PEGLAX Powder for 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
PEGLAX 10 g powder for oral solution in sachet.
Qualitative and quantitative composition
Each sachet contains 10 g of macrogol 4000. Excipient(s) with known effect: 0.0000018 mg of sulphur dioxide (E-220) per sachet and less than 1 mmol of sodium per sachet. For a full list of excipients, ...
Pharmaceutical form
Powder for oral solution in sachet. Almost white powder.
Therapeutic indications
Symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment PEGLAX 10 g should remain a temporary ...
Posology and method of administration
Oral use Posology 1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquids (e.g. water) after each dose. The effect of Peglax becomes apparent ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe inflammatory bowel disease (such as ulcerative colitis, Crohns disease) or toxic megacolon, associated ...
Special warnings and precautions for use
The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example: Increased intake of liquids and dietary fibre, Appropriate physical activity and ...
Interaction with other medicinal products and other forms of interaction
There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Peglax. The therapeutic effect of medicinal products with a narrow therapeutic index ...
Pregnancy and lactation
Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). There are limited amount of data (less than 300 pregnancy outcomes) ...
Effects on ability to drive and use machines
Peglax has no influence on ability to drive and use machines.
Undesirable effects
Undesirable effects are listed under headings of frequency using the following categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very ...
Overdose
Overdose could lead to diarrhoea, abdominal pain and vomiting which disappears when treatment is temporarily interrupted or the dosage is reduced. Excessive fluid loss by diarrhoea or vomiting may require ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for constipation. Osmotically acting laxatives ATC code: A06AD15 High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of ...
Pharmacokinetic properties
The pharmacokinetic data confirm that macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.
Preclinical safety data
Toxicological studies conducted in different animal species did not reveal any sign of systemic or local gastrointestinal toxicity. Macrogol 4000 had no teratogenic or mutagenic effect. No carcinogenicity ...
List of excipients
Saccharin sodium (E954), apple flavour* * Composition of the apple flavour: Natural flavour, maltodextrine, gum arabic E414, sulphur dioxide E220, alpha tocopherol E307
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Sachet made of heat-sealable polyethylene, aluminium and polyester film (polyester/aluminium/polyethylene complex). Single dose sachets presented in pack sizes of 10, 20, 30, 50, 60 and 100 sachets. Not ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Casen Recordati, S.L., Autovía de Logroño, Km 13,300, 50180 UTEBO, Zaragoza (Spain)
Marketing authorization number(s)
PL 43885/0006
Date of first authorization / renewal of the authorization
17/01/2016
Date of revision of the text
30/08/2018
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