FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from two clinical studies showed that women, who used another type of oestrogen/progestagen combination than the one in Activelle, had a slightly increased risk of cardiovascular disease in the first year of use.
Slovenian: Izsledki kliničnih študij so pokazali malenkost večje tveganje za srčnožilne bolezni v prvem letu uporabe pri ženskah, ki so jemale drugačno estrogensko-progestagensko kombinacijo, kot jo vsebuje zdravilo Activelle.
English: Spain - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Sweden - Activelle 0,5 mg/0,1 mg filmdragerade tabletter United Kingdom - Noviana film-coated tablets
Slovenian: Romunija - Noviana comprimate filmate Slovenija - Noviana™ filmsko obložene tablete Slovaška - Noviana filmom obalené tablety Španija - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Švedska - Activelle 0,5 mg/0,1 mg filmdragerade tabletter Velika Britanija- Noviana film-coated tablets
English: NAME OF THE MEDICINAL PRODUCT Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: NAVODILO ZA UPORABO Activelle in povezana imena (Glejte Dodatek I) 0,5 mg/0,1 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: Breakthrough bleeding and spotting may occur during the first months of treatment.
Slovenian: V prvih mesecih zdravljenja se lahko pojavijo vmesne krvavitve in krvavkast izcedek.
English: Vulvovaginal mycotic infection
Slovenian: Bolezni živčevja glavobol migrena omotica
English: • If you have endometrial hyperplasia (excessive growth of the womb lining) that is not being treated
Slovenian: • imate nezdravljeno hiperplazijo endometrija (čezmerno rast maternične sluznice),
English: Stroke
Slovenian: NALEPKA
English: For 1000 women who used oestrogen + progestagen combined HRT (CEE + MPA), the number of additional cases would be o Between 0 and 9 (best estimate = 4) for 5 years' use.
Slovenian: MPA) število dodatnih primerov med 0 in 9 (najboljša ocena = 4) za 5-letno uporabo.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edemi
English: Marketing authorisation holder and manufacturer
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
English: Activelle comprimés pelliculés
Slovenian: Activelle comprimés
English: • Dizziness
Slovenian: • zanosite,
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja srbenje ali urtikarija alopecija akne
English: cysts and polyps): Endometrial cancer
Slovenian: • Benigne in maligne neoplazme (vključno s cistami in polipi): rak na endometriju
English: o For users of oestrogen plus progestagen combined HRT,
Slovenian: • bi bilo pri 1.000 uporabnicah kombiniranega HNZ z estrogenom in progestagenom (KEE +
English: Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
Slovenian: 0,5 mg estradiola (v obliki hemihidrata) + 0,1 mg noretisteronacetata
English: GROUNDS
Slovenian: PODLAGA
English: • An irregular heartbeat.
Slovenian: • nereden srčni utrip.
English: A switch to a higher dose product, e.g. Activelle 1 mg/0.5 mg tablets, should be considered if the response after three months is insufficient for satisfactory symptom relief.
Slovenian: Če po treh mesecih ni zadovoljivega olajšanja simptomov, je možen prehod na zdravilo z večjim odmerkom, npr. tablete Activelle 1 mg/0,5 mg.
English: • Swelling or discomfort of the abdomen (stomach)
Slovenian: • otekanje ali nelagodje v trebuhu
English: Estradiol 0.5 mg (as hemihydrate) and norethisterone acetate 0.1 mg.
Slovenian: 0,5 mg estradiola (v obliki hemihidrata) in 0,1 mg noretisteronacetata.
English: Back pain Neck pain Pain in extremity
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v hrbtu bolečine v vratu bolečine v udih krči v nogah
English: Noviana filmtabletta Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
Slovenian: Norveška - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugalska - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película
English: Following oral administration of Activelle, 17β-estradiol is absorbed from the gastrointestinal tract, undergoes a first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration within 5-8 hours.
Slovenian: Podvržen je presnovi prvega prehoda v jetrih in drugih enteričnih organih.
English: The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Slovenian: Pogostnost neželenih učinkov, navedenih v nadaljevanju, je definirana v skladu z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnic) pogosti (pojavijo se pri 1 do 10 bolnic od 100) občasni (pojavijo se pri 1 do 10 bolnic od 1.000) redki (pojavijo se pri 1 do 10 bolnic od 10.000) zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnic) neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: EXPIRY DATE
Slovenian: Nastavite kazalec dneva
English: Other side effects of combined HRT
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: • Abdominal (stomach) pain
Slovenian: • bolečine v trebuhu
English: 28 film-coated tablets 3 x 28 film-coated tablets Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranj: - 1 × 28 filmsko obloženih tablet, - 3 x 28 filmsko obloženih tablet.
English: HOW TO STORE ACTIVELLE
Slovenian: SHRANJEVANJE ZDRAVILA ACTIVELLE
English: Pack sizes:
Slovenian: Navodilo vsebuje:
English: Adding a progestagen to oestrogen-only therapy greatly reduces this increased risk.
Slovenian: Povečanje tveganja se močno zmanjša, če je zgolj estrogenskemu zdravljenju dodan progestagen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: estradiol 0.5 mg (as hemihydrate), norethisterone acetate 0.1 mg
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 0,5 mg estradiola (v obliki hemihidrata) in 0,1 mg noretisteronacetata.
English: 6.3 Shelf life 30 months.
Slovenian: 6.3 Rok uporabnosti
English: The following side effects have been reported after taking medicines containing oestrogen/progestagens.
Slovenian: Drugi neželeni učinki kombiniranega HNZ Po uporabi estrogensko-progestagenskih zdravil so opisani naslednji neželeni učinki:
English: Route of administration
Slovenian: NAVODILO ZA UPORABO
English: Str. Izvor, Nr. 80, Et. 6-11
Slovenian: Izvor, Nr. 80, Et. 6-11
English: Marszałka J. Piłsudskiego 5 95-200 Pabianice
Slovenian: Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
English: Belgium TEVA PHARMA BELGIUM NV Laarstraat 16
Slovenian: TEVA PHARMA BELGIUM NV Laarstraat 16
English: 2614-504 Amadora Portugal
Slovenian: 2614-504 Amadora
English: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Slovenian: Portugalska Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa
English: 1070-274 Lisboa Portugal
Slovenian: 1070-274 Lisboa
English: Sweden sanofi-aventis AB Box 14142
Slovenian: Švedska sanofi-aventis AB Box 14142
English: Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Slovenian: Portugalska Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
English: Aurobindo Pharma (Portugal), Unipessoal Lda.
Slovenian: Portugalska Aurobindo Pharma (Portugal), Unipessoal Lda.
English: 2794-038 Carnaxide Portugal
Slovenian: 2794-038 Carnaxide
English: Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Slovenian: Latvija sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
English: Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
Slovenian: Portugalska Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
English: Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Slovenian: Danska sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
English: Luxembourg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Slovenian: Luksemburg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
English: Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Slovenian: Avstrija sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
English: Austria ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Slovenian: Avstrija ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
English: Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Slovenian: Nemčija neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
English: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Slovenian: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
English: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Slovenian: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
English: Cinfa Portugal, Lda.
Slovenian: Portugalska Cinfa Portugal, Lda.
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Slovenian: Portugalska Laboratórios Azevedos - Indústria Farmacêutica, S.A.
English: Meda Pharma - Produtos Farmacêuticos, S.A.
Slovenian: Portugalska Meda Pharma - Produtos Farmacêuticos, S.A.
English: Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Slovenian: Luksemburg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Slovenian: Luksemburg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Baarnsche Dijk 1 3741 LN BAARN The Netherlands
Slovenian: 3741 LN BAARN The Netherlands
English: Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Slovenian: SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark
Slovenian: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
English: Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Slovenian: MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Slovenian: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
English: Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Slovenian: Telecom Gardens Medialaan 40
English: Luxembourg Genthon BV Microweg, 22
Slovenian: Luksemburg Genthon BV Microweg, 22
English: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Slovenian: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
English: Sandoz Farmacêutica, Lda.
Slovenian: Portugalska Sandoz Farmacêutica, Lda.
English: Mylan, Lda.
Slovenian: Portugalska Mylan, Lda.
English: Sanofi - Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Sanofi - Produtos Farmacêuticos, Lda.
English: Genthon BV Microweg, 22
Slovenian: Nizozemska Genthon BV Microweg, 22
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Slovenian: Slovaška sanofi-aventis Slovakia s.r.o.
English: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Slovenian: 92931 Paris La Défense Cedex FRANCE
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Slovenian: Nizozemska ratiopharm Nederland B.V.
English: Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany
Slovenian: Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
English: Luxembourg Eurogenerics S.A. Esplanade Heysel, b22
Slovenian: Luksemburg Eurogenerics S.A. Esplanade Heysel, b22
English: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g.
Slovenian: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g. LT-09310 Vilnius Lithuania
English: Mylan B.V.
Slovenian: Nizozemska Mylan B.V.
English: Sandoz B.V.
Slovenian: Nizozemska Sandoz B.V.
English: Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal
Slovenian: Lagoas Park, Edifício 5 A, Piso 2
English: Veluwezoom 22 1327 AH ALMERE The Netherlands
Slovenian: 1327 AH ALMERE The Netherlands
English: Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal
Slovenian: Empreendimento Lagoas Park Edifício 7, 3º Piso
English: Czech Republic MEDA Pharma s.r.o.
Slovenian: MEDA Pharma s.r.o.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany
Slovenian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
English: VULM CZ, a.s. Olivova 1888 Ricany
Slovenian: Olivova 1888 Ricany
English: Sanofi Malta Ltd. St. Julian's Rd.
Slovenian: Sanofi Malta Ltd.
English: Belgium Eurogenerics S.A. Esplanade Heysel, b22
Slovenian: Nizozemska Eurogenerics S.A. Esplanade Heysel, b22
English: Meda Pharma B.V.
Slovenian: Nizozemska Meda Pharma B.V.
English: Synthon B.V.
Slovenian: Nizozemska Synthon B.V.
English: Zolpidem Genthion coated tablet oral use
Slovenian: Zolpidem Genthion obložena tableta peroralna uporaba
English: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Slovenian: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten šumeča tableta
English: Centrafarm B.V.
Slovenian: Nizozemska Centrafarm B.V.
English: Luxembourg Apotex Europe B.V. Darwinweg 20
Slovenian: Luksemburg Apotex Europe B.V.
English: 110 00 Prague 10
Slovenian: Kodaňská 1441/46 110 00 Prague 10
English: Actavis B.V.
Slovenian: Nizozemska Actavis B.V.
English: Stilnoct, tabletten 10 mg tablet oral use
Slovenian: Stilnoct, tabletten 10 mg tableta
English: Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Slovenian: Stilnoct 5mg fiilm-coated tablets obložena tableta peroralna uporaba
English: Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Slovenian: Takeda GmbH 2 Byk-Gulden Strasse
English: ADOH B.V.
Slovenian: Nizozemska ADOH B.V.
English: Zolpitop coated tablet oral use
Slovenian: Zolpitop obložena tableta peroralna uporaba
English: Šlandrova ulica 4
Slovenian: Swensweg 5
English: ADORMA 5 mg filmom obalené tablety 5 mg
Slovenian: ADORMA 5 mg filmom obalené tablety
English: Apotex Europe B.V. Darwinweg 20
Slovenian: Apotex Europe B.V.
English: Rua do Centro Cultural, 13 1749-066 Lisboa Portugal
Slovenian: 1749-066 Lisboa
English: ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona.
Slovenian: Osi, 7-9 Barcelona.
English: Zolsana 5 mg coated tablets coated tablet oral use
Slovenian: Zolsana 5 mg coated tablets obložena tableta peroralna uporaba
English: Stilnoct 10mg film-coated tablets coated tablet oral use
Slovenian: Stilnoct 10mg film-coated tablets obložena tableta peroralna uporaba
English: Czech Republic SANDOZ s.r.o.
Slovenian: SANDOZ s.r.o.
English: Zolsana 10 mg coated tablets coated tablet oral use
Slovenian: Zolsana 10 mg coated tablets obložena tableta peroralna uporaba
English: Czech Republic Apotex Europe B.V. Darwinweg 20
Slovenian: Nizozemska Apotex Europe B.V.
English: Sanval 10 mg filmsko obožene tablete 10 mg
Slovenian: Sanval 10 mg filmsko obožene tablete
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
Slovenian: Portugalska Generis Farmacêutica, S.A. Rua João de Deus, 19
English: EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
Slovenian: EDLUAR 10 mg nyelvalatti tabletta 10 mg podjezična tableta sublingvalna uporaba
English: Zolpidem "Hexal" - Filmtabletten
Slovenian: Zolpidem "Hexal" - Filmtabletten 10 mg
English: Italfarmaco S.p.A. Viale Fulvio 330 20126 Milano Italy
Slovenian: Viale Fulvio 330 20126 Milano Italy
English: ITALFARMACO S.p.A. Viale Fulvio Testi 330, 20126 Milano, Italy
Slovenian: Viale Fulvio Testi 330, 20126 Milano, Italy
English: Stilnoct coated tablet oral use
Slovenian: Stilnoct obložena tableta peroralna uporaba
English: Zolpeduar sublingual tablet sublingual use
Slovenian: Zolpeduar podjezična tableta sublingvalna uporaba
English: Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Slovenian: Zolpidemtartaat Actavis 5 mg, tabletten tableta
English: Sanval 10 mg filmom obložene tablete 10 mg
Slovenian: Sanval 10 mg filmom obložene tablete
English: Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Slovenian: Edluar 10 mg, tablet voor sublinguaal gebruik podjezična tableta sublingvalna uporaba
English: coated tablet oral use
Slovenian: obložena tableta peroralna uporaba
English: Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Slovenian: Edluar 5 mg, tablet voor sublinguaal gebruik podjezična tableta sublingvalna uporaba
English: Dodorest coated tablet oral use
Slovenian: Dodorest obložena tableta peroralna uporaba
English: Lunata 10 mg filmom obložene tablete 10 mg
Slovenian: Lunata 10 mg filmom obložene tablete
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet sublingual use
Slovenian: Edluar 10 mg Sublingualtabletten 10 mg podjezična tableta sublingvalna uporaba
English: Genthon GmbH Groesbeeker Weg, 1 D-47559 Kranenburg Germany
Slovenian: Portugalska Genthon GmbH Groesbeeker Weg, 1
English: Zolpidem-CT 5 mg Filmtabletten
Slovenian: Zolpidem-CT 5 mg Filmtabletten 5 mg
English: Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Slovenian: Zolpidemtartraat Actavis 10 mg, tabletten tableta
English: Edluar sublingual tablet sublingual use
Slovenian: Edluar podjezična tableta sublingvalna uporaba
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
Slovenian: Edluar 10 mg Sublingualtabletten 10 mg podjezična tableta peroralna uporaba
English: Zolpidem-Actavis 10 mg Filmtabletten 10 mg
Slovenian: Zolpidem-Actavis 10 mg Filmtabletten
English: Zolpidem Sandoz 10 mg Filmtabletten 10 mg
Slovenian: Zolpidem Sandoz 10 mg Filmtabletten
English: Zoldem 10 mg film coated tablets
Slovenian: Zoldem 10 mg film coated tablets 10 mg
English: sublingual tablet sublingual use
Slovenian: podjezična tableta sublingvalna uporaba
English: Edluar 10 mg podjezične tablete sublingual tablet sublingual use
Slovenian: Edluar 10 mg sublingual tablets podjezična tableta sublingvalna uporaba
English: Edluar 5 mg podjezične tablete sublingual tablet sublingual use
Slovenian: Edluar 5 mg sublingual tablets podjezična tableta sublingvalna uporaba
English: EDLUAR 5 mg nyelvalatti tabletta sublingual tablet sublingual use
Slovenian: EDLUAR 5 mg nyelvalatti tabletta 5 mg podjezična tableta sublingvalna uporaba
English: Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Slovenian: Švedska ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolpeduar sublingual tablet oral use
Slovenian: Zolpeduar podjezična tableta peroralna uporaba
English: Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Slovenian: Nemčija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Edluar 5mg sublingual tablets sublingual tablet oral use
Slovenian: Edluar 5mg sublingual tablets podjezična tableta peroralna uporaba
English: Finland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Slovenian: Finska ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolsana 5 mg filmsko obložene tablete 5 mg
Slovenian: Zolsana 5 mg filmsko obložene tablete
English: Zolsana 5 mg filmom obložene tablete 5 mg
Slovenian: Zolsana 5 mg filmom obložene tablete
English: Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
Slovenian: Zolpidemtartraat ratiopharm 5 mg, tabletten tableta
English: United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Slovenian: Velika Britanija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Edluar 5 mg sublingual tablets sublingual tablet oral use
Slovenian: Edluar 5 mg sublingual tablets podjezična tableta peroralna uporaba
English: INSOM 10 mg pezsgőtabletta effervescent tablet oral use
Slovenian: INSOM 10 mg pezsgőtabletta šumeča tableta
English: Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Slovenian: Zolpidemtartraat ratiopharm 10 mg, tabletten tableta
English: Edluar 10 mg sublingual tablets sublingual tablet oral use
Slovenian: Edluar 10 mg sublingual tablets podjezična tableta peroralna uporaba
English: Edluar 10mg sublingual tablets sublingual tablet oral use
Slovenian: Edluar 10mg sublingual tablets podjezična tableta peroralna uporaba
English: Stilnoct tablet oral use
Slovenian: Stilnoct tableta
English: tablet oral use
Slovenian: podjezična tableta peroralna uporaba
English: Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Slovenian: Nizozemska Sanofi-Aventis Netherlands B.V.
English: 10 mg/ml oral drops, solution oral use
Slovenian: 10 mg/ml peroralne kapljice, raztopina
English: The European Commission issued a decision on 5 October 2010.
Slovenian: Evropska komisija je odločbo izdala dne 5. oktobra 2010.
English: The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Slovenian: Družba je želela, da bi bilo dovoljenje za promet z zdravilom priznano v Bolgariji, Nemčiji, Franciji, na Irskem in v Italiji (v „zadevnih državah članicah“).
English: Kristina Dunder (Sweden)
Slovenian: Kristina Dunder (Švedska)
English: Daniela Melchiorri (Italy)
Slovenian: Daniela Melchiorri (Italija)
English: It is used to reduce the risk of fractures (in the hip and spine.
Slovenian: Uporablja se za zmanjšanje tveganja zlomov (kolkov in hrbtenice).
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je švedski regulatorni organ za zdravila dne 29. aprila 2010 zadevo napotil na CHMP v arbitražo.
English: Co-rapporteur:
Slovenian: Soporočevalka:
English: Blocking the action of these cells leads to less bone loss.
Slovenian: Zaviranje delovanja teh celic vodi do manjše izgube kostne mase.
English: 5 October 2010
Slovenian: 5. oktober 2010
English: Why was Norsed Combi D reviewed?
Slovenian: Zakaj je bilo zdravilo Norsed Combi D pregledano?
English: The grounds for the referral were concerns over the evidence provided of the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).
Slovenian: Razlogi za napotitev so bili zadržki glede dokazov o učinkovitosti tega kombiniranega zdravila, veljavnosti trditev, da ta način kombiniranja zdravilnih učinkovin bolnikom koristi bolj kot posamezne zdravilne učinkovine, ter veljavnosti trditev, da zdravilo izboljšuje vztrajanje bolnikov pri zdravljenju.
English: 20 May 2010
Slovenian: 20. maj 2010
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Slovenian: Ta zaustavlja delovanje osteoklastov, celic, ki sodelujejo pri razgradnji kostnega tkiva.
English: What is Norsed Combi D?
Slovenian: Kaj je zdravilo Norsed Combi D?
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Norsed Combi D outweigh its risks, and therefore the marketing authorisation for Norsed Combi D should be granted in all concerned Member States.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je CHMP zaključil, da koristi zdravila Norsed Combi D odtehtajo njegova tveganja, zato je treba odobriti dovoljenje za promet z zdravilom Norsed Combi D v vseh zadevnih državah članicah.