FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Danish: Ved at blokere disse receptorer får silodosin musklerne til at slappe af, hvilket gør det lettere at lade vandet og lindrer symptomerne på BPH.
English: The CHMP decided that Silodyx's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Silodyx opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Silodyx.
English: For the full list of all side effects and restrictions with Silodyx, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Silodyx fremgår af indlægssedlen.
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Silodyx, and by around 3.5 points in the men who took placebo.
Danish: Efter 12 uger var IPPS faldet med ca. 6,4 point hos mænd, der tog Silodyx, og med ca. 3,5 point hos mænd, der tog placebo.
English: What is the risk associated with Silodyx?
Danish: Hvilken risiko er der forbundet med Silodyx?
English: Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Danish: Silodyx anvendes til behandling af symptomer på godartet prostatahyperplasi (BPH, forstørrelse af blærehalskirtlen) hos voksne.
English: Why has Silodyx been approved?
Danish: Hvorfor blev Silodyx godkendt?
English: The prostate gland is an organ found at the base of the bladder in men.
Danish: Blærehalskirtlen er et organ, der sidder under blæren hos mænd.
English: What is Silodyx?
Danish: Hvad er Silodyx?
English: How has Silodyx been studied?
Danish: Hvordan blev Silodyx undersøgt?
English: What benefit has Silodyx shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Silodyx?
English: What is Silodyx used for?
Danish: Hvad anvendes Silodyx til?
English: How is Silodyx used?
Danish: Hvordan anvendes Silodyx?
English: How does Silodyx work?
Danish: Hvordan virker Silodyx?
English: MA (EU) Numbers
Danish: MF (EU)-nummer
English: Content (concentration)
Danish: Indhold (Koncentratio n)
English: Strength Pharmaceutical Form
Danish: MF (EU)-nummer Særnavn Styrke Lægemiddelform Administration Emballage
English: • Shorten the PSUR cycle to an annual submission
Danish: • PSUR-cyklussen afkortes til en årlig fremsendelsescyklus.
English: • Circulate the DHPC agreed upon with the CHMP, in accordance with the agreed communication plan.
Danish: • Den direkte meddelelse til sundhedspersonalet, der er indgået aftale med CHMP om, fremsendes i overensstemmelse med den vedtagne kommunikationsplan.
English: The protocol and the timelines of the DUS should be provided to the RMS within one month of the commission decision concluding this referral procedure.
Danish: • Der skal gennemføres en undersøgelse af lægemiddelanvendelsen for at overvåge, hvor effektive risikominimeringsforanstaltningerne er. Protokollen og tidsplanen for undersøgelsen af lægemiddelanvendelsen bør sendes til referencemedlemsstaten senest en måned efter Kommissionens afgørelse, som afslutter denne indbringelsesprocedure.
English: This is a summary of the European public assessment report (EPAR) for sildenafil.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for sildenafil.
English: The full EPAR for Sildenafil ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Sildenafil ratiopharm 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 Sildenafil ratiopharm on 23 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sildenafil ratiopharm den 23. december 2009.
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 sildenafil.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for sildenafil.
English: Sildenafil ratiopahrm EMA/432244/2013
Danish: Sildenafil ratiopharm EMA/432237/2013
English: Sildenafil ratiopharm is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity.
Danish: Sildenafil ratiopharm anvendes til behandling af voksne mænd med erektil dysfunktion (undertiden kaldet impotens), når de ikke kan få eller fastholde en tilstrækkelig stiv penis (erektion) til tilfredsstillende seksuel aktivitet.
English: For more information about treatment with sildenafil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med sildenafil, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The recommended dose of Sildenafil ratiopharm is 50 mg taken as needed about one hour before sexual activity.
Danish: Den anbefalede dosis Sildenafil ratiopharm er 50 mg, som tages efter behov ca. 1 time før seksuel aktivitet.
English: liver function or severely reduced kidney function should start treatment with the 25-mg dose.
Danish: Patienter med nedsat leverfunktion eller svært nedsat nyrefunktion skal påbegynde behandlingen med en dosis på 25 mg.
English: What are the benefits and risks of sildenafil?
Danish: Hvilke fordele og risici er der forbundet med sildenafil?
English: Other information about sildenafil
Danish: Andre oplysninger om sildenafil
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil ratiopharm has been shown to have comparable quality and to be bioequivalent to Viagra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sildenafil ratiopharm er af sammenlignelig kvalitet og er bioækvivalent med Viagra.
English: The Committee recommended that Sildenafil ratiopharm be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Sildenafil ratiopharm.
English: By blocking the breakdown of cGMP, Sildenafil ratiopharm restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Sildenafil ratiopharm den erektile funktion.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Danish: Det virker ved at blokere fosfodiesteraseenzymet, som normalt nedbryder et stof, der kaldes cyklisk guanosinmonofosfat (cGMP).
English: For Sildenafil ratiopharm to be effective, sexual stimulation is required.
Danish: For at få Sildenafil ratiopharm til at virke kræves der seksuel stimulering.
English: This means that Sildenafil ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Danish: Det betyder, at Sildenafil ratiopharm er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, nemlig Viagra.
English: The active ingredient in Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive indholdsstof i Sildenafil ratiopharm, sildenafil, tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5- (PDE5)-hæmmere.
English: Sildenafil ratiopharm is a ‘generic medicine'.
Danish: Sildenafil ratiopharm er et "generisk lægemiddel".
English: Sildenafil ratiopharm is a medicine that contains the active substance sildenafil.
Danish: Sildenafil ratiopharm er et lægemiddel, der indeholder det aktive stof sildenafil.
English: Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Sildenafil ratiopharm er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Sildenafil ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Danish: Da Sildenafil ratiopharm er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viagra.
English: If Sildenafil ratiopharm is taken with food, the onset of activity may be delayed compared with taking Sildenafil ratiopharm without food.
Danish: Hvis Sildenafil ratiopharm tages sammen med et måltid, kan virkningens indtræden forsinkes i forhold til, hvis det tages uden et måltid.
English: Sildenafil ratiopahrm sildenafil
Danish: Sildenafil ratiopharm sildenafil
English: Why has sildenafil been approved?
Danish: Hvorfor blev Sildenafil godkendt?
English: What is sildenafil?
Danish: Hvad er sildenafil?
English: What is sildenafil used for?
Danish: Hvad anvendes sildenafil til?
English: How has sildenafil been studied?
Danish: Hvordan blev sildenafil undersøgt?
English: How is sildenafil used?
Danish: Hvordan anvendes sildenafil?
English: How does sildenafil work?
Danish: Hvordan virker sildenafil?
English: • Only use Abseamed if it has been stored correctly - see section 5, How to store Abseamed.
Danish: • Brug kun Abseamed, hvis det er opbevaret korrekt - se punkt 5, Opbevaring.
English: Abseamed may not be suitable for you.
Danish: Det kan være, at Abseamed ikke passer til dig.
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Abseamed subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Danish: I de situationer, hvor lægen bedømmer, at patienten selv eller en omsorgsperson kan administrere Abseamed sikkert og effektivt subkutant, skal der gives instruktioner om korrekt dosering og administration.
English: Abseamed is a biosimilar medicinal product.
Danish: Abseamed er et biosimilært lægemiddel.
English: The dose of Abseamed you receive is based on your body weight in kilograms.
Danish: Den Abseamed-dosis, du får, er baseret på din kropsvægt i kilo.
English: Side effects from an overdose of Abseamed are unlikely.
Danish: Bivirkninger fra en overdosering af Abseamed er ikke sandsynligt.
English: During the maintenance phase, Abseamed can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Danish: I vedligeholdelsesfasen kan Abseamed administreres enten 3 gange ugentligt eller, i tilfælde af subkutan administration, én gang ugentligt eller én gang hver anden uge.
English: • Abseamed is given by injection under the skin.
Danish: • Abseamed gives via indsprøjtning under huden.
English: If signs and symptoms suggestive of these reactions appear, Abseamed should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer, som tyder på sådanne reaktioner, skal Abseamed straks seponeres, og en alternativ behandling skal overvejes.
English: Your doctor will monitor your blood pressure regularly while you are using Abseamed.
Danish: Din læge vil måle dit blodtryk regelmæssigt, mens du bruger Abseamed
English: If Abseamed is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Danish: Hvis Abseamed indsprøjtes under huden (subkutant), er mængden, der indsprøjtes normalt ikke over en milliliter (1 ml) i en enkelt indsprøjtning.
English: Treatment with Abseamed is divided into two stages - correction and maintenance phase.
Danish: Behandlingen med Abseamed er opdelt i 2 faser - en korrigeringsfase og vedligeholdelsesfase.
English: If you can't take medicines that prevent blood clotting, you must not have Abseamed.
Danish: Hvis du ikke kan tage medicin, der forhindrer blodpropper, må du ikke få Abseamed.
English: Abseamed should be administered after the completion of the blood donation procedure.
Danish: Abseamed skal administreres, efter at bloddonationen er afsluttet.
English: • You will usually continue Abseamed treatment for one month after the end of chemotherapy.
Danish: • Du vil normalt fortsætte behandlingen med Abseamed i én måned efter afslutningen af kemoterapien.
English: Your doctor has carried out blood tests and decided you need Abseamed.
Danish: Din læge har taget blodprøver og har bestemt, at du har behov for Abseamed.
English: Iron supplements and other blood stimulants may increase the effectiveness of Abseamed.
Danish: Jerntilskud og andre blodstimulerende midler kan øge virkningen af Abseamed.
English: Abseamed is given alone and not mixed with other liquids for injection.
Danish: Abseamed gives alene og må ikke blandes med andre væsker til indsprøjtning.
English: Later, your doctor may suggest that you or your caregiver learn how to inject Abseamed under the skin
Danish: Senere kan din læge foreslå, at du selv eller din omsorgsperson lærer at injicere Abseamed under huden
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Abseamed, treatment with Abseamed must not be restarted in this patient at any time.
Danish: Hvis patienten har udviklet en svær kutan bivirkning såsom SJS eller TEN på grund af brugen af Abseamed, må behandling med Abseamed ikke genoptages hos denne patient på noget tidspunkt.
English: For patients on peritoneal dialysis Abseamed may be given twice a week.
Danish: For patienter i peritonealdialyse kan Abseamed gives 2 gange ugentligt.
English: • Your doctor may initiate treatment with Abseamed if your haemoglobin is 10 g/dL or less.
Danish: • Din læge kan påbegynde behandling med Abseamed, hvis dit hæmoglobinniveau er 10 g/dl eller mindre.
English: Abseamed should not be used:
Danish: Abseamed må ikke anvendes:
English: Abseamed has no or negligible influence on the ability to drive and use machines.
Danish: Abseamed påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood.
Danish: Abseamed er indiceret hos voksne i et prædonationsprogram til at øge udbyttet af autologt blod.
English: If you are a cancer patient be aware that products that stimulate red blood cell production (like Abseamed) may act as a growth factor and therefore in theory may affect the progression of your cancer.
Danish: Hvis du er en kræftpatient, skal du være klar over, at præparater, der stimulerer dannelsen af røde blodlegemer (som Abseamed), kan virke som en vækstfaktor og derfor teoretisk kan accelerere din kræftsygdom.
English: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Danish: Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Tyskland
English: Your doctor will help you to decide if Abseamed is suitable for you.
Danish: Din læge vil hjælpe dig med at beslutte, om Abseamed er egnet til dig.
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Abseamed should be injected under the skin (subcutaneously).
Danish: Hvis denne adgang (i en vene eller slange) ikke er let tilgængelig, kan din læge beslutte, at Abseamed skal indsprøjtes under huden (subkutant).
English: - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Abseamed.
Danish: - Alle kontraindikationer forbundet med autologe prædonationsprogrammer skal respekteres hos patienter, der får supplerende Abseamed.
English: • If you are having dialysis treatment when you begin treatment with Abseamed, your dialysis regime may need to be adjusted.
Danish: • Hvis du får dialysebehandling, når du begynder din behandling med Abseamed, kan det være nødvendigt at justere dit dialyseprogram.
English: Abseamed contains sodium
Danish: Abseamed indeholder natrium
English: Because Abseamed stimulates the production of red blood cells, doctors can take more blood from these people.
Danish: Da Abseamed stimulerer produktionen af røde blodlegemer, kan lægerne udtage mere blod fra disse personer.
English: Stop using Abseamed if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge Abseamed, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Abseamed.
Danish: Hvis du tager et lægemiddel, der kaldes ciclosporin (anvendes f.eks. efter en nyretransplantation) kan din læge rekvirere blodprøver for at kontrollere niveauet af ciclosporin, mens du tager Abseamed.
English: If you are a cancer patient, be aware that use of Abseamed may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Danish: Hvis du er en kræftpatient, skal du være klar over, at anvendelsen af Abseamed kan være forbundet med kortere overlevelse og en højere dødelighed hos patienter med cancer i hoved og hals, og patienter med metastatisk brystcancer, som får kemoterapi.
English: • For adults and children Abseamed is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
Danish: • Abseamed gives til voksne og børn som en indsprøjtning enten i en vene (intravenøst) eller i en slange, der er indsat i en vene.
English: If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Danish: Hvis du får disse symptomer, når Abseamed injiceres i venen, kan det hjælpe med til at undgå dem, hvis injektionen i fremtiden gives langsommere.
English: Your Abseamed dose and frequency of administration may be further adjusted to maintain your response to treatment.
Danish: Din Abseamed-dosis og hvor ofte, den gives, kan justeres yderligere for at vedligeholde dit respons på behandlingen.
English: When treatment starts, Abseamed is usually injected by a medical professional or a nurse.
Danish: Når behandlingen begynder, injiceres Abseamed normalt af en læge eller sygeplejerske.
English: Abseamed can reduce the need for a blood transfusion.
Danish: Abseamed kan nedsætte behovet for blodtransfusion.
English: Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Danish: Behandling med Abseamed må kun påbegyndes under supervision af en læge med erfaring i behandlingen af patienter, hvor ovenstående indikationer er relevante.
English: This section contains information on how to give yourself an injection of Abseamed.
Danish: Dette afsnit indeholder information om, hvordan du kan give dig selv en indsprøjtning med Abseamed.
English: If you are given a product in this group other than Abseamed during your treatment, speak to your doctor or pharmacist before using it.
Danish: Hvis du får et andet lægemiddel end Abseamed fra denne gruppe i løbet af din behandling, skal du tale med lægen eller apoteket, før du bruger det.
English: • The usual starting dose of Abseamed for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Danish: • Den normale startdosis af Abseamed til voksne og børn er 50 internationale enheder (IE) pr. kilogram (/kg) kropsvægt, som gives 3 gange om ugen.
English: Abseamed is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Danish: Abseamed anvendes til voksne med moderat anæmi, som før en operation donerer noget af deres blod, så det kan gives til dem igen under eller efter operationen.
English: Abseamed can reduce the need for a blood transfusion in these patients.
Danish: Abseamed kan nedsætte behovet for en blodtransfusion hos disse patienter.
English: If you forget to use Abseamed
Danish: Hvis du har glemt at tage Abseamed
English: Abseamed should not be used and discarded - if the liquid is coloured or you can see particles floating in it, - if the seal is broken, - if you know, or think that it may have been accidentally frozen, or - if there has been a refrigerator failure.
Danish: - hvis væsken er farvet eller du kan se, at der flyder partikler rundt i den, - hvis forseglingen er brudt, - hvis du ved eller tror den utilsigtet har været nedfrosset eller - hvis køleskabet har svigtet.
English: Talk to your doctor, pharmacist or nurse before using Abseamed.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Abseamed.
English: • Abseamed is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Danish: • Abseamed gives via indsprøjtning under huden hver uge i tre uger inden operationen og på operationsdagen.
English: - Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4).
Danish: - Patienter, der udvikler pure red cell aplasia (PRCA) efter behandling med erytropoietin, bør ikke få Abseamed eller noget andet erytropoietin-præparat (se pkt.
English: • if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Abseamed).
Danish: • hvis du er blevet diagnosticeret med pure red cell aplasia (knoglemarven kan ikke danne nok røde blodlegemer) efter tidligere behandling med præparater, der stimulerer produktionen af røde blodlegemer (herunder Abseamed).
English: • If you are on a more extended dosing interval (greater than once weekly) of Abseamed, you may not maintain adequate haemoglobin levels and you may require an increase in Abseamed dose or frequency of administration.
Danish: • Hvis du har et mere udvidet doseringsinterval (længere end én uge) af Abseamed, vil du måske ikke opretholde tilstrækkelige hæmoglobinniveauer, og du kan have behov for en større dosis Abseamed eller hyppigere indgivelse.
English: • If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
Danish: • Hvis du ikke responderer tilstrækkeligt på Abseamed, vil din læge kontrollere din dosis og fortælle dig, hvis din Abseamed-dosis skal ændres.
English: • Abseamed is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Danish: • Abseamed gives via indsprøjtning i en vene, lige efter du har fået tappet blod i 3 uger før operationen.
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
Danish: • Din læge vil rekvirere blodprøver og kan justere dosis, afhængig af, hvordan din anæmi påvirkes af behandlingen med Abseamed.
English: Abseamed may be given by injection:
Danish: Abseamed kan gives som en indsprøjtning:
English: Abseamed is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Danish: Abseamed leveres med eller uden kanylebeskyttelse, og lægen eller sundhedspersonalet viser dig, hvordan du anvender den.
English: Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Abseamed.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du bliver opmærksom på nogle af disse bivirkninger, eller hvis du bemærker andre bivirkninger, mens du får behandling med Abseamed.