FrancophonIA/ELRC3.0 huggingface dataset:
English: It is very important that you also read the leaflets for the other medicines that you will be taking with ZEPATIER.
Danish: Det er meget vigtigt, at du også læser indlægssedlerne for de andre lægemidler, som du skal tage sammen med ZEPATIER.
English: Your doctor will tell you how many weeks you should take ZEPATIER for.
Danish: Din læge vil fortælle dig, i hvor mange uger du skal tage ZEPATIER.
English: The recommended dose is one tablet once daily.
Danish: Den anbefalede dosis er en tablet en gang dagligt.
English: Table 2 provides a listing of assessed or potential medicinal product interactions.
Danish: Tabel 2 viser en liste over dokumenterede eller potentielle lægemiddelinteraktioner.
English: This will give the medicine the best chance to treat your hepatitis C infection.
Danish: Derved får lægemidlet de bedste betingelser for at behandle din hepatitis C-infektion.
English: TN = Treatment-Naïve
Danish: TN = Behandlingsnaive
English: The active substances in the medicine work together by blocking two different proteins that the hepatitis C virus needs to grow and reproduce.
Danish: De aktive stoffer i dette lægemiddel arbejder sammen ved at blokere to forskellige proteiner, som hepatitis C-virusset skal bruge til at vokse og formere sig.
English: Store in the original package until use to protect from moisture.
Danish: Opbevares i den originale pakning indtil brug for at beskytte mod fugt.
English: • have ever taken any medicine for hepatitis C
Danish: • nogensinde har taget medicin mod hepatitis C
English: Your doctor may want to test your blood to check how your liver is working if you develop any of these symptoms.
Danish: Lægen vil eventuelt undersøge dit blod for at kontrollere, hvordan din lever virker, hvis du udvikler et eller flere af disse symptomer.
English: There are some medicines you must not take with ZEPATIER.
Danish: Der er visse lægemidler, som du ikke må tage sammen med ZEPATIER.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Danish: Hyppigheder er defineret på følgende måde: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000) eller Meget sjælden (< 1/10.000).
English: • It is very important that you read the information concerning pregnancy and contraception in the ribavirin package leaflet very carefully.
Danish: • Det er meget vigtigt, at du læser informationen vedrørende graviditet og prævention meget grundigt i indlægssedlen for ribavirin.
English: Less than 0.5 % of grazoprevir was recovered in dialysate over a 4-hour dialysis session.
Danish: Mindre end 0,5% af grazoprevir blev genfundet i dialysat i løbet af en 4-timers dialysesession.
English: • sunitinib to treat certain cancers
Danish: • sunitinib til behandling af visse cancertyper
English: Because reproduction animal studies are not always predictive of human response, ZEPATIER should be used only if the potential benefit justifies the potential risk to the fetus.
Danish: Eftersom reproduktionsstudier hos dyr ikke altid er prædiktive for human respons, må ZEPATIER kun anvendes, hvis den potentielle fordel opvejer den potentielle risiko for fostret.
English: The efficacy of ZEPATIER has not been demonstrated in HCV genotypes 2, 3, 5 and 6.
Danish: Virkning af ZEPATIER er ikke påvist for HCV-genotype 2, 3, 5 og 6.
English: It may harm them,
Danish: BLISTERFOLIE I BLISTEROMSLAG
English: There are no adequate and well-controlled studies with ZEPATIER in pregnant women.
Danish: Der foreligger ikke tilstrækkelige og velkontrollerede studier fra anvendelse af ZEPATIER til gravide kvinder.
English: ZEPATIER for 12 weeks
Danish: ZEPATIER i 12 uger
English: Race/Ethnicity
Danish: Race/etnisk oprindelse
English: • have any liver problems other than hepatitis C
Danish: • har andre leverproblemer end hepatitis C
English: Animal studies do not indicate harmful effects with respect to reproductive toxicity.
Danish: Dyrestudier indikerer ingen skadelige virkninger hvad angår reproduktionstoksicitet.
English: If you do miss a dose, work out how long it is since you should have taken ZEPATIER:
Danish: Hvis du glemmer en dosis, skal du regne ud, hvor længe der er gået, siden du skulle have taget ZEPATIER:
English: Includes subjects with virologic breakthrough.
Danish: Inkluderer forsøgspersoner med virologisk gennembrud.
English: • decide if you should take ZEPATIER and for how long
Danish: • beslutte, om du skal tage ZEPATIER og i hvor lang tid
English: The incidence of late ALT elevations was not affected by treatment duration.
Danish: Incidensen af sene ALAT-forhøjelser blev ikke påvirket af behandlingsvarigheden.
English: The tablet is 21 mm long and 10 mm wide.
Danish: Tabletten er 21 mm lang og 10 mm bred.
English: The effects of ZEPATIER in pregnancy are not known.
Danish: Virkningen af ZEPATIER under graviditet er ukendt.
English: Mean ratio (90 % confidence interval) for AUC, Cmax, C12 or C24 (likely mechanism of interaction)
Danish: Gennemsnitsratio (90% konfidensinterval) for AUC, Cmax, C12 eller C24 (sandsynlig interaktionsmekanisme)
English: Then take your next dose at your usual time.
Danish: Tag dernæst den næste dosis til sædvanlig tid.
English: STIMULANTS
Danish: STIMULANTIA
English: The long-term clinical impact of the emergence or persistence of virus containing ZEPATIER resistance-associated substitutions is unknown.
Danish: Den kliniske langtidseffekt ved forekomst af eller persistens hos virus, der har ZEPATIER-resistensassocierede substitutioner, kendes ikke.
English: Cirrhosis was not a risk factor for late ALT elevations.
Danish: Cirrose var ikke en risikofaktor for sene ALAT-forhøjelser.
English: Table 8: Studies conducted with ZEPATIER
Danish: Tabel 8: Studier udført med ZEPATIER Studie
English: These late ALT elevations generally occurred at or after treatment week 8.
Danish: Disse sene ALAT-forhøjelser forekom generelt i eller efter behandlingsuge 8.
English: Includes 1 subject with cirrhosis status of “unknown” in C-SCAPE.
Danish: Inkluderer 1 forsøgsperson med cirrosestatus “ukendt” i C-SCAPE.
English: Elbasvir and grazoprevir are extensively bound (> 99.9 % and 98.8 %, respectively) to human plasma proteins.
Danish: Elbasvir og grazoprevir har en høj bindingsgrad (hhv. >99,9% og 98,8%) til humane plasmaproteiner.
English: ENDOTHELIN ANTAGONIST
Danish: ENDOTHELIN-ANTAGONISTER
English: Embryo fetal and post natal development
Danish: Embryo-føtal og postnatal udvikling
English: The recommended dose is one tablet once a day with or without food.
Danish: Den anbefalede dosis er en tablet en gang dagligt med eller uden mad.
English: • tacrolimus to prevent organ transplant rejection
Danish: • tacrolimus til forebyggelse af afstødning af et transplanteret organ
English: • you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for elbasvir, grazoprevir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Each carton contains a total of 28 tablets.
Danish: Hver æske indeholder i alt 28 tabletter.
English: • feeling weak or lack of energy (asthenia)
Danish: • svaghedsfølelse eller manglende energi
English: ALT (IU/L) 5.1-10.0 × ULN
Danish: ALAT (IE/l) 5,1-10,0 × ULN
English: GT4 (treatmentexperienced)
Danish: GT4 (behandlingserfarne)
English: In clinical studies, the most commonly reported adverse reactions (greater than 10%) were fatigue and headache.
Danish: I kliniske studier var de hyppigst rapporterede bivirkninger (hos flere end 10%) træthed og hovedpine.
English: If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • decide what other medicines you should take with ZEPATIER and for how long
Danish: • beslutte, hvilke andre lægemidler du skal tage sammen med ZEPATIER og i hvor lang tid
English: An up “↑” or down “↓” arrow represents a change in exposure that requires monitoring or a dose adjustment of that medication, or the co-administration is not recommended or contraindicated.
Danish: Pil op “↑” eller ned “↓” angiver en ændring i eksponering, som kræver monitorering eller dosisjustering af det pågældende lægemiddel, eller samtidig administration anbefales ikke eller er kontraindiceret.
English: It is not known whether the two medicines in ZEPATIER pass into human breast milk.
Danish: Det vides ikke, om de to lægemidler i ZEPATIER udskilles i mælken hos mennesker.
English: • The active substances are: elbasvir and grazoprevir.
Danish: • Aktive stoffer: elbasvir og grazoprevir.
English: Includes four subjects infected with genotype 1 subtypes other than 1a or 1b.
Danish: Inkluderer fire forsøgspersoner inficeret med andre genotype 1-subtyper end 1a eller 1b.
English: This is due to liver function changes during treatment with ZEPATIER.
Danish: Dette skyldes, at leverfunktionen kan ændre sig under behandling med ZEPATIER.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Zepatier the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: For at vurdere recidiv af hepatocellulært karcinom associeret med Zepatier skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et prospektivt sikkerhedsstudie baseret på en vedtagen protokol med brug af data fra en kohorte af en veldefineret gruppe patienter.
English: Includes subjects with baseline sequencing data and who either achieved SVR12 or met criteria for virologic failure.
Danish: Inkluderer forsøgspersoner med sekventeringsdata ved baseline, og som enten opnåede SVR12 eller opfyldte kriterierne for virologisk svigt.
English: The film-coated tablets should be swallowed whole and may be taken with or without food (see section 5.2).
Danish: De filmovertrukne tabletter skal sluges hele og kan tages med eller uden mad (se pkt.
English: Aluminium or magnesium hydroxide; calcium carbonate
Danish: Aluminium- eller magnesiumhydroxid; calciumcarbonat
English: 12 Weeks
Danish: 12 uger
English: The rate of late ALT elevations during treatment is directly related to the plasma exposure to grazoprevir.
Danish: Forekomst af sene ALAT-forhøjelser under behandlingen er direkte relateret til eksponeringen for grazoprevir i plasma.
English: EBR with GZR
Danish: EBR med GZR
English: No clinically relevant change in exposure is represented by a horizontal arrow “↔”.
Danish: Ingen klinisk relevant ændring i eksponering er angivet med en vandret pil “↔”.
English: Both elbasvir and grazoprevir bind to human serum albumin and 1-acid glycoprotein.
Danish: Både elbasvir og grazoprevir bindes til humant serum-albumin og surt 1-glykoprotein.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking ZEPATIER.
Danish: Hvis noget af ovenstående gælder for dig (eller du er i tvivl), skal du tale med lægen eller apotekspersonalet, før du tager ZEPATIER.
English: ZEPATIER is sometimes taken with another medicine, ribavirin.
Danish: ZEPATIER tages nogle gange sammen med et andet lægemiddel, der hedder ribavirin.
English: Lamivudine Abacavir Entecavir
Danish: Lamivudin Abacavir Entecavir
English: Wait and take your next dose at your usual time.
Danish: Du skal vente og tage den næste dosis på det sædvanlige tidspunkt.
English: Pharmacotherapeutic group: Antivirals for systemic use, Direct acting antivirals, Antivirals for treatment of HCV infections, ATC code: J05AP54.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, direkte virkende antivirale midler, antivirale midler til behandling af HCV-infektioner, ATC-kode: J05AP54.
English: Carbamazepine Phenytoin
Danish: Carbamazepin Phenytoin
English: The following side effects may happen with this medicine:
Danish: Nedenstående bivirkninger kan forekomme, når du tager dette lægemiddel.
English: Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
Danish: Lav en liste over al den medicin, du får, og vis den til lægen eller apotekspersonalet, når du får et nyt lægemiddel.
English: Population Study Arms and Duration (Number of Subjects Treated)
Danish: Studiearme og behandlingsvarighed (antal behandlede forsøgspersoner)
English: Effect of baseline HCV polymorphisms on treatment response
Danish: Indvirkning af HCV-polymorfismer ved baseline på behandlingsrespons
English: When ZEPATIER is used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded.
Danish: Når ZEPATIER anvendes i kombination med ribavirin, skal kvinder i den fertile alder eller deres mandlige partner anvende sikker kontraception under behandlingen og i en periode efter ophørt behandling.
English: Concentrations of elbasvir were not quantifiable in the dialysate samples.
Danish: Koncentrationen af elbasvir var ikke kvantificerbar i dialysatprøver.
English: † (Grade 3) >10.0 × ULN (Grade 4) Total Bilirubin (mg/dL) 2.6-5.0 × ULN (Grade 3) >5.0 × ULN (Grade 4)
Danish: † (grad 3) >10,0 × ULN (grad 4) Total bilirubin (mg/dl) 2,6-5,0 × ULN (grad 3) >5,0 × ULN (grad 4)
English: • rosuvastatin, atorvastatin, fluvastatin, simvastatin, or lovastatin, for lowering blood cholesterol
Danish: • rosuvastatin, atorvastatin, fluvastatin, simvastatin eller lovastatin for at sænke indholdet af kolesterol i blodet
English: Therefore, no dose adjustment is required for CYP3A substrates when co-administered with ZEPATIER.
Danish: Derfor er dosisjustering af CYP3A-substrater ikke nødvendig, når de administreres sammen med ZEPATIER.
English: • dabigatran to prevent blood clots
Danish: • dabigatran til forebyggelse af blodpropper
English: ZEPATIER + RBV, 16 Weeks
Danish: ZEPATIER + RBV, 16 uger
English: The potential for grazoprevir to be a breast cancer resistance protein (BCRP) substrate cannot be excluded.
Danish: Det kan ikke udelukkes, at grazoprevir har potentiale til at være substrat for brystcancer-resistent protein (BCRP).
English: Clinical Isolates
Danish: Kliniske isolater
English: The medicinal product interactions described are based on results from studies conducted with either ZEPATIER or elbasvir (EBR) and grazoprevir (GZR) as individual agents, or are predicted medicinal product interactions that may occur with elbasvir or grazoprevir.
Danish: De beskrevne lægemiddelinteraktioner er baseret på resultater fra studier udført med enten ZEPATIER eller elbasvir (EBR) og grazoprevir (GZR) som enkeltstoffer, eller de lægemiddelinteraktioner, der kan forventes at opstå med elbasvir eller grazoprevir.
English: OPIOID-SUBSTITUTION THERAPY
Danish: OPIOID-SUBSTITUTIONSBEHANDLING
English: Hepatic laboratory testing should be performed prior to therapy, at treatment week 8, and as clinically indicated.
Danish: Laboratorieanalyser for leverfunktion skal udføres før behandling, i behandlingsuge 8 og som klinisk indiceret.
English: Median EC50 (range) nM
Danish: Median EC50 (interval) nM
English: • Discontinuation of ZEPATIER should be considered if ALT levels are confirmed to be greater than 10 times the ULN.
Danish: • Seponering af ZEPATIER skal overvejes, hvis det bekræftes, at ALAT er forhøjet til mere end
English: Expected: ↑ sunitinib
Danish: Forventet: ↑ sunitinib
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som ZEPATIER
English: ZEPATIER (administered alone or in combination with ribavirin) is not likely to have an effect on the ability to drive and use machines.
Danish: Det er ikke sandsynligt, at ZEPATIER (administreret som monoterapi eller i kombination med ribavirin) påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting ZEPATIER.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med ZEPATIER.
English: • You or your partner must use an effective method of contraception during treatment with ZEPATIER with ribavirin and for some time afterwards.
Danish: • Du eller din partner skal anvende en sikker præventionsmetode under behandlingen med ZEPATIER og ribavirin og i nogen tid derefter.
English: The primary route of elimination of elbasvir and grazoprevir is through faeces with almost all (> 90 %) of the radiolabeled dose recovered in faeces compared to < 1 % in urine.
Danish: Den primære eliminationsvej for elbasvir og grazoprevir er via fæces med størstedelen (>90%) af den radioaktive dosis genfundet i fæces sammenlignet med <1% i urin.
English: If ZEPATIER is co-administered with ribavirin, the information for ribavirin with regard to contraception, pregnancy testing, pregnancy, breast-feeding, and fertility also applies to this combination regimen (refer to the Summary of Product Characteristics for the co-administered medicinal product for additional information).
Danish: Hvis ZEPATIER administereres sammen med ribavirin gælder informationen for ribavirin med hensyn til kontraception, graviditetstest, graviditet, amning og fertilitet også for dette kombinationsregime (se produktresuméet for det lægemiddel, der administreres sammen med ZEPATIER, for yderligere oplysninger).
English: Uncommon: may affect up to 1 in 100 people • abnormalities in laboratory tests of liver function
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer • unormale prøveresultater for leverfunktionen
English: • Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discoloured faeces.
Danish: • Patienterne skal informeres om, at de straks skal kontakte sundhedspersonalet, hvis de oplever træthed, svaghed, appetitløshed, kvalme og opkastning, gulsot eller unormalt farvet fæces.
English: Recommendation concerning coadministration with ZEPATIER
Danish: Anbefalinger vedrørende administration sammen med ZEPATIER
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development with grazoprevir or elbasvir.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet med elbasvir eller grazoprevir.
English: Other includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Danish: Andet inkluderer forsøgspersoner, som afbrød behandlingen på grund af bivirkninger, manglende opfølgning eller udtræden af studiet.
English: ZEPATIER is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Danish: ZEPATIER anbefales ikke til børn og unge under 18 år, da sikkerheden og virkningen ikke er klarlagt i denne population.
English: Concentrations of dabigatran may increase when co-administered with elbasvir, with possible increased bleeding risk.
Danish: Koncentrationen af dabigatran kan stige ved administration sammen med elbasvir med mulig øget blødningsrisiko.
English: Population pharmacokinetics estimates of exposure of elbasvir and grazoprevir were comparable between Whites and Black/African Americans.
Danish: Populationsfarmakokinetiske estimater for eksponeringen for elbasvir og grazoprevir var sammenlignelige mellem kaukasere og negroide/afroamerikanere.
English: Co-administration with ZEPATIER is contraindicated.
Danish: Administration sammen med ZEPATIER er kontraindiceret.
English: It is unknown whether elbasvir or grazoprevir and their metabolites are excreted in human milk.
Danish: Det er ukendt, om elbasvir eller grazoprevir eller deres metabolitter udskilles i human mælk.
English: Elbasvir has minimal intestinal P-gp inhibition in humans, and does not result in clinically relevant increases in concentrations of digoxin (a P-gp substrate), with an 11% increase in plasma AUC.
Danish: Elbasvir hæmmer i minimal grad intestinal P-gp hos mennesker og medfører ikke klinisk relevant stigning i koncentrationen af digoxin (et P-gp-substrat) (stigning på 11% i plasma-AUC).
English: In population pharmacokinetic analyses, there was no effect of weight on elbasvir pharmacokinetics.
Danish: I farmakokinetiske populationsanalyser var der ingen indvirkning af vægt på elbasvirs farmakokinetik.
English: What ZEPATIER is used for ZEPATIER is used to treat long-term hepatitis C infection in adults aged 18 years and older.
Danish: ZEPATIER anvendes til at behandle langvarig hepatitis C-infektion hos voksne i alderen 18 år og derover.
English: If you forget to take ZEPATIER
Danish: Hvis du har glemt at tage ZEPATIER
English: Grazoprevir AUC is estimated to be 15 % higher in a 53 kg subject compared to a 77 kg subject.
Danish: AUC for grazoprevir estimeres at være 15% højere hos en forsøgsperson, der vejer 53 kg, i forhold til en forsøgsperson, der vejer 77 kg.
English: Interactions between ZEPATIER and other medicinal products
Danish: Lægemiddelinteraktioner mellem ZEPATIER og andre lægemidler
English: Do not take ZEPATIER if:
Danish: Tag ikke ZEPATIER:
English: Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicines for hepatitis C or if you have any other medical condition.
Danish: Kontakt lægen eller apotekspersonalet, før du tager ZEPATIER, hvis du nogensinde har taget medicin mod hepatitis C, eller hvis du har en anden sygdom.
English: • you have certain moderate or severe liver problems
Danish: • hvis du har visse leverproblemer, enten moderat alvorlige eller alvorlige.
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin ULN: Upper limit of normal according to testing laboratory.
Danish: Baseret på puljede data fra patienter, der fik ZEPATIER i 12 uger uden ribavirin ULN: Øvre normalgrænse i henhold til testlaboratoriet.
English: • You must not become pregnant if you are taking ZEPATIER with ribavirin.
Danish: • Du/din partner må ikke blive gravid, hvis du tager ZEPATIER sammen med ribavirin.
English: ZEPATIER combines two direct-acting antiviral agents with distinct mechanisms of action and nonoverlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Danish: ZEPATIER kombinerer to direkte virkende antivirale midler med forskellige virkningsmekanismer og ikke-overlappende resistensprofiler, der er målrettet HCV i flere faser af den virale livscyklus.
English: The highest dose of elbasvir was 200 mg once daily for 10 days, and a single dose of 800 mg.
Danish: Den højeste dosis af elbasvir var 200 mg en gang dagligt i 10 dage og en enkeltdosis på 800 mg.
English: • ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR).
Danish: • ZEPATIER skal seponeres, hvis ALAT-forhøjelse ledsages af symptomer på leverinflammation eller forhøjelse af konjugeret bilirubin, alkalisk fosfatase eller INR (International Normaliseret
English: Additional Study Details
Danish: Yderligere oplysninger om studiet
English: Higher rates of late ALT elevations occurred in females (2 % [11/652]), Asians (2 % [4/165]), and subjects aged ≥ 65 years (2 % [3/187]) (see sections 4.8 and 5.2).
Danish: Sene ALAT-forhøjelser forekom hos kvinder (2% [11/652]), asiatere (2% [4/165]) og hos forsøgspersoner ≥ 65 år (2% [3/187]) (se pkt.