FrancophonIA/ELRC3.0 huggingface dataset:
English: For the indication “prophylaxis of migraine headache”, two publications describe a double-blind, active, not placebo-controlled study on the effect of dihydroergocryptine (dihydroergotoxine is composed of a third of dihydroergocryptine) as compared to propranolol and flunarizine.
Croatian: Za indikaciju „profilaksa migrenske glavobolje”, dvije su publikacije opisale dvostruko slijepo, aktivno ispitivanje o djelovanju dihidroergokriptina koje nije bilo kontrolirano placebom (dihidroergotoksin je spoj koji sadrži trećinu dihidroergokriptina).
English: The CHMP considered that, although the risk of fibrotic reactions and ergotism associated with dihydroergotoxine is rare, it is established and these are severe adverse events with a possible fatal outcome.
Croatian: Mišljenje je CHMP-a da, iako je rizik od fibrotičkih reakcija i ergotizma povezan s dihidroergotoksinom rijedak, isti je utvrđen i ovo su ozbiljne nuspojave s mogućim smrtnim ishodom.
English: Overall, the CHMP reiterated that the risk minimisation measures proposed by the MAH are not considered by the Committee to effectively reduce the risk of fibrotic reactions and ergotism.
Croatian: Općenito gledano, CHMP je ponovio da Povjerenstvo ne smatra učinkovitima mjere smanjivanja rizika koje predlaže nositelj odobrenja s obzirom na smanjivanje rizika od fibrotičkih reakcija i ergotizma.
English: Overall summary of the scientific evaluation of dihydroergotoxine containing medicinal products (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijekova koji sadrže dihidroergotoksin (vidjeti Dodatak I)
English: The CHMP considered the MAHs proposals for risk minimisation measures.
Croatian: CHMP je razmotrio prijedloge nositelja odobrenja za mjere smanjenja rizika.
English: However, the presented studies assessed oral dihydroergotoxine in very heterogeneous vein diseases: peripheral and cerebrovascular insufficiency, chronic varicose eczema, ulcus cruris, varicose veins, venous insufficiency, cerebral vascular lesions, thrombophlebitis of the superficial veins, post-thrombophlebitis syndromes.
Croatian: No, dostavljena ispitivanja procijenila su oralni dihidroergotoksin u vrlo heterogenih venskih bolesti: perifernoj i cerebrovaskularnoj insuficijenciji, kroničnom varikoznom ekcemu, vrijedu potkoljenice, varikoznim venama, venskoj insuficijenciji, cerebralno-vaskularnim lezijama, tromboflebitisu površinskih vena, sindromima nakon tromboflebitisa.
English: In addition, a scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: U prosincu 2012. na zahtjev CHMP-a sazvana je znanstvena savjetodavna skupina (SAG) u okviru koje su stručnjaci, na temelju svog kliničkog iskustva, raspravljali o ulozi ove tvari u simptomatskom liječenju kroničnog patološkog, kognitivnog i neurosenzorskog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge vrste demencija).
English: The two comparative studies described by the MAH (Orma, 1958 and Vannas, 1958) were of poor methodological quality; moreover no information is available about the exact design or randomisation in the different groups tested.
Croatian: Dva komparativna ispitivanja, koja su opisali nositelji odobrenja (Orma, 1958. i Vannas, 1958.), bila su slabe metodološke kvalitete.
English: The CHMP noted that the incidence of adverse events (i.e. retroperitoneal fibrosis, pulmonary fibrosis, cardiac valvulopathy, ergotism) reported by the MAH with dihydroergotoxine is low.
Croatian: CHMP je napomenuo da je incidencija nuspojava kod primjene dihidroergotoksina (primjerice retroperitonelna fibroza, pulmonalna fibroza, srčana valvulopatija, ergotizam) koje su prijavili nositelji odobrenja niska.
English: Therefore, the CHMP maintained its opinion of 27 June 2013 and therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Croatian: Direktive 2001/83/EZ, CHMP preporučuje:
English: On the efficacy side for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, data were presented by the MAH by sub-areas of the cognitive function diseases: cerebrovascular impairment with arteriosclerosis, cerebrovascular insufficiency and stroke; and other causes with elderly/senile impairment, primary or not otherwise specified impairment, and organic brain syndrome.
Croatian: S obzirom na djelotvornost za indikaciju „simptomatsko liječenje kroničnog patološkog, kognitivnog i neurosenzornog oštećenja u starijih (isključujući Alzheimerovu bolest i druge demencije)”, nositelji odobrenja su dostavili podatke prema potpodručjima bolesti kognitivnih funkcija: cerebrovaskularno oštećenje s arteriosklerozom, cerebrovaskularna insuficijencija i moždani udar; te ostali uzroci oštećenja u starijih/senilni osoba, primarno oštećenje ili oštećenje koje nije drugdje navedeno te psihoorganski sindrom.
English: − Prophylaxis of migraine headache.
Croatian: − profilaksa migrenske glavobolje
English: The CHMP took note of the risk minimisation measures proposed by the MAH.
Croatian: CHMP je ocijenio mjere smanjivanja rizika koje predlaže nositelj odobrenja.
English: − Is not favourable for prophylaxis of migraine headache.
Croatian: − nije povoljan za profilaksu migrenske glavobolje;
English: The CHMP was therefore of the opinion that no conclusion on the efficacy of dihydroergotoxine as “Adjuvant symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)” or in another indication could be drawn.
Croatian: Stoga je mišljenje CHMP-a da se ne može donijeti zaključak o djelotvornosti dihidroergotoksina u indikaciji „adjuvansno simptomatsko liječenje kroničnog patološkog, kognitivnog i neurosenzornog oštećenja u starijih (isključujući Alzheimerovu bolest i druge demencije)” ili bilo kojoj drugoj indikaciji.
English: The relationship between fibrosis and serotoninergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Croatian: U literaturi je detaljno opisan odnos između fibroze i aktivacije serotoninergičnih receptora, posebice receptora 5HT2B, izazvane derivatima ergota.
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia) and in the latter proposed indication ‘symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia'.
Croatian: − nije povoljan za simptomatsko liječenje kroničnog patološkog kognitivnog i neurosenzornog oštećenja kod starijih (isključujući Alzheimerovu bolest i druge demencije) te u kasnije predloženoj indikaciji „simptomatsko liječenje kognitivnog oštećenja u starijih, isključujući Alzheimerovu bolest i druge demencije”;
English: The scope of the re-examination focused on the re-evaluation of the benefit-risk balance of dihydroergotoxine in the restricted indication proposed by the MAH which is “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia”.
Croatian: Područje ponovnog pregleda bilo je usredotočeno na ponovnu ocjenu omjera koristi i rizika dihidroergotoksina u ograničenoj indikaciji predloženoj od nositelje odobrenja, a koja glasi „simptomatsko liječenje kognitivnog oštećenja u starijih, isključujući Alzheimerovu bolest i druge demencije”.
English: The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergotoxine in the proposed indication “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia” is very limited.
Croatian: Povjerenstvo je mišljenja da je dokaz klinički značajne djelotvornosti dihidroergotoksina u predloženoj indikaciji „simptomatsko liječenje kognitivnog oštećenja u starijih, isključujući Alzheimerovu bolest i druge demencije” vrlo skroman.
English: • Symptomatic treatment of veno-lymphatic insufficiency
Croatian: • simptomatsko liječenje venolimfatičke insuficijencije
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: • simptomatsko liječenje kroničnog patološkog kognitivnog poremećaja i neurosenzornog poremećaja u starijih (isključujući Alzheimerovu bolest i druge demencije)
English: During the review, the MAH has suggested to restrict the indication to ‘symptomatic treatment of chronic cognitive impairment in elderly (excluding Alzheimer's disease and other dementia)'.
Croatian: Tijekom postupka pregleda, nositelj odobrenja predložio je ograničavanje indikacije tako da ista glasi „simptomatsko liječenje kroničnog kognitivnog oštećenja u starijih (isključujući Alzheimerovu bolest i druge demencije)”.
English: The Committee concluded that the benefit-risk balance of dihydroergotoxine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of Raynaud's syndrome, for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, for prophylaxis of migraine headache and for symptomatic treatment of veno-lymphatic insufficiency.
Croatian: Direktive 2001/83/EZ za simptomatsko liječenje kroničnog, patološkog kognitivnog i neurosenzorskog oštećenja u starijih (isključujući Alzheimerovu bolest i druge demencije), za pomoćno liječenje Raynaudova sindroma, za pomoćno liječenje smanjenja oštrine vida i poremećaja vidnog polja koji su vaskularnog porijekla, za profilaksu migrenske glavobolje i za simptomatsko liječenje venolimfatičke insuficijencije.
English: Grounds for the suspension/variation to the terms of the marketing authorisations
Croatian: Razlozi za izmjenu/suspenziju uvjeta odobrenja za stavljanje lijeka u promet Budući da:
English: − Is not favourable for symptomatic treatment of veno-lymphatic insufficiency.
Croatian: − nije povoljan za simptomatsko liječenje venolimfatičke insuficijencije.
English: − Symptomatic treatment of veno-lymphatic insufficiency.
Croatian: − simptomatsko liječenje venolimfatičke insuficijencije;
English: − Is not favourable for ancillary treatment of Raynaud's syndrome.
Croatian: − nije povoljan za pomoćno liječenje Raynaudova sindroma;
English: − Ancillary treatment of Raynaud's syndrome.
Croatian: − pomoćno liječenje Raynaudovog sindroma
English: Consequently, it was not possible for the CHMP to draw scientific conclusions regarding the benefit of dihydroergotoxine in peripheral vascular disease based on these study results and subsequently no conclusions could be drawn for the ancillary treatment of Raynaud's syndrome.
Croatian: Stoga CHMP nije mogao donijeti zaključke u vezi s koristi dihidroergotoksina u pomoćnom liječenju Raynaudova sindroma.
English: • The suspension of the marketing authorisation for dihydroergotoxine containing medicinal products referred to in Annex I if no other indications are approved as part of their marketing authorisation.
Croatian: • suspenziju odobrenja za stavljanje lijeka u promet za lijekove koji sadrže dihidroergotoksin navedenih u Dodatku
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Croatian: • pomoćno liječenje smanjenja oštrine vida i poremećaja vidnog polja koji su vaskularnog podrijetla
English: − Is not favourable for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Croatian: − nije povoljan za pomoćno liječenje smanjenja oštrine vida i poremećaja vidnog polja koji su vaskularnog podrijetla;
English: For the indication “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin”, seven clinical studies have been submitted.
Croatian: Dostavljeno je sedam kliničkih ispitivanja za indikaciju „pomoćno liječenje smanjenja oštrine vida i poremećaja vidnog polja koji su vaskularnog podrijetla”.
English: Dihydroergotoxine modulates synaptic neurotransmitter levels and increases blood flow to the brain; at one time, it was believed that the latter mechanism was the primary mode of action by which dihydroergotoxine exerts clinical effects.
Croatian: Dihidroergotoksin modulira razine sinaptičkih neurotransmitera i povećava dotok krvi u mozak.
English: With the current patient evaluation tools, the distinction between mild or moderate cognitive impairment and early stage of Alzheimer or of other dementia is difficult.
Croatian: Vrlo je teško napraviti distinkciju između blagog ili umjerenog kognitivnog oštećenja i rane faze Alzheimerove bolesti ili drugih oblika demencije koristeći se aktualnim alatima za evaluaciju bolesnika.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Croatian: − pomoćno liječenje smanjenja oštrine vida i poremećaja vidnog polja koji su vaskularnog podrijetla
English: Thus, the Committee concluded that the benefit-risk balance of dihydroergotoxine containing products in “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia” is not favourable.
Croatian: Stoga je Povjerenstvo zaključilo da omjer koristi i rizika lijekova koji sadrže dihidroergotoksin nije povoljan u indikaciji „simptomatsko liječenje kognitivnog oštećenja u starijih, isključujući Alzheimerovu bolest i druge demencije”.
English: Herbal medicines containing comminuted woody nightshade stem are usually available for soaking in water (infusion or decoction) to produce a liquid to be applied to the skin.
Croatian: Biljni lijekovi koji sadrže usitnjene paskvičine peteljke obično su dostupni za namakanje u vodi (infuz ili dekokt) kako bi se proizvela tekućina za nanošenje na kožu.
English: Woody nightshade stem preparations are obtained by comminuting (reducing into tiny pieces) the stems of two- to three-year old plants, harvested in spring before the leaves develop, or in late autumn after the leaves have dropped.
Croatian: Pripravci paskvičinih peteljki dobivaju se usitnjavanjem peteljki dvogodišnjih ili trogodišnjih biljaka ubranih u proljeće prije nego što izrastu listovi ili u kasnu jesen nakon što otpadnu listovi.
English: The HMPC conclusions on the use of woody nightshade stem medicines for mild eczema are based on their ‘traditional use' in this condition.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže paskvičine peteljke za blagi ekcem temelje se na njihovoj "tradicionalnoj uporabi" u ovom stanju.
English: The HMPC concluded that, on the basis of its long-standing use, woody nightshade stem can be used for the relief of the symptoms of repeated episodes of mild eczema (itchy, red rash).
Croatian: HMPC je zaključio da se, na temelju njihove dugogodišnje uporabe, paskvičine peteljke mogu koristiti za ublažavanje simptoma ponovljenih epizoda blagog ekcema (crvenog osipa koji svrbi).
English: Any applications for the licensing of medicines containing woody nightshade stem 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 paskvičine peteljke moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the HMPC assessment of woody nightshade stem 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 paskvičine peteljke uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with woody nightshade stem 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 paskvičine peteljke, 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: This summary is not intended to provide practical advice on how to use medicines containing woody nightshade stem.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže stabljiku paskvice.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing woody nightshade stem.
Croatian: Države članice Europske unije uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže paskvičine peteljke.
English: The HMPC took into account the well documented use of woody nightshade stem for this indication.
Croatian: HMPC je uzeo u obzir i dobro dokumentiranu uporabu paskvičinih peteljki za ovu indikaciju.
English: Information on the use and licensing of woody nightshade stem medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju za lijekove koji sadrže paskvičine peteljke u državama članicama Europske unije mogu se dobiti od nadležnih nacionalnih tijela.
English: Woody nightshade stem should only be used in adults and should not be used if symptoms last for longer than two weeks without seeking advice from a qualified healthcare practitioner.
Croatian: Paskvičine peteljke smiju se koristiti samo u odraslih osoba, te se ne smiju koristiti bez savjeta kvalificiranog zdravstvenog djelatnika ako simptomi traju dulje od dva tjedna. paskvičine peteljke mogu biti štetne ako se uzimaju kroz usta, te takva uporaba nije obuhvaćena zaključcima Povjerenstva.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of woody nightshade stem.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstvo za biljne lijekove (HMPC) u pogledu medicinske uporabe paskvičinih peteljki.
English: Detailed instruction on how to use woody nightshade stem medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o tome kako koristiti lijekove koji sadrže paskvičine peteljke i tko ih može koristiti dostupne su u uputi o lijeku koja je priložena uz lijek.
English: For practical information about using woody nightshade stem medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže stabljiku paskvice bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: For more information about treatment with woody nightshade stem medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže paskvičine peteljke pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with woody nightshade stem medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže paskvičine peteljke?
English: Woody nightshade stem is the common name for the stems of the plant Solanum dulcamara L. The plant is cultivated or gathered to obtain the stems for medicinal use.
Croatian: Paskvičine peteljke su uobičajeni naziv za peteljke biljke Solanum dulcamara L.
English: What is woody nightshade stem?
Croatian: Što su paskvičine peteljke?
English: What evidence supports the use of woody nightshade stem medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže paskvičine peteljke?
English: Other information about woody nightshade stem medicines
Croatian: Ostale informacije o lijekovima koji sadrže paskvičine peteljke
English: How are woody nightshade stem medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže paskvičine peteljke?
English: Committee on Herbal Medicinal Products (HMPC)
Croatian: EMA/HMPC/261736/2012 Povjerenstvo za biljne lijekove (HMPC)
English: It is infused over 30 minutes.
Croatian: Primjenjuje se davanjem infuzije tijekom 30 minuta.
English: The full EPAR for Invanz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Invanz nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is used in adults and children aged over 3 months to treat the following infections:
Croatian: Primjenjuje se u odraslih osoba i djece starije od tri mjeseca za liječenje sljedećih infekcija:
English: Invanz is an antibiotic.
Croatian: Invanz je antibiotik.
English: For younger patients (3 months to 12 years), a dose of 15 mg per kilogram body weight is given twice a day, up to a total of 1 g per day.
Croatian: U mlađih bolesnika (tri mjeseca do 12 godina) primjenjuje se doza od 15 mg po kilogramu tjelesne težine dvaput dnevno, u ukupnoj količini od najviše 1 g dnevno.
English: What measures are being taken to ensure the safe and effective use of Invanz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Invanz?
English: Invanz is given at a dose of 1 g once a day in adults and adolescents.
Croatian: Lijek Invanz primjenjuje se u dozi od 1 g jednom dnevno u odraslih osoba i adolescenata.
English: Why is Invanz approved?
Croatian: Zašto je Invanz odobren?
English: This is a summary of the European public assessment report (EPAR) for Invanz.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Invanz.
English: Invanz also has an effect on some blood tests.
Croatian: Lijek Invanz također utječe na određene krvne pretrage.
English: The studies examined if the infection was cured after 7 to 28 days of treatment, depending on the type of infection.
Croatian: U ispitivanjima se istraživalo je li infekcija izliječena nakon 7 do 28 dana liječenja, ovisno o vrsti infekcije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invanz on 18 April 2002.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Invanz u promet koje vrijedi na prostoru Europske unije od 18. travnja 2002.
English: Treatment with Invanz lasts between 3 and 14 days, depending on the type and the severity of the infection.
Croatian: Liječenje lijekom Invanz traje između 3 i 14 dana, ovisno o vrsti i težini infekcije.
English: What is Invanz and what is it used for?
Croatian: Što je Invanz i za što se koristi?
English: Treatment of infections
Croatian: Liječenje infekcija
English: • gynaecological infections;
Croatian: • ginekoloških infekcija;
English: For preventing infection after colorectal surgery in adults, a single dose of Invanz is given within 1 hour before the operation.
Croatian: Za sprečavanje infekcije nakon kolorektalnog kirurškog zahvata u odraslih osoba primjenjuje se jednokratna doza lijeka Invanz jedan sat prije operacije.
English: It attaches to certain proteins on the bacteria cells.
Croatian: Ertapenem se veže za određene proteine na bakterijskim stanicama.