natgillin/translations-raw huggingface dataset:
Prækliniske data udviser ingen specielle risici baseret på konventionelle studier af sikkerhed, farmakologi, toksicitet ved gentagen dosis, genotoksicitet og carcinogenicitet.
Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
I reproduktionstoksicitetsstudier blev ingen teratogen effekt observeret.
In reproductive toxicity studies, no teratogenic effects were observed.
Dog blev der observeret forlænget fødsel og nedsat levedygtighed af afkommet hos rotter ved plasmakoncentrationer (AUC) 10 gange højere end dem, der opnås ved kliniske doser.
However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.
< Ingen beviser på slimhindeirritation blev observeret efter daglig administration af op til 12 smeltetabletter (120 mg) ind i hamsterkindposer i fem dage. >
< No evidence of mucous membrane irritation was observed after daily administration of up to 12 tablets (120 mg) of oral lyophilisates into the hamster cheek pouch for five days. >
CPMP/ 1333/ 03 6. 3 Opbevaringstid
PHARMACEUTICAL PARTICULARS
61/ 62
60/ 61
6. 4 Særlige opbevaringsforhold
[To be completed nationally]
6. 5 Emballage (art og inhold)
6.4 Special precautions for storage
62/ 62
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European Medicines Agency
The European Medicines Agency
28 April 2004 CPMP/ 1333/ 03
28 April 2004 CPMP/ 1333/ 03
UDVALGET FOR FARMACEUTISKE SPECIALITETER (CPMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
loratadin Internationalt fællesnavn (INN): loratadin
loratadine International Non-Proprietary Name (INN): loratadine
Loratadin er en antihistaminforbindelse tilhørende gruppen af H- 1- antagonister.
Loratadine is an anti-histamine compound belonging to the H-1 antagonist group.
Loratadin er godkendt nationalt og via den gensidige anerkendelsesprocedure i EU’ s medlemsstater.
Loratadine has been authorised nationally and through MRP in the EU Member States.
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 hypospadia in the male newborn.
Databasen bestod af 1. 020 nyfødte, hvis moder 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.
I 1999 foretog det svenske Läkemedelsverket, Medicinska födelseregistret (MPA) og indehaveren af markedsføringstilladelsen for lægemidlet i Sverige, Schering Plough, en vurdering af dette signal fra en præklinisk synsvinkel og ved en gennemgang af de kliniske tilfælde.
During 1999, this signal was evaluated by the MPA, the SMBR and the MAH of the product in Sweden, Schering Plough, both by review of the clinical cases, and from a preclinical point of view.
Vurderingen ledte til den konklusion, at der kan have været tale om et tilfældigt fund.
This evaluation resulted in the conclusion that this may have been a random finding.
Endvidere tydede data fra en præklinisk undersøgelse udført af det svenske Läkemedelsverket ikke på, at loratadin har antiandrogen virkning, som kunne være en mulig mekanisme.
Furthermore, data from a preclinical study performed by the MAH in 1999 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 være forstærket.
In an analysis from November 2001, the previous signal appeared reinforced.
Af 2 780 eksponerede graviditeter var der i alt 15 tilfælde af hypospadi mod en forventet forekomst af 6- 7 tilfælde.
Among 2,780 exposed pregnancies there were in total 15 cases of hypospadia vs. the expected incidence of 6-7 cases.
Den 25. april 2002 indbragte Sverige en sag for EMEA i henhold til artikel 31 i direktiv 2001/ 83/ EF, med senere ændringer, 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.
On 25 April 2002, Sweden triggered a referral to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended, 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.
Proceduren for indbragte sager indledtes den 26. april 2002.
The referral procedure started 26 April 2002.
P.
The Rapporteur and Co-Rapporteur appointed were:
Salmonson.
Dr P Neels and Dr T Salmonson, respectively.
Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 14. august 2002, den 24. januar 2003, den 2. maj 2003, den 4. august 2003 og den 10. oktober 2003.
Written explanations were provided by the Applicants/ Marketing Authorisation Holders by 14 August 2002, 24 January 2003, 2 May 2003, 4 August 2003 and 10 October 2003.
På grundlag af vurderingen af de foreliggende oplysninger og evalueringsrapporterne fra rapportørerne var CPMP af den opfattelse, at benefit/ risk- forholdet for lægemidler indeholdende loratadin fortsat er gunstigt og anbefalede derfor i en udtalelse af 20. november 2003 udstedelse eller opretholdelse af ansøgningerne/ markedsføringstilladelserne for lægemidler indeholdende loratadin i overensstemmelse med produktresuméet i bilag III til CPMP’ s udtalelse. for indikationen: “ symptomatisk behandling af allergisk rinit og kronisk idiopatisk urticaria ” Listen over de pågældende lægemiddelnavne fremgår af bilag I.
Based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CPMP considered that the benefit/ risk profile of loratadine containing medicinal products remains favourable, and therefore adopted an opinion on 20 November 2003 recommending that the Applications/ Marketing Authorisations for loratadine containing medicinal products should be granted or maintained in accordance with the SPC set out in Annex III of the Opinion. in the indication: “ relief of symptoms associated with Allergic Rhinitis and Chronic Idiopathic Urticaria”.
De faglige konklusioner findes i bilag II og det ændrede produktresumé i bilag III.
The list of product names concerned is given in the Annex I.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 28 April 2004.
The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2004 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged * Bemærkninger:
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int EMEA 2004 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The final opinion was converted into a Decision by the European Commission on 28 April 2004. * Notes:
Oplysningerne i dette dokument og bilagene afspejler udelukkende CPMP’ s udtalelse af 20. november 2003.
The information given in this document and Annexes reflect only the CPMP Opinion dated 20 November 2003.
LISTE OVER LÆGEMIDLERNES NAVNE, INDEHAVERNE AF MARKEDSFØRINGSTILLADELSERNE, STYRKER, LÆGEMIDDELFORMER, INDGIVELSESVEJ, EMBALLAGE OG PAKNINGSSTØRRELSER I MEDLEMSSTATERNE
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES
CPMP/ 4060/ 03
CPMP/ 4060/ 03
1/ 20
1/ 21
Lægemidlets
Invented
Lægemiddelfor
Pharmaceutical
markedsføringstilladelse
State
m
Form
Clarinase - Manteldragees
Clarinase - Manteldragees
5 mg loratadine +120 mg pseudoephedri ne
5 mg loratadine +120 mg pseudoephedri ne
Fabrik GmbH.,
Fabrik GmbH.,
Clarinase
Clarinase
Overtrukket
Coated tablet
Badner Straße 23, A- 2514 Traiskirchen, Østrig
Badner Straße 23, A-2514 Traiskirchen, Austria
retard Dragees loratadine + 240 mg pseudoephedri ne
retard Dragees loratadine + 240 mg psuedoephedri ne
Clarinase 120/ 5 5 mg (Repetabs) loratadine (+ Pseudo - ephedrine sulfate 120 mg)
Clarinase 120/ 5 5 mg loratadine (Repetabs) (+ Pseudo- ephedrine sulfate 120 mg)
Depottablet
Prolonged- release tablet
14 10, 14, 20, 28, 30, 50, 100 – for export
14 10, 14, 20, 28, 30, 50, 100 – for export
Clarinase 10 mg 240/ 10 once loratadine (+ daily Pseudo - ephedrine sulfate 240 mg)
Clarinase 10 mg 240/ 10 once loratadine (+ daily Pseudo- ephedrine sulfate 240 mg)
1, 7, 10, 14, 20, 28, 30, 50, 100
1, 7, 10, 14, 20, 28, 30, 50, 100
Rue de Stalle 73
Rue de Stalle 73
Prospel 5 mg loratadine (+
Prospel 5 mg loratadine (+ Pseudo-
10, 14, 4, 10, 20, 28, 30,
10, 14, 4, 10, 20, 28, 30,
B- 1180 Brussels
B-1180 Brussels
Pseudo -
ephedrine
50, 100 – for export
50, 100 – for
ephedrine sulfate 120 mg)
sulfate 120 mg)
2/ 20
2/ 21
navn
State
Oral
Form
1, 7, 10, 14, 20, 28,
administratio n
CLARINASE
CLARINASE
10 mg loratadine + 240 mg pseudo - ephedrine sulphate
10 mg loratadine + 240 mg pseudo- ephedrine sulphate
CLARINASE REPETABS
CLARINASE REPETABS
5 mg loratadine + 120 mg pseudoephedri ne
5 mg loratadine + 120 mg pseudoephedri ne
Tablet med modificeret udløsning
Modified- release tablet
10, 14, 20
10, 14, 20
LORATADIN E/ SULFATE de PSEUDOEPH EDRINE
LORATADIN E/ SULFATE de PSEUDOEPH EDRINE
Clarityne D
Clarityne D
5 + 120 mg pseudoe - pinephri - nesulphate
5 + 120 mg pseudoe-phine phri-nesulphate
Clarityne- D
Clarityne-D
10 + 240 mg pseudo - epinephrine sulphate
10 + 240 mg pseudo- epinephrine sulphate
Schering- Plough Europe, Rue de Stalle, B- 1180 Brussels
Schering-Plough Europe, Rue de Stalle, B-1180 Brussels Belgium
10 mg loratadine + 240 mg
10 mg loratadine + 240 mg pseudoephedri ne
3/ 20
3/ 21
Styrke
IT
Lægemiddelfor
Italfarmaco SPA
Indgivelsesvej
Frinase
Emballage
Loratadine 5
Pakningsstørrelse
Modified-
navn
Oral use
Belgien
Blister
IT
20
Italfarmaco SPA Via Dei Lavoratori, 54 I- 20092 Cinisello Balsamo Milano Italien
Via Dei Lavoratori, 54 I-20092 Cinisello Balsamo Milano Italy
Loratadine 5 mg/ pseudoeph edrine sulph 120 mg
mg/ pseudoephedrin e sulph 120 mg
Modified- release Overtrukket tablet
release coated tablet
Loratadine 5 mg/ pseudoeph edrine sulph 120 mg
Loratadine 5 mg/ pseudoephedrin e sulph 120 mg
Modified- release Overtrukket tablet
Modified- release coated tablet
Narinex
Narinex
Loratadine 10 mg/ pseudoeph edrine sulph 240 mg
Loratadine 10 mg/ pseudoephedrin e sulph 240 mg
Blister (ACLAR/ P E/ PVC)
Blister (ACLAR/ P E/ PVC)
1, 7, 10, 14, 20, 28, 30, 50
1, 7, 10, 14, 20, 28, 30, 50
73, Rue de Stalle B- 1180 Brussels Belgien
73, Rue de Stalle B-1180 Brussels Belgium
Clarinase 120/ 5
Clarinase 120/ 5
5 mg + 120 mg pseudoephedri ne
5 mg + 120 mg pseudoephedrine
Clarinase 240/ 10 once daily
Clarinase 240/ 10 once daily
10 mg + 240 mg pseudoephedri ne
10 mg + 240 mg pseudoephedrine
7, 10, 20
7, 10, 20
Claridon
Claridon
5 mg loratadine + 120 mg pseudo - ephedrine
5 mg loratadine + 120 mg pseudo- ephedrine
4/ 20
4/ 21
C/ Argent 1.
C/ Argent 1.
Rinociveran
Rinociveran
Loratadine10 mg / pseudoephedri ne sulphate 240 mg
Loratadine10 mg/ pseudoephedrine sulphate 240 mg
Narine Repetabs
Narine Repetabs
Loratadina 5 mg/ pseudoeph edrine sulphate 120 mg
Loratadina 5 mg/ pseudoephedrin e sulphate 120 mg
Narine Retard
Narine Retard
Loratadina 10 mg / pseudoephedri ne 240 mg
Loratadina 10 mg/ pseudoephedrine 240 mg
5/ 20
5/ 21
CPMP/ 4060/ 03 FAGLIGE KONKLUSIONER
CPMP/ 4060/ 03 SCIENTIFIC CONCLUSIONS
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6/ 21
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF INDEHOLDENDE LORATADIN OG PSEUDOEPHEDRIN (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LORATADINE AND PSEUDOEPHEDRINE CONTAINING MEDICINAL PRODUCTS (see Annex I)
Loratadin er en antihistaminforbindelse tilhørende gruppen af 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.
Pseudoephedrin er et middel mod kongestion i næsen, som indirekte udøver sin sympatomimetiske virkning via frigivelse af adrenerge mediatorer fra postganglie nerveender.
Pseudo-ephedrine is a nasal decongestant, which exerts its sympathomimetic effects indirectly, predominantly through release of adrenergic mediators from postganglionic nerve terminals.
Kombinationen af loratadin og pseudoephedrin findes på markedet som en 5 mg loratadin/ 120 mg pseudoephedrin - eller 10 mg loratadin/ 240 mg pseudoephedrin- kombination.
The combination of loratadine and pseudoephedrine is on the market as a 5 mg loratadine/ 120 mg pseudoephedrine or 10 mg loratadine/ 240 mg pseudoephedrine combination.
Den 25. april 2002 indbragte Sverige en sag 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 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, at det var påvist, at loratadin i væsentlig grad begrænsede symptomerne på sæsonbetinget allergisk rhinitis (SAR), når disse var ledsaget af nasal kongestion.
The CPMP considered that loratadine has been shown to significantly reduce the symptoms of seasonal allergic rhinitis (SAR) when accompanied by nasal congestion.
Virkningen blev vurderet på grundlag af nedsættelsen af de samlede symptomer på rhinitis og symptomerne på tilstopning af næsen.
The efficacy was evaluated on the basis of reduction in total rhinitis symptoms and the symptoms of nasal stuffiness.
Kombinationen af loratadin og pseudoephedrin var mere effektiv end loratadin alene til at forbedre næsetilstoppethed, mere effektiv end pseudoephedrin alene til at begrænse de samlede symptomscorer og væsentlig mere effektiv end placebo til at begrænse SAR - symptomscorerne.
The combination of loratadine and pseudoephedrine was more effective than loratadine alone in improving nasal stuffiness, more effective than pseudoephedrine alone in reducing total symptom scores and significantly more effective than placebo in reducing SAR symptom scores.
CPMP betvivlede indikationen helårs allergisk rhinitis (PAR).
The CPMP queried the indication Perennial Allergic Rhinits (PAR).
Selv om patofysiologien kan være den samme som for SAR, lider patienter, som lider af PAR, hele året, hvilket indebærer en mere kronisk brug af kombinationen af loratadin og pseudoephedrin.
Although the pathophysiology may be the same as for SAR, patients suffering from PAR suffer the whole year, which implies a more chronic use of the combination of loratadine and pseudoephedrine.
Endvidere foreligger der ingen oplysninger om længden af den periode, der skal gå mellem de behandlingsforløb, som er nødvendige for at sikre, at gentagelsen af behandlingen er styret af symptomer på kongestion og ikke hænger sammen med et eventuelt afhængighedsfænomen.
Furthermore, there is no data available on length of time between treatment courses necessary to assure that recurrence of therapy is driven by congestive symptoms and not related to any dependency phenomena.
Efter CPMP’ s spørgsmål vedrørende den hensigtsmæssig brug af kombinationsproduktet i lyset af sikkerhedsprofilen for pseudoephedrin medtog ansøgerne/ indehaverne af markedsføringstilladelserne ikke længere indikationen helårs allergisk rhinitis i deres forslag til produktresumé (SPC), som blev fremsendt sammen med deres besvarelser.
Following the CPMP ’ s questions relating to appropriate use of combination product in the light of the safety profile of pseudoephedrine the Applicants/ MAHs no longer included the indication perennial allergic rhinitis in their proposed Summary of Product Characteristics (SPC) submitted as part of their answers.
CPMP betvivlede, at kombinationen af loratadin og pseudoephedrin kunne anvendes til børn under 15 år.
The CPMP questioned the use of the combination of loratadine and pseudoephedrine in children below the age of 15 years.
Der havde været inddraget børn mellem 12 og 15 år i de kliniske undersøgelser, hvor
Children between the age of 12 and 15 years had been included in the clinical trials evaluating the safety and efficacy of the combination.
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På grundlag af de foreliggende oplysninger konkluderede CPMP, at kombinationen loratadin og pseudoephedrin er effektiv til symptomatisk behandling af sæsonbetinget allergisk rhinitis, når denne ledsages af nasal kongestion.
On the basis of the available data the CPMP concluded that the combination of loratadine and pseudoephedrine is effective in the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
SIKKERHED Den samlede sikkerhedsprofil for lægemidler indeholdende loratadin blev gennemgået af CPMP.
SAFETY The overall safety profile of loratadine containing medicinal products was reviewed by the CPMP.
CPMP drøftede sikkerheden ved lægemidler 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.
De oftest indberettede bivirkninger af loratadin med hyppigere optræden end med placebo var døsighed, hovedpine, appetitøgning og søvnløshed.
The most frequent adverse reactions reported for loratadine in excess of placebo were somnolence, headache, increased appetite and insomnia.
For loratadin - og pseudoephedrin- kombinationsprodukter kan bivirkningsprofilen sammenlignes med bivirkningsprofilen for loratadin alene, bortset fra bivirkninger som søvnløshed, mundtørhed, svimmelhed og nervøsitet, som ofte eller meget ofte indberettes, og som sandsynligvis skyldes pseudoephedrin- komponenten.
For the loratadine and pseudoephedrine combination products the adverse event profile is comparable to that of loratadine alone except for adverse events like insomnia, dry mouth, dizziness and nervousness, which are commonly or very commonly reported and are likely due to the pseudoephedrine component.
CPMP betvivlede, at det var sikkert at bruge kombinationen i mere end 5 dage.
The CPMP queried the safe use of the combination for more than 5 days.
De kliniske undersøgelser blev gennemført over 14 dage og den samlede hyppighed af hermed forbundne bivirkninger, som blev indberettet i løbet af de første 5 dage, var mærkbart større end dem, der blev indberettet efter 5 dage.
The clinical trials were conducted over 14 days and the overall incidence of related AEs reported during the first 5 days was appreciably higher than those reported after 5 days.
CPMP konkluderede, at der i afsnit 4. 2 i produktresuméet burde være en angivelse af, at behandlingens varighed bør holdes på så kort et tidsrum som muligt og ikke bør fortsætte efter, at symptomerne er forsvundet.
The CPMP concluded that a statement stating that the duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared, should be given in section 4.2 of the SPC.
10 dage, da effekten af pseudoephedrin formindskes med tiden.
It should also be stated that it is advisable to limit treatment to about 10 days, as the activity of pseudoephedrine diminishes over time.
Benefit/ risk- forholdet for systemisk behandling med kombinationen af loratadin og pseudoephedrin versus behandling med loratadin og en topisk anvendelse af pseudoephedrin blev drøftet.
The benefit/ risk of the systemic treatment with the combination of loratadine and pseudoephedrine versus treatment with loratadine and a topical application of pseudoephedrine was discussed.
CPMP var af den opfattelse, at topisk anvendelse af pseudoephedrin også er forbundet med bivirkninger såsom tachyphylaksi, rebound- kongestion og rhinitis medicamentosa, som kan begrænse brugen af topiske lægemidler.
The CPMP considered that topical application of pseudoephedrine is also associated with adverse events, such as tachyphylaxis, rebound congestion, and rhinitis medicamentosa, which may limit the use of topical products.
CPMP rejste spørgsmålet om risikoen for kramper induceret af vasokonstriktorer.
The CPMP questioned the risk of convulsions induced by vasoconstrictors.
Der blev medtaget en advarsel i afsnit 4. 4 med en krydshenvisning til afsnit 4. 9 med angivelse af, at der gennem sympatomimetiske aminer kan opstå stimulering af centralnervesystemet med kramper eller kardiovaskulært kollaps med ledsagende hypotension, og at disse virkninger sandsynligvis vil forekomme oftere hos børn, ældre eller i tilfælde af overdosis.
A warning was included in section 4.4 with a cross reference to section 4.9 stating that central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines and that these effects may be more likely to occur in children, the elderly, or in cases of overdose.
CPMP behandlede problemerne med hensyn til sikkerhed og hensigtsmæssig anvendelse af kombinationen af loratadin og pseudoephedrin i lyset af den kendte farmakodynamiske effekt af pseudoephedrin på hjertet samt problemet med hensyn til pseudoephedrin i forbindelse med afhængighed og misbrug.
The CPMP addressed the concerns regarding the safe and appropriate use of the combination of loratadine and pseudoephedrine in the light of the known pharmacodynamic effect of pseudoephedrine on the heart, and the concern for pseudoephedrine related to dependency and addiction.
Dette omfattede en begrænsning af indikationen til sæsonbetinget rhinitis for at begrænse behandlingens varighed.
Data to substantiate these concerns were lacking in normal condition of use, in the context of what is required in Article 116 of Directive 2001/ 83/ EC, as amended and CPMP agreed to introduce adequate warnings and precautions in the SPC, this included limiting the indication to seasonal rhinitis to reduce the duration of treatment.
CPMP/ 4060/ 03 Hypospadi De til dato udførte undersøgelser Medicinska födelseregistret
CPMP/ 4060/ 03 Hypospadias Studies Conducted to Date Swedish Medical Birth Registry (SMBR)
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