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MITOCIN 20 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE

Active substance(s): MITOMYCIN

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Mitocin Package leaflet:
Information for the user

mitocin 20 mg

mitocin 20 mg

MITOMYCIN

powder for solution for injection/infusion or
intravesical use
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

LF00000361

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
Mitomycin is used in cancer therapy for the relief
of symptoms (palliative cancer therapy).
Intravenous application
When administered intravenously it is used in
monochemotherapy, i.e. treatment with only one
active substance, or in combined cytostatic
chemotherapy, i.e. treatment with several active
substances. Mitomycin is effective in the case of
the following tumours:
• advanced metastatic stomach cancer (stomach
carcinoma)
• advanced and/or metastatic breast cancer
(breast carcinoma)
• cancer of the respiratory tract (non-small cell
bronchial carcinoma)
• advanced cancer of the pancreas (pancreatic
carcinoma)
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
systemic or intravesical use
• if you are hypersensitive (allergic) to mitomycin
or any of the other constituents of Mitocin.
• during breastfeeding
• in the case of systemic administration if
you suffer from a major reduction in the
number of all types of blood cells (including
red and white blood cells as well as platelets
[pancytopenia]), or an isolated reduction of
white blood cells (leucopenia) or blood platelets

(thrombocytopenia), a tendency to bleeding
(haemorrhagic diathesis) or acute infections
(disease caused by pathogens).
• in the case of intravesical administration
(application in the urinary bladder) 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 be
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 to have 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.

3. How to use Mitocin
Mitomycin should only be administered by
healthcare professionals experienced in this kind of
therapy.

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.

Mitomycin is intended to be used for injection or
infusion into a blood vessel (intravenous use) or
for introduction into the urinary bladder
(intravesical instillation) after being dissolved.

There are reports from animal experiments that
the effect of mitomycin 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 mytomycin.
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.

Your doctor will prescribe a dose and
treatment regimen that is right for you
Before you receive mitomycin as injection or
infusion into a vein a blood test, check of lung,
kidney and liver function is recommended to
exclude any diseases, which could worsen during
mitomycin therapy.
The needle must remain in the vein while
mitomycin is being given. If the needle comes out
or becomes loose, or the medicinal product is
going into the tissue outside the vein (you may feel
discomfort or pain) - tell the doctor or nurse
immediately.
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)
• Dyspnoe, 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 over the night (dysuria, pollakisuria,
nocturia)
• Blood in urine (hematuria)
• Local irritation of the bladder wall

Chemical and physical in-use stability of reconstituted
solution has been demonstrated at room temperature
and light effect with:
• 0.9% sodium chloride solution for 2 hours
• water for injections for 1 hour.
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

Rare side effects (fewer than 1 in 1,000, but more
than 1 in 10,000 patients)
• Widespread skin rash

6. Contents of the pack and other
information

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)

The active substance is mitomycin.
1 vial powder for solution for injection/infusion or
intravesical use contains 20 mg mitomycin. After
reconstitution with 40 ml water for injections 1 ml
solution for injection/infusion contains 0.5 mg
mitomycin. After reconstitution with 20 ml solvent
1 ml solution for intravesical use contains 1 mg
mitomycin

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.

What Mitocin contains

The excipients are:
Mannitol (Ph.Eur.),
hydrochloric acid 36% and sodium hydroxide for
pH adjustment

What Mitocin looks like and contents of the
pack
Mitomycin is a grey powder.
Mitocin, powder for solution for injection/infusion or
intravesical use is available in packs containing 1 amber
glass vial and packs containing 5 amber glass vials with
powder for solution for injection/infusion or
intravesical use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
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

and

Manufacturer
Chester Medical Solutions
3-4 Apex Court
Bassendale Road
Bromborough
Wirral CH62 3RE
United Kingdom
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Belgium
Mitomycin Speciality European Pharma 20 mg,
Poudre pour solution injectable ou pour perfusion
et pour administration intravésicale / Pulver zur
Herstellung einer Injektions- bzw. Infusionslösung
und Herstellung einer Lösung zur intravesikalen
Anwendung / Poeder voor oplossing voor injectie
of infusie en voor oplossing voor intravesicaal
gebruik

Espana
Mitocin 20 mg, Polvo para solución inyectable y
para perfusión y para solución intravesical

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

Finland
Mitocin 20 mg, Injektiokuiva-aine / Infuusiokuivaaine, liuosta varten, Liuos virtsarakkoon

General Information
It is essential that the injection is administered
intravenous. If the medicinal product is injected
perivasally, extensive necrosis occurs in the area
concerned. To
avoid
necrosis
following
recommendations apply:
• Always inject into large veins in the arms.
• Do not directly inject intravenously, but rather
into the tube of a good and securely running
infusion.
• Before removing the cannula after central
venous administration, flush it through for a
few minutes using the infusion in order to
release any residual mitomycin.

Germany
Mitocin 20 mg Pulver und Lösungsmittel zur
Herstellung einer Lösung zur intravesikalen
Anwendung
Italy
Mitomycina Pharma Resources 20 mg, Polvere per
soluzione iniettabile / infusione e per soluzione
endovescicale
Luxembourg
Mitomycin SEP 20 mg, Poudre pour solution
injectable ou pour perfusion et pour administration
intravésicale / Pulver zur Herstellung einer
Injektions- bzw. Infusionslösung und Herstellung
einer Lösung zur intravesikalen Anwendung
The Netherlands
Mitomycine SEP 20 mg, Poeder voor oplossing voor
injectie of infusie en voor intravesicaal gebruik
Norway
Mitomycin Speciality European Pharma 20 mg,
Pulver til injeksjons-/infusjonsvæske, oppløsning og
til intravesikal oppløsning
Sweden
Mitomycin SEP 20 mg, Pulver till injektions-/
infusionsvätska, lösning och till intravesikal lösning
United Kingdom
Mitocin 20 mg, Powder for solution for injection/
infusion or intravesical use
This package leaflet was last approved in
11/2013

If extravasation occurs, it is recommended that the
area is immediately infiltrated with sodium
bicarbonate 8.4% solution, followed by an injection
of 4 mg dexamethasone. A systemic injection of
200 mg of Vitamin B6 may be of some value in
promoting the regrowth of tissues that have been
damaged.
Contacts with the skin and mucous membranes
must be avoided.
Method of administration
Mitomycin is intended to be used for intravenous
injection or infusion or for intravesical instillation
after being dissolved.
Preparation of the ready-to-use solution for
injection or infusion
The contents of a vial of Mitocin 20 mg are
dissolved in 40 ml of water for injection purposes
by swirling.

If the powder does not dissolve immediately, allow
it to stand at room temperature until it has
completely dissolved. The contents of the vial must
be clear when dissolved within 2 minutes.
For intravenous infusion the solution of Mitocin 20
mg can be diluted in 40 ml of water for injection
with isotonic sodium chloride infusion solution
down to a concentration of 20 - 40 micrograms of
mitomycin/ml.
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 water for injections or
sodium chloride 9 mg/ml (0.9%) solution.
Incompatibilities
Incompatibilities occur with highly acidic or alkaline
substances. The optimum pH value for the readyto-use mitomycin solution is 7.0.
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.
- Mitocin must not be used in mixed injections.
- Other injection solutions or infusion solutions
must be administered separately.
- It is essential that the injection is administered
intravenous

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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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