What Uromitexan is and what it is used for
Uromitexan solution for injection is only given by healthcare professionals, who can answer any additional questions you may have after reading the information below.
Uromitexan is used to prevent mucosal damage in the bladder during treatment with ifosfamide or cyclophosphamide. Some cytostatics (ifosfamide, cyclophosphamide) can damage the lining of the bladder so that there is blood in the urine. If Uromitexan is given at the same time, it has a protective effect and the risk of inflammation in the bladder and blood in the urine is reduced.
What you need to know before receiving Uromitexan
Do not use Uromitexan
- if you are allergic to mesna, other similar medicines ( thiols ), or any of the other ingredients, including benzyl alcohol in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Uromitexan:
- if you have previously experienced breathing difficulties, wheezing, skin redness, itching, or swelling after receiving Uromitexan.
- if you have any autoimmune disease, e.g. rheumatoid arthritis, systemic lupus erythematosus ( SLE ), or kidney inflammation, as these diseases can increase the risk of certain side effects.
- if you have previously had a blockage or obstruction in the urinary tract, preventing normal urine output. Morning urine should be examined each day before treatment for microscopic blood findings ( hematuria ).
Urine test strips for ketone bodies or red blood cells ( erythrocytes ) can give incorrect results during medication with Uromitexan. Contact a doctor or nurse if you are unsure.
Stop using Uromitexan and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Other medicines and Uromitexan
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
There is a limited amount of data on the use of Uromitexan in pregnant and lactating women.
If you are pregnant or breastfeeding, consult a doctor or pharmacist before using this medicine. See also the section “Uromitexan contains benzyl alcohol”.
Driving ability and use of machinery
Some side effects such as fainting, dizziness, drowsiness, and blurred vision can affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Uromitexan contains sodium and benzyl alcohol
Uromitexan contains sodium
This medicine contains approximately 59 mg sodium per 400 mg mesna. This is equivalent to 2.95% of the maximum recommended daily intake of sodium for adults.
Uromitexan contains benzyl alcohol
Uromitexan (with preservative ) contains 10.4 mg of benzyl alcohol per ml. Benzyl alcohol can cause allergic reactions. Benzyl alcohol is associated with the risk of serious side effects such as breathing difficulties in young children.
The medicine should not be used by newborns (up to 4 weeks of age) unless a doctor has prescribed it. Do not use the medicine for more than 1 week in newborns (younger than 3 years) unless a doctor has recommended it.
If you have impaired liver or kidney function, or are pregnant or breastfeeding, consult a doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
How to receive Uromitexan
The dose is determined by the doctor, who adjusts it individually for you depending on your treatment with cytostatics (ifosfamide or cyclophosphamide).
If you have been given too much Uromitexan
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
As the Uromitexan solution for injection is always given by healthcare professionals, you should first talk to them if you suspect that you have received too much of a dose.
Symptoms of overdose can be nausea, vomiting, stomach ache, diarrhea, headache, fatigue, pain in arms and legs, and joints, skin rash, hot flushes, low blood pressure, slow pulse, fast pulse, numbness, fever, and spasm in the muscles of the trachea.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
However, since Uromitexan is always taken at the same time as ifosfamide or cyclophosphamide, it is difficult to determine which of these preparations caused a side effect.
Contact a doctor immediately if you appear to have had an allergic reaction. Symptoms of this can be difficulty breathing, wheezing, skin redness, itching, or swelling.
An allergic or allergy-like reaction can occur with the medication being given or up to a few days after the medication has ended.
Very common side effects (may affect more than 1 in 10 users):
Headache, feeling faint, persistent unconsciousness/drowsiness, hot flashes, abdominal pain/painful intestinal cramping, nausea, diarrhea, rash, infusion site reactions such as itching and rash, fever, and flu-like illness.
Common side effects (may affect up to 1 in 10 users) :
Swollen/enlarged lymph nodes ( lymphadenopathy ), vomiting, decreased appetite, flatulence, constipation, anorexia , feeling dehydrated, insomnia, nightmares, dizziness, crawling or tingling in the skin ( paresthesia ), increased skin sensitivity ( hyperesthesia ), fainting ( syncope ), reduced sensitivity to touch ( hypoaesthesia ), impaired attention, inflammation of the conjunctiva of the eye , sensitivity to light, blurred vision, palpitation , nasal congestion, severe sharp pain when inhaling (pleuritic pain), dry mouth, spasm of the trachea, labored breathing, discomfort in the larynx, nosebleeds (epitaxy), stiffness, fatigue, chest pain, malaise, flushing , cough, pharyngitis, mucosal irritation , burning pain in the pit of the stomach/sternum, bleeding in the gums, increased levels in the blood of certain liver enzymes ( transaminases ), itching , greatly increased sweating which is usually pathological ( hyperhidrosis ), joint pain ( arthralgia ), back pain, muscle pain ( myalgia ), discomfort in the arms and legs, pain in the jaw, pain when emptying the bladder ( dysuria ), reactions at the infusion site such as pain, skin redness,hives and swelling.
Has been reported (occurring in an unknown number of users):
Hypersensitivity reaction er, severe allergic reaction with a rapid course (allergic shock, anaphylactoid reaction), decrease in all cells (red and white blood cells and platelets ) in the blood (pancytopenia), decrease in the number of white blood cells that fight infection er ( leukopenia , lymphopenia), abnormal high amounts of eosinophils (type of blood cells formed in the bone marrow ) in the blood or in body tissues ( eosinophilia ), lack of platelets ( thrombocytopenia ), seizures, swelling around the eyes (periorbital oedema), changes on the EKG (ST elevation or other abnormal result), fast heart rate , circulatory reactions, low or high blood pressure , shortness of breath, decreased levels of oxygen in the body ( hypoxia , decreased oxygen saturation), coughing up blood from the lungs or airways (hemoptysis) , inflammation of the mucous membrane of the mouth, bad taste in the mouth, inflammation of the liver, increased blood levels of certain liver enzymes (gamma-glutamyltransferase, alkaline phosphatase), blistering (vesiculation), life-threatening conditions that cause rashes, ulcers, sore throat, conjunctivitis and separation of the skin layers ( Lyells syndrome , Stevens Johnson syndrome), local tissue swelling (urticarial edema), itchy, red rashes that may develop into ulcers (erythema multiforme), redness of the skin ( erythema ), hypersensitivity reaction to drugs characterized by skin rashes, ulcers and/or larger blisters/bleeding of the skin and mucous membranes, swelling of the deeper layer of the skin caused by of fluid accumulation ( angioedema ), skin lesions that recur in the same area when the same drug is given (fixed drug eruption), skin rash due to increased sensitivity to light, hives ( urticaria ), burning sensation in the skin, acute kidney failure , weakness ( asthenia , lack of energy) , mucosal reactions, swelling of the face (facial oedema), swelling of tissueusually in the legs due to accumulation of fluid (peripheral oedema ), increased respiratory rate, reactions at the injection site ( thrombophlebitis , irritation), signs of severe coagulation disorder that increases the risk of blood clotting in vessels (disseminated intravascular coagulation ( DIC )), altered laboratory results (eg, prolonged prothrombin time, prolonged activated partial thromboplastin).
How to store Uromitexan
Store out of sight and reach of children.
Store at a maximum of 30 °C. Do not freeze.
Use before the expiry date stated on the packaging and label after EXP. The expiration date is the last day of the specified month.
The opened vial must be used within 8 days.
For solutions with additives, chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C. For microbiological reasons, it is recommended that mixed solutions be used immediately after preparation. If not used immediately, it is the user’s responsibility to ensure that instructions for shelf life and storage conditions are followed. However, 24 hours at 25 °C should not be exceeded.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures are to protect the environment.
Contents of the packaging and other information
- The active ingredient is mesna.
- Other ingredients are disodium edetate, sodium hydroxide, benzyl alcohol ( preservative ), and water for injections
Appearance and package sizes of the medicine
Vials 1 x 10 ml and 1 x 50 ml.
Baxter Medical AB
164 94 Coffin
Baxter Oncology GmbH