MESNA Film-coated tablets (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Mesna Tablets 400 mg.
Qualitative and quantitative composition
Mesna film-coated tablets: 400 mg as the active ingredient.
Pharmaceutical form
Film-coated tablets for oral use.
Therapeutic indications
For the prevention of urothelial toxicity including haemorrhagic cystitis, microhaematuria and macrohaematuria in patients treated with ifosfamide and cyclophosphamide, in doses considered to be urotoxic. ...
Posology and method of administration
Sufficient Mesna must be given to adequately protect the patient from the urotoxic effects of the oxazaphosphorine. The duration of Mesna treatment should equal that of the oxazaphosphorine treatment plus ...
Contraindications
Known hypersensitivity to Mesna or any of the excipients.
Special warnings and precautions for use
Warnings Hypersensitivity Hypersensitivity reactions to mesna have been reported following administration of mesna as an uroprotectant. These include various skin and subcutaneous tissue symptoms (see ...
Interaction with other medicinal products and other forms of interaction
The systemic effects of oxazaphosphorines are not affected by Mesna. In clinical trials it was shown that overdoses of Mesna did not diminish the acute toxicity, subacute toxicity, leucocytic activity, ...
Pregnancy and lactation
There are no adequate data from the use of mesna in pregnant or lactating women. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing mesna. ...
Effects on ability to drive and use machines
Patients undergoing treatment with mesna may experience undesirable effects (including, e.g., syncope, light-headedness, lethargy/drowsiness, dizziness, and blurred vision) which could affect the ability ...
Undesirable effects
The most frequently occurring adverse reactions (> 10%) associated with use of mesna are: headache, abdominal pain/colic, light headedness, lethargy/drowsiness, pyrexia, rash, diarrhoea, nausea, flushing, ...
Overdose
Reports of inadvertent overdose and observations from a high-dose tolerability study in healthy volunteers showed that, in adults, single doses in the range of approximately 4g to 7g of mesna can cause ...
Pharmacodynamic properties
Mesna is an antidote, and offers the possibility of reliably preventing urotoxic side-effects associated with aggressive cancer chemotherapy using oxazaphosphorine cytostatics. Extensive and wide-ranging ...
Pharmacokinetic properties
Mesna is easily and rapidly transformed by auto-oxidation into its only metabolite mesna-disulphide (dimesna). Dimesna remains in the intravascular compartment and is quickly transported to the kidneys. ...
Preclinical safety data
Nothing relevant.
List of excipients
Core: Lactose monohydrate Microcrystalline cellulose Dibasic calcium phosphate dihydrate Corn starch Povidone K25 Magnesium stearate Film-coating (Pharma coat): Hydroxypropylmethylcellulose Polyethylene ...
Incompatibilities
None.
Shelf life
Shelf life: 5 years.
Special precautions for storage
No specific storage conditions necessary.
Nature and contents of container
Folding box containing blister packs consisting of: aluminium 20 µm (top layer),polyamide 25 µm, aluminium 45 µm, PVC 60 µm (bottom layer). One blister strip contains 10 tablets. Pack sizes: 10 tablets, ...
Special precautions for disposal and other handling
No special instructions necessary.
Marketing authorization holder
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Marketing authorization number(s)
PL 00116/0396
Date of first authorization / renewal of the authorization
Date of first authorisation: 8<sup>th</sup> March 2004 Renewal of the authorisation: 10<sup>th</sup> December 2008
Date of revision of the text
October 2014
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