MANNITOL Solution for infusion Ref.[8194] Active ingredients: Mannitol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Baxter Healthcare, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Product name and form

Mannitol 15% w/v Solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless solution, free from visible particles.

Osmolarity: 823 mOsm/l (approx)

pH: 4.5- 7.0

Qualitative and quantitative composition

Mannitol: 150 g/l

Each ml contains 150 mg mannitol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mannitol

Mannitol is a naturally occurring sugar alcohol used clinically primarily for its osmotic diuretic properties.

List of Excipients

Water for injections

Pack sizes and marketing

The bags, known as Viaflo, are composed of polyolefin/polyamide co-extruded plastic (PL 2442) and contain Mannitol solution. The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene which serves only to provide physical protection to the bag.

The bag size is either 100, 250 or 500 ml.

Outer carton contents:

50 bags of 100 ml
30 bags of 250 ml
20 bags of 500 ml

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00116/0650

01/04/2010

Renewal: 20/06/2015

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