FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP is of the opinion that in the absence of data from clinical trial for the usual doses in paediatric population, the approximate range of usual effective doses should be specified in this subsection as well as recommendation to use the lowest effective dose.
Danish: Derfor mener CHMP, at der i mangel af data fra kliniske forsøg for den sædvanlige dosis hos den pædiatriske population skal angives det omtrentlige interval for sædvanlige effektive doser i dette delpunkt sammen med anbefalingen om at anvende den laveste effektive dosis.
English: • The Committee considered the divergences in the product information identified in the notification for Septanest and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the product information;
Danish: • Udvalget behandlede de konstaterede divergenser i produktinformationen for Septanest og relaterede navne, hvad angår indikationer, dosering, kontraindikationer, særlige advarsler og forsigtighedsregler vedrørende brugen samt de øvrige punkter i produktinformationen.
English: Septanest and associated names is a fixed-dose combination product containing articaine hydrochloride 40 mg/ml and adrenaline tartrate.
Danish: Septanest og relaterede navne er et fastdosis-kombinationsprodukt, der indeholder articainhydrochlorid 40 mg/ml og adrenalintartrat.
English: Sections 2 (qualitative and quantitative composition), 3 (pharmaceutical form), 4.7 (Effects on ability to drive and use machines), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties), 6.1 (list of excipients), 6.2 (incompatibilities), 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) of the SmPC have been updated in line with their respective harmonised Quality documentation provided in module 3 and in line with the latest QRD template.
Danish: 2 (kvalitativ og kvantitativ sammensætning), 3 (lægemiddelform), 4.7 (virkning på evnen til at føre motorkøretøj og betjene maskiner), 5.1 (farmakodynamiske egenskaber), 5.2 (farmakokinetiske egenskaber), 6.1 (hjælpestoffer), 6.2 (uforligeligheder), 6.3 (opbevaringstid), 6.4 (særlige opbevaringsforhold), 6.5 (emballagetype og pakningsstørrelser) og 6.6 (regler for bortskaffelse og anden håndtering) i produktresuméet er blevet opdateret i overensstemmelse med den respektive harmoniserede, kvalitetsrelaterede dokumentation i modul 3 og den nyeste QRDskabelon.
English: In addition, the MAH made reference to guidelines by the American Academy of Paediatric Dentistry on the use of local anaesthesia for paediatric dental patients (2015) in which articaine 40 mg/mL solution with adrenaline 0.01 mg/mL is listed among the injectable local anaesthetics that can be considered for children.
Danish: Derudover har indehaveren af markedsføringstilladelsen henvist til retningslinjer fra American Academy of Paediatric Dentistry for anvendelse af lokal anæstesi til pædiatriske dentalpatienter (2015), hvor articain 40 mg/ml opløsning med adrenalin 0,01 mg/ml er anført blandt de injicerbare lokale anæstetika, der kan overvejes til børn.
English: Moreover the MAH has submitted bibliographic data from publications regarding the efficacy, safety and pharmacology of articaine 40 mg/mL alone or with adrenaline in dental local anaesthesia.
Danish: Indehaveren af markedsføringstilladelsen har desuden indsendt bibliografiske data fra publikationer vedrørende virkning, sikkerhed og farmakologi for articain 40 mg/ml alene eller med adrenalin inden for dental lokal anæstesi.
English: A crossover, double blind Phase III study, comparing articaine/adrenaline 1:100 000 and 1:200 000, with a total of 11.9 mL (1.7 mL in each of 7 cartridges) of each formulation administered intra-orally to each subject, showed that the difference in adrenaline concentration did not lead to any significant difference in plasma levels of articaine and that no toxicity was observed on patients.
Danish: Et crossover-, dobbeltblindet fase III-forsøg, der sammenlignede articain/adrenalin 1:100.000 og 1:200.000, hvor i alt 11,9 ml (1,7 ml i hver af 7 patroner) af hver formulering blev administreret intraoralt til hver forsøgsperson, viste, at forskellen i adrenalinkoncentration ikke medførte signifikante forskelle i plasmaniveauer af articain, og at der ikke observeredes nogen toksicitet for patienterne.
English: In the subsection precautions for use, precautions are included for risk associated with accidental intravascular injection and risk associated with intraneural injection.
Danish: I delpunktet forsigtighedsregler vedrørende brugen, er der medtaget forsigtighedsregler vedrørende utilsigtet intravaskulær injektion og risici i forbindelse med intraneural injektion.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data.
Danish: Indehaveren af markedsføringstilladelsen foreslog harmoniserede dosisanbefalinger baseret på de undersøgte doser i kliniske forsøg og underbygget af farmakodynamiske og farmakologiske data.
English: Data obtained after intraoral administration of articaine 40 mg/mL with adrenaline 0.01 mg/mL at the maximum recommended dose for articaine showed that the maximum therapeutic dose of 500 mg does not produce signs of intoxication (cardiovascular issues) in healthy patients.
Danish: Data opnået efter intraoral administration af articain 40 mg/ml med adrenalin 0,01 mg/ml i den maksimale anbefalede dosis for articain viste, at den maksimale terapeutiske dosis på 500 mg ikke fremkalder tegn på forgiftning (kardiovaskulære problemer) hos raske patienter.
English: Section 4.2 - Posology and method of administration Posology
Danish: Punkt 4.2 - Dosering og administration Dosering
English: The section 4.4 of the SmPC (Warnings) has been summarized to include the below categories: patients with cardiovascular disorders, epileptic patients, patients with plasma cholinesterase deficiency, patients with renal disease, patients with severe hepatic disease, patients with myasthenia gravis treated by acetylcholinesterase inhibitors, patients with porphyria, patients with concomitant treatment with halogenated inhalation anaesthetics, patients receiving treatment with antiplatelets / anticoagulants and elderly patients.
Danish: 4.4 i produktresuméet (Advarsler) er blevet sammenfattet, så det indeholder følgende kategorier: Patienter med hjerte-karsygdom, epileptiske patienter, patienter med plasmacholinesterasemangel, patienter med nyresygdom, patienter med svær leversygdom, patienter med myasthenia gravis, som behandles med acetylcholinesterasehæmmere, patienter med porfyri, patienter med samtidig behandling med halogenerede inhalerede anæstetika, patienter i behandling med antitrombotiske midler/antikoagulantia og ældre patienter.
English: Interactions with other medicinal products (section 4.5 of the SmPC) have been summarised in additive interactions with other local anaesthetics, sedatives, halogenated volatile anaesthetics, postganglionic adrenergic blocking agents, non-selective beta-adrenergic blockers, tricyclic antidepressants, catechol-O-methyl transferase inhibitors, drugs causing arrhythmias, ergot-type oxytocic drugs, sympathomimetic vasopressors and phenothiazines.
Danish: 4.5 i produktresuméet) er blevet sammenfattet med hensyn til additive interaktioner med andre lokale anæstetika, sedativa, halogenerede, flygtige anæstetika, postganglionære adrenerge blokkere, non-selektive beta-adrenerge blokkere, tricykliske antidepressiva, catechol-O-methyl-transferasehæmmere, lægemidler, der forårsager arytmi, oxytociske lægemidler af ergot-typen, sympatomimetiske vasopressorer og phenothiaziner.
English: • In addition, the Committee reviewed the totality of the documentation submitted by the Marketing Authorisation Holder in support of the proposed harmonised Quality documentation (Module 3);
Danish: • Udvalget gennemgik derudover den samlede dokumentation, som indehaveren af markedsføringstilladelse havde indsendt til støtte for det foreslåede harmoniserede afsnit om kvalitet (modul 3).
English: • The Committee reviewed the totality of the data submitted by the Marketing Authorisation Holder in support of the proposed harmonisation of the product information;
Danish: • Udvalget gennemgik alle data, som indehaveren af markedsføringstilladelsen har forelagt til underbygning af den foreslåede harmonisering af produktinformationen.
English: The results of these studies indicate that articaine 40 mg/mL with 0.01 mg/mL or with 0.005 mg/mL adrenaline is effective as a local dental anaesthetic in adults and children above 4 years old.
Danish: Resultaterne af disse forsøg viser, at articain 40 mg/ml med 0,01 mg/ml eller med 0,005 mg/ml adrenalin er effektiv til lokal dental anæstesi hos voksne og hos børn over 4 år.
English: Whereas
Danish: Pkt.
English: It is available in 2 strengths: articaine/adrenaline 40/0.005 mg/ml and articaine/adrenaline 40/0.01 mg/ml.
Danish: Det fås i 2 styrker: articain/adrenalin 40/0,005 mg/ml og articain/adrenalin 40/0,01 mg/ml.
English: The MAH proposed not to specify the usual dose in children due to the lack of dose selection study in paediatric patients.
Danish: Indehaveren af markedsføringstilladelsen forslog, at angivelse af den sædvanlige dosis til børn skulle udelades på grund af manglende dosisfastsættende studier hos pædiatriske patienter.
English: Information about the time to onset and description of slow or delayed onset for dosing overdose has been included at the request of the CHMP.
Danish: Der er på anmodning fra CHMP blevet tilføjet oplysninger om tid til debut og beskrivelse af langsom eller forsinket debut for overdosering.
English: The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6 of the SmPC) with data supported from pre-clinical studies, rejecting detailed information regarding the preclinical studies that did not provide valuable information for healthcare professionals.
Danish: 4.6 i produktresuméet) med data underbygget af prækliniske studier, og afviste detaljerede oplysninger vedrørende prækliniske studier, der ikke gav værdifulde oplysninger til læger og sundhedspersonale.
English: The finished product is presented as a solution for injection containing articaine hydrochloride 40 mg/ml and adrenaline tartrate in 2 strengths: articaine/adrenaline 40/0.005 mg/ml and articaine/adrenaline 40/0.01 mg/ml.
Danish: Det færdige produkt præsenteres som en injektionsvæske, opløsning indeholdende articainhydrochlorid 40 mg/ml og adrenalintartrat i 2 styrker: articain/adrenalin 40/0,005 mg/ml og articain/adrenalin 40/0,01 mg/ml.
English: A harmonised version of section 4.8 of the SmPC regarding adverse events has been agreed by the CHMP after assessing data from the MAH's global pharmacovigilance database and literature data.
Danish: 4.8 af produktresuméet vedrørende bivirkninger efter vurdering af data fra markedsføringstilladelsesindehaverens globale farmakovigilansdatabase og data fra faglitteraturen.
English: The rate of 1 ml/min is considered optimal as it does not produce tissue damage during or after anaesthesia, as well as any serious reaction in the event of accidental intravascular injection.
Danish: fremkalder vævsskader under eller efter anæstesien eller alvorlige reaktioner i tilfælde af utilsigtet intravaskulær injektion.
English: • The Committee considered the harmonised product information and Quality documentation (Module 3) for Septanest and associated names to be acceptable; The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Septanest and associated names (see Annex I).
Danish: CHMP anbefalede ændring af betingelserne for de markedsføringstilladelser, for hvilke produktinformationen fremgår af bilag III for Septanest og relaterede navne (se bilag I).
English: history of hypersensitivity to articaine, to adrenaline or to any of the excipients of the finished product and patients with epilepsy not adequately controlled by treatment.
Danish: 4.3, blev diskuteret med indehaverne af markedsføringstilladelserne, og CHMP var enig i det givne rationale for at bibeholde dem i produktresuméet for patienter med kendt overfølsomhed over for articain, adrenalin eller et eller flere af hjælpestofferne i det færdige produkt og for patienter med epilepsi, der ikke er tilstrækkeligt reguleret med behandling.
English: Other Sections of the SmPC
Danish: Andre punkter i produktresuméet
English: Do not freeze.
Danish: Må ikke fryses
English: As an identified risk, an appropriate warning should be included in section 4.4.
Danish: Som en identificeret risiko, skal en passende advarsel inkluderes i afsnit 4.4.
English: - All tables will be based on generic and not product-specific data.
Danish: - Alle tabeller baseres på generiske og ikke på produktspecifikke data.
English: Product-specific data can be
Danish: Produktspecifikke data kan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/664/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/664/001
English: This medicine has been authorised under 'exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under ”særlige omstændigheder”.
English: Presentation of data will take into consideration the following recommendations:
Danish: Præsentationen af data skal tage følgende anbefalinger i betragtning:
English: Instructions for mixing and administration of the vaccine:
Danish: Instruktion for sammenblanding og administration af vaccinen:
English: SPECIAL STORAGE CONDITIONS Storage in a refrigerator.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab
English: Pandemic influenza vaccine should be used in accordance with official guidance.
Danish: Pandemisk influenzavaccine skal anvendes i overensstemmelse med officielle retningslinjer.
English: All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 18-60 years, >60 years
Danish: Alle hændelser opdelt på følgende aldersgrupper: 6-23 måneder, 2-8 år, 8-17 år, 18-60 år, > 60
English: One pack of Pumarix consists of:
Danish: En pakke Pumarix består af:
English: Adults from the age of 18 years onwards:
Danish: Voksne i alderen 18 år og derover:
English: Do not have Pumarix if any of the above apply to you.
Danish: Du må ikke få Pumarix, hvis noget af ovennævnte passer på dig.
English: - No line listings are required - these can be provided in signal evaluation reports as necessary.
Danish: - Der kræves ingen ”line listings” - disse kan angives efter behov i evalueringsrapporterne
English: Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows:
Danish: Under hensyntagen til PRACs evalueringsrapport for PSUR'en for Pumarix, er PRACs videnskabelige konklusioner som følger:
English: Depending on and after implementation of vaccine strain, when first pandemic will take place.
Danish: Afhængig af og efter implementeringen af vaccinestammen, når den første pandemi finder sted.
English: Day 180
Danish: dag 180
English: All events reported by patients that have been entered into the database by data-lock point
Danish: Alle hændelser, som patienterne har rapporteret, og som er lagt ind i databasen på tidspunktet for data-lock-point.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP er enig i PRACs videnskabelige konklusioner.
English: All events occurring in pregnant women
Danish: Alle hændelser hos gravide 6.
English: If this is not treated it may lead to shock.
Danish: Hvis det ikke bliver behandlet kan det medføre shock.
English: This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet.
English: • Serious stabbing or throbbing pain along one or more of your nerves
Danish: • Kraftigt stikkende eller bankende smerter langs en eller flere nerver
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får denne vaccine.
English: The vaccine contains an ‘adjuvant' AS03.
Danish: Vaccinen indeholder en 'adjuvans' AS03.
English: These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Danish: Disse antigener kan kaldes ”nye” antigener og simulerer en situation, hvor målgruppen for vaccinationen er immunologisk naive.
English: If this is not treated, it may lead to shock.
Danish: Hvis det ikke bliver behandlet, kan det medføre shock.
English: They may also happen with Pumarix.
Danish: De kan også forekomme ved Pumarix.
English: In such cases, the Western blot method is negative.
Danish: I disse tilfælde vil Western blot-analysen give negative resultater.
English: A summary of vaccine distribution shall be included and provide details of the number of EU member states for the reporting period by batch number,
Danish: Der skal indgå et resume over vaccinedistributionen og gives nærmere oplysninger om de i) EU's medlemsstater i rapporteringsperioden pr. batchnummer
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to
Danish: Når det er besluttet af CHMP at S-PSUR ikke længere er nødvendigt skal en fuld PSUR dækkende hele perioden fra data-lock point fra sidste rutine PSUR indsendes indenfor en tidsramme besluttet af
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Danish: Omgående analyse af de kumulative sikkerhedsoplysninger er i lyset af omfanget af eksponering afgørende for myndighedernes beslutning og beskyttelse af den population, der skal vaccineres.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14(8) i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme udføre
English: Some effects listed in Section 4 “Possible side effects” may affect your ability to drive or use tools or machines.
Danish: Nogle af de bivirkninger, der er nævnt i punkt 4 (”Bivirkninger”), kan påvirke din evne til at køre bil eller anvende maskiner.
English: Pumarix is not intended to be given at the same time as some other vaccines.
Danish: Pumarix er ikke beregnet til at blive givet samtidig med andre vacciner.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 March 2011
Danish: Dato for første markedsføringstilladelse: 4. marts 2011
English: An AS03-containing vaccine containing HA from H1N1v has been administered to women in each trimester of pregnancy.
Danish: En AS03-adjuveret vaccine indeholdende HA fra H1N1v er administreret til kvinder i alle trimestre af graviditeten.
English: Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Danish: Data fra mockup-vaccinen vil støtte den vaccinationsstrategi, der sandsynligvis vil blive anvendt til den pandemiske vaccine: kliniske immunogenicitets-, sikkerheds- og reaktogenicitetsdata fra mockup-vacciner er relevante i forbindelse med pandemiske vacciner.
English: In relation to the identified risk of fever in children (<6 years), the PRAC does not agree with the MAH that the EU SmPC contains appropriate information on this safety concern.
Danish: I forhold til den identificerede risiko for feber hos børn (< 6 år), er PRAC ikke enig med indehaveren af markedsføringstilladelsen i, at EU- produktresumeet indeholder relevante oplysninger om dette sikkerhedsproblem.
English: It is recommended that subjects who receive a first dose of Pumarix, complete the vaccination course
Danish: Det anbefales, at personer, som får Pumarix som den første dosis, fuldfører vaccinationsprogrammet
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Danish: Denne vaccine opfylder WHO's anbefalinger og EU's beslutning i forbindelse med en pandemi.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, skal dette lægemiddel ikke blandes med
English: Your doctor or nurse will give you Pumarix.
Danish: Lægen eller sygeplejersken vil give dig Pumarix.
English: Storage (2ºC-8ºC), do not freeze, protect from light
Danish: Opbevaring (2 °C - 8 °C), må ikke fryses, beskyttes mod lys
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Danish: Det immunologiske respons kan nedsættes, hvis patienten er i immunsupprimerende behandling.
English: - Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures and will only form part of the report if an issue of concern arises.
Danish: - Alvorlige, forventede reaktioner vurderes af indehaveren af markedsføringstilladelsen som en del af evalueringsprocedurerne, og vil kun indgår i rapporten, hvis et alvorligt tilfælde opstår.
English: Animal studies with Pumarix do not indicate reproductive toxicity (see section 5.3).
Danish: Dyrestudier med Pumarix indikerer ikke reproduktionstoksicitet (se pkt.
English: Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Danish: Mock-up-vacciner indeholder influenza-antigener, som er forskellige fra dem, der findes i den influenzavirus, der aktuelt er i omløb.
English: The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: Bivirkningerne nedenfor er set i dagene eller ugerne efter vaccination med den vaccine, som gives rutinemæssigt til beskyttelse af sæsoninfluenza.
English: Pumarix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Pumarix takes due account of the officially declared pandemic strain.
Danish: Pumarix kan kun markedsføres, hvis der findes en officiel WHO/EU-erklæring om en pandemisk influenza og kun på betingelse af at markedsføringstilladelsesindehaveren af Pandemrix tager passende hensyn til den officielt erklærede pandemiske vaccinestamme.
English: Moreover section 4.8 should be revised to reflect reactogenicity data from the three paediatric studies D-Pan H5N1-009, -013 and
Danish: Desuden skal afsnit 4.8 revideres, således at afsnittet afspejler reaktogenicitetsdata fra de tre pædiatriske studier, D- Pan H5N1 -009, -013 og -032.
English: The report shall include the following tables of aggregate data using the agreed templates:
Danish: Rapporten skal omfatte følgende tabeller over samlede data vha. de aftalte skabeloner:
English: Pumarix contains thiomersal
Danish: Pumarix indeholder thiomersal
English: • Swollen glands in your neck
Danish: • Hævede kirtler i halsen
English: This section describes the clinical experience with the mock-up vaccines following a two-dose
Danish: Dette afsnit beskriver den kliniske erfaring med mock-up-vacciner efter administration af et to-dosis
English: • if you have a bleeding problem or you bruise easily.
Danish: • hvis du har blødningsproblemer eller nemt får blå mærker.