MESNA Film-coated tablets Ref.[9333] Active ingredients: Mesna

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Product name and form

Mesna Tablets 400 mg.

Pharmaceutical Form
Film-coated tablets for oral use.

Qualitative and quantitative composition

Mesna film-coated tablets: 400 mg as the active ingredient.

Active Ingredient	Description
Mesna	Mesna is an antidote, and offers the possibility of reliably preventing urotoxic side-effects associated with aggressive cancer chemotherapy using oxazaphosphorine cytostatics.

List of Excipients
Core: Lactose monohydrate Microcrystalline cellulose Dibasic calcium phosphate dihydrate Corn starch Povidone K25 Magnesium stearate Film-coating (Pharma coat): Hydroxypropylmethylcellulose Polyethylene glycol 6000 Titanium dioxide E171 Simethicone

Pack sizes and marketing

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, 20 tablets, 50 tablets.

Marketing authorization holder

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Marketing authorization dates and numbers

PL 00116/0396

Date of first authorisation: 8^th March 2004
Renewal of the authorisation: 10^th December 2008

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