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| - Describe the absolute contraindications, ie, situations where the medicinal product must not be given for safety reasons. Such circumstances could include:
Particular clinical diagnosis
Concomitant diseases
Demographic factors (eg, gender, age)
Predispositions (eg, metabolic or immunologic factors, prior adverse reactions to the medicine or class of medicines)
The situations must be unambiguously, comprehensively, and clearly outlined.
Other medicines or classes of medicine that must not be used concomitantly or consecutively should be stated. Also, where there are strong theoretical reasons (eg, on grounds of pharmacokinetics, pharmacodynamics, or common state of knowledge in medicine) for not using the combination, these should be stated. If applicable, a cross-reference to Section 4.5 should be given.
In general, patient populations not studied in the clinical trial programme should be mentioned in Section 4.4 and not in this section unless a safety issue can be predicted (eg, use of renally‑cleared substances with narrow therapeutic margin in renal failure patients). If patients were actually excluded from studies as being contraindicated on serious grounds of safety, they should be mentioned in this section. If applicable, a cross-reference to Section 4.5 should be given.
Pregnancy should be mentioned here only if it is strictly contraindicated. Under Section 4.6, a cross-reference should be given and further information about the background should be provided.
Hypersensitivity to any of the excipients or residues from the manufacturing process should be included, as well as any contraindication arising from the presence of certain excipients (see Guideline on Excipients in the Label and Package Leaflet of Medicinal Products for Human Use).
For herbal medicinal products, hypersensitivity extended to other plants of the same family or to other parts of the same plant should be labelled as a contraindication, where applicable.
Delete any of the following statements that are not applicable:
přecitlivělost na léčivou látku nebo na jakoukoli pomocnou látkuAlternatively, enter unique text:
jaterní insuficience (včetně biliární cirhózy a nevysvětlených přetrvávajících abnormalit jaterních funkcí, např. přetrvávající zvýšení hladin transamináz v séru)
renální insuficience
děti (věk do 18 let)
známá fotoalergie nebo fototoxická reakce během léčby fibráty nebo ketoprofenem
onemocnění žlučníku
chronická nebo akutní pankreatitida s výjimkou případů akutní pankreatitidy způsobené těžkou hypertriglyceridémií
Tablety Lipanthylu S 215 mg nemají být podávány pacientům alergickým na arašídy, arašídový olej nebo sójový lecithin a příbuzné produkty vzhledem k riziku vzniku hypersenzitivních reakcí.
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