| salt:hasText
| - Jedna potahovaná tableta obsahuje 145.0 mg fenofibratum (nanočástice).
Úplný seznam pomocných látek viz bod 6.1.Full details of the medicinal product should be provided including: qualitative and quantitative composition in terms of the active substance(s) and constituents of the excipient, knowledge of which is essential for proper administration of the product. If appropriate, this information should be provided in section 4.3 or 4.4. A standard statement should be included at the end of the section, ie, ‘for full list of excipients, see section 6.1’. See also the ’Guideline on the Excipients in the Label and Package Leaflet of Medicinal Products for Human Use’ as published on the website of the European Commission in the Notice to Applicants, Volume 3B.
If a diluent is part of the medicinal product, information should be included in the relevant sections (usually Sections 3, 6.1, 6.5, and 6.6).
Qualitative declaration:
The active substance should be declared by its recommended INN, accompanied by its salt or hydrate form if relevant, or the European Pharmacopoeial name if that name represents an established name in Europe. If no INN exists, the European Pharmacopoeia name should be used or if the substance is not in the pharmacopoeia, the usual common name should be used. In the absence of a common name, the exact scientific designation should be given. Substances not having an exact scientific designation should be described by a statement of how and from what they were prepared. References to the pharmacopoeial quality should not be included.
Where the medicinal product is a (traditional) herbal medicinal product, the qualitative declaration should be in accordance with the Note for Guidance on Quality of Herbal Medicinal Products.
When the medicinal product is a radiopharmaceutical kit, the qualitative declaration should clearly indicate that the radioisotope is not part of the kit.
Quantitative declaration:
The quantity of the active substance must be expressed per dosage unit (for metered dose inhalation products - per delivered dose and/or per metered dose), per unit volume, or per unit of weight and must be related to the declaration of strength in the section above entitled ‘Name of the Medicinal Product.’
Salts and hydrates
Where the active substance is present in the form of a salt or hydrate, the quantitative composition should be expressed in terms of the mass (or biologic activity in International [or other] Units where appropriate) of the active entity (base, acid, or anhydrous material), eg, ‘60 mg toremifene (as citrate) or ‘toremifene citrate equivalent to 60 mg toremifene.’
Where a salt is formed in situ during manufacture of the finished product, the quantity of the active entity should be stated, with a reference to the in situ formation of the salt.
In the case of established active substances in medicinal products where the strength has traditionally been expressed in the form of a salt or hydrate, the quantitative composition may be declared in terms of the salt or hydrate, eg, ‘60 mg diltiazem hydrochloride.’ This may also apply when the salt is formed in situ.
Esters and pro-drugs
If the active substance is an ester or pro-drug, the quantitative composition should be stated in terms of the quantity of the ester or pro-drug. When the active entity is the active substance of an already approved medicinal product, the quantitative composition should also be in terms of the quantity of this active entity.
Oral powders for solution or suspension
The quantity should be stated per unit dose if the product is a single-dose preparation or otherwise per unit dose volume after reconstitution; a reference to the molar concentration may also be appropriate in some cases.
Parenterals
For single-dose parenterals, where the total contents of the container are given in a single dose (‘total use’), the quantity of active substance(s) should be stated per presentation (eg, 20 mg, etc.) not including any overages or overfill. The quantity per ml and per total labelled volume should also be given.
For single-dose parenterals, where the amount to be given is calculated on the basis of the patient’s weight or body surface or variable (‘partial use’), the quantity of active substance(s) should be stated per ml. The quantity per total labelled volume should also be given. Overages or overfills should not be included.
For multi-dose and large volume parenterals or parenterals, the quantity of active substance(s) should be stated per ml, per 100 ml, per 1000 ml, etc, as appropriate, except for multidose vaccines containing ‘n’ doses of the same dose. In this case, the strength should be expressed per dose volume. Overages or overfills should not be included.
Where appropriate, eg, for X-ray contrast media and parenterals containing inorganic salts, the quantity of active substance(s) should also be indicated in millimoles. For X-ray contrast media with iodine-containing active substances, the quantity of iodine per ml should be stated in addition to the quantity of the active substance.
Powders for reconstitution prior to parenteral administration
When the product is a powder to be reconstituted prior to administration, the total quantity of active substance in the container should be stated not including overages or overfills, as well as the quantity per ml when reconstituted. If there are several means of reconstituting or different quantities used that result in different final concentrations, then the overages or overfills should be stated.
Concentrates
The quantity should be stated as the content per ml in the concentrate and as the total content of the active substance. The content per ml when diluted as recommended should also be included unless the concentrate is to be diluted to within a range of different final concentrations.
Transdermal patches
The following quantitative details should be given: the content of active substance(s) per patch, the mean dose delivered per unit time, and the area of the releasing surface, eg ‘Each patch contains 750 micrograms of estradiol in a patch size of 10 cm2, releasing a nominal 25 micrograms of estradiol per 24 hours.’
Multidose solid or semi-solid products
Quantity of active substance should be stated, where possible, per unit dose, otherwise per gram, per 100 g, or percentage, as appropriate.
Biologic products
In the case of normal immunoglobulins, the IgG subclass distribution should be stated.
In the case of vaccines, the content of active substance per dose unit (eg, per 0.5 ml) should be stated. Adjuvants, if present, should be stated qualitatively and quantitatively.
The nature of any cellular system(s) used for production, and, if relevant, the use of recombinant DNA technology, including the use of the expression ‘produced in XXX cells by recombinant DNA technology’, should be mentioned in the SPC, in a pattern as set by the following examples:
‘produced in human diploid (MRC-5) cells’
‘produced in Escherichia coli cells by recombinant DNA technology’
‘produced in chick-embryo cells’
‘derived from human plasma donors’
Herbal medicinal products
The quantitative declaration should be in accordance with the Note for Guidance on Quality of Herbal Medicinal Products.
Indicate the name of the active substance(s) in the language of the text.
Examples:
“Each tablet contains X mg {active substance}.”
“Each bottle with Y ml of solution contains X mg {active substance} anhydrous, corresponding to Z mg {active substance} monohydrate. One ml solution contains XX mg {active substance} anhydrous corresponding to YY mg {active substance} monohydrate.”
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