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Qualitative and quantitative composition - deletion of reference to 'trihydrate' in relation to description of the active substance.
4.1 Therapeutic indications - deletion of info.: 'Levitra is not indicated for use by women.'
- deletion of info.: 'Levitra is not indicated for use by women.'
4.2 Posology and method of administration - Section 4.2 now sub-divided more clearly, including addition of the new headings, "Posology", "Special populations", "Paediatric population" and "Method of administration", and, deletion/modification of some existing sub-headings (e.g., "Use in elderly men"....). Editorial amendment to info. describing use in the elderly population. The order of some sub-sections has been rearranged and various other minor editorial corrections have been made.
Section 4.2 now sub-divided more clearly, including addition of the new headings, "Posology", "Special populations", "Paediatric population" and "Method of administration", and, deletion/modification of some existing sub-headings (e.g., "Use in elderly men"....). Editorial amendment to info. describing use in the elderly population. The order of some sub-sections has been rearranged and various other minor editorial corrections have been made.
4.3 Contraindications - Inclusion of full nomenclature (viz., 'phosphodiesterase') for 'PDE5' and replacement of 'Agents' by 'Medicinal products'.
Inclusion of full nomenclature (viz., 'phosphodiesterase') for 'PDE5' and replacement of 'Agents' by 'Medicinal products'.
4.4 Special warnings and precautions for use - editorial replacement of 'Agents' by 'Medicinal products'. Addition of new informative sub-section headings throughout. Re-ordering of 'tolerability max dose in elderly patients' statement. Replacement of existing statement regarding, 'Safety and efficacy of combinations of vardenafil and other treatments....is not recommended.", with amended statement, 'Safety and efficacy of combinations of Levitra...... and other treatments....is not recommended." Clarification of lowest starting dose of 5 mg by addition of, 'film-coated tablets', for 'concomitant use of alpha-blockers' text. Amendment to statement on influence of, '....grapefruit juice...', to, '....grapefruit or grapefruit juice....' on plasma concentrations of vardenafil. Amendment of, 'drug', to, 'active substance', within context of gatifloxacin and QTc interval text. Additional minor editorial changes.
editorial replacement of 'Agents' by 'Medicinal products'. Addition of new informative sub-section headings throughout. Re-ordering of 'tolerability max dose in elderly patients' statement. Replacement of existing statement regarding, 'Safety and efficacy of combinations of vardenafil and other treatments....is not recommended.", with amended statement, 'Safety and efficacy of combinations of Levitra...... and other treatments....is not recommended." Clarification of lowest starting dose of 5 mg by addition of, 'film-coated tablets', for 'concomitant use of alpha-blockers' text. Amendment to statement on influence of, '....grapefruit juice...', to, '....grapefruit or grapefruit juice....' on plasma concentrations of vardenafil. Amendment of, 'drug', to, 'active substance', within context of gatifloxacin and QTc interval text. Additional minor editorial changes.
4.5 Interaction with other medicinal products and other forms of interaction - clarification that the 10 mg dose described in the context of co-administration of indinavir refers to 'film-coated tablets'. Replacement of, 'Levitra', by, 'vardenafil' within the 'co-administration of ritonavir' text. Clarification that vardenafil doses described in bulleted 'benign prostatic hyperplasia....terazosin therapy' text refer to 'film-coated tablets'. Identical clarification provided within context of 'co-administration of warfarin/digoxin/alcohol' statements. Additional minor editorial changes.
clarification that the 10 mg dose described in the context of co-administration of indinavir refers to 'film-coated tablets'. Replacement of, 'Levitra', by, 'vardenafil' within the 'co-administration of ritonavir' text. Clarification that vardenafil doses described in bulleted 'benign prostatic hyperplasia....terazosin therapy' text refer to 'film-coated tablets'. Identical clarification provided within context of 'co-administration of warfarin/digoxin/alcohol' statements. Additional minor editorial changes.
4.6 Pregnancy and lactation - correction of section title to, "Fertility, pregnancy and lactation". Inclusion of new statement, '
- correction of section title to, "Fertility, pregnancy and lactation". Inclusion of new statement, '
There are no fertility data available.'
4.7 Effects on ability to drive and use machines - amendment of, 'machinery, to, 'machines'.
- amendment of, 'machinery, to, 'machines'.
4.8 Undesirable effects - Substantial update of existing film-coated tablets information in line with equivalent approved section 4.8 for 10 mg ODT formulation (content and editorial changes have been made).
- Substantial update of existing film-coated tablets information in line with equivalent approved section 4.8 for 10 mg ODT formulation (content and editorial changes have been made).
4.9 Overdose - Confirmation provided that 80 mg and 40 mg doses refer to 'film-coated tablets'.
- Confirmation provided that 80 mg and 40 mg doses refer to 'film-coated tablets'.
5.1 Pharmacodynamic properties - Replacement of 'Medicinal products....' with 'Urologicals, drugs...' in 'Pharmacotherapeutic group' section. Addition of new section for 10 mg ODT, "Further information on clinical trials with Levitra 10 mg orodispersible tablets" comprising four paragraphs of additional text. Correction of three data elements within existing section, "Further information on clinical trials", as follows: "...3750 men...", "...1630 patients...", and, "...over 730 patients...", respectively corrected to, "...17000 men...", "...2500 patients...", and, "...900 patients...". Correction of, 'Levitra', to 'vardenafil'. Clarification that the vardenafil referred to in 'pivotal trials'- and 'fixed dose studies' texts was in the form of 'film-coated tablets'. Multiple minor editorial corrections.
Replacement of 'Medicinal products....' with 'Urologicals, drugs...' in 'Pharmacotherapeutic group' section. Addition of new section for 10 mg ODT, "Further information on clinical trials with Levitra 10 mg orodispersible tablets" comprising four paragraphs of additional text. Correction of three data elements within existing section, "Further information on clinical trials", as follows: "...3750 men...", "...1630 patients...", and, "...over 730 patients...", respectively corrected to, "...17000 men...", "...2500 patients...", and, "...900 patients...". Correction of, 'Levitra', to 'vardenafil'. Clarification that the vardenafil referred to in 'pivotal trials'- and 'fixed dose studies' texts was in the form of 'film-coated tablets'. Multiple minor editorial corrections.
5.2 Pharmacokinetic properties - Addition of new paragraph one, describing the non-bioequivalence between 10 mg ODT and FCT formulations. Clarification that the vardenafil described in the existing two paragraphs of the 'Absorption' sub-section refers to 'Levitra film-coated tablets'. Addition of two new paragraphs of 'Absorption' info/data for the 10 mg ODT formulation. Amendment of the sub-section heading, 'Metabolism', to, 'Biotransformation', and clarification that the vardenafil described in the existing paragraphs of this sub-section refers to 'Levitra film-coated tablets'. Addition of data for mean terminal- and elimination half-life data for the 10 mg ODT formulation. Replacement of 'insufficiency' by 'impairment' in sub-section headings in 'Pharmacokinetics in special patient groups' section. Clarification that the vardenafil described in the 'elderly - hepatic clearance' text refers to 'Levitra film-coated tablets'. Addition of new paragraph describing AUC/Cmax data for elderly patients for new 10 mg ODT formulation. Editorial/typographical corrections throughout.
- Addition of new paragraph one, describing the non-bioequivalence between 10 mg ODT and FCT formulations. Clarification that the vardenafil described in the existing two paragraphs of the 'Absorption' sub-section refers to 'Levitra film-coated tablets'. Addition of two new paragraphs of 'Absorption' info/data for the 10 mg ODT formulation. Amendment of the sub-section heading, 'Metabolism', to, 'Biotransformation', and clarification that the vardenafil described in the existing paragraphs of this sub-section refers to 'Levitra film-coated tablets'. Addition of data for mean terminal- and elimination half-life data for the 10 mg ODT formulation. Replacement of 'insufficiency' by 'impairment' in sub-section headings in 'Pharmacokinetics in special patient groups' section. Clarification that the vardenafil described in the 'elderly - hepatic clearance' text refers to 'Levitra film-coated tablets'. Addition of new paragraph describing AUC/Cmax data for elderly patients for new 10 mg ODT formulation. Editorial/typographical corrections throughout.
6.1 List of excipients - minor editorial corrections - capitalization.
minor editorial corrections - capitalization.
6.5 Nature and contents of container - addition of 20 tablet pack size in current approved packaging.
- addition of 20 tablet pack size in current approved packaging.
8 Marketing Authorisation number(s) - addition of new MA no.s for additional pack sizes.
- addition of new MA no.s for additional pack sizes.
10 Date of revision of the text - editorial correction to text and amended date added = 20/04/11
- editorial correction to text and amended date added = 20/04/11
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