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| - Dospělí: doporučená zahajovací dávka je 160 mg denně, podávaná jako jedna tableta Lipanthylu Supra 160 mg.
Dávka může být titrována až do 215 mg denně, podávaná formou jedné tablety Lipanthylu S 215 mg.
Pacienti užívající v současnosti jednu tobolku přípravku Lipanthyl 267 M, mohou být převedeni na léčbu jednou tabletou přípravku Lipanthyl S 215 mg bez další úpravy dávky.
Lipanthyl S 215 mg má být vždy podáván spolu s jídlem, protože z prázdného žaludku se hůře vstřebává. Dietní opatření zahájená před léčbou mají být i nadále dodržována.
Další informace o zvláštních skupinách populace
Starší pacienti: u starších pacientů bez poruchy funkce ledvin se doporučuje podávat dávku obvyklou u dospělých.
Pacienti s ledvinovou/jaterní nedostatečností
U pacientů s ledvinovým poškozením je nutné snížení dávky. U těchto pacientů se doporučuje použití lékových forem obsahujících nižší dávku léčivé látky (tobolky mikronizovaného fenofibrátu s 67 mg nebo tobolky se 100 mg standardního fenofibrátu).
Pacienti s onemocněním jater nebyli zkoumáni.
Pediatrická populace
Použití lékové formy s obsahem 215 mg je u dětí kontraindikováno.
Pokud po několika měsících léčby fenofibrátem (např. po 3 měsících) nedošlo k uspokojivému snížení hladin tuků v séru, je potřeba zvážit dodatečné i jiné terapeutické možnosti.
Způsob podání:
Celé tablety by měly být polykány při jídle.
In case of restricted medical prescription, start this section by specifying the conditions.
Clearly specify the dosage for each method/route of administration and for each indication.
Where appropriate, a reference to official recommendations should be made (eg, for primary vaccination and antibiotics as well as for booster dose).
Specify dose recommendations per dose interval in an appropriate way (eg, mg, mg/kg, mg/m2) for each age category where appropriate (specify age ranges), ie, children as specified (see also the Note for Guidance on Clinical Investigation of Medicinal Products in Children: CPMP/EWP/462/95), adults, and elderly.
Short relevant instruction for correct administration/use should also be given here. In Section 6.6, ‘Special precautions for disposal of a used medicinal product and other handling of the product’, information should be placed for instructions for preparation and/or reconstitution and cross-referenced here.
Where appropriate, the following points should be addressed:
The maximum recommended single, daily, and/or total dose
The need for dose titration
The normal duration of use and any restrictions on duration and, if relevant, the need for tapering off, or advice on discontinuation
Advice on action to be taken if one or more dose(s) is (are) missed
Advice on preventive measures to avoid certain adverse drug reactions (ADRs) (eg, administration of antiemetics) with cross-reference to the Section 4.4
The intake of the product in relation to food intake
Advice regarding repeat use, with any information on intervals to be observed between courses of treatment, as appropriate
Interactions requiring specific dose adjustments with cross-reference to other appropriate sections of the SPC (eg, Sections 4.4, 4.5, 4.8, 5.1, and/or 5.2)
Where relevant to the particular product, an entry such as the following should appear. Modify or delete as appropriate.
When the medicinal product is to be used in children, a specific sub-section ‘paediatric patients’ should be identified..
Information should be given for the different sub-populations of children, ie, according to the ICH guideline E11.
The age limits should reflect the assessment of the available documentation and relate to age intervals where a different dosing is recommended. The information given should relate to ages for which satisfactory efficacy and safety have been shown. If necessary in preterm and term newborns, information should be written taking into account the gestational age or the post-conception age.
The dose schedule studied and found satisfactory should be given in this section. Taking account of available paediatric formulations, the dose may be related to weight or body surface area depending on what has been found optimal, eg, children age 2-4 years, 1 mg/bodyweight b.i.d. for one week (up to the adult dose).
If the product has not been studied in the paediatric population or if there are insufficient data on which to base an approval for paediatric use, it should be stated that the medicinal product is not recommended in the paediatric age group until further data become available. If available, additional information on the reason for the advice, and on the use in the paediatric age groups, can be included in Sections 4.4, 5.1 or 5.3, as appropriate, together with a cross-reference from this section.
Any such statement(s) regarding paediatric age groups should be transparent and reflect the available data.
In exceptional cases where the “adult formulation” of a medicinal product includes an indication and a posology for use in children, or includes, at least, posology recommendations for use in children, and where no adequate paediatric formulation can be developed based on duly justified scientific grounds (ie, where the extemporaneous preparation of a formulation for paediatric use from the adult one is necessary), relevant instructions for the extemporaneous preparation shall be included in Section 6.6 with a cross-reference in Section 4.2. Such information shall be provided by the Marketing Authorisation Holder (MAH) with a view to improve the quality, safety and efficacy of such extemporaneous preparations for use in children.
If a paediatric indication has not been approved, the following statements are suggested. Modify or delete those not applicable.
Method of administration: directions for proper use by healthcare professionals or by the patient. Further practical details for the patient can be included in the package leaflet (PL), eg, in the case of inhalers and subcutaneous self-injection.
Instructions for preparation are to be placed under Section 6.6 or 6.12 and cross-referenced here.
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