MITOMYCIN 2 Injection contains Mitomycin which belongs to a group of medicines called anti-neoplastic agent
WHAT MITOMYCIN 2 IS USED FOR?
It is used as palliative cancer therapy (for the relief of symptoms) in:
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)
It is also used for the prevention of a relapse in the case of superficial urinary bladder cancer after the ablation of tissue through the urethra (transurethral resection)
WARNINGS AND PRECAUTIONS:
TALK TO DOCTOR
Talk to your Doctor, if you:
Are allergic to any of the other ingredients of this medicine
Are suffering from impaired lung, kidney or liver function
Are undergoing radiation therapy
Are being treated with other cytostatic (substances which inhibit cell growth/cell division)
Have inflammation of the urinary bladder (in case of intravesical administration)
Have been told that you have bone marrow depression
Are immunized with live virus vaccine as this increase risk of infection
PREGNANCY & BREAST FEEDING
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
CHILDREN & ADOLESCENTS
The use of MITOMYCIN 2 Injection in children and adolescents is not recommended
DRIVING & USING MACHINES
It 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 conjunction with alcohol
INTERACTIONS:
Tell your doctor if you are taking,
Anti-cancer drugs (used to treat cancer)
Vaccines
DIRECTIONS & FOR USE:
MITOMYCIN 2 Injection must only be given by a doctor or nurse
It is intended to be used for injection or infusion into a blood vessel (intravenous use) or for introduction into the urinary bladder (intravesical instillation)
If you take more MITOMYCIN 2 Injection
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 forget to take MITOMYCIN 2 Injection
If you miss your scheduled injection, contact your doctor or nurse
Do not stop taking this medicine unless your doctor tells you to do so
SIDE EFFECTS OF MITOMYCIN 2 INJECTION 2MG:
SERIOUS
• Shortness of breath
• Dry cough and crackles during breath-in (interstitial pneumonia)
• Severe renal dysfunction (nephrotoxicity)
COMMON
• 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
• Lung disorders presenting as shortness of breath, dry cough and inspiratory crackles (interstitial pneumonia)
• Dyspnea, 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)
• Inflammation of connective tissue (cellulitis) and death of tissue (tissue necrosis) following accidental injection into the surrounding tissue (extravasation)
Installation in the bladder:
• Skin rashes (exanthema, allergic skin rash, contact dermatitis)
• Numbness, swelling and painful redness on palms and soles (palmar-plantar erythrodysaesthesia (PPE)/hand-foot syndrome)
• 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
UNCOMMON
• Inflammation of a mucous membrane (mucositis)
• Inflammation of the mucosa of the mouth (stomatitis)
• Diarrheic, fever
• V Hair loss (alopecia)
• Loss of appetite (anorexia)
RARE
• Life-threatening infection
• Blood poisoning (sepsis)
• Decrease in number of red blood cells sometimes together with acute renal dysfunction (hemolytic anemia, microangiopathic-hemolytic anemia), hemolytic uraemic syndrome
• 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)
• Liver dysfunction
• Increased levels of liver enzymes (transaminases)
Installation in the bladder:
• Widespread skin rash
VERY RARE
• Faintness
• Skin rash or hives, itching
• Swelling of lips
• Face and airway with difficulty in breathing
• Loss of consciousness
Installation in the bladder:
• 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)
STORAGE:
Keep this medicine out of reach of children
Store at a room temperature of 15-25°C
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