FrancophonIA/ELRC3.0 huggingface dataset:
English: Split influenza virus*, inactivated containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A).......................................3.8 micrograms**
Danish: Split influenzavirus*, inaktiveret indeholdende antigen svarende til: A/Californien/7/2009 (H1N1)-lignende stamme (NYMC X-179A)...............................................30 µg**
English: - One pack of 10 vials (type I glass) of 4.5 ml emulsion (adjuvant) with stopper (chlorobutyl).
Danish: - En pakke med 10 hætteglas (type I-glas), hver indeholdende 4,5 ml emulsion (adjuvans) med
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL (ANTIGEN)
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: HUMENZA consists of 2 separate vials: - One vial containing the antigen (suspension) - One vial containing the adjuvant (emulsion)
Danish: HUMENZA består af 2 forskellige hætteglas: - Et hætteglas med antigen (suspension) - Et hætteglas med adjuvans (emulsion)
English: In an open-label clinical trial, two doses (0.5 ml) of HUMENZA have been administered at a 3-week interval in 50 children from 3 to 8 years of age and 49 adolescents from 9 to 17 years of age.
Danish: To doser (0,5 ml) HUMENZA blev indgivet til 50 børn mellem 3 og 8 år og til 49 unge mellem 9 og 17 år med tre ugers mellemrum i en åben klinisk undersøgelse.
English: Total enrolled subjects N= 29
Danish: Inkludere de forsøgsper soner i alt N= 29
English: Very common: feeling generally unwell, muscular pain, shivering, fever.
Danish: Meget almindelig: følelse af generelt ubehag, muskelsmerter, kulderystelser, feber.
English: HUMENZA consists of two vials: one vial containing the antigen (suspension) and one vial containing the adjuvant (emulsion), which are mixed prior to use.
Danish: HUMENZA består af to hætteglas: Det ene glas indeholder antigen (suspension), og det andet glas indeholder adjuvans (emulsion), som sammenblandes inden indgivelse.
English: Common: feeling generally unwell, shivering, fever.
Danish: Almindelig: følelse af generelt ubehag, kulderystelser, feber.
English: Excipients: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Danish: Hjælpestoffer: natriumklorid, kaliumklorid, dinatriumfosfatdihydrat, kaliumdihydrogenfosfat og vand til injektioner.
English: Seroconversion rate** % [95% CI]
Danish: Serokonversionsrate** % [95 % KI]
English: Seronegative subjects prior to vaccination N= 1
Danish: Seronegative forsøgsperson er før vaccination N= 1
English: Total enrolled subjects N= 7
Danish: Inkludere de forsøgsper soner i alt N= 7
English: After mixing, the vaccine is a white opaque emulsion.
Danish: Den færdigblandede vaccine er en hvidlig emulsion.
English: Children from 3 years of age, adolescents and adults up to 60 years of age: One dose of 0.5 ml at an elected date.
Danish: Børn fra 3 år, unge og voksne op til 60 år:
English: Regarding unsolicited reactions after any vaccination, injection site warmth (4%) was reported in children from 3 to 8 years of age and oropharyngeal pain (6.1%) was reported in adolescents from 9 to 17 years of age.
Danish: Varme på injektionsstedet (4 %) blev rapporteret som spontan bivirkning efter enhver vaccination hos børn mellem 3 og 8 år.
English: Seroconversion factor*** [95% CI] * Proportion of subjects achieving a post-vaccination titer ≥1:40 ** For subjects with a pre-vaccination titer <1:10, proportion of subjects with a post-vaccination titer ≥1:40 and for subjects with a pre-vaccination titer ≥1:10, proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer *** Geometric mean of individual ratios (post-/pre-vaccination titers)
Danish: Serokonversionsfaktor*** % [95 % KI] * Andel af forsøgspersoner, som opnåede en titer efter vaccination ≥ 1:40 ** Andel af forsøgspersoner med en titer inden vaccination < 1:10, som havde en titer efter vaccination ≥1:40, og andel af forsøgspersoner med en titer inden vaccination ≥ 1:10, som havde en ≥ firedobbelt stigning af titer fra før til efter vaccination *** Geometrisk gennemsnit af individuelle forhold (titre før og efter vaccination)
English: Seronegative subjects prior to vaccination N= 14
Danish: Seronegative forsøgsperson er før vaccination N= 14
English: For instructions for preparation, see section 6.6.
Danish: For instruktioner vedrørende forberedelse af vaccinen, se pkt.
English: Seronegative subjects prior to vaccination N= 7
Danish: Seronegative forsøgsperson er før vaccination N= 7
English: * Proportion of subjects achieving a post-vaccination titer ≥1:40 ** For subjects with a pre-vaccination titer <1:10, proportion of subjects with a post-vaccination titer ≥1:40 and for subjects with a pre-vaccination titer ≥1:10, proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer *** Geometric mean of individual ratios (post-/pre-vaccination titers)
Danish: * Andel af forsøgspersoner, som opnåede en titer efter vaccination ≥ 1:40 ** Andel af forsøgspersoner med en titer inden vaccination < 1:10, som havde en titer efter vaccination ≥ 1:40, og andel af forsøgspersoner med en titer inden vaccination ≥ 10, som havde en ≥ firedobbelt stigning af titer fra før til efter vaccination *** Geometrisk gennemsnit af individuelle forhold (titre før og efter vaccination)
English: The vaccine is of a white opaque emulsion appearance.
Danish: Vaccinen er en hvidlig emulsion.
English: A second dose of vaccine should be given after an interval of at least three weeks.
Danish: En anden dosis af vaccinen bør gives mindst tre uger efter den første dosis.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Malaise
Danish: Utilpashed
English: At the injection site: pain, redness, swelling, bruising, hardness.
Danish: På injektionsstedet: smerter, rødmen, hævelse, hårdhed.
English: At the injection site: hardness, redness, swelling, bruising.
Danish: På injektionsstedet: hårdhed, rødmen, hævelse, blå mærker.
English: SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
English: At the injection site: pain, redness, hardness, swelling.
Danish: På injektionsstedet: smerter, rødmen, hårdhed, hævelse.
English: Common: injection site bruising, vomiting, cough.
Danish: Almindelig: blå mærker på injektionsstedet, opkastning, hoste.
English: - If you have any further questions, ask your doctor or nurse.
Danish: - Spørg lægen eller sygeplejersken eller på apoteket, hvis der er mere, du vil vide.
English: Date of first authorisation: 25 February 2013 Date of latest renewal: 10 November 2017
Danish: Dato for første markedsføringstilladelse: 25. februar 2013 Dato for seneste fornyelse: 10. november 2017
English: Together you will decide how to continue.
Danish: I vil sammen beslutte,
English: An updated RMP shall be submitted annually until renewal.
Danish: En opdateret RMP skal fremsendes årligt indtil forlængelse.
English: During pivotal trials the greatest improvement was observed within the first 4 weeks.
Danish: I pivotale forsøg sås den største forbedring inden for de første fire uger.
English: The estimated volume of distribution (Vd/F) is approximately 3200 l.
Danish: Det estimerede fordelingsvolumen (Vd/F) er ca. 3200 l.
English: Elderly patients (≥65 years of age)
Danish: Ældre patienter (≥65 år)
English: EU/1/12/815/001 7 tablets EU/1/12/815/002 14 tablets EU/1/12/815/003 28 tablets EU/1/12/815/004 42 tablets EU/1/12/815/005 98 tablets EU/1/12/815/006 49 tablets
Danish: EU/1/12/815/001 7 tabletter EU/1/12/815/002 14 tabletter EU/1/12/815/003 28 tabletter EU/1/12/815/004 42 tabletter EU/1/12/815/005 98 tabletter EU/1/12/815/006 49 tabletter
English: 1 year study
Danish: 1-årig undersøgelse
English: A high level of alcohol consumption is associated with an increased risk of health and social problems.
Danish: Et stort alkoholforbrug er forbundet med en øget risiko for problemer med helbredet og sociale problemer.
English: This change is considered unlikely to be of clinical relevance.
Danish: Det er usandsynligt, at denne ændring har klinisk relevans.
English: There are no or limited data (fewer than 300 pregnancy outcomes) from the use of nalmefene in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (færre end 300 graviditeter) fra anvendelse af nalmefen til gravide kvinder.
English: - You should take the tablet 1-2 hours before you start drinking alcohol.
Danish: • Du skal tage tabletten 1-2 timer, før du begynder at drikke alkohol.
English: Alcohol dependence occurs when a person has a physical or psychological dependence on the consumption of alcohol.
Danish: Der er tale om alkoholafhængighed, når en person har en fysisk eller psykisk afhængighed af indtagelse af alkohol.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: Meget almindelige (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1.000), meget sjældne (<1/10.000) eller ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: Libido decreased (including loss of libido)
Danish: Nedsat libido (inklusive tab af sexlyst)
English: Table 1 Frequencies of adverse reactions System Organ Class
Danish: Tabel 1 Hyppigheden af bivirkningerne Systemorganklasse
English: In this post hoc population, the treatment effect was larger than that in the total population.
Danish: Hos denne post-hoc population var behandlingseffekten større end behandlingseffekten hos den samlede population.
English: Responder analyses of the pooled data from the two studies are provided in Table 2.
Danish: Respondentanalyser af de samlede data fra de to undersøgelser er vist i Tabel 2.
English: The film-coated tablet should be swallowed whole.
Danish: Den filmovertrukne tablet skal synkes hel.
English: DK-2500 Valby Denmark
Danish: DK-2500 Valby Danmark
English: No unusual pattern of adverse reactions was observed in these settings, but experience is limited.
Danish: Der er ikke set usædvanlige bivirkningsmønstre i disse sammenhænge, men der er begrænset erfaring.
English: In some cases, it may be difficult for you to distinguish side effects from the symptoms you may feel when you reduce your alcohol consumption.
Danish: I nogle tilfælde kan det være svært at skelne mellem bivirkninger og de symptomer, du kan få, når du nedsætter dit alkoholforbrug.
English: Thereafter, the patient should be asked to record his or her alcohol consumption for approximately two weeks.
Danish: Lægen bør derefter bede patienten om at notere sit alkoholforbrug i ca. to uger.
English: Nalmefene Odds Ratio (95% CI) p-value
Danish: Nalmefen Odds ratio (95% CI) p-værdi
English: The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.
Danish: Den øgede selvmordsrisiko hos alkohol- og stofmisbrugere, med eller uden medfølgende depression, reduceres ikke ved indtagelse af nalmefen.
English: The maximum dose of Selincro is one tablet per day.
Danish: Den maksimale dosis Selincro er én tablet dagligt.
English: The tablet is engraved with ‘S' on one side.
Danish: Tabletten er præget med ”S” på den ene side af tabletten.
English: At randomisation, these patients consumed such a small amount of alcohol that there was little room for further improvement (floor effect).
Danish: Ved randomiseringen indtog disse patienter en så lille mængde alkohol, at der kun var en meget lille mulighed for yderligere reduktion ('floor effect').
English: This effect was considered to be an indirect effect related to toxicity to the dams.
Danish: Dette ansås for at være en indirekte virkning relateret til toksicitet hos moderdyret.
English: Selincro should not be used in children or adolescents below the age of 18 years because Selincro has not been tested in this age group.
Danish: Selincro må ikke bruges til børn eller unge under 18 år, fordi Selincro ikke er afprøvet i denne aldersgruppe.
English: Your doctor will provide you with counselling to help you keep to your treatment and thereby reduce your alcohol consumption.
Danish: Din læge vil yde rådgivning for at hjælpe dig med at følge din behandling og derved nedsætte dit alkoholforbrug.
English: - You can expect to be able to reduce your alcohol consumption within the first month after you start treatment with Selincro.
Danish: • Du kan forvente at kunne nedsætte dit alkoholforbrug i løbet af den første måned, efter at du er begyndt på behandlingen med Selincro.
English: Overall, the studies included 1,941 patients, 1,144 of whom were treated with Selincro 18 mg as-needed.
Danish: Undersøgelserne inkluderede i alt 1.941 patienter, hvoraf 1.144 blev behandlet med 18 mg Selincro efter behov.
English: If you are going to have a surgical procedure, talk to your doctor at least 1 week before the procedure.
Danish: Hvis du skal opereres, skal du tale med din læge mindst én uge inden operationen.
English: Patients with severe renal impairment (eGFR <30 ml/min per 1.73 m
Danish: Patienter med svært nedsat nyrefunktion (eGFR <30 ml/min pr. 1,73 m
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at rapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Patients with severe hepatic impairment (Child-Pugh classification).
Danish: Patienter med svært nedsat leverfunktion (Child-Pugh klassifikation).
English: Opioid administration
Danish: Administration af opioid
English: Reduction of alcohol consumption is an intermediate goal on the way to abstinence.
Danish: En reduktion af alkoholforbruget er et delmål hen imod afholdenhed.
English: If you believe you have taken too many Selincro tablets, contact your doctor or pharmacist.
Danish: Hvis du tror, du har taget for mange Selincro tabletter, skal du kontakte din læge eller apoteket.
English: The average protein-bound fraction of nalmefene in plasma is approximately 30%.
Danish: Nalmefens gennemsnitlige proteinbundne fraktion i plasma er ca. 30%.
English: Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies.
Danish: Der er indberettet konfusion og sjældent tilfælde af hallucinationer og dissociation i de kliniske undersøgelser.
English: If you feel detached from yourself, see or hear things that are not there, and this continues to recur for more than a few days, stop taking Selincro and talk to your doctor.
Danish: Hvis du føler dig ved siden af dig selv eller ser og hører ting, som ikke er der, og det gentager sig i mere end et par dage, skal du holde op med at tage Selincro og tale med din læge.
English: Nalmefene does not exhibit any substantial pharmacokinetic differences between sexes, between young and elderly, or between ethnic groups.
Danish: Nalmefen udviser ingen væsentlige farmakokinetiske forskelle mellem kønnene, mellem unge og ældre eller mellem etniske grupper.
English: - You can take Selincro with or without food.
Danish: • Du kan tage Selincro med eller uden mad.
English: If opioids are needed in an emergency, the dose must always be titrated individually.
Danish: Hvis der er brug for behandling med et opioid i en nødsituation, skal dosis altid titreres individuelt.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in alcohol dependence; ATC code: N07BB05
Danish: Farmakoterapeutisk klassifikation: Centralnervesystemet, øvrige lægemidler - lægemidler til alkoholafhængighed, ATC-kode: N07BB05
English: The physician should continue to assess the patient's progress in reducing alcohol consumption, overall functioning, treatment adherence, and any potential side effects.
Danish: Lægen skal fortsat vurdere patientens fremskridt i forhold til reduktion af alkoholforbruget, patientens generelle funktionsevne, overholdelse af behandlingen og evt. mulige bivirkninger.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsførringstilladelsen:
English: The AUC at the no observed adverse effect level (NOAEL) for these effects was below the human exposure at the recommended clinical dose.
Danish: Ved disse virkninger var AUC ved 'no observed adverse effect level' (NOAEL) lavere end eksponeringen hos mennesker ved den anbefalede kliniske dosis.
English: Your use of Selincro may affect your doctor's choice of emergency treatment.
Danish: Din brug af Selincro kan have indflydelse på lægens valg af akutbehandling.
English: Caution is advised if treatment aimed at reduction of alcohol consumption is started in such patients.
Danish: Der skal udvises forsigtighed, hvis der iværksættes behandling rettet mod reduktion af alkoholforbruget til sådanne patienter.
English: At baseline, the patients had, on average, 23 HDDs per month (11% of patients had fewer than 14 HDDs per month) and consumed 106 g/day.
Danish: Ved baseline havde patienterne i gennemsnit 23 HDDs pr. måned (11% af patienterne havde færre end 14 HDDs pr. måned) og drak 106 g dagligt.
English: In Studies 1 (n=579), and 2 (n=655), 18%, and 33%, of the total population, respectively, considerably reduced their alcohol consumption in the period between screening and randomisation.
Danish: I undersøgelse 1 (n=579) og 2 (n=655) reducerede hhv. 18% og 33% af den samlede population deres alkoholforbrug betragteligt i perioden mellem screening og randomisering.
English: There is no clinically relevant pharmacokinetic drug-drug interaction between nalmefene and alcohol.
Danish: Der er ikke nogen klinisk relevant farmakokinetisk lægemiddelinteraktion mellem nalmefen og alkohol.
English: If unusually large doses are required, close observation is necessary.
Danish: Hvis der er behov for usædvanligt store doser, skal patienten holdes under nøje observation.
English: Therefore, the patients who maintained a high or very high DRL at randomisation were defined post hoc as the target population.
Danish: Derfor blev de patienter, der fortsat havde et stort eller meget stort alkoholforbrug ved randomiseringen, post hoc defineret som målpopulationen.
English: For example, a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Danish: En flaske vin (750 ml; 12% alkoholvolumen) indeholder f.eks. ca. 70 g alkohol, og en øl (330 ml; 5% alkoholvolumen) indeholder ca. 13 g alkohol.
English: Intake of a single dose of 450 mg nalmefene has been reported without changes in blood pressure, heart rate, respiration rate, or body temperature.
Danish: Der er indberettet indtagelse af en enkelt dosis på 450 mg nalmefen uden ændringer i blodtryk, hjertefrekvens, respirationsfrekvens og legemstemperatur.
English: No in vivo drug-drug interaction studies have been conducted.
Danish: Der er ikke udført in vivo-lægemiddelinteraktionsstudier.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 49 film-coated tablets 98 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 42 filmovertrukne tabletter 49 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Les Bouillides Sophia Antipolis 06560 Valbonne France
Danish: Les Bouillides Sophia Antipolis 06560 Valbonne Frankrig
English: The absolute oral bioavailability of nalmefene is 41%.
Danish: Nalmefens fuldstændige perorale biotilgængelighed er 41%.
English: However, body size seems to affect the clearance of nalmefene to a minor degree (clearance increases with increasing body size), but this is considered unlikely to be of clinical relevance.
Danish: Det tyder imidlertid på, at kropsstørrelse kan påvirke nalmefens clearance i mindre grad (clearance stiger i takt med kropsstørrelsen), men det er usandsynligt, at det har klinisk relevans.
English: A significant reduction in the number of HDDs and TAC occurred in some patients in the period between the initial visit (screening) and randomisation due to non-pharmacological effects.
Danish: Hos nogle patienter sås en signifikant reduktion i antallet af HDDs og TAC i perioden mellem det første besøg (screeningen) og randomiseringen på grund af ikke-farmakologiske virkninger.
English: The patient should be closely monitored for symptoms of respiratory depression as a result of the opioid administration and for other adverse reactions.
Danish: Patienten skal overvåges nøje for symptomer på respirationshæmning efter administration af et opioid og for andre uønskede reaktioner.
English: After you stop treatment with Selincro, you may be less sensitive to the effects of medicines containing opioids for a few days.
Danish: Efter at du er holdt op med Selincro behandlingen, kan du i nogle dage være mindre følsom over for virkningen af lægemidler, der indeholder opioider.
English: These side effects may affect your skills when driving or doing anything that requires you to be alert, including operating machinery.
Danish: Bivirkningerne kan påvirke din evne til at køre bil eller lave andet, der kræver, at du er årvågen, herunder betjening af maskiner.
English: The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence.
Danish: Hyppigheden af bivirkningerne i Tabel 1 er beregnet på baggrund af tre randomiserede, dobbeltblinde, placebokontrollerede undersøgelser hos patienter med alkoholafhængighed.
English: No specific study with oral dosing has been conducted in patients ≥65 years of age.
Danish: Der er ikke udført nogen specifik undersøgelse med peroral administration hos patienter ≥65 år.
English: The safety and efficacy of Selincro in children and adolescents <18 years of age have not been established.
Danish: Selincros sikkerhed og virkning hos børn og unge <18 år er ikke klarlagt.
English: Selincro works by affecting processes in the brain that are responsible for your urge to continue drinking.
Danish: Selincro virker ved at påvirke de processer i hjernen, som er årsagen til din trang til at fortsætte med at drikke.
English: The oral clearance of nalmefene (CL/F) was estimated as 169 l/h and the terminal half-life was estimated as 12.5 hours.
Danish: Nalmefens orale clearance (CL/F) blev estimeret til 169 l/t, og den endelige halveringstid blev estimeret til 12,5 time.
English: No clinically relevant changes were seen in tmax for any of the groups.
Danish: Der blev ikke observeret klinisk relevante ændringer i tmax for nogen af grupperne.
English: Clinical data for the use of Selincro under randomised controlled conditions are available for a period of 6 to 12 months.
Danish: Der foreligger kliniske data for brug af Selincro under randomiserede, kontrollerede forhold i en periode på 6 til 12 måneder.
English: It is unknown whether nalmefene is excreted in human milk.
Danish: Det vides ikke, om nalmefen udskilles i human modermælk.
English: In a study in patients with interstitial cystitis, 20 patients received 108 mg/day of nalmefene for more than 2 years.
Danish: I et studie med patienter med interstitiel cystitis fik 20 patienter 108 mg nalmefen dagligt i mere end to år.
English: An HDD was defined as a day with a consumption ≥60 g of pure alcohol for men and ≥40 g for women.
Danish: En HDD blev defineret som en dag med et forbrug ≥60 g ren alkohol for mænds vedkommende og ≥40 g for kvinders vedkommende.
English: If you require emergency medical attention, tell your doctor that you are taking Selincro.
Danish: Hvis du får brug for akut lægehjælp, skal du fortælle lægen, at du tager Selincro.