FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.18 mg tablets Pramipexole
Croatian: NAZIV LIJEKA MIRAPEXIN 0,18 mg tablete pramipeksol
English: EU/1/97/051/012 [100 tablets]
Croatian: EU/1/97/051/012 [100 tableta]
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 0,25 mg pramipeksoldiklorid hidrata što odgovara 0,18 mg pramipeksola.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.35 mg tablets Pramipexole
Croatian: NAZIV LIJEKA MIRAPEXIN 0,35 mg tablete pramipeksol
English: Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 3 mg pramipeksoldiklorid hidrata što odgovara 2,1 mg pramipeksola.
English: BATCH NUMBER Lot {number} OTHER
Croatian: 13. BROJ SERIJE Lot {broj}
English: Uncommon may affect up to 1 in 100 people
Croatian: mogu se javiti u do 1 na 100 osoba
English: 4 tablets MIRAPEXIN 0.088 mg
Croatian: 4 tablete MIRAPEXIN 0,088 mg
English: Each prolonged-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 0,75 mg pramipeksoldiklorid hidrata što odgovara 0,52 mg pramipeksola.
English: Each prolonged-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 3.15 mg pramipexole.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 4,5 mg pramipeksoldiklorid hidrata što odgovara 3,15 mg pramipeksola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 1,0 mg pramipeksoldiklorid hidrata što odgovara 0,7 mg pramipeksola.
English: 2 tablets MIRAPEXIN 0.088 mg
Croatian: 2 tablete MIRAPEXIN 0,088 mg
English: The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele, plosnate, okruglog oblika, te imaju otisnutu oznaku (s jedne strane oznaku P6, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: 6 tablets MIRAPEXIN 0.088 mg
Croatian: 6 tableta MIRAPEXIN 0,088 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/016 [10 prolonged-release tablets] EU/1/97/051/017 [30 prolonged-release tablets] EU/1/97/051/018 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/016 [10 tableta s produljenim oslobađanjem] EU/1/97/051/017 [30 tableta s produljenim oslobađanjem] EU/1/97/051/018 [100 tableta s produljenim oslobađanjem]
English: Ascending dose schedule of MIRAPEXIN prolonged-release tablets Week Daily dose (mg of base)
Croatian: Postupak povećanja doze MIRAPEXIN tableta s produljenim oslobađanjem Tjedan
English: MIRAPEXIN 2.1 mg prolonged-release tablets
Croatian: MIRAPEXIN 2,1 mg tablete s produljenim oslobađanjem
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Croatian: Jedna tableta sadrži 0,25 mg pramipeksoldiklorid hidrata, što odgovara 0,18 mg pramipeksola.
English: INFORMATION IN BRAILLE MIRAPEXIN 2.1 mg prolonged-release tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU MIRAPEXIN 2,1 mg tablete s produljenim oslobađanjem
English: EU/1/97/051/002 [100 tablets]
Croatian: EU/1/97/051/002 [100 tableta]
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 0,5 mg pramipeksoldiklorid hidrata što odgovara 0,35 mg pramipeksola.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.7 mg tablets Pramipexole
Croatian: NAZIV LIJEKA MIRAPEXIN 0,7 mg tablete pramipeksol
English: Dyskinesia
Croatian: Doziranje
English: EU/1/97/051/006 [100 tablets]
Croatian: EU/1/97/051/006 [100 tableta]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/025 [10 prolonged-release tablets] EU/1/97/051/026 [30 prolonged-release tablets] EU/1/97/051/027 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/025 [10 tableta s produljenim oslobađanjem] EU/1/97/051/026 [30 tableta s produljenim oslobađanjem] EU/1/97/051/027 [100 tableta s produljenim oslobađanjem]
English: What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.
Croatian: MIRAPEXIN 0,088 mg tablete su bijele, okruglog oblika, plosnate, bez razdjelne crte.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/031 [10 prolonged-release tablets] EU/1/97/051/032 [30 prolonged-release tablets] EU/1/97/051/033 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/031 [10 tableta s produljenim oslobađanjem] EU/1/97/051/032 [30 tableta s produljenim oslobađanjem] EU/1/97/051/033 [100 tableta s produljenim oslobađanjem]
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P1, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, okruglog oblika, ukošenih rubova, te imaju otisnutu oznaku (s jedne strane oznaku P1, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/028 [10 prolonged-release tablets] EU/1/97/051/029 [30 prolonged-release tablets] EU/1/97/051/030 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/028 [10 tableta s produljenim oslobađanjem] EU/1/97/051/029 [30 tableta s produljenim oslobađanjem] EU/1/97/051/030 [100 tableta s produljenim oslobađanjem]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/013 [10 prolonged-release tablets] EU/1/97/051/014 [30 prolonged-release tablets] EU/1/97/051/015 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/013 [10 tableta s produljenim oslobađanjem] EU/1/97/051/014 [30 tableta s produljenim oslobađanjem] EU/1/97/051/015 [100 tableta s produljenim oslobađanjem]
English: Prolonged-release tablet
Croatian: Tableta s produljenim oslobađanjem.
English: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele, plosnate, ovalnog oblika, s razdjelnim urezom na obje strane, te imaju otisnutu oznaku (s jedne strane oznaku P8, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P2, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, okruglog oblika, ukošenih rubova, te imaju otisnutu oznaku (s jedne strane oznaku P2, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/022 [10 prolonged-release tablets] EU/1/97/051/023 [30 prolonged-release tablets] EU/1/97/051/024 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/022 [10 tableta s produljenim oslobađanjem] EU/1/97/051/023 [30 tableta s produljenim oslobađanjem] EU/1/97/051/024 [100 tableta s produljenim oslobađanjem]
English: The tablets are white, flat, of round shape, scored on both sides, and have a code embossed (one side with the code P9, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele, plosnate, okruglog oblika, s razdjelnim urezom na obje strane te imaju otisnutu oznaku (s jedne strane oznaku P9 a s druge strane simbol tvrtke Boehringer Ingelheim).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P5, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, ovalnog oblika, te imaju otisnutu oznaku (s jedne strane oznaku P5, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: 1 tablet MIRAPEXIN 0.18 mg
Croatian: Broj tableta 1 tableta MIRAPEXIN 0,18 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/019 [10 prolonged-release tablets] EU/1/97/051/020 [30 prolonged-release tablets] EU/1/97/051/021 [100 prolonged-release tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/019 [10 tableta s produljenim oslobađanjem] EU/1/97/051/020 [30 tableta s produljenim oslobađanjem] EU/1/97/051/021 [100 tableta s produljenim oslobađanjem]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/005 [30 tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/005 [30 tableta]
English: Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Croatian: Ako se pojave takvi simptomi treba razmisliti o sniženju doze / postupnom ukidanju lijeka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/003 [30 tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/003 [30 tableta]
English: - If you get any of the side effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, ovalnog oblika, te imaju otisnutu oznaku (s jedne strane oznaku P12, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P13, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, ovalnog oblika, te imaju otisnutu oznaku (s jedne strane oznaku P13, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/001 [30 tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/051/001 [30 tableta]
English: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P7, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele, plosnate, ovalnog oblika, s razdjelnim urezom na obje strane, te imaju otisnutu oznaku (s jedne strane oznaku P7, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P3, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, ovalnog oblika, te imaju otisnutu oznaku (s jedne strane oznaku P3, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P4, and one side with the Boehringer Ingelheim company symbol).
Croatian: Tablete su bijele do gotovo bijele boje, ovalnog oblika, te imaju otisnutu oznaku (s jedne strane oznaku P4, a s druge strane simbol tvrtke Boehringer Ingelheim).
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.62 mg prolonged-release tablets Pramipexole
Croatian: MIRAPEXIN 2,62 mg tablete s produljenim oslobađanjem pramipeksol
English: s r.o.
Croatian: PRILOG III.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 0,375 mg pramipeksoldiklorid hidrata što odgovara 0,26 mg pramipeksola.
English: 40 (1 cartridge x 40) tablets
Croatian: 40 (1 uložak x 40) tableta
English: Immediate Packaging Pack size
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja
English: Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene
English: EU number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: Name
Croatian: Unutarnje pakovanje
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: These constitute the majority of the available evidence, in particular in the indications that were first authorised (e.g. secretolytic indication).
Croatian: One čine većinu dostupnih dokaza, posebno u indikacijama koje su odobrene prve (npr. sekretolitička indikacija).
English: 2 - CMDh revised position
Croatian: 2 - Pregledano stajalište CMDh-a
English: All indications are not authorised in all EU MS.
Croatian: Nisu sve indikacije odobrene u svim državama članicama EU-a.
English: Further, the definition of the relevant clinical endpoints and the measurement of symptoms in these conditions are challenging (Rubin, 2007).
Croatian: Osim toga, definicija relevantnih kliničkih završnih točaka i mjerenje simptoma u tim stanjima zahtjevni su (Rubin, 2007.).
English: Whereas
Croatian: godine.
English: It is acknowledged that most of the indications are supported by old studies presenting limitations and deficiencies.
Croatian: Potvrđeno je da je većina indikacija podržana starim ispitivanjima koja sadrže ograničenja i nedostatke.
English: Based on its clinical experience, the PDCO was of the view that there is no need for the use of these products in this indication in children below 2 years of age.
Croatian: Na temelju svojeg kliničkog iskustva, PDCO je bio mišljenja da nema potrebe za uporabu tih lijekova u ovoj indikaciji u djece mlađe od 2
English: The PRAC noted that the worldwide estimated exposure of the originator's products alone is over 50 million patient-years and, in the EU over the last decade, around 6.8 million patient-years.
Croatian: PRAC je napomenuo kako je procijenjeno izlaganje samo lijekovima koji sadrže izvorni lijek na svjetskoj razini više od 50 milijuna bolesnika godišnje, te u EU-u tijekom posljednjeg desetljeća, otprilike 6,8 milijuna bolesnika godišnje.
English: The PDCO was also of the view that these products are no longer the preferred treatment option in IRDS.
Croatian: PDCO je također bio mišljenja da ti lijekovi više ne predstavljaju preferiranu terapijsku opciju za IRDS.
English: Consequently the PSUR cycle should be shortened to a 3-yearly cycle in order to periodically review these analyses.
Croatian: Posljedično, ciklus PSUR-a treba skratiti na ciklus od 3 godine kako bi se te analize periodički pregledavale.
English: Only these amendments, adopted and included in the CMDh position, are legally binding and must be implemented by the Member States.
Croatian: Samo su te izmjene, koje su donesene i uključene u stajalište CMDh-a, pravno obvezujuće te ih države članice moraju provesti.
English: The CMDh position was forwarded to the European Commission.
Croatian: Stajalište CMDh-a proslijeđeno je Europskoj komisiji.
English: Moreover SCARs cases should be analysed in details in future PSURs.
Croatian: Osim toga, slučajeve SCAR-ova treba detaljno analizirati u budućim PSUR-ovima.
English: In light of this, the PRAC recommendation and CMDh position was referred back to the Agency for further consideration.
Croatian: U tom svjetlu, preporuka PRAC-a i stajalište CMDh-a upućeni su Agenciji radi daljnjeg razmatranja.
English: Often a large placebo effect is seen in studies investigating respiratory conditions, particularly in non-serious, self-limiting conditions.
Croatian: Često je uočen veliki placebo učinak u ispitivanjima koja su istraživala respiratorna stanja, a posebice ne-ozbiljna, samoograničavajuća stanja.
English: During the decision making process, at a meeting of the Standing Committee on Medicinal Products for Human Use, some Member States raised new questions of technical nature which they considered had not been sufficiently addressed in the PRAC recommendation and CMDh position.
Croatian: Tijekom postupka donošenja odluke, na sjednici Stalnog odbora za lijekove za humanu uporabu, neke su države članice istaknule nova pitanja tehničke naravi za koja su smatrale da se u preporuci PRAC-a i stajalištu CMDh-a nisu riješila na zadovoljavajući način.
English: 1 - Overall summary of the scientific evaluation by the PRAC Safety issues
Croatian: 1 - Cjelokupan sažetak znanstvene ocjene PRAC-a Pitanje sigurne primjene
English: The level of evidence did not allow for further stratification by age group.
Croatian: Razina dokaza nije omogućila daljnju stratifikaciju po dobnim skupinama.
English: This is not unexpected considering the methodological challenges inherent to this therapeutic area and evidential standards and requirements at the time when these products were first developed.
Croatian: Ovo nije neočekivano, uzimajući u obzir metodološke izazove prisutne u ovom terapijskom području te standarde i zahtjeve u pogledu dokaza u vrijeme razvoja tih lijekova.
English: It is recognised also that the limitations and uncertainties attached to the dataset hinder the ability to draw robust conclusions on the efficacy.
Croatian: Također je prepoznato da ograničenja i nesigurnosti povezane sa skupom podataka otežavaju mogućnost donošenja detaljnih zaključaka o djelotvornosti.
English: The PRAC also considered the available data in the paediatric population.
Croatian: PRAC je također razmotrio podatke prikupljene u pedijatrijskoj populaciji.
English: However, prompt recognition of severe reactions and early withdrawal of the causative agent is the most important factor to minimise morbidity and mortality.
Croatian: No brzo prepoznavanje ozbiljnih nuspojava i rano ustezanje kauzativnih sredstava najvažniji je čimbenik za smanjivanje morbiditeta i mortaliteta.
English: In addition, the PRAC discussed the need to conduct post-authorisation studies, and concluded that such studies would likely not generate new robust information towards more definite conclusions.
Croatian: Osim toga, PRAC je raspravljao o potrebi za provođenje studija nakon davanja odobrenja te zaključio da se takvim studijama vjerojatno ne bi stvorile nove detaljne informacije za donošenje jasnijih zaključaka.
English: However, a shorter PSUR cycle should be introduced to continue to review periodically data that becomes available on the benefit-risk balance of the products.
Croatian: Međutim, trebao bi se uvesti kraći ciklus PSUR-a kako bi se moglo nastaviti periodičko pregledavanje podataka o omjeru koristi i rizika proizvoda koji postaju dostupni.
English: For these reasons studies conducted after the initial marketing authorisation do not provide new significant scientific data on the efficacy of the products.
Croatian: Zbog toga se u studijama provedenima nakon početnog odobrenja za stavljanje lijeka u promet ne pružaju novi značajni znanstveni podaci o djelotvornosti proizvoda.
English: It is acknowledged that clinical evidence from studies in children is weak due to their heterogeneity and to the lower number of children enrolled.
Croatian: Potvrđeno je da su klinički dokazi dostupni iz ispitivanja provedenih u djece slabiji zbog heterogenosti i manjeg broja djece prijavljene u ispitivanjima.
English: Ambroxol- and bromhexine-containing medicinal products have first been registered in a European Union (EU) Member State (MS) in 1978 and 1963, respectively, and are currently authorised in all EU MSs (as well as in Norway and Iceland) except the United Kingdom.
Croatian: Lijekovi koji sadrže ambroksol i bromheksin po prvi su put registrirani u državi članici Europske unije (EU) 1978., odnosno 1963., te su sada odobreni u svim državama članicama EU-a (kao i u Norveškoj i na Islandu), osim Ujedinjene Kraljevine.
English: Many drug reactions cannot be distinguished from naturally occurring or infection-induced eruptions, and thus misdiagnosis is common.
Croatian: Mnoge reakcije na lijekove ne mogu se razlikovati od izbijanja koja prirodno nastupaju ili koja su izazvana infekcijama, te je stoga česta pogrešna dijagnoza.
English: On 25 February 2015, the CMDh, having considered the PRAC recommendation, dated 9 January 2015, reached by majority the position that the marketing authorisations for the concerned medicinal products should be varied.
Croatian: Dana 25. veljače 2015., nakon što je razmotrio preporuku PRAC-a od 9. siječnja 2015., CMDh je većinski usvojio stajalište da je odobrenja za stavljanje dotičnih lijekova u promet potrebno izmijeniti.
English: However, when looking at the date of the reports, 40 reports, out of the 119 reported in total for the originator since the first marketing authorisation, appear to have been sent in two batches by the Chinese health authority to the MAH of the originator of these products.
Croatian: No promatrajući datum prijava, vidi se da je 40 od ukupno 119 prijava za izvorni lijek, podnesenih od trenutka izdavanja odobrenja za stavljanje lijeka u promet, nositelju odobrenja za izvorni lijek ovih proizvoda poslalo u dvije skupine kinesko nadležno zdravstveno tijelo.
English: The clinical studies performed during the development of bromhexine- and ambroxol-containing products between the 1950ies and 1980ies were considerably less standardised than would be necessary today, and would not completely fulfil contemporary requirements with regard to validated endpoints, statistical confirmation, or Good Clinical Practice (GCP).
Croatian: Klinička ispitivanja provedena tijekom razvojne faze lijekova bromheksin i ambroksol između 1950-ih i 1980-ih bila su daleko manje standardizirana nego što je to potrebno danas te ne udovoljavaju u potpunosti suvremenim zahtjevima vezanima uz potvrđene završne točke, statističke potvrde ili dobru kliničku praksu (DKP).
English: Taking into account these limitations, together with the weak evidence of a safety issue from the pharmacovigilance data, the PRAC could not conclude from the available evidence that risks outweighed benefits in the different indications.
Croatian: Uzimajući u obzir ta ograničenja, zajedno sa slabim dokazima o problemu sigurne primjene prikupljenima iz farmakovigilancijskih podataka, PRAC nije mogao zaključiti na temelju dostupnih dokaza da rizici nadmašuju koristi u različitim indikacijama.
English: In addition the PRAC recommended harmonising the terms related to hypersensitivity reactions in the product information.
Croatian: Nadalje, PRAC je preporučio usklađivanje termina povezanih s reakcijama preosjetljivosti u informaciji o lijeku.
English: Of note, drugs started less than 4 days or more than 8 weeks before the onset of the reaction are unlikely to be responsible.
Croatian: Nije izgledno da su odgovorni bezreceptni lijekovi s čijom je terapijom započeto manje od 4 dana ili više od 8 tjedana prije nastupanja reakcije.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for ambroxol- and bromhexine-containing medicinal products.
Croatian: • je PRAC razmotrio postupak u skladu sa člankom 31. Direktive 2001/83/EZ iz podataka za farmakovigilanciju za lijekove koji sadrže ambroksol i bromheksin;
English: Most often these patients receive a number of drugs concomitantly and causality assessment is difficult.
Croatian: U većini slučajeva ti bolesnici primaju istovremeno niz lijekova, te je ocjena kauzalnosti otežana.
English: Overall conclusion and grounds for the revised PRAC recommendation
Croatian: Opći zaključak i razlozi za pregledanu preporuku PRAC-a Budući da
English: However, the overall reporting rate is very low when the estimated exposure is considered and many confounders are present in these cases, the evidence supporting this risk is therefore weak.
Croatian: No cjelokupna stopa prijavljivanja vrlo je niska ako se uzme u obzir procijenjena izloženost te je prisutno mnogo latentnih zajedničkih uzroka u tim slučajevima, pa su stoga dokazi koji potvrđuju rizik slabi.