Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
LACTULOSE
MEGAPHARM LTD
A06AD11
SOLUTION (ORAL)
LACTULOSE 670 MG/ML
PER OS
Not required
FRESENIUS KABI AUSTRIA GmbH
LACTULOSE
LACTULOSE
Constipation. Acute and chronic hepatic encephalopathy.
2014-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Laevolac 3.3g/5ml Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 ml contain 3.3 g lactulose For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solution Clear colourless to pale brownish yellow, viscous solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Constipation. Acute and chronic hepatic encephalopathy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lactulose solution may be administered diluted or undiluted. The dose should be titrated according to the clinical response. Lactulose may be given as a single daily dose or up to three divided daily doses, using the measuring cup. A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time. The posology should be adjusted according to the individual needs of the patient. The starting dose can be adjusted after adequate treatment effect individually (maintenance dose). Several days (2-3 days) of treatment may be needed in some patients before adequate treatment effect occurs. In case of single daily dose, this should be taken at the same time of the day, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses). _Constipation_ After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs. Starting dose Maintenance dose Adults and adolescents 15 - 30 ml 15 - 30 ml Children (7 - 14 years) 15 ml 10 - 15 ml Children (1 - 6 years) 5 - 10 ml 5 - 10 ml infants under 1 year Up to 5 ml Up to 5 ml If diarrhoea occurs, the dosing regimen should be reduced. 1 _Treatment of portal systemic encephalopathy - for adults only: _ _ _ Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g Lactulose). The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should Citiți documentul complet