natgillin/translations-raw huggingface dataset:
5. 1), hvori 20. 536 patienter blev behandlet med enten < Zocord > 40 mg/ dag (n = 10. 269) eller placebo (n = 10. 267), var sikkerhedsprofilerne sammenlignelige mellem patienter behandlet med < Zocord > 40 mg og patienter behandlet med placebo over undersøgelsens gennemsnitlige 5 år.
In HPS (see section 5.1) involving 20,536 patients treated with 40 mg/ day of< Zocord > (n = 10,269) or placebo (n = 10,267), the safety pr ofiles were comparable between patients treated with < Zocord > 40 mg and patients treated with placebo over the mean 5 years of the study.
Antal behandlingsstop på grund af bivirkninger var sammenlignelige (4, 8% af patienterne behandlet med < Zocord > 40 mg sammenlignet med 5, 1% af patienterne behandlet med placebo).
Discontinuation rates due to side effects were comparable (4.8% in patients treated with< Zocord > 40 mg compared with 5.1% in patients treated with placebo).
Incidensen af myopati var 0, 1% for patienter behandlet med < Zocord > 40 mg.
The incidence of myopathy was < 0.1% in patients treated with< Zocord > 40 mg.
Forhøjede transaminaser (3 x ULN bekræftet ved gentagen test) forekom hos 0, 21% (n = 21) af patienterne behandlet med < Zocord > 40 mg sammenlignet med 0, 09% (n = 9) af patienterne behandlet med placebo.
Elevated transaminases (> 3 x ULN confirmed by repeat test) occurred in 0.21% (n = 21) of patients treated with< Zocord > 40 mg compared with 0.09% (n = 9) of patients treated with placebo.
Hyppigheden af bivirkninger er angivet i følgende rækkefølge:
The frequencies of adverse events are ranked according to the following:
Meget almindelig (> 1/ 10), Almindelig (≥ 1/ 100), < 1/ 10), Ikke almindelig (≥ 1/ 1000, < 1/ 100), Sjælden (≥ 1/ 10. 000, < 1/ 1000), Meget sjælden (< 1/ 10. 000) inklusive enkeltstående rapporter.
Very common (> 1/ 10), Common (≥ 1/ 100, < 1/ 10), Uncommon (≥ 1/ 1000, < 1/ 100), Rare (≥ 1/ 10,000, < 1/ 1000), Very Rare (< 1/ 10,000) including isolated reports.
Sjælden: anæmi
Rare: anaemia
Gastrointestinale lidelser:
Nervous system disorders:
Sjældent: hepatitis/ gulsot
Rare: headache, paresthesia, dizziness, peripheral neuropathy
Sygdomme i hud og subkutane væv:
Gastrointestinal disorders:
Sjældent: asteni.
Rare: constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis
Undersøgelser:
Hepato-biliary disorders:
CPMP/ 459/ 04
CPMP/ 459/ 04 Rare: hepatitis/ jaundice
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Sjældne: stigning i serumtransaminaser (alanin aminotransferase, aspartat aminotransferase, γ - glutamyl transpeptidase) (se pkt.
Rare: myopathy, rhabdomyolysis (see section 4.4), myalgia, muscle cramps
4. 4).
Rare: increases in serum transaminases (alanine aminotransferase, aspartate aminotransferase, γ - glutamyl transpeptidase) (see section 4.4 Hepatic effects), elevated alkaline phosphatase; increase in serum CK levels (see section 4.4).
Der er til dato kun rapporteret få tilfælde af overdosering; Den højeste dosis var 3, 6 g. alle patienter kom sig uden følgevirkninger.
All patients recovered without sequelae.
I dette tilfælde bør der tages symptomatiske og afhjælpende forholdsregler.
In this case, symptomatic and supportive measures should be adopted.
HMG- CoA reduktasehæmmer ATC- kode:
HMG-CoA reductase inhibitor ATC-Code:
C10A A01
C10A A01
Simvastatin, som er en inaktiv lakton, hydrolyseres i leveren efter oral indgivelse til den tilsvarende aktive β- hydroxysyre form, som har en potent aktivitet i hæmningen af HMG- CoA reduktase (3 hydroxy – 3 methylglutaryl CoA reduktase).
After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed in the liver to the corresponding active beta-hydroxyacid form which has a potent activity in inhibiting HMG-CoA reductase (3 hydroxy – 3 methylglutaryl CoA reductase).
Dette enzym katalyserer omdannelsen af HMG- CoA til mevalonat, et tidligt og hastighedsbegrænsende trin i kolesterols biosyntese.
This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
< Zocord > har vist sig at reducere både normale og forhøjede LDL- C koncentrationer.
< Zocord > has been shown to reduce both normal and elevated LDL-C concentrations.
LDL er dannet af et meget low- density protein (VLDL) og kataboliseres overvejende af den højaffinitive LDL receptor.
LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor.
Mekanismen i den LDL- sænkende effekt af < Zocord > kan indebære både reduktion af VLDL- kolesterol (VLDL- C) koncentrationen og induktion af LDL receptoren, hvilket kan føre til reduceret produktion og forøget katabolisme af LDL- C.
The mechanism of the LDL-lowering effect of< Zocord > may involve both reduction of VLDL-cholesterol (VLDL-C) concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C.
Apolipoprotein B falder også markant under behandling med < Zocord >.
Apolipoprotein B also falls substantially during treatment with< Zocord >.
Endvidere forøger < Zocord > HDL- C moderat og reducerer plasma TG.
In addition ,< Zocord > moderately increases HDL-C and reduces plasma TG.
Som et resultat af disse forandringer reduceres totalkolesterol til HDL- C og LDL - til HDL- C.
As a result of these changes the ratios of total- to HDL-C and LDL- to HDL-C are reduced.
Høj risiko for koronar hjertesygdom (CHD) eller eksisterende koronar hjertesygdom I Heart Protection Study (HPS) blev effekten af behandling med < Zocord > vurderet hos 20. 356 patienter (i alderen 40- 80 år) med eller uden hyperlipidæmi, og med koronar hjertesygdom, andre okklusive arterielle sygdomme eller diabetes mellitus.
High Risk of Coronary Heart Disease (CHD) or Existing Coronary Heart Disease In the Heart Protection Study (HPS), the effects of therapy with< Zocord > were assessed in 20,536 patients (age 40-80 years), with or without hyperlipidaemia, and with coronary heart disease, other occlusive arterial disease or diabetes mellitus.
I dette studie blev 10. 269 patienter behandlet med < Zocord > 40 mg/ dag, og 10. 267 patienter blev behandlet med placebo i en gennemsnitlig periode på 5 år.
In this study, 10,269 patients were treated with< Zocord > 40 mg/day and 10,267 patients were treated with placebo for a mean duration of 5 years.
Ved baseline havde 6. 793 patienter (33%) LDL- C niveauer under 116 mg/ dL; 5. 063 patienter (25%) havde niveauer mellem 116 mg/ dl og 135 mg/ dl; og 8. 680 patienter (42%) havde niveauer højere end 135 mg/ dl.
At baseline, 6,793 patients (33%) had LDL-C levels below 116 mg/ dL; 5,063 patients (25%) had levels between 116 mg/ dL and 135 mg/ dL; and 8,680 patients (42%) had levels greater than 135 mg/ dL.
Inden for gruppen af patienter med diabetes reducerede < Zocord > endvidere risikoen for at udvikle makrovaskulære komplikationer, inklusive perifere revaskulariseringsprocedurer (operation eller angioplastik), amputation af underekstremiteter eller sår på benene med 21% (p = 0, 0293).
CPMP/ 459/ 04 Treatment with< Zocord > 40 mg/day compared with
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EMEA 2004
@EMEA 2004 all
tilstedeværelse eller fravær af hypertension, og især dem med LDL kolesterol under 3, 0 mmol ved inklusion.
The proportional reduction in event rate was similar in each subgroup of patients studied, including those without coronary disease but who had cerebrovascular or peripheral artery disease, men and women, those aged either under or over 70 years at entry into the study, presence or absence of hypertension, and notably those with LDL cholesterol below 3.0 mmol/ l at inclusion.
I Scandinavian Simvastatin Survival Study (4S) blev effekten af behandling med < Zocord > på den totale mortalitet vurderet hos 4. 444 patienter med CHD og totalkolesterol ved baseline på 212 - 309 mg/ dl (5, 5- 8, 0 mmol/ l).
In the Scandinavian Simvastatin Survival Study (4S), the effect of therapy with< Zocord > on total mortality was assessed in 4,444 patients with CHD and baseline total cholesterol 212-309 mg/dL (5.5-8.0 mmol/L).
I dette multicenter studie, som er randomiseret, dobbelt- blindt og placebokontrolleret, blev patienter med angina eller tidligere myokardieinfarkt (MI) behandlet med diæt, standardpleje, og enten < Zocord > 20- 40 mg/ dag (n = 2. 221) eller placebo (n = 2. 223) i en gennemsnitlig periode på 5, 4 år. < Zocord > reducerede risikoen for dødsfald med 30% (absolut risikoreduktion på 3, 3%).
In this multicenter, randomised, double-blind, placebo-controlled study, patients with angina or a previous myocardial infarction (MI) were treated with diet, standard care, and either< Zocord > 20-40 mg/day (n = 2,221) or placebo (n = 2,223) for a median duration of 5.4 years. < Zocord > reduced the risk of death by 30% (absolute risk reduction of 3.3%).
Risikoen for CHD dødsfald blev reduceret med 42% (absolut risikoreduktion på 3, 5%). < Zocord > reducerede også risikoen for alvorligere koronare hændelser (CHD dødsfald samt hospitalsverificeret og ikke- symptomgivende non- fatal MI) med 34%.
The risk of CHD death was reduced by 42% (absolute risk reduction of 3.5%) .< Zocord > also decreased the risk of having major coronary events (CHD death plus hospital-verified and silent nonfatal MI) by 34%.
Endvidere reducerede < Zocord > risikoen væsentligt for fatale og non- fatale cerebrovaskulære hændelser (slagtilfælde og forbigående iskæmiske anfald) med 28%.
Furthermore ,< Zocord > significantly reduced the risk of fatal plus nonfatal cerebrovascular events (stroke and transient ischemic attacks) by 28%.
Der var ingen statistisk signifikant forskel mellem grupperne med henblik på non- kardiovaskulær mortalitet.
There was no statistically significant difference between groups in non-cardiovascular mortality.
Primær Hyperkolesterolæmi og Kombineret Hyperlipidæmi I undersøgelser der sammenligner effekt og sikkerhed af simvastatin 10, 20, 40 og 80 mg dagligt hos patienter med hyperkolesterolæmi, var de gennemsnitlige LDL- C reduktioner på henholdsvis 30, 38, 41 og 47%.
Primary Hypercholesterolaemia and Combined Hyperlipidaemia In studies comparing the efficacy and safety of simvastatin 10, 20, 40 and 80 mg daily in patients with hypercholesterolemia, the mean reductions of LDL-C were 30, 38, 41 and 47%, respectively.
I undersøgelser med patienter med kombineret (blandet) hyperlipidæmi, som fik simvastatin 40 mg og 80 mg, var middelreduktionerne for triglycerider på henholdsvis 28 og 33% (placebo:
In studies of patients with combined (mixed) hyperlipidaemia on simvastatin 40 mg and 80 mg, the median reductions in triglycerides were 28 and 33% (placebo:
2%), og gennemsnitlige forøgelser af HDL- C var henholdsvis13 og 16% (placebo:
2%), respectively, and mean increases in HDL-C were 13 and 16% (placebo:
3%).
3%), respectively.
Simvastatin er en inaktiv lakton som nemt hydrolyseres in vivo til den tilsvarende β- hydroxysyre, en potent HMG- CoA reduktasehæmmer.
Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA reductase.
Absorption Hos mennesker absorberes simvastatin godt, og det undergår udtalt first- pass metabolisme i leveren.
Absorption In man simvastatin is well absorbed and undergoes extensive hepatic first-pass extraction.
Ekstraktionen i leveren afhænger af levergennemblødningen.
The extraction in the liver is dependent on the hepatic blood flow.
Leveren er det primære virkningssted for den aktive form af stoffet.
The liver is the primary site of action of the active form.
Tilgængeligheden af β- hydroxysyre i den systemiske cirkulation efter en oral dosis simvastatin viste sig at være mindre end 5% af dosis.
The availability of the beta-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose.
Farmakokinetikken for enkel - og flergangsdosering af simvastatin viste ingen akkumulation af lægemidlet efter flergangsdosering.
Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin.
Fordeling Proteinbindingen i simvastatin og den aktive metabolit er > 95%.
Concomitant food intake does not affect the absorption.
Efter oral dosering af radioaktivt simvastatin til mennesker blev 13% af radioaktiviteten udskilt i urinen og 60% i fæces inden for 96 timer.
The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing.
Hverken hos rotter eller kaniner forårsagede simvastatin, ved de CPMP/ 459/ 04
CPMP/ 459/ 04 Distribution
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maksimale tolererede doser, misdannede fostre eller havde indvirkning på fertiliteten, den reproduktive funktion eller den neonatale udvikling.
At maximally tolerated doses in both the rat and the rabbit, simvastatin produced no foetal malformations, and had no effects on fertility, reproductive function or neonatal development.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
DATE OF FIRST AUTHORIZATION/ RENEWAL OF AUTHORIZATION
39/ 39
46/ 46
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State
McNeil Roderveld 1 B – 2600 Berchem Belgien
McNeil Roderveld 1 B – 2600 Berchem Belgium
UCB Pharma SA (Bruxelles) Allée de la Recherche, 60 B- 1070 Bruxelles
UCB Pharma SA (Brussels) Allée de la Recherche, 60 B-1070 Brussels
2 Bulgarien
Bulgaria
Box 22679 1523 Nicosia Cypern
Box 22679 1523 Nicosia Cyprus
UCB Pharma SA (BRAINE) Chemin du Foriest Braine- l' Alleud B- 1420 Belgien
UCB Pharma SA (BRAINE) Chemin du Foriest Braine-l'Alleud B-1420 Belgium
UCB Nordic A/ S (DK) Arne Jacobsens Allé 15 DK- 2300 København S
UCB Nordic A/ S (DK) Arne Jacobsens Allé 15 DK-2300 Kobenhavn S
UCB Pharma Oy Finland Malminkaari 5 FI- 00700 HELSINGFORS
UCB Pharma Oy Finland Malminkaari 5 FI-00700 HELSINKI
UCB Pharma Oy Finland Malminkaari 5 FI- 00700 HELSINFORS
UCB Pharma Oy Finland Malminkaari 5 FI-00700 HELSINKI
4 Frankrig
France
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 Frankrig
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France
1 D- 76139 Karlsruhe TYSKLAND
1 D-76139 Karlsruhe GERMANY
580 Avenue Vouliagmenis GR- 16452 Argyroupoli Athen
580 Avenue Vouliagmenis GR-16452 Argyroupoli Athens
UCB Magyarország Kft Árpád fejedelem útja 26- 28 1023 Budapest Ungarn
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
ZYRTEC START FILMTABLETT A
ZYRTEC START FILMTABLETTA
UCB Pharma Ireland Limited, United Drug House, Magna Drive City West Road Dublin 24 Irland
UCB Pharma Ireland Limited, United Drug House, Magna Drive City West Road Dublin 24 Ireland
Istituto Lusofarmaco Via Walter Tobagi 8 20068 Peschiera Borromeo (MI) Italien
Istituto Lusofarmaco Via Walter Tobagi 8 20068 Peschiera Borromeo (MI) Italy
SS 156km 50 04010 Borgo San Michele (LT) Italien
SS 156km 50 04010 Borgo San Michele (LT) Italy
Sinutab Decongestif & Antihistaminicu m
Sinutab Decongestif & Antihistaminicum
5mg
5mg
UCB Pharma SA (Bruxelles) Allée de la Recherche, 60 B- 1070
UCB Pharma SA (Brussels) Allée de la Recherche, 60 B-1070
9 Holland
Netherlands
Pfizer Consumer Healthcare BV Rivium Westlaan 142 NL- 2909 LD Capelle a/ d IJsel Holland
Pfizer Consumer Healthcare BV Rivium Westlaan 142 NL-2909 LD Capelle a/ d IJsel Nederland
Lage Mosten 33 NL- 4822 NK Breda Holland
Lage Mosten 33 NL-4822 NK Breda Nederland
McNeil Sweden AB, Sollentuna Sverige
McNeil Sweden AB, Sollentuna Sweden
Pfizer Consumer Healthcare (GB) Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Storbritannien
Pfizer Consumer Healthcare (GB) Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Great Britain
Mogilska 80 31- 546 Krakow Polen
Mogilska 80 31-546 Krakow Poland
10 Polen
Poland
11 Portugal
Portugal
Maria I Piso 1 A Quinta da Fonte 2770- 229 Paco de Arcos Portugal
Maria I Piso 1 A Quinta da Fonte 2770-229 Paco de Arcos Portugal
UCB GmbH Huttenstraße 205 D- 50170 Kerpen Tyskland
UCB GmbH Huttenstraße 205 D-50170 Kerpen Germany
UCB SA Pharma Secteur Chemin du Foriest, B- 1420 Braine l´Alleud Belgien
UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgium
ZYRTEC TBL FLM 10MG
ZYRTEC TBL FLM 10MG
(Slovenia) Brnciceva 1 SLO - 1001 Ljubljiana Slovenien
(Slovenia) Brnciceva 1 SLO - 1001 Ljubljiana Slovenia
12 Slovenien
Slovenia
Alfonso XII, 587 08918 Badalona (Barcelona) Spanien
Alfonso XII, 587 08918 Badalona (Barcelona) Spain
Lacer SA Sardenya 346 - 350 E - 08025 Barcelona Spanien
Lacer SA Sardenya 346 - 350 E - 08025 Barcelona Spain
13 Spanien
Spain
Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spanien
Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spain
UCB Nordic A/ S Arne Jacobsens Allé 15 DK- 2300 København S Danmark
UCB Nordic A/ S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark
14 Sverige
Sweden
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, Storbritannien
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, UK
BENADRYL FOR CHILDREN ALLERGY SOLUTION
BENADRYL FOR CHILDREN ALLERGY SOLUTION
McNeil Products Limited Walton Oaks, Dorking Road, Walton on the Hill, Surrey KT20 7NS Storbritannien
McNeil Products Limited Walton Oaks, Dorking Road, Walton on the Hill, Surrey KT20 7NS UK
Storbritannien
United kingdom
15 Storbritannien
United Kingdom
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
17 FAGLIGE KONKLUSIONER
19 SCIENTIFIC CONCLUSIONS
I 16 medlemsstater anbefales behandling med cetirizin også til spædbørn og små børn i alderen 1- 2 år.
In 16 member states, treatment with cetirizine is also recommended in infants and toddlers aged 1 to 2 years.
Derfor indbragte Europa- Kommissionen en sag i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, med henblik på at harmonisere de afvigende tekster i produktinformationerne i hele EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/ 83/ EC as amended in order to harmonise the divergent Product Information texts across the EU.
Hos voksne, børn, spædbørn og små børn, som er fyldt 2 år: • Cetirizin er indiceret til lindring af symptomer i næse og øjne på sæsonbetinget og vedvarende allergisk rinit. • Cetirizin er indiceret til lindring af kronisk idiopatisk urticaria.
In adults, children, infants and toddlers 2 year and above: • Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis • Cetrizine is indicated for the relief of chronic idiopathic urticaria.
• Børn i alderen 2 til 6 år:
• Children aged from 2 to 6 years:
2, 5 mg to gange dagligt (5 dråber to gange dagligt). • Børn i alderen 6 til 12 år:
2.5 mg twice daily (5 drops twice daily). • Children aged from 6 to 12 years:
5 mg to gange dagligt (10 dråber to gange dagligt). • Voksne og unge, som er fyldt 12 år:
5 mg twice daily (10 drops twice daily). • Adults and adolescents over 12 years of age:
10 mg en gang dagligt (20 dråber).
10 mg once daily (20 drops).
Den foreslåede dosering til børn er afprøvet i kliniske undersøgelser, men stammer også fra doseringstilpasninger baseret på legemsvægt og clearance, som varierer efter, hvor modent det renale
The posology proposed for children has been tested in clinical trials, but also results from dosing adaptations based on body weight and clearance that varies according to the maturation of the renal system.
Derfor foreslår den harmoniserede formulering ikke en vægtbaseret dosering, da vægt tydeligvis ikke er den eneste faktor, som definerer dosis.
This is why the harmonized wording does not propose a weight – based posology, as weight is clearly not the only factor to define the dose.
Indehaveren af markedsføringstilladelsen blev også bedt om at fremlægge data til begrundelse for den anbefalede dosis hos patienter med nedsat nyrefunktion samt fremlægge begrundelse for risk/ benefit - forholdet ved en dosishalvering.
20 The MAH was also asked to provide data in support of the recommended dosing in patients with renal impairment and provide justifications for the benefit/ risk ratio of halving the dose.
Indehaveren af markedsføringstilladelsen blev også bedt om at begrunde doseringen til pædiatriske patienter med nedsat nyrefunktion og doseringen efter vægt i aldersgruppen 2- 5 år og doseringen efter aldersgrupperne 2- 5, 6- 11 og 12- 18 samt dosering til børn, som er under 2 år gamle.
The MAH was also asked to justify the dosing in paediatric patients suffering from renal impairment and the dosing by weight in the 2-5 year age group and dosing by age groups 2-5, 6-11 and 12-18 as well as dosing for children less than 2 years old.
Indehaveren af markedsføringstilladelsen meddelte, at cetirizins kliniske risk/ benefit- forhold ikke er blevet specifikt vurderet hos patienter med nedsat nyrefunktion, og at dosen derfor udelukkende er baseret på farmakokinetiske beregninger.
The MAH stated that the clinical benefit/ risk ratio of cetirizine has not been specifically evaluated in patients with renal impairment and that the dose is therefore based on pharmacokinetic calculations only.
Imidlertid vil indehaveren af markedsføringstilladelsen gerne bibeholde kontraindikationen “ Patienter med svært nedsat nyrefunktion med mindre end 10 ml/ min. kreatininclearance. ”
No signal suggesting an unfavourable benefit/ risk ratio for Zyrtec compared to other anti- histamines was ever detected in pharmacovigilance during the 22 years on the market; however the MAH would like to retain the contraindication: “ Patients with severe renal impairment at less than 10 ml/ min creatinine clearance .”
Sætningen skal derfor ændres til: “ Hos pædiatriske patienter med nedsat nyrefunktion skal dosis justeres på individuel basis på grundlag af patientens renale clearance, alder og legemsvægt. ”
The sentence will therefore be adapted to: “ In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age, and his body weight”
De doser, som er foreslået til registrering, er påvist som sikre og effektive i mange undersøgelser med børn i alderen 2 - 12 år, som vurderet i den kliniske ekspertrapport i indehaveren af markedsføringstilladelsens data.
The doses proposed for registration have been demonstrated as being safe and effective in many trials performed in children 2 to 12 years old, as reviewed in the clinical expert report provided in the MAH dossier.
Vedrørende dosering efter aldersgruppe forsvarede indehaveren af markedsføringstilladelsen den samme dosering til aldersgruppen 12- 18 år som til voksne, fordi den øgede legemsvægt kompenseres af et fald i clearance, hvilket giver en tilsvarende systemisk eksponering.
Regarding the dosing by age group, the MAH defended the same dosing for age group 12 to 18 as in adults because the increase in body weight is compensated by a decrease in clearance, allowing for an equivalent systemic exposure.
Vedrørende dosering under 2 års- alderen begrundede indehaveren af markedsføringstilladelsen doseringen baseret på farmakokinetiske data.
Regarding dosage under the age of 2, the MAH justified the dosing based on PK data.