FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro and in vivo studies have shown glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes.
Slovenian: In vitro ter in vivo študije so pokazale, da glukozamin preko hondrocitov stimulira sintezo fizioloških glikozaminoglikanov in proteoglikanov, preko sinoviocitov pa sintezo hialuronske kisline.
English: The applicant was asked to demonstrate efficacy of glucosamine in the intended indication “relief of symptoms in mild to moderate osteoarthritis of the knee”.
Slovenian: Vlagatelj je bil naprošen, da dokaže učinkovitost glukozamina za predvideno indikacijo „lajšanje simptomov blagega do zmernega osteoartritisa kolena“.
English: Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans.
Slovenian: Glukozamin je endogena snov, običajen gradnik polisaharidne verige v hrustančnem matriksu in glikozaminoglikanov v sinovialni tekočini.
English: The following have been reported:
Slovenian: Poročali so o naslednjih neželenih učinkih:
English: White to light beige, oval tablet marked with “G” and a score line.
Slovenian: Bela do rahlo bež, ovalna tableta označena s črko “G” in razdelilno zarezo.
English: If you forget to take Glucomed
Slovenian: Če ste pozabili vzeti zdravilo Glucomed
English: - If you have a known risk factor for cardiovascular disease, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.
Slovenian: - če imate znan dejavnik tveganja za srčno-žilno bolezen, ker je bila pri nekaj bolnikih, ki so se zdravili z glukozaminom, opažena hiperholesterolemija.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Relief of symptoms in mild to moderate osteoarthritis of the knee.
Slovenian: Lajšanje simptomov blagega do zmernega osteoartritisa kolena.
English: In patients with impaired glucose tolerance, monitoring of the blood glucose levels and, where relevant, insulin requirements is recommended before start of treatment and periodically during treatment.
Slovenian: Pri bolnikih z okvarjeno toleranco za glukozo je pred pričetkom zdravljenja in periodično med zdravljenjem potrebno spremljanje koncentracij glukoze v krvi ter, če je potrebno, dodajanje inzulina.
English: What Glucomed contains - The active substance is glucosamine.
Slovenian: Kaj vsebuje zdravilo Glucomed - Zdravilna učinkovina je glukozamin.
English: Rare (≥ 1/10,000 to
Slovenian: Redko (≥ 1/10.000 do
English: Glucomed should not be used during pregnancy.
Slovenian: Zdravila Glucomed se med nosečnostjo ne sme uporabljati.
English: - if you are allergic (hypersensitive) to shellfish, since glucosamine is manufactured from shellfish.
Slovenian: - če ste alergični na (preobčutljivi za) lupinarje (školjke, polže, rake), ker je glukozamin pridobljen iz lupinarjev.
English: If you stop taking Glucomed
Slovenian: Če ste prenehali jemati zdravilo Glucomed
English: Many published reviews, national therapy recommendations and other publications have discussed and evaluated the robustness of efficacy data.
Slovenian: Robustnost podatkov o učinkovitosti so obravnavali in vrednotili v mnogih preglednih prispevkih, nacionalnih priporočilih za zdravljenje ter drugih publikacijah.
English: Glucomed is used for the relief of symptoms in mild to moderate osteoarthritis of the knee.
Slovenian: Glucomed se uporablja za lajšanje simptomov blagega do zmernega osteoartritisa kolena.
English: Glucomed must not be given to patients who are allergic to shellfish as the active substance is obtained from shellfish.
Slovenian: Glucomed se ne sme dajati bolnikom, ki so alergični na lupinarje (školjke, polže ali rake), saj je učinkovina pridobljena iz lupinarjev.
English: HOW TO TAKE GLUCOMED
Slovenian: KAKO JEMATI ZDRAVILO GLUCOMED
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS Blister text
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Impaired renal and/or liver function
Slovenian: Bolniki z okvarjeno ledvično in jetrno funkcijo
English: This leaflet was last approved on: {date} [To be completed nationally]
Slovenian: Navodilo je bilo odobreno: [Izpolni država članica]
English: Do not use Glucomed after the expiry date which is stated on the blister/carton or tablet container.
Slovenian: Zdravila Glucomed ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Hydroxypropyl cellulose
Slovenian: Hidroksipropilceluloza
English: More frequent controls of your blood glucose levels may be necessary when starting treatment with glucosamine.
Slovenian: Ob začetku zdravljenja z glukozaminom bo mogoče pri vas potrebna pogostejša kontrola koncentracij glukoze v krvi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 tablet contains: 625 mg of glucosamine (as glucosamine hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 tableta vsebuje: 625 mg glukozamina (v obliki glukozaminijevega klorida).
English: The use of glucosamine during breastfeeding is therefore not recommended as there is no data on the safety of the newborn.
Slovenian: Ker ni podatkov o varnosti pri novorojenčkih, uporaba glukozamina med dojenjem ni priporočljiva.
English: What Glucomed looks like and content of the pack Glucomed is a white to light beige, oval tablet marked with “G” and a score line.
Slovenian: Glucomed je bela do rahlo bež, ovalna tableta označena s črko “G” in razdelilno zarezo.
English: Headache Tiredness
Slovenian: Glavobol Utrujenost
English: NAME OF THE MEDICINAL PRODUCT Glucomed and associated names (see Annex I) 625 mg tablets [See Annex I - To be completed nationally]
Slovenian: Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I - Izpolni država članica]
English: No curative or disease-modifying treatment exists, apart from surgery with arthroplasty.
Slovenian: Razen kirurške artroplastike ne poznamo sredstva, ki bi omogočilo ozdravitev ali ki bi modificiralo bolezen.
English: The usual starting dose is 2 tablets (1250 mg glucosamine) once daily.
Slovenian: Običajen začetni odmerek je 2 tableti (1250 mg glukozamina) enkrat na dan. Glukozamin ni indiciran za zdravljenje akutnih bolečinskih simptomov.
English: No formal drug interaction studies have been performed with glucosamine-containing medicinal products.
Slovenian: Formalne raziskave medsebojnega delovanja med zdravili, ki vsebujejo glukozamin, niso bile izvedene, zaradi česar je predlagano, da se v SPC vključi splošno opozorilo.
English: NAME OF THE MEDICINAL PRODUCT Glucomed and associated names (see Annex I) 625 mg tablets [See Annex I - To be completed nationally] glucosamine
Slovenian: Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I - Izpolni država članica] glukozamin
English: In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed.
Slovenian: Pri bolnikih z okvarjeno ledvično ali jetrno funkcijo ali obojim niso bile opravljene posebne študije, zato pri tej skupini bolnikov ni posebnih priporočil glede odmerjanja.
English: HOW TO STORE GLUCOMED
Slovenian: SHRANJEVANJE ZDRAVILA GLUCOMED
English: If you have taken large quantities you must consult your doctor or a hospital.
Slovenian: Če ste vzeli večji odmerek zdravila Glucomed, kot bi smeli Če ste zaužili velike količine zdravila, se morate posvetovati z vašim zdravnikom ali pokličite v bolnišnico.
English: Always take Glucomed exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Glucomed natančno upoštevajte zdravnikova navodila.
English: - if you have kidney or liver dysfunction, since no studies have been performed in such patients dose recommendations cannot be given.
Slovenian: Zaradi pomanjkanja študij pri takšnih bolnikih ni posebnih priporočil za odmerjanje.
English: If you experience dizziness or drowsiness from the tablets, you should not be driving or operating machinery.
Slovenian: Ne upravljajte vozil ali strojev, če po zaužitju tablet občutite vrtoglavico ali zaspanost.
English: You should check with your doctor or pharmacist if you are not sure.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: Applicant
Slovenian: Sklep
English: BEFORE YOU TAKE GLUCOMED
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO GLUCOMED
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Papirnate škatle za pretisne omote
English: Conclusion
Slovenian: Zaprtje
English: 6 (3 x 2) pre-filled syringes (multipack)
Slovenian: 1,5 ml (140 mg/ml) 6 (3 x 2) napolnjenih injekcijskih brizg (skupno pakiranje)
English: 2 pre-filled syringes
Slovenian: 1,5 ml (140 mg/ml) 2 napolnjeni injekcijski brizgi
English: Member State (EU/EEA)
Slovenian: Država članica (EU/EGP)
English: 9 and GL
Slovenian: 9 in GL
English: The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain as concerned Member States.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom je bila predložena Združenemu kraljestvu kot referenčni državi članici ter zadevnim državam članicam Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Franciji, Nemčiji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemski, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji in Španiji.
English: This linear extrapolation is questionable, since the processes involved are not linear.
Slovenian: Linearna ekstrapolacija je vprašljiva, saj vpleteni procesi niso linearni.
English: The risk to the environment can be reduced by adhering to the following measures.
Slovenian: Tveganje za okolje se lahko zmanjša ob upoštevanju naslednjih ukrepov.
English: Toxicity will depend on environmental conditions and habitat types.
Slovenian: Toksičnost je odvisna od okoljskih pogojev in habitatnih tipov.
English: The bioavailable fraction of zinc in soils is small (<1%).
Slovenian: Biološko uporaben delež cinka v tleh je majhen (< 1 %).
English: Other precautions regarding impact on the environment
Slovenian: Drugi previdnostni ukrepi glede vpliva na okolje
English: Add the following text in the relevant sections of the product information:
Slovenian: Dodati naslednje besedilo v ustreznih poglavjih glede informacije o zdravilu:
English: Since the issues raised by France and the Netherlands remained unresolved, the Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 30 September 2014 under Article 33(4) of Directive 2001/82/EC.
Slovenian: Ker pa so vprašanja, ki sta jih izpostavili Francija in Nizozemska, ostala nerazrešena, zadevne države članice niso uspele doseči soglasja v zvezi z zdravilom, zato je bila zadeva dne 30. septembra 2014 predložena odboru CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
English: EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Slovenian: IZJEMNO NEVARNO ZA RIBE IN ŽIVLJENJE V VODI.
English: The applicant provided the robust summaries of the additional peer-reviewed studies used in the effect assessment that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Slovenian: Predlagatelj je predložil prepričljive povzetke dodatnih strokovno pregledanih študij, uporabljenih pri ocenjevanju učinka, ki niso bile vključene v poročilo EU RAR (2010), vključno z zaključkom o zanesljivosti in veljavnosti vsake študije.
English: Zinc oxide is included in veterinary medicinal products currently authorised in several EU Member States for use in pigs.
Slovenian: Cinkov oksid je sestavina zdravil za uporabo v veterinarski medicini, ki so trenutno odobrena v več državah članicah EU za uporabo pri prašičih.
English: The level of accumulation and time dependency for the different environmental compartments were evaluated.
Slovenian: Ovrednoteni sta bili stopnja kopičenja in časovna odvisnost za različne dele okolja.
English: This supportive data suggests a buffer zone of 3 m or more could reduce the run-off by 3 to 5-fold.
Slovenian: Ti podporni podatki kažejo, da bi varovalni pas 3 m ali več lahko zmanjšal odtekanje cinka za 3- do 5-krat.
English: However, this measure would slow down the accumulation of zinc and, hence, reduce the risk for each environmental compartment.
Slovenian: Vendar pa bi s tem ukrepom upočasnili kopičenje cinka in s tem zmanjšali tveganje za posamezne dele okolja.
English: Having considered the above, it can be accepted that the PNECs proposed by the applicant can be used for the characterisation of risks (calculation of risk quotients).
Slovenian: Glede na zgoraj navedeno je sprejemljivo, da se vrednosti PNEC, ki jih je predlagal predlagatelj, uporabijo za opredelitev tveganja (izračun količnikov tveganja).
English: The CVMP was asked to give its opinion on the concerns raised by France and the Netherlands and to conclude on the benefit-risk balance for Gutal.
Slovenian: Odbor CVMP so zaprosili, naj poda svoje mnenje o vprašanjih, ki sta jih izpostavili Francija in Nizozemska, ter ugotovi, kakšno je razmerje med tveganji in koristmi zdravila Gutal.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med zasedanjem skupine za koordinacijo z naslednjimi spremembami:
English: Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Slovenian: Zato je bil določen faktor „staranja“ 3, ki se je uporabil pri izračunu vrednosti PNEC za določeno območje.
English: In general terms, as for the benefits, other risks are expected to be the same as for the reference product and have not been evaluated by the CVMP.
Slovenian: Na splošno je mogoče pričakovati, da bodo druga tveganja, tako kot koristi, enaka kot pri referenčnem zdravilu, zato jih odbor CVMP ni ovrednotil.
English: However, it is apparent that, for all compartments, RQs will be exceeded either immediately (sediment) or eventually (soil, ground-, and surface waters), and these risks must be addressed.
Slovenian: Vendar pa je očitno, da bodo količniki tveganja za vse dele okolja preseženi bodisi takoj (sedimenti) ali sčasoma (tla ter podzemne in površinske vode), zato je ta tveganja treba ustrezno zmanjšati.
English: Usually piglets and sows are kept on the same farm allowing treated piglet manure to be diluted.
Slovenian: Običajno so prašički in svinje na isti kmetiji, kar omogoča redčenje gnoja zdravljenih prašičkov.
English: 8), where validation is concerned with substantiating claims on the applicability of predictions with reference to the intended use or purpose.
Slovenian: 8), kjer je validacija povezana z dokazovanjem trditev o uporabnosti napovedi glede na predvideno uporabo ali namen, je treba uporabiti pragmatičen pristop.
English: The predicted no effect concentrations (PNECs) reported in the European Union Risk Assessment Report (EU RAR) on zinc (2010)
Slovenian: Predvidene koncentracije brez učinka (PNEC), navedene v poročilu Evropske unije o oceni tveganja (EU RAR) za cink (2010)
English: Similar regulations concerning the control of open watercourses from exposure to nutrients are adhered to in line with Good Agricultural Practice.
Slovenian: Podobni predpisi v zvezi z zaščito odprtih vodotokov pred izpostavljenostjo hranilom naj bi se že upoštevali v skladu z dobro kmetijsko prakso.
English: The amended Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Slovenian: Spremenjeni povzetek glavnih značilnosti zdravila in navodilo za uporabo referenčne države članice sta opredeljena v Prilogi III.
English: Exposure: accumulation, bioavailability and model calculation of zinc concentrations in the environment
Slovenian: Izpostavljenost: kopičenje, biološka uporabnost in modelni izračun koncentracij cinka v okolju
English: Although Good Agricultural Practice varies amongst Member States and is followed on a voluntary basis, a similar RMM for Gutal may be practical and appropriate.
Slovenian: Čeprav se dobra kmetijska praksa med državami članicami razlikuje in je njeno izvajanje prostovoljno, bi podoben ukrep za zmanjšanje tveganja lahko bil praktičen in primeren tudi za zdravilo Gutal.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe zdravila in imetnikov dovoljenja za promet/predlagateljev
English: 1 are considered reliable and, hence, are suitable for use in the risk characterisation of Gutal.
Slovenian: 1, so bile ocenjene kot zanesljive in zato primerne za uporabo pri opredelitvi tveganja, povezanega z zdravilom Gutal.
English: Zinc is very toxic to aquatic organisms, but can affect growth, survival and reproduction in both aquatic and terrestrial plants and animals.
Slovenian: Cink je zelo toksičen za vodne organizme in lahko vpliva na rast, preživetje in reprodukcijo vodnih in kopenskih rastlin in živali.
English: For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
Slovenian: Kar zadeva sedimentne sisteme, je od izpeljave (EU RAR, 2010) predvidene okoljske koncentracije (PEC) za sedimente prišlo do pomembnih sprememb v načinu določanja koncentracij v sedimentih.
English: The IDMM also considers several soil compartments and the fluxes between these and aquatic compartments.
Slovenian: Prav tako model IDMM upošteva več delov tal ter pretok snovi med njimi in vodnim okoljem.
English: 5.3 Environmental properties
Slovenian: 5.3 Okoljske lastnosti
English: A pragmatic approach should be taken when considering the validation of environmental mechanistic models (e.g. IDMM and FOCUS
Slovenian: Pri obravnavanju validacije modelov za ocenjevanje mehanizmov okolja (npr. IDMM in FOCUS
English: By their nature, models are an incomplete representation of the system under investigation but that is not to say that they cannot be very useful and widely implemented.
Slovenian: Modeli zaradi svojih lastnosti pomanjkljivo prikazujejo proučevani sistem, vendar zaradi tega ni mogoče trditi, da niso zelo uporabni in primerni za široko uporabo.
English: , except in instances where they may not be line with common agricultural practice in a particular Member State, for example, in Member States where manure trading is common and, hence, the farmer may not be the person spreading the manure, or in instances where the effect of the RMM has not been definitively demonstrated (e.g. buffer zones).
Slovenian: , razen v primerih, ko niso skladni z običajno kmetijsko prakso v določeni državi članici, na primer v državah članicah, kjer je pogosto trgovanje z gnojem, zaradi česar kmet ni nujno oseba, ki trosi gnoj, in v primerih, ko vpliv ukrepov za zmanjšanje tveganja ni bil nedvoumno dokazan (npr. varovalni pasovi).
English: The information provided indicates that there are errors and these are more pronounced for the sediment compartment and at low loadings.
Slovenian: Predloženi podatki kažejo, da so prisotne napake, ki so bolj izražene pri sedimentih in pri majhnih obremenitvah.
English: Therefore, it will only be a matter of time before any PNECs are exceeded in these compartments.
Slovenian: Zato je samo še vprašanje časa, kdaj bodo v teh delih okolja presežene vrednosti PNEC.
English: At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Slovenian: Trenutno ni jasno, kateri naj bi bil razumen najslabši možni scenarij izpostavljenosti glede na količino nanesenega gnoja.
English: Despite the data gap, it may be accepted that such a measure would, most likely, reduce run-off of zinc to watercourses.
Slovenian: Kljub pomanjkanju podatkov je mogoče zaključiti, da bi takšen ukrep zelo verjetno zmanjšal odtekanje cinka v vodotoke.
English: However, since the data search for the EU RAR (2010) was completed more data have become available (e.g. those used in establishing the UK Environmental Quality Standard
Slovenian: Vendar so po koncu zbiranja podatkov za poročilo EU RAR (2010) postali na voljo dodatni podatki (npr. podatki, ki so jih v Združenem kraljestvu uporabili za
English: No matter which model and application rates are used, a risk to the environment is calculated with only the time needed to arrive at this risk varying.
Slovenian: Ne glede na to, kateri model in odmerki se uporabijo, je pri izračunu tveganja za okolje samo vprašanje časa, kdaj se bo to tveganje spremenilo.
English: Therefore, the CVMP recommended the granting of the marketing authorisations for the veterinary medicinal products referred to in Annex I with amendments to the Summary of Product Characteristics and package leaflet of the reference Member State.
Slovenian: Odbor CVMP je zato priporočil odobritev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, navedenimi v Prilogi I, skupaj s spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
English: However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface water.
Slovenian: Vendar pa je bilo ugotovljeno, da je opredelitev tveganja za sedimente veliko bolj negotova kot za tla in površinske vode.
English: In major pig breeding regions stringent rules and controls on manure application are in place, although it is realised that this advice is followed on a voluntary basis and Good Agricultural Practice may vary throughout the Member States.
Slovenian: Na območjih, kjer poteka obsežna prašičereja, veljajo strožja pravila in nadzor nad uporabo gnojil, vendar je upoštevanje teh priporočil prostovoljno, dobra kmetijska praksa pa se med državami članicami razlikuje.
English: Manure containing zinc should not be spread on the same area of land in successive years to avoid accumulation of zinc which may cause adverse effects in the environment.
Slovenian: Gnoj, ki vsebuje cink, ne razvažati na iste površine v zaporednih letih, da se izognete zbiranju cinka, ki lahko povzroči škodljive vplive na okolje.
English: The proposed RMMs fulfil the criteria laid out in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6
Slovenian: Predlagani ukrepi za zmanjšanje tveganja izpolnjujejo merila iz smernic CVMP za oceno vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicam VICH GL6
English: A critical consideration in relation to assessing environmental risk of metals is determining their bioavailability.
Slovenian: Ključen dejavnik pri ocenjevanju tveganja za okolje, povezanega s kovinami, je določitev njihove biološke uporabnosti.
English: During the CMD(v) procedure Belgium concluded that a marketing authorisation for Gutal can be granted provided that RMMs are included in the product information.
Slovenian: Med postopkom skupine CMD(v) je Belgija zaključila, da se dovoljenje za promet z zdravilom Gutal lahko odobri pod pogojem, da se v informacije o zdravilu vključijo ukrepi za zmanjšanje tveganja.