FrancophonIA/ELRC3.0 huggingface dataset:
English: • moderate: 1.5 x ULN < TB < 3 x ULN, AST any
Danish: • Moderat: 1,5 × øvre normalgrænse < total-bilirubin < 3 × øvre normalgrænse, alle værdier af ASAT
English: • symptomatic metastatic basal cell carcinoma
Danish: Metastatisk basalcellekarcinom-kohorte
English: Printing ink Shellac glaze Iron oxide black (E172)
Danish: Shellac-glasur Jernoxid, sort (E172)
English: Nausea Diarrhoea Constipation Vomiting Dyspepsia
Danish: Mave-tarm-kanalen Kvalme Diarré
English: For the laBCC cohort (n = 63), 94 % of patients had prior therapies including surgery (89 %), radiotherapy (27 %), and systemic/topical therapies (11 %).
Danish: I lokalt fremskredent basalcellekarcinom-kohorten (n = 63) havde 94% af patienterne tidligere fået behandling, inklusive operation (89%), stråleterapi (27%) og systemiske/topikale behandlinger (11%).
English: Cases of cuSCC have been reported in advanced BCC patients treated with Erivedge.
Danish: Der er rapporteret tilfælde af kutant planocellulært karcinom hos patienter med fremskredent basalcellekarcinom, der har fået Erivedge.
English: • A requirement to inform patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Danish: • Krav om at informere patienterne om den teratogene risiko, som er forbundet med Erivedge, og om nødvendigheden af at undgå føtal eksponering
English: • Information for women of childbearing potential
Danish: • Information til fertile kvinder
English: • Not to breastfeed during treatment and for 24 months after Erivedge treatment
Danish: • Ingen amning under behandling og i 24 måneder efter Erivedge-behandling
English: ‡ Progression in laBCC cohort is defined as meeting any of the following criteria: (1) ≥ 20 % increase in the sum of the longest dimensions (SLD) from nadir in target lesions (either by radiography or by externally visible dimension),
Danish: ‡ Progression i lokalt fremskredent basalcellekarcinom-kohorten defineres som, at et eller flere af følgende kriterier var opfyldt: (1) ≥20% stigning i summen af den længste dimension (SLD) fra nadir i target-læsioner (ved radiografi eller udvendigt synlig dimension), (2) Ny persisterende ulceration af target-læsion uden tegn på heling i mindst 2 uger, (3) Nye læsioner ved radiografi eller objektiv undersøgelse, (4) Progression af non-target-læsioner ved RECIST.
English: Do not breast-feed during your treatment and for 24 months after your final dose of this medicine.
Danish: Du må ikke amme under behandlingen og i 24 måneder efter sidste dosis af medicinen.
English: • Information for patients on the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Danish: • Information til patienter om den teratogene risiko, som er forbundet med Erivedge og om nødvendigheden af, at undgå føtal eksponering
English: You should not donate semen at any time during treatment and for 2 months after your final dose of this medicine.
Danish: Du må ikke være sæddonor på noget tidspunkt under behandlingen og i 2 måneder efter, du har fået den sidste dosis af medicinen.
English: The patient reminder card should contain the following key elements:
Danish: Huskekort til patienter skal indeholde følgende hovedpunkter:
English: • Not to donate semen during treatment and for 2 months after the final dose
Danish: • Ingen sæddonation under behandling og i 2 måneder efter sidste dosis
English: Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 71,5 mg lactosemonohydrat.
English: and moderate (BSA-indexed CrCl 30 to 50 mL/min, n=16) renal impairment, mild and moderate impaired renal function had no clinically significant effect on the pharmacokinetics of vismodegib (see section 4.2).
Danish: Baseret på en farmakokinetisk populationsanalyse af patienter med let (legemsoverfladeareal (BSA) indekseret CrCl 50-80 ml/min, n=58) og moderat (BSA-indekseret CrCl 30-50 ml/min, n=16) nedsat nyrefunktion, havde let og moderat nedsat nyrefunktion ingen klinisk signifikant effekt på farmakokinetiken af vismodegib (se pkt.
English: Blood donation Patients should not donate blood while taking Erivedge and for 24 months after the final dose.
Danish: Patienter må ikke være bloddonorer, mens de er i behandling med Erivedge og i 24 måneder efter sidste dosis.
English: Other medicines and Erivedge
Danish: Brug af anden medicin sammen med Erivedge
English: • You should not donate blood at any time during treatment and for 24 months after your final dose of this medicine.
Danish: • Du må ikke være bloddonor på noget som helst tidspunkt under behandlingen og i 24 måneder efter, du har taget den sidste dosis.
English: • She must not become pregnant while taking Erivedge and for 24 months after her final dose,
Danish: • hun ikke må blive gravid under behandlingen med Erivedge og i 24 måneder efter sidste dosis
English: • severe: 3 x ULN < TB < 10 x ULN, AST any
Danish: • Svær: 3 × øvre normalgrænse < total-bilirubin < 10 × øvre normalgrænse, hvilken som helst ASAT (se pkt.
English: How to take Erivedge
Danish: Sådan skal du tage Erivedge
English: After oral administration of a radiolabelled dose, vismodegib is absorbed and slowly eliminated by a combination of metabolism and excretion of parent drug substance, the majority of which is recovered in the faeces (82 % of the administered dose), with 4.4 % of the administered dose recovered in urine.
Danish: Størstedelen kan genfindes i fæces (82% af den administrerede dosis), og 4,4% af den administrerede dosis kan genfindes i urinen.
English: • loss of monthly periods in women of childbearing age,
Danish: • udeblevne menstruationer hos fertile kvinder
English: • Do not crush, open or chew the capsule, to avoid unintended exposure to the capsule contents.
Danish: Du undgår derved utilsigtet udsættelse for kapselindholdet.
English: • She must not breast-feed while taking Erivedge and for 24 months after the final dose.
Danish: • hun ikke må amme, mens hun er i behandling med Erivedge og i 24 måneder efter sidste dosis.
English: Severe cutaneous adverse reactions (SCARs) including cases of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening, have been reported during post-marketing use (see section 4.8).
Danish: Der er rapporteret tilfælde af svære kutane bivirkninger efter markedsføring af lægemidlet, herunder tilfælde af Stevens-Johnsons syndrom/toksisk epidermal nekrolyse, lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) og akut generaliseret eksantematøs pustulose, som kan være livstruende (se pkt.
English: • Inform patients that they should not donate blood during treatment with Erivedge and for 24 months after their final dose
Danish: • Information til patienterne om, at de ikke må donere blod under behandling med Erivedge og i 24 måneder efter sidste dosis
English: For the mBCC cohort, 97 % of patients had prior therapy including surgery (97 %), radiotherapy (58 %), and systemic therapies (30 %).
Danish: I metastatisk basalcellekarcinom-kohorten havde 97% af patienterne tidligere fået behandling, inklusive operation (97%), stråleterapi (58%) og systemiske behandlinger (30%).
English: • The healthcare professional should report confirmed pregnancies to the MAH
Danish: • Lægen skal rapportere alle graviditeter til indehaveren af markedsføringstilladelsen
English: You must tell your doctor immediately during the course of treatment or during the 24 months after your final dose of this medicine if:
Danish: Under behandlingen og i 24 måneder efter den sidste dosis af medicinen skal du straks kontakte lægen, hvis:
English: The healthcare professional's reminder card should contain the following key elements
Danish: Huskekort til sundhedspersoner skal indeholde følgende hovedpunkter:
English: • muscle, tendon, ligament, bone pain,
Danish: • smerter i muskler, sener, ledbånd eller knogler
English: Do not use while pregnant or breast-feeding You must follow the Erivedge Pregnancy Prevention Programme
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Risiko for svære fostermisdannelser Må ikke anvendes under graviditet eller amning Erivedge-programmet om svangerskabsforebyggelse skal overholdes
English: • Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes.
Danish: skællende hud, sår i mund, hals, næse, kønsorganer og øjne.
English: • The need to contact the healthcare professional if the female partner suspects that she is pregnant while the patient is treated with Erivedge or in the 2 months following treatment
Danish: • Nødvendigheden af straks at kontakte lægen ved mistanke om graviditet hos en kvindelig partner, mens manden er i behandling og i 2 måneder efter behandling
English: • She must use 2 methods of recommended contraception (see the ‘Contraception' section below and section 4.6) while she is taking Erivedge, unless she commits to not having sexual intercourse (abstinence),
Danish: • hun skal anvende to metoder af anbefalet prævention (se afsnittet ”Prævention” nedenfor og pkt.
English: • Tubal sterilisation,
Danish: • Sterilisering,
English: Clinically significant PK interactions between vismodegib and CYP450 inhibitors are not expected.
Danish: Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og CYP450-hæmmere forventes ikke.
English: 1-year survival rate (95 % CI)
Danish: 1-års overlevelsesrate konfidensinterval)
English: • Remind patients not to donate blood during treatment and for 24 months after the final dose
Danish: • Påminde patienter om ikke at donere blod under behandlingen og i 24 måneder efter sidste dosis
English: • Description of the patient reminder card
Danish: • Beskrivelse af huskekort til patienter
English: • Not to donate blood during treatment and for 24 months after the final dose
Danish: • Ingen bloddonation under behandling og i 24 måneder efter sidste dosis
English: Tel: +371 - 6 7 039831
Danish: Roche Latvija SIA Tel: +371 - 6 7 039831
English: Clinically significant PK interactions between vismodegib and pH elevating agents are not expected.
Danish: Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og midler der hæver pH forventes ikke.
English: • Premature puberty (precocious puberty)
Danish: • For tidlig indtræden af pubertet
English: • St. John's wort (Hypericum perforatum) - a herbal medicine used for depression, since you must not use it at the same time as Erivedge.
Danish: • og især perikon (Hypericum perforatum) - et naturlægemiddel, som bruges til depression.
English: • That the patient should not breastfeed during treatment and for 24 months after their final dose
Danish: • At patienten ikke må amme under behandlingen og i 24 måneder efter den sidste dosis
English: • At the end of your treatment you should return all unused capsules.
Danish: • Du skal aflevere alle ikke anvendte kapsler, når din behandling er afsluttet.
English: • a condom (with spermicide, if available)
Danish: • kondom (om muligt med sæddræbende creme)
English: Counselling For a WCBP Erivedge is contraindicated in a WCBP who does not comply with the Erivedge Pregnancy Prevention Programme.
Danish: Erivedge er kontraindiceret til fertile kvinder, der ikke overholder Erivedge-programmet for svangerskabsforebyggelse.
English: They are available in bottles with a child-resistant closure containing 28 capsules.
Danish: Kapslerne fås i beholdere med børnesikret låg med 28 stk. Hver pakning indeholder én beholder.
English: Weight decreased Fatigue
Danish: Vægttab Træthed Smerter
English: Usually this type of lesion appears on sun-damaged skin, remains local and can be cured.
Danish: Denne type kræft ses oftest på solskadet hud.
English: Figure 2 SHH4476g Locally Advanced BCC Cohort
Danish: Tabel 2 SHH4476g-studiet.
English: • Women of childbearing potential who do not comply with the Erivedge Pregnancy Prevention
Danish: • Fertile kvinder, der ikke overholder Erivedge-programmet for svangerskabsforebyggelse (se pkt.
English: Clinically significant PK interactions between vismodegib and P-gp inhibitors are not expected.
Danish: Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og P-glykoprotein (P-gp)hæmmere forventes ikke.
English: What Erivedge is and what it is used for What you need to know before you take Erivedge How to take Erivedge
Danish: Det skal du vide, før du begynder at tage Erivedge Sådan skal du tage Erivedge
English: Patients with severe renal impairment should be carefully monitored for adverse reactions.
Danish: Meget begrænset data er tilgængelig hos patienter med svært nedsat nyrefunktion.Patienter med svært nedsat nyrefunktion bør monitoreres omhyggeligt for bivirkninger.
English: For men
Danish: Til mænd:
English: • Diaphragm (with spermicide, if available).
Danish: • pessar (om muligt med sæddræbende creme).
English: • you need to continue contraception for 24 months after your final dose of this medicine because Erivedge may remain in your body for up to 24 months after your final dose.
Danish: • skal du fortsætte med at bruge prævention i 24 måneder efter din sidste dosis af medicinen
English: Hedgehog target genes.
Danish: Hæmmere af hedgehog-signalveje (se pkt.
English: Use one highly effective method, such as: • a contraceptive depot injection
Danish: Brug én meget sikker metode, som fx:
English: Responders
Danish: Rådgivning:
English: • That the patient should not donate blood during treatment and for 24 months after their final dose
Danish: • At patienten ikke må være bloddonor under behandlingen og i 24 måneder efter den sidste dosis
English: How to store Erivedge
Danish: Erivedge-behandling
English: Erivedge has been administered at doses 3.6 times higher than the recommended 150 mg daily dose.
Danish: Erivedge har været administreret i doser, der var 3,6 gange højere end den anbefalede daglige dosis på 150 mg. Der er i disse kliniske studier ikke set stigning i plasmakoncentrationen af vismodegib eller øget toksicitet.
English: Due to the long drug elimination half-life, these events may occur or progress after drug discontinuation.
Danish: Disse hændelser fortsatte i nogle tilfælde efter behandlingsstop grundet den lange elimineringshalveringstid.
English: Stop using Erivedge and seek medical attention immediately if you notice any of the symptoms described in section 4.
Danish: Hvis du oplever nogle af symptomerne beskrevet i afsnit 4, skal du straks stoppe med at tage Erivedge og kontakte lægen.
English: Tel: +370 5 2546799
Danish: UAB “Roche Lietuva” Tel: +370 5 2546799
English: For health care providers (HCP)
Danish: Til sundhedspersonalet:
English: In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day; the effect was not reversed by the end of an 8 week recovery period.
Danish: Der blev desuden observeret et fald i antal corpus luteum ved 100 mg/kg/dag i det generelle 26-ugers toksicitetsstudiet med vismodegib.
English: • has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate.
Danish: basalcellekarcinom), og lægen har vurderet, at operation eller strålebehandling er uhensigtsmæssig.
English: • locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
Danish: Erivedge er indiceret til behandling af voksne patienter med: symptomatisk metastatisk basalcellekarcinom lokalt fremskredent basalcellekarcinom, hvor operation eller stråleterapi ikke er hensigtsmæssig (se pkt.
English: • Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate.
Danish: • Kapslen indeholder: mikrokrystallinsk cellulose, lactosemonohydrat, natriumlaurilsulfat,
English: • Measures to ensure that all appropriate actions have been performed prior to Erivedge being prescribed and dispensed The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following: Product information Healthcare professional educational material Healthcare professional reminder card Patient educational material Patient reminder card The healthcare professional educational material for Erivedge should contain the following key elements:
Danish: Indehaveren af markedsføringstilladelsen skal løbende sikre, at alle læger, som forventes at ordinere Erivedge, modtager følgende:
English: Myalgia
Danish: • kløe
English: • Bones stop growing (epiphyses premature fusion)
Danish: • Knogler stopper med at vokse
English: • Patient Reminder Card
Danish: • Huskekort til patienter
English: Contraceptive steroids
Danish: • mavesmerter
English: Asthenia
Danish: • Leverskade
English: How Erivedge works
Danish: Hvordan virker Erivedge?
English: Tel: +353 (0) 1 469 0700
Danish: Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
English: The cap liner is aluminum foil-lined waxed pulp board.
Danish: Låget er beklædt med voksbehandlet træpap, som er foret med aluminiumfolie.
English: Cutaneous squamous cell carcinoma (cuSCC)
Danish: Kutant planocellulært karcinom
English: Muscle spasms Arthralgia Pain in extremity
Danish: Muskelspasmer Artralgi
English: This is because Erivedge may harm or cause the death of your unborn baby.
Danish: Hvis du tager Erivedge, kan det skade fostret eller slå fostret ihjel
English: Flank pain
Danish: Lever og galdeveje
English: Actrapid is given 30 minutes before a meal.
Danish: Actrapid indgives 30 minutter inden et måltid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Actrapid den 7. oktober 2002.
English: The full EPAR for Actrapid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Actrapid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Actrapid.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Actrapid.
English: Actrapid is used to treat diabetes.
Danish: Actrapid anvendes til behandling af diabetes.
English: EPAR summary for the public human insulin
Danish: EPAR - sammendrag for offentligheden human insulin
English: HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
Danish: HbA1c-niveauerne holdt sig forholdsvis stabilt i løbet af den seks måneder lange behandlingsperiode med Actrapid.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Actrapid.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Actrapid.
English: Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
Danish: Actrapid kan også indgives intravenøst (i en vene), men kun af en læge eller sygeplejerske.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Danish: HbA1c viser, hvor godt blodsukkeret reguleres.
English: Other information about Actrapid
Danish: Andre oplysninger om Actrapid:
English: For more information about treatment with Actrapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Actrapid, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Actrapid has been studied in patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type 2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients).
Danish: Actrapid blev undersøgt hos patienter med type 1-diabetes, hvor bugspytkirtlen ikke kan producere insulin (to undersøgelser, som omfattede 1954 patienter), eller type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt (en undersøgelse, som omfattede 182 patienter).
English: The CHMP decided that Actrapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Actrapid opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Actrapid.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinen fungerer på samme måde som naturligt produceret insulin og hjælper glukosen til at trænge ind i cellerne fra blodet.
English: The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Danish: I undersøgelserne sammenlignede man over en periode på seks måneder Actrapid med en anden erstatningsinsulin kaldet insulin aspart ved at måle niveauet af glykosyleret hæmoglobin (HbA1c), som er den procentdel af hæmoglobin i blodet, der binder glukose til sig.
English: The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: De hyppigste bivirkninger ved Actrapid (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
English: It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).
Danish: Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (NovoLet, InnoLet eller FlexPen).
English: Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins.
Danish: Actrapid er hurtigtvirkende insulin og kan anvendes sammen med mellemvirkende eller langtidsvirkende insulinpræparater.
English: What is the risk associated with Actrapid?
Danish: Hvilken risiko er der forbundet med Actrapid?
English: Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks).
Danish: Actrapid gives som injektion under huden i låret, bugvæggen (maveskindet), deltamuskelregionen (skulderen) ellr sædemuskelregionen (ballerne).
English: Actrapid must not be used in people who are hypersensitive to human insulin or any of the other ingredients.
Danish: Actrapid må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for human insulin eller andre af indholdsstofferne.
English: Why has Actrapid been approved?
Danish: Hvorfor blev Actrapid godkendt?
English: Actrapid is a solution for injection that contains the active substance human insulin.
Danish: Actrapid er en injektionsvæske, opløsning, som indeholder det aktive stof human insulin.
English: Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.
Danish: Actrapid er et erstatningsinsulin, der er næsten identisk med det insulin, der produceres af bugspytkirtlen.
English: For the full description of all side effects reported with Actrapid, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Actrapid fremgår af indlægssedlen.
English: How has Actrapid been studied?
Danish: Hvordan blev Actrapid undersøgt?
English: What benefit has Actrapid shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Actrapid?
English: What is Actrapid?
Danish: Hvad er Actrapid?
English: What is Actrapid used for?
Danish: Hvad anvendes Actrapid til?
English: How is Actrapid used?
Danish: Hvordan anvendes Actrapid?