FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC conclusions on the use of dittany of Crete herb medicines for cough, stomach, gut and skin problems are based on their ‘traditional use' in these conditions.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže zelen kretskog mravinca za kašalj, probleme sa želucem, crijevima i kožom temelje se na njihovoj „tradicionalnoj uporabi” za ta stanja.
English: Information on the use and licensing of dittany of Crete herb medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže zelen kretskog mravinca u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: Herbal teas containing dittany of Crete should only be used in adults and should not be used for longer than a week for cough, or for longer than two weeks for stomach and gut problems, without seeking advice from a qualified healthcare practitioner.
Croatian: Biljni čajevi koji sadrže zelen kretskog mravinca smiju se koristiti samo u odraslih osoba i ne smiju se koristiti dulje od tjedan dana za kašalj ili dulje od dva tjedna za liječenje želuca i crijeva bez traženja savjeta kvalificiranog zdravstvenog djelatnika.
English: Preparations of the herb are obtained by comminuting (reducing into tiny pieces) the harvested material.
Croatian: Pripravci biljke dobivaju se drobljenjem (usitnjavanjem) skupljenog materijala.
English: EMA/HMPC/441263/2013
Croatian: EMA/HMPC/441263/2013 Odbor za biljne lijekove (HMPC)
English: Any applications for the licensing of medicines containing dittany of Crete herb 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 kretskog mravinca 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 concluded that, on the basis of its long-standing use, dittany of Crete herb can be used as a herbal tea for the relief of cough associated with cold and for mild disorders of the stomach and gut such as a sensation of fullness or digestive problems.
Croatian: HMPC je zaključio da se, na temelju dugotrajne uporabe, zelen kretskog mravinca može koristiti kao biljni čaj za ublažavanje kašlja povezanog s prehladom i za blage poremećaje želuca i crijeva poput osjećaja sitosti ili probavnih problema.
English: Further information on the HMPC assessment of dittany of Crete herb 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 zelen kretskog mravinca, 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: Herbal medicines are usually available as comminuted herbal material that is used to make herbal teas or added to water to produce a liquid (infusion) to be applied to the skin.
Croatian: Biljni lijekovi su najčešće dostupni kao usitnjeni biljni materijal koji se koristi za pripravljanje biljnih čajeva ili se dodaje u vodu kako bi se proizvela tekućina - infuz (oparak) za primjenu na koži.
English: Further information on the risks associated with dittany of Crete herb 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 kretskog mravinca, 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: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dittany of Crete.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže zelen kretskog mravinca.
English: This summary is not intended to provide practical advice on how to use medicines containing dittany of Crete herb.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže zelen kretskog mravinca.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dittany of Crete herb.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Odbora za biljne lijekove (HMPC) u pogledu medicinske uporabe zeleni kretskog mravinca.
English: The infusion can also be used to soak a dressing and applied to the skin for minor skin inflammations and bruises.
Croatian: Oparak se također može koristiti za namakanje zavoja koji se zatim stavlja na kožu kod blažih upala kože i masnica.
English: Detailed instruction on how to use dittany of Crete medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Podrobnije informacije o načinu uporabe lijekova koji sadrže zelen kretskog mravinca kao i o tome tko ih smije koristiti možete pronaći u uputi o lijeku priloženoj uz lijek.
English: What are the risks associated with dittany of Crete herb medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže zelen kretskog mravinca?
English: For more information about treatment with dittany of Crete herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže zelen kretskog mravinca pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using dittany of Crete 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 zelen kretskog mravinca bolesnici moraju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: Dittany of Crete herb is the common name for the flowering above-ground (aerial) parts of Origanum dictamnus L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Croatian: Zelen kretskog mravinca uobičajeni je naziv za cvatuće dijelove biljke Origanum dictamnus L. koji se nalaze iznad zemlje (aerijalno).
English: Other information about dittany of Crete herb medicines
Croatian: Ostale informacije o lijekovima koji sadrže zelen kretskog mravinca
English: What is dittany of Crete herb?
Croatian: Što je zelen kretskog mravinca?
English: What evidence supports the use of dittany of Crete herb medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže zelen kretskog mravinca?
English: Dittany of Crete herb
Croatian: Zelen kretskog mravinca
English: How are dittany of Crete herb medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže zelen kretskog mravinca?
English: 2333 BE Leiden Netherlands
Croatian: 2333 BE Leiden Nizozemska
English: (frequency cannot be estimated from available data)
Croatian: (učestalost se ne može procijeniti iz dostupnih podataka)
English: % Difference [95% CI]
Croatian: % razlike [95% CI]
English: Currently available data are described in section 4.8, 5.1, 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2.
English: The powder will dissolve completely.
Croatian: Prašak će se potpuno otopiti.
English: (breakdown of red blood cells).
Croatian: (raspadanje crvenih krvnih stanica).
English: Your doctor may decide to adjust the dose of these medicines.
Croatian: Liječnik može odlučiti da Vam prilagodi dozu ovih lijekova.
English: Volume (concentration) of reconstituted powder
Croatian: Volumen (koncentracija) rekonstituiranog praška
English: Mycamine with food and drink
Croatian: Mycamine s hranom i pićem
English: The clinical relevance of this finding is not known.
Croatian: Klinička važnost ovog nalaza nije poznata.
English: DO NOT SHAKE.
Croatian: NE TRESTI.
English: Standard infusion (added up to 100 ml)
Croatian: Standardna infuzija (dodana do 100 ml)
English: Experience with Mycamine in patients less than 2 years of age is limited.
Croatian: Iskustvo s Mycamineom u bolesnika mlađih od 2 godine je ograničeno.
English: If you receive more Mycamine than you should
Croatian: Ako primite više Mycaminea nego što ste trebali
English: Possible allergic-like symptoms
Croatian: Mogući simptomi slični alergiji
English: Other medicines and Mycamine
Croatian: Drugi lijekovi i Mycamine
English: >R (Resistant)
Croatian: >R (otporno)
English: Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.
Croatian: Samo osposobljeni zdravstveni radnik koji je ispravno pročitao cijelu uputu može pripremiti ovaj lijek za primjenu.
English: The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority.
Croatian: Donja granica 95% CI bila je iznad unaprijed definirane margine neinferiornosti od -10%, čime se dokazala neinferiornost.
English: For reconstitution instructions see section 6.6.
Croatian: Upute o rekonstituciji vidjeti u dijelu 6.6.
English: Elimination and excretion
Croatian: Eliminacija i izlučivanje
English: The volume of distribution at steady state (Vss) was approximately 18-19 litres.
Croatian: Volumen raspodjele u stanju dinamičke ravnoteže (Vss) bio je približno 18-19 litara.
English: Consideration should be given to official/national guidance on the appropriate use of antifungal agents.
Croatian: Potrebno je razmotriti službene/nacionalne smjernice o pravilnoj primjeni antimikotika.
English: Mycamine must be prepared and given to you by a doctor or another healthcare professional.
Croatian: Mycamine Vam mora pripremiti i primijeniti liječnik ili drugi zdravstveni radnik.
English: The MAH should agree the final content, format and distribution modalities of the Prescriber checklist with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Croatian: Nositelj odobrenja treba dogovoriti konačni sadržaj, format i način raspodjele kontrolne liste za propisivača s nadležnim nacionalnim tijelima svake zemlje članice i osigurati da materijali sadržavaju ključne elemente, kako je opisano ispod.
English: Although the concentrate will foam, every effort should be made to minimise the amount of foam generated.
Croatian: Iako će se koncentrat zapjeniti, potrebno je učiniti sve da količina stvorene pjene bude što manja.
English: As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
Croatian: Budući da se Mycamine daje intravenski (u venu), nisu potrebna ograničenja u uzimanju hrane ili pića.
English: § The paediatric population was not sized to test for non-inferiority.
Croatian: § Pedijatrijska populacija nije bila prikladne veličine za ispitivanje neinferiornosti.
English: The drug is rapidly distributed into tissues.
Croatian: Lijek se brzo raspodjeljuje u tkiva.
English: These findings showed reversibility over a follow-up period of 18 months.
Croatian: Ovi su se nalazi pokazali reverzibilnima tijekom razdoblja praćenja od 18 mjeseci.
English: Contents of the pack and other information What Mycamine contains
Croatian: Sadržaj pakiranja i druge informacije Što Mycamine sadrži
English: Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
Croatian: Malo je bolesnika (1,1%; 0,4% ozbiljne) prekinulo liječenje zbog jetrenog događaja.
English: Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions.
Croatian: Na temelju iskustva iz kliničkih ispitivanja, ukupno je 32,2% bolesnika imalo nuspojave na lijek.
English: Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
Croatian: Izloženost ovim metabolitima je niska i oni ne pridonose ukupnoj djelotvornosti mikafungina.
English: If you are pregnant of breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: No adverse reactions associated with this high dose were noted.
Croatian: Nisu bile opažene nikakve nuspojave povezane s ovako visokom dozom.
English: In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Croatian: U sistemskoj je cirkulaciji mikafungin uglavnom vezan za proteine plazme (> 99%), prvenstveno za albumin.
English: What Mycamine is and what it is used for
Croatian: Što je Mycamine i za što se koristi
English: The concentrate should be used immediately.
Croatian: Koncentrat treba odmah primijeniti.
English: Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Croatian: Astellas Ireland Co., Ltd. Killorglin, County Kerry Irska
English: Insufficient evidence
Croatian: nema dovoljno podataka
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, i ovaj lijek može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: The dose regimen of micafungin depends on the body weight of the patient as given in the following tables:
Croatian: Režim doziranja mikafungina ovisi o tjelesnoj težini bolesnika, kako je prikazano u sljedećim tablicama:
English: If this happens, your doctor may decide to monitor your kidney function more closely.
Croatian: Ako se to dogodi, liječnik može odlučiti da pažljivije prati funkciju Vaših bubrega.
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018
Croatian: Datum posljednje obnove odobrenja: 19. veljače 2018.
English: Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
Croatian: Liječnik će Vam propisati Mycamine u sljedećim okolnostima, kad liječenje nekim drugim pogodnim antimikoticima nije dostupno (vidjeti dio 2):
English: The exposure levels at which these effects did not occur (NOAEL) were in the same range as the clinical exposure or lower.
Croatian: Izloženost pri kojima ovi učinci nisu nastali (NOAEL) bila je u istom rasponu kao i izloženost kod kliničke primjene ili niža.
English: The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies.
Croatian: Najvjerojatniji uzrok ovih razlika bile su različite podležeće bolesti u usporedbi s odraslim ili starijim pedijatrijskim bolesnicima promatranima u kliničkim ispitivanjima.
English: Therapy may be instituted before the results of the cultures and other laboratory studies are known.
Croatian: Terapija se može uvesti prije nego što se dobiju rezultati kultura i drugih laboratorijskih pretraga.
English: The potential risk of developing liver tumours in humans is not known, and your doctor will assess the benefits and risks of Mycamine treatment before starting your medicine.
Croatian: Mogući rizik od razvoja tumora jetre u ljudi nije poznat pa će Vaš liječnik procijeniti koristi i rizike liječenja Mycamineom prije nego što počnete uzimati taj lijek.
English: ‡ Adjusted for neutropenic status; primary endpoint.
Croatian: ‡ Prilagođeno prema neutropenijskom statusu; primarni ishod.
English: Following a single intravenous dose of 14C-micafungin (25 mg) to healthy volunteers, 11.6% of the radioactivity was recovered in the urine and 71.0% in the faeces over 28 days.
Croatian: Nakon jednokratne intravenske doze 14C-mikafungina (25 mg) zdravim dobrovoljcima, 11,6% radioaktivnosti je nađeno u urinu, a 71,0% u stolici tijekom 28 dana.
English: Mycamine is supplied in a box containing 1 vial.
Croatian: Mycamine se isporučuje u kutiji koja sadrži 1 bočicu.
English: Candida species
Croatian: Candida vrste
English: The vial is wrapped with an UV-protective film.
Croatian: Bočica je omotana filmom za zaštitu od UV-zračenja.
English: In case of overdose, general supportive measures and symptomatic treatment should be administered.
Croatian: U slučaju predoziranja potrebno je primijeniti opće potporne mjere i simptomatsko liječenje.
English: The majority were of mild to moderate intensity and not treatment limiting.
Croatian: Većinom su bili blagog do umjerenog intenziteta i nisu ograničavali liječenje.
English: All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Croatian: Sav rekonstituirani koncentrat treba izvući iz pojedine bočice i vratiti u bocu/vrećicu za infuziju iz koje se prvobitno uzela otopina.
English: There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Croatian: Nema dokaza sistemskog nakupljanja kod ponavljane primjene, a stanje dinamičke ravnoteže općenito se postiže u roku od 4 do 5 dana.
English: In addition, only a small number of cases involved these species in the clinical trials.
Croatian: Nadalje, samo je mali broj slučajeva koji su uključivali navedene vrste klinički ispitan.
English: Neutropenia persisted for a median of 13 days.
Croatian: Medijan trajanja neutropenije iznosio je 13 dana.
English: Mycamine is effective in treating systemic infections (those that have penetrated within the body).
Croatian: Mycamine je djelotvoran u liječenju sistemskih infekcija (onih koje su prodrle u tijelo).
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBN(O)A UPOZORENJE(A), AKO JE POTREBNO
English: What Mycamine looks like and contents of the pack
Croatian: Kako Mycamine izgleda i sadržaj pakiranja
English: This means there is insufficient evidence to indicate whether the wild-type population of these pathogens can be considered susceptible to micafungin.
Croatian: To znači da nema dovoljno dokaza koji bi ukazivali na to da je divlji tip populacije ovih patogena osjetljiv na mikafungin.
English: 1,3-β-D-glucan is not present in mammalian cells.
Croatian: 1,3-β-D-glukan nije prisutan u stanicama sisavaca.
English: More rapid infusions may result in more frequent histamine mediated reactions.
Croatian: Brže infuzije mogu dovesti do učestalijih reakcija posredovanih histaminom.
English: Liposomal Amphotericin B
Croatian: Liposomalni amfotericin B
English: - if you are allergic to micafungin, other echinocandins (Ecalta or Cancidas) or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na mikafungin, druge ehinokandine (Ecalta ili Cancidas) ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: However, the difference was not significant and whether it translates into a relevant clinical difference is unknown.
Croatian: Međutim, razlika nije bila značajna i nije poznato može li imati stvarni klinički utjecaj.
English: Older children (12-16 years) had mean clearance values similar to those determined in adult patients.
Croatian: Starija djeca (12-16 godina) imala su srednje vrijednosti klirensa slične onima koje su bile utvrđene u odraslih bolesnika.
English: Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
Croatian: Mikafungin ima niski potencijal za interakcije s lijekovima koji se metaboliziraju putem CYP3A.
English: Gender/Race: Gender and race (Caucasian, Black and Oriental) did not significantly influence the pharmacokinetic parameters of micafungin.
Croatian: Spol/rasa: Spol i rasa (bijelci, crnci i istočnjaci) nisu značajno utjecali na farmakokinetičke parametre mikafungina.
English: Mycamine should be administered once daily by slow intravenous (into a vein) infusion.
Croatian: Mycamine treba primijeniti jedanput na dan sporom intravenskom (u venu) infuzijom.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja pripremljenog lijeka odgovornost su korisnika i ne bi trebali iznositi više od 24 sata na temperaturi od 2 do 8°C, osim kad su rekonstitucija i razrjeđenje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants).
Croatian: Neinferiornost je bila dokazana u odraslih bolesnika, a slični nalazi su dobiveni i za pedijatrijske potpopulacije (uključujući novorođenčad i nedonoščad).
English: The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Croatian: Stopa uspjeha liječenja bila je statistički značajno viša za mikafungin nego za flukonazol (1,6% nasuprot 2,4% probojnih infekcija).
English: During treatment your liver functions will be monitored more closely.
Croatian: Tijekom liječenja pažljivo će se pratiti funkcija Vaše jetre.
English: Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days.
Croatian: Invazivna kandidijaza: Liječenje infekcije Candidom treba trajati najmanje 14 dana.
English: Unchanged micafungin is the principal circulating compound in systemic circulation.
Croatian: Neizmijenjeni mikafungin glavni je cirkulirajući spoj u sistemskoj cirkulaciji.
English: In reproductive and developmental toxicity studies, reduced birth weight of the pups was noted.
Croatian: U ispitivanjima reproduktivne i razvojne toksičnosti zabilježena je smanjena tjelesna težina mladunčadi.
English: The vial should be rotated gently.
Croatian: Bočicu treba nježno okretati.
English: As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Croatian: Kao i na sve antimikrobne lijekove, zabilježeni su slučajevi smanjene osjetljivosti i rezistencije pa se ne može isključiti unakrsna rezistencija s drugim ehinokandinima.
English: Binding to albumin is independent of micafungin concentration (10-100 µg/ml).
Croatian: Vezanje za albumin ne ovisi o koncentraciji mikafungina (10-100 µg/ml).
English: The relevance of the hepatocarcinogenic potential of micafungin for the human therapeutic use is not known.
Croatian: Važnost hepatokancerogenog potencijala mikafungina za terapijsku primjenu u ljudi nije poznata.
English: What Mycamine is and what it is used for What you need to know before you use Mycamine How to use Mycamine
Croatian: Što je Mycamine i za što se koristi Što morate znati prije nego počnete primjenjivati Mycamine Kako primjenjivati Mycamine
English: If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.
Croatian: Ako nastupe takve reakcije, infuziju mikafungina treba prekinuti i primijeniti odgovarajuće liječenje.
English: Information from clinical studies
Croatian: Podaci iz kliničkih ispitivanja
English: Mycamine may cause the following other side effects:
Croatian: Mycamine može prouzročiti i sljedeće nuspojave:
English: Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use, ATC code: J02AX05
Croatian: Farmakoterapijska skupina: antimikotici za sistemsku primjenu, drugi antimikotici za sistemsku primjenu, ATK oznaka: J02AX05