FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, from a microbiological point of view, the solution should be used immediately.
Danish: Ud fra et mikrobiologisk perspektiv skal injektionsvæsken anvendes straks efter rekonstitution.
English: Discard the vial and reconstitution needle together into the sharps disposal container.
Danish: Bortskaf hætteglasset og rekonstitutionskanylen i affaldsbeholderen til skarpe genstande.
English: SOLVENT PREFILLED SYRINGE LABEL
Danish: Fyldt injektionssprøjte med solvens, etiket
English: Gallbladder and bile ducts
Danish: Galdeblære og galdegange
English: After reconstitution, the solution should be used immediately.
Danish: Injektionsvæsken skal anvendes straks efter rekonstitution.
English: As a precautionary measure it is preferable to avoid the use of Revestive during breast-feeding.
Danish: For en sikkerheds skyld bør Revestive undgås under amning.
English: Revestive 5 mg powder for solution for injection teduglutide
Danish: Revestive 5 mg pulver til injektionsvæske, opløsning teduglutid
English: Use this medicine exactly as your doctor has told you.
Danish: Brug lægemidlet nøjagtigt efter lægens anvisning.
English: Thirty (30) of the 43 teduglutide-treated patients from the pivotal study who entered the extension study completed a total of 30 months of treatment.
Danish: 30 af de 43 teduglutid-behandlede patienter fra det pivotale studie, som indgik i forlængelsesstudiet, gennemførte behandling i 30 måneder i alt. Ud af disse opnåede 28 patienter (93 %) en reduktion i parenteral støtte på 20 % eller derover.
English: Revestive 5 mg powder and solvent for solution for injection Teduglutide
Danish: Revestive 5 mg pulver og solvens til injektionsvæske, opløsning Teduglutid
English: After reconstitution, each vial contains 1.25 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml.
Danish: Efter rekonstitution indeholder hvert hætteglas 1,25 mg teduglutid i 0,5 ml injektionsvæske, hvilket svarer til en koncentration på 2,5 mg/ml.
English: - if you have other severe diseases that are not well controlled.
Danish: hvis du lider af andre alvorlige sygdomme, som ikke er velkontrollerede, vil din læge tage hensyn hertil før ordination af denne medicin.
English: After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
Danish: Efter rekonstitution indeholder hvert hætteglas 5 mg teduglutid i 0,5 ml injektionsvæske, hvilket svarer til en koncentration på 10 mg/ml.
English: If polyps are found either before or during your treatment with Revestive, your doctor will decide whether you should continue using this medicine.
Danish: Din læge vil afgøre om du skal fortsætte med behandlingen med Revestive, hvis der konstateres polypper enten før eller under din behandling med denne medicin.
English: - Keep Revestive out of the sight and reach of children.
Danish: - Opbevar Revestive utilgængeligt for børn.
English: After reconstitution, each vial contains 5 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
Danish: Efter opløsning indeholder hvert hætteglas 5 mg teduglutid i 0,5 ml injektionsvæske, hvilket svarer til en koncentration på 10 mg/ml.
English: No dose adjustment is necessary for paediatric patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B adult subjects.
Danish: På baggrund af et studie udført hos voksne personer med Child Pugh klasse B er det vist, at dosisjustering ikke er nødvendig til pædiatriske patienter med let til moderat nedsat leverfunktion.
English: If polyps are found before your treatment with Revestive, your doctor will decide whether you should use this medicine.
Danish: Hvis der findes polypper, før du behandles med Revestive, vil lægen afgøre, om du skal bruge dette lægemiddel eller ej. Du må ikke få Revestive, hvis der påvises kræft ved koloskopien.
English: Intravenous use
Danish: Paknings-størrelse subkutan eller intravenøs anvendelse intravenøs anvendelse
English: The full EPAR for Zoledronic acid medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zoledronsyre medac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronsyre medac den 3. august 2012.
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 Zoledronic acid medac.
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, hvordan Zoledronsyre medac skal bruges.
English: This means that Zoledronic acid medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Danish: Det betyder, at Zoledronsyre medac er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zometa.
English: The usual dose of Zoledronic acid medac is one infusion of 4 mg over at least 15 minutes.
Danish: Den normale dosis Zoledronsyre medac er én infusion på 4 mg over mindst 15 minutter.
English: A risk management plan has been developed to ensure that Zoledronic acid medac is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronsyre medac anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronsyre medac.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid medac has been shown to have comparable quality and to be bioequivalent to Zometa.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronsyre medac er af sammenlignelig kvalitet og er bioækvivalent med Zometa.
English: It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.
Danish: Det fås som en 4 mg/100 ml infusionsvæske, opløsning (drop i en vene), og som et 4 mg/5 ml koncentrat til infusionsvæske, opløsning.
English: In addition, the company that markets Zoledronic acid medac will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Danish: Virksomheden, som markedsfører Zoledronsyre medac, vil desuden udarbejde et patientkort med oplysninger om risikoen for osteonekrose i kæben (beskadigelse af kæbebenene, der kan medføre smerter, sår i munden eller løse tænder) og en instruks til patienter om at kontakte deres læge, hvis de oplever symptomer.
English: For more information about treatment with Zoledronic acid medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zoledronsyre medac, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoledronsyre medac, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Zoledronic acid medac must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Danish: Zoledronsyre medac må kun anvendes af en læge med erfaring i brugen af denne type lægemiddel, som indgives i en vene.
English: No additional studies were needed as Zoledronic acid medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Danish: Der krævedes ingen supplerende undersøgelser, da Zoledronsyre medac er et generisk lægemiddel, der gives ved infusion og indeholder det samme aktive stof som referencelægemidlet Zometa.
English: Zoledronic acid medac can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Danish: Zoledronsyre medac kan anvendes til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
English: Because Zoledronic acid medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Zoledronsyre medac er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Zoledronic acid medac, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zoledronsyre medac, zoledronsyre, er et bisphosphonat.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid medac?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronsyre medac?
English: Zoledronic acid medac is a ‘generic medicine'.
Danish: Zoledronsyre medac er et "generisk lægemiddel".
English: Zoledronic acid medac is a medicine that contains the active substance zoledronic acid.
Danish: Zoledronsyre medac er et lægemiddel, der indeholder det aktive stof zoledronsyre.
English: What are the benefits and risks of Zoledronic acid medac?
Danish: Hvilke fordele og risici er der forbundet med Zoledronsyre medac?
English: By preventing the breakdown of bones, Zoledronic acid medac also helps to reduce the amount of calcium released into the blood.
Danish: Idet Zoledronsyre medac forebygger nedbrydningen af knoglerne, hjælper det samtidig med at reducere den mængde calcium, der afgives til blodet.
English: The Committee recommended that Zoledronic acid medac be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronsyre medac.
English: Other information about Zoledronic acid medac
Danish: Andre oplysninger om Zoledronsyre medac
English: Zoledronic acid medac zoledronic acid
Danish: Zoledronsyre medac zoledronsyre
English: Zoledronic acid medac can also be used to treat the hypercalcaemia caused by tumours.
Danish: Zoledronsyre medac kan også anvendes til at behandle forhøjet calciumindhold i blodet, der skyldes svulster (tumorer).
English: Why has Zoledronic acid medac been approved?
Danish: Hvorfor blev Zoledronsyre medac godkendt?
English: What is Zoledronic acid medac?
Danish: Hvad er Zoledronsyre medac?
English: How has Zoledronic acid medac been studied?
Danish: Hvordan blev Zoledronsyre medac undersøgt?
English: How does Zoledronic acid medac work?
Danish: Hvordan virker Zoledronsyre medac?
English: What is Zoledronic acid medac used for?
Danish: Hvad anvendes Zoledronsyre medac til?
English: How is Zoledronic acid medac used?
Danish: Hvordan anvendes Zoledronsyre medac?
English: It is taken once a day, consistently either in the morning or in the evening.
Danish: Det tages én gang dagligt, konsekvent enten om morgenen eller om aftenen.
English: The dose is then gradually increased until the disease is controlled well enough.
Danish: Derefter øges dosis gradvist, indtil sygdommen er tilstrækkeligt kontrolleret.
English: Sprycel received a marketing authorisation valid throughout the European Union on 20 November
Danish: Sprycel fik en markedsføringstilladelse med gyldighed i hele EU den 20. november 2006.
English: Further information on Sprycel can be found on the Agency's website ema.europa.eu/medicines/human/EPAR/Sprycel.
Danish: Yderligere information om Sprycel findes på agenturets websted under ema.europa.eu/medicines/human/EPAR/Sprycel.
English: Sprycel is also used in children to treat:
Danish: Sprycel anvendes også hos børn til behandling af:
English: None of these studies compared Sprycel with another medicine.
Danish: Ingen af disse studier sammenlignede Sprycel med et andet lægemiddel.
English: Other information about Sprycel
Danish: Andre oplysninger om Sprycel
English: Such events were: any sign of the disease in bone marrow, return of the disease anywhere in the body, a second cancer or death.
Danish: Disse hændelser var: tegn på sygdommen i knoglemarven, tilbagevenden af sygdommen hvor som helst i kroppen, en anden kræftsygdom eller død.
English: What measures are being taken to ensure the safe and effective use of Sprycel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sprycel?
English: The doses for Sprycel tablets and suspension are not the same.
Danish: Dosen af Spryceltabletterne og -suspensionen er ikke den samme.
English: As for all medicines, data on the use of Sprycel are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Sprycel løbende overvåget.
English: What is Sprycel and what is it used for?
Danish: Hvad er Sprycel, og hvad anvendes det til?
English: The European Medicines Agency decided that Sprycel's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Sprycel opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Sprycel are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Sprycel vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The starting dose depends on the condition being treated and, for children, their body weight.
Danish: Startdosis afhænger af, hvilken tilstand der behandles, og for børn deres kropsvægt.
English: An overview of Sprycel and why it is authorised in the EU
Danish: En oversigt over Sprycel, og hvorfor det er godkendt i EU
English: Sprycel is a cancer medicine.
Danish: Sprycel er et lægemiddel mod kræft.
English: For more information about using Sprycel, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Sprycel, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Why is Sprycel authorised in the EU?
Danish: Hvorfor blev Sprycel godkendt i EU?
English: The main measure of effectiveness was the proportion of patients who did not have an unwanted event within 3 years of treatment.
Danish: Virkningen blev hovedsageligt målt på andelen af patienter, der ikke havde en uønsket hændelse inden for 3 år efter behandlingen.
English: Among patients treated with Sprycel and chemotherapy, 66% did not have an unwanted event.
Danish: Blandt de patienter, der blev behandlet med Sprycel og kemoterapi, oplevede 66 % ikke en uønsket hændelse.
English: What are the risks associated with Sprycel?
Danish: Hvilke risici er der forbundet med Sprycel?
English: Treatment is stopped if the medicine no longer controls the condition or if the patient cannot take the medicine because of side effects.
Danish: Behandlingen stoppes, hvis lægemidlet ikke længere holder tilstanden under kontrol, eller hvis patienten ikke kan tage lægemidlet på grund af bivirkninger.
English: Sprycel is available as tablets (20, 50, 70, 80, 100 and 140 mg) and a powder to make up a suspension (10 mg/ml) to be taken by mouth.
Danish: Sprycel fås som tabletter (20, 50, 70, 80, 100 og 140 mg) og som pulver til fremstilling af en suspension (10 mg/ml), der tages gennem munden.
English: The doctor may reduce the dose or interrupt treatment if blood cell counts are too low or certain side effects occur.
Danish: Lægen kan nedsætte dosis eller afbryde behandlingen, hvis antallet af blodlegemer er for lavt, eller der opstår visse bivirkninger.
English: The most common side effects with Sprycel (seen in more than 1 patient in 10) are infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), abdominal pain (belly ache), skin rash, musculoskeletal pain, tiredness, swelling in the legs and arms and in the face, fever.
Danish: De hyppigste bivirkninger ved Sprycel (som optræder hos mere end 1 ud af 10 patienter) er infektioner, undertrykkelse af knoglemarven (faldende antal blodlegemer), hovedpine, blødning, væskeansamling ved lungerne (pleuraekssudat), vejrtrækningsbesvær (dyspnø), diarré, opkastning, kvalme, mavesmerter, hududslæt, muskuloskeletale smerter, træthed, hævelse i ben og arme og ansigt, feber.
English: Sprycel can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of leukaemia.
Danish: Sprycel udleveres kun efter recept, og behandlingen bør indledes af en læge med erfaring i diagnosticering og behandling af leukæmi.
English: In children with ALL who are also receiving other cancer medicines, a fixed dose of Sprycel is used throughout their treatment.
Danish: Hos børn med ALL, der også får andre lægemidler mod kræft, gives der en fast dosis af Sprycel under hele behandlingen.
English: In addition, the number of white blood cells containing the Philadelphia chromosome was reduced in around 33 to 66% of treated patients in the five main studies.
Danish: Desuden faldt antallet af hvide blodlegemer, der indeholder Philadelphiakromosomet, hos ca. 33-66 % af de behandlede patienter i de fem studier.
English: • CML in ‘chronic', ‘accelerated' and ‘blast' phases.
Danish: • CML i "kronisk", "accelereret" og "blast"-fase.
English: Sprycel was more effective than imatinib: within one year, 77% of patients receiving Sprycel no longer had the Philadelphia chromosome in their blood cells, compared with 66% of patients receiving imatinib.
Danish: Sprycel var mere effektivt end imatinib: i løbet af et år havde 77 % af de patienter, der fik Sprycel, ikke længere Philadelphiakromosomet i deres blodlegemer, sammenholdt med 66 % af dem, der fik imatinib.
English: Sprycel contains the active substance dasatinib.
Danish: Sprycel indeholder det aktive stof dasatinib.
English: • newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Danish: • nydiagnosticeret Ph+-ALL i kombination med kemoterapi (kræftlægemiddel).
English: The active substance in Sprycel, dasatinib, belongs to a group of medicines that block enzymes known as protein kinases.
Danish: Det aktive stof i Sprycel, dasatinib, tilhører en gruppe af lægemidler, der blokerer enzymer kaldet proteinkinaser.
English: The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working.
Danish: De fem hovedstudier med Sprycel hos voksne omfattede 515 patienter, som alle havde fået behandling med imatinib, der ikke virkede eller var holdt op med at virke.
English: This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably.
Danish: Dette enzym produceres af leukæmiceller og bevirker, at de formerer sig uhæmmet.
English: In a study involving 106 children and adolescents with newly diagnosed Ph+ ALL, patients were treated with Sprycel and chemotherapy.
Danish: I et studie med 106 børn og unge med nydiagnosticeret Ph+-ALL blev patienterne behandlet med Sprycel og kemoterapi.
English: In comparison, using results of previous studies, the figure was 49% in patients who had received chemotherapy alone and 59% in patients who had received imatinib and chemotherapy.
Danish: Sammenlignet med resultaterne fra tidligere studier var tallet 49 % hos patienter, der kun havde fået kemoterapi, og 59 % hos patienter, der havde fået imatinib og kemoterapi.
English: Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects.
Danish: Sprycel i engangsdosering og togangsdosering havde samme virkning, men engangsdoseringen gav færre bivirkninger.
English: By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells.
Danish: Ved at blokere Bcr-Abl-kinase og andre kinaser medvirker Sprycel til at nedbringe antallet af leukæmiceller.
English: • newly diagnosed Ph+ CML in the ‘chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
Danish: • nydiagnosticeret Ph+-CML i den "kroniske" fase, eller Ph+-CML, når andre behandlinger, herunder imatinib, ikke kan gives eller ikke har virket
English: Dasatinib acts mainly by blocking the Bcr-Abl protein kinase.
Danish: Dasatinib virker hovedsagelig ved at blokere proteinkinasen Bcr-Abl.
English: In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, around 25 to 33% of the patients had complete response.
Danish: Hos patienter med CML i andre faser (accelereret fase, myeloid blastfase og lymfoid blastfase) og med ALL opnåedes fuldstændig respons hos ca. 25-33 % af patienterne.
English: How is Sprycel used?
Danish: Hvordan anvendes Sprycel?
English: For the full list of side effects and restrictions with Sprycel, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Sprycel fremgår af indlægssedlen.
English: • chronic myeloid leukaemia (CML) in the ‘chronic' phase in newly diagnosed patients who are ‘Philadelphia chromosome positive' (Ph+).
Danish: • kronisk myeloid leukæmi (CML) i "kronisk" fase hos nydiagnosticerede patienter, som er "Philadelphiakromosompositive" (Ph+).
English: In the larger main study of patients with chronic phase CML, blood levels of platelets and white blood cells returned to within normal values in 90% of the patients.
Danish: I det store hovedstudie med patienter med CML i kronisk fase, vendte blodets indhold af blodplader og hvide blodlegemer tilbage til det normale hos 90 % af patienterne.
English: • Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast' CML.
Danish: • Ph+-akut lymfoblastisk leukæmi (ALL), hvor en anden type hvide blodlegemer (lymfocytter) dannes for hurtigt, eller ved "lymfoid blast"-CML.
English: A response was seen in around 90% of patients who could not use imatinib or it had not worked, and in 94% of newly diagnosed patients.
Danish: Der sås en bedring hos ca. 90 % af de patienter, som ikke kunne få eller ikke reagerede på imatinib, og hos 94 % af de nydiagnosticerede patienter.
English: In CML, granulocytes (a type of white blood cell) start growing out of control.
Danish: Ved CML begynder en type hvide blodlegemer (granulocytter) at vokse ukontrolleret.
English: Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph+ ALL.
Danish: Yderligere to studier sammenlignede virkningerne af Sprycel taget én eller to gange om dagen, det ene hos 670 patienter med CML i kronisk fase, det andet hos 611 patienter med fremskreden CML eller Ph+-ALL.
English: Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
Danish: Sprycel anvendes, når andre behandlinger, herunder imatinib (et andet lægemiddel mod kræft) ikke virker eller giver uacceptable bivirkninger
English: Sprycel is used when other treatments do not work or cause troublesome side effects.
Danish: Sprycel anvendes, når andre behandlinger ikke virker eller giver uacceptable bivirkninger.