FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Adverse reactions (reported in at least 2 patients) and adverse reactions reported in postmarketing setting, expanded access programs and non-controlled clinical trials, per System Organ
Danish: Tabel 1: Bivirkninger (indberettet fra mindst 2 patienter) og bivirkninger, der indberettet efter markedsføring, fra efterfølgende kliniske programmer og fra ikke-kontrollerede kliniske undersøgelser, i henhold til systemorganklasse og vist efter hyppighedskategori: meget almindelig (≥1/10), almindelig
English: Agitation Restlessness
Danish: Uro Rastløshed
English: When reconstituted as above, the reconstituted solution in the vial contains 5 mg alglucosidase alfa per ml.
Danish: Ved rekonstituering som ovenfor indeholder den rekonstituerede opløsning i hætteglasset 5 mg alglucosidase alfa pr. ml.
English: Respiratory distress Bronchospasm Wheezing Pharyngeal oedema Dyspnoea Tachypnoea Throat tightness Stridor
Danish: Åndedrætsbesvær Bronkospasme Hiven efter vejret Faryngal ødem Dyspnø
English: Severe cutaneous reactions, possibly immune mediated, have been reported with alglucosidase alfa, including ulcerative and necrotizing skin lesions (see section 4.8).
Danish: Alvorlige kutane reaktioner (muligvis immunmedierede) er blevet rapporteret med alglucosidase alfa, inklusive ulcerøse og nekrotiske hudlæsioner (se pkt.
English: Table 3: Results for endpoint survival using the Cox regression model
Danish: Tabel 3: Resultater med overlevelse som endepunkt ved hjælp af Cox-regressionsmodel Behandlede patienter
English: Using these medicines to suppress the immune system may further increase this risk.
Danish: Denne risiko kan stige yderligere, hvis De får medicin til at undertrykke immunsystemet.
English: One vial contains 50 mg of alglucosidase alfa.
Danish: Ét hætteglas indeholder 50 mg alglucosidase alfa.
English: At 104 weeks of treatment LVM assessments were available for 10 patients, of which 9 decreased to within normal limits.
Danish: Efter 104 uger med behandling var LVM-vurderingerne tilgængelige for 10 patienter, hvor værdien faldt til normalgrænserne for 9.
English: In the second year of treatment, 15 out of 17 patients had further improved weight-for-age percentiles (with individual patient treatment durations ranging from 78 to 142 weeks; mean follow-up period of 111 weeks), 10 out of 16 patients had further improved length-for-age percentiles (with individual patient treatment durations ranging from 90 to 130 weeks; mean follow-up period of 113 weeks) and
Danish: I det andet behandlingsår havde 15 af 17 patienter opnået en yderligere forbedring i vægt/alder-percentilen (med individuelle patientbehandlingsvarigheder fra 78 til 142 uger: gennemsnitlig opfølgningsperiode på 111 uger), 10 af 16 patienter havde opnået en yderligere forbedring i længe/alder-percentilen (med individuelle patientbehandlingsvarigheder fra 90 til 130 uger: gennemsnitlig opfølgningsperiode på 113 uger), og 11 af 15 patienter havde opnået en yderligere forbedring i hovedomkreds/alder-percentilen (med individuelle patientbehandlingsvarigheder fra 90 til 130 uger: gennemsnitlig opfølgningsperiode på 110 uger).
English: Chest discomfort Irritability
Danish: Kulderystelser Ubehag i brystet Irritabilitet
English: The pharmacokinetics of alglucosidase alfa were also evaluated in a separate trial in 21 patients with infantile-onset Pompe disease (all aged between 6 months and 3.5 years at treatment-onset) who received doses of 20 mg/kg of alglucosidase alfa.
Danish: Farmakokinetikken for alglucosidase alfa blev også vurderet i en separat undersøgelse med 21 patienter med Pompes sygdom med debut i spædbørnsalderen (alle mellem 6 måneder og 3,5 år ved behandlingsstart), der modtog doser på 20 mg/kg alglucosidase alfa.
English: Slowly inject the reconstituted Myozyme directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Injicer langsomt den rekonstituerede Myozyme direkte i 9 mg/ml (0,9 %) natriumchloridopløsningen til injektion.
English: Mean ± s.d.
Danish: Middel ± sd.
English: In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase alfa were evaluated in 15 patients with infantile-onset Pompe disease (all less than 6 months of age at treatment-onset) who received doses of 20 mg/kg or 40 mg/kg alglucosidase alfa as an approximate 4 to 6.5-hour infusion, respectively.
Danish: I en pivotalundersøgelse med 18 patienter blev farmakokinetikken for alglucosidase alfa vurderet hos 15 patienter med Pompes sygdom med debut i spædbørnsalderen (alle under 6 måneder ved behandlingens start), der modtog doser på hhv. 20 mg/kg eller 40 mg/kg alglucosidase alfa som en ca. 4 til 6,5 timers infusion.
English: Genzyme Europe B.V. Paasheuvelweg 25
Danish: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Holland
English: • Increased breathing rate
Danish: • Hurtigere vejrtrækning
English: Due to the rarity of the condition and the limited experience to date, the effect of IgG antibody formation on safety and efficacy is currently not fully established.
Danish: Et begrænset antal af de IgG-positive patienter, der blev vurderet, blev testet positive for inhibitorisk effekt ved in vitro test. På grund af tilstandens sjældne forekomst og de begrænsede erfaringer til dato er virkningen af IgG-antistofdannelsen på sikkerhed og effekt aktuelt ikke fuldt klarlagt.
English: Comparator Endpoint
Danish: Historisk referencekomparator Endepunkt
English: Do not shake or excessively agitate the infusion bag.
Danish: Infusionsposen må ikke rystes eller bevæges for meget.
English: • Increased sweating
Danish: • Øget svedtendens
English: Dizziness Paraesthesia Headache3
Danish: Svimmelhed Paræstesi Hovedpine3
English: Myozyme contains an artificial enzyme called alglucosidase alfa - this can replace the natural enzyme which is lacking in Pompe disease.
Danish: Myozyme kan erstatte det naturlige enzym, som mangles ved Pompes sygdom.
English: The pharmacokinetics of alglucosidase alfa were evaluated in a trial in 5 patients with late-onset Pompe disease aged 6-15 years who received 20 mg/kg alglucosidase alfa once every two weeks.
Danish: Farmakokinetikken for alglucosidase alfa blev vurderet i en undersøgelse med 5 patienter med sent debuterende Pompes sygdom i alderen 6-15 år, der modtog 20 mg/kg Myozyme én gang hver anden uge.
English: How Myozyme is given
Danish: Sådan får De Myozyme
English: Each vial contains 50 mg of alglucosidase alfa.
Danish: 1 hætteglas indeholder 50 mg alglucosidase alfa.
English: • Mottled skin
Danish: • Kløende hud
English: Paediatric and older people
Danish: Børn og ældre patienter:
English: • Decreased heart rate
Danish: • Langsommere hjerterytme
English: Infantile-onset Pompe disease1
Danish: Pompes sygdom med debut i spædbørnsalderen1
English: Eye disorders not known
Danish: Øjne ikke kendt
English: Myozyme 50 mg powder for concentrate for solution for infusion
Danish: Myozyme 50 mg pulver til koncentrat til infusionsvæske, opløsning.
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Danish: Efter rekonstituering indeholder opløsningen 5 mg alglucosidase alfa* per ml og efter fortynding varierer koncentrationen fra 0,5 mg til 4 mg/ml.
English: If you have missed an infusion, please contact your doctor.
Danish: Kontakt Deres læge, hvis De har sprunget en infusion over.
English: Chest discomfort Peripheral oedema Local swelling Fatigue3
Danish: Ubehag i brystet Perifert ødem Lokal hævelse Træthed3
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa per ml and after dilution the concentration varies from 0.5 mg to 4 mg/ml.
Danish: Efter rekonstituering indeholder opløsningen 5 mg alglucosidase alfa pr. ml og efter fortynding varierer koncentrationen fra 0,5 mg til 4 mg/ml.
English: 25 vials powder for concentrate for solution for infusion.
Danish: 25 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
English: • Redness of the skin
Danish: • Rødmen i huden
English: What Myozyme is and what it is used for What you need to know before you are given Myozyme How Myozyme is given
Danish: Det skal De vide, før De begynder at bruge Myozyme Sådan får De Myozyme
English: Late-onset Pompe disease
Danish: Sent debuterende Pompes sygdom2
English: Cardiac disorders very common
Danish: Hjerte meget almindelig
English: Should you experience any reaction like this, please tell your doctor immediately.
Danish: Fortæl det straks til Deres læge, hvis De oplever en sådan reaktion.
English: Nausea3
Danish: Opkastning Kvalme3
English: • Tiredness
Danish: • Bleghed
English: 10 vials powder for concentrate for solution for infusion.
Danish: 10 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
English: Patients who have experienced IARs (and in particular anaphylactic reactions) should be treated with caution when re-administering Myozyme (see sections 4.3 and 4.8).
Danish: Fornyet indgivelse af Myozyme til patienter, der har oplevet infusionsrelaterede reaktioner (og især anafylaktiske reaktioner), skal ske med forsigtighed (se pkt.
English: • Muscle pain
Danish: • Muskelspasmer
English: The pharmacokinetics of alglucosidase alfa were studied in a population analysis of 32 late-onset Pompe disease patients from the randomized, double-blind, placebo-controlled study ranging in age from 21 to 70 years who received Myozyme 20 mg/kg once every two weeks.
Danish: Farmakokinetikken for alglucosidase alfa blev undersøgt i en populationsanalyse på 32 patienter med sent debuterende Pompes sygdom, fra det randomiserede, dobbeltblindede, placebokontrollerede studie.
English: The study data demonstrated that prophylactic ITI prevents or reduces the occurrence of antibodies against alglucosidase alfa over time, which may maintain clinical benefit of ERT and improve survival in CRIM-negative IOPD patients.
Danish: Yngre patienter, som blev diagnosticeret og behandlet tidligt og som fik ITI samtidig med at enzymerstatningsterapi blev initieret, viste en tendens til bedre overlevelsesrate end patienter, der blev behandlet med et lignende regime men i en senere alder. Studiedata viste, at profylaktisk ITI forebygger eller reducerer forekomsten af antistoffer mod alglucosidase alfa over tid, hvilket kan opretholde de kliniske fordele ved enzymerstatningsterapi og forbedre overlevelsen hos CRIM-negative IOPD-patienter.
English: The mean area under the plasma concentration-time curve (AUC∞) ranged from 977.5 to 1,872.5 µg•h/ml for the 20 mg/kg and 40 mg/kg dose groups.
Danish: 1.872,5 µg•t/ml for 20 mg/kg og 40 mg/kg dosis.
English: Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1, when rechallenge was unsuccessful (see sections 4.4 and 4.8).
Danish: Livstruende overfølsomhed (anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
Danish: Sent debuterende Pompes sygdom; pivotalt klinisk studie Sikkerheden og effekten af Myozyme blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie med 90 patienter med sent debuterende Pompes sygdom i alderen 10-70 år ved start af behandlingen.
English: 1 vial powder for concentrate for solution for infusion.
Danish: 1 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
English: A tendency was observed for infantile-onset patients treated with a higher dose (40 mg/kg)
Danish: Hos patienter med debut i spædbørnsalderen, der blev behandlet med en højere dosis (40 mg/kg), blev der observeret en tendens til at udvikle højere titre af IgGantistoffer.
English: • Agitation
Danish: • Træthed
English: IARs are described in section 4.8.
Danish: 4.4 og 4.8).
English: If you are given more Myozyme than you should
Danish: Hvis De har brugt for meget Myozyme
English: • Increased heart rate
Danish: • Hurtigere hjerterytme
English: Infantile-onset Pompe disease; clinical trial in patients aged 6 months to 3.5 years A second open-label clinical trial also assessed the safety and efficacy of Myozyme in 21 patients with predominantly a non-typical form of infantile-onset Pompe disease who ranged in age from 6 months to 3.5 years at initiation of treatment.
Danish: En anden open-label undersøgelse vurderede ligeledes sikkerhed og effekt af Myozyme hos 21 patienter med hovedsagelig den atypiske form for Pompes sygdom med debut i spædbørnsalderen, der var fra 6 måneder til 3,5 år ved behandlingens start.
English: Musculoskeletal and connective tissue disorders common
Danish: Knogler, led, muskler og bindevæv almindelig
English: • Vomiting
Danish: • Fortynding
English: Infantile-onset Pompe disease
Danish: Sent debuterende Pompes sygdom
English: • Tremor
Danish: • Skælven
English: • Chest discomfort
Danish: • Ubehag i brystet
English: Reference
Danish: • Indgivelse
English: Vomiting common Retching Nausea
Danish: Opkastning almindelig Opkastningsfornemmelser Kvalme
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Danish: Hvert hætteglas indeholder 50 mg alglucosidase alfa Efter rekonstituering indeholder opløsningen 5 mg alglucosidase alfa/ml og efter fortynding varierer koncentrationen fra 0,5 mg til 4 mg/ml.
English: Infantile- and Lateonset Pompe disease
Danish: Pompes sygdom med debut i spædbørnsalderen samt sent debuterende Pompes sygdom
English: • Muscle spasms
Danish: • Muskelsmerter
English: Oxygen saturation decreased
Danish: Reduceret iltmætning Forhøjet hjertefrekvens
English: Infusion site extravasation
Danish: Kvælningsfornemmelser Stridor
English: Content (concentration)
Danish: AFSTYLA
English: Pack size
Danish: IU
English: Do not take Varuby more than once every two weeks.
Danish: Du må ikke tage Varuby mere end én gang hver anden uge.
English: Elderly people (≥ 65 years)
Danish: Ældre (≥ 65 år)
English: Date of first authorisation: 20 April 2017
Danish: Dato for første markedsføringstilladelse: 20 April 2017
English: This is not expected to be clinically relevant.
Danish: Dette forventes ikke at være klinisk relevant.
English: They will provide appropriate treatment.
Danish: De vil give dig en passende behandling.
English: The results were evaluated for each individual study and for the two studies combined.
Danish: Resultaterne blev evalueret for studierne hver for sig og for de to studier sammen.
English: - You can take Varuby with or without food.
Danish: • Du kan tage Varuby med eller uden mad.
English: Dialysis studies have not been performed.
Danish: Der er ikke udført dialyseundersøgelser.
English: The relevance of convulsions for humans is unknown.
Danish: Konvulsionernes relevans for mennesker er ikke kendt.
English: Relationship between concentration and effect
Danish: Forhold mellem koncentration og effekt
English: Age, Sex and Race/Ethnicity
Danish: Alder, køn og race/etnicitet
English: Study 1 and 2 Combined
Danish: Studie 1 og 2 kombineret
English: You may feel dizzy or tired after taking this medicine.
Danish: Du kan føle dig svimmel eller træt, når du har taget dette lægemiddel.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis det sker, må du ikke køre bil eller betjene værktøj eller maskiner.
English: The lowest effective dose of rosuvastatin is to be used.
Danish: Den laveste virksomme dosis af rosuvastatin skal anvendes.
English: N.S. a Primary endpoint was complete response in the delayed phase.
Danish: a Primært endepunkt var fuldstændigt respons i den sene fase.
English: Oral fungal infection Candidiasis Oral candidiasis
Danish: Oral svampeinfektion Candidiasis Oral candidiasis
English: Complete Response
Danish: Fuldstændigt respons
English: Varuby should not be taken by children and adolescents under 18 years because it has not been studied in this group.
Danish: Børn og unge under 18 år må ikke tage Varuby, da det ikke er undersøgt til denne gruppe.
English: There is no information on the effects of this medicine if taken during pregnancy.
Danish: Der er ingen oplysninger om virkningerne af denne medicin, hvis den tages under graviditet.
English: Recent guidance has updated these regimens to highly emetogenic.
Danish: Nye retningslinjer har opdateret disse regimer til højemetogene.
English: No Significant Nausea (maximum VAS <25 on 0-100 scale)
Danish: Ingen signifikant kvalme (maksimal VAS < 25 på skala 0-100)
English: Day 2 Day 3 Day 4
Danish: Dag 2 Dag 3 Dag 4
English: In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided.
Danish: I tilfælde af overdosering skal lægemidlet seponeres og generel understøttende behandling og monitorering iværksættes.
English: No dose adjustment is necessary for the elderly.
Danish: Dosisjustering er ikke nødvendig hos ældre.
English: The most common adverse reactions were fatigue (1.9%) and headache (1.5%).
Danish: De hyppigste bivirkninger var træthed (1,9 %) og hovedpine (1,5 %).
English: The safety and efficacy of rolapitant in children and adolescents below 18 years of age has not yet been established.
Danish: Rolapitants sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: NK1 Receptor Occupancy
Danish: Besættelse af NK1-receptorer
English: What you need to know before you take Varuby Do not take Varuby:
Danish: Det skal du vide, før du begynder at tage Varuby Tag ikke Varuby:
English: The tablets should be swallowed whole, with some water and may be taken with or without food.
Danish: Tabletterne skal synkes hele sammen med vand og kan tages med eller uden mad.
English: Therefore, the potential interactions associated with the inhibition of these UGT enzymes in the intestine cannot be excluded.
Danish: Derfor kan de potentielle interaktioner forbundet med hæmningen af disse UGT-enzymer i tarmen ikke udelukkes.
English: Individual results from Studies 1 and 2 as well as a summary of the key results from the combined analysis are shown in Table 1 below.
Danish: Individuelle resultater fra studie 1 og 2 samt et sammendrag af de vigtigste resultater af den kombinerede analyse er vist i tabel 1 nedenfor.
English: The proportion of patients with no impact on daily life was higher in the Varuby group than in the control group (MEC: 73.2% vs. 67.4%; p=0.027).
Danish: Andelen af patienter uden påvirkning af dagligdagen var højere i Varuby-gruppen end i kontrolgruppen (MEC: 73,2 % vs. 67,4 %; p = 0,027).
English: Rolapitant This medicine is subject to additional monitoring.
Danish: Rolapitant Dette lægemiddel er underlagt supplerende overvågning.
English: Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist.
Danish: Varuby gives som en del af et regime, hvori dexamethason og en 5-HT3-antagonist indgår.
English: Based on the environmental risk assessment, rolapitant is considered as very persistent, bioaccumulative and not readily biodegradable.
Danish: Baseret på miljørisikovurderingen anses rolapitant for at være meget persisterende, bioakkumulerende og ikke hurtigt bionedbrydeligt.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter 'Anvendes inden' eller 'EXP'.
English: The absolute bioavailability of rolapitant is approximately 100%, indicating minimal first pass effect.
Danish: Rolapitants absolutte biotilgængelighed er ca. 100 %, hvilket tyder på en minimal first pass-effekt.
English: Over 4,375 patients have been treated with Varuby or a comparator across Phase 1, 2, and 3 clinical studies.
Danish: Mere end 4.375 patienter er blevet behandlet med Varuby eller en komparator i kliniske fase 1-, 2- og 3-studier.
English: Varuby should be used with caution in these patients.
Danish: Varuby skal anvendes med forsigtighed til disse patienter.
English: The mechanism of the significant difference of half-lives observed between the rat and monkey (6-8 h) and human (7 days) is not elucidated.
Danish: Mekanismen bag den signifikante forskel i de observerede halveringstider mellem rotter og aber (6-8 timer) og mennesker (7 dage) er ikke klarlagt.
English: Do not take this medicine in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.
Danish: Du må ikke tage lægemidlet i dagene efter, at du har fået kemoterapi - medmindre du skal til at have en ny kemoterapicyklus.
English: At Day 6 to 8 following initiation of chemotherapy, patients were asked to recall whether they had any episode of vomiting or retching or nausea that interfered with normal daily life.
Danish: Ved dag 6 til 8 efter initiering af kemoterapi blev patienterne bedt om at huske, om de havde haft nogen episoder af opkastning eller opkastningsfornemmelser eller kvalme, som påvirkede deres normale dagligdag.
English: Rolapitant was highly protein bound to human plasma (99.8%).
Danish: Rolapitant var stærkt proteinbundet i humant plasma (99,8 %).
English: If the combination cannot be avoided, clinical and biological monitoring for adverse reactions related to the concomitant medicinal product must be made.
Danish: Hvis kombinationen ikke kan undgås, skal der klinisk og biologisk monitoreres for bivirkninger relateret til det samtidige lægemiddel.
English: In a mass balance study, the metabolite M19 was the major circulating metabolite.
Danish: I et massebalancestudie var metabolitten M19 den væsentligste cirkulerende metabolit.
English: Tablets are blue, debossed with T0101 on one side and 100 on the other.
Danish: Tabletterne er blå og præget med T0101 på den ene side og 100 på den anden.
English: OATP1B1 and 1B3 substrates
Danish: OATP1B1- og 1B3-substrater
English: Population pharmacokinetic analyses indicated that age, sex and race had no significant impact on the pharmacokinetics of Varuby.
Danish: Farmakokinetiske populationsanalyser tyder på, at alder, køn og race ikke har nogen signifikant indvirkning på Varubys farmakokinetik.
English: Also contains lactose.
Danish: Indeholder også lactose.
English: Of these 1332 patients, 629 received non-AC chemotherapy.
Danish: Af disse 1.332 patienter fik 629 kemoterapi uden AC.
English: If you have forgotten to take your dose, tell your doctor straight away.
Danish: Hvis du har glemt at tage din dosis, skal du fortælle det til lægen med det samme.
English: The percentage of patients who received carboplatin in Cycle 1 was 30%.
Danish: 30 % af patienterne fik carboplatin i cyklus 1.
English: Studies in animals have shown no teratogenic or embryo-foetal effects.
Danish: Dyrestudier har ikke påvist teratogene eller embryo-føtale virkninger på fosteret.
English: Study 3 (MEC)
Danish: Studie 3 (MEC)
English: Varuby may affect how some other medicines work.
Danish: Varuby kan påvirke virkningen af andre lægemidler.
English: A summary of the study results from the MEC Study (Study 3) is shown in Table 2 below.
Danish: Et sammendrag af resultaterne af MEC-studiet (studie 3) er vist i tabel 2 nedenfor.
English: - The recommended dose is 180 mg (two 90 mg tablets).
Danish: • Den anbefalede dosis er 180 mg (to 90 mg tabletter).
English: Antiemetic activity of rolapitant was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles.
Danish: Rolapitants antiemetiske aktivitet blev opretholdt under de efterfølgende cyklusserne for de patienter, som fortsatte i hver af de ekstra cyklusser.
English: Rolapitant doses up to 720 mg have been used in clinical studies without any safety concerns.
Danish: Der har været anvendt rolapitantdoser på op til 720 mg i kliniske studier, uden at det gav anledning til bekymring i forhold til sikkerheden.
English: - if you are allergic to rolapitant or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for rolapitant eller et af de øvrige indholdsstoffer i Varuby (angivet i punkt 6).