FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og darunavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: Tablet core
Danish: Tabletbeholderen
English: Cmax: ↓ 41% (↓ 51 to ↓ 29)
Danish: AUC: ↓ 29% (↓ 36 til ↓ 22) Cmax: ↓ 41% (↓ 51 til ↓ 29)
English: When using emtricitabine/tenofovir for pre-exposure prophylaxis individuals should be reassessed at each visit to ascertain whether they remain at high risk of HIV-1 infection.
Danish: Personer bør genevalueres ved hvert besøg for at bestemme, om de har en vedvarende høj risiko for HIV 1-infektion, når de anvender emtricitabine/tenofovir til profylakse før eksponering.
English: How to store Emtricitabine/Tenofovir disoproxil Krka
Danish: Sådan skal De tage Emtricitabine/Tenofovir disoproxil Krka
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og atazanavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede
English: Lamivudine/Tenofovir disoproxil Lamivudine: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12) Cmin: NC
Danish: AUC: ↓ 3% (↓ 8 til ↑ 15) Cmax: ↓ 24% (↓ 44 til ↓ 12) Cmin: IB
English: Blisters
Danish: Blistere
English: Section 4.4 “Special warnings and precautions for use” “The maximum recommended daily dose should not be exceeded (see section 4.2).”
Danish: Afsnit 4.4 “Særlige advarsler og forsigtighedsregler vedrørende brugen” ”Den maksimale dagsdosis bør ikke overskrides (se pkt.
English: Amendments to the Summary of Product Characteristics and Package Leaflet for all somatropin medicinal products:
Danish: Ændringer af produktresuméet og indlægssedlen for alle lægemidler indeholdende somatropin:
English: Section 4.3 “Contraindications” “Somatropin must not be used when there is any evidence of activity of a tumour.
Danish: Afsnit 4.3 ”Kontraindikationer” “Somatropin må ikke anvendes ved tegn på tumoraktivitet.
English: Treatment should be discontinued if there is evidence of tumour growth.”
Danish: Behandlingen skal seponeres ved tegn på tumorvækst.”
English: Before you use <(Invented) name of the product> Do not use <(Invented) name of the product> and tell your doctor if you have an active tumour (cancer).
Danish: Det skal du vide om <produktets (sær)navn> Sig det til lægen, hvis du har en aktiv tumor (kræft).
English: Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy.
Danish: Intrakranielle tumorer skal være inaktive og antitumorbehandling gennemført, før patienten sættes i behandling med væksthormon.
English: Amendments to the Summaries of Product Characteristics and Package Leaflets
Danish: Bilag III Ændringer af produktresuméerne og indlægssedlerne
English: Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with <(Invented) name of the product>.
Danish: Før du bliver sat i behandling med <produktets (sær)navn>, skal tumorer være inaktive, og du skal have gennemført din antitumorbehandling.
English: This should be taken into consideration when using the following information.
Danish: Dette skal tages i betragtning ved brug af følgende oplysninger.
English: Non-clinical data on the cold compound (non-radioactive lutetium (
Danish: Ikke-kliniske data om koldforbindelsen (ikke-radioaktivt lutetium (
English: This happens in many patients and is frequently temporary.
Danish: Dette sker hos mange patienter og er ofte midlertidigt.
English: The following checking should be carried out every week, for the next 10 weeks:
Danish: Efterfølgende kontrol skal udføres hver uge i de næste 10 uger:
English: People who need extra assistance
Danish: Personer der har brug for ekstra assistance
English: However, you must adhere to the following rules to maximize the safety of other persons.
Danish: Du skal dog overholde følgende regler for at maksimere andres sikkerhed.
English: Toilets must be used in a seated position, even for men.
Danish: Toiletter skal bruges i en siddende stilling, selv for mænd.
English: It is absolutely necessary to use toilet paper each time.
Danish: Det er absolut nødvendigt at bruge toiletpapir hver gang.
English: 20 to 30 minutes
Danish: 20-30 minutter
English: This is the only parameter to determine the procedure completion.
Danish: Dette er det eneste parameter til bestemmelse af en fuldført procedure.
English: It is helpful to estimate the effective dose that was applied.
Danish: Det kan være nyttigt at estimere den effektive dosis, der blev anvendt.
English: Use of toilets
Danish: Brug af toiletter
English: The final OS analysis is foreseen after 158 cumulative deaths.
Danish: Den endelige OSanalyse forventes efter 158 kumulative dødsfald.
English: • Brief introduction to the treatment and the administration procedure
Danish: • Kort introduktion til behandlingen og administrationsproceduren
English: It is also important to wash your hands to avoid contaminating the door handles.
Danish: Det er også vigtigt at vaske dine hænder for at undgå at forurene dørhåndtagene.
English: N: number of patients, CI: confidence interval.
Danish: N: antal patienter, CI: konfidensinterval.
English: These rules are the result of many years of experience in the use of radioactivity in medicine, and they include recommendations issued by international organizations.
Danish: Disse regler er resultatet af mange års erfaring inden for radioaktivitet i medicin, og de indeholder anbefalinger udstedt af internationale organisationer.
English: The minimum laboratory tests needed before each infusion are:
Danish: Det mindste antal påkrævede laboratorietests før hver infusion er:
English: Between 18 and 24 g
Danish: Mellem 18 og 24 g
English: If your partner is pregnant, extend this time to 15 days.
Danish: Hvis din partner er gravid, forlænges denne perioder til 15 dage.
English: The patient guide shall contain the following key elements:
Danish: Patientvejledningen skal indeholde følgende nøglelementer:
English: The safety and efficacy of this medicine has not yet been established in children and adolescents under 18 years of age.
Danish: Sikkerheden og effekten af dette lægemiddel er endnu ikke blevet fastslået hos børn og unge under 18 år.
English: The doctor will inform you when you can leave the controlled area or the hospital.
Danish: Lægen vil informere dig, når du kan forlade det kontrollerede område eller hospitalet.
English: Talk to your nuclear medicine doctor if you are under 18 years old.
Danish: Tal med din nuklearmedicinske læge, hvis du er under 18 år.
English: Follow your doctor's advice on how much fluid to drink.
Danish: Følg din læges råd om, hvor meget væske du skal drikke.
English: The use of television monitor systems to monitor the patients is recommended.
Danish: Brug af tv-overvågningssystemer til overvågning af patienterne anbefales.
English: The measurements should be performed using a calibrated system.
Danish: Målingerne skal udføres ved hjælp af et kalibreret system.
English: Most patients were Dutch (811) with the remaining (403) residents of various European and non-European countries.
Danish: De fleste patienter var hollandske (811) og de resterende (403) var indbyggere i forskellige europæiske og ikke-europæiske lande.
English: The average beta energy is approximately 0.13 MeV.
Danish: Den gennemsnitlige betaenergi er ca. 0,13 MeV.
English: Given the half-life of 177Lu it is specially recommended to avoid internal contamination.
Danish: På baggrund af halveringstiden for 177Lu anbefales det specielt at undgå intern forurening.
English: Therefore, it is recommended to monitor those patients more frequently during the treatment.
Danish: Det anbefales derfor at monitorere sådanne patienter hyppigere under behandlingen.
English: 1.5 L to 2.2 L
Danish: 1,5 l til 2,2 l
English: These tests should be performed at least once within 2 to 4 weeks prior to administration and shortly before the administration.
Danish: Disse tests skal foretages mindst én gang inden for 2-4 uger før administration og kort tid efter administration.
English: • Medicinal products to be administered:
Danish: • Lægemidler, der skal administreres:
English: It is also recommended to record the time of extravasation and the estimated volume extravasated.
Danish: Det anbefales også at notere tidspunktet for ekstravasation og den estimerede ekstravaserede volumen.
English: However, in rare cases the decrease in blood cells may be long standing and/or permanent.
Danish: Men i sjældne tilfælde kan faldet i blodlegemer være langvarigt og/eller permanent.
English: Symptoms, especially inflammation and/or pain, should be treated.
Danish: Symptomer, herunder inflammationer og/eller smerter, bør behandles.
English: Volume: {Y} mL
Danish: Volumen: {Y} ml
English: Considering current knowledge and experience in this field and the physical and pharmaceutical properties of the medicine, it is estimated that the health risks to your family members and the general public are low.
Danish: På baggrund af den nuværende viden og erfaring på dette område og medicinens fysiske og farmaceutiske egenskaber vurderes det, at sundhedsrisikoen for dine familiemedlemmer og offentligheden er lav.
English: You do not need to use bleach and do not need extra rinses.
Danish: Du behøver ikke bruge blegemiddel og behøver ikke ekstra skylninger.
English: • Administration room:
Danish: • Administrationsrum:
English: Patients with risk factors
Danish: Patienter med risikofaktorer
English: Mutagenicity studies und long-term carcinogenicity studies have not been carried out.
Danish: Mutagenicitetsundersøgelser og langvarige carcinogenicitetsundersøgelser er ikke udført.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1226/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1226/001
English: This preparation is likely to result in a relatively high radiation dose to most patients.
Danish: Dette præparat vil sandsynligvis resultere i en forholdsvis høj stråledosis til de fleste patienter.
English: Patients should sleep in a separate bedroom for 7 days, what should be extended to 15 days in case of pregnant partners or children.
Danish: Patienterne skal sove i et separat soveværelse i 7 dage, hvilket skal forlænges til 15 dage for gravide partnere eller børn.
English: The administration of 7,400 MBq may result in significant environmental hazard.
Danish: Indgivelsen af 7.400 MBq kan medføre betydelig miljøfare.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs hele denne indlægsseddel grundigt, inden De får dette lægemiddel, da den indeholder vigtige oplysninger til dig.
English: A member of the hospital staff will tell you how and when to get rid of these trash bags.
Danish: Et medlem af hospitalspersonalet vil fortælle dig, hvordan og hvornår du skal bortskaffe affaldet.
English: This includes the handling of any materials possibly contaminated with urine.
Danish: Dette omfatter håndtering af materialer, der eventuelt er forurenet med urin.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
Danish: Den administrerede aktivitet skal i alle tilfælde være så lav som rimeligt muligt for at opnå den nødvendige terapeutiske virkning.
English: Total Body *n=11 (male patients only) **n=9 (female patients only)
Danish: Hele kroppen *n = 11 (kun mandlige patienter) **n = 9 (kun kvindelige patienter)
English: Furthermore, drink frequently and try to urinate every hour on the day you received treatment and on the day after.
Danish: Desuden skal du drikke ofte og forsøge at urinere hver time på dagen du modtog behandling samt dagen efter.
English: 72 hours from the date and time of calibration.
Danish: 72 timer fra kalibreringstidspunktet og -datoen.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Danish: Din nuklearmedicinske læge vil oplyse dig om den normale varighed af proceduren.
English: Start time (min)
Danish: Starttidspunkt (min)
English: DoR (months)
Danish: DoR (måneder)
English: The extravasation area should be delimited with an indelible pen and a picture should be taken if possible.
Danish: Ekstravasationsområdet skal afgrænses med en uudslettelig pen, og et billede skal tages, om muligt.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Danish: ENTYDIG IDENTIFIKATOR - 2D STREGKODE Ikke relevant.
English: Lutathera will only be used in special controlled areas.
Danish: Lutathera vil kun blive anvendt i særlige, kontrollerede områder.
English: (not < 320 mL/h for commercial solutions)
Danish: (ikke < 320 ml/t for kommercielle opløsninger)
English: Low gamma energy is also emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Danish: Der udsendes også lav gammaenergi, f.eks. ved 113 keV (6,2 %) og 208 keV (11 %).
English: Clinical experience has not identified differences in responses between the elderly and younger patients.
Danish: Klinisk erfaring har ikke identificeret forskelle i reaktioner på behandling med dette lægemiddel hos hhv. ældre og yngre patienter.
English: Dosing may need to be modified based on the tests results.
Danish: Det vil muligvis være nødvendigt at modificere doseringen baseret på testresultaterne.
English: Due to the radiation emitted by this medicine, during the administration procedure, you should be isolated from other patients who are not receiving the same treatment.
Danish: På grund af den stråling, der udledes af dette lægemiddel under administrationsproceduren, skal du være isoleret fra andre patienter, som ikke får den samme behandling.
English: Administration procedure (gravity method)
Danish: Administrationsprocedure (gravitationsmetode)
English: Liver toxicity defined as either:
Danish: Levertoksicitet defineret som enten:
English: The main analysis has been conducted on 811 Dutch patients with different somatostatin receptor positive tumour types.
Danish: Hovedanalysen er blevet udført på 811 hollandske patienter med forskellige somatostatinreceptorpositive tumortyper.
English: This will allow quick identification of new safety information.
Danish: Dette giver mulighed for hurtig identifikation af nye sikkerhedsoplysninger.
English: Suitable precautions in accordance with national regulations should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
Danish: Der skal træffes passende forholdsregler i overensstemmelse med de nationale bestemmelser vedrørende aktiviteten elimineret af patienterne for at undgå forurening.
English: Contact your nuclear medicine doctor if you have any questions.
Danish: Kontakt din nuklearmedicinske læge, hvis du har spørgsmål.
English: The medicine infusion takes 20 to 30 minutes; but the complete administration procedure will take approximately 5 hours.
Danish: Lægemiddelinfusionen tager 20 til 30 minutter, men den komplette indgivelsesprocedure vil tage cirka 5 timer.
English: Please see Table 5 in case of dose modifying toxicity.
Danish: Se Tabel 5 i tilfælde af dosismodificerende toksicitet.
English: The extravasation area must be monitored until the patient is discharged from the hospital.
Danish: Ekstravasationsområdet skal monitoreres, indtil patienten udskrives fra hospitalet.
English: Before the use of Lutathera, pregnancy should be excluded using an adequate/validated test.
Danish: Før brug af Lutathera bør graviditet udelukkes ved anvendelse af en tilstrækkelig/valideret test.
English: The surface dose rates and the accumulated dose depend on many factors.
Danish: Overdoseringshastighederne og den akkumulerede dosis afhænger af mange faktorer.
English: It is necessary to wear waterproof gloves and suitable aseptic techniques when handling the medicinal product.
Danish: Det er nødvendigt at bære vandtætte handsker og egnede aseptiske teknikker ved håndtering af lægemidlet.
English: This medicinal product is not intended for regular or continuous administration.
Danish: Dette lægemiddel er ikke beregnet til regelmæssig eller kontinuerlig indgift.
English: Colleretto Giacosa (TO) Italy
Danish: Colleretto Giacosa (TO) Italien
English: The mean age of patients enrolled in the study was 58.4 years.
Danish: Den gennemsnitlige alder på deltagende patienter i studiet var 58,4 år.
English: Room and equipment preparation:
Danish: Rum- og udstyrsforberedelse:
English: • Bilirubinemia > 3 times the upper limit of normal,
Danish: • Bilirubinemi > 3 gange den øvre normalgrænse,
English: Demographics as well as patients and disease characteristics were very balanced between groups with median age of 64 years and 82.1% Caucasian in the general population.
Danish: Demografi samt patienter og sygdomsegenskaber var meget afbalancerede mellem grupper med medianalder på 64 år og 82,1 % kaukasiere i populationen generelt.
English: Leukopenia5 Neutropenia6
Danish: Leukopeni5 Neutropeni6
English: In all cases it is necessary to ensure that the risks of the radiation exposure are less than from the disease itself.
Danish: I alle tilfælde er det nødvendigt at sikre, at risikoen ved strålingseksponering er mindre end fra selve sygdommen.
English: The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT) (see Table 5).
Danish: Det anbefalede interval imellem hver administration er 8 uger, hvilket kan forlænges til op til 16 uger i tilfælde af dosismodificerende toksicitet (DMT) (se Tabel 5).
English: After administration of Lutathera
Danish: Efter administration af Lutathera
English: No additional medicinal product can be administered to the same side where the extravasation occurred.
Danish: Der kan ikke administreres andre lægemidler i den samme side, hvori der er foretaget ekstravasation.
English: • Previous chemotherapy;
Danish: • Tidligere kemoterapi;
English: To facilitate that, carry your discharge letter with you at all times.
Danish: For at lette dette, skal du altid medbringe dit udskrivningsbrev.
English: The solution should be visually inspected for damage and contamination before use, and only clear solutions free of visible particles should be used.
Danish: Opløsningen skal inspiceres visuelt for beskadigelse og forurening før brug, og kun klare opløsninger, der er fri for synlige partikler, bør anvendes.
English: In consequence, your doctor will ask you to have regular blood tests in order to check your eligibility for this treatment and to detect any side effects as early as possible.
Danish: Som følge heraf vil din læge bede dig om regelmæssige blodprøver for at kontrollere, om du er egnet til denne behandling samt for at opdage eventuelle bivirkninger så tidligt som muligt.
English: • History of other malignant tumours unless the patient is considered to be in remission for at least 5 years.
Danish: • Anamnese med ondartede tumorer, medmindre patienten betragtes som værende i bedring og har været det i mindst 5 år.
English: Octreotide LAR
Danish: Octreotid LAR
English: PFS differed significantly (p<0.0001) between the treatment groups.
Danish: PFS var signifikant forskellig (p<0.0001) mellem behandlingsgrupperne.
English: Somatostatin and its analogues competitively bind to somatostatin receptors.
Danish: Somatostatin og dets analoger binder kompetitivt til somatostatinreceptorer.
English: During 7 days after Lutathera administration: - Sleep in separate beds at a distance of at least 1 meter.
Danish: I 7 dage efter administration af Lutathera: - Sov i separate senge i en afstand på mindst 1 meter.
English: Radioprotection rules
Danish: Strålebeskyttelsesregler
English: Anaemia4
Danish: Anaæmi4
English: Lutathera is contraindicated in pregnant women.
Danish: Lutathera er kontraindiceret hos gravide kvinder.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA Ikke relevant
English: All*
Danish: Alle*
English: Other side effects include: nausea and vomiting (usually during the first 24 hours) and decreased appetite.
Danish: Andre bivirkninger omfatter: Kvalme og opkastning (normalt inden for de første 24 timer) og nedsat appetit.
English: Depending upon its seriousness, this event should be declared as an adverse reaction.
Danish: Afhængigt af alvoren, skal en sådan hændelse indberettes som en bivirkning.
English: Absorption The medicinal product is administered intravenously and is immediately and completely bioavailable.
Danish: Absorption Lægemidlet indgives intravenøst og er umiddelbart og fuldstændigt biotilgængeligt.
English: A risk to the suckling child associated with ionising radiation cannot be excluded.
Danish: En risiko for det ammende barn i forbindelse med ioniserende stråling kan ikke udelukkes.
English: Possible delayed (> first 24 hours) side effects of the radiation include fatigue.
Danish: Mulige forsinkede (> 24 timer) bivirkninger efter strålingen omfatter træthed.
English: • Severe heart failure defined as class III or IV in the NYHA classifications;
Danish: • Alvorlig hjerteinsufficiens defineret som klasse III eller IV i NYHA-klassificeringer;
English: A summary of side effects is given below by order of frequency:
Danish: Et resumé af bivirkninger er angivet nedenfor efter hyppighed:
English: • Previous external beam radiotherapy involving more than 25% of the bone marrow;
Danish: • Tidligere ekstern strålebehandling, der involverer mere end 25 %af knoglemarven;
English: Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff.
Danish: Målinger på stedet og under arbejdet er kritiske og bør praktiseres for mere præcis og lærerig bestemmelse af den samlede strålingsdosis til personalet.
English: Frequency of adverse reactions reported from clinical trials and from post-marketing surveillance
Danish: Hyppighed af bivirkninger rapporteret fra kliniske forsøg og overvågning efter markedsføring
English: Ionizing radiations of the medicine may potentially decrease your fertility.
Danish: Ioniserende stråling af medicinen kan potentielt nedsætte din fertilitet.
English: You might be asked to bring the bag back to your treatment facility, or, after 70 days, the bag may be removed as the other household waste.
Danish: Du kan blive bedt om at medbringe posen til hospitalet, eller efter 70 dage kan posen fjernes sammen med andet husholdningsaffald.
English: Lutetium (177Lu) has a half-life of 6.647 days.
Danish: Lutetium (177Lu) har en halveringstid på 6,647 dage.
English: The infusion of the medicinal product must be immediately ceased and the administration device (catheter, etc.) removed.
Danish: Infusionen af lægemidlet skal standses med det samme, hvorefter alle administrationsanordninger (kateter osv.) skal fjernes.
English: People who are confined to the bed or have reduced mobility will preferably receive assistance by a care provider.
Danish: Personer, der er sengeliggende eller har nedsat mobilitet, modtager fortrinsvis assistance fra plejepersonale.