FrancophonIA/ELRC3.0 huggingface dataset:
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment.
Croatian: Nakon uvođenja liječenja HCV infekcije direktno djelujućim antivirotikom (engl. direct acting antiviral, DAA), bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: SOF/VEL 12 weeks (n = 440)
Croatian: SOF/VEL 12 tjedana (n = 440)
English: SOF/VEL 12 weeks (n = 109)
Croatian: SOF/VEL 12 tjedana (n = 109)
English: l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination.
Croatian: l. Primjenjivani kao fiksna kombinacija elvitegravira, kobicistata, emtricitabina i tenofoviralafenamida.
English: Additionally, the pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Croatian: Osim toga, farmakokinetika voksilaprevira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min prema Cockcroft-Gaultu) nakon jedne doze od 100 mg voksilaprevira.
English: Atorvastatin (40 mg single dose) + sofosbuvir/ velpatasvir (400/100 mg once daily)f
Croatian: Atorvastatin (jedna doza od 40 mg) + sofosbuvir/ velpatasvir (400/100 mg jedanput na dan)f
English: No dose adjustment of Vosevi or voriconazole is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi ili vorikonazola.
English: Vosevi is contraindicated with rosuvastatin (see section 4.3).
Croatian: Vosevi je kontraindiciran s rosuvastatinom (vidjeti dio 4.3).
English: Co-administration with such medicinal products is not recommended with Vosevi (see section 4.4 and Table 2).
Croatian: Ne preporučuje se istodobna primjena takvih lijekova s lijekom Vosevi (vidjeti dio 4.4 i tablicu 2).
English: ↔ Lopinavir ↔ Sofosbuvir ↔ Velpatasvir ↑ Voxilaprevir
Croatian: ↔ Lopinavir ↔ Sofosbuvir ↔ Velpatasvir ↑ Voksilaprevir
English: • SOF/VEL 12 weeks (N=440)
Croatian: • SOF/VEL 12 tjedana (N=440)
English: Cmax
Croatian: Djelatna tvar Cmax
English: Voxilaprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Croatian: Voksilaprevir nije bio genotoksičan u bateriji testova in vitro ili in vivo, uključujući test mutagenosti na bakterijama, test kromosomske aberacije u limfocitima ljudske periferne krvi i mikronukleusni test u štakora in vivo.
English: • SOF/VEL/VOX 12 weeks (N=182)
Croatian: • SOF/VEL/VOX 12 tjedana (N=182)
English: Rifabutin
Croatian: Rilpivirin
English: • SOF/VEL 12 weeks (N=109)
Croatian: • SOF/VEL 12 tjedana (N=109)
English: In the POLARIS-2 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 12), a total of 21 of 501 (4%) patients (16 with genotype 1, 2 with genotype 2, 2 with genotype 4, and 1 with genotype 5) qualified for resistance analysis due to relapse.
Croatian: Ispitivanja u bolesnika koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima U skupini liječenoj sofosbuvirom/velpatasvirom/voksilaprevirom tijekom 8 tjedana u ispitivanju POLARIS-2 (vidjeti tablicu 12), ukupno se 21 od 501 (4 %) bolesnika (16 s genotipom 1, 2 s genotipom 2, 2 s genotipom 4 i 1 s genotipom 5) kvalificirao za analizu rezistencije zbog relapsa.
English: Breast-feeding Do not breast-feed during treatment with Vosevi.
Croatian: Nemojte dojiti tijekom liječenja lijekom Vosevi.
English: Co-administration of Vosevi with rifapentine is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi s rifapentinom (vidjeti dio 4.4).
English: c. SVR12 is 89% in genotype 1a patients enrolled at sites in the US and 97% in genotype 1a patients enrolled at sites outside the US d. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Croatian: b. Dva bolesnika imala su podtipove genotipa 1 koji nisu bili genotip 1a ili genotip 1b; oba su bolesnika postigla SVR12. c. Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja liječenja.
English: • SOF/VEL/VOX 8 weeks (N=501)
Croatian: • SOF/VEL/VOX 8 tjedana (N=501)
English: (Inhibition of OATP1B, P-gp and CYP3A)
Croatian: (Inhibicija OATP1B, P-gp-a i CYP3A)
English: Rifapentine (Induction of P-gp and CYPs)
Croatian: Rifapentin (Indukcija P-gp-a i CYP-ova)
English: Vosevi is contraindicated with rifampicin (see section 4.3).
Croatian: Vosevi je kontraindiciran s rifampicinom (vidjeti dio 4.3).
English: Patients with GT4-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Croatian: Bolesnici s GT4-6 infekcijom bili su uključeni samo u skupinu koja je primala SOF/VEL/VOX 12 tjedana.
English: The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Croatian: Farmakokinetika velpatasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min prema Cockcroft-Gaultu) nakon jedne doze od 100 mg velpatasvira.
English: Patients with GT2-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Croatian: Bolesnici s GT2-6 infekcijom bili su uključeni samo u skupinu koja je primala SOF/VEL/VOX 12 tjedana.
English: SOF/VEL/VOX 12 weeks (n = 263)
Croatian: SOF/VEL/VOX 12 tjedana (n = 263)
English: SOF/VEL/VOX 8 weeks (n = 110)
Croatian: SOF/VEL/VOX 8 tjedana (n = 110)
English: Pravastatin may be administered with Vosevi at a dose that does not exceed pravastatin 40 mg.
Croatian: Pravastatin se može primjenjivati s lijekom Vosevi u dozi koja nije veća od doze pravastatina od 40 mg.
English: Interaction only studied with sofosbuvir Expected:
Croatian: Interakcija je ispitana samo sa sofosbuvirom
English: • SOF/VEL/VOX 12 weeks (N=263)
Croatian: • SOF/VEL/VOX 12 tjedana (N=263)
English: Co-administration of Vosevi with ciclosporin is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi sa ciklosporinom (vidjeti dio 4.4).
English: Voriconazole (200 mg twice daily) + voxilaprevir (100 mg single dose)f
Croatian: Vorikonazol (200 mg dvaput na dan) + voksilaprevir (jedna doza od 100 mg)f
English: Rosuvastatin (10 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Croatian: Rosuvastatin (jedna doza od 10 mg) + sofosbuvir/ velpatasvir/voksilaprevir (400/100/100 mg jedanput na dan) + voksilaprevir (100 mg jedanput na dan)f
English: b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Croatian: b. Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja liječenja.
English: Relapseb
Croatian: Nuspojava
English: No NS3, NS5A, or NS5B NI RAVs emerged in either of these patients.
Croatian: Ni u jednog od tih bolesnika nisu se pojavili NS3, NS5A, ili NS5B NI RAVovi.
English: Pravastatin (40 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Croatian: Pravastatin (jedna doza od 40 mg) + sofosbuvir/velpatasvir/ voksilaprevir (400/100/100 mg jedanput na dan) + voksilaprevir (100 mg jedanput na dan) f
English: • SOF/VEL/VOX 8 weeks (N=110)
Croatian: • SOF/VEL/VOX 8 tjedana (N=110)
English: Co-administration of Vosevi with modafinil is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi s modafinilom (vidjeti dio 4.4).
English: GT-3 (n = 78)
Croatian: (n = 78)
English: d. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Croatian: d. Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja liječenja.
English: ↔ Sofosbuvir ↔ Voxilaprevir
Croatian: ↔ Sofosbuvir ↔ Voksilaprevir
English: DAA-naïve adults with genotype 3 HCV infection and compensated cirrhosis (POLARIS-3) Table 14 presents the SVR12 and virologic outcome for the POLARIS-3 study.
Croatian: Bolesnici s infekcijom HCV-om genotipa 3 i kompenziranom cirozom koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima (POLARIS-3)
English: Table 13 presents the SVR12 by HCV genotype by cirrhosis status for the POLARIS-2 trial.
Croatian: U tablici 13 prikazani su SVR12 prema genotipu HCV-a i cirozi za ispitivanje POLARIS-2.
English: Musculoskeletal and connective tissue disorders: Common myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
English: No NS3 and NS5B NI RAVs emerged in any of these 21 patients at failure.
Croatian: Ni u jednog od 21 bolesnika nisu se pojavili NS3 i NS5B NI RAV-ovi pri neuspjehu.
English: Table 7: SVR12 in DAA-naïve patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 8 weeks POLARIS-2 (n = 498)
Croatian: Tablica 7: SVR12 u bolesnika koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima s početnim NS3 ili NS5A RAV-ovima ili bez njih, prema ispitivanju sofosbuvir/velpatasvir/voksilaprevir 8 tjedana
English: Placebo-controlled study in which patients with GT1 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or placebo for 12 weeks.
Croatian: Placebom kontrolirano ispitivanje u kojem su bolesnici s GT1 infekcijom bili randomizirani u omjeru 1:1 u skupine koje su primale
English: Table 12: SVR12 by HCV genotype and virologic outcome in study POLARIS-2*
Croatian: Tablica 12: SVR12 prema genotipu HCV-a i virološkom ishodu u ispitivanju POLARIS-2* SOF/VEL/VOX
English: Omeprazole (20 mg once daily) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose)c
Croatian: Omeprazol (20 mg jedanput na dan) + sofosbuvir/velpatasvir/voksilaprevi r (jedna doza od 400/100/100 mg)c
English: SVR12 96%
Croatian: Ukupni SVR12 Genotip 1
English: No dose adjustment of Vosevi, raltegravir or emtricitabine/tenofovir disoproxil fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi, raltegravira ili emtricitabina/tenofovirdizopr oksilfumarata.
English: Ciclosporin (600 mg single dose)e + velpatasvir (100 mg single dose)f
Croatian: Ciklosporin (jedna doza od 600 mg)e + velpatasvir (jedna doza od 100 mg)f
English: Rifampicin (600 mg once daily) + velpatasvir (100 mg single dose)f
Croatian: Rifampicin (600 mg jedanput na dan) + velpatasvir (jedna doza od 100 mg)f
English: Rifampicin (600 mg once daily) + voxilaprevir (100 mg single dose)f
Croatian: Rifampicin (600 mg jedanput na dan) + voksilaprevir (jedna doza od 100 mg)f
English: No NS3, NS5A, or NS5B NI RAVs emerged in this patient infected with genotype 1a HCV.
Croatian: U ovog se bolesnika zaraženog HCV-om genotipa 1a nisu pojavili NS3, NS5A ili NS5B NI RAV-ovi.
English: j. Administered as emtricitabine, tenofovir disoproxil fumarate fixed-dose combination.
Croatian: j. Primjenjivani kao fiksna kombinacija emtricitabina i tenofovirdizoproksilfumarata.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)k + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir (400/100 mg once daily)f, h
Croatian: Raltegravir (400 mg dvaput na dan)k + emtricitabin/tenofovirdizoproksilf umarat (200/300 mg jedanput na dan)j + sofosbuvir/velpatasvir (400/100 mg jedanput na dan) f, h
English: Voxilaprevir is not renally eliminated.
Croatian: Voksilaprevir se ne uklanja putem bubrega.
English: i. Administered as emtricitabine, rilpivirine, and tenofovir alafenamide fixed-dose combination.
Croatian: Primjenjivani kao fiksna kombinacija emtricitabina, rilpivirina i tenofoviralafenamida.
English: GTs)a (n = 263)
Croatian: Ukupno (svi GT-i)a (n = 263)
English: Table 11: SVR12 by HCV genotype and virologic outcome in study POLARIS-4
Croatian: Tablica 11: SVR12 prema genotipu HCV-a i virološkom ishodu u ispitivanju POLARIS-4 SOF/VEL/VOX
English: Effect on sofosbuvir, velpatasvir and voxilaprevir concentrations not studied Expected:
Croatian: Učinak na sofosbuvir, velpatasvir i voksilaprevir nije ispitan
English: GT-6 (n = 6)
Croatian: (n = 6)
English: In vitro potential for sofosbuvir/velpatasvir/voxilaprevir drug-drug interactions
Croatian: In vitro potencijal interakcija lijekova sa sofosbuvirom/velpatasvirom/voksilaprevirom
English: and <50 mL/min/1.73 m2)
Croatian: Blago oštećenje bubrega (eGFR ≥ 50 i < 80 ml/ min/ 1,73 m2)
English: (may affect more than 1 in 10 people) • headache
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: POLARIS-3 (n =219)
Croatian: (n =219)
English: Ciclosporin (600 mg single dose)e + voxilaprevir (100 mg single dose)f
Croatian: Ciklosporin (jedna doza od 600 mg)e + voksilaprevir (jedna doza od 100 mg)f
English: Rifampicin (600 mg single dose) + velpatasvir (100 mg single dose)f
Croatian: Rifampicin (jedna doza od 600 mg) + velpatasvir (jedna doza od 100 mg)f
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 + 100 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg single dose)f
Croatian: Atazanavir pojačan ritonavirom (jedna doza od 300 + 100 mg) + sofosbuvir/velpatasvir/ voksilaprevir (jedna doza od 400/100/100 mg)f
English: Itraconazoled Posaconazoled Isavuconazoled
Croatian: Itrakonazold Posakonazold Izavukonazold
English: (Inhibition of OATP1B or
Croatian: (Inhibicija OATP1B ili P-gp-a ili
English: Otherd
Croatian: Ostalod
English: g. Administered as efavirenz, emtricitabine and tenofovir DF fixed-dose combination.
Croatian: Primjenjivani kao fiksna kombinacija efavirenza, emtricitabina i tenofovirdizoproksilfumarata.
English: Rifampicin (600 mg single dose) + voxilaprevir (100 mg single dose)f
Croatian: Rifampicin (jedna doza od 600 mg) + voksilaprevir (jedna doza od 100 mg)f
English: Vosevi is contraindicated with St. John's wort (see section 4.3).
Croatian: Vosevi je kontraindiciran s gospinom travom (vidjeti dio 4.3).
English: Carbamazepine (Induction of P-gp and CYPs)
Croatian: Rifabutin (Indukcija P-gp-a i CYP-ova)
English: Macrogol
Croatian: Metadon
English: Renal impairment
Croatian: Norelges tromin
English: 1a 1b 2a 2b 3a 4a
Croatian: 1a 1b
English: POLARIS-2 (n =941)
Croatian: (n =941)
English: DAA-naïve adults with genotype 1, 2, 3, 4, 5, or 6 HCV infection (POLARIS-2) Table 12 presents the SVR12 by HCV genotype and virologic outcome for the POLARIS-2 trial.
Croatian: Odrasli koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima s infekcijom HCV-om genotipa 1, 2, 3, 4, 5 ili 6 (POLARIS-2)
English: Clinical studies in DAA-experienced patients
Croatian: Klinička ispitivanja u bolesnika koji su prethodno bili liječeni direktno djelujućim antivirusnim lijekovima
English: Voxilaprevir had no adverse effects on behavior, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 238-times higher than the human exposure at the recommended clinical dose.
Croatian: Nisu opaženi teratogeni učinci u ispitivanjima razvojne toksičnosti s voksilaprevirom na štakorima i kunićima pri AUC izloženostima približno 141 odnosno 4 puta većima od ljudske izloženosti pri preporučenoj kliničkoj dozi.Voksilaprevir nije imao štetne učinke na ponašanje, reprodukciju ili razvoj potomstva u ispitivanjima prenatalnog i postnatalnog razvoja u štakora pri AUC izloženostima približno 238 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: No NS3, NS5A, or NS5B nucleoside inhibitor (NI) RAVs emerged in the other 5 patients who relapsed.
Croatian: U ostalih 5 bolesnika s relapsom nisu se pojavili NS3, NS5A ili NS5B NI RAVovi.
English: Colloidal anhydrous silica Copovidone
Croatian: Inhibitori protonske pumpe
English: No NS3 or NS5B NI RAVs emerged in either of these patients.
Croatian: Ni u jednog od tih bolesnika nisu se pojavili NS3 ili NS5B NI RAV-ovi.
English: Observed: Dabigatran ↑
Croatian: Digoksin ↑
English: POLARIS-4 (n =333)
Croatian: (n =333)
English: Excipients
Croatian: Famotidin
English: ↔ Sofosbuvir ↓ Velpatasvir ↔ Voxilaprevir
Croatian: ↔ Sofosbuvir ↓ Velpatasvir ↔ Voksilaprevir
English: Observed: Rilpivirine ↔ ↔ ↔
Croatian: R-metadon ↔ ↔ ↔ S-metadon ↔ ↔ ↔
English: c. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Croatian: c. Ostalo uključuje bolesnike za koje su nedostajali podaci i koji su prekinuli liječenje prije supresije virusa.
English: No NS3 and NS5B NI RAVs emerged in any of these 3 patients.
Croatian: Ni u jednog od ta 3 bolesnika nisu se pojavili NS3 i NS5B NI RAV-ovi.
English: GT-4 (n = 22)
Croatian: (n = 22)
English: Phenobarbital
Croatian: Fenitoin
English: e. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Croatian: e. Ostalo uključuje bolesnike za koje su nedostajali podaci i koji su prekinuli liječenje prije supresije virusa.
English: POLARIS-1 (n =415)
Croatian: (n =415)
English: d. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Croatian: d. Ostalo uključuje bolesnike za koje su nedostajali podaci i koji su prekinuli liječenje prije supresije virusa.
English: tenofovir disoproxil fumarate (600/200/300 mg once daily)g + sofosbuvir/
Croatian: Efavirenz/emtricitabin/tenofovirdi zoproksilfumarat (600/200/300 mg jedanput na dan)g + sofosbuvir/velpatasvir (400/100 mg jedanput na dan)f, h
English: b. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Croatian: b. Ostalo uključuje bolesnike za koje su nedostajali podaci i koji su prekinuli liječenje prije supresije virusa.
English: Outcome for patients without SVR Ontreatment virologic failurec
Croatian: Virološki neuspjeh uz liječenje 0/501 Relapsc
English: Patient disposition
Croatian: Značajke bolesnika
English: • palpitations;
Croatian: • povraćanje
English: Observed: atorvastatin
Croatian: atorvastatin
English: Co-administration with Vosevi is not recommended.
Croatian: Ne preporučuje se istodobna primjena s lijekom Vosevi.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da je, iako nema dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova vjerojatna te postoji dokaz njihove sigurne uporabe na ovaj način tijekom najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted.
Croatian: Ako simptomi traju dulje od dva tjedna tijekom liječenja, potrebno je konzultirati liječnika ili kvalificiranoga zdravstvenog radnika.
English: The plant is cultivated or gathered when flowering to obtain the above-ground parts for medicinal use.
Croatian: Biljka se uzgaja ili sakuplja nakon cvjetanja kako bi se dobili nadzemni dijelovi za medicinsku uporabu.
English: In its assessment, the HMPC also considered a few available clinical studies, including a study in patients suffering from sleep disorders, which suggested a positive effect on sleep.
Croatian: U svojoj ocjeni, HMPC je također razmotrio nekoliko dostupnih kliničkih ispitivanja, uključujući ispitivanje provedeno na bolesnicima koji pate od poremećaja spavanja, koje je pokazalo pozitivno djelovanje na spavanje.
English: California poppy EMA/HMPC/334023/2015
Croatian: Zelen kalifornijskog maka EMA/HMPC/334023/2015
English: California poppy is the common name for the above-ground parts of the plant Eschscholzia californica Cham.
Croatian: Zelen kalifornijskog maka je uobičajeni naziv za nadzemne dijelove biljke Eschscholzia californica Cham.
English: The HMPC concluded that, on the basis of its long-standing use, California poppy can be used for the relief of mild symptoms of mental stress and to aid sleep.
Croatian: HMPC je zaključio da se, na temelju njegove dugotrajne uporabe, zelen kalifornijskog maka može koristiti za ublažavanje blagih simptoma mentalnog stresa i kao pomoć pri spavanju.
English: Further information on the risks associated with California poppy medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže zelen kalifornijskog maka, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, možete pronaći u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of California poppy medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže zelen kalifornijskog maka, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing California poppy are usually available in solid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže zelen kalifornijskog maka najčešće su dostupni u čvrstim oblicima koji se uzimaju kroz usta.
English: Information on the use and licensing of California poppy medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže zelen kalifornijskog maka u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: Any applications for the licensing of medicines containing California poppy have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže zelen kalifornijskog maka moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: The HMPC conclusions on the use of California poppy medicines to relieve mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže zelen kalifornijskog maka za ublažavanje blagih simptoma mentalnog stresa i kao pomoć pri spavanju temelje se na njihovoj "tradicionalnoj uporabi".
English: This summary is not intended to provide practical advice on how to use medicines containing California poppy.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže zelen kalifornijskog maka.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of California poppy.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe zeleni kalifornijskog maka.
English: California poppy preparations are obtained by powdering the dried above-ground parts of the plant.
Croatian: Pripravci zeleni kalifornijskog maka dobivaju se usitnjavanjem u prah suhih nadzemnih dijelova biljke.
English: California poppy preparations should only be used in adults.
Croatian: Pripravci koji sadrže zelen kalifornijskog maka smiju se koristiti samo u odraslih osoba.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing California poppy.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže zelen kalifornijskog maka.