| salt:hasText
| - A Jádro tablety:
-Natrium-lauryl-sulfát
- Monohydrát laktosy
- Povidon
- Krospovidon
- Mikrokrystalická celulosa
- Koloidní bezvodý oxid křemičitý
- Natrium-stearyl-fumarát
Potahová vrstva:
Potahová soustava OPADRY obsahuje:
- Polyvinylalkohol
- Oxid titaničitý (E171)
- Mastek
- Sójový lecithin
- Xanthanovou klovatinu
- Hlinitý lak oranžové žluti (E110)
- Hlinitý lak červeně allura AC (E129)
- Hlinitý lak indigokarmínu (E132).list should be given of the excipients, expressed qualitatively only. All excipients in the product should be included, even those present in small amounts, such as printing inks; for further details on the excipients to be declared, refer to the section on definitions and examples in the Guideline on the Excipients in the Label and Package Leaflet of Medicinal Products for Human Use. For transdermal patches, all ingredients of the patch (including the adhesive, release liner, and backing film) should be mentioned.
The active substance itself, residues of substances used during manufacture of the finished product (eg, solvents, head-space gases or antibiotics in vaccine manufacture), lubricants for pre-filled syringes, and constituents of capsule shells for inhalation powders not intended to be taken should not be included.
However, certain residues such as residues of antibiotic or other antimicrobial agents used in production that are known allergens with a potential for inducing undesirable effects should be mentioned in Section 4.3.
Excipients should be referred to by their recommended INN if one exists, accompanied by the salt or hydrate form if relevant or by their European Pharmacopoeia name. If an excipient has neither an INN nor European Pharmacopoeial name, it should be described by its usual common name. References to the pharmacopoeial quality should not be included. E numbers should be given where they exist and when the excipient is listed in the “Guideline on the Excipients in the Label and Package Leaflet of Medicinal Products for Human Use” (as having recognised action or effect), along with the common name of the excipient.
The ingredients in excipient mixtures should be listed individually. In cases where the full composition of a flavour or fragrance is not known to the applicant, they may be declared in general terms (eg, ‘orange flavour,’ ‘citrus perfume’). However, any of the components that are known or have a recognized action or effect must be included.
Ingredients that may or may not be added for the pH adjustment should be followed by the parenthesis ‘(for pH-adjustment)’.
Invented names or general descriptive names such as ‘printing ink’ should not be used in place of the common name of an ingredient or of a mixture of ingredients but may be used in conjunction with the name(s) of the ingredient(s), so long as it is clear which ingredients are described by the name.
Chemically modified excipients should be declared in such a way as to avoid confusion with the unmodified excipients, eg, “pregelatinised starch.”
For clarity, it is recommended that each excipient be listed on a separate line. It can be useful to list excipients according to the different parts of the product, eg, tablet core/coat and capsule contents/shells. For products that are presented in more than one container or in dual-chamber containers, the excipients should be listed per container or per chamber.
Abbreviations for excipients should not be used. However, where justified for space considerations, abbreviations for excipient names may appear on the labelling, on condition that these abbreviations are designated in Section 6.1.
(cs)
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