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EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): EPIRUBICIN HYDROCHLORIDE

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Package leaflet: infor mation for the user
Epirubicin 2 mg/ml solution for injection or infusion
(Epirubicin hydrochloride)
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 or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist
In this leaflet:
1.
What Epirubicin 2 mg/ml solution for injection or infusion is and what it is used for?
2.
Before you use Epirubicin 2 mg/ml solution for injection or infusion.
3.
How to use Epirubicin 2 mg/ml solution for injection or infusion?
4.
Possible side effects.
5.
How to store Epirubicin 2 mg/ml solution for injection or infusion?
6.
Further information.
1.

WHAT EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION OR INFUSION
IS AND WHAT IT IS USED FOR?

Medicinal product group
Epirubicin belongs to the group of cytostatics (products to fight cancer).
Epirubicin makes sure that cancer cells cannot grow any more, which eventually kills them.
Epirubicin is administered for the treatment of:
breast cancer;
stomach cancer;
Epirubicin is also used intravesically (directly into the bladder) to treat early
(superficial) urinary bladder cancer and help prevent recurrence of bladder cancer after
surgery.
Epirubicin is often used concomitantly with other cancer fighting medicinal products (in socalled po1ychemotherapy schedules).
2.
BEFORE YOU USE EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION OR
INFUSION.
Do not use Epirubicin 2 mg/mL solution for injection or infusion
if you are allergic (hypersensitive) to epirubicin, similar me dicines ( called
anthracyclines, s ee be low) or a ny of t he ot her i ngredients of Epirubicin 2 m g/ml
solution for injection or infusion;
if you have been treated before with high doses of some other anti-cancer medicines
including dox orubicin a nd daunorubicin which belong t o t he s ame group of d rugs as
Epirubicin ( called anthracyclines). They ha ve s imilar s ide ef fects ( including t hose
effects on the heart);

-

if you suffered or currently have heart problems;
if you are breast feeding;
if you have a low blood count;
if you have a severe liver function disorder;
if you suffer from an acute severe infection.

When administered intravesically (directly into the bladder), Epirubicin 2 mg/ml solution for
injection or infusion should not be used if:
the cancer has penetrated the bladder wall;
you have an infection in your urine tract;
you have pain or inflammation in your bladder;
your doctor has problems inserting a catheter (tube) into your bladder;
there is a large volume of urine left in your bladder after you attempt to empty it;
if your urine contains blood;
if you have a contracted bladder.
Take special care with Epirubicin 2 mg/ml solution for injection or infusion
if you are elderly or a child, because of the higher risk of severe cardiac side effects.
Your cardiac function will be checked before and after the treatment with epirubicin.
if you have had problems with your heart in the past or if you are currently
experiencing such problems. You should inform your doctor. The dose of epirubicin
will have to be adjusted. Your doctor will regularly check if your heart is working
properly.
if you have previously been treated with products to fight cancer (such as with
doxorubicin or daunorubicin or anthracenedion derivatives) or if you have had
radiation, because the risk of severe cardiac side effects is greater. Inform your doctor
because this is included in determining the total dose of epirubicin you will be
administered.
if you have a liver or kidney disorder. This may cause an increase in side effects. Both
the kidney function and the liver function will be checked regularly and if needed the
dose will be adjusted.
if you desire to have children. Both men and women should use effective
contraceptive measures both during and for 6 months after the treatment. Men are
advised to request information about the possibility of storing sperm by means of
freezing before the treatment.
if you suffer from infections or bleedings. Epirubicin may affect the bone marrow.
The number of white blood cells in your blood will be reduced, which makes you more
susceptible to infections (leucopoenia). Bleedings can occur more easily
(thrombocytopenia). These side effects are temporary in nature. The reduction of the
number of white blood cells is greatest 10-14 days after the administration and usually
returns to normal 21 days after the administration.
if you have recently received or want to receive any vaccination.
to check the level of uric acid in your blood. Your doctor will check this.
to ensure the number of cells in your blood does not drop too low. Your doctor will
regularly check this.
if you are experiencing severe inflammation or ulcers in your mouth.
if you have received or are receiving radiotherapy to the chest area.
if you get a burning feeling at the site of the administration. This could indicate that
epirubicin is leaking outside the blood vessel. Warn your doctor about this.
Please consult your doctor if one of the above mentioned warnings is applicable to you,

or has been applicable to you in the past.
Using other medicines
Attention: the following remarks may also be applicable to the recent use of medicinal
products or their use in the near future.
The medicines mentioned in this section may be known to you under a different name, often
the br and na me. In t his s ection onl y t he a ctive i ngredient(s) of t he m edicinal pr oduct i s
mentioned, not t he br and na me! T herefore always carefully read on t he package or i n t he
patient leaflet what the active ingredient is of the medicines you are using.
An interaction means t hat ( medicinal) pr oducts that ar e us ed together c an influence each
other's effect and/ or side effect. An interaction can occur with the concomitant use of this
solution and:
the harmfulness to the heart can increase with prior or concomitant administration of
other pr oducts r elated t o e pirubicin, so-called anthracyclines (for i nstance t he can cer
fighting me
dicines
mitomycin-C, d
acarbazine, d
actinomycin
and
cyclophosphamide)or other me dicines th at may a ffect the he art (for instance t he
cancer f ighting m edicines 5-fluorouracil, c yclophosphaminde, c isplatin, t axanes).
Extra monitoring of the heart is then necessary.
epirubicin can increase the effect of radiation and even after quite some time after the
radiation it can cause serious side effects in the irradiated area.
rifampicin (product us ed f or t he t reatment of t uberculosis) a nd barbiturates
(products that are us ed for insomnia or epilepsy, such as for instance phenobarbital);
these products decrease the amount of epirubicin in the blood, which could lead to a
reduced effect of epirubicin.
paclitaxel and docetaxel (products that are used for some cancers); when paclitaxel is
administered before epi rubicin or doc etaxel i s adm inistered immediately a fter
epirubicin, the amount of epirubicin in the blood is increased, which could lead to an
increase of the side effects.
dexverapamil (a p roduct t hat i s us ed t o t reat some c ardiac di sorders); w hen us ed
together with epirubicin it may have a negative effect on bone marrow.
interferon a2b (a pr oduct us ed i n s ome c ancers a nd l ymphomas a nd s ome f orms of
hepatitis).
quinine (a pr oduct us ed f or t reatment of m alaria a nd f or l eg cramps); quinine m ay
speed up the distribution of epirubicin into the body, which may have a negative effect
on the red blood cells.
dexrazoxane (a product sometimes used with doxorubicin to reduce the risk of heart
problems); t he t ime t hat e pirubicin i s pr esent i n t he bod y m ay b e de creased, w hich
could lead to decreased effect of epirubicin.
cimetidine (a product to reduce the acid in your stomach); the amount of epirubicin in
the blood is increased, which could lead to an increase of the side effects.
previous or c oncomitant t reatment w ith ot her products w hich i nfluence t he bone
marrow ( for i nstance other pr oducts to treat can cer, sulfonamide,
chloramphenicol, diphenylhydantoin, amidopyrine-derivate, p roducts agai nst
certain virus); the formation of blood cells can be disturbed.
products that cause heart failure.
products that influence the liver function; the degradation of epirubicin by the liver
may be influenced, which may caus e a r educed effect of epirubicin or an increase of
the side effects.
live vac cines; there i s r isk of f atal di sease t herefore t his c ombination i s not
recommended.

-

cyclosporine (a product that suppresses the immune system); the immune system may
be suppressed to much.

Please t ell your doc tor or pha rmacist i f you a re us ing or ha ve r ecently used any ot her
medicines, including medicines obtained without a prescription.
Using Epirubicin 2 mg/ml solution for injection or infusion with food and drink
You s hould not dr ink w ithin 12 hour s be fore a pplication w hen epirubicin w ill be
administered in the bladder.
Pregnancy and breast-feeding
Pregnancy
Medicines t o f ight cancer a re onl y administered du ring pr egnancy in extreme cas es. The
benefits for the mother must be weighed against the possible danger to the unborn child. In
animal studies epirubicin proved to be harmful to the unborn child and can cause deformities.
Both m en and w omen s hould us e good contraceptive m easures ( pill, c ondom) bot h dur ing
and for 6 months after the use of this medicine to prevent pregnancy.
You should also prevent pregnancy if you partner is treated with epirubicin.
If pregnancy occurs during treatment with epirubicin, genetic counselling is recommended.
Men w ho w ish t o f ather c hildren i n t he f uture s hould s eek a dvice a bout f reezing s perm
before treatment with epirubicin is started.
Breast feeding
It i s not know n w hether e pirubicin i s e xcreted i n t he br east m ilk. Y ou should di scontinue
breast-feeding during treatment with Epirubicin 2 mg/ml solution for injection or infusion.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Because many people get very nauseous or have to vomit during the treatment, driving and
using machines is not recommended.
Important information about some of the ingredients of Epirubicin 2 mg/ml solution
for injection or infusion
This medicinal product contains 3.5 m g sodium per ml solution for injection or infusion. To
be taken into consideration by patients on a controlled sodium diet.
3.
HOW TO U SE EPIRUBICIN 2 MG/ML SOLUTION F OR I NJECTION O R
INFUSION
Epirubicin 2 m g/ml s olution f or i njection or i nfusion will onl y be given t o you und er
supervision of a doc tor s pecialised i n t his t ype of t reatment. Y ou s hould c heck w ith your
doctor or pharmacist if you are not sure.
The dose you are administered will depend on the type of cancer you have, your health, your
age, how well your liver functions and other medicines you are taking.
The usual dose is
Depending on your general health and possible previous treatments the dose schedule is
determined, whereby your length and your weight are taken into account. The amounts in the
dose schedule are expressed in numbers of milligrams per square metre of body surface area.

This medicine will be administered as
• an injection in a vein for 3 - 5 minutes
or
• an infusion in a vein for a maximum of 30 minutes.
If onl y e pirubicin i s a dministered, s o w ithout ot her c ancer medicines, the r ecommended
dose i s 60-90 m g/m² of bod y surface a rea. T his dos e i s administered as a s ingle dos e o r
distributed over 2-3 consecutive days. This is repeated every 21 days. In combination with
other cancer medicines the dose is reduced.
The administration occurs via a catheter or side line of a free running infusion of a sodium
chloride or glucose (sugar solution).
Higher doses are used for the treatment of
• lung cancer: 120 mg/m² of body surface area and
• might be given for the treatment breast cancer: 100 - 120 mg/m² of body surface area.
Administration via the bladder (intravesical administration)
The product can be given directly into the bladder (for the treatment of bladder cancer) by
means of a catheter. If this method is used, you must not drink any liquids for 12 hours
before t he t reatment, s o your u rine w ill not di lute t he m edicine t oo m uch. T he di ssolved
medicine should be kept in your bladder for 1 hour after it has been administered. You will
have t o c hange your pos ition oc casionally t o make s ure t he m edicine r eaches al l pa rts of
your bladder.
When you empty your bladder after the medicine has been given, make sure that your urine
does not get in contact with your skin. In case contact does take place, thoroughly wash the
site of contact with water and soap but do not scrub.
While epirubicin is being administered to you your doctor will perform blood tests. This is to
measure the effect of the medicine. Your doctor will also perform tests to see how your heart
functions. Both blood test and heart function tests are done before and during treatment with
epirubicin.
If you notice that Epirubicin 2 m g/ml solution for injection or infusion is too strong or too
weak, consult your doctor or pharmacist.
If m ore Epirubicin 2 mg/ml s olution for i njection or i nfusion was a dministered t han
should have been
Because t his m edicine i s adm inistered by m edical pe rsonnel t he risk of an overdose i s
unlikely. Immediately contact your doctor if you suspect that too much Epirubicin 2 mg/ml
solution for injection or infusion has been administered.
If you forget to use Epirubicin 2 mg/ml solution for injection or infusion
Because this medicine is administered by medical personnel it is unlikely that a dose is
missed.
You should check with your doctor if you are not sure.
If you stop using Epirubicin 2 mg/ml solution for injection or infusion
Consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all me dicines Epirubicin 2 m g/ml s olution f or i njection or i nfusion can cause s ide
effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist immediately.
The following side effects can, amongst others, occur:

More t han 10 % of t reated pa tients c an expect t o de velop und esirable e ffects. The m ost
common undesirable effects are
- myelosuppression,
- gastrointestinal side effects,
- anorexia,
- alopecia,
- infection.
Very common (affects more than 1 user in 10)
Blood: Bone marrow depression is an abnormality in the blood, which means that fewer new
blood c ells a re pr oduced ( resulting i n a s hortage of w hite bl ood c ells, r ed bl ood c ells,
platelets; r educed number of a t ype o f w hite b lood c ell ( neutrophilic g ranulocytes) w ith
fever), and which involves an increased sensitivity to infections (due to a shortage of white
blood cells (leucopoenia)) and anaemia. Your blood must be checked regularly.
Skin: Hair loss (alopecia, in 60-90% of treated cases. It involves poor beard growth in men.
Hair loss is dose-dependent and in most cases reversible)
Kidneys and urinary tract: Red coloration of urine for 1 to 2 days after administration
Common (affects 1 to 10 users in 100)
Infections: Infection
Immune s ystem: A llergic r eactions a fter int ravesical a dministration ( directly int o the
bladder).
Blood ve ssels: Hot f lashes, t hickening or hardening of t he w alls of t he ve ins
(phlebosclerosis)
Gastrointestinal system: Mucous membrane inflammation (mucositis (can occur 5 to 10 days
after the start of the treatment)), inflammation of the mucous membrane of the oesophagus
(esophagitis), inflammation of the muc ous me mbrane o f the mout h (stomatitis), vomiting,
diarrhoea which c an result i n dehydration, nausea (nausea and vom iting often occur within
the first 24 hours (in nearly all patients),loss of appetite (anorexia)
Kidneys a nd ur inary tract: Bladder i nfection, inflammation of t he bl adder, s ometimes
bleeding, local r eactions lik e bur ning s ensations a nd f requent ur ge t o u rinate ha ve be en
observed after administration into the bladder
Other: Redness at infusion site
Uncommon (affects 1 to 10 users in a 1000)

Blood: bruising and a tendency to bleed (due to shortage of platelets (thrombocytopenia))
Blood vessels: Redness along the veins (phlebitis), vascular inflammation with the forming
of a bl ood clot, of ten f elt a s a pa inful s omewhat ha rd c ore with a bove i t r ed s kin
(thrombophlebitis)
Rare (affects 1 to 10 users in 10,000)
Immune s ystem: S evere, imme diate a llergic reaction (anaphylactic/anaphylactoid reaction)
with or without shock including skin rash and itching; fever and chills.
Nervous system: Dizziness
Heart: Risk of a r educed e ffect of t he he art with a s a r esult c ongestion of t he bl ood
(congestive heart failure), heart fai1ure ( dyspnoea; accumulation of fluid in the whole body (
oedema), enlargement of the liver, accumulation of fluid in the lungs (ascites), accumulation
of f luid i n t he l ungs ( pulmonary oedema, pl eural e ffusions), abnormal rhythm of t he he art
(gallop rhythm) cardiotoxicity ( e.g. ECG a bnormalities, arrhythmias, heart mus cle di sease
(cardiomyopathy)), i ncreased f requency of he art be at arising f rom l ower c hambers of t he
heart ( ventricular t achycardia), slow he art r hythm ( bradycardia), c essation of i mpulse
transmission in the heart (AV block, bundle-branch block).
Skin: Skin rash with formation of little bum ps ( urticaria) or w ith severe itc hing ( pruritis),
redness along the vein that was used for the injection.
Kidneys and urinary tract: Increased bloodlevel of uric acid (hyperurecemia)
Sexual organs: Absence of menstruation, lack of sperm cells in sperm
Other: Concomitant administration of certain medicines for fighting cancer (so-called DNAdamaging antineoplastic substances) can in rare cases lead to certain forms of cancer of the
blood ( secondary a cute myeloid l eukaemia ( AML) w ith or w ithout pr e1eucaemic pha se).
These c ertain f orms of c ancer of t he bl ood c an onl y b e obs erved a fter 1 -3 years, Malaise,
weakness, (extremely high) fever, chills, changes in levels of certain enzymes (transaminase)
Not known (frequency cannot be estimated from the available data)
Infections: Blood poisoning (sepsis) and shock as a result of blood poisoning, pneumonia
Blood: Bleeding, shortage of oxygen in tissue
Nervous system: Certain disorder of the nerves (peripheral neuropathy), headache
Eyes: Inflammation of the eye (conjunctivitis or keratitis)
Heart: Decrease of fraction of bl ood pum ped out of a v entricle with e ach he art be at
(asymptomatic drops in left ventricular ejection fraction)
Blood ve ssels: Shock, f orming of bl ood c lots ( thromboembolism), i ncluding bl ood c lot
formation in the lungs (pulmonary emboli, in very rare cases this resulted in death)
Skin: Local r eactions, r ash, i tch, s kin changes, redness, flushes, c hanges i n s kin a nd n ail
(hyperpigmentation), sensitivity to light (photosensitivity) or allergic reaction in the case of
radiation (radiation-recall reaction)
Kidneys and urinary tract: Increased amount of proteins in urine (proteinuria) in patients who
were treated with a high dose
Severe s ide e ffects w hich affect t he w hole bo dy and allergic r eactions ar e r are w hen
Epirubicin 2 mg/ml solution for injection or infusion is given into the bladder.
If any of the side effects gets serious, or if you notice an y side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5.
HOW TO S TORE EP IRUBICIN 2 MG/ML SOLUTION F OR I NJECTION O R
INFUSION
Store in a refrigerator (2°C - 8°C).
Store and transport refrigerated.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
After first opening the product should be used immediately.
After dilution (in 0,9 % (9 mg/ml) sodium chloride or 5 % (50 mg/ml) glucose solution) to a
concentration of 0,1 mg/ml chemical and physical in-use stability has been demonstrated for
4 days at 25°C and for 14 days at 2-8°C.
After dilution (in 0,9 % (9 mg/ml) sodium chloride or 5 % (50 mg/ml) glucose solution) to a
concentration of 1.0 mg/ml chemical and physical in-use stability has been demonstrated for
7 days at 25°C and for 14 days (0,9 % (9 mg/ml) sodium chloride) or 7 days (5 % (50 mg/ml)
glucose solution) at 2-8°C.
From a m icrobiological point of vi ew, t he pr oduct s hould be us ed i mmediately after f irst
penetration of t he r ubber s topper. If not us ed imme diately, in-use s torage t imes and
conditions pr ior t o us e are t he r esponsibility of t he us er a nd w ould nor mally not be l onger
than 24 hours at 2 to 8°C.
Storage of the solution for injection at refrigerated conditions can result in the formation of a
gelled product. This gelled product will return to a slightly viscous to a mobile solution after
two to a maximum of four hours equilibration at controlled room temperature (15-25°C).
Keep out of the reach and sight of children!

Do not us e Epirubicin 2 m g/ml s olution f or i njection or i nfusion after t he ex piry date
mentioned on t he pa ckage after “exp.” The f irst 2 num bers i ndicate t he m onth; the la st
numbers indicate the year. The expiry date refers to the last day of that month.
Do not us e Epirubicin 2 m g/ml s olution for i njection or i nfusion if you see vi sual s igns of
deterioration
Medicines s hould not be di sposed of vi a w astewater or hous ehold waste. A sk your
pharmacist how t o di spose of m edicines no longer r equired. T hese m easures w ill he lp t o
protect the environment.
6.

FURTHER INFORMATION

What Epirubicin 2 mg/ml solution for injection or infusion contains
The active substance is epirubicin hydrochloride; 1 ml contains 2 mg epirubicin
hydrochloride.
The other ingredients (excipients) are sodium chloride, hydrochloric acid and water for
injections.
What Epirubicin 2 mg/ml solution for injection or infusion looks like and contents of
the pack
Epirubicin 2 mg/ml solution for injection or infusion is a medicine in the form of a clear red
solution for injection or infusion. It is delivered in glass injection vials with 25 ml (50 mg) or

100 ml (200 mg) of solution for injection or infusion.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Manufacturer
Agila Specialties Polska Sp z o o
10, Daniszewska Str
03-230 Warsaw
Poland
This leaflet was last revised in 04/2015

The following information is intended for medical and healthcare professional only:
PREPARATION GUIDE FOR USE WITH EPIRUBICIN, SOLUTION FOR
INJECTION OR INFUSION
It is important that you read the entire contents of this procedure prior to the preparation of
either the Epirubicin 2 mg/ml solution for injection or infusion.
1.

FORMULATION

Epirubicin hydrochloride 2 mg per ml solution for injection or infusion.
Excipients:
sodium chloride
hydrochloric acid, for pH adjustment
water for injections
2.

PRESENTATION

Store in a refrigerator (2°C - 8°C).
Store and transport refrigerated.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
After first opening the product should be used immediately.
After dilution (in 0,9 % (9 mg/ml) sodium chloride or 5 % (50 mg/ml) glucose solution) to a
concentration of 0,1 mg/ml chemical and physical in-use stability has been demonstrated for
4 days at 25°C and for 14 days at 2-8°C.
After dilution (in 0,9 % (9 mg/ml) sodium chloride or 5 % (50 mg/ml) glucose solution) to a
concentration of 1.0 mg/ml chemical and physical in-use stability has been demonstrated for
7 days at 25°C and for 14 days (0,9 % (9 mg/ml) sodium chloride) or 7 days (5 % (50 mg/ml)
glucose solution) at 2-8°C.

From a m icrobiological point of vi ew, t he pr oduct s hould be us ed i mmediately after fi rst
penetration of t he r ubber s topper. If not us ed i mmediately, i n-use s torage t imes and
conditions pr ior t o us e are t he r esponsibility of t he us er a nd w ould nor mally not be l onger
than 24 hours at 2 to 8°C.
Storage of the solution for injection at refrigerated conditions can result in the formation of a
gelled product. This gelled product will return to a slightly viscous to a mobile solution after
two to a maximum of four hours equilibration at controlled room temperature (15-25°C).
2.1

Epirubicin hydrochloride vial:

Epirubicin 2 mg/ml solution for injection or infusion is delivered in amber coloured, 30 ml or
100 m l Type 1 moulded glass vi als w ith fluorinated pol ymer coated bromobutyl rubber
stopper and flip off a luminium s eal, w ith r esp. 25 ml a nd 100 m l s olution f or i njection or
infusion.
Each carton contains a single vial.
Not all pack sizes may be marketed
2.2

Solvent for epirubicin hydrochloride

Epirubicin 2 mg/ml solution for injection or infusion can be diluted in NaCl 0.9% (9 mg/ml)
or Glucose 5% (50 mg/ml) and be administered intravenously. The solution must be prepared
immediately prior to use.
For intravesical administration the product must be diluted with NaCl 0.9% (9 mg/ml) or
sterile water. The concentration of the dilution has to be 0.6-2.6 mg/ml.
3.

RECOMMENDATIONS FOR THE SAFE HANDLING

If an infusion solution is to be prepared, this should be performed by trained personnel under
aseptic conditions.
Preparation of an infusion solution should be performed in a designated aseptic area.
People w orking w ith Epirubicin 2 m g/ml s olution f or i njection o r i nfusion are r equired t o
wear protective gloves, safety goggles and a mask.
Epirubicin 2 mg/ml solution for injection or infusion can be diluted in NaCl 0.9% (9 mg/ml)
or Glucose 5% (50 mg/ml) and be administered intravenously. The solution must be
prepared immediately prior to use.
For intravesical administration the product must be diluted with NaCl 0.9% (9 mg/ml) or
sterile water. The concentration of the dilution has to be 0.6-2.6 mg/ml.
The red solution should be clear and transparent.
Epirubicin 2 m g/ml s olution f or i njection o r i nfusion contains no p reservatives and i s
therefore onl y s uitable f or s ingle us e. A fter us e the unus ed r emainder s hould be de stroyed
according to the regulations for cytostatic agents. See also “Disposal”.
Inactivation of s pilled o r l eaked m edicinal pr oduct c an be obt ained w ith a 1 % s odium

hypochlorite solution or simply with a phosphate buffering agent (pH >8) until the solution
is deco1ourised. All cleaning materials are disposed of as mentioned under “Disposal”.
Pregnant women must avoid contact with cytostatic agents.
Excreta and vomit should be cleaned up with care.
In case of contact with eyes, wash them thoroughly with plenty of water.
Contact an ophthalmologist immediately.
In case o f s kin c ontact, thoroughly w ash the affected area with soap and water or s odium
bicarbonate solution. However, do not abrade the skin by using a scrub brush. Always wash
hands after removing gloves.
A damaged vial must be treated with the same precautions and must be considered as
contaminated waste. Contaminated waste must be stored in appropriate specially marked
waste containers. See under “Disposal”.
4.

PREPARATION OF THE SOLUTION

Epirubicin is only intended for intravenous or intravesical use.
4.1

PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

Epirubicin 2 mg/ml solution for injection or infusion can be diluted in NaCl 0.9% (9 mg/ml)
or Glucose 5% (50 mg/ml) and be administered intravenously. The solution must be
prepared immediately prior to use.
The concentration of the dilution has to be 0.6-2.6 mg/ml.
It is advisable that the red solution, which should be clear and transparent, is injected via the
catheter of a free running intravenous infusion of NaCl 0,9 % (9 mg/ml) or Glucose 5% (50
mg/ml) over a pe riod o f up t o a dur ation of 30 minutes ( depending on t he dos e a nd t he
volume of t he infusion). T he ne edle s hould be pr operly placed i n t he v ein. T his m ethod
reduces t he r isk of t hrombosis a nd e xtravasation that coul d lead to s evere cel lulites a nd
necrosis. In case of extravasation, administration should be stopped immediately. Injection
in small veins and repeated injection in the same vein can lead to venous sclerosis.
For t he t reatment with a hi gh dos e epirubicin c an be administered as an intravenous bol us
over 3 - 5 minutes or as an infusion up to 30 minutes duration.
4.2

PREPARATION FOR THE INTRAVESICAL ADMINISTRATION

For intravesical administration Epirubicin 2 mg/ml solution for injection or infusion must be
diluted with NaCl 0.9% (9 mg/ml) or sterile water. The concentration of the dilution has to
be 0.6-2.6 mg/ml.
DILUTION TABLE FOR BLADDER INSTILLATION SOLUTIONS
Dose epirubicin
required

Volume of 2 mg/ml
epirubicin injection

Volume of diluent
sterile water for
injection or 0.9% (9
mg/ml) NaCl

Total volume of
bladder instillation

30 mg
50 mg
80 mg
5.

15 ml
25 ml
40 ml

35 ml
25 ml
10 ml

50 ml
50 ml
50 ml

DISPOSAL

Any unused product, all materials used in the preparation and administration, or which have
come in contact with epirubicin hydrochloride in any way, must be destroyed in accordance
with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

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