FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: At least one new vertebral fracture (0-3 year)
Danish: Mindst en ny vertebral fraktur (0-1 år) Mindst en ny vertebral fraktur (0-2 år) Mindst en ny vertebral fraktur (0-3 år) ** p <0,0001
English: Zoledronic acid Teva Pharma is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Danish: Zoledronsyre Teva Pharma er kontraindiceret til patienter med kreatininclearance < 35 ml/min (se pkt.
English: EXP After opening: 24 hours at 2°C - 8°C
Danish: Udløbsdato Efter åbning: 24 timer ved 2°C-8°C.
English: Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.
Danish: Det anbefales at indtage tilstrækkeligt med calcium og D-vitamin i forbindelse med administration af Zoledronsyre Teva Pharma.
English: In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.2).
Danish: Yderligere tilrådes det kraftigt hos patienter med Pagets sygdom, at sikre et tilstrækkeligt calciumtilskud svarende til mindst 500 mg calcium to gange daglig i mindst 10 dage efter administration af Zoledronsyre Teva Pharma (se pkt.
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
Danish: 5.1) var den generelle forekomst af atrieflimren 2,5 % (96 ud af 3.862) og 1,9 % (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre og placebo.
English: What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid.
Danish: Zoledronsyre Teva Pharma indeholder: - Aktivt stof: zoledronsyre.
English: In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.4).
Danish: Det tilrådes kraftigt hos patienter med Pagets sygdom at sikre et tilstrækkeligt calciumtilskud svarende til mindst 500 mg calcium to gange daglig, i mindst 10 dage efter administration af Zoledronsyre Teva Pharma (se pkt.
English: The patient educational material should contain the following key messages:
Danish: Patientinformationsmaterialet skal indeholde følgende hovedelementer:
English: - if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Zoledronsyre Teva Pharma - hvis du er allergisk over for zoledronsyre, andre bisfosfonater eller et af de øvrige indholdsstoffer i Zoledronsyre Teva Pharma (angivet i punkt 6).
English: - Zoledronic acid Teva Pharma 5 mg solution for infusion is ready for use.
Danish: - Zoledronsyre Teva Pharma 5 mg infusionsvæske, opløsning er klar til brug.
English: The physician educational material should contain the following key messages:
Danish: Lægeundervisningsmateriale skal indeholde følgende hovedelementer:
English: • Once-yearly dosing regime
Danish: • Doseringsregime én gang årligt.
English: • Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Zoledronic acid Teva Pharma
Danish: • Nødvendigheden af inden hver behandling med Zoledronsyre Teva Pharma at beregne kreatininclearance på basis af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen
English: Zoledronic acid Teva Pharma with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Pharma, as directed by your doctor.
Danish: Sørg for at drikke tilstrækkelig væske (mindst 1 eller 2 glas) før og efter behandling med Zoledronsyre Teva Pharma, som din læge har fortalt dig.
English: For information on the infusion of Zoledronic acid Teva Pharma, see section 6.6.
Danish: For information angående infusion af Zoledronsyre Teva Pharma se pkt.
English: After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Danish: Efter åbning: Kemisk og fysisk stabilitet er påvist i 24 timer ved 2-8°C og 25°C.
English: Teva Pharmaceuticals Ireland, L-Irlanda Tel: +353 51 321740
Danish: Teva Pharmaceuticals Ireland Tel: +353 51 321 740
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Danish: Sjældne tilfælde af dialysekrævende nyresvigt og sjældne tilfælde med letal udgang er rapporteret hos patienter med forudeksisterende nedsat nyrefunktion eller andre risikofaktorer som fremskreden alder, samtidig anvendelse af nefrotoksiske lægemidler, samtidig anvendelse af diuretika eller dehydrering efter behandlingen med Zoledronsyre Teva Pharma (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/772/003 multipack with 5 bags
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/12/772/003 multipakning med 5 poser
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients, listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof, over for andre bisfosfonater eller over for et eller flere af hjælpestofferne, anført i pkt.
English: - Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. - Store below 30°C.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og posen efter EXP. - Må ikke opbevares ved temperaturer under 30°C.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver flaske med 100 ml opløsning indeholder 5 mg zoledronsyre (som monohydrat).
English: Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential.
Danish: Kvinder i den fertile alder Zoledronsyre Teva Pharma bør ikke anvendes til kvinder i den fertile alder.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis præparatet ikke bruges med det samme, er brugeren ansvarlig for opbevaringstid og -betingelser, som normalt ikke vil være længere end 24 timer ved 2°C - 8°C.
English: In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
Danish: I undergruppen med patienter, der havde fået glukokortikoider i 3 måneder eller derunder før randomisering, øgede zoledronsyre lænderygsøjlens BMD med 4,06 % i forhold til 2,71 % for risedronat (middeldifference: 1,36 %; p < 0,001).
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) Feber.
English: EU/1/12/772/004 multipack with 10 bags
Danish: EU/1/12/772/004 multipakning med 10 poser
English: In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001).
Danish: I undergruppen med patienter, der havde fået glukokortikoider i mindre end 3 måneder før randomisering, øgede zoledronsyre BMD i lænderygsøjlen med 2,60 % i forhold til 0,64 % for risedronat (middeldifference: 1,96 %; p > 0,001).
English: Solution for infusion Multipack: 5 bags of 100 ml Multipack: 10 bags of 100 ml
Danish: Multipakning: 5 poser med 100 ml
English: The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse.
Danish: Den sædvanlige dosis er 5 mg, som indgives af din læge eller sundhedspersonalet som en infusion i en vene.
English: Solution for infusion Multipack: 5 bottles of 100 ml Multipack: 10 bottles of 100 ml
Danish: Multipakning: 5 flasker med 100 ml
English: In patients with a recent lowtrauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
Danish: Det anbefales at give en støddosis D-vitamin på 50.000 til 125.000 IE oralt eller intramuskulært før den første Zoledronsyre Teva Pharma-infusion hos patienter med en nylig lavenergi-hoftefraktur.
English: Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma.
Danish: Tilfælde af osteonekrose af kæberne er blevet rapporteret efter markedsføring for Zoledronsyre Teva Pharma.
English: How to prepare and administer Zoledronic acid Teva Pharma
Danish: Tilberedelse og administration af Zoledronsyre Teva Pharma:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OVERPOUCH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPOSE
English: The use of Zoledronic acid Teva Pharma in children and adolescents has not been studied.
Danish: Zoledronsyre Teva Pharma frarådes til personer under 18 år, da brug af Zoledronsyre Teva Pharma til børn og unge ikke er undersøgt.
English: - After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Danish: - Efter åbning af flasken er kemisk og fysisk stabilitet påvist i 24 timer ved 2-8°C og 25°C.
English: While being treated with Zoledronic acid Teva Pharma, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Zoledronsyre Teva Pharma, skal du holde en god mundhygiejne (inkl.
English: What Zoledronic acid Teva Pharma looks like and contents of the pack Zoledronic acid Teva Pharma is a clear and colourless solution.
Danish: Zoledronsyre Teva Pharma er en klar, farveløs væske.
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle
Danish: EU/1/12/772/001 multipakning med 5 flasker EU/1/12/772/002 multipakning med 10 flasker EU/1/12/772/005 1 flaske
English: What you need to know before you are given Zoledronic acid Teva Pharma
Danish: Det skal du vide, før du begynder at blive behandlet med Zoledronsyre Teva Pharma
English: - After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Danish: - Efter åbning af posen er kemisk og fysisk stabilitet påvist i 24 timer ved 2-8°C og 25°C.
English: EU/1/12/772/004
Danish: EU/1/12/772/003 EU/1/12/772/004
English: Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Danish: Ikke almindelig Konjunktivit, øjensmerter Uveit, episklerit, irit
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller sundhedspersonalet.
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles
Danish: EU/1/12/772/001 multipakning med 5 flasker EU/1/12/772/002 multipakning med 10 flasker
English: Atrial fibrillation Uncommon Palpitations
Danish: Ikke almindelig Palpitationer
English: Solution for infusion 100 ml
Danish: 100 ml
English: How to store Zoledronic acid Teva Pharma
Danish: Sådan får du Zoledronsyre Teva Pharma
English: Check with your doctor or nurse if you are not sure.
Danish: Spørg lægen, på apoteket eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth,
Danish: Kvalme, opkastning, diarré Ikke almindelig Dyspepsi, øvre mavesmerter, mavesmerter, gastroøsofageal reflukssygdom, forstoppelse, mundtørhed,
English: Österreich ratiopharm Arzenimittel Vertriebs-GmbH
Danish: Österreich ratiopharm Arzenimittel Vertriebs-GmbH Tel: +43 1 97007-0
English: ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8).
Danish: Osteonekrose af kæberne er blevet rapporteret efter markedsføring hos patienter behandlet med Zoledronsyre Teva Pharma (zoledronsyre) for osteoporose (se pkt.
English: proteinuria
Danish: Hjælpestoffer
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Danish: Ikke almindelig Nakkesmerter, stivhed i bevægeapparatet, hævelse af led, muskelkramper, skuldersmerter, muskuloskeletale smerter i brystregionen, muskuloskeletale smerter, ledstivhed, artrit, muskelsvækkelse Atypiske subtrokantære og diafyseale femurfrakturer† (bisfosfonat klasseeffekt) Meget sjælden Osteonekrose af øregangen† (klassebivirkning for bisfosfonater).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON MED MULTIPAKNING (med blue box)
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
Danish: Ikke almindelig Perifert ødem, tørst, akut-fase reaktion, ikke-kardielle brystsmerter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON (uden blue box)
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Uregelmæssig hjerterytme (puls), kaldet atrieflimren, er set hos patienter behandlet med Zoledronsyre Teva Pharma for post-menopausal osteoporose.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis.
Danish: Efter markedsføring af produktet er en bivirkning kaldet osteonekrose i kæben (knogleskade i kæben) blevet set hos patienter behandlet med zoledronsyre mod osteoporose.
English: Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Danish: Ikke almindelig Udslæt, hyperhidrose, pruritus, erytem
English: Solution for infusion 1 bag of 100 ml.
Danish: 1 pose med 100 ml.
English: How to store Zoledronic acid Teva Pharma Contents of the pack and other information
Danish: Brug af Zoledronsyre Teva Pharma sammen med mad og drikke
English: In the HORIZON-RFT study zoledronic acid treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Danish: I HORIZON-RFT-studiet forøgede zoledronsyrebehandling signifikant BMD i forhold til placebo ved hofteledet og lårbenshalsen ved alle tidspunkter (12, 24 og 36 måneder).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles
Danish: LÆGEMIDLETS NAVN Zoledronsyre Teva Pharma 5 mg infusionsvæske, opløsning i flasker
English: Each bag contains 5 mg zoledronic acid (as monohydrate).
Danish: Hver pose indeholder 5 mg zoledronsyre (som monohydrat).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags
Danish: LÆGEMIDLETS NAVN Zoledronsyre Teva Pharma 5 mg infusionsvæske, opløsning i poser
English: • Creatinine clearance should be calculated based on actual body weight using the
Danish: • Før hver Zoledronsyre Teva Pharma-dosis bør kreatininclearance beregnes på basis af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen.
English: Zoledronic acid Teva Pharma may also cause other side effects Very common: may affect more than 1 in 10 people Fever.
Danish: Zoledronsyre Teva Pharma kan også give andre bivirkninger
English: One bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: En flaske indeholder 5 mg zoledronsyre (som monohydrat).
English: Tel.: +36 1 288 64 00
Danish: Magyarország Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
English: Each bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: Hver flaske indeholder 5 mg zoledronsyre (som monohydrat).
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF 11.
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid
Danish: Zoledronsyre Teva Pharma 5 mg infusionsvæske, opløsning i flasker zoledronsyre
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zoledronsyre Teva Pharma Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: - Do not use this medicine after the expiry date which is stated on the carton and bag after EXP.
Danish: - Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og posen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Danish: - Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og flasken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE (med blue box)
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bags zoledronic acid
Danish: Zoledronsyre Teva Pharma 5 mg infusionsvæske, opløsning i poser zoledronsyre
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON FOR ENKELTSTYKSPAKNING (med blue box)
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid
Danish: Zoledronsyre Teva Pharma 5 mg infusionsvæske, opløsning zoledronsyre
English: One bag contains 5 mg zoledronic acid (as monohydrate).
Danish: En pose indeholder 5 mg zoledronsyre (som monohydrat).
English: What Zoledronic acid Teva Pharma is and what it is used for What you need to know before you are given Zoledronic acid Teva Pharma How Zoledronic acid Teva Pharma is given
Danish: Det skal du vide, før du begynder at blive behandlet med Zoledronsyre Teva Pharma Sådan får du Zoledronsyre Teva Pharma
English: The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks.
Danish: Den anbefalede dosis er 210 mg én gang om ugen de første 3 uger, derefter hver anden uge.
English: This is a summary of the European public assessment report (EPAR) for Kyntheum.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kyntheum.
English: The full EPAR for Kyntheum can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Kyntheum findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kyntheum
Danish: Andre oplysninger om Kyntheum
English: Data from one study also showed that the benefits of treatment with Kyntheum were maintained when treatment was continued for one year.
Danish: Data fra den ene undersøgelse viste også, at fordelene ved behandling med Kyntheum blev opretholdt, når behandlingen blev fortsat i et år.
English: There have been some reports of suicidal behaviour in patients taking the medicine.
Danish: Der har været indberetninger om selvmordsadfærd hos patienter, der får lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Kyntheum?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kyntheum?
English: What is Kyntheum and what is it used for?
Danish: Hvad er Kyntheum, og hvad anvendes det til?
English: Studies have shown that Kyntheum was highly effective at clearing the skin and the positive effects were maintained with continued use.
Danish: Undersøgelser har vist, at Kyntheum var meget effektivt til at hele huden, og at de positive virkninger blev opretholdt ved fortsat anvendelse.
English: Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment.
Danish: Kyntheum er påvist at være effektivt til behandling af plaque-psoriasis i 3 hovedundersøgelser med over 4 300 patienter, som behøvede systemisk behandling.
English: Why is Kyntheum approved?
Danish: Hvorfor blev Kyntheum godkendt?
English: Kyntheum contains the active substance brodalumab.
Danish: Kyntheum indeholder det aktive stof brodalumab.
English: After training, patients may inject Kyntheum if their doctor considers it appropriate.
Danish: Efter opøvning kan patienten selv foretage indsprøjtningen med Kyntheum, hvis lægen finder det hensigtsmæssigt.
English: The active substance in Kyntheum, brodalumab, is a monoclonal antibody, a protein designed to block the activity of certain substances called interleukins 17 (A, F and A/F), which are messengers in the body's immune system (the body's natural defences).
Danish: Det aktive stof i Kyntheum, brodalumab, er et monoklonalt antistof, der er et protein, der er udformet til at blokere aktiviteten af stoffer med betegnelsen interleukin 17 (A, F og A/F), som er signalmolekyler i kroppens naturlige forsvar (immunsystemet).
English: The most common side effects with Kyntheum (which may affect more than 1 in 100 people) are joint pain, headache, tiredness, diarrhoea and oropharyngeal pain (pain in the mouth and throat).
Danish: De hyppigste bivirkninger ved Kyntheum (som optræder hos mere end 1 ud af 100 patienter) er ledsmerter, hovedpine, træthed, diarré og smerter i den mundhulenære del af svælget (oropharynx).
English: Although there is no evidence of a link to the medicine, the decision to start Kyntheum in patients who have had suicidal behaviour in the past or suffered from depression or anxiety should be made after carefully looking at all the risks and benefits for that patient.
Danish: Skønt der ikke er tegn på en sammenhæng med lægemidlet, bør beslutningen om at indlede behandlingen med Kyntheum hos patienter med tidligere selvmordsadfærd, depression eller angst kun træffes efter nøje gennemgang af alle risici og fordele for patienten.
English: It is not intended to provide practical advice on how to use Kyntheum.
Danish: Det er ikke en praktisk vejledning i, hvordan Kyntheum bør anvendes.
English: The European Medicines Agency therefore decided that Kyntheum's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde derfor, at fordelene ved Kyntheum overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: Although there have been recent advances in the treatment of plaque psoriasis, there remains a need for new treatment options.
Danish: Uanset de senere fremskridt i behandlingen af plaque-psoriasis er der fortsat behov for nye behandlingsmuligheder.