FrancophonIA/ELRC3.0 huggingface dataset:
English: The vial of buffer contains approximately 32.5 mg of sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hætteglasset med buffer indeholder ca. 32,5 mikrogram natrium.
English: After 7 minutes, remove the vial from the dry bath, place it in an appropriately labelled lead shield and let it cool down at room temperature for approximately 10 minutes.
Danish: Efter 7 minutter fjernes hætteglasset fra tørbadet og placeres i en passende mærket blyafskærmning.
English: Method of preparation
Danish: Fremstillingsmetode
English: No adverse reactions related to gallium (68Ga) edotreotide have been reported.
Danish: Der er ikke rapporteret bivirkninger ved gallium (68Ga)-edotreotid.
English: In GEP-NET, a more intense gallium (68Ga) edotreotide uptake than normal background is a consistent finding.
Danish: I GEP-NET findes konsekvent en højere optagelse af gallium (68Ga)-edotreotid end normalt.
English: Precautions with respect to environmental hazard are in section 6.6.
Danish: Forholdsregler i relation til fare for miljøet, se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of powder contains 40 micrograms of edotreotide
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas med pulver indeholder 40 mikrogram edotreotid.
English: The activity of gallium (68Ga) edotreotide has to be measured with an activimeter immediately prior to injection.
Danish: Aktiviteten af gallium (68Ga)-edotreotid skal måles med et aktivimeter (en type geigertæller)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED PULVER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BUFFER VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED BUFFER
English: In patients with Cushing syndrome, the normalisation of hypercortisolism should be considered before performing PET with SomaKit TOC.
Danish: Der foreslås en normalisering af hyperkortisolismen, før der udføres PET
English: With a low dead space 1 ml sterile syringe carefully withdraw 100 µl and keep the reaction buffer in syringe for step “g”.
Danish: Træk 100 μl reaktionsbuffer op med en 1 ml steril sprøjte med lille deadspace og behold reaktionsbufferen i sprøjten indtil trin “g”.
English: Flip off cap from the Vial 2 (Reaction buffer) and swab the top of the vial closure with an appropriate antiseptic to disinfect the surface, and then allow the stopper to dry.
Danish: Vip låget af hætteglas 2 (med reaktionsbuffer), aftør proppen med et egnet antiseptisk middel for at desinficere overfladen og lad proppen tørre.
English: Figure 1: Radiolabelling procedure when using GalliaPharm generator Reconstitution with Galli Ad generator:
Danish: Figur 1: Procedure til radioaktiv mærkning ved brug af GalliaPharm generator
English: What you need to know before SomaKit TOC is used
Danish: Det skal du vide, før du får SomaKit TOC
English: One vial of powder contains 40 µg of edotreotide.
Danish: Hvert hætteglas indeholder 40 mikrogram edotreotid.
English: Image acquisition
Danish: Billeddannelse
English: EXP After radiolabelling, use within 4 hours.
Danish: EXP Skal anvendes inden for 4 timer efter radioaktiv mærkning.
English: Flip off cap from the vial of powder and swab the top of the vial closure with an appropriate antiseptic to disinfect the surface, and then allow the stopper to dry.
Danish: Vip låget af hætteglasset med pulver, aftør proppen med et egnet antiseptisk middel for at desinficere overfladen og lad proppen tørre.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms powder for solution for injection edotreotide
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) SomaKit TOC 40 mikrogram pulver til injektionsvæske, opløsning edotreotid i.v.
English: SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation Edotreotide
Danish: SomaKit TOC 40 mikrogram radiofarmaceutisk præparationssæt edotreotid
English: NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
Danish: LÆGEMIDLETS NAVN SomaKit TOC 40 mikrogram radiofarmaceutisk præparationssæt
English: The acquisition must include a whole body acquisition from skull to mid-thigh.
Danish: Billeddannelsen skal omfatte helkropsscanning fra hovedet til midt på låret.
English: The three remaining retrospective studies recruited small samples (ranging from 20 to 28 GEP-NET patients or those with cancer of unknown origin) and found that semiquantitative uptake in the pre-PRRT gallium (68Ga)
Danish: De sidste tre retrospektive studier rekrutterede mindre populationer (rangerende fra 20 til 28 GEP-NET-patienter eller patienter med cancer af ukendt oprindelse) og fandt, at semikvantitativ optagelse af præ-PRRT gallium (68Ga)-edotreotid PET korrelerede med de tumor-absorberede doser per injiceret aktivitet i den efterfølgende første behandlingscyklus, var forskellig mellem læsioner, klassificeret som responderende og som ikke-responderende, efter tre PRRT-forløb og var en hjælp til at adskille levermetastaser fra normalt levervæv.
English: Ga) edotreotide to structures or receptors other than SSTR remains unknown.
Danish: Desuden er in vivo-binding af gallium (68Ga)-edotreotid til strukturer og andre receptorer end SSTR stadig ukendt.
English: Concomitant use of somatostatin analogues It is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) before the next administration of a somatostatin analogue.
Danish: Samtidig brug af somatostatin-analoger Billeddannelse med gallium (68Ga)-edotreotid bør udføres dagen(e) før den næste dosis af en somatostatin-analog, se pkt.
English: Thyroid
Danish: Myresyre
English: Gallium (68Ga) edotreotide PET and CT showed a concordant result in 32 patients
Danish: Gallium (68Ga)-edotreotid PET-scanning og CT
English: Thus, in patients with GEP-NET and Cushing syndrome, normalisation of hypercortisolism should be suggested before performing PET with gallium (68Ga)
Danish: Derfor foreslås normalisering af hyperkortisolismen, før der udføres PET-scanning med gallium (68Ga)-edotreotid hos patienter med GEP-NET og Cushings syndrom.
English: Connect the male luer of the outlet line of the 68Ge/68Ga generator with a sterile needle (coated with silicone or other appropriate material able to reduce metal impurity tracenot supplied).
Danish: Sæt en steril nål (coatet med silicone eller andet egnet materiale, som kan reducere spor af metalurenheder - medfølger ikke) på han-luer'en på 68Ge/68Ga-generatorens udløbsslange.
English: Take this into consideration if you are on a controlled sodium diet.
Danish: Hvis du er på en natrium- eller saltfattig diæt, skal du tage hensyn hertil.
English: A schematic representation of the radiolabelling procedure is shown in
Danish: En skematisk oversigt over proceduren til radioaktiv mærkning er vist i Figur 1.
English: How SomaKit TOC is used
Danish: Sådan får du SomaKit TOC
English: • Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips Mobile phase: sodium Citrate 0.1 M (pH 5) in water
Danish: • Mobil fase: natriumcitrat 0,1 M (pH 5) i vand
English: Labelling efficiency
Danish: Kvalitetskontrol
English: At the chemical concentrations used for diagnostic examinations, gallium (68Ga) edotreotide does not appear to have any clinically relevant pharmacodynamic effect.
Danish: Farmakodynamisk virkning Ved de kemiske koncentrationer, der bruges ved diagnostiske undersøgelser, ser gallium (68Ga)
English: Contents of the vials are intended only for use in the preparation of gallium (68Ga) edotreotide solution for injection and are not to be administered directly to the patient without first undergoing the preparative procedure.
Danish: opløsning og må ikke administreres direkte til patienten uden forudgående forberedelsesprocedure.
English: After radiolabelling, store below 25°C.
Danish: Skal opbevares ved temperaturer under 25°C efter radioaktiv mærkning.
English: Name and address of the manufacturer responsible for batch release Gipharma S.r.l.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Danish: - Spørg den nuklearmedicinske læge, der har tilsyn med undersøgelsen, hvis der er mere, du vil vide.
English: edotreotide.
Danish: strimlen.
English: Other medicines and SomaKit TOC
Danish: Hvis du har fået for meget SomaKit TOC
English: Half-life Given that the elimination rate is substantially slower than the physical half-life of gallium (68Ga)
Danish: På grund af den lave pH (surt miljø) i injektionsvæsken med radioaktivt mærket gallium (68Ga)
English: What SomaKit TOC contains - The active substance is edotreotide.
Danish: SomaKit TOC indeholder følgende: - Aktivt stof: edotreotid Et hætteglas med pulver indeholder 40 mikrogram edotreotid.
English: • you are over 65 years of age
Danish: • er over 65 år
English: Your doctor will discuss this with you.
Danish: Det vil din læge tale med dig om.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEA´s medlemslande under følgende navne
English: Rapid development of symptoms including:
Danish: Hurtig udvikling af symptomer, herunder:
English: • seeing or hearing things that aren't there (hallucinations)
Danish: • ser eller hører ting, der ikke findes (hallucinationer)
English: Orion Corporation Orionintie 1
Danish: Finland Orion Corporation Orionintie 1
English: Adequate hydration should be maintained.
Danish: Tilstrækkelig hydrering skal opretholdes.
English: The CHMP found the new proposal acceptable.
Danish: CHMP fandt det nye forslag acceptabelt.
English: Specific documentation was submitted taking into account updated data.
Danish: Der blev fremlagt specifik dokumentation, som tog højde for opdaterede data.
English: Recommendations for use also show differences.
Danish: Anbefalinger vedrørende brug er også forskellige.
English: The level of information differs across Members States.
Danish: Informationsniveauet er forskelligt i medlemsstaterne.
English: Some Member States have recommendations of a higher dose than other member states in specific situations.
Danish: Nogle medlemsstater anbefaler en højere dosis end andre medlemsstater i konkrete tilfælde.
English: Member State EU/EEA
Danish: Medlemsstat EU/EE
English: The CHMP adopted a List of Questions on 20 November 2008 and other three Lists of outstanding issues.
Danish: CHMP vedtog den 20. november 2008 en liste med spørgsmål samt tre andre lister med uafklarede spørgsmål.
English: Valtrex is not usually harmful, unless you take too much over several days.
Danish: Valtrex er normalt uskadelig, medmindre du tager for meget i flere dage.
English: Similar type of data is presented but the level of factual detail varies significantly.
Danish: Der præsenteres sammenlignelige data, men det faktuelle detaljeringsniveau varierer betydeligt.
English: For maximum clinical benefit, the treatment should be started within 48 hours.
Danish: For at opnå maksimalt klinisk udbytte skal behandlingen påbegyndes inden for 48 timer.
English: Symptoms and Signs
Danish: Symptomer og tegn
English: These observations support safety of treatment of HSV in both groups although the possibility of increasing resistance should continuously be observed.
Danish: Disse observationer understøtter sikkerheden ved behandling af HSV i begge grupper, selvom muligheden for øget resistens hele tiden bør observeres.
English: The data were therefore not sufficient for subgroup analyses of efficacy and safety.
Danish: Dataene var derfor utilstrækkelige til undergruppeanalyser af effekt og sikkerhed.
English: This is important to prevent you passing the infection on to others.
Danish: Det er vigtigt for at forhindre, at du overfører infektionen til andre.
English: A recent metaanalysis (Lebrun-Vignes, 2007) provided additional supportive data for this indication.
Danish: En nylig metaanalyse (Lebrun-Vignes, 2007) gav yderligere data til støtte for denne indikation.
English: 169 29 Solna, Sweden
Danish: 169 29 Solna, Sverige
English: The extent of exposure in this population is difficult to quantify.
Danish: Det er vanskeligt at kvantificere omfanget af eksponering i denne population.
English: The duration of treatment will usually be 90 days, but may need to be extended in high-risk patients.
Danish: Behandlingsvarigheden er sædvanligvis 90 dage, men det kan være nødvendigt at forlænge denne hos højrisiko-patienter.
English: The reported adverse events (AEs) were listed events and no new and significant safety signals could be identified.
Danish: De rapporterede hændelser (AE'er) var listede hændelser, og der kunne ikke identificeres nye og signifikante sikkerhedssignaler.
English: Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Valtrex
Danish: Bulgarien, Cypern, Estland, Finland, Grækenland, Irland, Island, Letland, Litauen, Malta, Norge, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Østrig: Valtrex.
English: Nevertheless, given the relatively benign indication, a conservative approach might be appropriate to reduce the potential safety risk.
Danish: Som følge af den relativt benigne indikation kan en konservativ tilgang ikke desto mindre være passende for at reducere den potentielle sikkerhedsrisiko.
English: Nausea and vomiting may also occur.
Danish: Kvalme og opkastning kan også forekomme.
English: • Take this medicine by mouth.
Danish: • Tag medicinen gennem munden.
English: 105 Reykjavík, Iceland
Danish: 105 Reykjavík, Island
English: People over 65 years of age or with kidney problems
Danish: Personer over 65 år eller personer med nyreproblemer
English: • Swallow the tablets whole with a drink of water.
Danish: • Synk tabletterne hele sammen med lidt vand.
English: • confused or disturbed thoughts
Danish: • forvirrede eller forstyrrede tanker
English: Patients should be observed closely for signs of toxicity.
Danish: Patienter bør observeres nøje for tegn på toksicitet.
English: • Don't take a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Although rare, this is thought to be associated with high peak concentrations rather than AUC.
Danish: Dette er sjældent og menes at være associeret med høje peakkoncentrationer snarere end AUC.
English: The estimated daily AUCs are appreciably greater.
Danish: De estimerede, daglige AUC-værdier er væsentligt højere.
English: The dose that you should take will depend on why your doctor has prescribed Valtrex for you.
Danish: Den dosis, du skal tage, afhænger af, hvorfor din læge har ordineret Valtrex til dig.
English: Analysis of the published literature showed no new significant safety concerns for the babies or the mothers.
Danish: Analyser af den publicerede litteratur viste ingen nye signifikante betænkeligheder med hensyn til sikkerheden for spædbørn eller mødre.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALTREX AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN VIDENSKABELIGE VURDERING AF VALTREX OG TILKNYTTEDE NAVNE (SE BILAG I)
English: • fall in blood pressure leading to collapse.
Danish: • blodtryksfald, der kan føre til kollaps.
English: 82104 Bratislava
Danish: 82104 Bratislava Slovakiet
English: When using this dosing regimen, treatment should not exceed one day, since this has been shown not to provide additional clinical benefit.
Danish: Når dette doseringsregime anvendes, bør behandlingen ikke fortsætte i mere end 1 dag, da dette ikke har vist yderligere kliniske fordele.
English: Treatment should be re-evaluated after 6 to 12 months of therapy.
Danish: Behandlingen skal revurderes efter 6-12 måneders behandling.
English: It should be kept in mind that the modelling is based on some not very strong relationships, e.g. Cmax as a function of creatinine clearance.
Danish: Man skal huske, at modellen er baseret på nogle ikke særligt stærke relationer, f.eks. Cmax som funktion af kreatininclearance.
English: The conclusion summarises that the prevalence of aciclovir resistant HSV has not changed significantly during the last three decades.
Danish: Konklusionen opsummerer, at prævalensen af aciclovirresistent HSV ikke har ændret sig signifikant i de sidste tre årtier.
English: Caution is required to prevent inadvertent overdosing.
Danish: Der skal udvises forsigtighed for at undgå utilsigtet overdosering.
English: These data give confidence that the potential for development of resistance has not diminished the established benefit/risk profile of valaciclovir.
Danish: Disse data giver tillid til, at potentialet for udvikling af resistens ikke har mindsket valaciclovirs fastslåede benefit/risk-profil.
English: Uncommon side effects that may show up in blood tests:
Danish: Ikke almindelige bivirkninger, som måske viser sig i blodprøver:
English: 152 32 Halandri, Athens, Greece
Danish: 152 32 Halandri, Athens, Grækenland
English: The CHMP considered that only studies of limited size and unknown quality have been reported.
Danish: CHMP vurderede, at kun undersøgelser af begrænset størrelse og ukendt kvalitet er rapporteret.
English: Valtrex is not usually recommended for use during pregnancy.
Danish: Valtrex må normalt ikke anvendes under graviditet.
English: Dosing should begin as early as possible.
Danish: Behandlingen skal påbegyndes så hurtigt som muligt.
English: Several indications were not approved in all Member States, in particular for immunocompromised patients.
Danish: Flere indikationer var ikke godkendt i alle medlemsstater, især for immunkompromitterede patienter.
English: Based on the results of these two studies the International Herpes Management forum (IHMF) [Gilbert.
Danish: Ud fra resultaterne af disse to undersøgelser anbefaler International Herpes Management Forum (IHMF) [Gilbert.
English: • Do not use Valtrex after the expiry date which is stated on the carton.
Danish: • Brug ikke Valtrex efter den udløbsdato, der står på pakningen.
English: For recurrent episodes, treatment should be for three to five days.
Danish: Ved recidiverende episoder skal der behandles i 3 til 5 dage.
English: These studies were selected as most representative of the product safety profile for the general population exposed to valaciclovir and cover approximately 5855 subjects.
Danish: Disse undersøgelser er udvalgt som de mest repræsentative for produktsikkerhedsprofilen for den almindelige befolkning, som er eksponeret for valaciclovir, og dækker ca. 5855 personer.
English: Trading as;
Danish: Storbritannien Trading as;
English: 30 to 49 10 to 29
Danish: 30 til 49 10 til 29
English: For initial episodes, which can be more severe, treatment may have to be extended to ten days.
Danish: Ved initiale episoder, som kan være mere voldsomme, skal behandlingsvarigheden muligvis forlænges til 10 dage.
English: Creatinine clearance estimates were similar between treatments and between the two studies.
Danish: Kreatininclearanceestimater var sammenlignelige mellem behandlingerne og mellem de to undersøgelser.
English: The virulence of these variants resembles that of the wild-type virus.
Danish: Virulensen af disse varianter minder om vild-typens.
English: There are no data on treatment started more than 72 hours after onset of the zoster rash.
Danish: Der er ingen data for behandling, der er påbegyndt mere end 72 timer efter udbrud af zosterudslæt.
English: Viral resistance differs from a condition where the drug must not be given for safety reasons and a distinction is to be made between safety risks versus reduced efficacy.
Danish: Viral resistens adskiller sig fra en tilstand, hvor lægemidlet ikke må gives af sikkerhedsårsager, og der skal skelnes mellem sikkerhedsrisici kontra nedsat effekt.
English: Clinical response should be closely monitored in these patients.
Danish: Det kliniske respons skal monitoreres tæt hos disse patienter.
English: Valtrex belongs to a group of medicines called antivirals.
Danish: Valtrex tilhører en gruppe lægemidler, som kaldes antivirale lægemidler.
English: The areas of disharmony mainly pertain to sections 4.1, 4.2, 4.3 and 4.6 of the SPC.
Danish: De områder, der er uenighed om, vedrører hovedsageligt punkt 4.1, 4.2, 4.3 og 4.6 i produktresumeet.
English: Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.
Danish: En påvirkning af sådanne aktiviteter kan ikke forudsiges ud fra farmakologien af det aktive stof.
English: Creatinine Clearance (mL/min)
Danish: Kreatininclearance (ml/min)
English: /n.v., rue du Tilleul 13, B-1332 Genval, Belgium
Danish: /n.v., rue du Tilleul 13, B-1332 Genval, Belgien
English: The French guidelines recommend valaciclovir 1000 mg 3 times daily (TID) with close follow-up [Yeni, 2008].
Danish: De franske retningslinjer anbefaler valaciclovir 1000 mg 3 gange dagligt (TID) med tæt opfølgning [Yeni, 2008].
English: The Valtrex dosage should be adjusted accordingly.
Danish: Dosis af Valtrex skal justeres i overensstemmelse hermed.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: Indlægsseddel Information til brugeren
English: Some Member States have an additional contraindication for pregnancy and lactation.
Danish: Nogle medlemsstater har en yderligere kontraindikation for graviditet og amning.
English: The approved dosages were based on comparative estimates of systemic aciclovir exposure (Weller, 2000).
Danish: De godkendte doser var baseret på komparative estimater af systemisk aciclovireksponering (Weller, 2000).
English: Estimates for total area under the acyclovir concentrationtime curve (AUC) are also considered.
Danish: Der tages også hensyn til estimater for det samlede areal under aciclovirkoncentration-tid-kurven (AUC).
English: This will help to reduce side effects that can affect the kidney or nervous system.
Danish: Dette vil afhjælpe bivirkninger, der kan påvirke nyrerne eller nervesystemet.
English: The median aciclovir concentration in breast milk was 2.24 micrograms/ml (9.95 micromoles/L).
Danish: Den gennemsnitlige koncentration af aciclovir i brystmælk var 2,24 mikrogram/ml (9,95 mikromol/l).
English: GlaxoSmithKline agreed with the European Medicines Agency to harmonise the CMC quality data (Module 3) during this Article 30 referral.
Danish: GlaxoSmithKline aftalte med Det Europæiske Lægemiddelagentur at harmonisere CMC-kvalitetsdata (modul 3) under denne artikel 30-indbringelse.
English: This requirement for activation of aciclovir by a virusspecific enzyme largely explains its selectivity.
Danish: Dette krav om aktivering af aciclovir ved hjælp af et virusspecifikt enzym forklarer i høj grad dets selektivitet.
English: • You should take Valtrex for seven days.
Danish: • Du skal tage Valtrex i 7 dage.
English: Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster.
Danish: Patienter skal rådes til at indlede behandlingen så tidligt som muligt, efter diagnosen herpes zoster er stillet.
English: • You should take Valtrex for one day (two doses) only.
Danish: • Du skal kun tage Valtrex i én dag (to doser).
English: In situations where there were different incidences across studies, the most conservative approach was taken i.e. frequency category was based on the higher incidence.
Danish: I situationer, hvor der var forskellige incidenser i undersøgelserne, anvendte man den mest konservative tilgang, dvs. hyppighedskategorien blev baseret på den højere incidens.
English: The incidence of aciclovir resistance is stable, has not changed in the nearly three decades aciclovir has been available, and is not different between treated patients and untreated subjects.
Danish: Incidensen af aciclovirresistens er stabil, har ikke ændret sig i de næsten tre årtier, hvor aciclovir har været tilgængelig, og er ikke forskellig hos behandlede patienter og ubehandlede personer.