LAEVOLAC Oral solution (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Laevolac Plum 10 g/15 ml oral solution.
2. 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.
3. Pharmaceutical form
Oral solution. Clear colourless to pale brownish yellow, viscous solution with plum odour and taste.
4.1. Therapeutic indications
Symptomatic Treatment of Constipation. Laevolac Plum 10 g/15 ml oral solution is indicated in adults and in children and adolescents aged 7 to 18 years.
4.2. Posology and method of administration
Posology Laevolac Plum 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 in two to three divided ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use in patients with galactosaemia. Acute inflammatory bowel disease (ulcerative colitis, Crohns disease), gastrointestinal ...
4.4. Special warnings and precautions for use
In case of insufficient therapeutic effect after 3 days consultation of a physician is advised. From the route of synthesis Laevolac Plum may contain small amounts of sugars (not more than 67 mg/ml lactose, ...
4.5. Interaction with other medicinal products and other forms of interaction
Lactulose may increase the loss of potassium induced by other drugs (e.g. thiazides, steroids and amphothericin B). Concomitant use of cardiac glycosides can increase the effect of the glycosides through ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of lactulose in pregnant women. There are no relevant epidemiological data available. No effects during pregnancy are anticipated, since systemic ...
4.7. Effects on ability to drive and use machines
Laevolac Plum has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such ...
4.9. Overdose
If the dose is too high, the following may occur: <u>Symptom:</u> Diarrhoea and abdominal pain. <u>Treatment:</u> Cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Osmotically acting laxatives <b>ATC code:</b> A06AD11 Lactulose is a synthetic disaccharide formed from D-galactose and fructose. In the colon lactulose is metabolised ...
5.2. Pharmacokinetic properties
Lactulose is practically not absorbed, because in man there is no corresponding disaccharidase available in the upper intestinal tract. Not being absorbed as such, it reaches the colon unchanged. There ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of single and repeated dose toxicity. A long term animal study does not indicate a carcinogenic potential. Tests on genotoxicity are ...
6.1. List of excipients
Plum flavour The plum flavour consists of plum extract, ethyl alcohol, propylene glycol, aromatic substance and caramel colour.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Partially used sachets have to be discarded.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Sachets containing 15 ml made of polyester/aluminium/polyethylene layer membrane: 10 and 20 sachets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Fresenius Kabi Austria GmbH, Hafnerstraße 36, 8055 Graz, Austria
8. Marketing authorization number(s)
PA0773/005/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11th July 2014 Date of last renewal: 26th January 2017
10. Date of revision of the text
October 2016
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