LAEVOLAC Oral solution Ref.[49844] Active ingredients: Lactulose

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: Fresenius Kabi Austria GmbH, HafnerstraรŸe 36, 8055 Graz, Austria

Product name and form

Laevolac Plum 10 g/15 ml oral solution.

Pharmaceutical Form

Oral solution.

Clear colourless to pale brownish yellow, viscous solution with plum odour and taste.

Qualitative and quantitative composition

One sachet (15 ml) contains 10 g Lactulose (as lactulose liquid).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lactulose

Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut. Its mode of action in constipation is as an osmotic agent producing soft stools.

List of Excipients

Plum flavour

The plum flavour consists of plum extract, ethyl alcohol, propylene glycol, aromatic substance and caramel colour.

Pack sizes and marketing

Sachets containing 15 ml made of polyester/aluminium/polyethylene layer membrane: 10 and 20 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Austria GmbH, HafnerstraรŸe 36, 8055 Graz, Austria

Marketing authorization dates and numbers

PA0773/005/001

Date of first authorisation: 11th July 2014
Date of last renewal: 26th January 2017

Drugs

Drug Countries
LAEVOLAC Austria, France, Ireland, Israel, New Zealand, Turkey

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