natgillin/translations-raw huggingface dataset:
28 hætteglas med 1,25 mg teduglutid som pulver 28 fyldte injektionssprøjter med solvens
Materials provided in the pack: - 28 vials with 1.25 mg teduglutide as a powder - 28 pre-filled syringes with solvent
Ud fra et mikrobiologisk perspektiv skal injektionsvæsken anvendes straks efter rekonstitution.
After reconstitution, from a microbiological point of view, the solution should be used immediately.
Bortskaf hætteglasset og rekonstitutionskanylen i affaldsbeholderen til skarpe genstande.
Discard the vial and reconstitution needle together into the sharps disposal container.
Fyldt injektionssprøjte med solvens, etiket
SOLVENT PREFILLED SYRINGE LABEL
Galdeblære og galdegange
Gallbladder and bile ducts
Injektionsvæsken skal anvendes straks efter rekonstitution.
After reconstitution, the solution should be used immediately.
For en sikkerheds skyld bør Revestive undgås under amning.
As a precautionary measure it is preferable to avoid the use of Revestive during breast-feeding.
Revestive 5 mg pulver til injektionsvæske, opløsning teduglutid
Revestive 5 mg powder for solution for injection teduglutide
Brug lægemidlet nøjagtigt efter lægens anvisning.
Use this medicine exactly as your doctor has told you.
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.
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.
Revestive 5 mg pulver og solvens til injektionsvæske, opløsning Teduglutid
Revestive 5 mg powder and solvent for solution for injection Teduglutide
Efter rekonstitution indeholder hvert hætteglas 1,25 mg teduglutid i 0,5 ml injektionsvæske, hvilket svarer til en koncentration på 2,5 mg/ml.
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.
hvis du lider af andre alvorlige sygdomme, som ikke er velkontrollerede, vil din læge tage hensyn hertil før ordination af denne medicin.
- if you have other severe diseases that are not well controlled.
Efter rekonstitution indeholder hvert hætteglas 5 mg teduglutid i 0,5 ml injektionsvæske, hvilket svarer til en koncentration på 10 mg/ml.
After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
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.
If polyps are found either before or during your treatment with Revestive, your doctor will decide whether you should continue using this medicine.
- Opbevar Revestive utilgængeligt for børn.
- Keep Revestive out of the sight and reach of children.
Efter opløsning indeholder hvert hætteglas 5 mg teduglutid i 0,5 ml injektionsvæske, hvilket svarer til en koncentration på 10 mg/ml.
After reconstitution, each vial contains 5 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
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.
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.
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.
If polyps are found before your treatment with Revestive, your doctor will decide whether you should use this medicine.
Paknings-størrelse subkutan eller intravenøs anvendelse intravenøs anvendelse
Intravenous use
Den fuldstændige EPAR for Zoledronsyre medac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronsyre medac den 3. august 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.
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.
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.
Det betyder, at Zoledronsyre medac er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zometa.
This means that Zoledronic acid medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Den normale dosis Zoledronsyre medac er én infusion på 4 mg over mindst 15 minutter.
The usual dose of Zoledronic acid medac is one infusion of 4 mg over at least 15 minutes.
Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronsyre medac anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Zoledronic acid medac is used as safely as possible.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronsyre medac.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac.
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.
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.
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.
It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.
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.
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.
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.
For more information about treatment with Zoledronic acid medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoledronsyre medac, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
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.
Zoledronsyre medac må kun anvendes af en læge med erfaring i brugen af denne type lægemiddel, som indgives i en vene.
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.
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.
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.
Zoledronsyre medac kan anvendes til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
Zoledronic acid medac can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Da Zoledronsyre medac er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
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.
Det aktive stof i Zoledronsyre medac, zoledronsyre, er et bisphosphonat.
The active substance in Zoledronic acid medac, zoledronic acid, is a bisphosphonate.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronsyre medac?
What measures are being taken to ensure the safe and effective use of Zoledronic acid medac?
Zoledronsyre medac er et "generisk lægemiddel".
Zoledronic acid medac is a ‘generic medicine'.
Zoledronsyre medac er et lægemiddel, der indeholder det aktive stof zoledronsyre.
Zoledronic acid medac is a medicine that contains the active substance zoledronic acid.
Hvilke fordele og risici er der forbundet med Zoledronsyre medac?
What are the benefits and risks of Zoledronic acid medac?
Idet Zoledronsyre medac forebygger nedbrydningen af knoglerne, hjælper det samtidig med at reducere den mængde calcium, der afgives til blodet.
By preventing the breakdown of bones, Zoledronic acid medac also helps to reduce the amount of calcium released into the blood.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronsyre medac.
The Committee recommended that Zoledronic acid medac be given marketing authorisation.
Andre oplysninger om Zoledronsyre medac
Other information about Zoledronic acid medac
Zoledronsyre medac zoledronsyre
Zoledronic acid medac zoledronic acid
Zoledronsyre medac kan også anvendes til at behandle forhøjet calciumindhold i blodet, der skyldes svulster (tumorer).
Zoledronic acid medac can also be used to treat the hypercalcaemia caused by tumours.
Hvorfor blev Zoledronsyre medac godkendt?
Why has Zoledronic acid medac been approved?
Hvad er Zoledronsyre medac?
What is Zoledronic acid medac?
Hvordan blev Zoledronsyre medac undersøgt?
How has Zoledronic acid medac been studied?
Hvordan virker Zoledronsyre medac?
How does Zoledronic acid medac work?
Hvad anvendes Zoledronsyre medac til?
What is Zoledronic acid medac used for?
Hvordan anvendes Zoledronsyre medac?
How is Zoledronic acid medac used?
Det tages én gang dagligt, konsekvent enten om morgenen eller om aftenen.
It is taken once a day, consistently either in the morning or in the evening.
Derefter øges dosis gradvist, indtil sygdommen er tilstrækkeligt kontrolleret.
The dose is then gradually increased until the disease is controlled well enough.
Sprycel fik en markedsføringstilladelse med gyldighed i hele EU den 20. november 2006.
Sprycel received a marketing authorisation valid throughout the European Union on 20 November
Yderligere information om Sprycel findes på agenturets websted under ema.europa.eu/medicines/human/EPAR/Sprycel.
Further information on Sprycel can be found on the Agency's website ema.europa.eu/medicines/human/EPAR/Sprycel.
Sprycel anvendes også hos børn til behandling af:
Sprycel is also used in children to treat:
Ingen af disse studier sammenlignede Sprycel med et andet lægemiddel.
None of these studies compared Sprycel with another medicine.
Andre oplysninger om Sprycel
Other information about Sprycel
Disse hændelser var: tegn på sygdommen i knoglemarven, tilbagevenden af sygdommen hvor som helst i kroppen, en anden kræftsygdom eller død.
Such events were: any sign of the disease in bone marrow, return of the disease anywhere in the body, a second cancer or death.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sprycel?
What measures are being taken to ensure the safe and effective use of Sprycel?
Dosen af Spryceltabletterne og -suspensionen er ikke den samme.
The doses for Sprycel tablets and suspension are not the same.
Som for alle lægemidler, er data vedrørende brug af Sprycel løbende overvåget.
As for all medicines, data on the use of Sprycel are continuously monitored.
Hvad er Sprycel, og hvad anvendes det til?
What is Sprycel and what is it used for?
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Sprycel opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Sprycel's benefits are greater than its risks and it can be authorised for use in the EU.
Bivirkninger rapporteret for Sprycel vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Sprycel are carefully evaluated and any necessary action taken to protect patients.
Startdosis afhænger af, hvilken tilstand der behandles, og for børn deres kropsvægt.
The starting dose depends on the condition being treated and, for children, their body weight.
En oversigt over Sprycel, og hvorfor det er godkendt i EU
An overview of Sprycel and why it is authorised in the EU
Sprycel er et lægemiddel mod kræft.
Sprycel is a cancer medicine.
For mere information om brug af Sprycel, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
For more information about using Sprycel, see the package leaflet or contact your doctor or pharmacist.
Hvorfor blev Sprycel godkendt i EU?
Why is Sprycel authorised in the EU?
Virkningen blev hovedsageligt målt på andelen af patienter, der ikke havde en uønsket hændelse inden for 3 år efter behandlingen.
The main measure of effectiveness was the proportion of patients who did not have an unwanted event within 3 years of treatment.
Blandt de patienter, der blev behandlet med Sprycel og kemoterapi, oplevede 66 % ikke en uønsket hændelse.
Among patients treated with Sprycel and chemotherapy, 66% did not have an unwanted event.
Hvilke risici er der forbundet med Sprycel?
What are the risks associated with Sprycel?
Behandlingen stoppes, hvis lægemidlet ikke længere holder tilstanden under kontrol, eller hvis patienten ikke kan tage lægemidlet på grund af bivirkninger.
Treatment is stopped if the medicine no longer controls the condition or if the patient cannot take the medicine because of side effects.
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.
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.
Lægen kan nedsætte dosis eller afbryde behandlingen, hvis antallet af blodlegemer er for lavt, eller der opstår visse bivirkninger.
The doctor may reduce the dose or interrupt treatment if blood cell counts are too low or certain side effects occur.
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.
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.
Sprycel udleveres kun efter recept, og behandlingen bør indledes af en læge med erfaring i diagnosticering og behandling af leukæmi.
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.
Hos børn med ALL, der også får andre lægemidler mod kræft, gives der en fast dosis af Sprycel under hele behandlingen.
In children with ALL who are also receiving other cancer medicines, a fixed dose of Sprycel is used throughout their treatment.
Desuden faldt antallet af hvide blodlegemer, der indeholder Philadelphiakromosomet, hos ca. 33-66 % af de behandlede patienter i de fem studier.
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.
• CML i "kronisk", "accelereret" og "blast"-fase.
• CML in ‘chronic', ‘accelerated' and ‘blast' phases.
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.
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.
Sprycel indeholder det aktive stof dasatinib.
Sprycel contains the active substance dasatinib.
• nydiagnosticeret Ph+-ALL i kombination med kemoterapi (kræftlægemiddel).
• newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Det aktive stof i Sprycel, dasatinib, tilhører en gruppe af lægemidler, der blokerer enzymer kaldet proteinkinaser.
The active substance in Sprycel, dasatinib, belongs to a group of medicines that block enzymes known as protein kinases.
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.
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.
Dette enzym produceres af leukæmiceller og bevirker, at de formerer sig uhæmmet.
This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably.
I et studie med 106 børn og unge med nydiagnosticeret Ph+-ALL blev patienterne behandlet med Sprycel og kemoterapi.
In a study involving 106 children and adolescents with newly diagnosed Ph+ ALL, patients were treated with Sprycel and chemotherapy.
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.
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.
Sprycel i engangsdosering og togangsdosering havde samme virkning, men engangsdoseringen gav færre bivirkninger.
Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects.
Ved at blokere Bcr-Abl-kinase og andre kinaser medvirker Sprycel til at nedbringe antallet af leukæmiceller.
By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells.
• nydiagnosticeret Ph+-CML i den "kroniske" fase, eller Ph+-CML, når andre behandlinger, herunder imatinib, ikke kan gives eller ikke har virket
• newly diagnosed Ph+ CML in the ‘chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
Dasatinib virker hovedsagelig ved at blokere proteinkinasen Bcr-Abl.
Dasatinib acts mainly by blocking the Bcr-Abl protein kinase.
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.
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.
Hvordan anvendes Sprycel?
How is Sprycel used?
Den fuldstændige liste over bivirkninger og begrænsninger ved Sprycel fremgår af indlægssedlen.
For the full list of side effects and restrictions with Sprycel, see the package leaflet.
• kronisk myeloid leukæmi (CML) i "kronisk" fase hos nydiagnosticerede patienter, som er "Philadelphiakromosompositive" (Ph+).
• chronic myeloid leukaemia (CML) in the ‘chronic' phase in newly diagnosed patients who are ‘Philadelphia chromosome positive' (Ph+).
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.
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.
• Ph+-akut lymfoblastisk leukæmi (ALL), hvor en anden type hvide blodlegemer (lymfocytter) dannes for hurtigt, eller ved "lymfoid blast"-CML.
• Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast' CML.
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.
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.
Ved CML begynder en type hvide blodlegemer (granulocytter) at vokse ukontrolleret.
In CML, granulocytes (a type of white blood cell) start growing out of control.
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.
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.
Sprycel anvendes, når andre behandlinger, herunder imatinib (et andet lægemiddel mod kræft) ikke virker eller giver uacceptable bivirkninger
Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
Sprycel anvendes, når andre behandlinger ikke virker eller giver uacceptable bivirkninger.
Sprycel is used when other treatments do not work or cause troublesome side effects.
Der blev foretaget to studier af kronisk CML (198 og 36 patienter), ét af accelereret CML (120 patienter), ét af myeloid blast-CML (80 patienter) og ét af Ph+-ALL- og lymfoid blast-CML (81 patienter).
Two studies were in patients with chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients).
I de fleste af studierne blev patienternes reaktion på behandlingen vurderet ved at måle, om antallet af hvide blodlegemer og blodplader var ved at vende tilbage til det normale, og om antallet af hvide blodlegemer, som indeholdt Philadelphiakromosomet, var faldende.
Most of these studies assessed how well the leukaemia responded to treatment by measuring the levels of white cells and platelets in the blood, to see if they were returning to within normal levels, and by measuring the number of white blood cells that contained the Philadelphia chromosome, to see if it was decreasing.
Endnu et hovedstudie så på virkningen af Sprycel hos 113 børn med Ph+-CML i kronisk fase, herunder 29 patienter, der ikke kunne få eller ikke havde reageret på imatinib, samt 84 nydiagnosticerede børn, som ikke tidligere var blevet behandlet.
Another main study looked at the effectiveness of Sprycel in 113 children with Ph+ chronic phase CML, including 29 patients who could not use imatinib or it had not worked, as well as 84 newly diagnosed children who had not been previously treated.
Hvilke fordele viser studierne, at der er ved Sprycel?
What benefits of Sprycel have been shown in studies?