouth.
If epirubicin hydrochloride is injected directly into
the bladder you may experience pain or difficulty
when passing urine. Blood may also be seen in
your urine.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Epirubicin
Hydrochloride Powder for
Solution for Injection or Infusion
Keep out of the reach and sight of children.
Store in the original package.
Do not use Epirubicin Hydrochloride Powder for
Solution for Injection or Infusion after the expiry
date which is printed on the label and carton
after EXP. The expiry date refers to the last day of
that month.
Do not use Epirubicin Hydrochloride Powder for
Solution for Injection or Infusion if you notice any
visible signs of deterioration.
Medicines should not be disposed of via
wastewater or houshold waste. Ask your
pharnacist how to dispose medicines no longer
required. These measures will help to protect the
environment.

6. Further information
What Epirubicin Hydrochloride
Powder for Solution for Injection or
Infusion contains
The active substance is epirubicin hydrochloride.
One vial contains 50mg epirubicin hydrochloride.
The other ingredients are: lactose monohydrate,
methyl parahydroxybenzoate.

What Epirubicin Hydrochloride
Powder for Solution for Injection or
Infusion looks like and contents of the
pack
Epirubicin powder is a red-orange powder
delivered in a colourless vial.
Each pack contains a single vial.

Manufacturer(s):
S.C. SINDAN- PHARMA S.R.L., 11 Ion Mihalache
Blvd, 011171 Bucharest, Romania

Marketing Authorisation Holder:
Actavis Group PTC ehf, Reykjavikurvegi 76-78,
220 Hafnarfjordur, Iceland.
Leaflet was last revised in June 2013

If you would like a
leaflet with larger
text, please contact
01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

AAAE5945

Guidelines for the safe handling and disposal
of antineoplastic agents:
1. f an infusion solution is to be prepared, this
I
should be performed by trained personnel
under aseptic conditions.
2.  reparation of an infusion solution should be
P
performed in a designated aseptic area.
3.  dequate protective disposable gloves,
A
goggles, gown and mask should be worn.
4.  recautions should be taken to avoid the
P
medicinal product accidentally coming into
contact with the eyes. In the event of contact
with the eyes, irrigate with large amounts of
water and/or 0.9% sodium chloride solution.
Then seek medical evaluation by a physician.

Storage
Product as packaged for sale: Store in the original
package.
After reconstitution according to directions:
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 – 8 °C, unless reconstitution
has taken place in controlled and validated
conditions.
Please refer to the Summary of Product
Characteristics (SPC) for further information
about Epirubicin Hydrochloride Powder for
Solution for Injection or Infusion.

5. n case of skin contact, thoroughly wash
I
the affected area with soap and water or
sodium bicarbonate solution. However, do
not abrade the skin by using a scrub brush.
Always wash hands after removing gloves.
6.  pillage or leakage should be treated with
S
dilute sodium hypochlorite (1% available
chlorine) solution, preferably by soaking, and
then water. All cleaning materials should be
disposed of as detailed below.
7.  regnant staff should not handle the
P
cytotoxic preparation.
8.  dequate care and precautions should be
A
taken in the disposal of items (syringes,
needles etc) used to reconstitute and/or
dilute cytotoxic medicinal products. Any
unused product or waste material should
be disposed of in accordance with local
requirements.
Actavis, Barnstaple, EX32 8NS, UK

Epirubicin Hydrochloride 50mg Powder PIL - UK
item no:

AAAE5945

dimensions: 130 x 600

print proof no: 8
origination date: 22-11-12
approved for print/date

pharmacode:
min pt size:

originated by:

BW

revision date:

17.06.13

Technical Approval

revised by:

SA

date sent: 22-11-12

supplier: Sindan

technically app. date: 23-11-12

colours/plates:
1. Black
2.
3.
4.
5.
6.
Non Printing Colours
1.
2.
3.

Expand view ⇕

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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