FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, and scientific discussion within the Committee was of the opinion that the benefit/risk ratio of Calcium
Danish: Efter at CHMP havde behandlet vurderingsrapporterne fra rapportøren/medrapportøren og taget hensyn til den faglige drøftelse i udvalget, var CHMP af den opfattelse, at Calcium Sandoz brusetabletter, 500/1000 mg og tilknyttede navne udviste et gunstigt benefit/risk-forhold.
English: Sandoz Effervescent tablets, 500/1000 mg and associated names is considered to be favourable.
Danish: Calcium Sandoz brusetabletter, 500/1000 mg og tilknyttede navne til følgende godkendte terapeutiske indikationer:
English: Calcium Sandoz Effervescent tablets, 500/1000 mg and associated names for the following agreed therapeutic indications: -Prevention and treatment of calcium deficiency -Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis
Danish: - Calciumtilskud som supplement til specifik terapi ved forebyggelse og behandling af steoporose
English: Novartis Consumer Health SA presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national SPCs of the medicinal product Calcium Sandoz Effervescent tablets, 500/1000 mg and associated names and additionally to harmonise the pharmaceutical documentation.
Danish: Sandoz brusetabletter, 500/1000 mg og tilknyttede navne og endvidere også for at harmonisere den farmaceutiske dokumentation.
English: 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
Danish: 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tabletter
English: Memantine Accord 5 mg + 10 mg +
Danish: 5 mg + 10 mg + 15 mg + 20 mg
English: This can be repeated if necessary.
Danish: Dette kan om nødvendigt gentages.
English: • if you think you might be pregnant.
Danish: • hvis du mener, du kan være gravid.
English: • if you are to be given a vaccine.
Danish: • hvis du skal have en vaccine.
English: Date of first authorisation: 23 August 2018
Danish: Dato for første markedsføringstilladelse: 23 august 2018
English: and immediately thereafter start a 5-minute timer.
Danish: Start umiddelbart derefter en 5-minutters tidtager.
English: This leaflet was last revised in October 2019 Other sources of information
Danish: Denne indlægsseddel blev senest ændret Oktober 2019 Andre informationskilder
English: Contact your doctor or nurse as soon as possible.
Danish: Kontakt din læge eller sygeplejersken snarest muligt.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser brugerens eget ansvar.
English: (0.03 to 1.3 times the approved recommended dosage).
Danish: (0,03 til 1,3 gange den godkendte anbefalede dosis).
English: Each consolidation
Danish: Hver konsolidering
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Danish: Dræbte eller inaktiverede vacciner kan administreres, dog kan responset på sådanne vacciner være reduceret.
English: Efficacy results for study 301
Danish: Effektresultater for studie 301
English: EU/1/18/1308/001 1 vial EU/1/18/1308/002 2 vials EU/1/18/1308/003 5 vials
Danish: EU/1/18/1308/001 1 hætteglas EU/1/18/1308/002 2 hætteglas EU/1/18/1308/003 5 hætteglas
English: If you miss an appointment
Danish: Hvis du har glemt en konsultation
English: Severe myelosuppression
Danish: Alvorlig myelosuppression
English: • The infusion is given over one and a half hours (90 minutes).
Danish: • Infusionen gives i et tidsrum på halvanden time (90 minutter).
English: Distearoylphosphatidylcholine Distearoylphosphatidylglycerol Cholesterol
Danish: Distearoylphosphatidylcholin Distearoylphosphatidylglycerol Cholesterol
English: There is no specific experience in the management of overdose in patients.
Danish: Der er ingen specifik erfaring med behandling af overdosering hos patienterne.
English: Death (Grade 5) is used for some of the criteria to denote a fatality.
Danish: Død (grad 5) bruges til nogle af kriterierne som betegnelse for en letalitet.
English: These active substances act in different ways to kill cancer cells by stopping them from growing and dividing.
Danish: Disse aktive stoffer virker på forskellige måder for at dræbe kræftceller ved at forhindre dem i at vokse og dele sig.
English: • increased blood pressure or a fall in blood pressure
Danish: • forhøjet blodtryk eller fald i blodtrykket
English: Cardiac function should be closely monitored.
Danish: Hjertefunktionen skal overvåges nøje.
English: Study 301 in patients with untreated high risk AML
Danish: Studie 301 med patienter med ubehandlet højrisiko-AML
English: Each course is given as a separate infusion and can be given weeks apart.
Danish: Hver cyklus gives som en separat infusion og kan blive givet med ugers mellemrum.
English: • if you have any allergic (hypersensitivity) reactions.
Danish: • hvis du har haft allergiske reaktioner (overfølsomhed).
English: The first consolidation cycle should be administered 5 to 8 weeks after the start of the last induction.
Danish: Den første konsolideringscyklus skal administreres 5 til 8 uger efter starten på den seneste induktion.
English: Applicable special handling and disposal procedures should be followed.
Danish: Særlige gældende procedurer for håndtering og bortskaffelse skal følges.
English: It does not contain any preservatives.
Danish: Det indeholder ingen konserveringsmidler.
English: Dosing should be delayed or permanently discontinued, if necessary, as described below.
Danish: Doseringen bør om nødvendigt udsættes eller afbrydes permanent som beskrevet nedenfor.
English: Tel: +44 8450305089 Email: medinfo-int@jazzpharma.com
Danish: Tlf.: +44 8450305089 E-mail: medinfo-int@jazzpharma.com
English: The medicinal product name and dose should be verified prior to administration to avoid dosing errors.
Danish: Lægemidlets navn og dosis bør bekræftes inden administration for at undgå doseringsfejl.
English: The mechanism of action is not completely understood, but it appears that ara-CTP acts primarily through inhibition of DNA synthesis.
Danish: Virkningsmekanismen er ikke helt forstået, men det forekommer, at ara-CTP primært virker gennem hæmning af DNA-syntese.
English: The primary endpoint was overall survival measured from the date of randomisation to death from any cause.
Danish: Det primære endemål var den samlede overlevelse, målt fra randomiseringsdatoen til dødsfald uanset årsag.
English: The infusion should not be restarted.
Danish: Infusionen må ikke genstartes.
English: • if you have low numbers of platelets, red or white blood cells in your blood (you will have a blood test before starting treatment).
Danish: • hvis du har lave antal af blodplader, røde eller hvide blodlegemer i dit blod (du vil få taget en blodprøve, inden behandlingen starter).
English: This medicine will be given to you in a hospital by a doctor or nurse.
Danish: Du vil få dette lægemiddel på et hospital, hvor det bliver givet af en læge eller sygeplejerske.
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); not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres som følger: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • cancer medicines that can affect your heart, such as doxorubicin.
Danish: • kræftmedicin, der kan påvirke dit hjerte, for eksempel doxorubicin
English: • medicines that can affect your liver.
Danish: • medicin, som kan påvirke din lever
English: Unused portions should not be saved for later administration.
Danish: Ubrugte portioner må ikke gemmes til senere brug.
English: The product is intended for single use only.
Danish: Produktet er kun beregnet til engangsbrug.
English: Plasma protein binding was not evaluated.
Danish: Plasmaproteinbindingen blev ikke undersøgt.
English: There may be residual product remaining in the vial.
Danish: Der kan stadig være restprodukt i hætteglasset.
English: This limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum.
Danish: Denne grænse forekommer lavere (400 mg/m2) hos patienter, som har fået strålebehandling på mediastinum.
English: Insufficient pharmacokinetic data were collected in paediatric patients to draw conclusions.
Danish: Der blev ikke indsamlet tilstrækkelige farmakokinetiske data fra pædiatriske patienter til at drage nogen konklusioner.
English: The pharmacokinetics of each medicinal product was based on total plasma concentrations (i.e., encapsulated plus unencapsulated medicinal product).
Danish: Hvert lægemiddels farmakokinetik var baseret på totale plasmakoncentrationer (dvs. indkapslet plus uindkapslet lægemiddel).
English: • if you have ever had a heart problem or heart attack, or you have previously taken ‘anthracycline' cancer medicines.
Danish: • hvis du nogensinde har haft hjerteproblemer eller et hjerteanfald, eller du tidligere har fået kræftmedicin, der kaldes for antracykliner.
English: Complete response rate
Danish: Komplet respons-rate
English: The incidence of fatal infections was 6.9%.
Danish: Forekomsten af letale infektioner var 6,9%.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: • if you have had problems with your kidneys or liver.
Danish: • hvis du har haft problemer med nyrer eller lever.
English: If this applies to you, your doctor may check your heart before starting, and during treatment.
Danish: Hvis det gælder for dig, vil din læge muligvis kontrollere dit hjerte, inden behandlingen starter og under behandlingen.
English: Your doctor or nurse will work out your dose of the medicine based on your weight and height.
Danish: Din læge eller sundhedspersonalet vil beregne din dosis af medicinen på baggrund af din vægt og højde.
English: This medicinal product could have potential risk for the environment due to the cytotoxic and antimitotic activities, which could induce possible reproductive effects.
Danish: Dette lægemiddel kan potentielt udgøre en risiko for miljøet på grund af de cytotoksiske og antimitotiske aktiviteter, der muligvis kan fremkalde virkninger på reproduktionsevnen.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis det sker, må du ikke køre bil, motorcykel eller cykle eller bruge værktøj og maskiner.
English: Therefore, caution is recommended when driving or operating machines.
Danish: Der tilrådes derfor til forsigtighed i forbindelse med kørsel og betjening af maskiner.
English: • slow, fast, or irregular heartbeat, chest pain (which may be a sign of infection)
Danish: • langsom, hurtig eller uregelmæssig hjerterytme, brystsmerter (som kan være et tegn på infektion)
English: Therefore you must tell your doctor immediately if you experience:
Danish: Du skal derfor straks fortælle det til din læge, hvis du får:
English: Unopened vials 2 years.
Danish: Uåbnede hætteglas 2 år.
English: Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved.
Danish: Toksicitet er klassificeret som let (grad 1), moderat (grad 2), alvorlig (grad 3) eller livstruende (grad 4) med parametre, der er specifikke alt efter det involverede organsystem.
English: The attainment of a normal-appearing bone marrow may require more than one induction course.
Danish: Opnåelse af normalt udseende knoglemarv kan kræve mere end én induktionscyklus.
English: • on days 1 and 3 as subsequent course of induction therapy, if needed.
Danish: • på dag 1 og 3 som efterfølgende cyklusser af induktionsbehandling, om nødvendigt
English: • Do not use this medicine if you notice any particles in the diluted solution.
Danish: • Brug ikke dette lægemiddel, hvis der er partikler i den fortyndede opløsning.
English: • chills, low body temperature, or high body temperature
Danish: • kulderystelser, lav kropstemperatur eller høj kropstemperatur
English: In any case, cardiologic examination and a blood count are recommended in foetuses and newborns born to mothers who received treatment during pregnancy.
Danish: Under alle omstændigheder anbefales hjerteundersøgelse og blodtælling hos fostre og nyfødte af mødre, der har fået behandling under graviditeten.
English: Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction is required.
Danish: En undersøgelse af knoglemarven efter restituering fra den foregående cyklus af induktionsbehandling bestemmer, om yderligere en induktionscyklus er påkrævet.
English: Gastrointestinal mucositis and diarrhoea
Danish: Gastrointestinal mucositis og diaré
English: A second induction was highly recommended for patients who did not achieve a CR or CRi in the first induction course and was mandatory for patients achieving greater than 50% reduction in percent blasts.
Danish: En ekstra induktion blev anbefalet på det kraftigste for patienter, der ikke opnåede CR eller CRi i den første induktionscyklus, og var obligatorisk for patienter, der opnåede et fald på mere end 50% i blastceller.
English: A subsequent course of induction may be administered in patients who do not show disease progression or unacceptable toxicity.
Danish: En efterfølgende induktionscyklus kan administreres til patienter, der ikke udviser sygdomsprogression eller uacceptabel toksicitet.
English: The study included 2 phases, 1) Treatment Phase during which patients received up to 2 induction and 2 consolidation courses, and 2) a Follow-up Phase, which began 30 days after the last induction or consolidation course and continued for up to 5 years from randomisation.
Danish: Studiet havde to faser; 1) behandlingsfasen, hvori patienterne fik op til 2 induktions- og 2 konsolideringscyklusser; og 2) en opfølgningsfase, der startede 30 dage efter den sidste induktions- eller konsolideringscyklus og fortsatte i op til 5 år efter randomisering.
English: Daunorubicin per dose
Danish: Daunorubicin pr. dosis
English: Post-remission therapy with haematopoietic stem cell transplantation (HSCT) was permitted either in place of or after consolidation chemotherapy.
Danish: Behandling efter remission med hæmatopoietisk stamcelletransplantation (HSCT) var tilladt enten i stedet for eller efter konsolideringskemoterapi.
English: The accumulation ratio was 1.3 for daunorubicin and 1.4 for cytarabine.
Danish: Akkumuleringsratio var 1,3 for daunorubicin og 1,4 for cytarabin.
English: ADRs have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical studies.
Danish: Bivirkninger er anført under den relevante kategori i nedenstående tabel efter den højeste kategori, der er observeret i alle de kliniske hovedstudier.
English: Environmental risk assessment has shown that Vyxeos liposomal is not anticipated to have the potential to be persistent, bioaccumulative, or toxic to the environment.
Danish: En miljørisikovurdering har vist, at Vyxeos liposomal ikke forventes at have potentiale til at være persistent, bioakkumulerende eller toksisk for miljøet.
English: Kaplan-Meier curve for overall survival, ITT population
Danish: Figur 1: Kaplan-Meier-kurve for samlet overlevelse, ITT-population
English: Pneumonia, sepsis and bacteriaemia were the most frequently seen serious infection ADRs in the clinical studies population.
Danish: Pneumoni, sepsis og bakteriæmi var de hyppigst observerede alvorlige infektionsreaktioner i den kliniske studiepopulation.
English: No dose adjustment is required in elderly patients (≥65 years) (see section 5.2).
Danish: Der er ikke behov for justering af dosis til ældre patienter (≥ 65 år) (se pkt.
English: Patients should be monitored for haematologic response and toxicities.
Danish: Patienterne skal monitoreres for hæmatologisk respons og toksiciteter.
English: Recommended dosing schedule for consolidation
Danish: Anbefalet doseringsskema for konsolidering
English: • After reconstitution, let it rest for 15 minutes.
Danish: • Lad det hvile i 15 minutter efter rekonstituering.
English: Immunosuppressant effects/Increased susceptibility to infections Administration of live or live-attenuated vaccines in patients that are immunocompromised by chemotherapeutic agents may result in serious or fatal infections.
Danish: Immunsupprimerende virkninger/øget følsomhed over for infektioner Administration af levende eller levende svækkede vacciner til patienter, der er immunkompromitterede på grund af kemoterapeutika, kan medføre alvorlige eller letale infektioner.
English: Packaging them in liposomes prolongs their action in the body and helps them to enter and kill the cancer cells.
Danish: Ved at pakke dem ind i liposomer forlænges deres virkning i kroppen, og de kan bedre komme ind i kræftcellerne og dræbe dem.
English: Pharmacotherapeutic group: other antineoplastic agents, combinations of antineoplastic agents, ATC code: L01XY01.
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske midler, kombinationer af antineoplastiske midler, ATC-kode: L01XY01.
English: It should be taken into consideration that the absorption of oral accompanying medicinal products may be considerably influenced by gastrointestinal mucositis and/or diarrhoea frequently occurring in association with intensive chemotherapy.
Danish: Der skal tages højde for, at absorptionen af orale samtidige lægemidler kan blive påvirket markant af gastrointestinal mucositis og/eller diaré, som ofte opstår i forbindelse med intensiv kemoterapi.
English: The demographic and baseline disease characteristics were generally balanced between the study arms.
Danish: Demografi og sygdomskarakteristika ved baseline var generelt afbalanceret mellem de to studiearme.
English: Assessment of cardiac function prior to start of treatment is recommended, especially in patients with a high risk of cardiac toxicity.
Danish: Undersøgelse af hjertefunktion inden behandlingsstart anbefales, især hos patienter med høj risiko for kardiotoksicitet.
English: The number of inductions and consolidations a patient received depended upon Complete Response (CR) or Complete Response with incomplete recovery (CRi), which was confirmed by bone marrow assessment.
Danish: Det antal induktioner og konsolideringer, en patient fik, afhang af komplet respons (CR) eller komplet respons med ufuldstændig genoprettelse (CRi), der blev bekræftet med knoglemarvsundersøgelser.
English: The most frequently reported hypersensitivity ADRs were rash and the majority of these were not serious (38.9%).
Danish: De hyppigst indberettede overfølsomhedsreaktioner var udslæt, og størstedelen af disse var ikke alvorlige (38,9%).
English: Cardiotoxicity (72) Arrhythmia a
Danish: Kardiotoksicitet (72) Arytmi a
English: Uncommon side effects (may affect up to 1 in 100 people): • numbness and rash in the hands and feet (palmar-plantar erythrodysaesthesia syndrome).
Danish: Ikke almindelige bivirkninger (kan ramme op til 1 ud af 100 personer): • følelsesløshed og udslæt på hænder og fødder (palmoplantar erytrodysæstesi-syndrom).
English: Vyxeos liposomal demonstrated superiority in overall survival in the ITT population compared with the comparator 7+3 treatment regimen (Figure 1).
Danish: Vyxeos liposomal udviste superioritet i samlet overlevelse i ITT-populationen sammenlignet med komparatoren med behandlingsregimenet 7+3 (figur 1).
English: • on days 1, 3, and 5 as the first course of induction therapy.
Danish: • på dag 1, 3 og 5 som første cyklus af induktionsbehandling
English: Vyxeos liposomal is not recommended for use in children and adolescents under 18 years.
Danish: Vyxeos liposomal anbefales ikke til børn og unge under 18 år.
English: FLT3 mutation was identified in 15% (43/279) of patients tested and NPM1 mutation was identified in 9% (25/283) patients tested.
Danish: FLT3-mutation blev identificeret hos 15% (43/279) af de testede patienter, og NPM1-mutation blev identificeret hos 9% (25/283) af de testede patienter.
English: The randomised patients had a median age of 68 (range 60-75 years), 61% were male, and 88% had an ECOG performance status of 0-1.
Danish: De randomiserede patienter havde en medianalder på 68 (inden for intervallet 60-75 år), 61% var mænd, og 88% havde en ECOG performance status på 0-1.
English: Your doctor will monitor you during treatment.
Danish: Din læge vil overvåge dig under behandlingen.
English: • problems with your sight, blurred vision
Danish: • problemer med synet, sløret syn
English: • The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visual particulates.
Danish: • Det rekonstituerede produkt skal være en uigennemsigtig, violet, homogen dispersion, der ikke i væsentlig grad indeholder synlige partikler.
English: Incorporation into DNA and RNA may also contribute to cytarabine cytotoxicity.
Danish: Indarbejdning i DNA og RNA kan også bidrage til cytarabins cytotoksicitet.
English: Women of childbearing potential should use effective contraception while they or their male partner undergo treatment.
Danish: Kvinder i den fertile alder skal bruge sikker kontraception, mens de eller deres mandlige partner er i behandling.
English: Although central nervous system (CNS) and cardiovascular system parameters were included in these studies, given the observed morbidity and mortality, there was insufficient information to arrive at an integrated assessment of safety pharmacology of Vyxeos liposomal.
Danish: Selvom parametre for centralnervesystem (CNS) og det kardiovaskulære system blev inkluderet i disse studier, var der i lyset af den observerede morbiditet og mortalitet ikke tilstrækkelig information til at nå frem til en helhedsvurdering af Vyxeos liposomal' sikkerhedsfarmakologi.
English: When the patient is retreated, Vyxeos liposomal should be given at the same dose and rate and with premedication.
Danish: Når patienten igen behandles, skal Vyxeos liposomal gives i samme dosis og hastighed og med præmedicinering.
English: For classification of ADRs which occur at Grades 3-5, a comprehensive listing is available from the NCI at NCI CTCAE.
Danish: Hvad angår klassificering af bivirkninger, der opstår som grad 3-5, fås en omfattende liste fra NCI (NCI CTCAE).
English: Your doctor will monitor you with regards to your general health during treatment and may also give you other medicines to support your treatment, either before or with Vyxeos liposomal.
Danish: Din læge vil kontrollere dig hvad angår dit generelle helbred under behandlingen og vil muligvis også give dig anden medicin til at understøtte din behandling - enten inden behandling med Vyxeos liposomal eller samtidigt.
English: It must not be administered via an intramuscular, intrathecal, or subcutaneous route.
Danish: Det må ikke administreres via intramuskulær, intratekal eller subkutan vej.
English: A subsequent course of consolidation may be administered in patients who do not show disease progression or unacceptable toxicity within the range of 5 to 8 weeks after the start of the first consolidation.
Danish: Der kan administreres en efterfølgende konsolideringscyklus til patienter, der ikke udviser sygdomsprogression eller uacceptabel toksicitet inden for intervallet 5 til 8 uger efter starten på den første konsolideringsbehandling.
English: There were 153 patients randomised to Vyxeos liposomal and 156 patients randomised to the 7+3 control arm.
Danish: Der blev randomiseret 153 patienter til Vyxeos liposomal og 156 patienter til 7+3-kontrolarmen.
English: Arrhythmia a
Danish: Arytmi a