40 mg powder and liquid for intravesical solution
mitomycin
What Mitomycin medac is and what it is used for
Mitomycin medac is a medicine used to treat cancer. The drug prevents or significantly delays the division of active cells by affecting their metabolism in various ways ( cytostatics ). When using chemotherapy drugs in cancer treatment, the fact is that cancer cells differ from normal cells in the body, among other things through faster cell division. This is due to a lack of control over the growth of cancer cells.
Areas of use
Mitomycin medac is inserted into the bladder ( intravesical application) to prevent the recurrence of superficial bladder cancer after tissue affected by cancer has been removed through the urethra ( transurethral resection ).
Mitomycin contained in Mitomycin medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Mitomycin medac
Only a doctor who has experience with this type of treatment will prescribe this medicine for you. Your doctor will decide which type of treatment is right for you.
Do not use Mitomycin medac
- if you are allergic to mitomycin or any of the other ingredients of this medicine (listed in section 6),
- if you are breast-feeding: you must not breast-feed during treatment with mitomycin,
- if you have a perforated bladder wall,
- if you have an inflammation of the bladder ( cystitis ).
Warnings and cautions
Talk to your doctor or pharmacist before using Mitomycin medac.
Special care is required when using Mitomycin medac
- if you have a bad general condition
- if you have impaired lung, kidney or liver function
- if you are receiving radiation therapy
- if you are being treated with other chemotherapy drugs (substances that prevent cell growth / cell division)
- if you have been told that you have bone marrow depression (your bone marrow cannot make the blood cells you need). It may worsen (especially in the elderly and during long-term treatment with mitomycin); Infection can be exacerbated due to a low number of blood cells and lead to life-threatening conditions
- if you are of childbearing potential , as mitomycin may affect your ability to have children in the future.
Tell your doctor immediately if you experience abdominal pain or pain in the pelvic area that occurs immediately after or weeks or months after using Mitomycin medac in the bladder. Your doctor may need to have an ultrasound scan of your abdomen to find out the cause of your pain.
Mitomycin is a substance that can cause significant hereditary changes in the genome and possibly cause cancer in humans.
Avoid contact with skin and mucous membranes.
Read the instructions for general hygiene after an intravesical instillation into the bladder:
It is recommended that you sit down when urinating to avoid splashing urine and that you wash your hands and the area around the genitals after urinating. This is especially true the first time you urinate after the administration of mitomycin.
Children and young people
The use of Mitomycin medac in children and adolescents is not recommended.
Other medicines and Mitomycin medac
There are no known interactions with other drugs and mitomycin given in the bladder ( intravesical administration ).
Possible interaction during injection or infusion into a blood vessel ( intravenous administration )
If other treatments (especially other anti-cancer drugs, radiation) that also have a detrimental effect on the bone marrow are used at the same time, the harmful effects of mitomycin on the bone marrow may be intensified.
Combination with vinca alkaloids or bleomycin (medicines belonging to the group of chemotherapy drugs ) may aggravate the harmful effect on the lungs.
An increased risk of a specific form of kidney disease (hemolytic uremic syndrome ) has been reported in patients receiving concomitant intravenous mitomycin and 5-fluorouracil or tamoxifen.
There are reports from animal experiments that the effect of mitomycin is lost if given together with vitamin B 6.
You should not be vaccinated with live vaccines during treatment with mitomycin, as this may put you at increased risk of becoming infected with the live vaccine.
The harmful effect on the heart of Adriamycin (doxorubicin, a drug belonging to the group of chemotherapy drugs ) may be exacerbated by mitomycin.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Mitomycin can cause hereditary genetic damage and harm fetal development.
You must not become pregnant during treatment with mitomycin: if you become pregnant, you must receive genetic counseling.
You should not use mitomycin during pregnancy.
If treatment with mitomycin is necessary during pregnancy, your doctor must assess the benefit with the risk of harmful effects on the baby.
Breast-feeding
Mitomycin is probably excreted in human milk. Breast-feeding must be discontinued during treatment with Mitomycin medac.
Fertility/contraception in men and women
Sexually mature patients must use contraception or be sexually abstinent during chemotherapy and for 6 months thereafter.
Mitomycin can cause hereditary genetic damage. Men treated with mitomycin are therefore advised against having children during treatment and for 6 months thereafter and seeking advice on sperm preservation before starting treatment due to the risk of irreversible sterility caused by mitomycin treatment.
Driving and using machines
Even if used per the instructions, this medicine may cause nausea and vomiting and thus worsen reaction times to such an extent that the ability to drive motor vehicles or use machines is impaired. This is especially true in connection with alcohol consumption.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Mitomycin medac
Mitomycin medac is only given by trained healthcare professionals.
This medicine is intended for insertion into the bladder ( intravesical instillation ) after reconstitution with diluent.
Your doctor will prescribe a dose that is right for you.
Mitomycin medac is inserted into the bladder at low pressure using a catheter. You must empty your bladder before treatment. The drug should remain in the bladder for 1-2 hours. To enable this, do not drink too much fluid before, during, and after treatment. While the solution remains in the bladder, it should have sufficient contact with the entire surface of the mucosa. The treatment benefits if you move. After 2 hours, empty the bladder into a sitting position to avoid splashing.
If you use more Mitomycin medac than you should
If you have accidentally received a higher dose, you may experience symptoms such as fever, nausea, vomiting, and blood disorders. Your doctor can give you supportive treatment for any symptoms that may occur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects after instillation into the bladder ( intravesical use)
Tell your doctor immediately if you notice any of the following reactions (which have been observed in very rare cases after instillation into the bladder), as treatment with mitomycin must be stopped:
- severe allergic reaction with symptoms such as dizziness, rash or hives, itching , swelling of the lips, face and respiratory tract with difficulty breathing, unconsciousness,
- severe lung disease manifested as shortness of breath, dry cough and crackling sounds when inhaled (interstitial lung disease),
- severe renal impairment: kidney disease when little or no urine comes out.
Common: may affect up to 1 in 10 people
- inflammation of the bladder ( cystitis ) which may be accompanied by blood in the bladder / urine
- painful urination ( dysuria )
- frequent urination at night (nocturia)
- very frequent urination (pollakiuria)
- blood in the urine ( hematuria )
- local irritation in the bladder wall
- local rash (local exanthema)
- allergic skin rash
- skin rash caused by contact with mitomycin ( contact dermatitis )
- numbness, swelling and painful redness in the palms and soles of the feet (palmoplantart erythema )
Rare: may affect up to 1 in 1,000 people
- rash all over the body (generalized exanthema)
Very rare: may affect up to 1 in 10,000 people
- inflammation of the bladder with damage to the bladder tissue ( necrotizing cystitis )
- allergic inflammation of the bladder ( eosinophilic cystitis )
- narrowing of the urinary tract ( stenosis )
- reduced bladder capacity
- calcium deposits in the bladder wall (calcification of the bladder wall)
- partial conversion of bladder wall tissue to connective tissue (bladder wall fibrosis)
- decreased white blood cell count ( leukopenia ) , which increases the risk of infection
- decreased platelet count ( thrombocytopenia ), causing bruising and bleeding
- allergic reactions (not just in and around the bladder)
- lung disease manifested as shortness of breath, dry cough and crackling sound when inhaled (interstitial lung disease)
- elevated levels of liver enzymes (elevated transaminase levels)
- hair loss ( alopecia )
- nausea and vomiting
- diarrhea
- impaired renal function when little or no urine comes out
- fever
No known frequency (can not be calculated from the available data)
If mitomycin inadvertently reaches areas other than the bladder:
- damage to the bladder
- pockets with abs in the abdomen ( abscess )
- (adipose) tissue death ( necrosis ) in the surrounding area
- bladder fistula
Possible side effects after injection or infusion into a blood vessel ( intravenous administration )
Very common: may affect more than 1 in 10 people
- inhibition of the production of blood cells in the bone marrow (bone marrow suppression)
- decreased white blood cell count ( leukopenia ) , which increases the risk of infection
- decreased platelet count ( thrombocytopenia ), causing bruising and bleeding
- nausea and vomiting
Common: may affect up to 1 in 10 people
- lung disease manifested as shortness of breath, dry cough and crackling sound when inhaled (interstitial pneumonia )
- difficulty breathing ( dyspnoea ), cough, shortness of breath
- skin rash (exanthema)
- allergic skin rash
- skin rash caused by contact with mitomycin ( contact dermatitis )
- numbness, swelling and painful redness in the palms and soles of the feet (palmoplantart erythema )
- kidney disease (decreased kidney function, nephrotoxicity , glomerulopathy, elevated levels of creatinine in the blood) when little or no urine comes out
In case of injection or leakage of mitomycin into the surrounding tissue (extravasation):
- inflammation of connective tissue ( cellulite )
- tissue death (tissue necrosis)
Uncommon: may affect up to 1 in 100 people
- inflammation of the mucous membranes ( mucositis )
- inflammation of the oral mucosa ( stomatitis )
- diarrhea
- hair loss ( alopecia )
- fever
- loss of appetite
Rare: may affect up to 1 in 1,000 people
- life-threatening infection
- blood poisoning ( sepsis )
- decreased number of red blood cells due to abnormal degradation of these blood cells ( hemolytic anemia )
- bruises (purpura) and red and purple dots ( petechiae ) on the skin (thrombotic thrombocytope purpura)
- heart failure after previous treatment with anti-cancer drugs ( anthracyclines )
- elevated blood pressure in the lungs, which e.g. leads to shortness of breath, dizziness and fainting
- disease with occlusion of the veins in the lungs (venous occlusive lung disease)
- hepatic impairment
- elevated levels of liver enzymes ( transaminases )
- yellowing of the skin and whites of the eyes (jaundice)
- disease with occlusion of the veins in the liver (venous occlusive liver disease)
- rash all over the body (generalized exanthema)
- a special form of renal failure ( hemolytic uremic syndrome , HYY), which is characterized by the breakdown of red blood cells faster than bone marrow production ( hemolytic anemia ), acute renal failure and low platelet count
- a type of hemolytic anemia , caused by factors in the small blood vessels (microangiopathic hemolytic anemia , MAHA)
No known frequency (can not be calculated from the available data)
- infection
- decreased number of blood cells ( anemia )
How to store Mitomycin medac
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 the carton after “EXP” / “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Keep the vial in the outer carton. Sensitive to light.
After reconstitution, this medicine should be used immediately.
The reconstituted solution is light-sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mitomycin.
1 vial of powder for solution for intravesical use contains 40 mg mitomycin. After reconstitution with 40 ml of diluent, 1 ml of solution for intravesical use contains 1 mg of mitomycin.
- Other ingredients are:
Powder for solution for intravesical use:
Urea
Diluent for intravesical solution:
Sodium chloride and water for injections.
What the medicine looks like and contents of the pack
Mitomycin medac is a gray to gray-blue powder.
The diluent is a clear and colorless solution.
Mitomycin medac, 40 mg, powder, and liquid for intravesical solution (installation kit) are supplied in packs of 1, 4, or 5 vials of clear glass (50 ml) with a coated rubber stopper and aluminum seal. Installation kits for intravesical instillation also include 1, 4, or 5 PVC bags with a volume of 40 ml containing 9 mg/ml (0.9%) sodium chloride solution for injection. The kits are available with or without catheters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
medac society for clinical specialties mbH
Theater. 6
22880 Wedel
Germany
tel: +49 4103 8006-0
fax: +49 4103 8006-100
This medicinal product is authorized under the European Economic Area under the names:
Belgium, Denmark, Estonia, Finland, Ireland, Iceland, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Czech Republic, Austria:
Mitomycin medac
Germany:
mito-extra
Italy, Portugal:
Mitomicină medac
Slovenia:
Mitomicin medac
UK:
Mitomycin medac