LACTUGAL Oral solution (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Lactugal.
Qualitative and quantitative composition
Active ingredient: Lactulose Solution BP 99.897% v/v. (Equivalent to 62.0-74.0% w/v of Lactulose)
Pharmaceutical form
Oral solution.
Therapeutic indications
Constipation; hepatic encephalopathy (portal systemic encephalopathy).
Posology and method of administration
For oral administration. The lactulose solution may be administered diluted or undiluted. Each dose may, if necessary, be taken with water or fruit juices etc. Each dose of lactulose should be swallowed ...
Contraindications
Lactugal is contra-indicated in patients with: Galactosaemia. Gastro-intestinal obstruction, digestive perforation or risk of digestive perforation. Hypersensitivity to the active substance or to any of ...
Special warnings and precautions for use
Consultation of a physician is advised in case of: Painful abdominal symptoms of undetermined cause before the treatment is started. Insufficient therapeutic effect after several days. Lactulose should ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible. Lactulose can be used during pregnancy. Breast-feeding No effects on the breastfed newborn/infant ...
Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines.
Undesirable effects
A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by ...
Overdose
If the dose is too high, the following may occur: diarrhoea and abdominal pain Treatment A dose reduction or cessation of therapy should be considered. Excessive fluid loss due to diarrhoea or vomiting ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Osmotically acting laxatives <b>ATC code:</b> A06AD11 Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular ...
Pharmacokinetic properties
Lactulose is poorly absorbed from the gastro-intestinal tract and it reaches the colon unchanged. There are no human lactulose disaccharide enzymes; metabolism of lactulose to lactic acid occurs via gastro-intestinal ...
Preclinical safety data
The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk ...
List of excipients
Banana flavour (17.41.0042) Quinoline yellow (E104)
Incompatibilities
There are no known incompatibilities.
Shelf life
36 months from the date of manufacture.
Special precautions for storage
Store at a temperature not exceeding 20°C. Do not freeze.
Nature and contents of container
Amber glass winchesters with polypropylene caps as closures: pack sizes 300 ml, 500 ml, 1000 ml and 2000 ml. Polyethylene containers with polypropylene caps as closures: pack sizes 250 ml, 300 ml, 500 ...
Special precautions for disposal and other handling
There are no special storage or handling instructions for this product.
Marketing authorization holder
Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berkshire SL6 6PT, United Kingdom
Marketing authorization number(s)
PL 17509/0011
Date of first authorization / renewal of the authorization
24 November 2004
Date of revision of the text
28<sup>th</sup> February 2018
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