FrancophonIA/ELRC3.0 huggingface dataset:
English: All participants received 1,000 mg elemental calcium plus 400 to 1,000 IU vitamin D supplementation per day.
Danish: Alle deltagere fik 1.000 mg usammensat calcium plus 400 til 1.000 IE D-vitamin pr. dag.
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Danish: - Svært nedsat nyrefunktion med kreatininclearance < 35 ml/min (se pkt.
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 er kemisk og fysisk stabilitet påvist i 24 timer ved 2-8°C og 25°C.
English: For information on the infusion of zoledronic acid, see section 6.6.
Danish: For information angående infusion af zoledronsyre, se pkt.
English: Effect on bone mineral density (BMD)
Danish: Effekt på knoglemineraltæthed (BMD)
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Danish: Frekvensen af atrieflimren som alvorlig utilsigtet hændelse var øget hos patienter i behandling med zoledronsyre (1,3 %) (51 ud af 3.862) sammenlignet med patienter som modtog placebo (0,6 %) (22 ud af 3.852) Mekanismen bag den øgede forekomst af atrieflimren er ukendt.
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis#
Danish: Kvalme, opkastning, diarré Ikke almindelig Dyspepsi, øvre mavesmerter, mavesmerter, gastroøsofageal reflukssygdom, forstoppelse, mundtørhed, øsofagit, tandpine, gastrit#
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Danish: Ikke almindelig Serumkreatinin øget, pollakisuri, proteinuri
English: All participants received 1,000 to 1,500 mg of elemental calcium plus 800 to 1,200 IU of vitamin D supplementation per day.
Danish: Alle deltagerne modtog dagligt 1.000 til 1.500 mg usammensat calcium plus 800 til 1.200 IE D-vitaminsupplement.
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 to 8°C.
Danish: Hvis produktet ikke anvendes straks, er opbevaringstid og -forhold før brug brugerens ansvar og er normalt ikke mere end 24 timer ved 2°-8°C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/912/004
English: Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Danish: Manglende akkumulering af stof givet som flere doser uanset nyrefunktionen, indikerer, at dosisjustering af zoledronsyre ved mild (Clkr = 50-80 ml/min) og moderat nedsat nyrefunktion ned til en kreatininclearance på 35 ml/min ikke er nødvendig.
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 sygeplejerske som en infusion i en vene.
English: In patients with a recent low-trauma 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-infusion hos patienter med en nylig lavenergi-hoftefraktur.
English: Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Danish: Zoledronsyre er kontraindiceret til patienter med kreatininclearance < 35 ml/min (se pkt.
English: Days of disability
Danish: Dage med nedsat funktionsevne
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller sygeplejersken.
English: Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5. zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Danish: Omkring 42 % af patienterne havde en lårbenshals BMD T-score lavere end -2,5 og omkring 45 % af patienterne havde en lårbenshals BMD T-score over -2,5.
English: - Patients with hypocalcaemia (see section 4.4).
Danish: - Hypokalcæmi (se pkt.
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 produktet ikke anvendes med det samme, er brugeren ansvarlig for opbevaringstid og -betingelser, og vil normalt ikke være længere end 24 timer ved 2°C - 8°C.
English: Zoledronic acid treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks.
Danish: Laveste niveau blev nået for resorptionsmarkørerne efter 7 dage og for formationsmarkørerne efter 12 uger.
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 Generics (se pkt.
English: Allow the refrigerated solution to reach room temperature before administration.
Danish: Lad den afkølede opløsning få stuetemperatur før administration.
English: Zoledronic acid (N = 1,065) event rate (%)
Danish: Zoledronsy re (N=3.875) hændelsesrate (%)
English: How to prepare and administer Zoledronic acid Teva Generics in bags
Danish: Tilberedelse og administration af Zoledronsyre Teva Generics i poser:
English: What Zoledronic acid Teva Generics looks like and contents of the pack Zoledronic acid Teva Generics is a clear and colourless solution for infusion.
Danish: Zoledronsyre Teva Generics er en klar, farveløs væske til infusion.
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Hovedpine, svimmelhed, kvalme, opkastninger, diarré, muskelsmerter, knogle- og/eller ledsmerter, smerter i ryg, arme eller ben, influenzalignende symptomer (fx træthed, kuldegysninger, led- og muskelsmerter), kuldegysninger, følelse af træthed og manglende interesse, svækkelse, smerter, sygdomsfølelse.
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Danish: Opbevares ved temperaturer under 30°C.
English: The use of Zoledronic acid Teva Generics in children and adolescents has not been studied.
Danish: Zoledronsyre Teva Generics frarådes til personer under 18 år, da brug af Zoledronsyre Teva Generics til børn og unge ikke er undersøgt.
English: Zoledronic acid Teva Generics contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Danish: Zoledronsyre Teva Generics indeholder natrium Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 100 ml, det vil sige er praktisk taget "natriumfrit".
English: - Zoledronic acid Teva Generics 5 mg solution for infusion is ready for use.
Danish: - Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning er klar til brug.
English: • A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Danish: • En enkelt dosis zoledronsyre bør ikke overstige 5 mg, og infusionsvarigheden bør være mindst
English: For information on the infusion of Zoledronic acid Teva Generics, see section 6.6.
Danish: For information angående infusion af Zoledronsyre Teva Generics se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL MULTIPAKNING (med blue box)
English: Identified in post-marketing experience.
Danish: † Set efter markedsføring.
English: How to prepare and administer Zoledronic acid Teva Generics
Danish: Tilberedelse og administration af Zoledronsyre Teva Generics:
English: - Store below 30°C.
Danish: - Opbevares ved temperaturer under 30°C.
English: Effect on hip fractures
Danish: Effekt på hoftefrakturer
English: - Zoledronic acid Teva Generics 5 mg solution for infusion in bags is ready for use.
Danish: - Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning i poser er klar til brug.
English: Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Danish: Ikke-vertebral fraktur (1) *p-værdi <0,05, **p-værdi <0,01 (1) Ekskl.
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
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) Ikke kendt** Kæbeosteonekrose (se pkt.
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Generics 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 Generics for post-menopausal osteoporose.
English: Uncommon Hypertension, flushing Not known** Hypotension (some of the patients had underlying risk factors)
Danish: Ikke almindelig Forhøjet blodtryk, rødmen Ikke kendt** Hypotension (nogle af patienterne havde underliggende risikofaktorer) Luftveje, thorax og mediastinum Ikke almindelig Hoste, dyspnø Mave-tarm-kanalen
English: Non-vertebral fracture (1) *p-value <0.001, **p-value <0.0001 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Danish: Ikke-vertebral fraktur (1) *p-værdi <0,001, **p-værdi <0,0001 (1) Ekskl.
English: Skin and subcutaneous tissue disorders Uncommon Rash, hyperhydrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Danish: Ikke almindelig Udslæt, hyperhidrose, pruritus, erytem Knogler, led, muskler og bindevæv Almindelig
English: - Do not throw away any medicines via wastewater (or household waste).
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag contains 5 mg zoledronic acid (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver pose indeholder 5 mg zoledronsyre (som monohydrat).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml; i.e. essentially “sodiumfree.”
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 100 ml, dvs. det er praktisk taget ”natriumfrit”.
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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver flaske indeholder 5 mg zoledronsyre (som monohydrat).
English: Each ml of the solution contains 0.05 mg zoledronic acid (as monohydrate).
Danish: Hver ml af opløsningen indeholder 0,05 mg zoledronsyre (som monohydrat).
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: Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Danish: 4.4 og 4.8 Klasseeffekter)
English: C-reactive protein increased Uncommon Blood calcium decreased
Danish: Stigning i C-reaktivt protein Ikke almindelig Nedsat calcium i blodet Observeret i patienter, der samtidigt tager glukokortikoider.
English: Relative reduction in fracture incidence % (CI)
Danish: Relativ reduktion af frakturincidens % (CI)
English: Zoledronic acid is contraindicated during breast-feeding (see section 4.3).
Danish: Zoledronsyre er kontraindiceret til ammende kvinder (se pkt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodiumfree.”
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per 100 ml hætteglas, dvs. det er i det væsentlige natriumfrit.
English: One bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: En flaske indeholder 5 mg vandfri zoledronsyre (som monohydrat).
English: EXPIRY DATE
Danish: EXP:
English: How to store Zoledronic acid Teva Generics
Danish: Sådan får du Zoledronsyre Teva Generics
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (without blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE (uden blue box)
English: Absolute reduction in fracture incidence % (CI)
Danish: Absolut reduktion i frakturhændelsesrate % (CI)
English: Uveitis, episcleritis, iritis
Danish: Nyrer og urinveje
English: 1 bottle of 100 ml.
Danish: Infusionsvæske, opløsning 1 flaske med 100 ml.
English: 1 bag of 100 ml
Danish: Infusionsvæske, opløsning 1 pose med 100 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE (med blue box)
English: Store below 30°C.
Danish: Opbevares under temperaturer på 30°C.
English: Zoledronic acid Teva Generics 5 mg solution for infusion in bottles zoledronic acid
Danish: Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning i flasker zoledronsyre
English: What you need to know before you are given Zoledronic acid Teva Generics Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid Teva Generics.
Danish: Følg nøje alle lægens, farmaceutens eller sundhedspersonalets instruktioner, før du anvender Zoledronsyre Teva Generics.
English: 1 bottle of 100 ml
Danish: Infusionsvæske, opløsning 1 flaske med 100 ml
English: Check with your doctor or nurse if you are not sure.
Danish: Spørg lægen, farmaceuten eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
Danish: En ml opløsning indeholder 0,05 mg zoledronsyre (som monohydrat).
English: Flu-like symptoms, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Danish: Influenzalignende symptomer, kulderystelser, træthed, asteni, smerter, utilpashed, reaktioner på infusionsstedet Ikke almindelig Perifert ødem, tørst, akut-fase reaktion, ikke-kardielle brystsmerter
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 zoledronsyre-behandling signifikant BMD i forhold til placebo ved hofteledet og lårbenshalsen ved alle tidspunkter (12, 24 og 36 måneder).
English: One bag contains 5 mg zoledronic acid (as monohydrate).
Danish: En pose indeholder 5 mg vandfri zoledronsyre (som monohydrat).
English: Osteonecrosis of the jaw (ONJ)
Danish: Osteoporose (knogleskørhed)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver flaske indeholder 5 mg zoledronsyre (som monohydrat).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bags
Danish: LÆGEMIDLETS NAVN Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning i poser.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 5 mg zoledronic acid (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 flaske indeholder 5 mg zoledronsyre (som monohydrat).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bottles
Danish: LÆGEMIDLETS NAVN Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning i flasker.
English: Respiratory, thoracic and mediastinal disorders
Danish: Infusionsvæske, opløsning 100 ml
English: Relative risk reduction in fracture incidence % (CI)
Danish: Relativ risikoreduktion i frakturincidens % (CI)
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion zoledronic acid
Danish: Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning zoledronsyre
English: Nederland Teva Nederland B.V. Tel: +31 800 0228400
Danish: Tel: +31 800 0228400
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på karton og flaske efter udløbsdato.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bag contains 5 mg zoledronic acid (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver pose indeholder 5 mg zoledronsyre (som monohydrat).
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 kendt** Dehydrering sekundært til symptomer som feber, opkastning og diarré efter behandlingen.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING OVERPOUCH (without blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE YDERPOSE (uden blue box)
English: Uncommon Influenza, nasopharyngitis
Danish: Infektioner og parasitære sygdomme Ikke almindelig Influenza, nasofaryngit Blod og lymfesystem
English: Blood and lymphatic system disorders
Danish: kliniske frakturer på torakale og lumbale ryghvirvler
English: PHARMACOLOGICAL PROPERTIES
Danish: Farmakodynamisk virkning
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bottles zoledronic acid
Danish: Indlægsseddel: Information til brugeren Zoledronsyre Teva Generics 5 mg infusionsvæske, opløsning i flasker zoledronsyre
English: What Zoledronic acid Teva Generics is and what it is used for What you need to know before you are given Zoledronic acid Teva Generics How Zoledronic acid Teva Generics is given Possible side effects
Danish: Det skal du vide, før du begynder at blive behandlet med Zoledronsyre Teva Generics Sådan får du Zoledronsyre Teva Generics
English: • then at least every month after that.
Danish: • mindst hver måned derefter.
English: This is called a ‘response'.
Danish: Dette kaldes et 'respons'.
English: This may lead to very serious infection.
Danish: Dette kan føre til en meget alvorlig infektion.
English: However, on some days you do not take any of the medicines.
Danish: På nogle af dagene tager du imidlertid ikke nogen af lægemidlerne.
English: • every week for the first 8 weeks of treatment
Danish: • hver uge de første 8 uger af behandlingen
English: However, the signs and symptoms can be greatly reduced or disappear for a period of time.
Danish: Tegn og symptomer kan imidlertid kraftigt reduceres eller forsvinde i en periode.
English: If you are able to become pregnant
Danish: Hvis du kan blive gravid
English: • The patient has acknowledged the aforementioned conditions.
Danish: • Patienten har anerkendt ovennævnte betingelser
English: An updated RMP should be submitted:
Danish: En opdateret RMP skal fremsendes:.
English: Time to event
Danish: Tid til hændelse
English: Take your next capsule at the usual time the next day.
Danish: Tag den næste kapsel på det sædvanlige tidspunkt næste dag.
English: Your doctor will ask you to have a blood test:
Danish: Lægen vil bede dig om at få taget en blodprøve:
English: Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established.
Danish: Yderligere opfølgning og evaluering kan være relevant, hvis der ikke kan stilles en alternativ diagnose.
English: • That the patient should not donate blood
Danish: • At patienten ikke må donere blod
English: The median age was 73 in the 3 arms.
Danish: Medianalderen var 73 i de 3 arme.
English: An extended follow-up efficacy analysis was conducted with a median follow-up of 130.7 weeks.
Danish: En udvidet opfølgningsanalyse af effekten blev gennemført med en median opfølgning på 130,7 uger.
English: ATC code: L04AX04.
Danish: ATC-kode: L04 AX04.
English: Although it was observed at maternotoxic levels they may be attributable to a direct effect.
Danish: Selvom det blev observeret ved maternotoksiske niveauer, kan det skyldes en direkte effekt.
English: The following can be considered to be examples of suitable methods of contraception:
Danish: Følgende kan betragtes som eksempler på velegnede præventionsmetoder:
English: Date of first authorisation: 20th September 2018
Danish: Dato for første markedsføringstilladelse: 20. september 2018
English: • Disposal of unwanted medicine
Danish: • Bortskaffelse af uønsket medicin
English: The median overall survival time was 105.9 months
Danish: Den mediane samlede overlevelsestid var 105,9
English: Infection with or without neutropenia
Danish: Infektion med eller uden neutropeni
English: • That patients should be capable of complying with the requirements for the safe use of
Danish: • Patienterne skal være i stand til at overholde de krav, der stilles til sikker brug af
English: • Verification that appropriate counselling has taken place
Danish: • Bekræftelse på at der er gennemført en passende rådgivning
English: Common C-reactive protein increased
Danish: Almindelig Forhøjet C-reaktivt protein
English: This medicine belongs to a group of medicines which affect how your immune system works.
Danish: Dette lægemiddel tilhører en gruppe lægemidler, som påvirker den måde, dit immunsystem virker på.
English: g Best assessment of adjudicated response during the treatment phase of the study (for definitions of each response category, Data cut-off date = 24 May 2013).
Danish: g Bedste vurdering af adjudikeret respons i løbet af behandlingsfasen af studiet (for definitioner på hver responskategori), dataafskæring 24. maj 2013.
English: Overall response [n, %] Complete response [n, %]
Danish: Samlet respons [N, %] Fuldstændig respons [N, %]
English: Otherwise, decrease by one dose level at start of next cycle.
Danish: Ellers nedsættes med et dosisniveau ved starten af den næste cyklus.