FrancophonIA/ELRC3.0 huggingface dataset:
English: constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting
Danish: forstoppelse, abdominalsmerter, dyspnø, abdominalt ubehag, opkastning
English: Instructions for reconstitution and dilution
Danish: Retningslinjer for rekonstitution og fortynding
English: After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin
Danish: Efter fortynding skal opløsningen til infusion have en endelig koncentration på 1 til 5 mg/ml dalbavancin.
English: Contents of the pack and other information What Xydalba contains
Danish: Pakningsstørelser og yderligere information Xydalba indeholder:
English: Do not use this medicine after the expiry date which is stated on the vial after EXP.
Danish: Brug ikke Xydalba efter den udløbsdato, der står på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Potential for dalbavancin to affect the pharmacokinetics of other medicinal products.
Danish: Dalbavancins potentiale til at påvirke andre lægemidlers farmakokinetik
English: Other medicines and Xydalba
Danish: Brug af anden medicin sammen med Xydalba
English: Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution.
Danish: Opløsninger med natriumchlorid kan forårsage udskillelse og bør IKKE bruges til rekonstitution eller fortynding.
English: • Abdominal pain (stomach ache) and/or watery diarrhoea.
Danish: • Mavesmerter og/eller vandig diarré.
English: Dalbavancin toxicity has been evaluated after daily intravenous administration for durations of up to
Danish: Dalbavancins toksicitet er blevet evalueret hos rotter og hunde efter daglig intravenøs administration i op til 3 måneder.
English: Sodium chloride solutions may cause precipitation and must not be used for reconstitution or dilution (see section 6.6).
Danish: Opløsninger med natriumchlorid kan forårsage udfældning og må ikke bruges til rekonstitution eller fortynding (se pkt.
English: Rare aspartate aminotransferase increased, blood uric acid increased, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, platelet count increased, body temperature increased, hepatic enzyme increased, gamma-glutamyl transferase increased,
Danish: Undersøgelser forhøjet laktatdehydrogenase, forhøjet alanin-aminotransferase, forhøjet aspartat-aminotransferase, forhøjet urinsyre i blodet, unormale prøver for leverfunktion, forhøjede aminotransferaser, forhøjet basisk fosfatase i blodet, forhøjet trombocyttal, forhøjet kropstemperatur, forhøjede leverenzymer, forhøjet gammaglutamyltransferase
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash
Danish: Hud og subkutane væv pruritus, urticaria, udslæt
English: Recommended dose and duration of treatment for adults The recommended dose of dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg (see sections 5.1 and 5.2).
Danish: Anbefalet dosis og behandlingsvarighed for voksne Den anbefalede dosis dalbavancin til voksne patienter med ABSSSI er 1.500 mg administreret enten som en enkelt infusion på 1.500 mg eller som 1.000 mg efterfulgt af 500 mg en uge senere (se pkt.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSEN
English: What Xydalba is and what it is used for What you need to know before you are given Xydalba How you will be given Xydalba Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Xydalba Sådan får du Xydalba
English: What you need to know before you are given Xydalba
Danish: Det skal du vide, før du får Xydalba
English: Powder for concentrate for solution for infusion 1 vial
Danish: Pulver til koncentrat til infusionsvæske 1 hætteglas
English: Uncommon - may affect up to 1 in 100 people: Vaginal infections, fungal infections, oral thrush Urinary tract infections Anaemia (low levels of red blood cells), high blood platelet counts (thrombocytosis), increased blood counts of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cell (leucopenia, neutropenia) Changes in other blood tests Decreased appetite
Danish: • Anæmi (nedsat antal røde blodceller), højt antal blodplader (trombocytose), højt antal af en type hvide blodlegemer ved navn eosinofiler (eosinofili), lavt antal af andre typer af hvide blodlegemer (leukopeni, neutropeni)
English: Lactose monohydrate,
Danish: Lactosemonohydrat,
English: Two-dose regimen2
Danish: Behandling med to doser2
English: Vascular disorders flushing, phlebitis
Danish: Vaskulære sygdomme flushing, flebit
English: Nervous system disorders headache dysgeusia, dizziness
Danish: Nervesystemet hovedpine dysguesia, svimmelhed
English: The diluted solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin (see section 6.6).
Danish: Den fortyndede infusionsvæske skal have en endelig koncentration på 1 til 5 mg/ml dalbavancin (se pkt.
English: It is not known if dalbavancin is an inhibitor of transporters.
Danish: Det vides ikke, om dalbavancin hæmmer transportører.
English: Based on simulations, dose adjustment is needed for patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regular haemodialysis (see sections 4.2 and 5.2).
Danish: Baseret på simulationer er dosisreduktion nødvendig hos patienter med kronisk nyreinsufficiens med kreatininclearance < 30 ml/min, som ikke er i regelmæssig hæmodialyse (se pkt.
English: • Group G streptococci
Danish: • Gruppe G streptokokker
English: The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles.
Danish: Det rekonstituerede koncentrat skal være en klar farveløs til gul opløsning uden synlige partikler.
English: Common - may affect up to 1 in 10 people: Headache
Danish: Almindelig - kan ramme 1 ud af 10 behandlede
English: Gastrointestinal disorders nausea, diarrhoea,
Danish: Mave-tarmkanalen kvalme, diarré,
English: • Change in sense of taste
Danish: • Ændringer i smagssans
English: The solution for infusion must be clear, colourless to yellow solution with no visible particles.
Danish: Infusionsopløsningen skal være klar, en farveløs til gul opløsning uden synlige partikler.
English: Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5 %) glucose solution for infusion.
Danish: Xydalba skal rekonstitueres med sterilt vand til injektionsvæsker og efterfølgende fortyndes med 50 mg/ml (5 %) glukose-opløsning til infusion.
English: Package leaflet: Information for the patient Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Danish: Indlægsseddel: Information til patienten Xydalba 500 mg pulver til koncentrat til infusionsvæske dalbavancin
English: The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
Danish: Forenelighed for rekonstitueret Xydalba-koncentrat er kun blevet fastslået med 50 mg/ml (5 %) glukose-opløsning til infusion.
English: : Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l,
Danish: • Staphylococcus spp: Følsom ≤ 0,125 mg/l; resistent > 0,125 mg/l,
English: Talk to your doctor, pharmacist or nurse if you get any of the following side effects:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Single-dose regimen3
Danish: Behandling med en enkelt dosis3
English: To dilute the reconstituted concentrate, the appropriate volume of the 20 mg / ml concentrate must be transferred from the vial to an intravenous bag or bottle containing 50 mg/ml (5 %) glucose solution for infusion.
Danish: For at fortynde rekonstitutionskoncentratet skal den rette mængde af 20 mg/ml af koncentratet overføres fra hætteglasset til intravenøs pose eller flaske, som indeholder 50 mg/ml (5 %) glukose-opløsning til infusion.
English: How to store Xydalba
Danish: Sådan får du Xydalba
English: After reconstitution each ml contains 20 mg dalbavancin.
Danish: Efter rekonstitution indeholder hver ml koncentrat 20 mg dalbavancin.
English: • Abdominal pain and discomfort, indigestion, constipation
Danish: • Mavesmerter og ubehag i maven, fordøjelsesbesvær, forstoppelse
English: The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion.
Danish: Rekonstitutionskoncentratet skal fortyndes yderligere med 50 mg/ml (5 %) glukose-opløsning til infusion.
English: Koidu str. 20-19
Danish: Lorenzo Pharma OÜ Koidu str. 20-19
English: The reconstituted concentrate in the vial contains 20 mg/ml dalbavancin.
Danish: Det rekonstituerede koncentrat i hætteglasset indeholder 20 mg/ml dalbavancin.
English: Xydalba vials are for single-use only.
Danish: Xydalba hætteglas er kun til éngangsbrug.
English: Metabolism and nutrition disorders decreased appetite
Danish: Metabolisme og ernæring
English: Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
Danish: Hvert hætteglas indeholder dalbavancinhydrochlorid svarende til 500 mg dalbavancin.
English: Xydalba 500 mg powder for concentrate for solution for infusion
Danish: Xydalba 500 mg pulver til koncentrat til infusionsvæske
English: • Inflammation and swelling of surface veins, flushing
Danish: • Inflammation (betændelseslignende reaktion) og hævelse af overfladiske vener,
English: Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Danish: Xydalba 500 mg pulver til koncentrat til infusionsvæske dalbavancin
English: For single use only
Danish: Til engangsbrug.
English: Pain, redness or swelling at the place where the infusion was given Feeling hot
Danish: • Smerte, rødme eller hævelse ved infusionsstedet
English: Respiratory, thoracic and mediastinal disorders cough bronchospasm
Danish: Luftveje, thorax og mediastinum
English: Genital itching (females)
Danish: • Kløe i kønsorganer (kvinder)
English: Puh/Tel: +41 848 00 79 70 medinfo@correvio.com
Danish: CorrevioPuh/Tel: +41 848 00 79 70 medinfo@correvio.com
English: Possible side effects
Danish: Klasse-bivirkninger
English: No experience exists with these situations.
Danish: Der er ingen erfaring med disse situationer.
English: It is used to treat:
Danish: Det anvendes til at behandle:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/740/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/740/001
English: Lower 97.5% Confidence Limit
Danish: Nedre 97,5 % konfidensgrænse
English: A distance of at least 1 cm is to be maintained.
Danish: Der skal holdes en afstand på mindst 1 cm til disse områder.
English: Positive allergy tests were reported in the study.
Danish: Der blev rapporteret positive allergitests i studiet.
English: Allemagne / Deutschland / Duitsland / Германия / Německo / Saksamaa / Γερμανία / Njemačka / Germany / Þýskaland / Germania / Vācija / Vokietija / Németország / Il-Ġermanja / Niemcy /
Danish: Allemagne / Deutschland / Duitsland / Германия / Německo / Saksamaa / Γερμανία / Njemačka / Germany / Þýskaland / Germania / Vācija / Vokietija / Németország / Il-Ġermanja / Niemcy / Alemanha / Nemčija / Nemecko,
English: However, in some cases they may persist for 1 to 2 weeks or even longer.
Danish: I nogle tilfælde kan de dog fortsætte i 1 til 2 uger eller endnu længere.
English: In conclusion, even though subgroup sizes are too small to draw significant conclusions on individual groups, the distribution of the two products to the relevant subgroups is very similar.
Danish: Det kan konkluderes, at selvom undergrupperne er for små til at drage signifikante konklusioner om individuelle grupper, er fordelingen af de to præparater i de relevante undergrupper meget ens.
English: The latter causes damage of cellular components and eventually destroys the target cells.
Danish: Sidstnævnte forårsager skade på cellulære komponenter, og til sidst ødelægger de målcellerne.
English: Patients with more than 1 BCC
Danish: Undergrupper: Patienter med mere end 1 BCC
English: BCCs located in this region mainly belong to the superficial subtype.
Danish: BCC'er i dette område tilhører primært den superficielle undertype.
English: Before PDT (%) 12 months after PDT (%)
Danish: Før PDT (%) 12 måneder efter PDT (%)
English: Risk of allergic reaction
Danish: Risiko for allergisk reaktion
English: Daylight may not be sufficient for Ameluz daylight treatment during winter months in certain parts of Europe.
Danish: Det kan være, at dagslyset ikke er tilstrækkeligt til at behandle med Ameluz i vintermånederne i visse dele af Europa.
English: Thus, it seems not plausible that this could negatively impact the non-inferiority claim of the primary study endpoint or the general trends observed across all subgroups.
Danish: Det synes derfor ikke plausibelt, at dette kunne have negativ indvirkning på påstanden om non-inferioritet med hensyn til det primære studieeffektmål eller de generelle tendenser, der blev observeret på tværs af alle undergrupper.
English: Your doctor will decide which treatment option to use, depending on your lesions.
Danish: Din læge vil beslutte, hvilken behandlingsmulighed, der skal bruges, afhængigt af dine læsioner.
English: 1 This reaction also occurs before illumination.
Danish: 1 Denne reaktion forekommer også før belysning.
English: Protection from sun light exposure for 48 hours and observation are nevertheless recommended.
Danish: Beskyttelse mod sollys i 48 timer og observation anbefales dog.
English: Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.
Danish: Lægen vil beslutte, hvor godt hver hudlæsion har responderet, og det kan være nødvendigt at gentage behandlingen på det tidspunkt.
English: Considerations before treatment
Danish: Overvejelser før behandling
English: Although the exact mechanism is not known, stress and pain associated with PDT may increase the risk to develop transient amnesia.
Danish: Selvom den præcise mekanisme er ukendt, kan stress og smerter forbundet med PDT øge risikoen for udvikling af transitorisk amnesi.
English: Ameluz daylight photodynamic therapy is feasible all year long in southern Europe, from February to October in middle Europe, and from March to October in northern Europe.
Danish: Den fotodynamiske behandling med Ameluz kan udføres hele året rundt i Sydeuropa, fra februar til oktober i Centraleuropa og fra marts til oktober i Nordeuropa.
English: 3 severe very thick and / or obvious AK
Danish: Meget tyk og/eller tydelig AK
English: Ameluz transiently increases phototoxicity
Danish: Ameluz øger fototoksicitet forbigående
English: Ameluz is only used on the skin.
Danish: Ameluz anvendes kun på huden.
English: Sodium benzoate (E211) Purified water
Danish: Natriumbenzoat (E211) Renset vand
English: Unopened tube: 18 months After first opening: 12 weeks
Danish: Uåbnet tube: 18 måneder Efter anbrud: 12 uger
English: It is important to ensure that the correct light dose is administered.
Danish: Det er vigtigt at sikre, at der gives den korrekte dosis lys.
English: In the presence of oxygen, reactive oxygen species are formed.
Danish: Gennem tilstedeværelsen af oxygen dannes reaktive oxygenarter.
English: Rinse with water if such contact occurs.
Danish: Skyl med vand hvis der opstår sådan en kontakt.
English: There is no need to protect healthy untreated skin.
Danish: Der er ikke behov for at beskytte sund, ubehandlet hud.
English: The light dose delivered should be monitored if a suitable detector is available.
Danish: Lysdosen skal monitoreres, hvis en egnet detektor er til rådighed.
English: Each side of the face/scalp was treated with one of the two products.
Danish: Hver side af ansigtet/issen blev behandlet med et af de 2 præparater.
English: Overdose following topical administration is unlikely and has not been reported in clinical studies.
Danish: Overdosering efter topikal anvendelse er ikke sandsynlig og er ikke blevet rapporteret i de kliniske studier.
English: All these adverse reactions were non serious.
Danish: Ingen af disse bivirkninger var alvorlige.
English: If Ameluz is accidentally ingested, systemic toxicity is unlikely.
Danish: Hvis Ameluz ved et uheld indtages, er systemisk toksicitet ikke sandsynlig.
English: Taking shelter in the shade in hot weather is acceptable.
Danish: Det er acceptabelt at søge skygge i varmt vejr.
English: Illumination using a red-light lamp
Danish: Belysning med en rød lampe
English: Date of latest renewal: 21 November 2016
Danish: Dato for første markedsføringstilladelse: 14. december 2011 Dato for seneste fornyelse: 21. november 2016
English: Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as
Danish: Informer lægen, hvis du bruger medicin, der forøger allergiske reaktioner eller andre skadelige reaktioner efter lyspåvirkning, f.eks.
English: After 24 hours, the mean cumulative absorption (including accumulation in the dermis) through human skin was 0.2% of the administered dose.
Danish: Efter 24 timer var den gennemsnitlige kumulative absorption (inklusive akkumulation i huden) gennem human hud 0,2 % af den anvendte dosis.
English: The percentage of patients with skin impairment before PDT and 12 months after PDT is listed in the table below.
Danish: Procenten af patienter med hudlidelser før PDT og 12 måneder efter PDT er angivet i tabellen nedenfor.
English: Some reactions at the application site have been observed before the use of light.
Danish: Nogle reaktioner på påføringsstedet er blevet observeret før anvendelse af lys.
English: • if you have other skin conditions caused by, or made worse by, exposure to light
Danish: • hvis du har andre hudlidelser, der forårsages af eller forværres af eksponering for lys
English: All should wear suitable protective goggles during illumination.
Danish: Alle skal bære egnede beskyttelsesbriller under belysningen.
English: The study of Ameluz using daylight showed similar types of side effects; however, with lower intensity.
Danish: Studier af brugen af Ameluz i dagslys viste tilsvarende typer bivirkninger, men med en mindre intensitet.
English: In this study a total of 138 patients were treated with Ameluz.
Danish: I dette studie blev i alt 138 patienter behandlet med Ameluz.
English: Risk of Transient Global Amnesia (TGA)
Danish: Risiko for transitorisk global amnesi (TGA)
English: Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.
Danish: Aktiniske keratoser og basalcellekarcinomer forekommer ikke hos børn og unge, undtagen i ekstremt sjældne tilfælde.
English: In 12 cases the reactions started before illumination.
Danish: I 12 af tilfældene startede reaktionerne før belysning.
English: Carcinogenicity studies have not been performed with ALA.
Danish: Der er ikke udført karcinogenicitetsstudier med ALA.
English: None of the post-dose levels were increased in comparison to the naturally occuring predose levels, showing absence of a relevant systemic absorption after topical administration.
Danish: Ingen af niveauerne var forhøjede efter anvendelsen sammenlignet med de naturligt forekommende niveauer før anvendelsen, hvilket påviser fravær af relevant systemisk absorption efter topisk administration.
English: On sunny days, shelter in the shade could be taken should the patient feel uncomfortable in direct sunlight.
Danish: På solrige dage kunne der søges skygge, hvis patienten følte sig utilpas i direkte sollys.
English: • In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
Danish: • I meget sjældne tilfælde kan fotodynamisk behandling øge risikoen for udvikling af forbigående hukommelsestab.
English: Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy.
Danish: Protoporphyrin IX aktiveres ved belysning med rødt lys med en egnet bølgelængde og energi.
English: Do not use Ameluz:
Danish: Brug ikke Ameluz:
English: Email: ameluz@biofrontera.com
Danish: E-mail: ameluz@biofrontera.com
English: This therapy is known as photodynamic therapy (PDT).
Danish: Denne behandling kaldes fotodynamisk behandling (PDT).
English: Adverse events and tolerability were comparable for both treatments.
Danish: Bivirkninger og tolerabilitet var sammenlignelige for begge behandlinger.
English: Nodular BCC lesions are often covered by an intact epidermal keratin layer which should be removed.
Danish: Nodulære BCC-læsioner er ofte dækket af et intakt epidermalt keratinlag, som skal fjernes.
English: Ameluz is not recommended during pregnancy, due to insufficient knowledge.
Danish: Ameluz bør ikke anvendes under graviditet, på grund af utilstrækkelig viden.
English: Intensity of adverse reactions, particularly pain, was lower when Ameluz was used in combination with daylight PDT.
Danish: Intensiteten af bivirkningerne, især smerter, var lavere, når Ameluz blev anvendt i kombination med PDT i dagslys.
English: Do not use this medicine after the expiry date which is stated on the tube and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på tuben og pakningen efter ”EXP” eller ”Anv.
English: • rash, red or purple spots on the body
Danish: • udslæt, røde eller lilla pletter på kroppen
English: Side effects at the application site occur in about 9 out of 10 users and indicate that the affected cells are responding to treatment.
Danish: Der opstår virkning på påsmøringsstedet hos ca. 9 ud af 10 brugere, og det er et tegn på, at de angrebne celler reagerer på behandlingen.
English: Actinic keratosis lesion severity was graded according to the scale described by Olsen et al., 1991 (J Am Acad Dermatol 1991; 24: 738-743):
Danish: Sværhedsgraden af læsioner med aktinisk keratose blev bedømt i henhold til skalaen i Olsen et al.,1991 (J Am Acad Dermatol 1991; 24: 738-743):
English: It is unknown whether 5-aminolaevulinic acid/metabolites are excreted in human milk.
Danish: Det er ukendt, om 5-aminolevulinsyre/metabolitter udskilles i human mælk.
English: Keep the tube tightly closed after first opening.
Danish: Hold tuben tæt tillukket efter anbrud.
English: These factors vary with lamp type.
Danish: Disse faktorer varierer efter lampetype.
English: The dressing is removed after 3 hours.
Danish: Forbindingen fjernes efter 3 timer.
English: Each tube contains 2 g of gel.
Danish: Hver tube indeholder 2 g gel.
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 Lægemiddelsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The table additionally includes serious adverse reactions reported post-marketing.
Danish: Tabellen viser også alvorlige bivirkninger, der blev rapporteret efter markedsføring.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of 5-aminolaevulinic acid in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af 5-aminolevulinsyre til gravide kvinder.
English: The light dose is determined by factors such as the size of the light field, the distance between lamp and skin surface, and the illumination time.
Danish: Lysdosen fastsættes ved hjælp af faktorer som lysfeltets størrelse, afstanden mellem lampe og hudoverflade og belysningstiden.
English: Table 3a: Skin quality parameters in the treated area during 12- month follow-up
Danish: Tabel 3a: Parametre for hudkvalitet i det behandlede område ved opfølgning efter 12 måneder