natgillin/translations-raw huggingface dataset:
Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7 82031 Grünwald Germany 
Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7 82031 Grünwald Germany feksofenadin
3771 ME Barneveld The Netherlands 
3771 ME Barneveld The Netherlands feksofenadin
Waymade PLC Sovereign House Miles Grat Road, Basildon Essex SS14 3FR United Kingdom 
Waymade PLC Sovereign House Miles Grat Road, Basildon Essex SS14 3FR United Kingdom venlafaksin hidroklorid
50-507 Wrocław Poland 
50-507 Wrocław Poland desloratadin
Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal 
Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide
Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom 
Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom klopidogrel
DK-5260 Odense S Denmark 
DK-5260 Odense S Denmark feksofenadin
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania 
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania telmisartan
Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal 
Couceiro, 29 - Venda Nova 2700-451 Amadora
Eurogenus Farmacêutica, Sociedade Unipessoal, Lda. 
Portugalska Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Athenry Road, Loughrea, Co Galway Ireland 
Athenry Road, Loughrea, Co Galway Ireland feksofenadin
Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda. 
Portugalska Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Chanelle Medical Dublin road Loughrea, Co. Galway Ireland 
Chanelle Medical Dublin road Loughrea, Co. Galway Ireland feksofenadin
Doc Generici SRL Via Turati, 40 20121 Milano Italy 
Doc Generici SRL Via Turati, 40 20121 Milano Italy desloratadin
Sandoz Farmaceutica Lda. 
Portugalska Sandoz Farmaceutica Lda.
115 Narborough Road Leicester, LE3 0PA United Kingdom 
115 Narborough Road Leicester, LE3 0PA United Kingdom metformin hidroklorid
Alembic Pharmaceuticals Europe Limited Palazzo Pietro Stiges, 103, Strait Street 
Palazzo Pietro Stiges, 103, Strait Street
Germed Farmacêutica, Lda. 
Portugalska Germed Farmacêutica, Lda.
22, quai Galliéni 92150 Suresnes France 
22, quai Galliéni 92150 Suresnes France desloratadin
Farmalider, S.A. Aragoneses 15 28108 Madrid Spain 
Farmalider, S.A. Aragoneses 15 28108 Madrid Spain valsartan/hidroklorot iazid
Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom 
Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom feksofenadin
Capsule, hard Oral use 
Kapsula, trda Peroralna uporaba
Radnička cesta 47 Zagreb 10000 Croatia 
Radnička cesta 47 Zagreb 10000 Croatia tramadol/paracetam ol
Maksimirska 120 Zagreb 10000 Croatia 
Maksimirska 120 Zagreb 10000 Croatia trimetazidin hidroklorid
Forum Products Limted Crown House 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom 
Forum Products Limted Crown House 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom venlafaksinijev klorid Foraven XL 150mg Modified Release
Labormed Pharma SA Bd. Theodor Pallady nr. 44 B 032266, sector 3, Bucureşti România 
Labormed Pharma SA Bd. Theodor Pallady nr. 44 B 032266, sector 3, Bucureşti România desloratadin
20142 Milan Italy 
20142 Milan Italy feksofenadin
Metoclopramide Orifarm 10 mg Tablet 
Metoclopramide Orifarm 10 mg Tableta
Auden McKenzie Limited McKenzie House Bury Street, Ruislip Middlesex HA4 7TL United Kingdom 
Auden McKenzie Limited McKenzie House Bury Street, Ruislip Middlesex HA4 7TL United Kingdom klobazam
Zydus France Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France 
Zydus France Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France desloratadin
00-777 Warszawa Poland 
00-777 Warszawa Poland desloratadin
Plom 2-4, 5º Planta 8038 Barcelona Spain 
Plom 2-4, 5º Planta 8038 Barcelona Spain esomeprazol
Teva Pharma - Produtos Farmacêuticos,Lda. 
Portugalska Teva Pharma - Produtos Farmacêuticos,Lda.
TioFarma b.v. 
Nizozemska TioFarma b.v.
DE-22765 Hamburg Germany 
DE-22765 Hamburg
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom 
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom valsartan
92931 La Défense Cedex France 
92931 La Défense Cedex France feksofenadin
Czech Republic Bluefish Pharmaceuticals AB Torsgatan 11 
Nizozemska Bluefish Pharmaceuticals AB Torsgatan 11
92707 Colombes Cedex 
92707 Colombes Cedex feksofenadin
04-790 Warszawa Poland 
04-790 Warszawa Poland desloratadin
SE-104 35 Stockholm Sweden 
SE-104 35 Stockholm Sweden feksofenadin
01-919 Warszawa Poland 
01-919 Warszawa Poland desloratadin
Czech Republic Labormed-Pharma, SA Theodor Pallady, 44B 032266 Bucharest 
Portugalska Labormed-Pharma, SA Theodor Pallady, 44B 032266 Bucharest
Alendronic acid Alendronato Pensa 70 mg compresse 
Italy alendronska kislina Alendronato Pensa 70 mg compresse
821 02 Bratislava 
821 02 Bratislava Slovak Republic desloratadin
Germany betapharm Arzneimittel GmbH Kobelweg 95 
Nemčija betapharm Arzneimittel GmbH
Labormed-Pharma, SA Theodor Pallady, 44B 032266 Bucharest Romania 
Labormed-Pharma, SA Theodor Pallady, 44B 032266 Bucharest Romania desloratadin
Alendronic acid Alendronat Accord Veckotablett 
United Kingdom alendronska kislina Alendronat Accord Veckotablett
0,5 mg Tablet 
0,5 mg Tableta
50-984 Wrocław Poland 
50-984 Wrocław Poland feksofenadinijev klorid
Donepezil/Generics 
ESOMEPRAZOLE/ GENERICS
2,5 mg Tablet 
2,5 mg Tableta
Alendronic acid ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG 
Spain alendronska kislina ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal atorvastatin
200 mg Capsule, hard Oral use 
200 mg Kapsula, trda Peroralna uporaba
Ciprofloxacin 
Germany ciprofloksacin
Alendronic acid Ácido alendrónico Labesfal tablet 
Portugal alendronska kislina Ácido alendrónico Labesfal
Alendronic acid Alendronic Acid Once Weekly 70 mg Tablets 
United Kingdom alendronska kislina Alendronic Acid Once Weekly 70 mg Tablets
Valsartan/Hydrochlorothiaz ide Fair-Med 160 mg/12.5 mg film-coated tablets. 
Valsartan/Hydrochloroth iazide Fair-Med 160 mg/12.5 mg film-coated tablets.
Levodopa/carbidop a/entacapone 
Portugal levodopa/karbidopa/ entakapon
Bendroflumethiazide Bendroflumetiazid Alternova 
DK-4230 Skælskør Denmark bendroflumetiazid Bendroflumetiazid Alternova
Alendronic acid alendronic acid 70mg Once Daily Tablets 
United Kingdom alendronska kislina alendronic acid 70mg Once Daily Tablets
Orodispersible tablet 
Orodisperzibilna tableta
Clonazepam Clonazepam Sandoz 0,5 mg, tabletten 
1327 AH Almere The Netherlands klonazepam Clonazepam Sandoz 0,5 mg, tabletten
0,06 mg Orodispersible tablet 
0,06 mg Orodisperzibilna tableta
Alendronic acid alendronic acid 10mg Tablets 
United Kingdom alendronska kislina alendronic acid 10mg Tablets
150 mg Capsule, hard Oral use 
150 mg Kapsula, trda Peroralna uporaba
0,24 mg Orodispersible tablet 
0,24 mg Orodisperzibilna tableta
Alendronic acid Alendroninezuur 70 Ranbaxy, tabletten 70 mg 
Untied Kingdom alendronska kislina Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Escitalopram oxalate 
Greece escitalopramijev oksalat
Valsartan/hydrochl orothiazide 
Germany valsartan/hidroklorot iazid
Teva Nederland B.V. Swensweg 5 
Nizozemska Teva Nederland B.V.
2,5 mg Orodispersible tablet 
2,5 mg Orodisperzibilna tableta
Clonazepam Clonazepam Sandoz 2 mg, tabletten 
1327 AH Almere The Netherlands klonazepam Clonazepam Sandoz 2 mg, tabletten
Laboratórios Anova - Produtos Farmacêuticos, Lda. 
Portugalska Laboratórios AnovaProdutos Farmacêuticos, Lda.
Venlagamma 37,50 mg 37,5 mg Prolongedreleased capsule, hard 
Venlagamma 37,50 mg 37,5 mg Kapsula s podaljšanim sproščanjem, trda
Veluwezoom 22 1327 AH Almere The Netherlands 
1327 AH Almere The Netherlands klobazam
Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/25 mg film-coated tablets 
Valsartan/Hydrochloroth iazide Fair-Med 320 mg/25 mg film-coated tablets
Alendronic acid Alendroninezuur Accord 10mg Tabletten 
United Kingdom alendronska kislina Alendroninezuur Accord 10mg Tabletten
Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom 
Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom repaglinid
Fexofenadine 
Portelinha
0,12 mg Orodispersible tablet 
0,12 mg Orodisperzibilna tableta
Slovak Republic Alkaloid - INT d.o.o. 
Portugalska Alkaloid - INT d.o.o.
Generis Farmacêutica, S. A. Rua João de Deus, 19 2700-487 Amadora Portugal 
Portugalska Generis Farmacêutica, S. A. Rua João de Deus, 19
Donepezil Mylan 10 mg orodisperzibilne tablete 
Donepezil Odis Mylan 10 mg Orodisperzibilna tableta
Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg 
Valsartan/Hydrochloroth iazide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg
Bosentan Abdi 125 mg potahované tablety 
Portugal bosentan monohidrat Bosentan Abdi 125 mg potahované tablety
Venlafaxina Eurogenus 37,5 mg Prolongedreleased capsule, hard 
Venlafaxina Eurogenus 37,5 mg Kapsula s podaljšanim sproščanjem, trda
VENLAFAXINA PENSA 75 mg Prolongedreleased capsule, hard 
VENLAFAXINA PENSA 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlafaxina Eurogenus 75 mg Prolongedreleased capsule, hard 
Venlafaxina Eurogenus 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlafaxina Eurogenus 150 mg Prolongedreleased capsule, hard 
Venlafaxina Eurogenus 150 mg Kapsula s podaljšanim sproščanjem, trda
VENLAFAXINA PENSA 150 mg Prolongedreleased capsule, hard 
VENLAFAXINA PENSA 150 mg Kapsula s podaljšanim sproščanjem, trda
15 mg Gastro - resistant tablet 
15 mg Gastrorezistentn a tableta
15 mg Prolongedreleased capsule, hard 
15 mg Kapsula s podaljšanim sproščanjem, trda
Alendronic acid Alendroninezuur Accord 70mg Tabletten 
United Kingdom alendronska kislina Alendroninezuur Accord 70mg Tabletten
Desloratadine 
Croatia desloratadin
150mg Prolongedreleased capsule, hard 
150mg Kapsula s podaljšanim sproščanjem, trda
75 mg Prolongedreleased capsule, hard 
75 mg Kapsula s podaljšanim sproščanjem, trda
1526 Ljubljana Slovenia 
1526 Ljubljana Slovenia trimetazidin hidroklorid
Donepezil 
Portugal donepezil
Fluconazole 150mg capsule 150 mg Capsule, hard Oral use 
Fluconazol Bluefish 150 mg Kapsula, trda Peroralna uporaba
VENLAFAXINE ORION 75 mg Prolongedreleased capsule, hard 
VENLAFAXINE ORION 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlagamma 150 mg 150 mg Prolongedreleased capsule, hard 
VENLAGAMMA 150 MG 150 mg Kapsula s podaljšanim sproščanjem, trda
VENLAGAMMA 150 MG 150 mg Prolongedreleased capsule, hard 
Venlagamma 150 mg 150 mg Kapsula s podaljšanim sproščanjem, trda
Trimetazidine dihydrochloride 
Hungary trimetazidin dihidroklorid
Escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete 
Radnička cesta 47 Zagreb 10000 Croatia escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Trimetazidine hydrochloride 
United Kingdom trimetazidin hidroklorid
VENLAGAMMA 75 MG 75 mg Prolongedreleased capsule, hard 
VENLAGAMMA 75 MG 75 mg Kapsula s podaljšanim sproščanjem, trda
Bosentan Abdi 62,5 mg potahované tablety 
Portugal bosentan monohidrat Bosentan Abdi 62,5 mg potahované tablety
VENLAFAXINE ORION 37,5 mg Prolongedreleased capsule, hard 
VENLAFAXINE ORION 37,5 mg Kapsula s podaljšanim sproščanjem, trda
37,5 mg Prolongedreleased capsule, hard 
37,5 mg Kapsula s podaljšanim sproščanjem, trda
Belgium Takeda Belgium Gentsesteenweg 615 
Takeda Belgium Gentsesteenweg 615 1080 Brussels Belgium alendronska kislina Alendromono
VENLAFAXINE ORION 150 mg Prolongedreleased capsule, hard 
VENLAFAXINE ORION 150 mg Kapsula s podaljšanim sproščanjem, trda
Bosentan Sandoz 125 mg 
Czech Republic bosentan monohidrat Bosentan Sandoz 125 mg
Desloratadine Labormed 2,5 mg Orodispersible tablet 
Desloratadine Labormed 2,5 mg Orodisperzibilna tableta
Alendronic acid ALENDRONIC ACID ACCORD 70mg 
United Kingdom alendronska kislina ALENDRONIC ACID ACCORD 70MG
Bosentan Sandoz 62,5 mg 
Czech Republic bosentan monohidrat Bosentan Sandoz 62,5 mg
200 mg Modified - release capsule, hard 
200 mg Kapsula s prirejenim sproščanjem, trda
Alendronic acid Ácido alendrónico Accord 70 mg tablet 
United Kingdom alendronska kislina Alendronic Acid Accord 70 mg Tableta
150 mg Prolongedreleased capsule, hard 
150 mg Kapsula s podaljšanim sproščanjem, trda
Alendronic acid ALENDRONATO AHCL 
United Kingdom alendronska kislina ALENDRONATO AHCL 10 mg Tableta
Venlafaxina Bluepharma 37,5 mg Prolongedreleased capsule, hard 
Venlafaxina Bluepharma 37,5 mg Kapsula s podaljšanim sproščanjem, trda
Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use 
0,5 mg Kapsula, trda Peroralna uporaba
37,5 mg Prolongedrelease tablet 
37,5 mg Tableta s podaljšanim sproščanjem
Donezil 
Carnaxide
100 mg Tablet 
10 mg Tableta
Venlafaxina Bluepharma 75 mg Prolongedreleased capsule, hard 
Venlafaxina Bluepharma 75 mg Kapsula s podaljšanim sproščanjem, trda
Desloratadina Labesfal OD 2,5 mg Orodispersible tablet 
Desloratadina Labormed 2,5 mg Orodisperzibilna tableta
Metoclopramide hydrochloride 
United Kingdom metoklopramid hidroklorid
Venlafaxine Bluefish XL 75 mg Prolongedreleased capsule, hard 
Venlafaxine Bluefish XL 75 mg Kapsula s podaljšanim sproščanjem, trda
Phenoxymethylpenicillin 250mg Film-coated Tablets 
TW4 5DQ Middlesex United Kingdom fenoksimetil penicilin Phenoxymethylpenicillin 250mg Film-coated
Quetiapina Daquimed 
Portugal kvetiapin
Venlafaxina Bluepharma 150 mg Prolongedreleased capsule, hard 
Venlafaxina Bluepharma 150 mg Kapsula s podaljšanim sproščanjem, trda
Clindamycin hydrochloride 
Slovenia trimetazidin dihidroklorid
30 mg Gastro - resistant tablet 
30 mg Gastrorezistentn a tableta
Iceland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany 
Islandija ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany desloratadin
BOSENTAN SANDOZ 62,5 mg Film - coated tablet 
BOSENTAN SANDOZ 62,5 mg Filmsko obložena tableta
Scored tablet 
Filmom obalená tableta
France ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany 
Francija ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany nebivolol
Venlafaxina Bluefish XR 75 mg Prolongedreleased capsule, hard 
Venlafaxina Bluefish XR 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlafaxine Bluefish XL 150 mg Prolongedreleased capsule, hard 
Venlafaxine Bluefish XL 150 mg Kapsula s podaljšanim sproščanjem, trda
37,5 mg Prolongedrelease capsule 
37,5 mg Kapsula s podaljšanim sproščanjem
Alendronic acid ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG 
46015- Valencia (Valencia) Spain alendronska kislina ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Clindamycin Alternova 
Germany levocetirizin
Norway ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany 
Norveška ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany desloratadin
Irbesartan/hydroch lorothiazide 
Romania irbesartan/hidrokloro tiazid
Germany ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany 
Nemčija ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany nebivolol
VENLAFAXINE FAIR-MED 37,5 mg Prolongedrelease capsule, hard 
Venlafaxine Fair-Med 37,5 mg Kapsula s podaljšanim sproščanjem, trda
REPAGLINIDE MYLAN 0,5 mg Tablet 
REPAGLINIDE MYLAN 0,5 mg Tableta
75 mg Prolongedrelease capsule 
75 mg Kapsula s podaljšanim sproščanjem
Fluconazole 
Portugal flukonazol
Venlafaxina Bluefish XR 150 mg Prolongedreleased capsule, hard 
Venlafaxina Bluefish XR 150 mg Kapsula s podaljšanim sproščanjem, trda
Wałbrzyska 13 
Veluwezoom 22
Finland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany 
Finska ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany desloratadin
BOSENTAN SANDOZ 125 mg Film - coated tablet 
BOSENTAN SANDOZ 125 mg Filmsko obložena tableta
VENLAFAXINE FAIR-MED 150 mg Prolongedrelease capsule, hard 
Venlafaxine Fair-Med 150 mg Kapsula s podaljšanim sproščanjem, trda
Levetiracetam Levetiracetam-Generics 750 mg Film - coated tablet 
Levetiracetam-Generics 750 mg Filmsko obložena tableta
Alendronic acid Alendromono 
United Kingdom alendronska kislina Ácido alendrónico Accord
Venlafaxine hydrochloride 
Portugal venlafaksinijev klorid Venlafaxina Labesfal
Cefpodoxima Alkaloid 
Italy metoklopramid
75 mg Modified - release capsule, hard 
75 mg Kapsula s prirejenim sproščanjem, trda
Fexofenadina Mylan 120 mg Film - coated tablet 
Fexofenadina Mylan 120 mg Filmsko obložena tableta
Bosentan 
Bulgaria bosentan
Levetiracetam Levetiracetam-Generics 500 mg Film - coated tablet 
Levetiracetam-Generics 500 mg Filmsko obložena tableta
Desloratadine Ratiopharm 5 mg 
Desloratadine Apotex 5 mg
This is repeated every 21 days for six courses or until the disease gets worse. 
To je treba ponoviti na vsakih 21 dni, skupaj šestkrat ali dokler se stanje bolezni ne poslabša.
It is used on its own to treat patients with: 
Uporablja se kot samostojno zdravilo za zdravljenje bolnikov:
The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Potactasol, veljavno po vsej Evropski uniji, izdala 6. januarja 2011.
The full EPAR for Potactasol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Potactasol je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What are the benefits and risks of Potactasol? 
Kakšne so koristi in tveganja, povezani z zdravilom Potactasol?
The company has provided data from the published literature on topotecan. 
Družba je predstavila podatke o topotekanu iz objavljene literature.
This is a summary of the European public assessment report (EPAR) for Potactasol. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Potactasol.
This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Hycamtin.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Potactasol. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For more information about treatment with Potactasol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Potactasol preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy. 
Zdravljenje z zdravilom Potactasol lahko poteka samo pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix). 
Zdravilo se uporablja tudi skupaj s cisplatinom (drugo vrsto zdravila proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v napredovalem stadiju (rak se je razširil zunaj materničnega vratu).
Other information about Potactasol 
Druge informacije o zdravilu Potactasol
Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Potactasol generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Potactasol be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Potactasol izda dovoljenje za promet.
Potactasol also affects non-cancer cells, which causes side effects. 
Zdravilo Potactasol vpliva tudi na nerakave celice, kar povzroča neželene učinke.
The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Potactasol primerljivo z zdravilom Hycamtin.
It is available as a powder to be made up into a solution for infusion (drip) into a vein. 
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient's weight and height. 
Odmerek zdravila Potactasol je odvisen od vrste raka, ki se zdravi, ter bolnikove telesne mase in višine.
When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1). 
Če se zdravilo Potactasol uporablja skupaj s cisplatinom za zdravljenje raka materničnega vratu, se daje v obliki infuzije 1., 2. in 3. dan (cisplatin se daje 1. dan).
For both ovarian and lung cancer, Potactasol is given every day for five days with a three-week interval between the start of each course. 
Pri raku jajčnikov in pljučnem raku se zdravilo Potactasol daje vsak dan pet dni, čemur sledi tritedenski premor pred pričetkom novega cikla zdravljenja.
The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'. 
Zdravilna učinkovina zdravila Potactasol, topotekan, je zdravilo za zdravljenje raka, ki spada v skupino zaviralcev topoizomeraze.
Why has Potactasol been approved? 
Zakaj je bilo zdravilo Potactasol odobreno?
When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes. 
Če se rak jajčnikov zdravi zgolj z zdravilom Potactasol, se ta daje z več kot 30-minutno infuzijo.
Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Hycamtin, odtehtajo znana tveganja.
Potactasol is a ‘generic medicine'. 
Zdravilo Potactasol je „generično zdravilo“.
Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects. 
Glede na neželene učinke bo morda treba odmerke zdravila Potactasol prilagoditi ali zdravljenje odložiti.
Potactasol is a medicine that contains the active substance topotecan. 
Potactasol je zdravilo, ki vsebuje zdravilno učinkovino topotekan.
No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin. 
Ker je zdravilo Potactasol generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, niso bile potrebne nobene dodatne študije.
How has Potactasol been studied? 
Kako je bilo zdravilo Potactasol raziskano?
What is Potactasol used for? 
Za kaj se zdravilo Potactasol uporablja?
What is Potactasol? 
Kaj je zdravilo Potactasol?
Potactasol is a cancer medicine. 
Potactasol je zdravilo proti raku.
How is Potactasol used? 
Kako se zdravilo Potactasol uporablja?
How does Potactasol work? 
Kako zdravilo Potactasol deluje?
Route of Administration 
Velikost pakiranja
The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented: 
Države članice morajo zagotoviti uvedbo vseh pogojev ali omejitev v zvezi z varno in učinkovito uporabo medicinskih izdelkov, kot je opisano spodaj:
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling 
• Povzetek lastnosti zdravila (SPC) z navodilom za uporabo in označbo