natgillin/translations-raw huggingface dataset:
7, 10, 14, 20, 21, 30, 50, 60, 100,
7, 10, 14, 20, 21, 30, 50,
250 7, 10, 14, 20, 21, 30, 50, 60, 100, 250
60, 100, 250 7, 10, 14, 20, 21, 30, 50, 60, 100, 250
Schering- Plough Europe Rue de Stalle 73 B- 1180 Brussels, Belgien
Schering-Plough Europe Rue de Stalle 73 B-1180 Brussels, Belgium
10, 14, 28, 30 and 100
10, 14, 28, 30 and 100
10, 100
10, 100
12, 30, 100
12, 30, 100
Stada Arzneimittel AG Stadastraße 2- 18 D- 61118 Bad Vibel Tyskland
Stada Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vibel Germany
Alpharma Limited Whiddon Valley Barnstaple EX32 8NS Det Forenede Kongerige
Alpharma Limited Whiddon Valley Barnstaple EX32 8NS UK
Alpharma Loratadine Tablets
Alpharma Loratadine Tablets
Blister Strip
Blister Strip
7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100, 500
7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100, 500
Alpharma Limited Whiddon Valley Barnstaple EX32 8NS, Det Forenede Kongerige
Alpharma Limited Whiddon Valley Barnstaple EX32 8NS, UK
Loratadine 5mg/ 5ml Syrup
Loratadine 5mg/ 5ml Syrup
50, 70, 100, 125, 150, 500ml
50, 70, 100, 125, 150, 500ml
Approved Prescription Services Ltd 41 Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG, Det Forenede Kongerige
Approved Prescription Services Ltd 41 Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG, UK
Loratadine 10 mg Tablets
Loratadine 10 mg Tablets
5, 7, 10, 15, 20, 28, 30, 50, 100
5, 7, 10, 15, 20, 28, 30, 50, 100
Loratadine 1mg/ 1ml Oral Solution
Loratadine 1mg/ 1ml Oral Solution
50, 60, 100, 120, 150, 200ml
50, 60, 100, 120, 150, 200ml
Egis Pharmaceuticals UK Limited 127 Shirland Road London W9 2EP, Det Forenede Kongerige
Egis Pharmaceuticals UK Limited 127 Shirland Road London W9 2EP, UK
Generics (UK) Limited Station Close Potters Bar EN6 1TL Det Forenede Kongerige
Generics (UK) Limited Station Close Potters Bar EN6 1TL UK
Loratadine 10 mg film- coated Tablets
Loratadine 10 mg film- coated Tablets
Filmovertrukket tablets
Film-coated Tablets
Lagap Pharmaceuticals Limited Unit 37, Woolmer Way Bordon, Hampshire, GU35 9QE, Det Forenede Kongerige
Lagap Pharmaceuticals Limited Unit 37, Woolmer Way Bordon, Hampshire, GU35 9QE, UK
Loratadine 10 mg tablets
Loratadine 10 mg tablets
størrelse
7, 10, 30
Loratadine tablets
Loratadine 10 mg tablets
7, 10, 14, 20, 30, 50, 100
7, 10, 14, 20, 30, 50, 100
Niche Generics Limitd Waterford Road Clonmel Co.
Niche Generics Limitd Waterford Road Clonmel Co.
Tipperary, Irland
Tipperary, Ireland
Bioglan Generics Loratadin Tablets
Bioglan Generics Loratadin Tablets
7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 100, 125, 150
7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 100, 125, 150
Norton Healthcare Limited Ivax Quays, Albert Basin Armada Way, Royal Docks London, E16 2QJ Det Forenede Kongerige
Norton Healthcare Limited Ivax Quays, Albert Basin Armada Way, Royal Docks London, E16 2QJ UK
Hay- Rite Allergy Tablets
Hay-Rite Allergy Tablets
Hayrite Tablets
Hayrite Tablets
20, 30
20, 30
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Rockspring Healthcare Ltd Nerin House 26 Bridgeway Street Douglas IM1 1EL – Isle of Man Det Forenede Kongerige
Ranbaxy UK Ltd 97-107 Uxbridge Road Ealing London UK
Loratadine tablets
Loratadine 10 mg Tablets
Blister
Blister Strip
7
7, 30
Schering Plough Ltd Shire Park Welwyn Garden City AL7 1TW Det Forenede Kongerige
Ranbaxy UK Ltd 97-107 Uxbridge Road Ealing London UK
Clarityn Tablets
Loratadine 10 mg Tablets
1, 7, 8, 10, 30
7, 10, 14, 21
Schering Plough Ltd Shire Park Welwyn Garden City AL7 1TW Det Forenede Kongerige
Rockspring Healthcare Ltd Nerin House 26 Bridgeway Street Douglas IM1 1EL – Isle of Man UK
Clarityn
Loratadine 10 mg tablets
Syrup
10 mg
1 mg/ ml
Tablet
Flaske
Blister
50, 60, 100, 200 ml
7, 10, 14, 28, 30, 56, 60, 84, 90, 100, 120, 150
2, 5, 7, 10, 14, 20, 21, 30
7
Sterwin Medicines Limited One Onslow Street Guilford Surrey GU1 4YW Det Forenede Kongerige
Schering Plough Ltd Shire Park Welwyn Garden City AL7 1TW UK
Loratadine Tablets
Clarityn Rapide Tablets
7, 10, 14, 28, 30, 56, 60, 84, 90, 100, 120, 150
50, 60, 100, 200 ml
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markedsføringstilladelse m
Clarityn Tablets
størrelse
2, 5, 7, 10, 14, 20, 21, 30
Sterwin Medicines Limited One Onslow Street Guilford Surrey GU1 4YW Det Forenede Kongerige
Sterwin Medicines Limited One Onslow Street Guilford Surrey GU1 4YW UK
Allergy and Hayfever Relief tablets
Allergy and Hayfever Relief tablets
Teva Pharma BV 3640 AE Mijdrecht Nederlandene
Teva Pharma BV 3640 AE Mijdrecht Netherlands
Teva Loratadine Tablets
Teva Loratadine Tablets
Teva Pharma Loratadine Syrup
Teva Pharma Loratadine Syrup
50, 60, 100, 120, 150, 200 ml
50, 60, 100, 120, 150, 200 ml
Ranbaxy UK Ltd 97- 107 Uxbridge Road Ealing London Det Forenede Kongerige
Ranbaxy UK Ltd 97-107 Uxbridge Road Ealing London UK
7, 30
7, 30
7, 10, 14, 21
7, 10, 14, 21
Waymade Plc Miles Gray Road Basildon SS14 3FR Det Forenede Kongerige
Waymade Plc Miles Gray Road Basildon SS14 3FR UK
Waymade Loratadine Tablets
Waymade Loratadine Tablets
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FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF DE AF EMEA FORELAGTE PRODUKTRESUMÉER
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
CPMP/ 1333/ 03 FAGLIGE KONKLUSIONER
CPMP/ 1333/ 03 SCIENTIFIC CONCLUSIONS
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SAMLET RESUMÉ AF DEN FAGLIGE
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LORATADINE CONTAINING MEDICINAL PRODUCTS (see Annex I)
Loratadin er et antihistamin tilhørende gruppen H- 1 antagonister og har i mange medlemsstater været på markedet i mindst 10 år.
Loratadine is an anti-histamine compound belonging to the H-1 antagonist group and has been on the market of many Member States for at least 10 years.
I begyndelsen af 1999 blev man i det svenske Läkemedelsverket (MPA) gjort opmærksom på oplysninger fra Medicinska födelseregistret (SMBR), som tydede på, at anvendelse af loratadin i første trimester af graviditeten kunne være forbundet med øget risiko for hypospadi hos nyfødte drenge.
In early 1999, the Medical Products Agency (MPA) was made aware of data from the Swedish Medical Birth Registry (SMBR), which indicated that use of loratadine in the first trimester of pregnancy might be associated with an increased risk of hypospadias in the male newborn.
Databasen bestod af 1 020 nyfødte, hvis mødre angav at have brugt loratadin før den første graviditetskonsultation.
The database consisted of 1,020 infants born to women who reported use of loratadine before the first antenatal visit.
Nærmere vurdering fra en præklinisk synsvinkel og af de kliniske tilfælde ledte til den konklusion, at der kan have været tale om et tilfældigt fund.
Further assessment from a preclinical point of view and of the clinical cases resulted in the conclusion that this may have been a random finding.
Endvidere tydede data fra en præklinisk undersøgelse ikke på, at loratadin har antiandrogen virkning, som kunne være en mulig mekanisme.
Furthermore, data from a preclinical study did not indicate that loratadine has an anti-androgenic effect, which could be one possible mechanism.
I en analyse fra november 2001 syntes det foregående signal at blive bekræftet.
In an analysis from November 2001, the previous signal appeared reinforced.
Ud af 2 780 eksponerede graviditeter var der i alt 15 tilfælde af hypospadi mod en forventet forekomst på 6- 7 tilfælde.
Among 2,780 exposed pregnancies there were in total 15 cases of hypospadias vs. the expected incidence of 6-7 cases.
Läkemedelsverket konkluderede på grundlag af disse oplysninger, at det ikke kan udelukkes, at brug af loratadin i første trimester kan være forbundet med øget risiko for hypospadi.
Based on these data, the MPA considered that it could not be excluded that the use of loratadine during the first trimester of pregnancy may be associated with an increased risk of hypospadia.
Den 25. april 2002 indledte Sverige en indbringelse for EMEA i henhold til artikel 31 i direktiv 2001/ 83/ EF, med senere ændringer.
On 25 April 2002, Sweden triggered a referral to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended.
På grundlag af oplysninger fra Medicinska födelseregistret, som ikke kunne udelukke, at brug af loratadin i første trimester kan være forbundet med øget risiko for hypospadi, fandt Sverige, at det ville være i Fællesskabets interesse at revurdere hele benefit/ risk - forholdet for loratadin, og anmodede CPMP om at afgive en udtalelse om, hvorvidt ansøgninger og markedsføringstilladelser for lægemidler indeholdende loratadin skulle udstedes, opretholdes, ændres, suspenderes eller inddrages.
Based on the data from the Swedish Medical Birth Registry, which could not exclude that the use of loratadine during the first trimester of pregnancy may be associated with increased risk of hypospadia, Sweden considered that there was Community interest in reassessing the full benefit/ risk profile of loratadine and requested the CPMP to give an opinion on whether the applications and marketing authorisations for loratadine containing medicinal products should be granted, maintained, changed, suspended or withdrawn.
VIRKNING CPMP drøftede virkningen af produkterne indeholdende loratadin på grundlag af evalueringsrapporterne fra rapportøren/ medrapportøren og de af ansøgerne/ indehaverne af markedsføringstilladelserne forelagte oplysninger.
EFFICACY A discussion on the efficacy of loratadine containing medicinal products took place in CPMP based on the Rapporteur and Co-Rapporteur’ s Assessment Reports and the data presented by the Applicants/ MAHs.
CPMP fandt det godtgjort, at loratadin giver væsentlig symptomnedsættelse ved allergisk rhinitis (AR), herunder sæsonbetinget allergisk rhinitis (SAR) og helårs allergisk rhinitis (PAR), samt kronisk idiopatisk urticaria (CIU).
The CPMP considered that loratadine has been shown to significantly reduce the symptoms of allergic rhinitis (AR), including seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU).
For hver af disse indikationer er der påvist bedre virkning end af placebo på ændring fra grundlinieniveauet for total symptomscore (f. eks. hudkløe, erythem, nældefeber).
For each of these indications, superiority to placebo was demonstrated in the change from baseline of total symptom scores (e. g rhinitis symptom score) or disease symptoms and signs (e. g. skin itching, erythema, hives).
Det er også godtgjort, at loratadin erligeså effektiv som sammenligningsantihistamin.
Loratadine was also shown to be as effective as comparator antihistamines.
CPMP fandt indikationen “ allergisk dermatitis som f. eks. kronisk urticaria ” for bred og anmodede ansøgerne/ indhaverne af markedsføringstilladelserne om at forelægge data til dokumentation for andre indikationer end CIU.
The CPMP considered the indication “ allergic dermatitis such as chronic urticaria” to be too broad and requested the Applicants/ MAHs to provide data in support of indications other than CIU.
Efter CPMP’ s anmodning om dokumentation for andre indikationer end CIU blev indikationen af ansøgerne/ indehaverne af markedsføringstilladelsen begrænset til CIU i det foreslåede produktresumé, der blev forelagt sammen med deres besvarelser.
Following the CPMP’ s request for data in support of indications other than CIU the Applicants/ MAHs restricted the indication to CIU in their proposed SPC submitted as part of their answers.
CPMP anmodede om dokumentation for indikationen CIU hos børn mellem 2 og 12 år.
The CPMP requested the data supporting the indication CIU for children between the age of 2 and 12 years.
På grundlag af besvarelserne fandt CPMP, at skønt der ikke foreligger placebokontrollerede data, er CIU hos børn mellem 2 og 12 år ikke en anderledes sygdomsenhed sammenlignet med sygdommen hos voksne, og at data fra voksne lader sig ekstrapolere til børn, eftersom de farmakokinetiske oplysninger underbygger dette.
Based on the responses the CPMP considered that although there are no placebo-controlled data, CIU in children between 2 and 12 years is not a different disease entity compared to the disease in adults and that data from adults can be extrapolated to children, as the pharmaco-kinetic data are supportive.
CPMP anmodede desuden om dokumentation for anvendelse af loratadin til børn under 2 år.
The CPMP also requested the data supporting the use of loratadine in children below the age of 2 years.
Efter CPMP’ s anmodning om dokumentation for anvendelse af loratadin til børn under 2 år begrænsede ansøgerne/ indehaverne af markedsføringstilladelsen anvendelsen til børn over 2 år, og følgende erklæring blev indsat i afsnit 4. 2: “ Virkning og sikkerhed ved anvendelse til børn under 2 år er ikke dokumenteret ”.
Following the CPMP’ s request for data supporting the use of loratadine below the age of 2 years the Applicants/ MAHs restricted the use to children above 2 years of age and the following statement was included in section 4.2: “ Efficacy and safety in children under 2 years of age have not been established”.
På grundlag af de foreliggende oplysninger konkluderede CPMP, at loratadin er effektiv til bedring af symptomerne ved allergisk rhinitis og idiopatisk kronisk urticaria.
On the basis of the available data the CPMP concluded that loratadine is effective in the relief of symptoms associated with allergic rhinitis and chronic idiopathic urticaria.
CPMP/ 1333/ 03 SIKKERHED
CPMP/ 1333/ 03 SAFETY
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Den samlede sikkerhedsprofil for lægemidler indeholdende loratadin blev gennemgået af CPMP.
The overall safety profile of loratadine containing medicinal products was reviewed by the CPMP.
CPMP drøftede sikkerheden ved produkter indeholdende loratadin på grundlag af evalueringsrapporterne fra rapportøren/ medrapportøren og de af ansøgerne/ indehaverne af markedsføringstilladelserne forelagte oplysninger.
A discussion on the safety of loratadine containing medicinal products took place in CPMP based on the Rapporteur and Co-Rapporteur’ s Assessment Reports and the data presented by the Applicants/ MAHs.
Det vigtigste sikkerhedsproblem, der drøftedes, var den mulige øgede risiko for hypospadi efter anvendelse af loratadin under graviditet.
The main safety issue discussed was the possible increased risk of hypospadia following the use of loratadine during pregnancy.
Generelle sikkerhedsmæssige aspekter CPMP gennemgik de foreliggende oplysninger, der omfattede samlede resuméer af kliniske undersøgelser og data fra overvågningen efter markedsføringen.
General safety The CPMP reviewed the available data, which included overall summaries of clinical studies and post- marketing data.
De oftest indberettede bivirkninger med hyppigere optræden end med placebo var døsighed, hovedpine, appetitøgning og søvnløshed.
The most frequent adverse reactions reported in excess of placebo were somnolence, headache, increased appetite and insomnia.
Andre reaktioner, der i overvågningsperioden efter markedsføring indberettedes meget sjældent, var: anafylaksi, svimmelhed, takykardi, palpitationer, kvalme, mundtørhed, gastritis, leverfunktionspåvirkning, udslæt, alopeci og træthed.
Other adverse reactions reported very rarely during the post-marketing period were: anaphylaxis, dizziness, tachycardia, palpitation, nausea, dry mouth, gastritis, abnormal hepatic function, rash, alopecia, and fatigue.
CPMP konkluderede, at der ikke var fundet yderligere sikkerhedsproblemer.
The CPMP concluded that no additional safety concerns were identified.
Hypospadi De til dato udførte undersøgelser Medicinska födelseregistret I Sverige registreres brug af lægemidler ved den første graviditetskonsultation, der for mindst 90% af de gravide finder sted inden uge 14 i graviditeten.
Hypospadias Studies Conducted to Date Swedish Medical Birth Registry (SMBR) In Sweden, drug use is recorded at the first antenatal care visit, which for at least 90% of pregnant women is made before week 14 of pregnancy.
Det registrerede lægemiddelforbrug i første trimester indføres i Medicinska födelseregistret, og oplysningerne sammenholdes derefter med oplysninger om resultatet af graviditeten.
The recorded drug use in the first trimester is entered into the SMBR, and these data are thereafter linked to data on pregnancy outcome.
Næsten alle fødsler (mindst 98%) i Sverige bliver indberettet til Medicinska födelseregistret, dvs. ca.
Thus, drug use is recorded prospectively to pregnancy outcome.
90 000 årligt, og databasen omfatter over 500 000 graviditeter.
Nearly all deliveries (at least 98%) in Sweden are reported to the SMBR, i. e. about 90 000 / year, and the database contains more than 500 000 pregnancies.
I en analyse af data fra Medicinska födelseregistret i november 2001 fandtes 15 tilfælde af hypospadi ud af 2 780 loratadin- eksponerede graviditeter.
In an analysis of data from the SMBR in November 2001, 15 cases of hypospadias were identified among 2,780 loratadine-exposed pregnancies.
Den samlede forekomst af hypospadi, som kunne iagttages i Medicinska födelseregistret, er 2, 1 ud af hver 1000 graviditeter (drenge og piger).
The total prevalence of hypospadias observed in the SMBR is 2.1 out of 1000 pregnancies (boys and girls).
Det tilsvarende tal for børn (drenge og piger) født af mødre, som angiver at have taget loratadin tidligt i graviditeten, var 5, 4.
The corresponding figure in children (boys and girls) born by mothers who claim to have taken loratadine during early pregnancy was 5.4.
Den samlede korrigerede odds ratio, stratificeret efter fødselsår, moderens alder og antal tidligere fødsler, var 2, 3 [95% SI 1, 4- 3, 6].
The overall adjusted odds ratio, stratifying for year of birth, maternal age and parity, was 2.3 [95% CI 1.4-3.6].
Af de 15 tilfælde var sværhedgraden registreret som let i 11 tilfælde, moderat i ét tilfælde og ikke angivet i tre tilfælde.
Among the 15 cases, the severity was recorded as mild in 11 cases, moderate in one case and not recorded in 3 cases.
Hypospadi er en forholdsvis almindelig misdannelse.
Hypospadias is a relatively common malformation.
1000 levendefødte.
Reported background incidences show large variation; however, the CPMP found that the total prevalence of hypospadias in the SMBR falls within the reported background incidences of 0.5 to 3 per 1000 live births.
CPMP fandt, at eventuelle bias, der er fundet i Medicinska födelseregistret, herunder misklassifikation, ville give risikoestimatet en bias i retning mod 1 eller være uden indflydelse.
The CPMP considered that possible biases that have been identified in the SMBR, including misclassifications, would bias the risk estimate towards 1 or not affect it.
Eventuel foreliggende misklassifikation må anses for at bidrage til signalets styrke.
The existence of misclassifications should be viewed as contributing to the strength of the signal.
At en skævhed forårsaget af ikke- differentieret misklassifikation medfører undervurdering af den faktiske sammenhæng, er på linie med epidemiologisk teori og erfaringsgrundlag.
That the effect of non-differential misclassification bias is to underestimate the real association is in line with known epidemiological theory and experience.
At der skulle være en skævhed i den modsatte retning, f. eks ved registreringen af medicinanvendelsen (resultatet af graviditeten kendes ikke på tidspunktet for graviditetskonsultationen) eller ved diagnosticeringen af hypospadi, er usandsynligt.
That there would be any bias in the opposite direction e. g. through the recording of the drug use (the outcome of the pregnancy is not known at the time of the antenatal visit) or the diagnosis of hypospadias is unlikely.
CPMP fandt, at der i analyserne var blevet korrigeret for kendte samtidigt indvirkende faktorer (f. eks antal tidligere fødsler, rygning, alder osv.).
The CPMP found that the known confounding factors have been corrected for in the analyses (e. g. parity, smoking, age etc).
Andre fødselsregistre, databaser og case- kontrolundersøgelser Der blev forelagt oplysninger fra to andre fødselsregistre.
Other birth registries, databases, and Case Control Studies Data were presented from two other birth registries.
Tilsammen angiver de erfaringerne med 318 kvinder, der har være eksponeret for loratadin i første trimester af graviditeten.
When combined they provide experience in 318 loratadine-exposed women during the first trimester of pregnancy.
Undersøgelsen fandt ingen indberetninger om hypospadi knyttet til brug af loratadin hos moderen, og ingen tegn på øget frekvens af alvorlige medfødte misdannelse hos børn af mødre eksponeret for loratadin i første trimester.
Examination revealed no reports of hypospadias associated with maternal loratadine use and no evidence of an increased rate of major congenital abnormalities among offspring of mothers exposed to loratadine during the first trimester.
CPMP fandt, at de forelagte registeroplysninger peger i retning af at bekræfte, at loratadin ikke repræsenterer nogen væsentlig teratogen risiko.
The CPMP considered that the presented registry data tend to confirm that loratadine does not represent a major teratogenic risk.
Skønt der ikke er påvist en sammenhæng mellem loratadin og hypospadi, kan man dog ikke deraf slutte, at loratadin ikke øger forekomsten af hypospadi, da antallet af graviditeter i registrene var for lille.
However, even if no association between loratadine and hypospadia was identified, it can not be concluded that loratadine does not increase the rate of hypospadias since the number of pregnancies in the registries was too small.
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I disse indberetninger indgår de 15 tilfælde af hypospadi fra Medicinska födelseregistret samt 8 spontane indberetninger, der er modtaget efter indledning af artikel 31- proceduren for indbragte sager.
include the 15 hypospadias cases from the SMBR, and 8 spontaneous reports that were received following the initiation of the Article 31 referral procedure.
På grundlag af disse indberetninger og under hensyn til den skønnede anvendelse af loratadin på verdensbasis konkluderede CPMP, at de spontant indberettede data ikke rejser betænkeligheder ved brug af loratadin under graviditet.
Based on these reports and taking the estimated worldwide use of loratadine into account, the CPMP concluded that the spontaneous reporting data did not raise concerns regarding the use of loratadine during pregnancy.
Når der på den anden side tages hensyn til den forventede betydelige underrapportering, er disse data ikke robuste nok til, at det kan konkluderes, at brug af loratadin under graviditet er sikker.
On the other hand, considering an expected considerable underreporting, these data are not robust enough to conclude that use of loratadine during pregnancy is safe.
Det samlede antal loratadin- eksponerede graviditeter på verdensbasis er ukendt, men er formodentlig stort.
The total number of loratadine-exposed pregnancies worldwide is unknown, but is probably large.
Hvis spontan indberetning giver pålidelige oplysninger, skulle man have forventet et antal hypospadier på grundlag af den ‘ naturlige ’ baggrundsincidens.
If spontaneous reporting would provide reliable data, a number of hypospadias would have been expected based on the ‘ natural’ background incidence.
De fremlagte oplysninger viser derfor, at hypospadi ikke er blevet indberettet spontant som en lægemiddelbivirkning.
Hence, the data presented show that hypospadias have not been spontaneously reported as an adverse drug reaction.
De spontane indberetninger giver derfor kun en beskeden tryghed med hensyn til brug af loratadin under graviditet.
Thus, the spontaneous reporting provides minor reassurance regarding the safety of loratadine use in pregnancy.
De foreliggende oplysninger i den medicinske litteratur tyder ikke på øget risiko for medfødte misdannelser ved anvendelse af loratadin.
The information available in the medical literature does not indicate an increased risk of congenital malformation with loratadine use.
Ved søgning i den publicerede litteratur fandtes hverken indberetninger om tilfælde af hypospadi eller om medfødte misdannelser forbundet med loratadin.
Neither reports of hypospadias nor reports of congenital malformations associated with loratadine were identified in a search of the published literature.
Der blev fundet tre undersøgelser, som sammenligner resultaterne af loratadin- eksponerede graviditeter med kontrolgrupper.
Three studies comparing the outcomes of loratadine-exposed pregnancies to controls were identified.