natgillin/translations-raw huggingface dataset:
l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination.
l.Uporabljeno kot fiksna kombinacija elvitegravirja, kobicistata, emtricitabina in tenofoviralafenamida.
Genotype 1b
Genotip 1b Genotip 2
Co-administration with such medicinal products is not recommended with Vosevi (see section 4.4 and Table 2).
Sočasna uporaba teh zdravil z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
The safety assessment of Vosevi was based on data from Phase 2 and 3 clinical trials in which 1383 patients received sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir + voxilaprevir for 8 or 12 weeks.
1.383 bolniki, ki so prejemali sofosbuvir/velpatasvir/voksilaprevir ali sofosbuvir/velpatasvir +
No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
darunavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksil tenofovirijevega fumarata ni treba prilagajati.
The pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Farmakokinetiko voksilaprevirja so proučili z enkratnim 100-miligramskim odmerkom voksilaprevirja pri bolnikih, negativnih za HCV, z zmerno in hudo jetrno okvaro (stopnja B in C po CPT).
The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Farmakokinetiko velpatasvirja so proučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, z zmerno in hudo jetrno okvaro (stopnja B in C po CPT).
No dose adjustment of Vosevi or dolutegravir is required.
Odmerka zdravila Vosevi ali dolutegravirja ni treba prilagajati.
The physician in charge of the diabetic care of the patient should be informed when DAA therapy is initiated.
O začetku zdravljenja z neposredno delujočim protivirusnim zdravilom je treba obvestiti zdravnika, odgovornega za zdravljenje sladkorne bolezni pri zadevnem bolniku.
Impact of DAA therapy on drugs metabolized by the liver
Vpliv zdravil z direktnim delovanjem na viruse (DAA - direct-acting antivirals) na zdravila, ki se presnavljajo prek jeter
No NS3, NS5A, or NS5B NI RAVs emerged in this patient infected with genotype 1a HCV.
Pri tem bolniku, okuženim z virusom HCV genotipa 1a, ni prišlo do nobenih RAV NI NS3, NS5A ali NS5B.
a. Two patients with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
a. V skupini SOF/VEL/VOKS sta SVR12 dosegla dva bolnika z nedoločenim genotipom.
Ciclosporin ↔ ↔ Voxilaprevir ↑
Ciklosporin ↔ ↔ Voksilaprevir
i. Administered as emtricitabine, rilpivirine, and tenofovir alafenamide fixed-dose combination.
i. Uporabljeno kot fiksna kombinacija emtricitabina, rilpivirina in tenofoviralafenamida.
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.
Voksilaprevir v nizu raziskav in vitro ali in vivo ni bil genotoksičen, vključno z bakterijskim testom mutagenosti, testom kromosomske aberacije z uporabo limfocitov humane periferne krvi in in vivo v testu mikronukleusa pri miših.
No NS3, NS5A, or NS5B NI RAVs emerged in either of these patients.
Pri nobenem od teh bolnikov ni prišlo do nobenih RAV NI NS3, NS5A ali NS5B.
Of these 3 patients, 1 patient (33%) had virus with emergent NS5A RAV Y93N at failure.
(33 %) virus, pri katerem je prišlo do RAV NS5A Y93N ob neuspehu.
g. Administered as efavirenz, emtricitabine and tenofovir DF fixed-dose combination.
g. Uporabljeno kot fiksna kombinacija efavirenza, emtricitabina in dizoproksiltenofovirijevega fumarata.
The most common adverse reactions in patients receiving voxilaprevir 900 mg were diarrhoea (34%), nausea (17%) and headache
so bili diareja (34 %), navzea (17 %) in glavobol (9 %).
Voriconazole (200 mg twice daily) + voxilaprevir (100 mg single dose)f
Vorikonazol (200 mg dvakrat na dan) + voksilaprevir (100 mg enkratni odmerek)f
Not applicable.
ob neuspehu.
• St. John's wort (a herbal medicine used to treat depression);
• šentjanževko (zdravilo rastlinskega izvora, ki se uporablja za zdravljenje depresije);
It is recommended to separate antacid and Vosevi administration by 4 hours.
Priporoča se, da med uporabo antacida in zdravila Vosevi minejo 4 ure.
Co-administration of Vosevi with ciclosporin is not recommended (see section 4.4).
Vosevi s ciklosporinom ni priporočljiva (glejte poglavje
hr After Dialysis
1 uro pred dializo
At clinically relevant concentrations, velpatasvir is not an inhibitor of hepatic transporters BSEP, sodium taurocholate cotransporter protein (NTCP), OATP1A2 or OCT1, renal transporters OCT2, OAT1, OAT3, MRP2 or MATE1, or CYP or UGT1A1 enzymes.
OATP1A2 ali OCT1, ledvičnih prenašalcev OCT2, OAT1, OAT3, MRP2 ali MATE1 ali encimov
Vosevi is contraindicated with ethinylestradiol-containing medicinal products (see section 4.3).
Uporaba zdravila Vosevi v kombinaciji z zdravili, ki vsebujejo etinilestradiol, je kontraindicirana (glejte poglavje 4.3).
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
Raltegravir (400 mg dvakrat na dan)k + emtricitabin/ dizoproksiltenofovirijev fumarat (200/300 mg enkrat na dan)j +
After a single 100 mg dose of [14C]-voxilaprevir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.8.
100-miligramskem odmerku [14C]-voksilaprevirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi 0,5-0,8.
Patient population
Starejši bolniki
Ciclosporin (600 mg single dose)e + velpatasvir (100 mg single dose)f
Ciklosporin (600 mg enkratni odmerek)e + velpatasvir (100 mg enkratni odmerek)f
DAA-experienced adults who had not received an NS5A inhibitor (POLARIS-4) Table 11 presents the SVR12 by HCV genotype and virologic outcome for the POLARIS-4 trial.
Klinične študije pri bolnikih, ki so bili predhodno že zdravljeni z DAA Odrasli bolniki, ki so bili predhodno že zdravljeni z zaviralci NS5A (POLARIS-1) V preglednici 10 je predstavljen SVR12 po genotipu HCV za preskušanje POLARIS-1.
Vosevi is contraindicated with rifabutin (see section 4.3).
Uporaba zdravila Vosevi v kombinaciji z rifabutinom je kontraindicirana (glejte poglavje 4.3).
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.
Odrasli bolniki z okužbo z virusom HCV genotipa 3 in kompenzirano cirozo, ki predhodno še niso bili zdravljeni z DAA (POLARIS-3)
j. Administered as emtricitabine, tenofovir disoproxil fumarate fixed-dose combination.
j. Uporabljeno kot fiksna kombinacija emtricitabina in dizoproksiltenofovirijevega fumarata.
Outcome for patients without SVR On-treatment virologic failure
Virološki neuspeh med zdravljenjemc
Rifampicin (600 mg once daily) + velpatasvir (100 mg single dose)f
Rifampicin (600 mg enkrat na dan) + velpatasvir (100 mg enkratni odmerek)f
Othere a. Two patients without cirrhosis with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Drugoe a. V skupini SOF/VEL/VOKS sta SVR12 dosegla dva bolnika brez ciroze z nedoločenim genotipom.
Renal impairment No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro prilagajanje odmerka zdravila Vosevi ni potrebno.
Rifampicin (600 mg once daily) + voxilaprevir (100 mg single dose)f
Rifampicin (600 mg enkrat na dan) + voksilaprevir (100 mg enkratni odmerek)f
Suomi/Finland
Španci/Latinoameričani
Effect on velpatasvir or voxilaprevir exposure not studied.
velpatasvir ali voksilaprevir niso ugotovili.
Ciclosporin (600 mg single dose)e + voxilaprevir (100 mg single dose)f
Ciklosporin (600 mg enkratni odmerek)e + voksilaprevir (100 mg enkratni odmerek)f
Body weight did not have a clinically significant effect on sofosbuvir, velpatasvir or voxilaprevir exposure according to a population pharmacokinetic analysis.
Glede na analizo populacijske farmakokinetike telesna masa ni klinično pomembno vplivala na izpostavljenost sofosbuvirju, velpatasvirju ali voksilaprevirju.
The proportion of patients who permanently discontinued treatment due to adverse reactions was 0.1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
Pri bolnikih, ki so sofosbuvir/velpatasvir/voksilaprevir prejemali 8 tednov, je bil delež bolnikov, ki so zaradi neželenih učinkov trajno prekinili zdravljenje, 0,1 %.
Co-administration of Vosevi with efavirenz/emtricitabine/tenofovir disoproxil fumarate is not recommended (see section 4.4).
Vosevi z efavirenzom/emtricitabinom/ dizoproksiltenofovirijevim fumaratom ni priporočljiva
Effect of baseline HCV resistance-associated variants on treatment outcome
Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja Študije pri bolnikih, ki so bili predhodno že zdravljeni z DAA
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.
V študiji razvoja pri podganah pred kotitvijo in po njej pri izpostavljenosti vrednostim na podlagi AUC, ki so bile približno 238-krat večje od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, voksilaprevir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
Vosevi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Uporaba zdravila Vosevi v kombinaciji s fenobarbitalom in fenitoinom je kontraindicirana (glejte poglavje 4.3).
Medicinal products that inhibit OATP1B, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentrations of velpatasvir or voxilaprevir.
Zdravila, ki zavirajo OATP1B, CYP2B6, CYP2C8 ali
Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 3-fold higher than the human exposure at the recommended clinical dose.
V študiji razvoja pri podganah pred kotitvijo in po njej pri izpostavljenosti vrednostim na podlagi AUC, ki so bile približno 3-krat večje od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, velpatasvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
No NS3 and NS5B NI RAVs emerged in any of these 3 patients.
Pri nobenem od teh 3 bolnikov ni prišlo do nobenih RAV NI NS3 in NS5B.
STIMULANTS Modafinil
STIMULANTI
(may affect more than 1 in 10 people) • headache
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Without Cirrhosis
Brez ciroze
Rifampicin (600 mg single dose) + voxilaprevir (100 mg single dose)f
Rifampicin (600 mg enkratni odmerek) + voksilaprevir (100 mg enkratni odmerek)f
Gilead Sciences Ireland UC Carrigtohill
Gilead Sciences Ireland UC
POLARIS-2 (open label)
POLARIS-2
No NS3, NS5A, or NS5B nucleoside inhibitor (NI) RAVs emerged in the other 5 patients who relapsed.
NS5A ali NS5B, povezane z odpornostjo na nukleozidne zaviralce (RAV NI NS3, NS5A, NS5B; NInucleoside inhibitor).
Table 11: SVR12 by HCV genotype and virologic outcome in study POLARIS-4
V preglednici 11 sta predstavljena SVR12 po genotipu HCV in virološki izid za preskušanje POLARIS-4.
Vosevi [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Vosevi [samo zunanja ovojnina]
Cimetidined Nizatidined Ranitidined
Blaga ledvična okvara
For velpatasvir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were L31I/V and Y93H.
Za velpatasvir v replikonih genotipa 1-6 so bile z odpornostjo povezane substitucije, selekcionirane v
• diarrhoea • feeling sick (nausea)
• glavobol • driska
Phenobarbital
Modafinil
Vosevi is contraindicated with rifampicin (see section 4.3).
Uporaba zdravila Vosevi v kombinaciji z rifampicinom je kontraindicirana (glejte poglavje 4.3).
Rifampicin (600 mg single dose) + velpatasvir (100 mg single dose)f
Rifampicin (600 mg enkratni odmerek) + velpatasvir (100 mg enkratni odmerek)f
Table 13 presents the SVR12 by HCV genotype by cirrhosis status for the POLARIS-2 trial.
V preglednici 12 sta predstavljena SVR12 po genotipu HCV in virološki izid za preskušanje POLARIS-2.
Colloidal anhydrous silica Copovidone
Dizoproksiltenofovirijev fumarat
United Kingdom
ZDA
Age (years) median (range) Male Gender Race Black/African American 14% (60) White Hispanic/Latino Genotype Genotype 1a Genotype 1b Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 IL28B CC HCV RNA ≥ 800,000 IU/mL 74% (306) Compensated cirrhosis Site US Non-US
Genotip 1a Genotip 1b Genotip 2 Genotip 3 Genotip 4 Genotip 5 Genotip 6 IL28B CC
DAA experienced patients* without cirrhosis or with compensated cirrhosis
Bolniki brez ciroze ali s kompenzirano cirozo, ki so bili predhodno že zdravljeni z DAA*
POLARIS-4 (open label)
POLARIS-4
tenofovir disoproxil fumarate (600/200/300 mg once daily)g + sofosbuvir/
(600/200/300 mg enkrat na dan)g + sofosbuvir/velpatasvir
Outcome for patients without SVR On-treatment virologic failurea
Izid za osebe brez SVR
Emtricitabine/rilpivirine/ tenofovir alafenamide (200/25/25 mg once daily)i + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Emtricitabin/rilpivirin/ tenofoviralafenamid (200/25/25 mg enkrat na dan)i
No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-PughTurcotte [CPT] Class A).
Pri bolnikih z blago jetrno okvaro (stopnja A po Child-Pugh-Turcotteu [CPT]) odmerka zdravila Vosevi ni treba prilagajati.
Vosevi is contraindicated with carbamazepine (see section 4.3).
Uporaba zdravila Vosevi v kombinaciji s karbazepinom je kontraindicirana (glejte poglavje 4.3).
The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Monohidroksilirani in demetilirani velpatasvir sta bila presnovka,
Population pharmacokinetic analysis in HCV-infected patients indicated that patients with cirrhosis (CPT Class A) had 73% higher exposure of voxilaprevir than those without cirrhosis (see section 4.2).
Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da je bila pri bolnikih s cirozo (stopnja A
Vosevi contains lactose.
Zdravilo Vosevi vsebuje laktozo.
POLARIS-3 (open label)
POLARIS-3
↔ Sofosbuvir ↓ Velpatasvir ↔ Voxilaprevir
↓ Sofosbuvir ↓ Velpatasvir ↓ Voksilaprevir
↓ Sofosbuvir ↓ Velpatasvir ↓ Voxilaprevir
↔ Sofosbuvir ↓ Velpatasvir ↔ Voksilaprevir
NS5A inhibitor-experienced adults (POLARIS-1)
Odrasli bolniki, ki so bili predhodno že zdravljeni z DAA, vendar niso prejemali zaviralcev NS5A (POLARIS-4)
ANTIARRHYTHMICS Amiodarone
Antagonisti receptorjev H2
Outcome for patients without SVR Ontreatment virologic failurec
Virološki neuspeh med zdravljenjem 0/501 Relapsc
The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with once daily sofosbuvir/velpatasvir 400/100 mg for
Farmakokinetiko sofosbuvirja, GS-331007 in velpatasvirja so preučili pri bolnikih, okuženih s HCV, z
Pravastatin (40 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
voksilaprevir (400/100/100 mg enkrat na dan) + voksilaprevir (100 mg enkrat na dan)f (zaviranje OATP1B in
Relapsed
Posakonazold
Tablet core:
Bolezni živčevja:
e. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
e. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinile zdravljenje pred virološko supresijo.
Interaction only studied with sofosbuvir Expected:
Preučevane so bile samo interakcije s sofosbuvirjem.
Patients with GT2-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Bolniki z okužbo GT 26 so bili vključeni samo v skupino za 12
Rosuvastatin (10 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
voksilaprevir (400/100/100 mg enkratni odmerek) + voksilaprevir (100 mg enkratni odmerek)f (zaviranje P-gp)
c. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
c. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinile zdravljenje pred virološko supresijo.
c. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
c. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
• outer cartons containing 1 bottle of 28 film-coated tablets
• škatle, ki vsebujejo 1 plastenko z 28 filmsko obloženimi tabletami Imetnik dovoljenja za promet z zdravilom Gilead Sciences Ireland UC
Patients with GT1-3 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or SOF/VEL for 12 weeks.
Bolniki z okužbo GT 1-3 so bili randomizirani v razmerju 1 : 1 za 12
b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
b. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
No dose adjustment of Vosevi or emtricitabine/rilpivirine/tenofovi r alafenamide is required.
Odmerka zdravila Vosevi ali emtricitabina/rilpivirina/ tenofoviralafenamida ni treba prilagajati.
b. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
b. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinili zdravljenje pred virološko supresijo.
Close monitoring of INR is recommended when Vosevi is co-administered with all vitamin K antagonists.
Ko se zdravilo Vosevi daje sočasno z antagonisti vitamina
d. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
d. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinile zdravljenje pred virološko supresijo.
a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
a. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
d. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
d. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
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.
bolnika (16 z genotipom 1, 2 z genotipom 2, 2 z genotipom 4 in 1 z genotipom 5) primernih za analizo odpornosti zaradi relapsa.
Overall SVR12a
Skupni SVR12 Genotip 1
No NS3 and NS5B NI RAVs emerged in any of these 21 patients at failure.
Pri nobenih od teh 21 bolnikov ni prišlo do nobenih RAV NS3 in
(Inhibition of OATP1B or
(zaviranje OATP1B,
Relative to healthy subjects (n = 137), velpatasvir AUC0-24 and Cmax were 41% lower and 39% lower, respectively, in HCV-infected patients.
primerjavi z zdravimi osebami (n = 137) sta bili pri bolnikih, okuženih s HCV, vrednosti AUC0-24 in
In vitro potential for sofosbuvir/velpatasvir/voxilaprevir drug-drug interactions
In vitro potencial za medsebojne interakcije med sofosbuvirjem, velpatasvirjem in voksilaprevirjem
Excipients
Elvitegravir
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.
V svoji oceni je odbor HMPC prav tako upošteval nekaj razpoložljivih kliničnih študij, vključno s študijo pri bolnikih z motnjami spanja, ki je pokazala pozitiven učinek na spanje.
The plant is cultivated or gathered when flowering to obtain the above-ground parts for medicinal use.
Rastlina se goji in nabira ob cvetenju za pridobivanje nadzemnih delov za medicinsko uporabo.
California poppy EMA/HMPC/334023/2015
Zel kalifornijskega zlatega maka EMA/HMPC/334023/2015
California poppy is the common name for the above-ground parts of the plant Eschscholzia californica Cham.
Zel kalifornijskega zlatega maka je splošno ime za nadzemne dele rastline Eschscholzia californica Cham.
California poppy preparations should only be used in adults.
Pripravki iz zeli kalifornijskega zlatega maka se smejo uporabljati samo pri odraslih.
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.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
This summary is not intended to provide practical advice on how to use medicines containing California poppy.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel kalifornijskega zlatega maka.
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.
Odbor HMPC je zaključil, da se na podlagi njegove dolgotrajne uporabe zel kalifornijskega zlatega maka lahko uporablja za lajšanje blagih simptomov stresa in za pomoč pri spanju.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of California poppy.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli zlatega kalifornijskega maka.
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.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
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.
Dodatne informacije o oceni zdravil, ki vsebujejo zel kalifornijskega zlatega maka, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
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'.
Zaključki odbora HMPC glede uporabe zdravil, ki vsebujejo zel kalifornijskega zlatega maka, za lajšanje blagih simptomov stresa in kot pomoč pri spanju temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing California poppy.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel kalifornijskega zlatega maka.