FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of midazolam, other benzodiazepines or other CYP3A4 substrates is required when coadministered with Daklinza.
Latvian: Lietojot vienlaicīgi ar Daklinza, midazolāma, citu benzodiazepīnu vai citu CYP3A4 substrātu deva nav jāpielāgo
English: Daklinza 90 mg: the film-coated tablet is light green, biconvex, round shape with "BMS" embossed on one side and "011" on the other side
Latvian: Daklinza 90 mg: apvalkotā tablete ir gaiši zaļa, abpusēji izliekta, apaļas formas ar iespiestu “BMS” vienā pusē un “011” otrā pusē.
English: On-treatment virologic failure
Latvian: Viroloģiska neveiksme Viroloģiska neveiksme ārstēšanas laikā
English: Oy Bristol-Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 230
Latvian: Ab Puh/Tel: + 358 9 251 21 230
English: An oral contraceptive containing ethinylestradiol 35 μg and norgestimate
Latvian: Daklinza lietošanas laikā ieteicams perorāls pretapaugļošanās līdzeklis, kas satur 35 μg etinilestradiola un
English: ↑ Dolutegravir AUC: 1.33 (1.11, 1.59) Cmax: 1.29 (1.07, 1.57) Cmin: 1.45 (1.25, 1.68)
Latvian: AUC: 1,33 (1,11; 1,59) Cmax: 1,29 (1,07; 1,57) Cmin: 1,45 (1,25; 1,68)
English: ANTIDEPRESSANTS Selective serotonin reuptake inhibitors Escitalopram 10 mg once daily (daclatasvir 60 mg once daily)
Latvian: Selektīvie serotonīna atpakaļsaistes inhibitori Escitaloprāms 10 mg vienreiz dienā (daklatazvīrs 60 mg vienreiz dienā)
English: Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation, Study ALLY-1
Latvian: Terapijas iznākumi pēc 12 nedēļas ilgas daklatazvīra, sofosbuvīra un ribavirīna kombinācijas lietošanas pacientiem, kam pēc aknu transplantācijas bija ciroze vai HCV recidīvs (pētījums ALLY-1)
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Latvian: PRETMIKOBAKTĒRIJU LĪDZEKĻI Rifampicīns 600 mg vienreiz dienā (daklatazvīrs 60 mg vienā devā)
English: Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side and "213" on the other side.
Latvian: Zaļa, abpusēji izliekta, piecstūru tablete, izmērs 7,2 mm x 7,0 mm, ar iespiestu “BMS” vienā pusē un “213” otrā pusē.
English: ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
Latvian: Ketokonazols 400 mg vienreiz dienā (daklatazvīrs 10 mg vienā devā)
English: No dose adjustment of Daklinza is required.
Latvian: Daklinza deva nav jāpielāgo
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Latvian: Pretvīrusu terapijas pārtraukšanas noteikumu, kas attiektos uz Daklinza un sofosbuvīra kombināciju,
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Latvian: Bristol-Myers Squibb Pharma EEIG
English: Shortness of breath
Latvian: Barošana ar krūti
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with atazanavir/ritonavir, atazanavir/cobicistat or other strong inhibitors of CYP3A4.
Latvian: Daklinza deva jāsamazina līdz 30 mg vienreiz dienā, lietojot kopā ar atazanavīru/ritonavīru, atazanavīru/kobicistatu vai citiem spēcīgiem CYP3A4
English: Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Latvian: Daklinza un karbamazepīna, okskarbazepīna, fenobarbitāla, fenitoīna vai citu spēcīgu CYP3A4 induktoru vienlaicīga lietošana ir kontrindicēta (skatīt
English: Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Latvian: Kuņģa-zarnu trakta traucējumi ļoti bieži slikta dūša bieži caureja, vemšana, sāpes vēderā, gastroezofageālā atviļņa slimība, aizcietējums, sausa mute,
English: CP A CP B CP C Genotype 1 1a 1b Genotype 2 Genotype 3 Genotype 4 Genotype 6 ND: Not determined * 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR.
Latvian: CP A CP B CP C 1. genotips 1a 1b 2. genotips 3. genotips 4. genotips 6. genotips NN - nav noteikts
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Latvian: EU/1/14/939/003 28 tabletes (kalendāriepakojums) EU/1/14/939/004 28 x 1 tablete
English: Virologic breakthrough
Latvian: Viroloģisks uzliesmojums
English: Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir.
Latvian: Lietojot Daklinza kopā ar eritromicīnu, var paaugstināties daklatazvīra koncentrācija.
English: Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Latvian: Par mijiedarbību ar citām lietošanas shēmas zālēm lasiet attiecīgajos zāļu aprakstos.
English: ↔ Daclatasvir ↔ NRTI
Latvian: ↔ Daklatazvīrs ↔ NRTI
English: No dose adjustment of Daklinza or rilpivirine is required.
Latvian: Daklinza vai rilpivirīna deva nav jāpielāgo
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Latvian: Ja Daklinza lieto kombinācijā ar sofosbuvīru un vienlaicīgi lieto amiodaronu un/vai citas zāles, kas palēnina sirdsdarbību (skatīt 4.4. un 4.5. apakšpunktu), ziņots par smagas bradikardijas un sirds blokādes gadījumiem.
English: End of treatment HCV RNA undetectable
Latvian: Ārstēšanas beigās HCV RNS nav konstatējamas
English: Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir:
Latvian: OATP 1B1 un/vai BCRP:
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Latvian: (cART shēmas), ieskaitot papildinātu PI, NNRTI un integrāzes inhibitoru (INSTI) terapijas bāzi,
English: Relapse**
Latvian: Recidīvs**
English: Daclatasvir in vitro did not inhibit (IC50 >40 µM) CYP enzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6.
Latvian: Daklatazvīrs in vitro neinhibēja (IC50 > 40 µM) CYP enzīmus 1A2,
English: Daklinza 60 mg: the film-coated tablet is light green, biconvex, pentagonal shape with "BMS" debossed on one side and "215" on the other side.
Latvian: Daklinza 60 mg: apvalkotā tablete ir gaiši zaļa, abpusēji izliekta, piecstūru formas ar iespiestu “BMS” vienā pusē un “215” otrā pusē.
English: Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Latvian: nieze, sausa āda Skeleta-muskuļu un saistaudu sistēmas bojājumi bieži artralģija, mialģija artralģija, mialģija
English: No dose adjustment of Daklinza or methadone is required.
Latvian: Daklinza vai metadona deva nav jāpielāgo
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Latvian: Telaprevīrs 500 mg ik pēc 12 h (daklatazvīrs 20 mg vienreiz dienā)
English: ↑ Simeprevir AUC: 1.44 (1.32, 1.56) Cmax: 1.39 (1.27, 1.52) Cmin: 1.49 (1.33, 1.67)
Latvian: AUC: 1,44 (1,32; 1,56) Cmax: 1,39 (1,27; 1,52) Cmin: 1,49 (1,33; 1,67)
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Latvian: Daklinza + sofosbuvīrs ± ribavirīns 24 nedēļas (skatīt 5.1. apakšpunktu)
English: General disorders and administration site conditions very common fatigue fatigue
Latvian: Vispārēji traucējumi un reakcijas ievadīšanas vietā ļoti bieži nogurums nogurums
English: Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Latvian: Ieteicamā Daklinza kombinētās terapijas shēma bez interferona Pacientu populācija*
English: 600 mg daily
Latvian: 600 mg dienā
English: Advanced cirrhosis and post-liver transplant (ALLY-1) In study ALLY-1, the regimen of daclatasvir, sofosbuvir, and ribavirin administered for 12 weeks was evaluated in 113 adults with chronic hepatitis C and Child-Pugh A, B or C cirrhosis (n=60) or HCV recurrence after liver transplantation (n=53).
Latvian: 113 pieaugušajiem, kam bija hronisks C hepatīts un Child-Pugh A, B vai C pakāpes ciroze (n=60) vai recidivējoša HCV infekcija pēc aknu transplantācijas (n=53).
English: Other HCV antivirals
Latvian: Citi pretvīrusu līdzekļi, kas darbojas pret HCV
English: ↔ Lopinavir* AUC: 1.15 (0.77, 1.72) Cmax: 1.22 (1.06, 1.41) Cmin: 1.54 (0.46, 5.07)
Latvian: AUC: 1,15 (0,77; 1,72) Cmax: 1,22 (1,06; 1,41) Cmin: 1,54 (0,46; 5,07)
English: Discontinue Daklinza, peginterferon alfa and ribavirin
Latvian: Pārtraukt Daklinza, alfa peginterferona un ribavirīna lietošanu
English: No dose adjustment of Daklinza or warfarin is required.
Latvian: Daklinza vai varfarīna deva nav jāpielāgo
English: ↑ Daclatasvir
Latvian: ↑ Dabigatrāna eteksilāts
English: If you are unsure of any information in the package leaflets, please contact your doctor or pharmacist.
Latvian: Ja kaut kas no lietošanas instrukcijās sniegtās informācijas Jums nav skaidrs, sazinieties ar ārstu vai farmaceitu.
English: No dose adjustment of Daklinza or raltegravir is required.
Latvian: Daklinza vai raltegravīra deva nav jāpielāgo
English: daclatasvir + pegIFN/RBV N=82
Latvian: pegIFN/RBV N=82
English: Haemoglobin >12 g/dL
Latvian: >12 g/dl
English: ↔ Daclatasvir AUC: 1.41 (1.32, 1.50) Cmax: 0.77 (0.70, 0.85)
Latvian: AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70; 0,85)
English: All Genotype 3 N=18
Latvian: Visi ar 3. genotipa vīrusu inficētie pacienti N=18
English: Overall, SVR12 was achieved by 97% (149/153) of patients administered daclatasvir and sofosbuvir for 12 weeks in ALLY-2.
Latvian: Pētījumā ALLY-2 pēc daklatazvīra un sofosbuvīra kombinācijas lietošanas 12 nedēļu garumā pavisam 97% pacientu (149 no 153) sasniedza SVR12.
English: Expected due to CYP3A4 inhibition by the calcium channel blocker:
Latvian: Paredzama, jo kalcija kanālu blokatori inhibē CYP3A4:
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg daclatasvir (as dihydrochloride) The other ingredients are - Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172)
Latvian: - Apvalks: hipromeloze, titāna dioksīds (E171), makrogols 400, indigokarmīna alumīnija krāsviela (E132), dzeltenais dzelzs oksīds (E172).
English: Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
Latvian: FibroTest vērtējumpunktu skaita ≥ 0,75 un aspartātaminotransferāzes (AsAT) un trombocītu attiecības indeksa (APRI) > 2.
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study AI444010.
Latvian: AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 un
English: Data from compassionate use programmes which included patients with genotype 3 infection and cirrhosis, support the use of Daklinza + sofosbuvir for 24 weeks in these patients.
Latvian: Dati no eksperimentālās lietošanas programmām, kurās iekļauti pacienti ar 3. genotipa infekciju un cirozi, atbalsta šiem pacientiem
English: ANTIBACTERIALS Clarithromycin Telithromycin
Latvian: ANTIBAKTERIĀLIE LĪDZEKĻI Klaritromicīns
English: ↔ Daclatasvir AUC: 1.40 (1.29, 1.53) Cmax: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71)
Latvian: AUC: 1,40 (1,29; 1,53) Cmax: 1,04 (0,94; 1,15) Cmin: 1,56 (1,41; 1,71)
English: Treatmentexperienced*
Latvian: Ar iepriekš saņemtu terapiju*
English: N.V. Bristol-Myers Squibb Belgium S.A.
Latvian: Bristol-Myers Squibb Belgium S.A.
English: All Genotype 2 N=26
Latvian: Visi ar 2. genotipa vīrusu inficētie pacienti N=26
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Latvian: IMŪNSUPRESANTI Ciklosporīns 400 mg vienā devā (daklatazvīrs 60 mg vienreiz dienā)
English: Table 14: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1 through 3
Latvian: Apkopojums par novēroto jauno terapijas vai novērošanas laikā radušos HCV NS5A substitūciju, ārstējot vai novērojot pacientus, kam ir 1.
English: AUC: 0.98 (0.83, 1.15) Cmax: 1.03 (0.84, 1.25) Cmin: 1.06 (0.88, 1.29)
Latvian: ↔ Daklatazvīrs AUC: 0,98 (0,83; 1,15) Cmax: 1,03 (0,84; 1,25) Cmin: 1,06 (0,88; 1,29)
English: Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Latvian: Informāciju par pierādītu vai iespējami nozīmīgu zāļu mijiedarbību skatīt 4.5. apakšpunktā
English: No dose adjustment of Daklinza or enfuvirtide is required.
Latvian: Daklinza vai enfuvirtīda deva nav jāpielāgo
English: No dose adjustment of Daklinza or tenofovir is required.
Latvian: Daklinza vai tenofovīra deva nav jāpielāgo
English: Genotype 3
Latvian: 3. genotips
English: Population pharmacokinetic analysis identified gender as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) with female subjects having slightly lower CL/F, but the magnitude of the effect on daclatasvir exposure is not clinically important.
Latvian: Populācijas farmakokinētikas analīzē noskaidrots, ka dzimums ir statistiski nozīmīga daklatazvīra šķietamā perorālā klīrensa (CL/F) kovariante.
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see section 5.2).
Latvian: Nieru darbības traucējumi Pacientiem ar jebkādas pakāpes nieru darbības traucējumiem Daklinza deva nav jāpielāgo (skatīt
English: CP C
Latvian: CP A CP B CP C
English: Hypromellose
Latvian: inhibitoriem
English: The safety and efficacy of Daklinza in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daklinza + sofosbuvir +/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C (see sections 4.2 and 5.1).
Latvian: Daklinza efektivitāte un drošums, ārstējot HCV infekciju pacientiem, kam ir C pakāpes aknu slimība (pēc Child-Pugh klasifikācijas), ir vērtēta klīniskajā pētījumā ALLY-1 jeb AI444215, kura laikā Daklinza, sofosbuvīra un ribavirīna kombinācija tika lietota 12 nedēļas.
English: Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily)
Latvian: Atazanavīrs 300 mg/ritonavīrs 100 mg vienreiz dienā (daklatazvīrs 20 mg vienreiz dienā)
English: Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
Latvian: Paredzama, jo atazanavīrs/kobicistats inhibitē CYP3A4: ↑ Daklatazvīrs
English: Expected due to CYP3A4 induction by etravirine or nevirapine:
Latvian: Paredzama, jo etravirīns vai nevirapīns inducē CYP3A4: ↓ Daklatazvīrs
English: Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Latvian: Telaprevīrs 750 mg ik pēc 8 h (daklatazvīrs 20 mg vienreiz dienā)
English: No dose adjustment of Daklinza or maraviroc is required.
Latvian: Daklinza vai maraviroka deva nav jāpielāgo
English: ↑ Norbuprenorphine AUC: 1.62 (1.30, 2.02) Cmax: 1.65 (1.38, 1.99) Cmin: 1.46 (1.12, 1.89)
Latvian: AUC: 1,62 (1,30; 2,02) Cmax: 1,65 (1,38; 1,99) Cmin: 1,46 (1,12; 1,89)
English: There was no Y93H RAV present at baseline for genotype-3 infected patients treated for 12-weeks with sofosbuvir + daclatasvir + ribavirin, and thus SVR outcomes cannot be assessed.
Latvian: Tā kā pacientiem, kam 3. genotipa infekcija 12 nedēļas tika ārstēta ar sofosbuvīra, daklatazvīra un ribavirīna kombināciju, nebija Y93H RSV, ar SVR saistītos iznākumus nav iespējams novērtēt.
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with boceprevir or other strong inhibitors of CYP3A4.
Latvian: Daklinza deva jāsamazina līdz 30 mg vienreiz dienā, lietojot vienlaicīgi ar boceprevīru vai citiem spēcīgiem CYP3A4
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Latvian: Simeprevīrs 150 mg vienreiz dienā (daklatazvīrs 60 mg vienreiz dienā)
English: ↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74)
Latvian: AUC: 1,15 (1,07; 1,24) Cmax: 0,67(0,61; 0,74)
English: ↔ Ribavirin AUC: 0.94 (0.80, 1.11) Cmax: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17)
Latvian: AUC: 0,94 (0,80; 1,11) Cmax: 0,94 (0,79; 1,11) Cmin: 0,98 (0,82; 1,17)
English: Daklinza 90 mg film-coated tablets
Latvian: Daklinza 90 mg tabletes daclatasvirum
English: In study ALLY-3, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 152 adults infected with HCV genotype 3; 101 patients were treatment-naïve and 51 patients had failed prior antiviral therapy.
Latvian: pieaugušajiem, kas inficēti ar 3. genotipa HCV infekciju; 101 pacients nebija iepriekš ārstēts un 51
English: ↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02)
Latvian: AUC: 1,03 (0,97; 1,09) Cmax: 0,96 (0,91; 1,02)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with telaprevir or other strong inhibitors of CYP3A4.
Latvian: Daklinza deva jāsamazina līdz 30 mg vienreiz dienā, lietojot vienlaicīgi ar telaprevīru vai citiem spēcīgiem CYP3A4
English: daclatasvir + pegIFN/RBV
Latvian: plus pegIFN/RBV.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
Latvian: ZĀĻU NOSAUKUMS Daklinza 90 mg apvalkotās tabletes daclatasvirum
English: Ribavirin may be added based on clinical assessment of an individual patient.
Latvian: Pēc katra konkrētā pacienta klīniskas izmeklēšanas terapijas shēmu var papildināt arī ar ribavirīnu.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg film-coated tablets daclatasvir
Latvian: ZĀĻU NOSAUKUMS Daklinza 60 mg apvalkotās tabletes daclatasvirum
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Latvian: Daklinza vienlaicīga lietošana ar divšķautņu asinszāli vai citiem spēcīgiem CYP3A4 induktoriem ir kontrindicēta (skatīt
English: Detectable HCV RNA at end of treatment
Latvian: Konstatējama HCV RNS terapijas beigās
English: Daklinza 30 mg film-coated tablets
Latvian: Daklinza 30 mg tabletes daclatasvirum
English: Daklinza 60 mg film-coated tablets
Latvian: Daklinza 60 mg tabletes daclatasvirum
English: GT: Genotype; CP: Child Pugh * Includes patients co-infected with human immunodeficiency virus (HIV).
Latvian: GT - genotips; CP - Child Pugh
English: No dose adjustment of Daklinza or the NRTI is required.
Latvian: Daklinza vai NRTI deva nav jāpielāgo
English: Age (years): median (range) Race: White Black/African American Other HCV genotype: 1a 1b
Latvian: Rase: baltādainie melnādainie/afroamerikāņi
English: CYP3A4 inhibition by ketoconazole
Latvian: Ketokonazols inhibē CYP3A4
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with efavirenz.
Latvian: Lietojot vienlaicīgi ar efavirenzu, Daklinza deva jāpalielina līdz 90 mg vienreiz dienā
English: Expected due to CYP3A4 inhibition by the antibacterial:
Latvian: Paredzama, jo antibakteriālie līdzekļi inhibē CYP3A4:
English: ↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04)
Latvian: AUC: 0,87 (0,83; 0,92) Cmax: 0,95 (0,88; 1,04)
English: ↔ Darunavir AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
Latvian: AUC: 0,90 (0,73; 1,11) Cmax: 0,97 (0,80; 1,17) Cmin: 0,98 (0,67; 1,44)
English: No dose adjustment of either medicinal product is required when Daklinza is coadministered with cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil.
Latvian: Nevienu zāļu deva nav jāpielāgo, ja Daklinza lieto vienlaicīgi ar ciklosporīnu,
English: HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Latvian: (Hypericum perforatum)
English: Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Latvian: Takrolims 5 mg vienā devā (daklatazvīrs 60 mg vienreiz dienā)
English: daclatasvir + sofosbuvir N=13
Latvian: Daklinza +sofosbuvīrs+
English: SEDATIVES
Latvian: Izkliede
English: ↔ GS-331007** AUC: 1.0 (0.95, 1.08) Cmax: 0.8 (0.77, 0.90) Cmin: 1.4 (1.35, 1.53)
Latvian: AUC: 1,0 (0,95; 1,08) Cmax: 0,8 (0,77; 0,90) Cmin: 1,4 (1,35; 1,53)
English: CYP3A4 inhibition by telaprevir
Latvian: Telaprevīrs inhibē CYP3A4
English: ↔ Alprazolam
Latvian: ↔ Ribavirīns
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Latvian: Ir svarīgi neaizmirst par šo zāļu devas lietošanu.
English: NARCOTIC ANALGESICS
Latvian: Satur laktozi
English: Peginterferon alfa 180 µg once weekly and ribavirin 1000 mg or 1200 mg/day in two divided doses (daclatasvir 60 mg once daily)
Latvian: 1000 mg vai 1200 mg dienā divās dalītās devās (daklatazvīrs 60 mg vienreiz dienā)
English: HCV Genotype 3 (ALLY-3)
Latvian: un 4. genotipa HCV - 100%.
English: Common (may affect up to 1 in 10 people): difficulty sleeping dizziness migraine nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise
Latvian: migrēna; slikta dūša (šķebināšana), caureja, sāpes vēderā; locītavu sāpes, muskuļu sāpes vai jutīgums, ko nav izraisījusi fiziska slodze.
English: Virologic breakthrough**
Latvian: Viroloģiska neveiksme Viroloģisks uzliesmojums**
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Latvian: Katra apvalkotā tablete satur 30 mg daklatazvīra (dihidrohlorīda veidā).
English: Patients with cirrhosis
Latvian: Pacienti, kam ir ciroze
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone with or without other drugs that lower heart rate.
Latvian: Ja Daklinza lieto kombinācijā ar sofosbuvīru un vienlaicīgi lieto amiodaronu kopā ar citām zālēm, kas palēnina sirdsdarbību, vai bez tām, ziņots par smagas bradikardijas un sirds blokādes gadījumiem.
English: Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Latvian: Pētījumā ALLY-2 novērotie terapijas iznākumi pēc daklatazvīra un sofosbuvīra kombinācijas lietošanas pacientiem, kam vienlaikus bija HCV un HIV infekcija
English: ↔ Daclatasvir
Latvian: Dabigatrāna eteksilāts
English: Impact of baseline NS5A RAVs on cure rates
Latvian: rodoties NS5A RSV M28: T
English: Very common (may affect more than 1 in 10 people): decreased appetite difficulty sleeping headache shortness of breath nausea fatigue flu-like illness, fever itching, dry skin, unusual hair loss or thinning, rash diarrhoea cough joint pain, aching or tender muscles, not caused by exercise, unusual weakness irritability reduction in red blood cells (anaemia), reduction in white blood cells
Latvian: locītavu sāpes, muskuļu sāpes vai jutīgums, ko nav izraisījusi fiziska slodze, neparasts vājums; aizkaitināmība; sarkano asins šūnu skaita samazināšanās (anēmija), balto asins šūnu skaita samazināšanās.
English: Daklinza 30 mg and 60 mg film-coated tablets
Latvian: Uzglabāšanas laiks Daklinza 30 mg un 60 mg apvalkotās tabletes 30 mēneši
English: Inhibition of P-gp and BCRP by daclatasvir
Latvian: Daklatazvīrs inhibē P-gp un BCRP.
English: daclatasvir + sofosbuvir + ribavirin N=5
Latvian: Daklatazvīrs + sofosbuvīrs + ribavirīns
English: What Daklinza looks like and contents of the pack Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side.
Latvian: Daklinza 30 mg: apvalkotā tablete ir zaļa, abpusēji izliekta, piecstūru formas ar iespiestu “BMS” vienā pusē un “213” otrā pusē.
English: Amlodipine
Latvian: Nifedipīns Amlodipīns
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Latvian: Katra apvalkotā tablete satur 60 mg daklatazvīra (dihidrohlorīda veidā).