Examples of using Spcs in English and their translations into Danish
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The following sections of the SPCs were presented for harmonisation.
The CHMP noted that there were contraindications present in one or several local SPCs.
As many documents as possible, andat least the SPCs, should be presented in English.
Så mange af dokumenterne som muligt,og i det mindste produktresumeerne, skulle forelægges på engelsk.It is noted that a daily dose of 2 X 15 mg/ kg bw is recommended in several SPCs.
Det bemærkes, at en daglig dosis på 2 X 15 mg/ kg kropsvægt anbefales i flere produktresuméer.All other sections of the SPCs will be harmonised as approved in the Mutual Recognition Procedure.
Alle andre afsnit i produktresuméet vil blive harmoniseret som godkendt i proceduren for gensidig anerkendelse.Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
Der er identificeret væsentlige forskelle i forhold til referenceproduktet i afsnittet om dosering i produktresuméerne.Finally, the referral SPCs were revised in accordance with the European Commission(EC) Guideline on SPC, October 2005.
Endelig blev de indbragte produktresuméer revideret i henhold til Europa- Kommissionens retningslinje vedrørende However, the wording(and therefore the precise meaning)of the indication is very different in the nationally approved SPCs.
Imidlertid er ordvalget(og dermed den præcise betydning)af teksten til indikationen meget forskellig i de nationalt godkendte produktresumeer.The CHMP noted that some of the contraindications in local SPCs(such as acute hypertension or primary aldosteronism) were in fact non-indications.
CHMP bemærkede, at nogle af kontraindikationerne i lokale produktresuméer(såsom akut hypertension og primær aldosteronisme) faktisk var ikke- indikationer.According to the PSURs, covering more than 3 years of use,safety is consistent with the details of the SPCs.
I henhold til de periodiske, opdaterede sikkerhedsindberetninger, som omhandler mere end tre års anvendelse,er sikkerheden i overensstemmelse med oplysningerne i produktresuméerne.Revised SPCs and PLs provide updated information in relation to best use of the product considering latest clinical data.
Reviderede produktresuméer og indlægssedler skal indeholde ajourførte oplysninger vedrørende den bedste anvendelse af produktet under hensyntagen til de seneste kliniske oplysninger.The text in the harmonised SPC is not so dissimilar to the currently approved SPCs that it will significantly change clinical practices Section 4.4.
Teksten i det harmoniserede The SPCs proposed by the MAH were those approved through the MRP in the"old" member states and in CY and IS.
De produktresuméer, som indehaveren af markedsføringstilladelsen foreslog, var The text in the harmonised SPC is not so dissimilar to the currently approved SPCs that it will significantly change clinical practices.
Teksten i det harmoniserede The indications given in these SPCs are the most restrictive among the approved indications in EU member states, and are approved in the most number of countries.
Indikationerne i disse produktresuméer er de mest restriktive blandt de godkendte indikationer i EU- medlemslandene og er godkendt i det største antal lande.The indication for prevention and control of coccidiosis andmention of repeated treatment should be removed from those SPCs which currently include it.
Indikationen til forebyggelse og kontrol af coccidiose ogomtalen af gentagen behandling bør fjernes fra de produktresuméer, der på nuværende tidspunkt indeholder dette.However, it was noted that the indications,species and posology in the SPCs of some of the authorised products were different and these therefore need to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Det blev imidlertid bemærket, at indikationer,arter og dosering i produktresuméerne for nogle af de godkendte produkter var forskellige, og disse skal derfor ændres, så de bringes i overensstemmelse med de indikationer og dosisregimer, der benyttes i miljørisikovurderingen.SPC Section 4.3- Contraindications The MAH was asked to harmonise Section 4.3,for which the following differences between SPCs needed to be evaluated.
Afsnit 4. 3 i produktresuméet- kontraindikationer Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4. 3 i produktresuméet,hvori følgende forskelle mellem produktresuméerne skulle vurderes.Furthermore, the latest variation procedure was finalised on 10th September 2007, and the SPCs that were then approved are in line with the proposals of the MAH in this referral.
Desuden afsluttedes Although the products in single and multi-dose presentations differ by the quantity of excipients in the finished product,the Applicant wishes to harmonize the SPCs for both presentations.
Skønt produkterne i enkelt- og multidosisbeholdere er forskellige med hensyn til mængden af hjælpestoffer i det færdige præparat,ønsker ansøgeren produktresuméerne harmoniseret for de to emballager.However, it was noted that the indications,species and posology in SPCs of some of the authorised products were different and these therefore needed to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Det blev dog bemærket, at indikationerne,arterne og doseringsanvisningen i produktresuméet for nogle af de godkendte produkter var forskellige, og de skulle derfor ændres for at bringe dem i overensstemmelse med de indikationer og doseringsanvisninger, der blev anvendt i miljørisikovurderingen.The CHMP, in the light of the data submitted andthe scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
På grundlag af de fremlagte oplysninger ogden faglige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméet, etiketteringen og indlægssedlen skulle harmoniseres inden for EU.Taking into account the originator SPCs of cefuroxime axetil and recommendations from the literature on the use of cefuroxime in the treatment of uncomplicated gonorrhoea, it was argued that the inclusion of this indication is fully justified from a clinical and pharmacological point of view.
På baggrund af de oprindelige produktresuméer for cefuroximaxetil og anbefalingerne i litteraturen om anvendelse SPC Section 4.4- Special Warnings and Precautions for Use The MAH was asked to harmonize Section 4.4,for which the following differences between SPCs needed to be evaluated.
Afsnit 4. 4 i produktresuméet- særlige advarsler og forsigtighedsregler vedrørende brugen Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4. 4,hvori følgende forskelle mellem produktresuméerne skulle vurderes.The data from SPCs, literature and generated during clinical development combined with recent surveillance data from the United Kingdom and Canada suggest that vaccine effectiveness remained high in unprimed subjects who had been vaccinated in their second year of life with a single dose.
Data fra produktresuméer, faglitteratur og data, som er genereret under den kliniske udvikling kombineret med nye overvågningsdata fra Storbritannien og Canada, tyder på, at vaccinens effektivitet forblev høj hos personer, hvor effekten af vaccinen ikke var igangsat(priming), men som i deres andet leveår var blevet vaccineret med en enkelt dosis.SPC Section 4.5- Interaction with other medicinal products and other forms of interaction The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics,for which the following differences between SPCs needed to be evaluated.
Afsnit 4. 5 i produktresuméet- interaktion med andre lægemidler og andre former for interaktion Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4. 5 i produktresuméet,hvori følgende forskelle mellem produktresuméerne skulle vurderes.The MAHs are requested to provide from the dossier submitted for each country of the EEA wherethe products are authorised: a the Part I Summary of the dossier including SPCs, expert reports and the full composition of the products; b if applicable, Part IV of the application dossier; c an Assessment of the Periodic Safety Update Reports(PSURs) in relation to target animal safety and possible lack of efficacy.
Indehaverne af markedsføringstilladelsen anmodes om at tilvejebringe følgende fra det indsendte dossier for hvert land i Det Europæiske Økonomiske Samarbejdsområde(EØS),hvor lægemidlet er tilladt,: a resumé af dossieret(del I), herunder produktresumé, ekspertudtalelser og den fuldstændige sammensætning af lægemidlerne b del IV i ansøgningsdossieret, hvis det er relevant c en vurdering af de periodiske, opdaterede sikkerhedsindberetninger(PSUR) vedrørende sundheden hos de dyr, lægemidlet er beregnet til samt eventuel manglende effektivitet.Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products(and its associated names), Denmark notified the CHMP/ EMEA Secretariat of an official referral under Article 30 of Directive 2001/ 83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
På baggrund af divergerende nationale beslutninger, som medlemsstaterne havde taget vedrørende godkendelsen af ovennævnte produkter(og tilknyttede navne), indbragte Danmark i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer,sagen for CHMP/ EMEA' s sekretariat for at udrede afvigelser mellem de nationalt godkendte produktresuméer og dermed harmonisere produkternes divergerende produktresuméer i hele EU.SPC Section 4.8- Undesirable effects The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH' s CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Afsnit 4. 8 i produktresuméet- bivirkninger Indehaveren af markedsføringstilladelsen blev anmodet om at identificere forskellene mellem de anførte bivirkninger i de nationalt godkendte produktresuméer og indehaverens CDS(Core Data Sheet) og om at organisere afsnit 4. 8 i overensstemmelse med MedDRA- systemets organklasser.Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product(and its associated names), the European Commission notified the CHMP/ EMEA Secretariat of an official referral under Article 30 of Directive 2001/ 83/ EC as amended in order toresolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Som følge af de divergerende nationale beslutninger, der er truffet af medlemsstaterne vedrørende godkendelsen af ovennævnte lægemiddel(og tilknyttede navne), har Europa- Kommissionen anmodet CHMP/ EMEA- sekretariatet om en officiel indbringelse i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer,for at få afhjulpet forskellene mellem de nationalt godkendte produktresuméer og derved harmonisere de divergerende produktresuméer i hele EU.
