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MITOCIN 20 MG POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION

Active substance(s): MITOMYCIN

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Package leaflet: Information for the user

mitocin 20 mg

powder and solvent for intravesical solution

mitocin 20 mg

MITOMYCIN

Active substance: mitomycin
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, 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

LF00000288

What is in this leaflet:
1. What Mitocin is and what it is used for.
2. What you need to know before you use Mitocin
3. How to use Mitocin
4. Possible side effects
5. How to store Mitocin
6. Contents of the pack and other information
1. What Mitocin is and what it is used for
Mitomycin is a medicine for the treatment of cancer,
i.e. a medicine which prevents or considerably
delays the division of active cells by influencing
their metabolism in various ways. The therapeutic
application of medicinal products for the treatment
of cancer is based on the fact that one way in which
cancer cells differ from normal cells in the body is
that the rate of cell division is increased due to a
lack of control of their growth.

Therapeutic Indications
Intravesical application
Application in the urinary bladder (intravesical
application) for the prevention of a relapse in the
case of superficial urinary bladder cancer after the
ablation of tissue through the urethra (transurethral
resection).
2. What you need to know before you use
Mitocin
Mitocin must not be administered in the
case of intravesical use
• if you are hypersensitive (allergic) to mitomycin
or any of the other constituents of Mitocin.
• during breastfeeding
• if you have perforation of the bladder wall
Warnings and precautions
Talk to your doctor or pharmacist before using
Mitocin
• if you are suffering from impaired lung, kidney
or liver function.
• if your general state of health is not good
• if you are undergoing radiation therapy
• if you are being treated with other cytostatics
(substances which inhibit cell growth/cell
division)
• if you have inflammation of the urinary bladder
(in case of intravesical administration).
• if you have been told that you have bone
marrow depression (your bone marrow is not
able to make the blood cells that you need); it
may get worse (especially in elderly and during
long term treatment with mitomycin); infection
may be aggravated due to bone marrow
depression and may lead to fatal conditions
• if you are capable of having a baby as mitomycin
may affect your ability to have children in the
future.

You will be given the treatment under the
supervision of a healthcare professional who is
experienced in this particular branch of medicine
to minimise any unwanted side effects in the
injection site.
Children and adolescents
The use of mitomycin in children and adolescents is
not recommended.
Other medicines and Mitocin
Tell your doctor or pharmacist if you are taking/
using, have recently taken/used or might take/use
any other medicines.
Through the additional use of other types of
therapy (in particular other anti-cancer medicines,
radiation) which also have harmful effects on you,
it is possible that the adverse effects of mitomycin
will be reinforced.
There are reports from animal experiments that
the effect of mitomycin is lost, if administered
together with Vitamin B6.
You should not get vaccinated, especially with live
vaccines during mitomycin treatment.
Please note that the above also applies to
medications used in the recent past.
Pregnancy, breastfeeding and fertility
Mitomycin should not be used during pregnancy.
Your doctor has to evaluate the benefit against the
risk of harmful effects on your child, if mitomycin
treatment during pregnancy is necessary.
Women of child-bearing age should avoid becoming
pregnant. Contraceptive measures must be taken
by both male and female patients during and for at
least six months after cessation of therapy. Still, if
you become pregnant during this period you must
immediately inform your doctor.

Breast-feeding must be discontinued before you
start to use mitomycin.
Driving and using machines
Even when used in accordance with instructions
this medicine may cause nausea and vomiting and
thereby reduce your reaction times to such an
extent that the ability to drive a motor vehicle
or operate machinery is impaired. This applies in
particular in conjunction with alcohol.
Mitocin 20 mg after reconstitution in the bag
containing the solvent, contains 3.08 mmol (70.8
mg) of sodium per 20 ml of solution. This should
be taken into consideration by patients on a
controlled sodium diet.
3. How to use Mitocin
Mitomycin should only be administered by
healthcare professionals experienced in this kind of
therapy.
Mitomycin is intended to be introduced into the
urinary bladder (intravesical instillation) after being
dissolved.
Your doctor will prescribe a dose and
treatment regimen that is right for you.
If you use more Mitocin than you should
If you have been accidentally given a higher dose you
may experience symptoms such as fever, nausea,
vomiting and blood disorders. Your doctor may give
you supportive treatment for any symptoms that
may occur.
If you have any further questions on the use of this
medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Possible side effects following administration
into a vein
Severe lung disease presenting as shortness of
breath, dry cough and crackles during breath-in
(interstitial pneumonia) as well as severe renal
dysfunction (nephrotoxicity) may occur. If you
notice any of the above reactions please inform
your doctor immediately because mitomycin
therapy must be stopped.
Very common side effects (more than 1 in 10
patients)
• Blood disorders: Inhibition of blood cell
production in the bone marrow; decreased
number of white blood cells (leucopenia)
increasing the risk of infections; decreased
number of platelets (thrombocytopenia) causing
bruises and bleedings
• Nausea, vomiting
Common side effects (fewer than 1 in 10, but more
than 1 in 100 patients)
• Lung disorders presenting as shortness of
breath, dry cough and inspiratory crackles
(interstitial pneumonia)
• Dyspnoea, cough, shortness of breath
• Skin rashes and irritation of the skin
• Numbness, swelling and painful redness on
palms and soles (palmar-plantar erythema)
• Kidney disorders (renal dysfunction,
nephrotoxicity, glomerulopathy, increased levels
of creatinine in the blood) - the kidneys may not
be able to work
• Inflammation of connective tissue (cellulitis)
and death of tissue (tissue necrosis) following
accidental injection into the surrounding tissue
(extravasation)
Uncommon side effects (fewer than 1 in 100, but
more than 1 in 1,000 patients)
• Inflammation of a mucous membrane
(mucositis)








Inflammation of the mucosa of the mouth
(stomatitis)
Diarrhoea
Hair loss (alopecia)
Fever
Loss of appetite (anorexia)

Rare side effects (fewer than 1 in 1,000, but more
than 1 in 10,000 patients)
• Life-threatening infection
• Blood poisoning (sepsis)
• Decrease in number of red blood cells
sometimes together with a acute renal
dysfunction (haemolytic anaemia,
microangiopathic-haemolytic anaemia (MAHA
syndrome), Haemolytic uraemic syndrome
(HUS))
• Loss of cardiac function (heart failure) after
previous therapy with other anti-cancer
medicines (anthracyclines)
• Increase in blood pressure in the vasculature
of the lungs, e,g, leading to shortness of breath,
dizziness and fainting (pulmonary hypertension)
• Obstructive disease of the pulmonary veins
(pulmonary veno-occlusive disease [PVOD])
• Liver disease (liver dysfunction)
• Increased levels of liver enzymes (transaminases)
• Yellowing of the skin and whites of the eyes
(icterus)
• Blockage of the small veins in the liver
(veno-occlusive disease [VOD] of the liver)
leading to fluid retention, increased liver size
and raised levels of bilirubin in the blood
• Widespread skin rash
Very rare side effects (fewer than 1 of 10,000
patients)
• Severe allergic reaction (symptoms may include
faintness, skin rash or hives, itching, swelling of
lips, face and airway with difficulty in breathing,
loss of consciousness)

Possible side effects following installation in
the bladder
Common side effects(fewer than 1 in 10, but more
than 1 in 100 patients)
• Skin rashes (exanthema, allergic skin rash,
contact dermatitis)
• Numbness, swelling and painful redness on
palms and soles (palmar-plantar erythema)
• Bladder inflammation (cystitis) - which may be
accompanied with blood in the bladder/urine
• Painful urination, excessive frequent urination
sometimes at night (dysuria, pollakisuria,
nocturia)
• Blood in urine (hematuria)
• Local irritation of the bladder wall
Rare side effects (fewer than 1 in 1,000, but more
than 1 in 10,000 patients)
• Widespread skin rash
Very rare side effects (fewer than 1 of 10,000
patients)
• Severe inflammation of the bladder where
portions of the bladder wall may undergo tissue
death (allergic cystitis, necrotizing cystitis)
• Stenosis of the efferent urinary tract
• Reduction in bladder capacity
• Hardening of bladder wall (bladder wall
calcification, bladder wall fibrosis)
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
5. How to store Mitocin
Do not store above 25°C.
Keep the vial in the outer carton in order to
protect from light.

Chemical and physical in-use stability of
reconstituted solution has been demonstrated at
room temperature and light effect with:
• sodium chloride 9 mg/ml (0.9%) solution (for
intravesical use) for 2 hours
All reconstituted solutions should be used
immediately.
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 folding box after
“EXP”. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment
6. Contents of the pack and other
information
What Mitocin contains
The active substance is mitomycin.
1 vial powder for intravesical solution contains 20
mg mitomycin. After reconstitution 1 ml intravesical
solution contains 1 mg mitomycin.
The excipients are:
Powder for intravesical use:
Mannitol (Ph.Eur.),
hydrochloric acid 36% and sodium hydroxide for
pH adjustment
Solvent for intravesical solution:
Sodium chloride and
water for injections.

What Mitocin looks like and contents of the
pack
Mitomycin is a grey powder.
Mitocin powder and solvent for intravesical solution
(instillation set) is available in packs with 1, 4 or 5
amber glass vials. Instillation sets for intravesical
instillation also include 1, 4 or 5 PVC bags with a
volume of 20 ml containing sodium chloride 9 mg/
ml (0.9%) solution (for intravesical use) and 1, 4 or
5 Tiemann catheters.
Not all pack sizes may be marketed.

Espana
Mitocin 20 mg, Polvo y disolvente para solución
intravesical

------------------------------------------------------------

Finland
Mitocin 20 mg, Injektiokuiva-aine ja liuotin, Liuos
virtsarakkoon

General Information
Contacts with the skin and mucous membranes
must be avoided.

Germany
Mitocin 20 mg Pulver und Lösungsmittel zur
Herstellung einer Lösung zur intravesikalen
Anwendung

Method of administration

The following information is intended for
medical or healthcare professionals only:

Preparation of the ready-to-use solution for
intravesical administration
The contents of 1 - 2 vials of Mitocin 20 mg are
dissolved in 20 - 40 ml of sodium chloride 9 mg/ml
(0.9%) solution (for intravesical use).

Marketing Authorisation Holder and
Manufacturer

Italy
Mitomycina Pharma Resources 20 mg, Polvere e
solvente per soluzione endovescicale

Marketing Authorisation Holder
Speciality European Pharma Limited

14 Took’s Court, London EC4A 1LB

Tel: +44 (0)20 7421 7400

Fax: +44 (0)20 7421 7401


Luxembourg
Mitomycin SEP 20 mg, Poudre et solvant pour
administration intravésicale / Pulver und
Lösungsmittel zur Herstellung einer Lösung zur
intravesikalen Anwendung

For the use of the instillation set of Mitocin 20
mg the corresponding instructions for use must
be followed. The sodium chloride 9 mg/ml (0.9%)
solution (for intravesical use) in the bag is used for
preparation of the reconstituted solution.

Manufacturer
Chester Medical Solutions
3-4 Apex Court
Bassendale Road
Bromborough
Wirral CH62 3RE
United Kingdom

The Netherlands
Mitomycine SEP 20 mg, Poeder en oplosmiddel
voor oplossing voor intravesicaal gebruik

Incompatibilities
Incompatibilities occur with highly acidic or alkaline
substances. The optimum pH value for the readyto-use mitomycin solution is 7.0.

This medicinal product is authorised in
the Member States of the EEA under the
following names:

Sweden
Mitomycin SEP 20 mg, Pulver och vätska till
intravesikal lösning

Belgium
Mitomycin Speciality European Pharma 20 mg,
Poudre et solvant pour administration intravésicale
/ Pulver und Lösungsmittel zur Herstellung einer
Lösung zur intravesikalen Anwendung / Poeder en
oplosmiddel voor oplossing voor intravesicaal
gebruik

Norway
Mitomycin Speciality European Pharma 20 mg,
Pulver og væske til intravesikal oppløsning

United Kingdom
Mitocin 20 mg, powder and solvent for intravesical
solution
This package leaflet was last approved in
11/2013

Note
• All reconstituted solutions are intended for
immediate use!
• Only clear solutions may be used.
• The contents of the vials are intended for
single use only.
• Unused solutions are to be discarded.

•••

1

2

Place the violet adapter centrally
and vertically on the rubber
stopper and press the violet
adapter into the rubber stopper
of the vial until it locks into
place.

Remove the white cap from the
vial.

Take the Mitocin vial out of the
folding box.

•••

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Instructions for use
for the solvent for
intravesical solution
(instillation set)
Remove the bag with the sodium
chloride 9 mg/ml (0.9%) solution
(for intravesical use) out of the
transparent protective film.
The white clip below the bag
containing the sodium chloride 9
mg/ml (0.9%) solution (for
intravesical use) should be and
remain open.
Pull the protective cap off the
violet adapter. Ensure that the
disposal bag is readily available.

Blue connector
for catheter

Clip open

Bag with
sodium
chloride
solution

Violet
connector
Glass vial

•••

3

Bend the part of the violet
adapter located in the tube at
the predetermined breaking
point backwards and forwards
until the cone breaks off and the
connection is open.

Sharp cone
ined
term
Prede g point
in
break

•••

4

Hold the solvent-containing bag
with the vial facing downwards.
Squeeze the bag together several times until the solvent has
flowed into the vial.

•••

5
Turn the vial upwards.

Press the air out of the solvent
bag into the vial: if the pressure
falls, the mitomycin solution
collects in the bag.

Repeat this step once or twice if
necessary. It is acceptable for a
small residue of the liquid to
finally remain in the Mitocin vial.

•••

6

When you have inserted the
catheter into the urethra /
bladder and would like to begin
with the instillation, pull the
transparent cap off the blue
catheter adapter. Then push the
blue catheter adapter firmly into
the green attachment of the
catheter.

•••

7

Break off the blue catheter adapter in the tube section at the
predetermined breaking point in
such a way that the mitomycin
solution can flow through the
catheter into the bladder.

In order to prevent subsequent
trickling you can close the clip
after instillation.

Please use the disposal bag to dispose of
all parts which have come into contact
with the mitomycin solution in the special
waste.

ined
term
Prede g point
in
break

151138 Mitem 20mg LF00000290_v5_151138 Mitem 20mg LF00000290_v4 05/06/2013 16:03 Page 5

L F 00000290

Instructions for use

for the solvent for
intravesical solution
(instillation set)

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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