Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
mesna, Quantity: 100 mg/mL
Baxter Healthcare Pty Ltd
Mesna
Injection, solution
Excipient Ingredients: disodium edetate; water for injections; nitrogen; sodium hydroxide
Intravenous
5 ampoules, 25 ampoules, 10 ampoules
(S4) Prescription Only Medicine
For the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see Adverse Effects sections of the cyclophosphamide and ifosfamide Product Information).
Visual Identification: Clear colourless aqueous solution free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2017-08-01
MESNA-CLARIS INJ (mesna) Consumer Medicine Information MESNA-CLARIS INJ CMI 060405 Page 1 of 4 Baxter MESNA-CLARIS _Mesna_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mesna-Claris. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Mesna- Claris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT MESNA-CLARIS IS USED FOR Mesna –Claris is a protective agent which is used to prevent damage to your bladder and urinary system, that may be caused by some drugs used to treat cancer or auto-immune diseases. These drugs can cause a condition of the bladder, with pain in the bladder or back and blood in the urine. Mesna-Claris can help prevent this. Your doctor may have prescribed Mesna-Claris for another reason. Ask your doctor if you have any questions about why Mesna-Claris has been prescribed for you. Mesna-Claris is not addictive. This medicine is available only with a doctor’s prescription . BEFORE YOU ARE GIVEN MESNA-CLARIS _WHEN YOU MUST NOT BE GIVEN MESNA-CLARIS _ DO NOT HAVE MESNA-CLARIS IF YOU HAVE AN ALLERGY TO MESNA OR ANY RELATED PRODUCTS (THIOLS), OR TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to Mesna-Claris may include: • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest • swelling of the face, lips, tongue or other parts of the body • rash, itching, hives or flushed, red skin • dizziness or lightheadedness • fast heart beat IF YOU ARE NOT SURE WHETHER YOU SHOULD START HAVING MESNA-CLARIS, TALK TO YOUR DOCTOR OR PHARMACIST. _BEFORE YOU ARE GIVEN IT _ Tell your doctor or pharmacist if you have allergies to: • any other medicines • Read the complete document
PRODUCT INFORMATION MESNA-CLARIS Claris Lifesciences Australia Pty Ltd NAME OF THE MEDICINE Mesna 200 mg/2 mL, 400 mg/4 mL and 1000 mg/10 mL, concentrated solution for infusion. The chemical name of mesna is sodium 2-sulfanylethanesulfonate. The CAS number is 19767-45-4 The empirical formula is C 2 H 5 NaO 3 S 2 The molecular weight is 164.2 DESCRIPTION Mesna is a white or slightly yellow, hygroscopic crystalline powder. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in cyclohexane. M e s n a - C l a r i s is a c l e a r , c o l o u r l e s s , sterile, aqueous solution for intravenous administration. M e s n a - C l a r i s contains 100 mg/mL mesna, edetate disodium, sodium hydroxide for pH adjustment and water for injections. The solution has a pH range of 6.50 -7.30. PHARMACOLOGY Mesna was developed as a prophylactic agent to prevent and reduce the urothelial toxicity (haemorrhagic cystitis) induced by oxazaphosphorine alkylating agents such as ifosfamide or cyclophosphamide. Analogous to the physiological cysteine-cystine system, following intravenous administration, mesna is rapidly and easily converted by autoxidation to its only metabolite, disodium 2,2’- dithio-bisethane sulphonate (mesna disulphide, dimesna) forming a disulphide link. Following I.V. injection, only a small portion of the administered dose is detected in the blood as a reduced thiol compound (mesna). Mesna disulphide remains in the intravascular space and is rapidly delivered to the kidney. In the renal tubular epithelium a considerable proportion of mesna disulphide is again reduced to a free thiol compound, presumably mediated by glutathione reductase. Acrolein or other urotoxic oxazaphosphorine metabolites are detoxified by chemical reaction with the free thiol compound i.e. mesna. The first and most important step towards detoxification is the reaction of mesna with the double bond of acrolein, resulting in the formation of a stable thioether which can be detected in the urine by chromatography. Read the complete document