FrancophonIA/ELRC3.0 huggingface dataset:
English: Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 4 weeks and may decrease dung fly abundance during that period.
Croatian: Nakon liječenja goveda ovim VMP-om, moguće je izlučivanje razina moksidektina koje su potencijalno toksične za vrstu jesenja kućna muha tijekom razdoblja od više od četiri tjedna te je moguće smanjenje zastupljenosti jesenje kućne muhe u tom razdoblju.
English: Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 2 weeks and may decrease dung fly abundance during that period.
Croatian: Nakon liječenja goveda ovim VMP-om, moguće je izlučivanje razina moksidektina koje su potencijalno toksične za vrstu jesenja kućna muha tijekom razdoblja od više od dva tjedna te je moguće smanjenje zastupljenosti jesenje kućne muhe u tom razdoblju.
English: Sweden Continental Farmaceutica Rue Laid Burniat 1,
Croatian: Norveška Continental Farmaceutica Rue Laid Burniat 1,
English: CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link OECD guideline for the testing of chemicals no. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link OECD guideline for the testing of chemicals no. 202: Daphnia sp.
Croatian: 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link 6 OECD guideline for the testing of chemicals no.
English: Belgium Continental Farmaceutica Rue Laid Burniat 1,
Croatian: Nizozemska Continental Farmaceutica Rue Laid Burniat 1,
English: Dung flies were shown to be the most sensitive species as demonstrated in laboratory tests and in field studies.
Croatian: U laboratorijskim i terenskim ispitivanjima dokazano je da su jesenje kućne muhe najosjetljivija vrsta.
English: Whereas
Croatian: A.
English: EQUEST GEL ORALE Moxidectin Oral gel
Croatian: EQUEST GEL ORALE Moksidektin Oralni gel
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja EU/1/13/831/001
English: Pack size
Croatian: Kapecitabin SUN Kapecitabin SUN
English: Moreover, the intended use does not require medical supervision.
Croatian: Nadalje, predviđena uporaba ne zahtjeva medicinski nadzor.
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, iako nema dovoljno dokaza dostupnih iz kliničkih ispitivanja, djelotvornost ovih biljnih lijekova je vjerodostojna i postoji dokaz da se sigurno koriste na taj način barem 30 godina (uključujući posljednjih 15 godina na području EU-a).
English: • in patients with a temporary loss of appetite.
Croatian: • u bolesnika s privremenim gubitkom apetita.
English: White horehound should only be used in adults and adolescents aged over 12 years.
Croatian: Maruljinu zelen treba primjenjivati samo u odraslih osoba i adolescenata starijih od 12 godina.
English: • for treating mild dyspepsia symptoms, such as bloating and flatulence;
Croatian: • za liječenje blagih simptoma dispepsije, poput napuhavanja i nadimanja;
English: Marrubium vulgare L., herba
Croatian: Marrubium vulgare L., zelen
English: If symptoms of cough persist for longer than one week, patients should consult a qualified healthcare practitioner.
Croatian: Ako se simptomi kašlja nastave dulje od tjedan dana, bolesnik se mora obratiti kvalificiranom zdravstvenom djelatniku.
English: • as an expectorant (a medicine to help bring up phlegm) in patients with cough associated with a cold;
Croatian: • kao ekspektorans (lijek koji pomaže pri izbacivanju sluzi) u bolesnika s kašljem povezanim s prehladom;
English: For dyspepsia and loss of appetite, patients are advised to consult healthcare practitioner if symptoms last longer than two weeks.
Croatian: U slučaju dispepsije i gubitka apetita, bolesnicima se savjetuje da se obrate zdravstvenom djelatniku ako simptomi potraju dulje od dva tjedna.
English: In addition, there were published experimental studies suggesting a number of properties that could plausibly help in patients with mild dyspepsia.
Croatian: Također objavljena su eksperimentalna ispitivanja koja upućuju na brojna svojstva za koja se opravdano vjeruje da bi mogla pomoći bolesnicima s blagom dispepsijom.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Croatian: U trenutku ocjene od strane HMPC-a, za ovaj lijek nije bilo prijavljenih nuspojava.
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Croatian: Za podrobnije informacije o studijama koje je HPMC ocijenio pogledajte izvješće HMPC-a o ocjeni.
English: White horehound EMA/HMPC/446032/2013
Croatian: Maruljina zelen EMA/HMPC/446032/2013
English: The HMPC conclusions on the use of white horehound medicines in patients with cough, dyspepsia symptoms and loss of appetite are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže maruljinu zelen u pacijenata koji imaju kašalj, simptome dispepsije i gubitak apetita temelje se na njihovoj „tradicionalnoj uporabi”.
English: The HMPC concluded that, on the basis of its long-standing use, white horehound can be used in the following ways:
Croatian: HMPC je zaključio da se, na temelju dugotrajne uporabe, maruljina zelen može koristiti na sljedeće načine:
English: What is white horehound?
Croatian: Što je maruljina zelen?
English: This summary is not intended to provide practical advice on how to use medicines containing white horehound.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže maruljinu zelen.
English: The HMPC noted that the bitter substances and essential oils the medicine contains may stimulate appetite and secretions from the lining of the airways.
Croatian: HMPC je napomenuo da gorke tvari i eterična ulja koja lijek sadrži mogu stimulirati apetit i sluzi iz sluznice zračnih putova.
English: In its assessment the HMPC considered the well documented and longstanding use of white horehound in the approved indications.
Croatian: U svojoj ocjeni HMPC je uzeo u obzir dobro dokumentiranu i dugotrajnu primjenu maruljine zeleni za odobrene indikacije.
English: White horehound preparations are obtained by comminuting (reducing into tiny pieces) or powdering the above-ground parts of the plant, by making a liquid extract or pressing the juice from the plant.
Croatian: Pripravci maruljine zeleni dobivaju se drobljenjem (usitnjavanjem) ili mljevenjem u prašak dijelova biljke koji se nalaze iznad tla ili pripremanjem tekućeg ekstrakta ili istiskivanjem soka iz biljke.
English: Information on the use and licensing of white horehound medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže maruljinu zelen u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: Further information on the HMPC assessment of white horehound 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 procjeni lijekova koji sadrže maruljinu zelen, uključujući pojedinosti zaključaka Odbora, nalaze se 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 white horehound 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 maruljinu zelen, uključujući odgovarajuće mjere opreza za sigurnu uporabu, nalazi se u dokumentu u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing white horehound 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 maruljinu zelen moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: EMA/HMPC/446032/2013
Croatian: EMA/HMPC/446032/2013 Odbor za biljne lijekove (HMPC)
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of white horehound.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Odbora za biljne lijekove (HMPC) u pogledu medicinske uporabe maruljine zeleni.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing white horehound.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže maruljinu zelen.
English: Other information about white horehound medicines
Croatian: Ostale informacije o lijekovima koji sadrže maruljinu zelen
English: White horehound can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Maruljina zelen je dostupna i u kombinaciji s drugim biljnim tvarima u pojedinim biljnim lijekovima.
English: What are the risks associated with white horehound medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže maruljinu zelen?
English: Herbal medicines containing white horehound are usually available in a comminuted form for herbal tea, or in solid or liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže maruljinu zelen najčešće su dostupni u usitnjenom obliku za pripremu biljnoga čaja te u krutom ili tekućem stanju za peroralnu primjenu.
English: White horehound
Croatian: Maruljina zelen
English: What evidence supports the use of white horehound medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže maruljinu zelen?
English: For more information about treatment with white horehound medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže maruljinu zelen pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using white horehound 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 maruljinu zelen bolesnici moraju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: How are white horehound medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže maruljinu zelen?
English: Detailed instruction on how to take white horehound medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Za podrobnije informacije o načinu uporabe lijekova koji sadrže maruljinu zelen kao i tome tko ih smije koristiti pogledajte uputu o lijeku priloženu uz lijek.
English: White horehound is the common name for the plant Marrubium vulgare L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Croatian: Maruljina zelen je uobičajen naziv za Marrubium vulgare L.
English: These paragraphs were not included in the CSP.
Croatian: Ovi paragrafi nisu uključeni u CSP.
English: This was supported since it is of interest in the states where both formulations are used.
Croatian: Ovo je podržano s obzirom da je to u interesu država, u kojima se koriste obje formulacije.
English: At the time of submission, patients of 17 years of age maximum qualified as “children”.
Croatian: U trenutku podnošenja, bolesnici u dobi od maksimalno 17 godina kvalificirani su kao „djeca“.
English: Recommendation
Croatian: Preporuka
English: Furthermore, not all indications are approved in each country.
Croatian: Nadalje, sve indikacije nisu odobrene u svakoj državi.
English: Not all strengths and pharmaceutical forms are registered in each country.
Croatian: Sve jačine i farmaceutski oblici nisu registrirani u svakoj državi.
English: • Clinical aspects
Croatian: • Klinički aspekti
English: The promising benefit was offset by the renal dysfunction and hypertension.
Croatian: Obećavajuća korist bila je nadoknada renalne disfunkcije i hipertenzije.
English: The administration started within 2-20 hours prior to surgery.
Croatian: Primjena lijeka započeta je unutar 2-20 sati prije kirurškog zahvata.
English: The MAH proposed two different wordings for each of the paragraphs on transplantation:
Croatian: Nositelj odobrenja predložio je dvije različite formulacije za svaki paragraf o transplantaciji:
English: Although the proposed text was already approved in the majority of EU countries, the CHMP is of the opinion that some structural modification of the text was needed.
Croatian: Iako je predloženi tekst već odobren u većini država EU, mišljenje je CHMP-a da su potrebne određene strukturalne modifikacije teksta.
English: Section 4.5 - Interaction with Other Medicinal Products and Other Forms of Interaction
Croatian: Dio 4.5 - Interakcije s drugim lijekovima i drugi oblici interakcija
English: 15 EU countries already have exactly the proposed label and in those which do not, the deviations are not considered large.
Croatian: 15 država EU već ima točno predložene naljepnice, a devijacije se ne mogu smatrati velikima u slučaju onih koje nemaju.
English: Sections 4.3 to 4.9 - from “Contraindications” to “Overdose”
Croatian: Dijelovi 4.3 do 4.9 - od „Kontraindikacija“ do „Predoziranja“
English: Pediatric data from controlled and uncontrolled studies were also provided.
Croatian: Dostavljeni su i pedijatrijski podaci iz kontroliranih i nekontroliranih ispitivanja.
English: Posology:
Croatian: Doziranje:
English: • Rheumatoid arthritis (RA)
Croatian: • Reumatoidni artritis (RA)
English: European controlled double-blind trials used 5 mg/kg/d that allowed a downward titration to find the maximum tolerated dose.
Croatian: Europska kontrolirana dvostruka slijepa istraživanja koristila su 5 mg/kg/d što je omogućilo silaznu titraciju da bi se utvrdila maksimalna podnošljiva doza.
English: • Psoriasis
Croatian: • Psorijaza
English: • Endogenous uveitis
Croatian: • Endogeni uveitis
English: Renal dysfunction above the critical threshold, defined as creatinine increased by 3050% over baseline, was less of a problem when starting with a dose of 2.5 mg/kg/day.
Croatian: Renalna disfunkcija preko kritičnoga praga, definirana kao kreatinin povećan za 30-50% u odnosu na osnovnu vrijednost, bila je manji problem prilikom početne doze od 2.5 mg/kg/dnevno.
English: Given the fact that a harmonized label was agreed among the EU community in February 2011 through the PSUR 13 WS procedure, the MAH's position was to use the agreed CSP entirely (i.e. without any further changes).
Croatian: S obzirom na činjenicu da je usklađena naljepnica dogovorena unutar Europske zajednice u veljači 2011. godine putem postupka PSUR 13 WS, stav nositelja odobrenja je da upotrijebi usuglašeni CSP u cijelosti (odnosno bez daljnjih izmjena).
English: Section 4.7 - Effects on Ability to Drive and Use Machines
Croatian: Dio 4.7 - Učinak na sposobnost upravljanja vozilima i rada sa strojevima
English: The CHMP also raised questions regarding the risk of aggravation of the neurological manifestations of Behcet's disease by Ciclosporin.
Croatian: CHMP je također postavio pitanje u vezi s rizikom od pogoršanja neurološke manifestacije Behçetove bolesti povezanim s uzimanjem ciklosporina.
English: The review of the original Sandimmun Dossiers from major markets such as France, the U.S. and UK which contains the clinical results from a total of 15 global studies has been performed.
Croatian: Proveden je pregled izvornih dosjea lijeka Sandimmun za veća tržišta, poput Francuske, SAD-a i Ujedinjenog Kraljevstva, koji sadrže kliničke rezultate ukupno 15 globalnih ispitivanja.
English: Subsequent, studies using lower doses showed a better risk-benefit ratio.
Croatian: Naknadno, ispitivanja koja su koristila manje doze pokazala su bolji omjer koristi i rizika.
English: However the CHMP considers that data of use in children in nephrotic syndrome should be included under the heading Paediatric population.
Croatian: No, CHMP smatra da se podaci za primjenu u djece s nefrotskim sindromom trebaju uvrstiti pod naslovom Pedijatrijska populacija.
English: The CHMP agreed that general information applicable to all these indications was relevant to include.
Croatian: CHMP složio se da je bitno uključiti opće informacije primjenjive na sve ove indikacije.
English: Seven trials were conducted for the prevention of graft-versus host disease (GVHD), one trial for the treatment of acute GVHD.
Croatian: Sedam ispitivanja provedeno je za prevenciju bolesti presatka protiv primatelja (GVHD), te jedno ispitivanje za liječenje akutnog GVHD-a.
English: Section 4.6 - Pregnancy and Lactation
Croatian: Dio 4.6 - Trudnoća i dojenje
English: The MAH presented respectively the clinical efficacy outcome of the US and Canada studies and then the European studies.
Croatian: Nositelj odobrenja predstavio je ishod kliničke djelotvornosti američkih i kanadskih ispitivanja, te zatim europskih ispitivanja.
English: Since not all countries have such a text included in their national labels and in some countries only Sandimmun Neoral is available, the MAH recommended shortening the proposed text.
Croatian: S obzirom da sve države nisu uključile takav tekst u svoje nacionalne naljepnice, te je u pojedinim državama dostupan samo lijek Sandimmun Neoral, nositelj odobrenja preporučio je skraćivanje predloženog teksta.
English: The control groups were either using placebo, or azathioprine, or D-penicillamine.
Croatian: Kontrolne su grupe koristile placebo, azatioprin ili D-penicilamin.
English: • Nephrotic syndrome (NS)
Croatian: • Nefrotski sindrom (NS)
English: The indication aplastic anemia is only approved in France.
Croatian: Indikacija aplastične anemije odobrena je samo u Francuskoj.
English: Sandimmun Neoral is a microemulsified formulation of ciclosporin.
Croatian: Sandimmun Neoral je mikroemulziona formulacija ciklosporina.
English: As stated above, the MAH proposed a following wording for the above-mentioned paragraph based on the wordings used in the CDS and CSP.
Croatian: Kako je prethodno navedeno, nositelj odobrenja predložio je sljedeću formulaciju za prethodno navedeni paragraf na temelju formulacije korištene u CDS-u i CSP-u.
English: Based on the most commonly approved wording in EU member states and the recent version of the company core data sheet (CDS) dated 13 February 2012, the MAH proposed a wording which is already approved in 13 EU MS.
Croatian: Na temelju najčešće odobrenog teksta u državama članicama EU i posljednje verzije Liste ključnih podataka pravne osobe (CDS) od dana 13. veljače 2012. godine, nositelj odobrenja predložio je formulaciju koja je odobrena već u 13 država članica EU.
English: The MAH proposed a wording that was approved in between 18 an 24 MS, depending on subsections.
Croatian: Nositelj odobrenja predložio je formulaciju koju je odobrilo između 18 i 24 država članica, ovisno o poddijelovima.
English: The MAH agreed with the CHMP that no specific organ transplantations should be mentioned in section 4.1 unless not appropriate to use.
Croatian: Nositelj odobrenja suglasan je sa CHMP-om da nije potrebno navoditi transplantacije specifičnih organa u djelu 4.1, osim ako isti nije primjeren za uporabu.
English: • Atopic dermatitis
Croatian: • Atopički dermatitis
English: As an outcome of this full review, both CDSs were finalized with a release date of 13 February 2012.
Croatian: Ishod ovog pregleda je bio da su oba CDS-a završena i izdana dana 13. veljače 2012. godine.
English: However concerning HMG CoA reductase inhibitors (statins), the CHMP agreed that a strict contraindication may not be warranted, however, information in section 4.4 should be strengthened.
Croatian: No, u vezi s inhibitorima HMG-CoA reduktaze (statina), CHMP je suglasan da se stroge kontraindikacije ne mogu jamčiti, no, informacije u dijelu 4.4 moraju se postrožiti.
English: The CHMP is of the view that the indication should be limited to primary glomerulonephritis cases as specified above.
Croatian: Mišljenje je CHMP-a da se indikacija mora ograničiti na slučajeve primarnog glomerulonefritisa, kako je prethodno navedeno.
English: Moreover, recent trials have confirmed the benefit of Sandimmun Neoral in different forms of nephrotic syndrome in children and adults.
Croatian: Nadalje, posljednja su istraživanja potvrdila koristi lijeka Sandimmun Neoral u slučaju različitih oblika nefrotskog sindroma u djece i odraslih.
English: In the following, the entire section 4.2 is reviewed, sub-section by sub-section.
Croatian: U niže navedenom tekstu pregledan je cijeli dio 4.2, poddio po poddio.
English: The CHMP therefore requested the MAH to justify the positive benefit risk for all nephrotic conditions except the primary minimal change glomerulonephritis, primary focal segmental glomerulosclerosis, or primary membranous glomerulonephritis.
Croatian: Stoga je CHMP zatražio od nositelja odobrenja da opravda pozitivne koristi za sva nefrotska stanja izuzev primarnog minimalno promijenjenog glomerulonefritisa, primarnog fokalnog segmentalnog glomerulosklerozisa ili primarnog membranoznog glomerulonefritisa.
English: Finally in this section, the MAH proposed two additions to this section, under the format of two new sub-sections on Acute and chronic nephrotoxicity and Paediatric population.
Croatian: Naposljetku u ovom poglavlju nositelj odobrenja predložio je dva dodatka u obliku dva nova poddijela o Akutnoj i kroničnoj nefrotoksičnosti i Pedijatrijskoj populaciji.
English: The MAH stated in their response package that the absolute changes may be considered small, but in view of the narrow therapeutic window for ciclosporin, standardised intake in relation to food intake would be preferable to reduce intra-individual variability.
Croatian: Nositelj odobrenja naveo je u svojem paketu odgovora da se apsolutne promjene mogu smatrati malima, no s obzirom na terapijski prozor ciklosporina, standardizirani unos u vezi s unosom hrane bio bi poželjan kako bi se smanjila intraindividualna varijabilnost.
English: In their response the MAH confirmed that the data from these studies as well as extensive clinical experience are supportive of the indication “Prevention of graft rejection” for Ciclosporin.
Croatian: U svojem odgovoru, nositelj odobrenja potvrdio je da podaci ovih ispitivanja kao i opširna klinička iskustva potvrđuju indikaciju „prevencija odbacivanja presatka“ za ciklosporin.
English: In addition, the CHMP considered that substrates for CYP3A4 and/or P-gp and for which elevated plasma levels are associated with serious safety concerns should not be combined with ciclosporin (e.g. dabigatran etexilate, bosentan, aliskiren).
Croatian: Nadalje, CHMP smatra da se supstrati za CYP3A4 i/ili P-glikoprotein, a za koje se povišene razine plazme povezuju s ozbiljnim sigurnosnim problemima, ne smiju kombinirati sa ciklosporinom (odnosno dabigatran eteksilatom, bosentanom, aliskirenom).