PICOLAX Powder for oral solution (2021)
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Περιεχόμενα
1. Name of the medicinal product
PICOLAX powder for oral solution.
2. Qualitative and quantitative composition
Each sachet contains the following active ingredients: Sodium picosulfate: 10.0mg Magnesium oxide, light: 3.5g Citric acid, anhydrous: 12.0g <u>Each sachet also contains:</u> Potassium hydrogen carbonate ...
3. Pharmaceutical form
Powder for oral solution. White crystalline powder.
4.1. Therapeutic indications
PICOLAX is indicated in adults, adolescents and children from the age of 1 year: To clean the bowel prior to X-ray examination or endoscopy. To clean the bowel prior to surgery when judged clinically necessary ...
4.2. Posology and method of administration
Posology Adults (including elderly) The two PICOLAX sachets (see Method of Administration section below for reconstitution guidance) are taken dependent on the planned time of the procedure: The first ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Congestive cardiac failure Gastric retention Gastro-intestinal ulceration Toxic colitis Toxic megacolon Ileus ...
4.4. Special warnings and precautions for use
Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. ...
4.5. Interaction with other medicinal products and other forms of interaction
As a purgative, PICOLAX increases the gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may be decreased ...
4.6. Fertility, pregnancy and lactation
Pregnancy For PICOLAX no clinical data on exposed pregnancy are available. Studies in animals have shown reproductive toxicity (see section 5.3). As picosulfate is a stimulant laxative, for safety measure, ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The most common adverse reactions are vomiting, nausea, abdominal pain and headache. Hyponatraemia is rare but is the most commonly reported serious adverse reaction. Adverse reactions from spontaneous ...
4.9. Overdose
Overdose would lead to profuse diarrhoea. Treatment is by general supportive measures and correction of fluid and electrolyte balance.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Contact Laxatives <b>ATC code:</b> A06AB58 The active components of PICOLAX are sodium picosulfate and magnesium citrate. Sodium picosulfate is a locally acting stimulant ...
5.2. Pharmacokinetic properties
Both active components are locally active in the colon, and neither are absorbed in any detectable amounts.
5.3. Preclinical safety data
Prenatal developmental studies in rats and rabbits did not reveal any teratogenic potential after oral dosing of sodium picosulfate, but embryotoxicity has been observed in rats at 1000 and 10000 mg/kg/day ...
6.1. List of excipients
Potassium hydrogen carbonate Sodium saccharin Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid, butylated hydroxyanisole
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Once the sachet has been opened, use immediately and discard any unused powder or solution.
6.4. Special precautions for storage
Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Sachet: 4 layers: paper-low density polyethylene-aluminium-thermofusible resin Pairs of sachets can be separated by tearing apart the perforated strip. Weight of sachet contents: 16.1g A measuring spoon ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
8. Marketing authorization number(s)
PL 03194/0014
9. Date of first authorization / renewal of the authorization
1<sup>st</sup> September 2013
10. Date of revision of the text
February 2021
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