FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sygeplejersken, hvis du tager anden medicin eller har gjort det for nylig.
English: Tell your doctor or nurse straight away if you get any signs of an infusion-related reaction.
Danish: Fortæl det altid omgående til lægen eller sygeplejersken, hvis du får tegn på en infusionsrelateret reaktion.
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs).
Danish: Alle patienter skal gives præmedikation inden administration af Onpattro for at reducere risikoen for infusionsrelaterede reaktioner (IRR'er).
English: Onpattro has not been studied in patients with severe renal impairment or end-stage renal disease.
Danish: Onpattro er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet.
English: In the double-blind placebo-controlled study, 18.9% of Onpattro-treated patients experienced IRRs, compared to 9.1% of placebo-treated patients.
Danish: I det dobbeltblindede, placebokontrollerede studie oplevede 18,9 % af patienter behandlet med Onpattro IRR'er sammenlignet med 9,1 % af patienter behandlet med placebo.
English: The pharmacokinetic properties of Onpattro were characterised by measuring the plasma concentrations of patisiran and the lipid components DLin-MC3-DMA and PEG2000-C-DMG.
Danish: De farmakokinetiske egenskaber af Onpattro blev karakteriseret ved at måle plasmakoncentrationerne af patisiran og lipidkomponenterne DLin-MC3-DMA og PEG2000-C-DMG.
English: Onpattro has not been studied in patients with severe renal impairment or end-stage renal disease and should not be used in these patients unless the anticipated clinical benefit outweighs the potential risk (see section 5.2).
Danish: Onpattro er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet og bør ikke anvendes til disse patienter, medmindre den forventede kliniske fordel opvejer den mulige risiko (se pkt.
English: If refrigeration is not available, Onpattro can be stored at room temperature (up to 25°C) for up to 14 days.
Danish: Hvis opbevaring i køleskab ikke er muligt, kan Onpattro opbevares ved stuetemperatur (op til 25 °C) i op til 14 dage.
English: • The patient should be observed during the infusion and, if clinically indicated, following the infusion (see section 4.4).
Danish: • Patienten skal observeres under infusionen, og hvis det er klinisk indiceret efter infusionen (se pkt.
English: In patients with pre-defined cardiac involvement, centrally-assessed echocardiograms showed decreases in LV wall thickness (LS mean difference: −0.9 mm [95% CI −1.7, −0.2]) and longitudinal strain (LS mean difference: −1.37% [95% CI -2.48, -0.27]) with Onpattro treatment relative to placebo.
Danish: Hos patienter med prædefineret involvering af hjertet viste centralt vurderet ekkokardiogrammer reduktioner i tykkelsen af venstre ventrikelvæg (LS gennemsnitlig forskel: -0,9 mm [95 % KI -1,7, -0,2]) og longitudinel belastning (LS gennemsnitlig forskel: -1,37 % [95 % KI -2,48, -0,27]) med Onpattro-behandling i forhold til placebo.
English: The accumulation of AUCτ was 3.2-fold at steady-state compared to the first dose.
Danish: Akkumuleringen af AUCτ var 3,2 gange højere ved steady-state sammenlignet med den første dosis.
English: • Dilute the required volume of filtered Onpattro into an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for a total volume of 200 mL.
Danish: • Fortynd det påkrævede volumen af filtreret Onpattro i en infusionspose med natriumklorid 9 mg/ml (0,9 %) opløsning til et samlet volumen på 200 ml.
English: A white to off-white coating may be observed on the inner surface of the vial, typically at the liquid-headspace interface.
Danish: En hvid til off-white belægning kan ses på indersiden af hætteglasset, typisk ved kontaktfladen mellem væske og tomrum.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Onpattro 2 mg/mL sterile concentrate patisiran
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Onpattro 2 mg/ml sterilt koncentrat patisiran i.v.
English: The median patient age at baseline was 62 (range, 24 to 83) years and 74% of patients were male, 26% were female.
Danish: Patienternes gennemsnitlige alder ved baseline var 62 (interval: 24 til 83 år).
English: Severe hypersensitivity (e.g., anaphylaxis) to the active substance or any of the excipients listed in section 6.1.
Danish: Alvorlig overfølsomhed (f.eks. anafylaksi) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Rapid heart rate
Danish: • Hurtig hjertefrekvens
English: • A dedicated line with an infusion set containing a 1.2 micron polyethersulfone (PES) in-line infusion filter must be used.
Danish: • En dedikeret slange med et infusionssæt, der har et 1,2 mikron polyethersulfon (PES) in-line infusionsfilter skal bruges.
English: A97S (9%), T60A (7%), E89Q (6%), and S50R (5%).
Danish: Niogtredive (39) forskellige TTR-mutationer var repræsenteret; de mest almindelige (≥ 5 %) var V30M (43 %), A97S (9 %), T60A (7 %), E89Q (6 %), og S50R (5 %).
English: Women of childbearing potential have to use effective contraception during treatment with Onpattro.
Danish: Fertile kvinder skal anvende sikker kontraception under behandling med Onpattro.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml indeholder patisirannatrium svarende til 2 mg patisiran.
English: The duration of infusion may be extended in the event of an IRR (see section 4.4).
Danish: Infusionsvarigheden kan forlænges i tilfælde af en IRR (se pkt.
English: The patient should receive at least 3 consecutive infusions of Onpattro without experiencing IRRs before each reduction in corticosteroid premedication.
Danish: Patienten skal gives mindst 3 konsekutive infusioner med Onpattro uden at have haft en IRR inden hver reduktion af præmedikation med et kortikosteroid.
English: The patient should receive at least 3 consecutive IV infusions of Onpattro without experiencing IRRs before each reduction in corticosteroid premedication.
Danish: Patienten skal gives mindst 3 konsekutive i.v.-infusioner med Onpattro uden at have haft en IRR inden hver reduktion af præmedikation med kortikosteroid.
English: Medicines given during treatment with Onpattro Before each infusion of Onpattro, you will be given medicines that help to lower the risk of infusionrelated reactions.
Danish: Inden hver infusion af Onpattro vil du få medicin, som hjælper med at reducere risikoen for infusionsrelaterede reaktioner.
English: Other medicines and Onpattro
Danish: Brug af anden medicin sammen med Onpattro
English: As a result, during treatment with Onpattro, laboratory tests for serum vitamin A do not reflect the total amount of vitamin A in the body and should not be used to guide vitamin A supplementation (see sections 4.4 and 5.1).
Danish: Derfor afspejler laboratorietest af vitamin A i serum ikke den totale mængde vitamin A i kroppen, og de bør ikke anvendes til vejledning om tilskud af vitamin A under behandling med Onpattro (se pkt.
English: At the dose regimen of 300 micrograms per kg every 3 weeks, mean ± SD steady state plasma clearance (CLss) of patisiran was 3.0 ± 2.5 mL/h/kg.
Danish: Ved doseringsregimen på 300 mikrogram per kg hver 3. uge var den gennemsnitlige ± SD plasmaclearance (CLss) af patisiran ved steady-state 3,0 ± 2,5 ml/t/kg.
English: • Intravenous H2 blocker (ranitidine 50 mg, or equivalent)
Danish: • Intravenøs H2-blokker (ranitidin 50 mg eller tilsvarende)
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: • Onpattro must be administered through a secure and free-flowing venous access line.
Danish: • Onpattro skal indgives gennem et sikkert venekateter med frit indløb.
English: • The diluted solution of Onpattro should be infused intravenously over approximately 80 minutes at an initial infusion rate of approximately 1 mL/min for the first 15 minutes, followed by an increase to approximately 3 mL/min for the remainder of the infusion.
Danish: • Den fortyndede opløsning af Onpattro skal gives intravenøst over cirka 80 minutter ved en initial infusionshastighed på cirka 1 ml/min.
English: • Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent)
Danish: • Intravenøs H1-blokker (diphenhydramin 50 mg eller tilsvarende)
English: Available toxicological data in animals have shown excretion of small amounts of the lipid components DLin-MC3-DMA and PEG2000-C-DMG in milk (see section 5.3).
Danish: Tilgængelige toksikologiske data hos dyr har påvist udskillelse af små mængder af de lipide komponenter DLin-MC3-DMA og PEG2000-C-DMG i mælk (se pkt.
English: • Indigestion (dyspepsia)
Danish: • Fordøjelsesbesvær (dyspepsi)
English: • Feeling tired (fatigue)
Danish: • Træthed (udmattelse)
English: What you need to know before you are given Onpattro You must not be given Onpattro
Danish: Det skal du vide, før du får Onpattro Du må ikke få Onpattro:
English: Onpattro must be diluted with sodium chloride 9 mg/mL (0.9%) solution prior to intravenous infusion.
Danish: Onpattro skal fortyndes med natriumklorid 9 mg/ml (0,9 %) opløsning inden intravenøs infusion.
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild hepatic impairment (bilirubin ≤ 1 x ULN and AST > 1 x ULN, or bilirubin > 1.0 to 1.5 x ULN and any AST) on patisiran exposure or TTR reduction compared to patients with normal hepatic function.
Danish: Populationsfarmakokinetik og farmakodynamiske analyser angav ingen effekt af let nedsat leverfunktion (bilirubin ≤ 1 x ULN og ASAT > 1 x ULN, eller bilirubin > 1,0 til 1,5 x ULN og enhver ASAT) på eksponering for patisiran eller reduktion i TTR sammenlignet med patienter med normal leverfunktion.
English: • Discard any unused portion of Onpattro.
Danish: • Kassér eventuelt ubrugt Onpattro.
English: How much Onpattro is given
Danish: Så meget Onpattro vil du få
English: Serum vitamin A levels should not be used to guide vitamin A supplementation during treatment with Onpattro (see section 4.5).
Danish: Serumniveauer af vitamin A bør ikke anvendes til vejledning om tilskud af vitamin A under behandling med Onpattro (se pkt.
English: • After completion of the infusion, the intravenous administration set should be flushed with sodium chloride 9 mg/mL (0.9%) solution to ensure that all medicinal product has been administered.
Danish: • Efter fuldført infusion, skal infusionssættet til intravenøs administration skylles med 9 mg/ml (0,9 %) natriumkloridopløsning for at sikre, at alt lægemidlet blev indgivet.
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs) (see section 4.4).
Danish: Alle patienter skal gives præmedikation inden administration af Onpattro for at reducere risikoen for infusionsrelaterede reaktioner (IRR'er) (se pkt.
English: Disodium hydrogen phosphate, heptahydrate Potassium dihydrogen phosphate, anhydrous Sodium chloride
Danish: Dinatriumhydrogenfosfat, heptahydrat Kaliumdihydrogenfosfat, vandfrit Natriumchlorid
English: The recommended dose of Onpattro is 300 micrograms per kg body weight administered via intravenous (IV) infusion once every 3 weeks.
Danish: Den anbefalede dosis af Onpattro er 300 mikrogram per kg legemsvægt administreret via intravenøs (i.v.)
English: At the dose regimen of 300 micrograms per kg every 3 weeks, the mean ± SD steady-state volume of distribution (Vss) of patisiran, DLin-MC3-DMA and PEG2000-C-DMG was 0.26 ± 0.20 L/kg, 0.47 ± 0.24 L/kg and 0.13 ± 0.05 L/kg, respectively.
Danish: Ved doseringsregimet på 300 mikrogram per kg hver 3. uge var det gennemsnitlige ± SD fordelingsvolumen (Vss) af patisiran, DLin-MC3-DMA og PEG2000-C-DMG ved steady-state hhv. 0,26 ± 0,20 l/kg, 0,47 ±0,24 l/kg og 0,13 ±0,05 l/kg.
English: • Feeling dizzy or faint (vertigo)
Danish: • Svimmelhed eller besvimelse (vertigo)
English: Therefore, pregnancy should be excluded before initiating Onpattro and women of childbearing potential should practise effective contraception.
Danish: Graviditet skal derfor udelukkes før iværksættelse af behandling med Onpattro, og fertile kvinder skal anvende sikker kontraception.
English: • Stuffy or runny nose (rhinitis)
Danish: • Stoppet eller løbende næse (rhinitis)
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild or moderate renal impairment (eGFR ≥ 30 to < 90 mL/min/1.73m2) on patisiran exposure or TTR reduction compared to subjects with normal renal function.
Danish: Populationsfarmakokinetiske og farmakodynamiske analyser angav ingen indvirkning af let eller moderat nedsat nyrefunktion (eGFR ≥ 30 til < 90 ml/min./1,73 m2) på eksponering for patisiran eller reduktion i TTR sammenlignet med hos forsøgspersoner med normal nyrefunktion.
English: • Shortness of breath (dyspnoea)
Danish: • Åndenød (dyspnø)
English: DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoate) PEG2000-C-DMG (α-(3'-{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylene)
Danish: DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoat)
English: • Onpattro must be administered through a free-flowing venous access line.
Danish: • Onpattro skal indgives gennem et venekateter med frit indløb.
English: Do not use if discolouration or foreign particles are present.
Danish: Undlad at bruge produktet, hvis det er misfarvet eller indeholder fremmedlegemer.
English: How long to use Onpattro
Danish: Så længe skal Onpattro bruges
English: Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles.
Danish: Hvert hætteglas indeholder patisiran natrium svarende til 10 mg patisiran formuleret som lipidnanopartikler.
English: Referral for ophthalmological assessment is recommended if patients develop ocular symptoms suggestive of vitamin A deficiency, including reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening or corneal perforation.
Danish: A-vitaminmangel, herunder nedsat nattesyn eller natteblindhed, vedvarende tørre øjne, øjenbetændelse, korneal inflammation eller -sår, korneal fortykkelse eller korneal perforering.
English: • The active substance is patisiran.
Danish: • Aktivt stof: Patisiran
English: In the placebo-controlled study, 62 (41.9%) patients treated with Onpattro were ≥ 65 years of age and
Danish: I det placebokontrollerede forsøg var 62 (41,9 %) patienter behandlet med Onpattro ≥ 65 år og 9 (6,1 %) patienter var ≥ 75 år.
English: dmBMI: body mass index (BMI; kg/m2) multiplied by serum albumin (g/L); a higher number indicates better nutritional status; nutritional status favoured Onpattro as early as 3 months.
Danish: bEt lavere tal angiver mindre svækkelse/færre symptomer cEt højere tal angiver mindre invaliditet/mindre svækkelse dmBMI: kropsmasseindeks (BMI; kg/m2) ganget med serumalbumin (g/l); et højere tal angiver bedre ernæringstilstand; ernæringstilstand var bedre for Onpattro så tidligt som efter 3 måneder
English: Disodium hydrogen phosphate, heptahydrate
Danish: Dinatriumhydrogenosfat, heptahydrat
English: Additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs, if needed (see sections 4.4 and 4.8).
Danish: Der kan gives flere eller højere doser af et eller flere præmedikamenter for at reducere risikoen for IRR'er, hvis nødvendigt (se pkt.
English: Onpattro 2 mg/mL concentrate for solution for infusion patisiran
Danish: Onpattro 2 mg/ml koncentrat til infusionsvæske, opløsning patisiran
English: With repeat dosing every 3 weeks, mean reductions of serum TTR after 9 and 18 months of treatment were 83% and 84%, respectively.
Danish: Gennemsnitlig serum TTR var reduceret med cirka 80 % inden for 10 til 14 dage efter en enkelt dosis Onpattro på 300 mikrogram per kg. Med gentagen dosering hver 3. uge var de gennemsnitlige reduktioner i serum TTR efter 9 og 18 måneders behandling hhv. 83 % og 84 %.
English: The estimated DLin-MC3-DMA mean ± SD steady-state CLss was 2.1 ± 0.8 mL/h/kg.
Danish: Den estimerede gennemsnitlige DLin-MC3-DMA ± SD CLss ved steady-state var 2,1 ±0,8 ml/t/kg.
English: The estimated PEG2000-C-DMG mean ± SD steady-state CLss was 2.1 ± 0.6 mL/h/kg.
Danish: Den estimerede gennemsnitlige PEG2000-C-DMG ± SD CLss ved steady-state var 2,1 ±0,6 ml/t/kg.
English: Vitamin A deficiency
Danish: A-vitaminmangel
English: If you are a woman of child-bearing age, you should practice effective contraception during treatment with Onpattro.
Danish: Hvis du er kvinde og kan blive gravid , bør du anvende sikker prævention, mens du behandles med Onpattro.
English: The estimated patisiran mean ± SD steady-state peak concentration (Cmax), trough concentration (Ctrough), and area under the curve (AUCτ) were 7.15 ± 2.14 µg/mL, 0.021 ± 0.044 µg/mL, and 184 ± 159 µg·h/mL, respectively.
Danish: Den estimerede gennemsnitlige ± SD peakkoncentration (Cmax), laveste koncentration (Cthrough), og arealet under kurven (AUCτ) af patisiran ved steady-state var hhv. 7,15 ± 2,14 mikrog./ml, 0,021 ± 0,044 mikrog./ml, og 184 ± 159 mikrog.·t/ml.
English: The estimated PEG2000-C-DMG mean ± SD steady-state Cmax, Ctrough and AUCτ were 4.22 ± 1.22 µg/mL, 0.0236 ± 0.0093 µg/mL, and 145 ± 64.7 µg·h/mL, respectively.
Danish: Den estimerede PEG2000-C-DMG-middel ± SD Cmax, Ctrough og AUCτ ved steady-state var hhv. 4,22 ±1,22 mikrog./ml, 0,0236 ±0,0093 mikrog./ml og 145 ±64,7 mikrog.·t/ml.
English: The estimated DLin-MC3-DMA mean ± SD steady-state Cmax, Ctrough and AUCτ were 40.2 ± 11.5 µg/mL, 1.75 ± 0.698 µg/mL, and 1403 ± 105 µg·h/mL, respectively.
Danish: Den estimerede DLin-MC3-DMA-middel ± SD Cmax, Ctrough og AUCτ ved steady-state var hhv. 40,2 ±11,5 mikrog./ml, 1,75 ±0,698 mikrog./ml og 1.403 ±105 mikrog.·t/ml.
English: How Onpattro is given
Danish: Sådan får du Onpattro
English: NAME OF THE MEDICINAL PRODUCT Onpattro 2 mg/mL concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Onpattro 2 mg/ml koncentrat til infusionsvæske, opløsning.
English: Do not shake or vortex.
Danish: Undlad at ryste eller hvirvle.
English: • Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Danish: • Hver ml indeholder 2 mg patisirannatrium svarende til 2 mg patisiran.
English: • Each 5 mL vial contains patisiran sodium equivalent to 10 mg patisiran.
Danish: • Hvert hætteglas med 5 ml indeholder patisirannatrium svarende til 10 mg patisiran
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller skraldespanden.
English: If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (intravenous, IV), or equivalent.
Danish: 2,5 mg til en minimumsdosis på 5 mg dexamethason (intravenøst, i.v.)
English: No impact on male or female fertility was detected in animal studies (see section 5.3).
Danish: Dyreforsøg angav ingen påvirkning af fertilitet hos hverken hanner eller hunner (se pkt.
English: In rats, while there were parental decreases in serum TTR (≥ 90%), thyroxine (≥ 66%) and vitamin A
Danish: Hos rotter blev der ikke set nogen effekt på fertilitet hos hanner eller hunner eller på embryo-føtal udvikling eller udvikling før og efter fødslen, selvom der var reduktioner i niveauer af TTR (≥ 90 %) i serum, thyroxin (≥ 66 %) og vitamin A (≥ 75%) med et rotte-specifikt surrogat for patisiran hos forældredyrene.
English: • Redness of the skin (erythema)
Danish: • Hudrødme (erytem)
English: • Feeling sick (nausea)
Danish: • Opkastningsfornemmelser (kvalme)
English: AST > 1 x ULN, or bilirubin > 1.0 to 1.5 x ULN and any AST).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (bilirubin ≤ 1 x ULN og ASAT > 1 x ULN, eller bilirubin > 1,0 til 1,5 x ULN og enhver ASAT).
English: If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (IV), or equivalent.
Danish: 2,5 mg til en minimumsdosis på 5 mg dexamethason (i.v.)
English: • Pain in the joints (arthralgia)
Danish: • Ledsmerter (artralgi)
English: Potassium dihydrogen phosphate, anhydrous
Danish: Kaliumdihydrogenfosfat, vandfrit
English: The infusion sets must be free of di(2-ethylhexyl)phthalate (DEHP).
Danish: Infusionssæt skal være uden di(2-ethylhexyl)phthalat (DEHP).
English: A
Danish: )c
English: Use infusion bags that are free of di(2-ethylhexyl)phthalate (DEHP).
Danish: Brug infusionsposer uden di(2-ethylhexyl)phthalat (DEHP).
English: Sinusitis
Danish: Sinuitis
English: Endpointa
Danish: Endepunkta
English: Use infusion bags that are free of di(2ethylhexyl)phthalate (DEHP).
Danish: Anvend infusionsposer uden di(2ethylhexyl)phthalat (DEHP).
English: 10-metre walk test (m/sec)c p < 0.001
Danish: 10-meter gangtest (m/sek.
English: What Onpattro is and what it is used for What you need to know before you are given Onpattro How Onpattro is given
Danish: Virkning og anvendelse Det skal du vide, før du får Onpattro Sådan får du Onpattro
English: What Onpattro looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Peripheral oedema
Danish: Mave-tarm-kanalen
English: • Muscle spasms
Danish: • Muskelspasmer
English: The infusion sets and lines must be free of di(2ethylhexyl)phthalate (DEHP).
Danish: Infusionssættet og slangerne må ikke indeholde di(2-ethylhexyl)phthalat (DEHP).
English: Renal impairment
Danish: Perifert ødem
English: Preparation of the solution for infusion
Danish: Forberedelse af infusionsvæsken, opløsningen
English: Your doctor will discuss this with you.
Danish: Din læge vil diskutere det med dig.
English: Doses up to this level were well tolerated.
Danish: Doser op til dette niveau var veltolereret.
English: Specific percentages for these are not available.
Danish: Specifikke procenter for disse er ikke tilgængelige.
English: Do not wait until the next planned cycle.
Danish: Vent ikke indtil den næste planlagte serie.
English: Do not stop using this medicine without talking to your doctor first.
Danish: Stop ikke med at få dette lægemiddel uden at tale med din læge først.
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Danish: TTP = tid indtil progression; “ne” betyder, at grænsen ikke kunne estimeres, eller at den endnu ikke var nået.
English: Time to steadystate*** (week)
Danish: Tid til steadystate*** (uge)
English: Official recommendations on HER2 testing may also apply.
Danish: Officielle anbefalinger for HER2-testning kan også anvendes.
English: Clinical experience is limited in patients above 65 years of age.
Danish: Den kliniske erfaring er begrænset hos patienter over 65 år.
English: They are usually temporary.
Danish: De er for det meste forbigående.
English: • Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Danish: • Hjerteproblemer kan nogle gange forekomme under behandlingen og lejlighedsvis efter, at behandlingen er stoppet, og kan være alvorlige.
English: Other side effects that have been reported (frequency cannot be estimated from the available data):
Danish: Andre bivirkninger som er blevet rapporteret (hyppighed kan ikke vurderes ud fra tilgængelige data):
English: The number of infusions you receive will depend on how you respond to the treatment.
Danish: Antallet af infusioner, som du får, vil afhænge af, hvordan du reagerer på behandlingen.
English: Sites of progression
Danish: Steder for progression
English: Study M77001: Full analysis set (intent-to-treat), 24 months results
Danish: Studie M77001: Fuld analysegruppe (intent-to-treat), 24 måneders resultater
English: If this happens to you, contact your doctor immediately.
Danish: Hvis det sker for dig, skal du øjeblikkeligt kontakte en læge.
English: Final concentration
Danish: Endelig koncentration