FrancophonIA/ELRC3.0 huggingface dataset:
English: In this PDX model talazoparib decreased tumour growth and increased γH2AX level and apoptosis in the tumours.
Danish: I denne PDX-model nedsatte talazoparib tumorvæksten og øgede γH2AXniveauet og apoptosen i tumorerne.
English: The Kaplan-Meier curves for PFS is displayed in Figure 1.
Danish: Kaplan-Meier-kurver for PFS er vist på figur 1.
English: Contact with the capsule content should be avoided.
Danish: Undgå at komme i kontakt med kapslens indhold.
English: You should not breast-feed while taking Talzenna and for at least 1 month after the last dose.
Danish: Du må ikke amme, mens du tager Talzenna og i mindst 1 måned efter sidste dosis.
English: No significant effect of acid-reducing agents on talazoparib exposure is expected, given sufficient solubility of talazoparib at all pHs between 1 and 6.8.
Danish: Der forventes ingen signifikant effekt af syreneneutraliserende midler på eksponering for talazoparib, da talazoparib er opløseligt ved alle pH-værdier mellem 1 og 6,8.
English: Abbreviations: BRCA=breast cancer susceptibility gene; ER=estrogen receptor; HER2=human epidermal growth factor receptor 2; N=number of patients; n=number of patients in category; PgR=progesterone receptor.
Danish: Forkortelser: BRCA=gen for forhøjet risiko for brystkræft; ER=østrogenreceptor; HER2=human epidermal vækstfaktor receptor 2; N=antal patienter; n=antal patienter i kategorien; PgR=progesteronreceptor.
English: What Talzenna is used for
Danish: Hvad bruges Talzenna til
English: If you are allergic to talazoparib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Talzenna - Hvis du er allergisk over for talazoparib eller et af de øvrige indholdsstoffer i Talzenna (angivet i afsnit 6).
English: PARP enzymes are involved in cellular DNA damage response signalling pathways such as DNA repair, gene transcription, and cell death.
Danish: PARP-enzymer er involveret i cellernes DNA-skade signaler såsom DNA-reparation, gen-transkription og celledød.
English: If co-administration of strong BCRP inhibitors cannot be avoided, patient should be monitored for potential increased adverse reactions.
Danish: Hvis samtidig administration af kraftige BCRP-hæmmere ikke kan undgås, skal patienten monitoreres med henblik på øgede bivirkninger.
English: To manage adverse drug reactions, interruption of treatment or dose reduction based on severity and clinical presentation should be considered (Table 2).
Danish: Til håndtering af bivirkninger skal det overvejes at afbryde behandlingen eller reducere dosis baseret sværhedsgrad og den kliniske tilstand (tabel 2).
English: No talazoparib dose adjustments are required when co-administered with rifampin.
Danish: Det er ikke nødvendigt med justering af talazoparib-dosen ved samtidig administration med rifampin.
English: No adverse reactions were reported in one patient who accidentally self-administered thirty 1-mg capsules of talazoparib on Day 1 and was immediately treated with gastric decontamination.
Danish: Der blev ikke indberettet bivirkninger for en patient, der ved et uheld selvadministrerede 30 x 1 mg kapsler talazoparib på dag 1, og som straks blev behandlet med gastrointestinal dekontaminering.
English: It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor'.
Danish: Det er lægemiddel mod kræft, der også kaldes ”PARP-hæmmer” (poly-adenosindifosfat-ribose-polymerase-PARP).
English: Other medicines and Talzenna
Danish: Brug af anden medicin sammen med Talzenna
English: Talazoparib is a substrate of P-gp and BCRP transporters.
Danish: Talazoparib er et substrat af P-gp- og BCRP-transportproteiner.
English: When the strong P-gp inhibitor is discontinued, the Talzenna dose should be increased (after 3‐5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the strong P-gp inhibitor (see section 4.5).
Danish: Hvis den kraftige P-gphæmmer seponeres, skal dosis af Talzenna øges (efter 3-5 af P-gp-hæmmerens halveringstider) til den dosis, der blev anvendt inden start af behandling med den kraftige P-gp-hæmmer (se pkt.
English: Hormone receptor status, n (%)
Danish: Hormonreceptorstatus, n (%)
English: In the event of overdose, treatment with talazoparib should be stopped, and physicians should consider gastric decontamination, follow general supportive measures and treat symptomatically.
Danish: I tilfælde af overdosering skal behandlingen med talazoparib straks ophøre, hvorefter gastrointestinal dekontaminering samt symptom- og generel understøttende behandling bør iværksættes.
English: The European Medicines Agency has waived the obligation to submit the results of studies with talazoparib in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med talazoparib i alle undergrupper af den pædiatriske population for brystkræft (se pkt.
English: Talazoparib anti-tumour activity was also observed in a patient-derived xenograft (PDX) BRCA mutant breast cancer model where the patient was previously treated with a platinum-based regimen.
Danish: Den tumorhæmmende aktivitet ved talazoprib blev også observeret i en patientafledt xenograft (PDX) BRCA-muterende brystkræftsmodel, hvor patienten tidligere havde været behandlet med et platinbaseret regime.
English: Demographic, baseline, and disease characteristics - EMBRACA study Talazoparib
Danish: Karakteristika for demografi, baseline og sygdom - EMBRACA-studiet Talazoparib
English: Abbreviations: aBC=advanced breast cancer; CI=confidence interval; CNS=central nervous system; HR+=hormone receptor-positive; ITT=intent-to-treat; PCT=physician's choice treatment (chemotherapy); PFS=progression-free survival; TNBC=triple-negative breast cancer.
Danish: Forkortelser: aBC=fremskreden brystkræft; CI=konfidensinterval; CNS=centralnervesystemet; HR+=hormonreceptor-positiv; ITT=intent-to-treat; PCT=behandling valgt af lægen (kemoterapi); PFS=progressionsfri overlevelse; TNBC=triple-negativ brystkræft.
English: The effect of food
Danish: Virkning af fødeindtagelse
English: Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound.
Danish: Talazoparib er et substrat for transportørerne P-gp og Breast Cancer Resistance Protein (BCRP), og det udskilles primært uforandret gennem nyrerne.
English: To avoid contact with the capsule content, the capsules should be swallowed whole, and must not be opened or dissolved.
Danish: Kapslerne skal synkes hele og må ikke åbnes eller opløses i noget.
English: Concomitant use of strong P-gp inhibitors (including but not limited to amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, and verapamil) should be avoided.
Danish: Samtidig brug af kraftige P-gp-hæmmere (herunder blandt andet amiodaron, carvedilol, clarithromycin, cobicistat, darunavir, dronedaron, erythromycin, indinavir, itraconazol, ketoconazol, lapatinib, lopinavir, propafenon, quinidin, ranolazin, ritonavir, saquinavir, telaprevir, tipranavir og verapamil) skal undgås.
English: Consider resuming Talzenna at next lower dose or discontinue
Danish: Overvej genoptagelse af Talzenna ved næste reducerede dosis eller seponer
English: Summary of efficacy results - EMBRACA study Talazoparib
Danish: Opsummering af virkningsresultater - EMBRACA-studiet Talazoparib
English: Myelosuppression-related adverse events associated with dose modifications were reported for up to approximately 30% of patients in the talazoparib 1 mg/day population and those associated with permanent study drug discontinuation were reported for less than 1% of patients.
Danish: Bivirkninger relateret til myelosuppression i forbindelse med dosisændringer blev indberettet for op til ca. 30% af patienterne populationen, der fik talazoparib 1 mg/dag, og de bivirkninger, der var forbundet med permanent seponering af studiemedicinen udgjorde mindre end 1% af patienterne.
English: Women of childbearing potential should not become pregnant while receiving Talzenna and should not be pregnant at the beginning of treatment.
Danish: Fertile kvinder må ikke blive gravide, mens de får Talzenna, og må ikke være gravide ved behandlingsstart.
English: PARP inhibitors (PARPi) exert cytotoxic effects on cancer cells by 2 mechanisms, inhibition of PARP catalytic activity and by PARP trapping, whereby PARP protein bound to a PARPi does not readily dissociate from a DNA lesion, thus preventing DNA repair, replication, and transcription, thereby resulting in apoptosis and/or cell death.
Danish: PARP-hæmmere (PARPi) udøver cytotoksiske virkninger på kræftceller i form af 2 mekanismer: Hæmning af PARP's katalytiske aktivitet og ved indfangning af PARP, hvorved PARP-protein, der er bundet til en PARPi, ikke umiddelbart dissocieres fra en DNA-læsion, hvilket hindrer DNA-reparation, replikation og transkription, hvilket medfører apoptose og/eller celledød.
English: If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to 0.75 mg once daily.
Danish: Hvis samtidig administration med en kraftig P-gp-hæmmer ikke kan undgås, skal dosis af Talzenna reduceres til 0,75 mg 1 gang dagligt.
English: A population PK analysis was conducted using data from 490 patients with cancer to evaluate the impact of age (ranging from 18 to 88 years), sex (53 males and 437 females), and body weight (ranging from 35.7 kg to 162 kg) on the PK of talazoparib.
Danish: Der blev gennemført en farmakokinetisk analyse af populationen med data fra 490 patienter med cancer for at vurdere betydning af alder (18-88 år), køn (53 mænd og 437 kvinder) samt kropsvægt (35,7-162 kg) på for talazoparibs farmakokinetik.
English: These toxicity findings are consistent with the pharmacology of talazoparib and its tissue distribution pattern.
Danish: Disse toksikologiske fund stemmer overens med farmakologien for talazoparib og det vævsfordelingsmønster.
English: The primary efficacy endpoint was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review (BICR).
Danish: Response Evaluation Criteria in Solid Tumors (RECIST) Version 1,1, som vurderet af blindet uafhængig central gennemgang (BICR).
English: How much to take The recommended dose is one 1-mg capsule taken by mouth once daily.
Danish: Hvor meget skal man tage Den anbefalede dosis er 1 kapsel af 1 mg dagligt.
English: Table 3 summarises adverse reactions based on pooled dataset listed by system organ class, and frequency category.
Danish: Tabel 3 giver et overblik over bivirkningerne efter systemorganklasse og hyppighed.
English: Following a single oral dose of talazoparib with high-fat, high-calorie food (approximately 827 calories, 57% fat), the mean Cmax of talazoparib was decreased by approximately 46%, the median Tmax was delayed from 1 to 4 hours, while the AUCinf was not affected.
Danish: Efter en enkelt oral dosis talazoparib samtidig med fedtholdig, kalorieholdig føde (ca. 827 kalorier, 57 % fedt) faldt den gennemsnitlige Cmax for talazoparib med ca. 46 %, median Tmax blev forsinket fra 1 til 4 timer, hvorimod AUCinf ikke blev påvirket.
English: In an embryo-foetal development study in rats, talazoparib resulted in embryo-foetal death, foetal malformation (depressed eye bulge, small eye, split sternebrae, fused cervical vertebral arch) and structural variations in bones at a maternal systemic AUC24 exposure approximately 0.09-fold the relevant human exposure at the recommended dose.
Danish: I et studie omfattende undersøgelse af embryo-føtal udvikling hos rotter førte talazoparib til embryoføtal død, fostermisdannelse (indsunkne øjne, små øjne, delt sternebra, sammenvokset arcus vertebrae cervicalis) og strukturelle variationer i knoglerne ved systemisk AUC24 eksponering af moderen med ca. 0,09 gange den relevante humane eksponering ved den anbefalede dosis.
English: Your doctor may want to test your bone marrow to check for these problems.
Danish: Det kan være, at lægen vil undersøge din knoglemarv for at se, om det kunne være tilfældet for dig.
English: The population mean apparent volume of distribution (Vss/F) of talazoparib was 420 L. In vitro, talazoparib is approximately 74% bound to plasma proteins with no concentration dependence over the concentration range of 0.01 µM to 1 µM.
Danish: Talazoparibs mediane tilsyneladende fordelingsvolumen (Vss/F) var 420 l. In vitro er ca. 74 % af talazoparib bundet til plasmaproteiner uden koncentrationsafhængighed over koncentrationsintervallet 0,01 mikroM til 1 mikroM.
English: The most common (≥ 25%) adverse reactions in patients receiving talazoparib in these clinical studies were fatigue (57.1%), anaemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia (29.6%), and headache (26.5%).
Danish: De mest almindelige (≥ 25%) bivirkninger hos patienter, der fik talazoparib i disse kliniske studier, var træthed (57,1%), anæmi (49,6%), kvalme (44,3%), neutropeni (30,2%), thrombocytopeni (29,6%) og hovedpine (26,5%).
English: The dose may be lowered to 0.75 mg (taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg (one 0.25-mg capsule) once daily.
Danish: Dosis kan nedsættes til 0,75 mg (tages som 3 kapsler af 0,25 mg 1 gang dagligt) eller til 0,5 mg (2 kapsler af 0,25 mg 1 gang dagligt) eller til 0,25 mg (1 kapsel af 0,25 mg 1 gang dagligt).
English: In repeat-dose toxicity studies in rats and in dogs, the main findings at subtherapeutic exposures included bone marrow hypocellularity with dose-dependent decrease in haematopoietic cells, depletion of lymphoid tissue in multiple organs and atrophy and/or degenerative changes in testes, epididymis and seminiferous tubules.
Danish: I toksicitetsstudier med gentagne doser hos rotter og hunde har de primære fund ved subterapeutisk eksponering omfattet knoglemarvs-hypocellularitet med dosisafhængig reduktion af de hæmatopoietiske celler, svind af lymfevæv i flere organer samt atrofi og/eller degenerative ændringer af testikler, epedidymis og tubuli seminiferi.
English: Following repeated daily dosing of 1 mg talazoparib to patients, the geometric mean (% coefficient of variation [CV%]) area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of talazoparib at steady-state was in the range of 126 (107) ng•hr/mL to 208 (37) ng•hr/mL and 11 (90) ng/mL to 19 (27) ng/mL, respectively.
Danish: Efter gentagen daglig dosering med talazoparib 1 mg til patienterne lå det geometriske gennemsnitsareal (% koefficient af variationen (CV%)) under plasmakoncentration-tidskurven (AUC) og den maksimalt observerede plasmakoncentration (Cmax) for talazoparib ved steady-state i intervallet henholdsvis 126 (107) ng x t/ml til 208 (37) ng x t/ml og 11 (90) ng/ml til 19 (27) ng/ml.
English: Median PFS=8.6 months 95% CI (7.2, 9.3)
Danish: Median PFS=8,6 måneder 95% CI (7,2; 9,3)
English: Treatment of cancer cell lines that are harbouring defects in DNA repair genes with talazoparib single agent leads to increased levels of γH2AX, a marker of double stranded DNA breaks, and results in decreased cell proliferation and increased apoptosis.
Danish: Behandling af kræftcellelinjer med defekter i de DNA-reparerende gener med talazoparib-enkeltstof fører til øget indhold af γH2AX, en markør for dobbeltstrengede DNA-brud, og medfører nedsat celleproliferation og øget apoptose.
English: Agents that may affect talazoparib plasma concentrations
Danish: Stoffer, der kan påvirke plasmakoncentrationerne af talazoparib
English: Based on a population PK analysis that included 490 patients, where 41 patients were Asian and 449 patients were Non-Asian (361 White, 16 Black, 9 Others, and 63 Not reported), talazoparib CL/F was higher in Asian patients compared to Non-Asian patients, leading to 19% lower exposure (AUC) in Asian patients.
Danish: Ud fra en farmakokinetisk analyse af populationen, der omfattede 490 patienter, hvoraf 41 patienter var asiater og 449 patienter var ikke-asiater (361 hvide, 16 sorte, 9 andre og 63 ikke angivet), var talazoparib CL/F højere hos asiatiske patienter sammenlignet patienter, der ikke var asiatiske, førende til 19,2 % lavere eksponering (AUC) for asiatiske patienter.
English: Abbreviations: n=number of patients; N/A=not applicable.
Danish: Forkortelser: n=antal patienter.
English: Excretion of unchanged talazoparib in urine was the major route of elimination accounting for 55% of the administered dose, while unchanged talazoparib recovered in the faeces accounted for 14%.
Danish: Talazoparib udskilles overvejende uændret via urinen med 55 % af den administrerede dosis, hvorimod uændret talazoparib fundet i fæces udgjorde 14 %.
English: Grade 3 and Grade 4 myelosuppression-related events were reported for anaemia 34.8% and 0.4%, neutropenia 15.6% and 1.8%, and thrombocytopenia 12.8% and 4.0%.
Danish: Bivirkninger relateret til myelosuppression grad 3 og grad 4 blev indberettet for anæmi med 34,8% og 0,4%, for neutropeni med 15,6% og 1,8% og for thrombocytopeni med 12,8% og 4,0%.
English: Also some medicines can affect the way Talzenna works.
Danish: Noget medicin kan påvirke måden, Talzenna virker på.
English: In particular, the following may increase the risk of side effects with Talzenna: Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine and verapamilgenerally used to treat heart problems.
Danish: Det er navnlig følgende, som kan øge risikoen for bivirkninger med Talzenna: - Amiodaron, carvedilol, dronedaron, propafenon, kinidin, ranolazin og verapamil, der almindeligvis bruges til behandling af problemer med hjertet.
English: Population pharmacokinetic (PK) analysis has also shown that concomitant use of strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone.
Danish: Farmakokinetisk populationsanalyse har også vist, at samtidig brug af kraftige P-gp-hæmmere øgede eksponeringen for talazoparib med 45 % sammenlignet med talazoparib givet alene.
English: Abbreviations: BICR=blinded independent central review; CI=confidence interval; CMH=CochranMantel-Haenszel; CR=complete response; IQR=interquartile range; ITT=intent-to-treat; ORR=objective response rate; OS=overall survival; PR=partial response; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1. a. Hazard ratio was based on stratified Cox regression model with treatment as the only covariate
Danish: Forkortelser: BICR=blindet udafhængig central gennemgang; CI=konfidensinterval; CMH=CochranMantel-Haenszel; CR=klomplet respons; IQR=interkvartilt interval; ITT=intent-to-treat; ORR=objektiv responsrate; OS=samlet overlevelse; PR=partielt respons; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1.
English: Median age (y [range]) Age category (y), n (%)
Danish: Middel alder (år (interval)) Alderskategori (år), n (%)
English: Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib.
Danish: Der er indberettet tilfælde af myelodysplastisk syndrom/akut myeloid leukæmi (MDS/AML) hos patienter, der har fået PARP-hæmmere (poly-adenosindifosfat-ribose-polymerase), herunder talazoparib.
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Danish: Der skal foretages en graviditetstest af alle fertile kvinder forud for behandling.
English: Talzenna may only be used in patients with moderate or severe hepatic impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for hepatic function and adverse events.
Danish: Talzenna må kun bruges til patienter med moderat til kraftigt nedsat leverfunktion, hvis fordelene opvejer de mulige risici, og patienten skal nøje monitoreres med hensyn til leverfunktion og bivirkninger.
English: Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.
Danish: Talzenna bruges til behandling af voksne med en type brystkræft, der kaldes HER2-negativ brystkræft, som har et unormalt arveligt BRCA-gen.
English: Ciclosporin - used in organ transplantation to prevent rejection.
Danish: - Cyklosporin bruges ved organtransplantation for at forhindre afstødning af det nye organ.
English: Manufacturer Excella GmbH & Co. KG Nürnberger Strasse 12 90537 Feucht Germany
Danish: KG Nürnberger Strasse 12 90537 Feucht Tyskland
English: Twenty-eight percent (28%) of the patients in the pivotal study were taking acid-reducing agents, mainly proton pump inhibitors.
Danish: 28 % af patienterne i det pivotale studie tog syreneutraliserende midler, hovedsageligt protonpumpehæmmere.
English: Concomitant use of strong P-gp inhibitors during treatment with talazoparib should be avoided.
Danish: Samtidig brug af kraftige P-glykoprotein-hæmmere under behandling med talazoparib skal undgås.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: The mean (±standard deviation) terminal plasma half-life of talazoparib was 90 (±58) hours and the population mean (inter-subject variability) apparent oral clearance (CL/F) was 6.5 (31%) L/h in cancer patients.
Danish: Talazoparibs gennemsnitlige plasmahalveringstid (±standardafvigelse) var 90 timer (±58), og populationens gennemsnitlige (variationen mellem forsøgspersonerne), tilsyneladende orale clearance (CL/F) var 6,5 (31%) l/t for cancerpatienterne.
English: Of the 431 patients randomised in the EMBRACA study, 408 (95%) were centrally confirmed to have a deleterious or suspected deleterious gBRCAm using a clinical trial assay; out of which 354 (82%) were confirmed using the BRACAnalysis CDx®.
Danish: Ud af de 431 patienter, der blev randomiseret i EMBRACA-studiet, blev det bekræftet centralt ved klinisk studieanalyse, at 408 (95%) havde risikogivende BRCA, heraf blev 354 (82%) bekræftet ved hjælp af BRACAnalysis CDx
English: Talzenna 1 mg hard capsules EU/1/19/1377/005
Danish: Talzenna 1 mg hårde kapsler EU/1/19/1377/005
English: How to store Talzenna 6.
Danish: Sådan skal du tage Talzenna 4.
English: Talazoparib Chemotherapy
Danish: Talazoparib Kemoterapi
English: A highly effective method of contraception is required for female patients during treatment with Talzenna, and for at least 7 months after completing therapy.
Danish: Det er nødvendigt med yderst effektiv kontraception til kvindelige patienter, mens de behandles med Talzenna og i mindst 7 måneder efter behandlingen.
English: Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 90 × 1 capsules in unit dose blisters.
Danish: Pakningsstørrelser: Karton med 30 × 1 kapsler eller 60 × 1 kapsler eller 90 × 1 kapsler i blister med enkeltdoser.
English: Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Danish: Talzenna er indiceret som monoterapi til behandling af voksne patienter med germline BRCA1/2mutationer, som har lokalt fremskreden eller metastatisk HER2-negativ brystkræft.
English: Additional findings at higher exposures included dose-dependent increase in apoptosis/necrosis in the gastrointestinal (GI) tract, liver and ovary.
Danish: Yderligere fund ved højere eksponeringer omfattede dosisafhængig forøgelse af apoptose/nekrose i mave-tarm-kanal, lever og ovarier.
English: Pregnant women should be advised of the potential risk to the foetus (see section 4.6).
Danish: Gravide skal vejledes om den potentielle risiko for fosteret (se pkt.