FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended posology in children of an average 0.75 mg (0.025 ml) of mepivacaine solution per kg of body weight is in line with the work-sharing procedure led by EMA in 2010 in accordance with Article 45 of the Paediatric Regulation 1901/2006 (AT/W/0002/pdWS/001).
Danish: Den anbefalede dosering hos børn på gennemsnitligt 0,75 mg (0,025 ml) mepivacain-opløsning pr. kg legemsvægt er i overensstemmelse med den arbejdsdelingsprocedure, som EMA indledte i 2010 i henhold til artikel 45 i den pædiatriske forordning 1901/2006 (AT/W/0002/pdWS/001).
English: Pharmacokinetic changes are also observed with aging.
Danish: Der er også set farmakokinetiske ændringer i forbindelse med aldring.
English: Changes introduced in the SmPC were consistently reflected in the labelling, with some sections left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen, idet nogle punkter blev overladt til national tilpasning.
English: • The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including based on the documentation submitted and the scientific discussion within the Committee;
Danish: • Udvalget gennemgik de af markedsføringstilladelsesindehaveren fremlagte data til underbygning af den foreslåede harmonisering af produktinformationen, herunder den indsendte dokumentation og den videnskabelige drøftelse i udvalget
English: Consequently, metabolism and elimination of mepivacaine can be significantly altered by the presence of hepatic or renal diseases.
Danish: Derfor kan mepivacains metabolisme og elimination være signifikant ændret ved tilstedeværelse af lever- eller nyresygdom.
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) have been updated in line with their respective harmonised Quality documentation provided in module 3 and in line with the latest QRD template.
Danish: Punkterne 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 (Farmakodynamiske 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) er blevet opdateret i overensstemmelse med den respektive harmoniserede, kvalitetsrelaterede dokumentation i modul 3 og den nyeste QRD-skabelon.
English: In section 4.4, the warnings have been re-organised in five categories: patients with cardiovascular disorders, hepatic disease, kidney disease, epileptic and elderly patients.
Danish: 4.4 er advarslerne blevet reorganiseret i fem kategorier: patienter med kardiovaskulære sygdomme, leversygdom, nyresygdom, epilepsi-patienter og ældre.
English: The recommendations on lower doses for patients with reduced health and pre-existing conditions such as vascular obliterations, arteriosclerosis or diabetes-related nerve damage are not supported by sufficient data and are not endorsed by the CHMP.
Danish: Anbefalingerne vedrørende lavere doser til patienter med dårligere almentilstand og eksisterende sygdomme som f.eks. tillukning af små blodkar, arteriosklerose eller diabetesrelaterede nerveskader er ikke underbygget af tilstrækkelige data og støttes ikke af CHMP.
English: Mepivacaine is largely metabolised in the liver by microsomal enzymes and the principal route of excretion is via the kidney.
Danish: Mepivacain metaboliseres i overvejende grad i leveren af mikrosomale enzymer, og den primære udskillelsesvej er via nyrerne.
English: • In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation (Module 3);
Danish: • Udvalget gennemgik derudover den dokumentation, som indehaveren af markedsføringstilladelse havde indsendt til støtte for det foreslåede harmoniserede afsnit om kvalitet (modul 3)
English: Information for medical staff on how to avoid a blood vessel penetration during injection as well as instructions to avoid injections to inflamed or infected tissues are maintained in the SmPC.
Danish: Oplysninger til sundhedspersoner om, hvordan man undgår at penetrere blodkar under injektion, samt instruktioner i, hvordan man undgår at injicere i inflammeret eller inficeret væv, fastholdes i produktresuméet.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data and in line with international, European and national guidelines.
Danish: Indehaveren af markedsføringstilladelsen foreslog harmoniserede doseringsanbefalinger, der var baseret på de anvendte doser i kliniske undersøgelser, underbygget af farmakodynamiske og farmakokinetiske data og i overensstemmelse med internationale, europæiske og nationale retningslinjer.
English: A harmonised description of the symptoms and the management of overdose has been agreed in accordance with the EMA SmPC guideline (2009).
Danish: En harmoniseret beskrivelse af symptomerne på overdosering og behandlingen deraf er aftalt i overensstemmelse med EMA's vejledning for produktresuméer (2009).
English: No clinical data on fertility and nursing mothers are available on humans.
Danish: Der er ingen tilgængelige kliniske data vedrørende fertilitet og ammende mødre.
English: • The Committee considered the identified divergences for Scandonest and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet;
Danish: • Udvalget behandlede de konstaterede divergenser for Scandonest og relaterede navne, hvad angår indikationer, dosering, kontraindikationer, særlige advarsler og forsigtighedsregler vedrørende brugen samt de øvrige punkter i produktresuméet, etiketteringen og indlægssedlen
English: The CHMP is of the opinion that in case of vasoconstrictor contraindication there are alternative options, such as other local anaesthetics (procaine, bupivacaine and lidocaine), general anaesthesia and nitrous oxide.
Danish: CHMP er af den opfattelse, at der i tilfælde af vasokonstriktor-kontraindikation findes alternative muligheder som f.eks. andre lokalanalgetika (procain, bupivacain og lidocain), generelle analgetika og dinitrogenoxid.
English: Therefore, mepivacaine is contraindicated in patients with atrioventricular disorders not compensated by a pacemaker.
Danish: Derfor er mepivacain kontraindiceret hos patienter med atrioventrikulære sygdomme, der ikke er kompenseret af en pacemaker.
English: The relevant posology section for the mepivacaine use in chiropody procedure will be removed as the CHMP supported the deletion of this indication.
Danish: Doseringsafsnittet vedrørende brug af mepivacain ved fodpleje-procedurer vil blive fjernet, idet CHMP støttede, at denne indikation skulle fjernes.
English: The MAH has provided a summary of the literature and studies to support the indication “anaesthesia in dental procedures”.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt en oversigt over litteraturen og studier som støtte for indikationen "anæstesi ved dentale procedurer".
English: On 25 August 2017 Septodont on behalf of all marketing authorisation holders (MAHs) presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics (SmPC), labelling, package leaflet and quality Module 3 of the medicinal products Scandonest and associated names (see Annex I of CHMP opinion).
Danish: Den 25. august 2017 indledte Septodont på vegne af alle indehavere af markedsføringstilladelse en indbringelsesprocedure i henhold til artikel 30 i direktiv 2001/83/EF med henblik på at harmonisere produktresuméet, etiketteringen, indlægssedlen og det kvalitetsrelaterede modul 3 for lægemidlerne Scandonest og relaterede navne (se bilag I til CHMP's udtalelse).
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Scandonest and associated names (see Annex I).
Danish: CHMP anbefalede ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægssedler fremgår af bilag III for Scandonest og relaterede navne (se bilag I)
English: {(Invented) name and associated names, strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Danish: (særnavn) og relaterede navne, styrke, lægemiddelform) er et lokalt virkende bedøvelsesmiddel, der er indiceret til lokal og lokoregional anæstesi ved dental kirurgi hos voksne, unge og børn i alderen 4 år og opefter (legemsvægt på ca. 20 kg).
English: Thus, local anaesthetics should not be used in epileptic patients whose seizures are poorly controlled.
Danish: Derfor bør lokalanalgetika ikke anvendes hos epileptiske patienter, hvis krampeanfald er dårligt regulerede.
English: The rate of 1 ml/min is considered ideal as it does not produce tissue damage during or after anaesthesia and any serious reaction in the event of accidental intravascular injection.
Danish: vurderes at være ideel, da der derved ikke opstår vævsskader under eller efter anæstesien eller alvorlige reaktioner i tilfælde af utilsigtet intravaskulær injektion.
English: The CHMP noted that there is literature evidence that mepivacaine provides vasoconstrictive features compared with anaesthetics from other pharmaceutical groups, however this cannot consist an indication itself.
Danish: CHMP bemærkede, at der i litteraturen er evidens for, at mepivacain har en vasokonstriktiv virkning sammenholdt med analgetika fra andre farmaceutiske grupper, men dette kan ikke i sig selv udgøre en indikation.
English: The CHMP considers that the data submitted in support of the chiropody procedures indication are not adequate to establish the efficacy of using mepivacaine for all chiropody applications and recommended the deletion of this indication.
Danish: CHMP vurderer, at de data, der er indsendt til støtte for indikationen fodpleje, ikke er relevante i forhold til at fastslå virkningen af mepivacain ved alle fodpleje-anvendelser, og anbefalede fjernelsen af denne indikation.
English: Mepivacaine is an intermediate-acting local anaesthetic, which inhibits the conduction of nerve impulses by decreasing sodium (Na+) flow during propagation of the nerve action potential.
Danish: Mepivacain er et lokalt bedøvelsesmiddel, der virker på mellemlang sigt, og som hæmmer overførslen af nervesignaler ved at reducere natriumflowet (Na+) under udbredelsen af nervernes aktionspotentiale.
English: Interactions with other medicinal products (section 4.5) have been summarised in additive interactions with other local anaesthetics, H2 antihistaminics, sedatives, antiarrhythmic drugs, CYP1A2 inhibitors and propranolol.
Danish: 4.5) er opsummeret i additive interaktioner med andre lokalanalgetika, H2-antihistaminer, sedativa, antiarytmika, CYP1A2-hæmmere og propranolol.
English: This recommendation is also supported by the inconsistency of recognition and professional rights of chiropodist profession across EU.
Danish: Anbefalingen understøttes også af det faktum, at der mellem EU's medlemsstater hersker forskelle vedrørende anerkendelsen af og de faglige rettigheder for fodpleje-erhvervet.
English: As the drug concentration rises in the brain, the excitatory pathways are inhibited and CNS depression occurs.
Danish: Når lægemiddelkoncentrationen stiger i hjernen, hæmmes de eksitatoriske mekanismer, og CNS
English: Mepivacaine is contraindicated in patients with a history of hypersensitivity to the product, to any other amide anaesthetics or to any of the excipients.
Danish: Mepivacain er kontraindiceret hos patienter med tidligere overfølsomhed over for produktet, andre amidanalgetika eller et eller flere af hjælpestofferne.
English: The package leaflet (PL) was amended in accordance with the changes made to the SmPC.
Danish: Indlægssedlen blev ændret i overensstemmelse med ændringerne af produktresuméet.
English: 20 kg of body weight).
Danish: - Børn under 4 år (legemsvægt på ca. 20 kg)
English: Section 4.2 - Posology and methods of administration Posology
Danish: Punkt 4.2 - Dosering og administration
English: The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6) with data supported from pre-clinical studies.
Danish: CHMP blev enig om en fælles ordlyd vedrørende fertilitet, graviditet og amning (pkt.
English: Therefore, the CHMP recommended that the statement regarding mepivacaine's use when vasoconstrictor is contraindicated should be moved from section 4.1 to 5.1 (pharmacodynamic properties) of the SmPC.
Danish: Derfor anbefalede CHMP, at udsagnet vedrørende brug af mepivacain, når en vasokonstriktor er kontraindiceret, bør flyttes fra pkt.
English: The revised therapeutic indications in section 4.1 of the SmPC are:
Danish: 4.1 i produktresuméet er:
English: This information should be reflected in the SmPC section 4.2 with a cross reference to section 4.5 (Interactions with other medicinal products).
Danish: 4.5 (Interaktion med andre lægemidler).
English: If sedatives are used to reduce patient anxiety, lower doses of the anaesthetic should be used, since there is increased risk of adverse effects when central nervous system (CNS) depressants are combined.
Danish: Den maksimale anbefalede dosis er 4,4 mg/kg legemsvægt med en absolut maksimal dosis på 300 mg.Hvis der anvendes beroligende midler for at mindske patientens angst, bør der bruges lave doser af bedøvelsesmidlet, da der er en øget risiko for bivirkninger ved kombination af lægemidler, der undertrykker centralnervesystemet.
English: A harmonised version of section 4.8 of adverse events has been agreed by the CHMP after assessing data from global pharmacovigilance database and literature and in line with data assessed in previous periodic update assessment reports (PSURs).
Danish: Efter vurdering af data fra globale databaser for lægemiddelovervågning og litteratur og i overensstemmelse med de data, der er gennemgået i forbindelse med tidligere periodiske sikkerhedsopdateringer (PSUR'er), har CHMP aftalt en harmonisering af pkt.
English: Whereas
Danish: Dosering
English: Therefore, the CHMP concluded in the inclusion of the contraindications summarised below: - Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1, - Children below 4 years of age (ca. 20 kg body weight), - Severe disorders of atrioventicular conduction not compensated by pace maker, - Poorly controlled epileptic patient.
Danish: - Overfølsomhed over for det aktive stof (eller eventuelle lokalanalgetika af amidtypen) eller over for et eller flere af hjælpestofferne anført i pkt.
English: In post marketing experience: Hypersensitivity reactions may occur in very rare cases.
Danish: Erfaring efter markedsføring: Overfølsomhedsreaktioner kan forekomme i meget sjældne tilfælde.
English: Each dose of 2 ml contains:
Danish: Hver dosis af 2 ml indeholder:
English: In laboratory studies and field trials:
Danish: I laboratoriestudier og feltforsøg:
English: Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum.
Danish: Derfor bør man sikre sig, at hver enkelt gris indtager en tilstrækkelig mængde kolostrum.
English: Aqueous, white to nearly white.
Danish: Vandig, hvid til næsten hvid.
English: Administer 1 dose (2 ml) of vaccine per animal in the neck in the area behind the ear.
Danish: Administrer 1 dosis (2 ml) vaccine pr. dyr i halsen i området bag øret.
English: Protection of piglets is achieved by colostrum intake.
Danish: Beskyttelse af smågrise opnås ved optagelse af kolostrum.
English: ATC vet code: QI09AB08.
Danish: ATCvetkode: Q109AB08.
English: Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: Vaccinate only healthy animals.
Danish: Vacciner kun raske dyr.
English: Pigs (sows and gilts)
Danish: Svin (søer og gylte)
English: Revaccination: A single revaccination is carried out 2 to 4 weeks before the expected date of farrowing.
Danish: Revaccination: En enkelt vaccination gives 2-4 uger før forventet faringstidspunkt.
English: Date of first authorisation: 14/06/2012 Date of last renewal: 29/03/2017
Danish: Dato for første markedsføringstilladelse: 14-06-2012 Dato for seneste fornyelse af markedsføringstilladelse: 29-03-2017
English: Aqueous, white to nearly white suspension for injection.
Danish: Vandig, hvid til næsten hvid suspension til injektion.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: No adverse reactions other than those mentioned in section 4.6 have been observed.
Danish: Der er ikke observeret bivirkninger ud over dem, der allerede er nævnt under afsnit 4.6.
English: A slight redness and/or roughness may transiently occur after a double dose vaccination.
Danish: Forbigående let rødmen og/eller ujævnhed kan forekomme ved dobbelt dosis.
English: Vaccination results in an antibody response with neutralizing activity against LT toxin.
Danish: Vaccination resulterer i et antistofsvar med neutraliserende virkning over for LT-toksin.
English: 1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose
Danish: 1 Gennemsnitlig antistoftiter (Ab-titer) opnået efter vaccination af mus med 1/20 eller 1/40 svinedosis.
English: ≥20 IU2
Danish: ≥ 20 IE2
English: 2 International units of beta antitoxin according to Ph. Eur.
Danish: 2 Internationale Enheder af beta antitoxin svarende til Ph.Eur.
English: The vials are closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Danish: Hætteglas er lukket med en halogenbutylgummiprop og forseglet med en aluminiumshætte.
English: No adverse reactions other than those mentioned in section 6 have been observed.
Danish: Der er ikke observeret bivirkninger ud over dem, der allerede er nævnt under afsnit 6.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: The active substances being a principle of biological origin intended to produce passive immunity are not within the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere passiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: Primary vaccination: Sows/gilts which have not yet been vaccinated with the product are given a primary injection 6 to 8 weeks before the expected date of farrowing and a second injection 4 weeks later.
Danish: Basisvaccination: Søer og gylte, der ikke tidligere er vaccineret med lægemidlet, gives første vaccination 6-8 uger før forventet faringstidspunkt efterfulgt af endnu en vaccination 4 uger senere.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the vial: 10 hours
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første åbning af den indre emballage: 10 timer
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusiv adjuvanser) som er anført i punkt 6.1 af SPC'et er tilladte hjælpestoffer, for hvilke MRL-værdier ikke er påkrævet som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Shelf life after first opening the container: 10 hours.
Danish: Opbevaringstid efter første åbning af beholderen: 10 timer
English: Withdrawal period: Zero days
Danish: Tilbageholdelsestid: 0 dage
English: An increase in body temperature up to 2°C was very commonly observed on the day of vaccination.
Danish: Meget almindeligt kan på vaccinationsdagen observeres en stigning i legemstemperaturen på op til 2 °C.
English: EXP {month/year} Once broached, use within 10 hours.
Danish: {måneder/år} Efter anbrud/åbning anvendes inden 10 timer.
English: Packsizes:
Danish: Pakningsstørrelser:
English: E.coli: fimbrial adhesins, LT toxoid C. perfringens toxoid
Danish: E. coli: fimbrieadhæsin, LT toxoid C. perfringens toxoid
English: Per dose of 2 ml: E. coli: F4ab fimb.
Danish: Pr. dosis af 2 ml: E.coli: F4ab fimbrieadhæsin
English: EU/2/12/141/004 EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009
Danish: EU/2/12/141/001 EU/2/12/141/002 EU/2/12/141/003 EU/2/12/141/004 EU/2/12/141/005
English: Before use, allow the vaccine to reach room temperature.
Danish: Lad vaccinen opnå rumtemperatur før brug.
English: Buckinghamshire, MK7 7AJ, UK
Danish: Waltor Manor, Walton, Milton Keynes Buckinghamshire, MK7 7AJ, UK
English: Pig pictogram
Danish: Svin/pictogram
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Reduced activity and lack of appetite on the day of vaccination commonly occurred and/or a sometimes painful and hard swelling up to 10 cm diameter for up to 25 days were very commonly observed at the site of injection.
Danish: På injektionsstedet kan der meget almindeligt ses en smertefuld og hård hævelse på op til 10 cm i diameter i op til 25 dage efter injektionen.
English: Clostridium perfringens component: - Type C (strain 578) beta toxoid
Danish: Clostridium perfringens komponent: - Type C (stamme 578) betatoxoid
English: Porcilis ColiClos suspension for injection
Danish: Porcilis ColiClos injektionsvæske, suspension
English: Escherichia coli components: - F4ab fimbrial adhesin
Danish: Escherichia coli komponenter: -F4ab fimbrieadhæsin
English: For animal treatment only.To be supplied only on veterinary prescription.
Danish: Kun til dyr - må kun udleveres efter veterinærrecept.
English: C. perfringens type C toxoid
Danish: Clostridium perfringens type C toxoid
English: dl-α-tocopheryl acetate
Danish: dl-α-tocopherylacetat
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccine.
Danish: Farmakoterapeutisk gruppe: Immunologica til Suidae (svin).
English: Shake vigorously before use and at intervals during use.
Danish: Omryst omhyggeligt før og under brug.