FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
Danish: CVMP indledte på sit møde i december 2006 en indbringelsesprocedure for Enurace 50 i overensstemmelse med artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer.
English: A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended.
Danish: Den anbefalede startdosering er 2 mg ephedrinhydrochlorid pr. kg kropsvægt pr. dag, fordelt på to orale doser.
English: Proposed dose of 1 - 3 mg Ephedrine HCl /kg/day, divided in two oral doses is effective and safe, but some animals may need a higher dose, which is associated with individual variation in the response to ephedrine.
Danish: Den foreslåede dosis på 1-3 mg ephedrinhydrochlorid pr. kg kropsvægt pr. dag, fordelt på to doser oralt, er effektiv og sikker, men nogle dyr kan have behov for større dosis som følge af den individuelle variation i responsen på ephedrin.
English: Regarding cardiac dysfunction, this was one of the exclusion criteria so the studies give no information on use of the product in animals with such a condition but there is also no data suggesting that the cardiac patients must not be treated with the substance.
Danish: Kardial dysfunktion var blandt eksklusionskriterierne, hvorfor undersøgelserne ikke indeholder oplysninger om anvendelse af produktet hos dyr med sådanne lidelser, men de foreliggende oplysninger tyder ikke på, at det bør undgås at behandle hunde med hjertelidelser med stoffet.
English: For the reason of very limited treatment options, high risk of euthanasia if treatment fails or is not affordable, ephedrine is a substance of other eventual choice - Propalin instead Enurace and vice versa, considering that sympathicomimetic treatment of urinary incontinence is far better than hormonal treatment (an alternative is surgical therapies as colposuspension, urethropexy and the endoscopic injection of collagen in refractory cases).
Danish: Som følge af de meget begrænsede behandlingsmuligheder og den høje risiko for eutanasi i de tilfælde, hvor behandlingen ikke virker eller ikke er overkommelig i pris, er ephedrin et andet muligt valg - Propalin i stedet for Enurace og vice versa, når det tages i betragtning, at sympatomimetisk behandling af urininkontinens er langt at foretrække frem for hormonbehandling (et alternativ er operative indgreb som kolposuspension, urethropeksi og endoskopisk injektion af kollagen i behandlingsrefraktære tilfælde).
English: Taking the benefit of the treatment into account and the relatively low level of adverse effects, as it appears from PMS studies, the risk/benefit balance is considered favourable.
Danish: I betragtning af behandlingens fordele og den relativt lave forekomst af bivirkninger, således som den fremgår af undersøgelserne efter markedsføringen, anses benefit/risk-forholdet for gunstigt.
English: Indeed, treatment is not successful in all animals, but the level of efficacy is such that there is an advantage in treatment.
Danish: Skønt behandlingen ikke virker på alle dyr, er virkningen tilstrækkelig til, at behandlingen er forbundet med fordele.
English: The dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.
Danish: Hundens kardiovaskulære funktion bør vurderes omhyggeligt, før behandlingen med Enurace 50 påbegyndes, og den bør overvåges med jævne mellemrum under behandlingen.
English: For oral administration only, to be administered with food
Danish: 50 mg Tæver Kun til oral administration, indgives sammen med foderet
English: Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant has provided some post-marketing information regarding the use in dogs.
Danish: Skønt der måske foreligger få oplysninger om toksiciteten hos måldyrearten, er bivirkningerne ved brug af ephedrin velkendte fra human anvendelse, og ansøgeren har forelagt en del post-marketing oplysninger om brug hos hunde.
English: The use of human labelled preparations or dosage forms obtained from a compounding pharmacy which contain ephedrine constitute a much more dangerous alternative for treatment of urinary incontinence in dogs if the product with a marketing authorisation and a proved efficacious use in the RMS for many years is not available.
Danish: Anvendelse af humane præparater eller apoteksfremstillede lægemidler indeholdende ephedrin vil udgøre et langt farligere alternativ ved behandling af urininkontinens hos hunde, hvis der ikke findes et produkt med markedsføringstilladelse og med påvist mangeårig virkning i referencemedlemsstaten over mange år.
English: With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Danish: 4.5 med tilføjelse af sætningen: "hundens hjerte-karfunktion bør omhyggeligt vurderes før påbegyndelse af behandlingen med Enurace 50 og bør jævnligt overvåges under behandlingen".
English: European Medicines Agency Veterinary Medicines and Inspections
Danish: Lægemiddelform Styrke Dyreart Doseringshyppighed og indgivelsesvej
English: Treatment is given in 28-day cycles.
Danish: Behandlingen gives i cyklusser på 28 dage.
English: Empliciti received a marketing authorisation valid throughout the EU on 11 May 2016.
Danish: Empliciti fik en markedsføringstilladelse med gyldighed i hele EU den 11. maj 2016.
English: It is given once a week for the first 2 cycles and less frequently in subsequent cycles.
Danish: Det gives én gang om ugen i de første 2 cyklusser og mindre hyppigt i de efterfølgende cyklusser.
English: The dose of Empliciti depends on the patient's weight.
Danish: Dosen af Empliciti afhænger af patientens vægt.
English: Further information on Empliciti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/empliciti.
Danish: Yderligere information om Empliciti findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/empliciti.
English: Other information about Empliciti
Danish: Andre oplysninger om Empliciti
English: As for all medicines, data on the use of Empliciti are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Empliciti løbende overvåget.
English: What is Empliciti and what is it used for?
Danish: Hvad er Empliciti, og hvad anvendes det til?
English: The European Medicines Agency therefore decided that Empliciti's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Empliciti opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable.
Danish: Selv om der hyppigere sås bivirkninger, navnlig infektioner, ved Empliciti, synes risiciene samlet set at være håndterbare.
English: All patients had previously received other treatments but the treatments had not worked or the cancer had come back.
Danish: Alle patienterne havde tidligere fået andre behandlinger, men enten havde behandlingerne ikke virket, eller også var kræften vendt tilbage.
English: An overview of Empliciti and why it is authorised in the EU
Danish: En oversigt over Empliciti, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Empliciti?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Empliciti?
English: Empliciti contains the active substance elotuzumab.
Danish: Empliciti indeholder det aktive stof elotuzumab.
English: Why is Empliciti authorised in the EU?
Danish: Hvorfor er Empliciti godkendt i EU?
English: In addition, the cancer cleared partially or completely in 79% of patients treated with the Empliciti combination compared with 66% of patients treated with the other two medicines.
Danish: Desuden forsvandt kræften helt eller delvist hos 79 % af de patienter, der fik Empliciti-kombinationsbehandlingen, sammenlignet med 66 % af de patienter, der fik de to andre lægemidler.
English: To prevent infusion reactions, the patient is given an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion.
Danish: For at forhindre infusionsreaktioner får patienten et betændelsesdæmpende lægemiddel, et antihistamin og paracetamol før hver infusion.
English: The most common side effects with Empliciti (which may affect more than 1 in 10 people) are headache, tiredness, fever, diarrhoea, sore throat, nose and throat infections, cough, pneumonia (lung infection), low levels of white blood cells and weight loss.
Danish: De hyppigste bivirkninger ved Empliciti (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, træthed, feber, diarré, ondt i halsen, næse- og halsinfektioner, hoste, lungebetændelse, lavt antal hvide blodlegemer og vægttab.
English: Side effects reported with Empliciti are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Empliciti vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Empliciti, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Empliciti, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: What are the risks associated with Empliciti?
Danish: Hvilke risici er der forbundet med Empliciti?
English: Treatment must be started and supervised by a doctor experienced in treating multiple myeloma, and the medicine can only be obtained with a prescription.
Danish: Behandlingen skal indledes og overvåges af en læge med erfaring i behandling af myelomatose, og lægemidlet fås kun på recept.
English: Empliciti is given as an infusion (drip) into a vein.
Danish: Empliciti gives som infusionsvæske (drop) i en vene.
English: The patient is also given other cancer medicines (dexamethasone with either lenalidomide or pomalidomide) during each cycle.
Danish: Patienten får også andre kræftlægemidler (dexamethason med enten lenalidomid eller pomalidomid) i hver cyklus.
English: Patients' previous treatment should have included the multiple myeloma medicines lenalidomide and a class of medicines called proteasome inhibitors (e.g. bortezomib, carfilzomib and ixazomib).
Danish: Patientens tidligere behandling bør have omfattet myelomatoselægemidlerne lenalidomid og en kategori af lægemidler kaldet proteasomhæmmere (f.eks. bortezomib, carfilzomib og ixazomib).
English: It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment.
Danish: Det anvendes sammen med to andre lægemidler (lenalidomid og dexamethason) og gives til voksne, der har fået mindst én tidligere kræftbehandling.
English: Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells.
Danish: Elotuzumab binder sig også til SLAMF7-proteinet på kræftcellerne og gør dem dermed mere sårbare over for immuncellernes angreb.
English: The active substance in Empliciti, elotuzumab, is a monoclonal antibody that attaches to SLAMF7, a protein on immune cells, causing the cells to attack the multiple myeloma cancer cells and thereby slow down the disease.
Danish: Det aktive stof i Empliciti, elotuzumab, er et monoklonalt antistof, der binder sig til SLAMF7, et protein på immuncellerne, som får cellerne til at gå til angreb på myelomatose-kræftcellerne og derved bremse sygdommen.
English: For the full list of side effects and restrictions of Empliciti, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Empliciti fremgår af indlægssedlen.
English: Adding Empliciti to lenalidomide and dexamethasone can delay the worsening of multiple myeloma and improve clearance of the cancer in patients whose disease did not improve with previous treatment or whose disease came back.
Danish: Ved at tilføje Empliciti til lenalidomid og dexamethason kan forværringen af myelomatose forsinkes, og clearance af kræftsygdommen kan forbedres hos patienter, hvis sygdom ikke er blevet forbedret med tidligere behandling, eller hvis sygdom er vendt tilbage.
English: A second main study involved 117 multiple myeloma patients who had received at least two other treatments previously, including a proteasome inhibitor and lenalidomide.
Danish: Et andet hovedstudie omfattede 117 patienter med myelomatose, som tidligere havde fået mindst to andre behandlinger, herunder en proteasomhæmmer og lenalidomid.
English: In patients who had already been treated with at least two treatments including a proteasome inhibitor and lenalidomide (and the treatment had not worked or the disease had come back), Empliciti plus pomalidomide and dexamethasone delayed worsening of the disease, compared with just pomalidomide and dexamethasone.
Danish: Hos patienter, der allerede havde fået mindst to behandlinger, herunder en proteasomhæmmer og lenalidomid (og hvor behandlingen ikke havde virket, eller sygdommen var vendt tilbage), sinkede Empliciti plus pomalidomid og dexamethason forværringen af sygdommen, sammenlignet med kun pomalidomid og dexamethason.
English: How is Empliciti used?
Danish: Hvordan anvendes Empliciti?
English: The average time before the disease got worse was 18.5 months in patients treated with the Empliciti combination compared with 14.3 months in those treated with just lenalidomide and dexamethasone.
Danish: Den gennemsnitlige tid før sygdommen blev værre var på 18,5 måneder hos de patienter, der blev behandlet med Empliciti-kombinationen, sammenlignet med 14,3 måneder hos dem, der kun blev behandlet med lenalidomid og dexamethason.
English: In a main study of 646 multiple myeloma patients a combination of Empliciti plus lenalidomide and dexamethasone was compared with only lenalidomide and dexamethasone.
Danish: I et hovedstudie, der omfattede 646 patienter med myelomatose, blev en kombination af Empliciti og lenalidomid og dexamethason sammenlignet med kun lenalidomid og dexamethason.
English: Patients treated with a combination of Empliciti plus pomalidomide and dexamethasone lived on average for over 5.5 months longer without their disease getting worse compared with patients treated with pomalidomide and dexamethasone.
Danish: De patienter, der blev behandlet med en kombination af Empliciti plus pomalidomid og dexamethason, levede i gennemsnit i mere end 5,5 måneder længere, uden at sygdommen blev værre, i sammenligning med de patienter, der blev behandlet med pomalidomid og dexamethason.
English: What benefits of Empliciti have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Empliciti?
English: Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow).
Danish: Empliciti er et lægemiddel til behandling af myelomatose (kræft i knoglemarven).
English: Empliciti is also used together with the medicines pomalidomide and dexamethasone to treat multiple myeloma that was previously treated with at least two other treatments but the cancer had come back.
Danish: Empliciti anvendes også sammen med lægemidlerne pomalidomid og dexamethason til behandling af myelomatose, som tidligere er blevet behandlet med mindst to andre behandlinger, men hvor kræften er vendt tilbage.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Empliciti have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Empliciti.
English: How does Empliciti work?
Danish: Hvordan virker Empliciti?
English: If you see more than one drop:
Danish: Hvis du ser mere end en enkelt dråbe:
English: • unusual taste in the mouth
Danish: • usædvanlig smag i munden
English: Then, move on to section 2 - getting started.
Danish: Fortsæt derefter til Afsnit 2 - Kom i gang.
English: • loss of energy and strength
Danish: • tab af energi og styrke
English: Date of first authorisation: 20 November 2006 Date of latest renewal: 22 July 2016
Danish: Dato for første markedsføringstilladelse: 20. november 2006 Dato for seneste fornyelse: 22. juli 2016
English: What do the arrows mean?
Danish: Hvad betyder pilene?
English: Twice daily
Danish: To gange dagligt
English: It is not known if this medicine may harm your unborn child.
Danish: Det er uvist, om dette lægemiddel kan skade dit ufødte barn.
English: Do not give this medicine to children and adolescents less than 18 years as there is no experience with this medicine in this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, da der ikke er nogen erfaring med dette lægemiddel til denne aldersgruppe.
English: • Wash hands prior to use.
Danish: • Vask hænder inden brug.
English: The injection is complete when:
Danish: Injektionen er afsluttet når:
English: Lipid profiles should be monitored regularly.
Danish: Lipidprofiler skal overvåges regelmæssigt.
English: Read this section completely before you begin.
Danish: Læs hele dette afsnit før du begynder.
English: • You are now ready for your first dose of Byetta.
Danish: • Du er nu klar til din første Byetta-dosis.
English: Continue to follow your food and exercise plan.
Danish: Fortsæt med at følge din kost- og motionsplan.
English: Do not throw away.
Danish: Smid den ikke væk.
English: Also contains metacresol.
Danish: Indeholder også metacresol.
English: • A small air bubble is normal.
Danish: • En lille luftboble er normal.
English: The arrows mean you are ready for the next step.
Danish: Pilene betyder, at du er klar til det næste trin.
English: You should see your doctor immediately if you experience symptoms such as
Danish: Du skal straks søge læge, hvis du får symptomer såsom
English: This incidence was not statistically significant when adjusted for survival.
Danish: Incidensen var ikke statistisk signifikant, når den blev justeret for overlevelse.
English: Do not use this medicine after your meal.
Danish: Tag ikke dette lægemiddel efter måltidet.
English: Spontaneous reports data (unknown denominator)
Danish: Data fra spontane rapporter (ukendt denominator)
English: When the pen is empty, you cannot use it again.
Danish: Når pennen er tom, kan du ikke bruge den igen.
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Danish: Pankreatitis kan være en alvorlig og potentielt livstruende tilstand.
English: The mean age of subjects was 59 years and the mean duration of diabetes was 12.3 years.
Danish: Gennemsnitsalderen for patienterne var 59 år, og den gennemsnitlige varighed af diabetes var 12,3 år.
English: Weight loss of this rate may have harmful consequences.
Danish: Vægttab i denne størrelsesorden kan have skadelige konsekvenser.
English: Your doctor should tell you how to treat low blood sugar.
Danish: Din læge bør fortælle dig, hvordan lavt blodsukker skal behandles.
English: • No.
Danish: • Nej.
English: Do not change your dose unless your doctor has told you to.
Danish: Du må ikke ændre dosis, medmindre lægen har foreskrevet det.
English: (See Storing Your ByettaPenin Section 1 of this user manual for more information.)
Danish: (Se Opbevaring af din Byetta-pen i afsnit 1 i denne brugsanvisning for mere information.)
English: If you stop using this medicine this can affect your blood sugar levels.
Danish: Hvis du holder op med at tage dette lægemiddel, kan det påvirke dit blodsukkerniveau.
English: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Ireland
Danish: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon industrial Estate, Shannon, Co. Clare Irland
English: The clinical experience in patients > 75 years is very limited.
Danish: Den kliniske erfaring hos patienter >75 år er meget begrænset.
English: (See section 3 “How to use Byetta”).
Danish: (Se punkt 3 "Sådan skal du tage Byetta").
English: Use this medicine at any time within the 60 minutes (1 hour) before your meal.
Danish: Tag dette lægemiddel når som helst inden for 60 minutter (1 time) før et måltid.
English: Now that you have done the New Pen Setup, follow Section 3 for all of your injections.
Danish: Nu hvor du har klargjort pennen, så følg afsnit 3 for alle dine injektioner.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to  1/10), uncommon ( 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelige (≥1/10), almindelige (≥1/100 til 1/10), ikke almindelige (≥1/1.000 til <1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Animal studies did not indicate direct harmful effects with respect to fertility or pregnancy.
Danish: Dyreforsøgene indikerede ingen direkte skadelige virkninger med hensyn til fertilitet eller graviditet.
English: - How to inject this medicine.
Danish: - Hvordan dette lægemiddel skal indsprøjtes.
English: Replace the needle and repeat the step above.
Danish: Udskift nålen og gentag ovenstående.
English: Beta-cell function
Danish: Beta-celle-funktion
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen, da den indeholder vigtige oplysninger.
English: Your doctor or nurse must teach you how to inject Byetta before you use it for the first time.
Danish: Lægen eller sygeplejersken skal instruere dig i at indsprøjte Byetta, før du tager det for første gang.
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Danish: Brug af GLP-1-receptoragonister er blevet forbundet med en risiko for udvikling af akut pancreatitis.
English: Do not inject another dose.
Danish: Tag ikke yderligere en dosis.
English: Pruritus, and/ or urticaria
Danish: Pruritus og/eller urticaria
English: What should I do if Byetta does not come out of the needle tip after four tries during New Pen Setup?
Danish: Hvad skal jeg gøre, hvis der ikke kommer Byetta ud af nålespidsen efter fire forsøg under Klargøring af ny pen?
English: These reductions in HbA1c were generally observed at 12 weeks after initiation of treatment.
Danish: Denne reduktion af HbA1c blev sædvanligvis observeret ved uge 12 efter behandlingsstart.
English: − Some antibiotics may need to be taken an hour before your Byetta injection.
Danish: − Visse typer antibiotika skal tages en time før din Byetta-indsprøjtning.
English: In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient's clinical signs and symptoms.
Danish: I tilfælde af overdosering skal passende afhjælpende behandling (eventuelt indgivet parenteralt) iværksættes i overensstemmelse med patientens kliniske tegn og symptomer.
English: Read and follow the directions in this section only after you've read section 1-what you need to know about your Byetta pen.
Danish: Læs og følg først vejledningen i dette afsnit, når du har læst Afsnit 1 - Hvad du har brug for at vide om din Byetta-pen
English: Do not use Byetta if it has been frozen.
Danish: Anvend ikke Byetta, hvis den har været nedfrosset.
English: This medicine is for you; never share a Byetta pen with others.
Danish: Denne medicin er ordineret til dig, og du må aldrig dele en Byetta-pen med andre.
English: Digoxin, lisinopril and warfarin
Danish: Digoxin, lisinopril og warfarin