HIDRASEC Granules for oral suspension (2015)
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Περιεχόμενα
Name of the medicinal product
Hidrasec 10 mg, Granules for oral suspension.
Qualitative and quantitative composition
Each sachet contains 10 mg of racecadotril. Each sachet contains 966.5 mg of sucrose. For a full list of excipients, see section 6.1.
Pharmaceutical form
Granules for oral suspension. White powder with characteristic apricot smell.
Therapeutic indications
Complementary symptomatic treatment of acute diarrhoea in infants (older than 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient ...
Posology and method of administration
Hidrasec 10 mg is administered via the oral route, together with oral rehydration (see section 4.4). Hidrasec Infants is intended for children <13 kg The recommended dose is determined according to body ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose ...
Special warnings and precautions for use
The administration of Hidrasec does not modify the usual rehydration regimens. Rehydration is highly important in the management of acute diarrhoea in infants. The requirement for rehydration and route ...
Interaction with other medicinal products and other forms of interaction
No interactions with other active substances have been described in humans to date. In humans, joint treatment with racecadotril and loperamide or nifuroxazide does not modify the kinetics of racecadotril. ...
Fertility, pregnancy and lactation
Fertility Fertility studies conducted with racecadotril on Rats demonstrate no impact on fertility. Pregnancy There are no adequate data from the use of racecadotril in pregnant women. Animal studies do ...
Effects on ability to drive and use machines
Not relevant. Racecadotril has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Data from clinical acute diarrhoea studies are available for 860 paediatric patients treated with racecadotril, and 441 treated with placebo. The following adverse drug reactions listed below have occurred ...
Overdose
No cases of overdose have been reported. In adults, single doses above 2 g, which is equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects have been described.
Pharmacodynamic properties
Pharmacotherapeutic group: Other antidiarrhoeals ATC code: A07XA04 Racecadotril is a pro-drug that needs to be hydrolysed to its active metabolite thiorphan, which is an inhibitor of enkephalinase, a cell ...
Pharmacokinetic properties
Absorption Following oral administration, racecadotril is rapidly absorbed. The exposure at steady state is comparable with the exposure following a single dose. Distribution In plasma, after an oral dose ...
Preclinical safety data
Chronic 4-week toxicity studies in monkeys and dogs, relevant for the duration of treatment in human, do not point out any effect at doses up to 1250 mg/kg/day and 200 mg/kg, respectively corresponding ...
List of excipients
Sucrose Anhydrous colloidal silica Polyacrylate dispersion 30 per cent Apricot aroma
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Thermowelded paper/aluminium/polyethylene sachets. Packs containing 10, 16, 20, 30, 50 and 100 sachets (100 sachets only for hospital use). Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Bioprojet Europe Ltd., 29 Earlsfort Terrace, EI-Dublin 2, IRELAND
Marketing authorization number(s)
PL 39418/0001
Date of first authorization / renewal of the authorization
05/09/2011
Date of revision of the text
16/07/2015
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