FrancophonIA/ELRC3.0 huggingface dataset:
English: Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s.r.o.)
Danish: Bicalutamid, filmovertrukne tabletter, 150 mg (Ingers Industrial Solutions s.r.o.)
English: Slovakia
Danish: Slovakien
English: 2003 RN Haarlem The Netherlands
Danish: Swensweg 5, Postbus 552 2003 RN Haarlem Nederlandene
English: The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
Danish: Den gældende tekst til produktresumé er den endelige version der er fastlagt ved behandling i koordinationsgruppen med følgende ændringer.
English: 0.75 (0.61 to 0.91)
Danish: 0,75 (0,61 til 0,91)
English: The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
Danish: Den gældende tekst til indlægsseddel er den endelige version der er fastlagt ved behandling i koordinationsgruppen med følgende ændringer.
English: 0.56 (0.40 to 0.78)
Danish: 0,56 (0,40 til 0,78)
English: Pharmachemie B.V. Swensweg 5, Postbus
Danish: Pharmachemie B.V.
English: Bicaluplex 150 mg tablets are indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Danish: Bicaluplex 150 mg tabletter er indiceret til behandling af lokalt avanceret prostatacancer med høj risiko for sygdomsprogression, enten som behandling alene eller som adjuvant behandling ved radikal prostatektomi eller ved strålebehandling (se afsnit 5.1).
English: Tablets
Danish: INDLÆGSSEDDEL
English: The effectiveness of bicalutamide 150 mg in the treatment of patients with locally advanced prostatic carcinoma without metastases, for whom primary treatment with hormones was indicated, was evaluated separately using the meta-analysis of two studies comprising 480 patients with prostatic carcinoma without metastases (M0) who had not been treated before.
Danish: Effektiviteten af bicalutamid 150 mg til behandling af patienter med lokalt avanceret prostatakarcinom uden metastaser, for hvem primær hormonbehandling var indiceret, blev evalueret separat.
English: Table 1 Progression-free survival in locally advanced disease by therapy sub-group Analysis population Events (%) in Bicalutamide patients
Danish: Tabel 1 Progressionsfri overlevelse ved lokalt avanceret sygdom pr. behandlingsundergruppe
English: Bicalutamide is a racemate, the (R)-enantiomer of which has most of the anti-androgen activity.
Danish: Den antiandrogene effekt skyldes næsten udelukkende (R)-enantiomeren.
English: Table 2 Overall survival in locally advanced disease by therapy sub-group Analysis population Deaths (%) in Bicalutamide patients
Danish: Tabel 2 Total overlevelse ved lokalt avanceret sygdom pr. behandlingsundergruppe
English: TEVA Pharma B.V., Industrieweg 23, P.O.
Danish: Teva Pharma B.V.
English: BicalutamideTEVA
Danish: PRODUKTRESUME
English: BicamidGRY 150 mg Filmtabletten
Danish: Bicamid-GRY 150 mg Filmtabletten
English: Bicalutamide 150 mg Filmcoated
Danish: Bicalutamide 150 mg Filmcoated Tablets
English: BicalutamidTeva
Danish: Bicalutamid-Teva
English: London, 21 June 2007 Doc.
Danish: London, den 21. juni 2007 Ref.dok.
English: The studies in human involved a total of 222 patients in two main studies.
Danish: Undersøgelserne hos mennesker omfattede i alt 222 patienter i to hovedundersøgelser.
English: Ref. EMEA/287136/2008
Danish: EMEA/381416/2007
English: These toxic effects can be life-threatening.
Danish: Disse giftvirkninger kan være livstruende.
English: International non-proprietary name (INN): glucarpidase
Danish: Internationalt fællesnavn (INN): glucarpidase
English: Methotrexate is used to treat a number of diseases, including some types of cancer.
Danish: Methotrexat anvendes til behandling af en række sygdomme, herunder visse kræftformer.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for VORAXAZE
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VORAXAZE
English: It contains the active substance glucarpidase.
Danish: Det indeholder det aktive stof glucarpidase.
English: The effects of Voraxaze were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Voraxaze blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The production of the medicine had moved from the factory that made the medicine used in the studies, to another factory that was to make the commercial product.
Danish: Produktionen af lægemidlet var blevet flyttet fra den fabrik, der fremstillede den medicin, der var blevet anvendt i undersøgelserne, til en anden fabrik, hvor præparatet til markedsføring skulle fremstilles.
English: What is Voraxaze?
Danish: Hvad er Voraxaze?
English: The recombinant enzyme acts in the same way as the natural carboxypeptidase G2.
Danish: Det rekombinante enzym virker på samme måde som det naturlige carboxypeptidase G2.
English: What was Voraxaze expected to be used for?
Danish: Hvad forventedes Voraxaze anvendt til?
English: Voraxaze was not compared to another treatment.
Danish: Voraxaze blev ikke sammenlignet med noget andet lægemiddel.
English: The main concerns of the CHMP were related to the manufacture of Voraxaze.
Danish: CHMP's vigtigste betænkelighed vedrørte fremstillingen af Voraxaze.
English: The Committee had concerns that this move was not yet fully organised, especially with regards to the way the production would be controlled (validation), and that the consequences of the move on the product's purity were not been fully understood.
Danish: I udvalget var der betænkelighed ved, at flytningen ikke syntes at være var helt på plads, specielt hvad angår metoden til kontrol af produktionen (validering), og at det var ikke helt klart, hvilke konsekvenser flytningen ville få for produktets renhed.
English: This helps the body eliminate excess methotrexate, and therefore reduces the potential for toxic effects.
Danish: Dette hjælper kroppen til at udskille overskydende methotrexat og mindsker derved muligheden for giftvirkninger.
English: The active substance in Voraxaze, glucarpidase, is a copy of the naturally-occurring enzyme carboxypeptidase G2. Carboxypeptidase G2 was originally found in a Pseudomonas bacterium.
Danish: Det aktive stof i Voraxaze, glucarpidase, er en kopi af det naturlige enzym carboxypeptidase G2. Carboxypeptidase G2 blev oprindeligt fundet i en bakterie af slægten Pseudomonas.
English: The glucarpidase in Voraxaze is made by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Danish: Glucarpidasen i Voraxaze fremstilles ved "rekombinant DNA-teknologi": Den produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
English: Because the number of patients with this condition is low, it is considered ‘rare', and glucarpidase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 February 2003.
Danish: Da der kun findes få patienter med denne tilstand, blev glucarpidase den 3. februar 2003 udpeget som "lægemiddel til sjældne sygdomme".
English: The company informed the CHMP that there are no consequences for patients currently included in the clinical trials of Voraxaze.
Danish: Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i de kliniske undersøgelser med Voraxaze.
English: The company also plans to continue their compassionate use programme.
Danish: Firmaet har desuden til hensigt at forsætte programmet for anvendelse med særlig udleveringstilladelse.
English: How is Voraxaze expected to work?
Danish: Hvordan forventes Voraxaze at virke?
English: On 21 May 2007, Protherics PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Voraxaze, for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Danish: Den 21. maj 2007 meddelte Protherics PLC officielt til Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Voraxaze til supplerende behandling af patienter, der er udsat for giftvirkning fra methotrexat eller risikerer at blive det.
English: It can break down methotrexate into substances that do not have any toxic effects.
Danish: Det kan nedbryde methotrexat til ugiftige stoffer.
English: The Committee also had some concern regarding the use of Voraxaze with folinic acid.
Danish: I udvalget var der desuden nogen betænkelighed vedrørende brugen af Voraxaze sammen med folinsyre.
English: Some cancer patients receive high doses, and, because of this, can experience toxic effects, such as damage to the kidneys, bone marrow suppression (leading to anaemia, an increased risk of infection and bleeding) and mucositis (an inflammation of the mucosa, the lining of organs such as the mouth, with soreness, redness and ulceration).
Danish: Nogle kræftpatienter får høje doser og udsættes derved for giftvirkninger som nyreskader, nedsat knoglemarvsfunktion (som medfører blodmangel og øget risiko for infektion og blødning) samt slimhindebetændelse, f.eks. i munden, med ømhed, rødme og sårdannelse.
English: The main measure of effectiveness was the reduction in blood levels of methotrexate.
Danish: Behandlingens virkning blev hovedsagelig bedømt ved reduktionen i blodets indhold af methotrexat.
English: Folinic acid can also be broken down in the body by Voraxaze, and further studies should be carried out to look at the consequences of this when managing patients with methotrexate toxicities.
Danish: Også folinsyre kan i kroppen nedbrydes af Voraxaze, og der bør udføres flere undersøgelser af, hvilke følger dette får for behandlingen af patienter med giftvirkninger af methotrexat.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Voraxaze?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse med Voraxaze?
English: Voraxaze was to be given to adults or children as a single injection if the level of methotrexate in the patient's blood was above a given ‘threshold' at certain times after administration of methotrexate.
Danish: Voraxaze skulle gives som en enkelt indsprøjtning til voksne eller børn, hvis blodets indhold af methotrexat var over en given "tærskel" på bestemte tidspunkter efter at have fået methotrexat.
English: All patients received the medicine as part of a compassionate use programme: the doctor requested Voraxaze from the manufacturer as soon as they encountered a patient with methotrexate toxicities who could possibly benefit from the medicine.
Danish: Alle patienter fik lægemidlet som led i et program for "anvendelse med særlig udleveringstilladelse": Lægerne bestilte Voraxaze fra fremstilleren, når de kom ud for en patient, der var udsat for giftvirkning af methotrexat og muligvis ville få gavn af lægemidlet.
English: Voraxaze is a powder to be made up into a solution for injection.
Danish: Voraxaze er et pulver, der anvendes til fremstilling af en injektionsvæske, opløsning.
English: Voraxaze would have been used either as a treatment in patients who had developed such toxic effects, or as prevention in patients who were at risk of developing them, such as patients who have high levels of methotrexate in their blood, or those who have poorly functioning kidneys (when methotrexate may be eliminated more slowly).
Danish: Voraxaze skulle have været anvendt hos patienter, der kommer ud for sådanne giftvirkninger eller til at forebygge dem hos patienter, der har risiko for at få dem, f.eks. patienter med høj koncentration af methotrexat i blodet eller med dårlig nyrefunktion (som kan forsinke udskillelsen af methotrexat).
English: Another medicine, folinic acid, is often given after the methotrexate to help control the toxicities (‘rescue' treatment) but these may still develop despite the rescue treatment.
Danish: Efter behandling med methotrexat gives ofte et andet lægemiddel, folinsyre, for at begrænse giftvirkningen, men giftvirkning kan alligevel opstå.
English: Voraxaze was to be used as an add-on treatment in patients already receiving a medicine, methotrexate, to prevent or treat the toxic effects of methotrexate.
Danish: Voraxaze skulle anvendes til supplerende behandling af patienter, der i forvejen fik lægemidlet methotrexat.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Voraxaze could not have been approved for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål var der i CHMP betænkelighed på det tidspunkt, hvor ansøgningen blev trukket tilbage.
English: This summary was last updated in March 2012.
Danish: Dette sammendrag blev sidst ajourført i marts 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Oxyglobin on 14 July 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Oxyglobin den 14. juli 1999.
English: Haemoglobin glutamer 200
Danish: Hæmoglobin glutamer-200
English: The most appropriate dose depends on the severity of the anaemia and how long the dog has been anaemic, as well as the desired duration of the medicine's effect.
Danish: Den mest hensigtsmæssige dosis afhænger af, hvor alvorlig anæmien er, og i hvor lang tid hunden har været anæmisk, samt af den ønskede varighed af lægemidlets effekt.
English: It took longer until additional treatment was needed in dogs treated with Oxyglobin.
Danish: Der gik længere tid, før det var nødvendigt med yderligere behandling af hunde, som blev behandlet med Oxyglobin.
English: This oxygen can then be supplied to tissues such as muscle.
Danish: Denne ilt kan så tilføres vævet, f.eks. muskler.
English: Other common side effects are vomiting, loss of appetite and fever.
Danish: Andre almindelige bivirkninger er opkastning, appetitløshed og feber.
English: Additional studies supported these results, showing that Oxyglobin can take up, transport and release oxygen in animals other than cows.
Danish: Yderligere forsøg understøttede disse resultater, idet det blev påvist, at Oxyglobin kan optage, transportere og frigive ilt hos andre dyr end køer.
English: In the main study in dogs, 95% of the animals treated with Oxyglobin needed no other type of oxygen-carrying treatment after 24 hours, compared with 32% of the dogs that did not receive any treatment.
Danish: I hovedundersøgelsen med hunde havde 95 % af de dyr, som blev behandlet med Oxyglobin, ikke behov for anden iltbærende behandling efter 24 timer sammenlignet med 32 % af de hunde, som ikke fik behandling.
English: There are no precautions necessary.
Danish: Ikke relevant.
English: Oxyglobin should be used for at least 24 hours.
Danish: Der skal gives Oxyglobin i mindst 24 timer.
English: This increases the amount of oxygen carried in the blood in the arteries, helping to reduce the symptoms of anaemia.
Danish: Herved øges mængden af ilt, der transporteres i blodet i arterierne, hvilket er med til at reducere symptomerne på anæmi.
English: Information on the prescription status of this product may be found on the label of the carton.
Danish: Oplysninger om udleveringsbestemmelserne for dette lægemiddel findes på etiketten på emballagen.
English: The side effects seen with Oxyglobin are caused both by the medicine and by the underlying cause of the anaemia.
Danish: De bivirkninger, der ses i forbindelse med Oxyglobin, skyldes både lægemidlet og den bagvedliggende årsag til anæmien.
English: Oxyglobin is first warmed to 37°C, then given to the dog as 30 ml per kilogram body weight, administered at a rate of up to 10 ml/kg per hour.
Danish: Oxyglobin varmes først op til 37° C og gives herefter til hunden med en dosis på 30 ml pr. kilo kropsvægt og en hastighed på op til 10 ml/kg pr. time.
English: The medicine also increased levels of haemoglobin in the blood and improved the dogs' physical condition.
Danish: Lægemidlet øgede også niveauet af hæmoglobin i blodet og forbedrede hundens fysiske tilstand.
English: The study compared the effects of Oxyglobin with no treatment.
Danish: I undersøgelsen blev Oxyglobins effekt sammenlignet med ingen behandling.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oxyglobin exceed the risks for the provision of oxygen-carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition, and recommended that Oxyglobin be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Oxyglobin er større end risiciene, når lægemidlet anvendes til at yde iltbærende støtte til hunde og afhjælpe de kliniske tegn på anæmi i mindst 24 timer, uafhængigt af den bagvedliggende tilstand, og anbefalede udstedelse af markedsføringstilladelse for Oxyglobin.
English: Oxyglobin contains bovine haemoglobin glutamer-200 (at a strength of 130 mg/ml), which belongs to a class of medicines having an oxygen-carrying action.
Danish: Oxyglobin indeholder hæmoglobinglutamer-200 fra kvæg (med en styrke på 130 mg/ml), der hører til klassen af lægemidler med en iltbærende aktion.
English: When Oxyglobin is given to dogs, it increases the amount of haemoglobin in the blood, as well as increasing the volume of blood in the body.
Danish: Når Oxyglobin gives til hunde, øges mængden af hæmoglobin i blodet samt blodvolumenet i kroppen.
English: They include discoloration of the skin, mucous membranes (lining of body cavities) and sclera (whites of the eyes), dark faeces and discoloured or turbid (opaque) urine.
Danish: De omfatter misfarvning af huden, slimhinderne (foringen af legemshuler) og sclerae (det hvide i øjnene), mørk afføring og misfarvet eller grumset (uigennemsigtig) urin.
English: Oxyglobin should not be used in animals that have received Oxyglobin in the past, or in dogs that are at an increased risk of circulatory overload with conditions such as oliguria or anuria (infrequent or no urination) or advanced heart disease.
Danish: Oxyglobin må ikke anvendes til dyr, der har fået Oxyglobin tidligere, eller til hunde, der har øget risiko for overbelastning af kredsløbet med tilstande som oliguri eller anuri (sjælden eller ingen vandladning) eller fremskreden hjertesygdom.
English: Oxyglobin does not need to be matched to the dog's blood type.
Danish: Det er ikke nødvendigt at tilpasse Oxyglobin efter hundens blodtype.
English: Oxyglobin has been tested in a study of dogs with short or long-term anaemia due to conditions such as blood loss, the abnormal breakdown of red blood cells or low levels of red blood cell production.
Danish: Oxyglobin blev afprøvet i en undersøgelse med hunde med kort- eller langvarig anæmi som følge af tilstande som blodtab, unormal nedbrydning af røde blodlegemer eller for lav produktion af røde blodlegemer.
English: It contains haemoglobin glutamer-200, which is made from haemoglobin (the protein in red blood cells that carries oxygen around the body) extracted from cows' blood and diluted in a standard solution (Ringer's lactate) used to replace blood volume.
Danish: Den indeholder hæmoglobinglutamer200, der er fremstillet ud fra hæmoglobin (proteinet i de røde blodlegemer, der transporterer ilt rundt i kroppen), som er ekstraheret fra koblod og fortyndet i en standardopløsning (Ringers laktat), der benyttes til at erstatte blodvolumen.
English: Oxyglobin is a solution for infusion (drip into a vein).
Danish: Oxyglobin er en opløsning til infusion (drop i en vene).
English: Oxyglobin is intended for a single use only.
Danish: Oxyglobin er kun beregnet til engangsbrug.
English: A common side effect is ‘circulatory overload' (when the blood fluid leaks out of the blood vessels), which causes tachypnea (rapid breathing), dyspnea (shortness of breath), harsh lung sounds and pulmonary oedema (fluid accumulation in the lungs).
Danish: En almindelig bivirkning er 'overbelastning af kredsløbet' (når blodet siver ud gennem blodkarrene), hvilket giver takypnø (hurtig vejrtrækning), dyspnø (åndenød), disharmoniske lungelyde og lungeødem (ophobning af væske i lungerne).
English: What is the risk associated with Oxyglobin?
Danish: Hvilken risiko er der forbundet med Oxyglobin?
English: Oxyglobin is used to increase the oxygen content of the blood in dogs with anaemia (low red blood cell count).
Danish: Oxyglobin anvendes til at øge iltindholdet i blodet hos hunde med anæmi (lavt antal røde blodlegemer).
English: Other information about Oxyglobin:
Danish: Andre oplysninger om Oxyglobin
English: Oxyglobin is a haemoglobin-based oxygen-carrying solution.
Danish: Oxyglobin er en hæmoglobinbaseret iltbærende opløsning.
English: Why has Oxyglobin been approved?
Danish: Hvorfor blev Oxyglobin godkendt?
English: For a full list of all side effects reported with Oxyglobin, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Oxyglobin fremgår af indlægssedlen.
English: What is Oxyglobin?
Danish: Hvad er Oxyglobin?
English: What is Oxyglobin used for?
Danish: Hvad anvendes Oxyglobin til?
English: For further information, see the Package Leaflet.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: How has Oxyglobin been studied?
Danish: Hvordan blev Oxyglobin undersøgt?
English: What benefit has Oxyglobin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Oxyglobin?
English: How does Oxyglobin work?
Danish: Hvordan virker Oxyglobin?
English: 1 vial l t o r
Danish: Paknings-størrelse t r
English: Cetrotide received a marketing authorisation valid throughout the EU on 13 April 1999.
Danish: Cetrotide fik en markedsføringstilladelse med gyldighed i hele EU den 13. april 1999.
English: The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening.
Danish: Den anbefalede dosis er 0,25 mg med 24 timers mellemrum, enten om morgenen eller om aftenen.
English: Further information on Cetrotide can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cetrotide.
Danish: Yderligere information om Cetrotide findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/cetrotide.
English: The medicine should be injected slowly at different places on the abdomen every day.
Danish: Lægemidlet bør injiceres langsomt på et nyt sted i abdomen hver dag.
English: Other information about Cetrotide
Danish: Andre oplysninger om Cetrotide
English: Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor, and the patient closely watched for 30 minutes.
Danish: På grund af risikoen for svære allergiske reaktioner bør den første injektion overvåges af en læge, og patienten bør være under nøje observation i 30 minutter.
English: As for all medicines, data on the use of Cetrotide are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Cetrotide løbende overvåget.
English: Once the assisted-reproduction procedure was completed, 23% of patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.
Danish: Efter at den assisterede reproduktionsprocedure var gennemført, blev 23 % af de patienter, der havde fået Cetrotide, gravide sammenlignet med 32 % i sammenligningsgrupperne.
English: Cetrotide can only be obtained with a prescription and treatment should be carried out by a doctor who has experience in this type of fertility treatment.
Danish: Cetrotide fås kun på recept, og behandlingen bør foretages af en læge med erfaring i denne type fertilitetsbehandling.