FrancophonIA/ELRC3.0 huggingface dataset:
English: In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Latvian: Pētījumā TURQUOISE I SVR12 dati dalībniekiem ar vienlaicīgu CHV/HIV-1 infekciju atbilda SVR12 datiem
English: SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Latvian: SVR12 dati ar 1.a genotipa vīrusu inficētiem iepriekš neārstētiem pacientiem PEARL IV pētījumā
English: Mechanism: Effect on tacrolimus is due to
Latvian: Mehānisms: takrolīma darbību ietekmē ritonavīra izraisīta
English: 600 mg twice daily
Latvian: Gemfibrozils 600 mg divas reizes dienā
English: CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to
Latvian: CYP3A/efluks a transportvielu inhibīcija var palielināt paritaprevīra iedarbības intensitāti.
English: The pharmacokinetic properties of the combination of Exviera with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 17 shows mean Cmax and AUC of Exviera 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers.
Latvian: 17. tabulā redzamas vidējās Cmax un AUC vērtības pēc vairākkārtīgas Exviera lietošanas pa 250 mg divas reizes dienā un ombitasvīra/paritaprevīra/ritonavīra 25 mg/150 mg/100 mg lietošanas vienu reizi dienā kopā ar pārtiku klīniski veseliem brīvprātīgajiem.
English: Lopinavir/ritonavir 400/100 mg twice daily or 800/200 mg once daily is contraindicated dasabuvir
Latvian: PRETKRAMPJU LĪDZEKĻI Karbamazepīn s 200 mg vienu reizi dienā, pēc tam200 mg divas reizes dienā Mehānisms: karbamazepīn s inducē
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Latvian: A grupa: Exviera un ombitasvīrs/paritaprevīrs/ritonavīrs + RBV (12 nedēļas)
English: Three interrupted Exviera and ombitasvir/paritaprevir/ritonavir for one to seven days, including one on ethinylestradiol.
Latvian: Trīs pacienti, no kuriem viena paciente lietoja etinilestradiolu, īslaicīgi pārtrauca Exviera un ombitasvīra/paritaprevīra/ritonavīra lietošanu uz 1-7 dienām.
English: Potential for other medicinal products to affect the pharmacokinetics of dasabuvir
Latvian: Citu zāļu iespējamā ietekme uz dasabuvīra farmakokinētiku Zāles, kas inhibē CYP2C8
English: Co-administration of Exviera and ombitasvir/paritaprevir/ ritonavir with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QTprolongation coadministered medicinal products.
Latvian: ritonavīra lietošana kopā ar rilpivirīnu vienu reizi dienā var tikt apsvērta tikai pacientiem bez
English: 200 mg once daily followed by
Latvian: 200 mg vienu reizi dienā/
English: Table 8 shows the SVR12 rates for genotype 1b-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL III.
Latvian: 8. tabulā redzami SVR12 dati ar 1.b genotipa vīrusu inficētiem, iepriekš neārstētiem pacientiem, kuri PEARL III pētījumā 12 nedēļas lietoja Exviera un ombitasvīru/paritaprevīru/ritonavīru kopā ar ribavirīnu vai bez tā.
English: Ciclosporin 100 mg dosed alone and 30 mg administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Latvian: Ciklosporīnu lietojot pa 100 mg monoterapijas veidā un pa 30 mg kopā ar Exviera un ombitasvīru/paritaprevīru/ritonavīru, nepieciešama ciklosporīna devu attiecības normalizēšana ciklosporīna mijiedarbības dēļ ar Exviera un ombitasvīru/paritaprevīru/ritonavīru.
English: buprenorphin e/ naloxone 4-24 mg/16 mg once daily
Latvian: naloksons 4-24 mg/ 1-6 mg vienu reizi dienā5 Mehānisms: ritonavīrs inhibē
English: Ethinylestradiol containing oral contraceptives are contraindicated (see section 4.3).
Latvian: Etinilestradiolu saturoši perorālie kontracepcijas līdzekļi ir kontrindicēti (skatīt
English: Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Latvian: Mehānisms: iespējams, paritaprevīrs, ombitasvīrs un dasabuvīrs var inhibēt UGT.
English: Exviera + ombitasvir/paritaprevir/ritonavir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim.
Latvian: Visos zāļu mijiedarbības pētījumos, izņemot zāļu mijiedarbības pētījumus ar karbamazepīnu, gemfibrozilu, ketokonazolu un sulfometoksazolu/trimetoprimu, tika lietotas vairākkārtīgas Exviera un ombitasvīra/paritaprevīra/ritonavīra devas.
English: ↑ GS
Latvian: Digoksīns
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Latvian: Katra apvalkotā tablete satur 250 mg dasabuvīra (nātrija sāls monohidrāta veidā).
English: Table 10 shows the SVR12 rates for treatment-experienced subjects with genotype 1-infection receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-II.
Latvian: 10. tabulā redzami SVR12 dati ar 1. genotipa vīrusu inficētiem, iepriekš ārstētiem pacientiem, kuri SAPPHIRE II pētījumā 12 nedēļas lietoja Exviera un ombitasvīru/paritaprevīru/ritonavīru kombinācijā ar ribavirīnu.
English: Lansoprazole
Latvian: Esomeprazols Lansoprazols
English: Caution should be used when sulfasalazine is co-administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Latvian: Atazanavīrs jālieto vienlaicīgi ar Exviera un ombitasvīru/paritapre vīru/ritonavīru.
English: In the genotype 1a replicon, the activity of dasabuvir was reduced 21- to 32-fold by the M414T, S556G or Y561H substitutions; 152- to 261-fold by the A553T, G554S or S556R substitutions; and 1472- and 975-fold by the C316Y and Y448H substitutions, respectively.
Latvian: S556G vai Y561H substitūcijas, 152 līdz 261 reizi - A553T, G554S vai S556R substitūcijas, bet 1472 un
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol 3350 Talc (E553b) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Latvian: Dzeltenais dzelzs oksīds (E172) Sarkanais dzelzs oksīds (E172) Melnais dzelzs oksīds (E172) 6.2.
English: Table 11 shows the SVR12 rates for genotype 1b-infected, treatment-experienced subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL II.
Latvian: 11. tabulā redzami SVR12 dati ar 1.b genotipa vīrusu inficētiem, iepriekš ārstētiem pacientiem, kuri PEARL II pētījumā 12 nedēļas lietoja Exviera un ombitasvīru/paritaprevīra/ritonavīra kombināciju kopā ar ribavirīnu vai bez tā.
English: r paritaprevir
Latvian: paritaprevīrs
English: NA Decrease in amlodipine dose by 50% and monitor patients for clinical effects.
Latvian: N/A Amlodipīna devu jāsamazina par 50%
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 28.4% had a body mass index of at least 30 kg/m2; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 81.8% had IL28B non-CC genotype; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Latvian: 70,3% dalībnieku bija vīrieši; 3,2% dalībnieki bija melnādaini; 28,4% dalībnieku ķermeņa masas indekss bija vismaz 30 kg/m2; 14,7% dalībnieku trombocītu skaits bija mazāks par 90 x 109/l; 49,7% dalībnieku albumīna līmenis bija zemāks par 40 g/l; 86,1% dalībnieku CHV RNS līmenis pirms terapijas uzsākšanas bija vismaz 800 000 SV/ml; 81,8% dalībnieku bija IL28B ne-CC genotips; 24,7% pacientu anamnēzē bija depresija vai bipolāri traucējumi; 68,7% dalībnieku bija 1.a genotipa CHV infekcija; 31,3% dalībnieku bija
English: The combination of atazanavir and ombitasvir/paritaprevir/ ritonavir + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen, see sections 4.4 and
Latvian: Atazanavīrs kopā ar ombitasvīra/ paritaprevīra/ ritanovīra kombināciju izraisa bilirubīna līmeņa paaugstināšanos, sevišķi, ja ribavirīns ietilpst
English: dasabuvir ombitasvir paritaprevir
Latvian: dasabuvīrs ombitasvīrs paritaprevīrs
English: Deferasirox may increase dasabuvir exposures and should be used with caution.
Latvian: Deferaziroks var paaugstināt dasabuvīra iedarbību un tas ir
English: Nausea
Latvian: Bezmiegs
English: Pruritus
Latvian: Pravastatīns
English: paritaprevir
Latvian: paritaprevīrs/
English: TURQUOISE-II- genotype 1, treatment-naïve or peginterferon+ribavirin-experienced subjects with compensated cirrhosis
Latvian: B grupa: Exviera un ombitasvīrs/paritaprevīrs/ritonavīrs Iepriekš neārstēti un ar peginterferonu + ribavirīnu iepriekš ārstēti pacienti ar kompensētu cirozi
English: INFORMATION IN BRAILLE exviera
Latvian: 16. INFORMĀCIJA BRAILA RAKSTĀ
English: 50 mg once daily
Latvian: 25 mg vienu reizi dienā,
English: Table 7 shows the SVR12 rates for genotype 1-infected, treatment-naïve subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-I.
Latvian: 7. tabulā redzami SVR12 dati ar 1. genotipa vīrusu inficētiem, iepriekš neārstētiem pacientiem, kuri SAPPHIRE I pētījumā 12 nedēļas lietoja Exviera un ombitasvīru/paritaprevīru/ritonavīru kombinācijā ar ribavirīnu.
English: HIV-1 Co-infection
Latvian: HIV blakusinfekcija
English: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
Latvian: ↓ dasasvīrs ↓ ombitasvīrs ↓ paritaprevīrs
English: Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks
Latvian: Exviera un ombitasvīrs/paritaprevīrs/ritonavīrs 12 nedēļas
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Latvian: Takrolīmu lietojot pa 2 mg monoterapijas veidā un pa 2 mg kopā ar Exviera un ombitasvīru/paritaprevīru/ritonavīru, nepieciešama takrolīma devu attiecības normalizēšana tā mijiedarbības dēļ ar Exviera un ombitasvīru/paritaprevīru/ritonavīru.
English: Clinical Comments ritonavir.
Latvian: AUC Ctrough Klīniskie komentāri iedarbības intensitāti.
English: ANTICONVULSANTS carbamazepine
Latvian: Ciklobenzaprīns, karisoprodols
English: BIGUANIDE ORAL ANTIHYPERGLYCEMICS Metformin
Latvian: BIGUANĪDU GRUPAS PRETHIPERGLIKĒMIJAS LĪDZEKĻI IEKŠĶĪGAI LIETOŠANAI Metformīns Exviera +
English: Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Latvian: Exviera un ombitasvīrs/paritaprevīrs/ritonavīrs kopā ar RBV 12 nedēļas
English: Darunavir combined with ombitasvir/paritaprevir/ ritonavir + dasabuvir is not recommended in patients with extensive PI resistance.
Latvian: Nav ieteicama darunavīra lietošana kopā ar ombitasvīru/ paritaprevīru/ ritonavīru pacientiem ar plašu rezistenci pret PI.
English: ↑ sulfasalazine
Latvian: ↑ sulfasalazīns
English: You should not breastfeed during treatment with Exviera.
Latvian: Zāles, ko nedrīkst lietot vienlaicīgi ar Exviera
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Latvian: Cits b a. Pierādīts CHV RNS līmenis ≥ 25 SV/ml pēc tam, kad terapijas laikā panāktais CHV RNS līmenis bija < 25 SV/ml, tika pierādīts CHV RNS līmeņa paaugstinājums par 1 log10 SV/ml, salīdzinot ar zemāko līmeni, vai CHV RNS līmenis pastāvīgi bija ≥ 25 SV/ml vismaz 6 terapijas nedēļas.
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Latvian: Exviera un ombitasvīrs/paritaprevīrs/ritonavīrs kopā ar RBV 12 nedēļas n/N
English: HCV RNA levels (no response guided algorithm).
Latvian: Terapijas ilgums visos klīniskajos pētījumos bija noteikts, un tas nebija atkarīgs no pētījuma dalībnieka CHV RNS līmeņa (netika ievērots no reakcijas atkarīgs algoritms).
English: TURQUOISE-II was a randomised, global multicentre, open-label trial conducted exclusively in 380 genotype 1-infected subjects with compensated cirrhosis (Child-Pugh A) who were either treatmentnaïve or did not achieve SVR with prior treatment with pegIFN/RBV.
Latvian: 380 pieaugušie ar 1. genotipa C hepatīta vīrusa infekciju un kompensētu aknu cirozi (A klase pēc Child-Pugh klasifikācijas), kuri vai nu nebija iepriekš ārstēti, vai arī pēc iepriekšējās terapijas laikā ar pegIFN/RBV nesasniedza SVR.
English: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Latvian: Terapiju saņēmušo pētījuma dalībnieku (N = 419) vidējais vecums bija 50 gadi (intervāls: no 19 līdz 70 gadu vecumam); 45,8% dalībnieku bija vīrieši; 4,8% dalībnieku bija melnādaini; 16,5% dalībnieku ķermeņa masas indekss bija vismaz 30 kg/m2; 9,3% pacientu anamnēzē bija depresija vai bipolāri traucējumi;
English: carbamaze pine 10, 11epoxide dasabuvir
Latvian: 10,11-epoksīd s dasabuvīrs
English: Genotype 1b, without cirrhosis or with compensated cirrhosis
Latvian: 1.b genotips, ar kompensētu aknu cirozi vai bez tās ombitasvīrs/paritaprevīrs/ritonavīrs
English: ↑ rilpivirine
Latvian: ↑ sofosbuvīrs
English: Mechanism: CYP2C19 induction by ritonavir
Latvian: S-mefenitoīns Mehānisms: ritonavīrs inducē
English: 300 mg single dose
Latvian: Viena 60 mg ombitasvīrs/ paritaprevīrs/
English: Mechanism: CYP3A4 inhibition by ritonavir
Latvian: Mehānisms: ritonavīrs inhibē
English: In genotype 1b, substitutions C316N, C316Y, M414T, Y448H, and S556G in HCV NS5B reduced susceptibility to dasabuvir.
Latvian: 1.b genotipa CHV NS5B jutību pret dasabuvīru samazināja C316N, C316Y, M414T, Y448H un
English: Exviera is administered with ombitasvir/paritaprevir/ritonavir.
Latvian: Exviera lieto kopā ar ombitasvīru/paritaprevīru/ritonavīru.
English: Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
Latvian: IL28B ne-CC genotips, n (%)
English: No dose adjustment is necessary for raltegravir or Exviera + ombitasvir/paritaprevir/ ritonavir.
Latvian: Raltegravīra vai ombitasvīra/ paritaprevīra/ ritanovīra devas pielāgošana nav nepieciešama.
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 19.8% had a body mass index of at least 30 kg/m2; 20.6% had a history of depression or bipolar disorder; 89.6% had IL28B non-CC genotype; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Latvian: 19,8% dalībnieku ķermeņa masas indekss bija vismaz 30 kg/m2; 20,6% pacientu anamnēzē bija depresija vai bipolāri traucējumi; 89,6% dalībnieku bija IL28B ne-CC genotips; 87,1% dalībnieku CHV RNS līmenis pirms terapijas uzsākšanas bija vismaz 800 000 SV/ml; 17,8% dalībnieku bija portālā fibroze (F2), bet 14,5% dalībnieku bija tiltveida fibroze (F3); 58,4% dalībnieku bija 1.a genotipa CHV infekcija;
English: Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 19.7% had a body mass index of at least 30 kg/m2; 20.7% had a history of depression or bipolar disorder; 69.2% had IL28B non-CC genotype; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Latvian: Terapiju saņēmušo pētījuma dalībnieku (N = 305) vidējais vecums bija 54 gadi (intervāls: no 19 līdz 70 gadu vecumam); 65,2% dalībnieku bija vīrieši; 11,8% dalībnieku bija melnādaini; 19,7% dalībnieku ķermeņa masas indekss bija vismaz 30 kg/m2; 20,7% pacientu anamnēzē bija depresija vai bipolāri traucējumi;
English: • The other ingredients are:
Latvian: DERĪGUMA TERMIŅŠ Derīgs līdz:
English: Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir
Latvian: Mehānisms: paritaprevīrs, ritonavīrs un dasabuvīrs inhibē
English: What Exviera contains
Latvian: Ko Exviera satur
English: S-warfarin dasabuvir ombitasvir
Latvian: S-varfarīns dasabuvīrs ombitasvīrs paritaprevīrs
English: Mitotane
Latvian: Mitotāns
English: patients is recommended.
Latvian: N/A Ir ieteicama pacientu klīniska novērošana.
English: OATP1B1 inhibition by gemfibrozil.
Latvian: NS5B inhibitoriem farmakoterapeitiskās grupas ietvaros.
English: Exviera and ombitasvir/paritaprevir /ritonavir + ribavirin
Latvian: Exviera un ombitasvīrs/paritaprev īrs/ritonavīrs + ribavirīns
English: 25 mg once daily administered in the morning, with food
Latvian: lietojot no rīta kopā ar ēdienu2
English: Exviera ombitas vir/parit aprevir/r itonavir cyclobenzap rine
Latvian: ombitasvīrs/ paritaprevīrs/ ritonavīrs ciklobenzaprīn s
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment.
Latvian: Pētījuma dalībnieki 12 nedēļas vai 24 nedēļas lietoja Exviera un ombitasvīru/paritaprevīru/ritonavīru kopā ar ribavirīnu.
English: Exviera ombitas vir/parit aprevir/r itonavir atazanavir dasabuvir ombitasvir paritaprevir
Latvian: ombitasvīrs/ paritaprevīrs/ ritonavīrs atazanavīrs dasabuvīrs ombitasvīrs paritaprevīrs
English: d. Observed in combination in genotype 1b-infected subjects.
Latvian: 1.b genotipa CHV infekcija.
English: ↑ sofosbuvir
Latvian: ↑ hidrokodons
English: 34 subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Latvian: 34 pētījumā iekļautajiem dalībniekiem (29 ar 1.a genotipa CHV infekciju un 5 ar 1.b genotipa
English: Тел.
Latvian: gp.
English: ↑ darunavir ↓ dasabuvir ombitasvir paritaprevir lopinavir / ritonavir 400/100 mg
Latvian: Viena 300 mg deva ombitasvīrs/ paritaprevīrs/ ritonavīrs paracetamols
English: ↓ darunavir
Latvian: ↔ dasabuvīrs
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Latvian: Mehānisms: atazanavīra izraisīta OATP inhibīci ja par palielināt paritaprevīra ombitasvīrs/ paritaprevīrs/ ritonavīrs atazanavīrs
English: Atazanavir must be administered at dasabuvir ombitasvir
Latvian: ↔ dasabuvīrs abakavīra vai lamivudīna deva nav jāpielāgo.
English: Table 9 shows the SVR12 rates for genotype 1a-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL IV. Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin was not non-inferior to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin.
Latvian: 9. tabulā redzami SVR12 dati ar 1.a genotipa vīrusu inficētiem, iepriekš neārstētiem pacientiem, kuri PEARL IV pētījumā 12 nedēļas lietoja Exviera un ombitasvīru/paritaprevīru/ritonavīru kopā ar ribavirīnu vai bez tā.
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
Latvian: ritonavīra lietošana devās 400/100 mg divas reizes dienā vai
English: Exviera and ombitasvir/paritaprevir/ritonavir (12 weeks)
Latvian: GT1b Exviera un ombitasvīrs/paritepravīrs/ritonavīrs (12 nedēļas)
English: tenofovir dasabuvir ombitasvir paritaprevir
Latvian: Paredzams: ↑ dabigatrāna eteksilāts ombitasvīrs/
English: Qtern contains two different active substances, which work in different ways:
Latvian: Qtern satur divas dažādas aktīvās vielas, kas darbojas dažādos veidos:
English: Other information about Qtern
Latvian: Cita informācija par Qtern
English: The recommended dose is one tablet taken once a day.
Latvian: Ieteicamā deva ir viena tablete vienreiz dienā.
English: This is a summary of the European public assessment report (EPAR) for Qtern.
Latvian: Šis ir Eiropas Publiskā novērtējuma ziņojuma (EPAR) kopsavilkums par Qtern.
English: The full EPAR for Qtern can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Latvian: Pilns Qtern EPAR teksts ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Qtern?
Latvian: Kas tiek darīts, lai nodrošinātu nekaitīgu un efektīvu Qtern lietošanu?
English: It is not intended to provide practical advice on how to use Qtern.
Latvian: Tas nav paredzēts kā praktiski ieteikumi par Qtern lietošanu.
English: Why is Qtern approved?
Latvian: Kāpēc Qtern tika apstiprinātas?
English: Saxagliptin has been authorised in the EU as Onglyza since 2009.
Latvian: Saksaglitpīns ES ir reģistrēts kā Onglyza kopš 2009. gada.
English: The CHMP therefore considered that Qtern should only be used in patients already receiving at least one component to avoid over-treatment and so that the value of each component can be judged individually.
Latvian: Tāpēc CHMP uzskatīja, ka Qtern drīkst lietot tikai pacientiem, kas jau saņem vismaz vienu komponentu, lai nepieļautu pārāk intensīvu ārstēšanu, un tā, lai katra komponenta vērtību varētu izvērtēt atsevišķi.
English: • saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Latvian: • saksagliptīns ir dipeptidilpeptidāzes-4 (DPP-4) inhibitors.
English: Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3 main studies involving 1,169 adults with type 2 diabetes.
Latvian: Dapagliflozīnu kombinācijā ar saksagliptīnu (tāda pati kombinācija kā Qtern) novērtēja trīs pamatpētījumos, iesaistot 1169 pieaugušos ar 2. tipa diabētu.
English: Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription.
Latvian: Qtern ir pieejamas tabletēs (5 mg saksagliptīna un 10 mg dapagliflozīna), un tās var iegādāties tikai pret recepti.
English: What benefits of Qtern have been shown in studies?
Latvian: Kādas bija Qtern priekšrocības šajos pētījumos?
English: On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Latvian: Pamatojoties uz iepriekšējo pētījumu rezultātiem ar atsevišķiem Qtern komponentiem, ko lieto kopā ar sulfonilurīnvielu, CHMP apstiprināja arī Qtern un sulfonilurīnvielas kombināciju.
English: It works by blocking the breakdown of incretin hormones in the body.
Latvian: Tas darbojas, bloķējot “inkretīnu” hormonu sadalīšanos organismā.
English: What is Qtern and what is it used for?
Latvian: Kas ir Qtern un kāpēc tās lieto?
English: For practical information about using Qtern, patients should read the package leaflet or contact their doctor or pharmacist.
Latvian: Lai iegūtu praktisku informāciju par Qtern lietošanu, pacientiem jāizlasa zāļu lietošanas instrukcija vai jāsazinās ar ārstu vai farmaceitu.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels of glucose in the blood or when the body is unable to respond to insulin effectively.
Latvian: 2. tipa cukura diabēts ir slimība, kuras gadījumā aizkuņģa dziedzeris nesintezē pietiekami daudz insulīna, lai kontrolētu glikozes līmeni asinīs, vai kad organisms nespēj efektīvi reaģēt uz insulīnu.
English: Although both components of Qtern contribute to lowering blood glucose levels, the effects of each may vary in different patients.
Latvian: Lai gan abi Qtern komponenti pazemina glikozes līmeni asinīs, katra komponenta efektivitāte dažādiem pacientiem var atšķirties.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Latvian: Abu aktīvo vielu darbības rezultātā pazeminās glikozes līmenis asinīs, un tas palīdz kontrolēt 2. tipa cukura diabētu.