FrancophonIA/ELRC3.0 huggingface dataset:
English: nBDP is also indicated in allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhino-pharyngeal tract.
Slovenian: Zdravilo nBDP je indicirano tudi pri alergijskem in idiopatskem rinitisu ter vnetnih in alergijskih reakcijah nosnih votlin in nosno-žrelnega predela.
English: 4 Allergic Rhinitis and its Impact on Asthma (ARIA) guideline 2015: Available from http://www.whiar.org/Documents&Resources.php
Slovenian: Smernica za alergijski rinitis in njegov vpliv na astmo (Allergic Rhinitis and its Impact on Asthma - ARIA), 2015.
English: The package leaflet has been amended to reflect the changes of the SmPC
Slovenian: Navodilo za uporabo je spremenjeno tako, da izraža spremembe povzetka glavnih značilnosti zdravila.
English: Profita M. et al ‘ Effect of Nebulized Beclomethasone on Airway Inflammation and Clinical Status of Children with Allergic Asthma and Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Study'.
Slovenian: otrok z alergijsko astmo in rinitisom: randomizirana, dvojno slepa, s placebom nadzorovana študija).
English: The Netherlands ratiopharm Nederland bv
Slovenian: Nizozemska ratiopharm Nederland bv
English: CC Zaandam, The
Slovenian: CC Zaandam,
English: POSSIBLE SIDE EFFECTS Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila imajo lahko tudi obliži Fentanyl-ratiopharm neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: - asthma, respiratory depression or any lung disease - low blood pressure - impaired liver function - impaired kidney function - if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g.
Slovenian: - astma, depresija dihanja ali katero koli bolezen pljuč - nizek krvni tlak - okvarjeno delovanje jeter - okvarjeno delovanje ledvic - če ste imeli poškodovano glavo, možganski tumor ali znake povišanega intrakranialnega tlaka
English: 6.4 Special precautions for storage
Slovenian: Posebna navodila za shranjevanje
English: the CHMP has recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet which are set out in Annex III for Fentanyl-ratiopharm and associated names (see Annex I).
Slovenian: CHMP priporočil podelitev dovoljenj(a) za promet in dopolnitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, kot je podano v Dodatku III za zdravilo Fentanylratiopharm in z njim povezana imena (glejte Dodatek I).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYLRATIOPHARM AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA FENTANYLRATIOPHARM IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: - Če katerikoli neželeni učinek postane resen ali, če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Fentanyl ratiopharm 100 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 100 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 100 µg/uur, pleister voor transdermaal gebruik Velika Britanija Telfanyl 100 microgram/hr Transdermal patch
English: Fentanyl ratiopharm 75 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 75 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik Velika Britanija Telfanyl 75 microgram/hr Transdermal patch
English: Telfanyl 100 microgram/hr Transdermal patch (pending)
Slovenian: Telfanyl 100 microgram/hr Transdermal patch (v obravnavi)
English: Fentanyl ratiopharm 25 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 25 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik Velika Britanija Telfanyl 25 microgram/hr Transdermal patch
English: Telfanyl 75 microgram/hr Transdermal patch (pending)
Slovenian: Telfanyl 75 microgram/hr Transdermal patch (v obravnavi)
English: Fentanyl ratiopharm 50 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 50 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 50 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 50 µg/uur, pleister voor transdermaal gebruik Velika Britanija Telfanyl 50 microgram/hr Transdermal patch
English: Telfanyl 25 microgram/hr Transdermal patch (pending)
Slovenian: Telfanyl 25 microgram/hr Transdermal patch (v obravnavi)
English: Telfanyl 50 microgram/hr Transdermal patch (pending)
Slovenian: Telfanyl 50 microgram/hr Transdermal patch (v obravnavi)
English: Fentanyl-ratiopharm 100 µg/h Matrixpflaster and associated names (see Annex I)
Slovenian: Fentanyl-ratiopharm 100 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: Fentanyl-ratiopharm 75 µg/h Matrixpflaster and associated names (see Annex I)
Slovenian: Fentanyl-ratiopharm 75 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h Matrixpflaster and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: NAVODILO ZA UPORABO Fentanyl-ratiopharm 100 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: 50 µg/h transdermal patch transdermal use 8.25 mg/15 cm² which release 50 µg fentanyl per hour
Slovenian: Graf-Arco-Str. 3 89079 Ulm Nemčija ratiopharm 50 µg/h, dispositif transdermique obliž uporaba površina: 15 cm2) vsebuje 8,25 mg fentanila (ustreza hitrosti sproščanja učinkovine 50 mikrogramov/h).
English: Fentanyl-ratiopharm 50 µg/h Matrixpflaster and associated names (see Annex I)
Slovenian: Fentanyl-ratiopharm 50 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h Matrixpflaster and associated names (see Annex I) [See Annex I - To be completed nationally]
Slovenian: Fentanyl-ratiopharm 25 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h Matrixpflaster and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: Fentanyl-ratiopharm 75 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h Matrixpflaster and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: Fentanyl-ratiopharm 25 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: Albert-SchweitzerGasse 3, 1140 WIEN, Austria transdermales Matrixpflaster
Slovenian: Albert-SchweitzerGasse 3, 1140 WIEN, Avstrija µg/h transdermales Matrixpflaster vsebuje 4,125 mg fentanila (ustreza hitrosti sproščanja učinkovine 25 mikrogramov/h)
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 50 µg/h Matrixpflaster and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: Fentanyl-ratiopharm 50 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica] fentanil
English: Primary prevention
Slovenian: Primarna preventiva
English: This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.
Slovenian: Tega niso opazili v prej omenjenih podskupinah bolnikov z dislipidemijo, izostali pa so tudi jasni dokazi koristi pri ženskah z dislipidemijo, zdravljenih s fenofibratom in simvastatinom, pa tudi možnosti neželenih učinkov v teh podskupinah ni mogoče izključiti.
English: [Product name] belongs to a group of medicines commonly known as fibrates.
Slovenian: Zdravilo [Ime zdravila] spada v skupino zdravil, imenovanih fibrati.
English: After one year, the mean HDL-C level was 6% higher and the mean triglyceride level was 31% lower in the gemfibrozil group than in the placebo group.
Slovenian: Po enem letu je bila pri skupini z gemfibrozilom srednja vrednost HDL holesterola 6% višja, srednja vrednost trigliceridov pa 31% nižja v primerjavi s skupino s placebom.
English: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebocontrolled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin.
Slovenian: Preskušanje maščob v okviru preskušanja ACCORD (Action to Control Cardiovascular Risk in DiabetesACCORD) je bila randomizirana, s placebom kontrolirana študija pri 5.518 bolnikih s sladkorno boleznijo tipa 2, ki so bili poleg simvastatina dodatno zdravljeni s fenofibratom.
English: [Product name] may also be prescribed to people who cannot be prescribed other lipid-lowering medicines for lowering blood cholesterol levels.
Slovenian: [Ime izdelka] se lahko predpiše tudi ljudem, katerim ne moremo predpisati drugih zdravil za znižanje vrednosti holesterola v krvi.
English: - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
Slovenian: - mešana hiperlipidemija pri bolnikih z visokim tveganjem za kardiovaskularne dogodke dodatno k zdravljenju s statinu, kadar trigliceridi in holesterol HDL niso pod ustreznim nadzorom.
English: Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Slovenian: Analiza druge predhodno označene podskupine, opredeljene kot statistično značilna interakcija zdravljenja za spol (p = 0,01), kaže na možne koristi zdravljenja s kombinirano terapijo za moške (p = 0,037), a potencialno večje tveganje za primarni izid pri ženskah, zdravljenih s kombinirano terapijo v primerjavi s simvastatinom v monoterapiji (p = 0,069).
English: There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.
Slovenian: Obstajajo dokazi, da zdravljenje s fibrati lahko zmanjša dogodke povezane s koronarno boleznijo srca, ni pa dokazov, da fibrati zmanjšajo umrljivost zaradi vseh vzrokov pri primarni ali sekundarni preventivi kardiovaskularnih bolezni.
English: The VA-HIT study was a double-blind study comparing gemfibrozil (1200 mg per day) with placebo in 2531 men with a history of coronary heart disease, HDL-C levels of < 40 mg/dL (1.0 mmol/L), and normal LDL C levels.
Slovenian: Z dvojno slepo študijo VA-HIT so primerjali učinek gemfibrozila (1200 mg na dan) s placebom pri 2531 moških z anamnezo koronarne srčne bolezni, z vrednostjo HDL holesterola < 40 mg/dL (1,0 mmol/L) in z normalnimi vrednostmi LDL holesterola.
English: [Product name] is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
Slovenian: Zdravilo [Ime zdravila] je indicirano kot dodatek k dieti in drugim nefarmakološkim načinom zdravljenja (npr. telesna aktivnost, zmanjšanje telesne mase) za: - zdravljenje hude hipertrigliceridemije z nizkimi ali neznižanimi ravnmi HDL holesterola.
English: [Product name] can be used in addition to other medicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone.
Slovenian: [Ime zdravila] se lahko v nekaterih okoliščinah, ko ravni maščob v krvi niso pod nadzorom samo s statini, uporablja dodatno z drugimi zdravili [statini].
English: These medicines are used to lower the level of fats (lipids) in the blood.
Slovenian: Ta zdravila se uporabljajo za znižanje koncentracije maščob (lipidov) v krvi, na primer maščob, imenovanih trigliceridi.
English: Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event when a statin is contraindicated or not tolerated (see section 5.1).
Slovenian: Zmanjšanje srčnožilne umrljivosti pri moških s povišano vrednostjo ne-HDL holesteroloa in z visoko stopnjo tveganja za prvi srčnožilni dogodek, ko je statin kontraindiciran ali pa ga bolniki ne prenašajo.
English: Section 4.1 - Therapeutic indications (to replace current text)
Slovenian: Poglavje 4.1 - Terapevtske indikacije (zamenja trenutno besedilo)
English: [Product name] can be used when other medicines [statins] are unsuitable, to reduce the occurrence of heart problems in men who are at high risk and who have increased ‘bad cholesterol'
Slovenian: [Ime izdelka] se lahko uporablja za zmanjšanje pojavljanja težav s srcem pri moških z visokim tveganjem in s povišanim ‘slabim holesterolom', v primeru, ko druga zdravila niso ustrezna.
English: The primary event of non-fatal myocardial infarction or cardiac death occurred in 17.3% of gemfibrozil-treated and 21.7% of placebotreated patients (reduction in relative risk 22%; 95% CI, 7 to 35 %; P=0.006).
Slovenian: Primarni dogodek miokardnega infarkta brez smrtnega izida ali srčne smrti je nastopil pri 17,3% bolnikih, zdravljenih s gemfibrozilom in pri 21,7% bolnikih s placebom (22% relativno zmanjšanje tveganja; 95% CI, 7 do 35 %; P=0.006).
English: Section 5.1 - Pharmacodynamic properties (in addition to current text)
Slovenian: Poglavje 5.1 - Farmakodinamične lastnosti (dodatno k trenutnemu besedilu)
English: In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; absolute risk reduction: 4.95%).
Slovenian: V predhodno označeni podskupini bolnikov z dispilidemijo, opredeljenih kot bolniki z najnižjim tercilom HDL-C (≤ 34 mg/dl ali 0,88 mmol/l) in najvišjim tercilom TG (≥ 204 mg/dl ali 2,3 mmol/l) ob izhodišču, je zdravljenje s fenofibratom in simvastatinom pokazalo 31 % relativno zmanjšanje v primerjavi s simvastatinom v monoterapiji za sestavljen primarni izid (razmerje tveganja [RT] 0,69, 95 % IZ 0,49-0,97, p = 0,03; absolutno zmanjšanje tveganja: 4,95 %).
English: Among secondary outcomes, patients treated with gemfibrozil experienced relative risk reductions of 25% (95% CI -647%, p=0.10) for stroke, 24% (95% CI 11-36%, p< 0.001) for the combined outcome of death from CHD, non-fatal myocardial infarction, or confirmed stroke, 59% (95% CI 33-75%, p< 0.001) for transient ischaemic attack, and 65% (95% CI 37-80%, p< 0.001) for carotid endarterectomy.
Slovenian: Med sekundarnimi izsledki so pri bolnikih, zdravljenih z gemfibrozilom, ugotovili relativno zmanjšanje tveganja za kap 25% (95% CI -6-47%, p=0.10), za skupno število smrti zaradi CHD, miokardnega infarkta brez smrtnega izida ali potrjene kapi 24% (95% CI 11-36%, p< 0.001), za tranzitorno ishemično atako 59% (95% CI 33-75%, p< 0.001) in za karotidno endarterektomijo 65% (95% CI 37-80%, p< 0.001).
English: - Primary hypercholesterolaemia when a statin is contraindicated or not tolerated.
Slovenian: - Pri primarni hiperholesterolemiji, ko je statin kontraindiciran ali pa ga bolniki ne prenašajo.
English: Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, nonfatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%).
Slovenian: Zdravljenje s fenofibratom in simvastatinom ni pokazalo značilnih razlik v primerjavi s simvastatinom v monoterapiji pri sestavljenem primarnem izidu miokardinega infarkta in kapi brez smrtnega izida, in kardiovaskularno smrtjo (razmerje tveganja [RT] 0,92, 95 % IZ 0,79-1,08, p = 0,32; absolutno zmanjšanje tveganja: 0,74 %).
English: Amendments to be included in the relevant sections of the package leaflet for gemfibrozil containing medicinal products
Slovenian: Dopolnitve, ki jih je potrebno vključiti v ustrezna poglavja navodila za uporabo pri zdravilih, ki vsebujejo učinkovino gemfibrozil
English: Amendments to be included in the relevant sections of the summary of product characteristics for gemfibrozil containing medicinal products
Slovenian: Dopolnitve, ki jih je potrebno vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila, ki vsebuje učinkovino gemfibrozil
English: - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Slovenian: - zdravljenje mešane hiperlipidemije, kadar je zdravljenje s statini kontraindicirano ali jih bolnik ne prenaša.
English: [Product name] is used, alongside a low fat diet and other non-medical treatment such as exercise and weight loss, to lower levels of fat in the blood.
Slovenian: Zdravilo [Ime zdravila] se uporablja skupaj z dieto z malo maščobami in drugimi načini zdravljenja brez zdravil (npr. telesna aktivnost in zmanjšanje telesne mase) za zmanjšanje koncentracije maščob v krvi.
English: Amendments to be included in the relevant sections of the package leaflet for fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) containing medicinal products
Slovenian: Dopolnila, ki se vključijo v ustrezna poglavja Navodila za uporabo zdravil z zdravilno učinkovino fenofibrat (100, 300, 67, 200, 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete)
English: Amendments to be included in the relevant sections of the summary of product characteristics for fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) containing medicinal products
Slovenian: Dopolnila, ki se vključijo v ustrezna poglavja Povzetka glavnih značilnosti za zdravila z zdravilno učinkovino fenofibrat (100, 300, 67, 200, 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete)
English: Amendments to be included in the relevant sections of the summary of product characteristics for bezafibrate, ciprofibrate and fenofibrate (267 mg capsules and 215 mg film coated tablets) containing medicinal products
Slovenian: Dopolnila, ki se vključijo v ustrezna poglavja Povzetka glavnih značilnosti za zdravila z zdravilno učinkovino bezafibrat, ciprofibrat in fenofibrat (267 mg kapsule in 215 mg filmsko obložene tablete)
English: Amendments to be included in the relevant sections of the package leaflet bezafibrate, ciprofibrate and fenofibrate (267 mg capsules and 215 mg film coated tablets) containing medicinal products
Slovenian: Dopolnila, ki se vključijo v ustrezna poglavja Navodila za uporabo za zdravila z zdravilnimi učinkovinami bezafibrat, ciprofibrat in fenofibrat (267 mg kapsule in 215 mg filmsko obložene tablete)
English: What is [Product name] and what it is used for [Product name] belongs to a group of medicines, commonly known as fibrates.
Slovenian: Kaj je zdravilo [ime zdravila] in za kaj ga uporabljamo
English: Annex III Amendments to the summaries of product characteristics and package leaflets
Slovenian: Skupna dopolnila, ki se vključijo v ustrezna poglavja Povzetka glavnih značilnosti zdravila in Navodila za uporabo
English: Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE
Slovenian: Olinka (UK) Limited 38/40 Chamberlayne Road London, Velika Britanija NW10 3JE
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PANTOPRAZOLE OLINKA AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PANTOPRAZOLE OLINKA IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Czech Republic, Germany, Poland and Slovak Republic.
Slovenian: Referenčna država članica decentraliziranega postopka za uporabo zdravila Pantoprazole Olinka je bila Združeno kraljestvo, zadevne države članice pa so bile Češka republika, Nemčija, Poljska in Slovaška.
English: Within the response, the Applicant submitted also the results of the confirmatory bioequivalence study (2009-2106) with sampling period up to 30 hours.
Slovenian: Odgovoru je predlagatelj priložil tudi rezultate potrditvene bioekvivalenčne študije (2009-2106) z obdobjem vzorčenja do 30 ur.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Introduction to the Study - PAN-2006-006, Food Interaction The Applicant presented the main analysis of the plasma samples excluding outliers in study PAN-2006/006 and also the analysis of the whole sample including all cases.
Slovenian: Uvod v študijo - PAN-2006-006, medsebojno delovanje s hrano Predlagatelj je predstavil glavno analizo vzorcev plazme, razen osamelcev, v študiji PAN-2006/006 in analizo celotnega vzorca, vključno z vsemi primeri.
English: The basis of Pantoprazole Olinka application is the establishment of bioequivalence between the proposed generic formulation and the originator (Pantecta 40 mg by Altana Pharma AG, Spain).
Slovenian: Podlaga vloge za zdravilo Pantoprazole Olinka je vzpostavitev bioekvivalence med predlagano generično formulacijo in originatorskim zdravilom (Pantecta 40 mg družbe Altana Pharma AG, Španija).
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure as mentioned in Annex III for Pantoprazole Olinka and associated names (see Annex I).
Slovenian: Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so enaki zadnjim različicam, pripravljenim v postopku usklajevalne skupine in navedenim v Dodatku III za zdravilo Pantoprazole Olinka in z njim povezana imena (glejte Dodatek I).
English: Olinka submitted two bioequivalence studies which compared the proposed 40 mg formulation to the reference product, Pantecta 40 mg gastro-resistant tablets; one study was conducted under fasting conditions [PAN-2006/007] and the other study under the fed condition [PAN-2006/006].
Slovenian: Za zdravilo Pantoprazole Olinka sta bili predloženi dve bioekvivalenčni študiji, v katerih so primerjali predlagano formulacijo 40 mg z referenčnim zdravilom Pantecta 40 mg gastrorezistentnimi tabletami; ena študija je bila izvedena na tešče [PAN-2006/007], druga po zaužitju hrane [PAN-2006/006].
English: Standard criteria for bioequivalence were used i.e. the 90 % CI for the AUC and Cmax ratios must lie within the accepted range of 80.00-125.00.
Slovenian: Uporabljena so bila standardna merila bioekvivalence tj. 90 % intervalov zaupanja za razmerja AUC in Cmaks mora biti v sprejemljivem razponu 80,00-125,00.
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OVOJNINA IN NAVODILO ZA UPORABO
English: Gastro-resistant tablet
Slovenian: Gastorezistentne tablete Peroralna uporaba
English: Final study report should be submitted by 31 December
Slovenian: Končno poročilo o študiji je treba predložiti do 31. decembra