natgillin/translations-raw huggingface dataset:
Taking all of the above into consideration, the PRAC concluded that the data reviewed supported amendments of the product information to reflect the risk of severe cutaneous adverse reactions, and that further age restrictions to reflect the concerns about the benefit-risk balance of ambroxol- and bromhexine-containing products are not justified on the basis of the data available.
Upoštevajoč vse zgornje podatke je odbor PRAC zaključil, da pregledani podatki podpirajo spremembe informacij o zdravilu, in sicer tako, da se vanje vključi tveganje hudih kožnih neželenih učinkov, in da dodatne omejitve glede starosti, ki odražajo pomisleke o razmerju med tveganji in koristmi zdravil, ki vsebujejo ambroksol in bromheksin, niso upravičene na podlagi razpoložljivih podatkov.
An increase was observed in the reporting frequency of anaphylactic reactions over 2012-2014 linked to ambroxol.
Med letoma 2012 in 2014 so opazili povečanje pogostosti poročanja o anafilaktičnih reakcijah, povezanih z ambroksolom.
Analysis of the safety information submitted by the MAH, from Eudravigilance and from the literature, demonstrates that ambroxol and bromhexine formulations in their different indications have been associated with reports of serious immediate hypersensitivity reactions.
Analiza varnostnih podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, iz sistema Eudravigilance in literature, kaže, da so bile formulacije ambroksola in bromheksina pri različnih indikacijah povezane s poročili o takojšnjih resnih preobčutljivostnih reakcijah.
In addition, ambroxol and bromhexine have been approved in some EU MS in airway diseases indications in fixed dose combinations with various active substances.
Poleg tega sta se ambroksol in bromheksin v nekaterih državah članicah EU odobrila za indikacijo bolezni dihal v kombinacijah z različnimi zdravilnimi učinkovinami s fiksnim odmerkom.
As ambroxol is a metabolite of bromhexine and hypersensitivity reactions are not dependent on the dose of the allergenic substance absorbed, the FAMHP considered that any confirmed risk with ambroxol could also be found in bromhexine-containing medicinal products with regards to these reactions.
Ker je ambroksol presnovek bromheksina in preobčutljivostne reakcije niso odvisne od odmerka absorbiranega alergena, je organ FAMHP menil, da bi lahko potrjeno tveganje za te reakcije pri ambroksolu veljalo tudi za zdravila, ki vsebujejo bromheksin.
The authorised indications of bromhexine, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, alteration in the production or elimination of mucus (acute and chronic sinusitis) and Sjögren's syndrome.
Odobrene indikacije za bromheksin, kot je navedeno v glavnem podatkovnem listu imetnika dovoljenja za originator, so sekretolitična terapija, spremembe v tvorbi ali izločanju sluzi (akutni in kronični sinusitis) ter Sjögrenov sindrom.
The PRAC was of the view that the possible risk of SCARs can be adequately addressed by the proposed amendments to the PI to inform caregivers and patients of the risk and allow early identification of signs of SCARs and immediate discontinuation of treatment should they occur.
Odbor PRAC je menil, da se lahko morebitno tveganje za SCAR zadostno obravnava s predlaganimi spremembami informacij o zdravilu, ki bodo negovalce in bolnike obveščale o tveganju, omogočale zgodnje prepoznavanje znakov SCAR in opozarjale na takojšnjo prekinitev jemanja, če se taki znaki pojavijo.
It is acknowledged that clinical evidence from studies in children is weak due to their heterogeneity and to the lower number of children enrolled.
Znano je, da so zaradi heterogenosti in manjšega števila vključenih otrok klinični dokazi iz študij pri otrocih šibkejši.
Based on the evaluation of the individual case reports, considering the nature of these events the PRAC was of the view that there is a reasonable possibility that all ambroxol and bromhexine-containing products are associated with an increased risk of SCARs including combination products.
Na podlagi ocene posameznih poročil o primerih in glede na naravo teh dogodkov je odbor PRAC menil, da obstaja možnost, da so vsa zdravila, ki vsebujejo ambroksol in bromheksin, povezana s povečanim tveganjem za SCAR, vključno s kombiniranimi zdravili.
The PRAC however noted that the observed increase in reporting of anaphylactic reactions for ambroxol-containing products was likely an artefact resulting from the implementation of a new pharmacovigilance regulation in China and did not constitute a new safety concern.
Vendar je sklepal, da je opaženo povečanje poročanja o anafilaktičnih reakcijah na zdravila, ki vsebujejo ambroksol, verjetno artefakt, ki je posledica uvedbe novega farmakovigilančnega predpisa na Kitajskem, in ne predstavlja novega varnostnega zadržka.
In relation to the efficacy of ambroxol- and bromhexine-containing products, the PRAC concluded that although modest positive results were reported, the evidence of efficacy of ambroxol and bromhexine suffered from a number of limitations and deficiencies.
Glede učinkovitosti zdravil, ki vsebujejo ambroksol in bromheksin, je odbor PRAC zaključil, da imajo dokazi o učinkovitosti ambroksola in bromheksina kljub zmerno pozitivnim rezultatom mnoge omejitve in pomanjkljivosti.
The CMDh, having considered the revised PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and reached the position that the marketing authorisations for ambroxol- and bromhexine-containing medicinal products should be varied.
Po preučitvi revidiranega priporočila odbora PRAC se je skupina CMDh strinjala z njegovimi splošnimi znanstvenimi zaključki in menila, da je treba dovoljenja za promet z zdravili, ki vsebujejo ambroksol in bromheksin, spremeniti.
The PRAC considered that the evidence of risk of SCARs associated with ambroxol and bromhexine is weak.
Odbor PRAC je menil, da so dokazi o tveganju za SCAR, povezanem z ambroksolom in bromheksinom, šibki.
The PRAC considered all these elements in its review of the available data on the efficacy of ambroxol- and bromhexine-containing products.
Odbor PRAC je pri svojem pregledu razpoložljivih podatkov o učinkovitosti zdravil, ki vsebujejo ambroksol in bromheksin, upošteval vse te elemente.
When considering data in support of the safety issues, the PRAC was of the view that ambroxol- and bromhexine-containing products are associated with case reports of immediate and delayed hypersensitivity including hypersensitivity reactions, anaphylactic reactions including anaphylactic shock, angioedema, pruritus, rash and urticaria.
Na podlagi podatkov, ki podpirajo varnostne zadržke, je odbor PRAC menil, da so zdravila, ki vsebujejo ambroksol in bromheksin, povezana s poročili o primerih takojšnje in zapoznele preobčutljivosti, kot so preobčutljivostne reakcije, anafilaktične reakcije, vključno z anafilaktičnim šokom, angioedem, srbenje, izpuščaji in urtikarija.
• The PRAC was of the view that the risk of SCARs should be addressed by its inclusion in the product information accompanied by a warning in order for patients and caregivers to recognise the prodromes of SCARs and discontinue treatment immediately in the event of such signs.
• odbor PRAC je menil, da je treba tveganje za SCAR obravnavati tako, da se v informacije o zdravilu vključi opozorilo za bolnike in negovalce, kako prepoznati prodromske znake SCAR in da je treba takoj prekiniti zdravljenje, če se taki znaki pojavijo;
• The PRAC considered that ambroxol and bromhexine are associated with an increased risk of hypersensitivity reactions.
• odbor PRAC je menil, da sta ambroksol in bromheksin povezana s povečanim tveganjem preobčutljivostnih reakcij;
Hypersensitivity reactions are dose and formulation independent, therefore the possible risk of developing hypersensitivity reactions including SCARs is inherent to all ambroxol- and bromhexinecontaining products.
Preobčutljivostne reakcije niso odvisne od odmerka in formulacije, zato morebitno tveganje za razvoj preobčutljivostnih reakcij, vključno s SCAR, velja za vsa zdravila, ki vsebujejo ambroksol in bromheksin.
The authorised indications of ambroxol, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, prophylaxis and treatment of Infant Respiratory Distress Syndrome (IRDS), prophylaxis and treatment of post-operative bronchopulmonary complications (PPC) and pain relief in acute sore throat.
Odobrene indikacije za ambroksol, kot je navedeno v glavnem podatkovnem listu imetnika dovoljenja za originator, so sekretolitična terapija, profilaksa in zdravljenje sindroma respiratorne stiske pri dojenčkih, profilaksa in zdravljenje pooperacijskih bronhopulmonalnih zapletov ter lajšanje bolečine pri akutno bolečem žrelu.
Often a large placebo effect is seen in studies investigating respiratory conditions, particularly in non-serious, self-limiting conditions.
V študijah, ki preučujejo bolezni dihal, predvsem neresna, samoomejujoča stanja, pogosto opažajo velik učinek placeba.
With regards to delayed hypersensitivity reactions associated with SCARs, a few cases have been assessed as certainly related to ambroxol.
Nekaj primerov zapoznelih preobčutljivostnih reakcij, povezanih s SCAR, so ocenili kot zagotovo povezane z ambroksolom.
The PRAC considered that there was a reasonable possibility that ambroxol and bromhexine are associated with serious delayed-type hypersensitivity reactions associated with SCARs.
Odbor PRAC je menil, da obstaja možnost, da sta ambroksol in bromheksin povezana z resnimi preobčutljivostnimi reakcijami zapoznelega tipa, povezanimi s SCAR.
The CMDh considered the PRAC recommendation that the evidence available did not provide sufficient grounds to demonstrate a change to the established benefit-risk balance, provided the recommended amendments to sections 4.4 and 4.8 of the product information, detailed in annex III, are implemented.
Skupina CMDh je upoštevala priporočilo odbora PRAC, da razpoložljivi dokazi niso zadosten razlog za spremenjeno razmerje med tveganji in koristmi, pod pogojem, da se po priporočilih spremenita poglavji 4.4 in 4.8 informacij o zdravilu, kot je pojasnjeno v Prilogi III. Samo te spremembe, ki jih sprejme skupina CMDh in jih vključi v svoje stališče, so pravno zavezujoče in jih morajo države članice izvesti.
Nevertheless, modest but positive results were reported for ambroxol and bromhexine.
Kljub temu so pri ambroksolu in bromheksinu poročali o zmernih, vendar pozitivnih rezultatih.
• The PRAC considered that there is a reasonable possibility of a risk of SCARs associated with ambroxol and bromhexine.
• odbor PRAC je menil, da obstaja možnost tveganja za SCAR, povezanega z ambroksolom in bromheksinom;
These products are contra-indicated in different subsets of the paediatric population in the EU MS. Ambroxol and bromhexine are marketed in several formulations for oral, nasal, oromucosal, intravenous or rectal administration under various invented names.
Ambroksol in bromheksin se v več formulacijah in z različnimi izmišljenimi imeni tržita za peroralno, nazalno, oralno, intravensko in rektalno uporabo.
In addition, all studies conducted more recently submitted by the MAHs were also considered by the PRAC.
Poleg tega je odbor PRAC preučil vse študije, ki so jih predložili imetniki dovoljenj za promet z zdravili in so bile opravljene v zadnjem času.
Therefore, the PRAC recommends the variation to the terms of the marketing authorisations, for all ambroxol- and bromhexine-containing medicinal products identified in Annex I and for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III of the revised PRAC recommendation.
• odbor PRAC je menil, da razpoložljivi podatki niso zadostni za upravičenje novih starostnih omejitev; odbor PRAC je zato priporočil spremembo pogojev dovoljenj za promet z vsemi zdravili, ki vsebujejo ambroksol in bromheksin ter so navedena v Prilogi I, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III k revidiranemu priporočilu odbora PRAC.
Ambroxol- and bromhexine-containing medicines are available as over-the-counter (OTC) as well as prescription-only medicines (POM).
Zdravila, ki vsebujejo ambroksol in bromheksin, se izdajajo bodisi brez recepta bodisi le na recept.
Further to the evaluation of a Worksharing PSUR of ambroxol-containing medicinal products started in January 2012 and of follow-up submissions as well as signal detection activities, the Belgian national competent authority (FAMHP) identified an increase in reporting of hypersensitivity reactions over the years 2012-2014, reports of severe cutaneous adverse reactions (SCARs) and a benefit-risk evaluation in children below 6 years of age concluded that while there was no indication of a different safety profile, insufficient evidence of efficacy was available in secretolytic therapy in this age group, leading to a negative benefit-risk balance.
Na podlagi poročil o hudih kožnih neželenih učinkih ter ocene razmerja med tveganji in koristmi pri otrocih, mlajših od šest let, so sklenili, da so dokazi glede učinkovitosti sekretolitične terapije pri tej starostni skupini nezadostni (čeprav ne kažejo na drugačen varnostni profil), kar posledično kaže na negativno razmerje med tveganji in koristmi.
If this happens, do not drive.
Če pride do tega, ne vozite.
Contains E223.
Vsebuje E223.
The right dose for you will depend on your needs.
Ustrezni odmerek za vas je odvisen od vaših potreb.
The effect was maintained over a 6 months period.
Učinek so vzdrževali v obdobju 6 mesecev.
It is also likely to lower the amount of milk you produce.
Prav tako lahko zmanjša količino mleka.
This is because it may change the colour of the skin.
To je zato, ker lahko spremeni obarvanost kože.
Interactions with other forms of hormonal contraception have not been investigated.
Interakcije z drugimi oblikami hormonske kontracepcije niso bile raziskane.
Additional studies to further evaluate the specific pathology have not been performed.
Dodatnih študij za nadaljnjo oceno specifične patologije niso opravili.
All differences between the active treatments and placebo were statistically significant.
Vse razlike med aktivnimi zdravljenji in placebom so bile statistično pomembne.
The safety profile was comparable, with the exception of application site reactions.
Varnostni profil je bil primerljiv, z izjemo reakcij na mestu apliciranja.
Treatment of overdose may require general supportive measures to maintain the vital signs.
Pri zdravljenju prevelikega odmerjanja bodo morda potrebni splošni podporni ukrepi za vzdrževanje vitalnih znakov.
Periodic assessment of efficacy should be performed, along with evaluation of safety, including augmentation.
Voditi bi bilo treba periodično oceno učinkovitosti, skupaj z oceno varnosti, vključujoč avgmentacijo.
This is when you and your doctor agree that the symptoms are being controlled well enough and the side effects of the medicines are acceptable.
To je takrat, ko se vi in vaš zdravnik strinjata, da so simptomi ustrezno nadzorovani in neželeni učinki zdravil sprejemljivi.
Do not give this medicine to children below 18 years of age because it is not known if it is safe or effective in this age group.
Ne dajajte zdravila otrokom, mlajšim od 18 let, ker njegova varnost in učinkovitost za to starostno skupino nista znani.
The primary outcome assessment was the reduction in “off” time (hours).
Primarna ocena izida je bilo zmanjšanje časa »izklop« (v urah).
Also do not use them on or near a patch you are already wearing.
Prav tako jih ne uporabljajte v bližini obliža, ki ga že nosite.
30 months.
30 mesecev.
The relevance of these findings to humans is not known.
Pomen teh ugotovitev za človeka ni znan.
Efficacy/safety data is insufficient to establish a relation between exposure and response (see also paediatric information in section 4.2).
Podatki o učinkovitosti/varnosti ne zadoščajo za vzpostavitev povezave med izpostavljenostjo in odzivom (glejte tudi pediatrične informacije v poglavju 4.2).
The safety profile was unchanged from that observed in previous studies.
Varnostni profil je ostal nespremenjen v primerjavi s prejšnjimi študijami.
High Level Term b
Izraz visoke stopnje b
This should be considered when prescribing rotigotine.
To je treba upoštevati pri predpisovanju rotigotina.
They will discuss ways of managing or reducing symptoms.
Poiskal bo način obvladovanja ali zmanjšanja simptomov.
It is thin and has three layers.
Je tanek in ima tri plasti.
Observed in open-label studies c
Opaženo pri odprtih študijah c
This is because the medicine may be released faster.
To velja zato, ker se lahko v teh primerih zdravilo sprosti hitreje.
Both indications:
Obe indikaciji:
For information on fertility studies, please see section 5.3.
Za informacije o študijah plodnosti glejte poglavje 5.3.
What to do with the used and unused patches
Kaj storiti z rabljenimi in nerabljenimi obliži
However, there is no indication of a relevant impact on the clinical outcome.
Vendar to nima pomembnega vpliva na klinični izid.
• abnormal thoughts about reality
• nenormalne misli o resničnosti
The safety and efficacy of rotigotine in children and adolescents have not yet been established.
Varnost in učinkovitost rotigotina pri otrocih in mladostnikih še nista bili dokazani.
Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Poročali so o nenadnem spancu med dnevnimi aktivnostmi, v nekaterih primerih brez zavedanja kakršnihkoli opozorilnih znakov.
The majority of erythema observed was mild and none severe.
Večina eritemov, ki so jih opazili, je bilo blagih, noben ni bil hud.
It is recommended that the application site should be rotated on a daily basis (e.g. from the right side to the left side and from the upper body to the lower body).
Mesto aplikacije je priporočljivo vsak dan zamenjati (npr. z desne strani na levo in z zgornjega dela telesa na spodnjega).
Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
Učinkovitost je bila dokazana v kontrolnih študijah na bolnikih, zdravljenih do 29 tednov.
Women of childbearing potential, contraception in females
Ženske v rodni dobi, kontracepcija pri ženskah
• The reactions normally go away after a few hours - once you remove the patch.
• Te reakcije navadno izginejo nekaj ur po odstranitvi obliža.
• Please follow the instructions of the prescriber carefully.
• Pozorno sledite navodilom zdravnika.
(see Special populations)
(glejte Posebne populacije)
Observed during post-marketing d
Opaženo v postmarketinškem obdobju d
Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Vse uporabljene in neuporabljene obliže zavrzite v skladu z lokalnimi predpisi ali jih vrnite v lekarno.
Rotigotine may have major influence on the ability to drive and use machines.
Rotigotin ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
• abnormal thinking or behaviour - most of the symptoms occur more frequently in patients with
• nenormalno mišljenje ali vedenje - večina simptomov se pogosteje pojavi pri bolnikih s
CPK levels have not been routinely measured in other populations.
CPK vrednosti niso rutinsko merili pri drugih populacijah.
• Keep it pressed for about 30 seconds.
• Pritiskajte približno 30 sekund.
The dose recommendations made are in nominal dose.
Priporočila za odmerjanje so v nominalnih odmerkih.
Both treatments showed improvements in early morning motor function and sleep.
Pri obeh skupinah se je pokazalo izboljšanje motoričnih funkcij zgodaj zjutraj in spanja.
The absolute bioavailability after transdermal application is approximately 37%.
Absolutna biološka uporabnost po transdermalni uporabi je približno 37 %.
Date of first authorisation: 16 June 2011 Date of latest renewal: 14 January 2016
Datum zadnjega podaljšanja dovoljenja za promet: 14. januar 2016
• unable to achieve or maintain an erection
• nezmožnost doseganja ali ohranjanja erekcije
The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
Bolnika je treba skrbno nadzorovati, vključno s frekvenco bitja srca, srčnim ritmom in krvnim tlakom.
Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.
Ker so bili bolniki s klinično pomembno srčnožilno boleznijo izključeni iz teh študij, je treba bolnike s hudo srčnožilno boleznijo vprašati o simptomih sinkope in predsinkope.
Therefore, it is recommended to taper treatment (see section 4.2).
Zato se priporoča, da se zdravljenje opušča počasi (glejte poglavje 4.2).
This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour.
To pa zato, da lahko družinski član ali negovalec obvesti vas ali vašega zdravnika, če je zaskrbljen zaradi sprememb v vašem vedenju.
Loss of consciousness can occur
Pojavi se lahko izguba zavesti
If any of the above apply to you, do not use Leganto.
Če kaj od zgoraj navedenega velja za vas, ne uporabljajte zdravila Leganto.
• Used patches still contain the active substance ‘rotigotine', which may be harmful to others.
• Obliž po uporabi še vedno vsebuje učinkovino ‘rotigotin', ki je lahko škodljiva za druge.
The apparent volume of distribution in humans is approximately 84 l/kg.
Navidezni volumen porazdelitve pri človeku je 84 l/kg.
• medicines that lower blood pressure.
• zdravila, ki znižujejo krvni tlak.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja)
• Parkinson's disease - Leganto can be used on its own or with another medicine called levodopa.
• Parkinsonove bolezni - zdravilo Leganto se lahko uporablja samostojno ali z drugim zdravilom, imenovanim levodopa.
Sulphite sensitivity
Občutljivost na sulfit
The same site should not be used within 14 days.
Istega mesta se v 14 dneh ne sme uporabiti znova.
These are usually mild or moderate in intensity and transient even if treatment is continued.
Ponavadi so blagi ali zmerni ter prehodni, tudi če se zdravljenje nadaljuje.
• uncontrolled shopping or spending too much
• nenadzorovano pretirano nakupovanje ali zapravljanje
These packages are usually needed for the first four weeks of therapy, but depending on your response to Leganto, you may not need to use all of the dose packages included or you may need additional higher doses after week 4, which are not covered by this package.
Ta pakiranja se ponavadi potrebujejo za prve štiri tedne zdravljenja, vendar odvisno od vašega odziva na zdravilo Leganto morda ne boste uporabili vseh priloženih pakiranj ali pa boste potrebovali dodatne večje odmerke po 4. tednu, ki jih v tem pakiranju ni.
The effects were more pronounced in female rats.
Učinki so bili izrazitejši pri podganjih samicah.
• Gently wash the area with warm water and mild soap.
• Mesto nežno umijte s toplo vodo in blagim milom.
• altered or increased sexual interest and behaviour which causes significant concern to you or others - for example, an increased sex drive
• spremenjena ali povečana želja po spolnosti in vedenje, ki je zaskrbljujoče za vas ali druge, na primer - povečan spolni nagon
For example, put it on the right side of your body one day, then on the left side of your body the next day.
Na primer, dajte ga na desno stran telesa en dan, nato na levo stran naslednji dan. Ali pa na zgornji del telesa en dan, nato naslednji dan na spodnji del telesa.