FrancophonIA/ELRC3.0 huggingface dataset:
English: Clonazepam Clonazepam 2mg Tablet
Finnish: Clonazepam 2mg Tablet 2 mg
English: Entacapone
Finnish: Entakaponi
English: NEBIVOLOLRATIOPHARM 5 MG Tabletten
Finnish: NEBIVOLOL-RATIOPHARM 5 mg Tabletten
English: Telmisartan/Hydrochlorothi azide 40mg/12.5mg Tablets
Finnish: Telmisartan/Hydrochlorot hiazide 40mg/12.5mg Tablets
English: Telmisartan 40mg Tablets 40 mg
Finnish: Telmisartan 40mg Tablets
English: VALSARTAN/HIDROCLORO TIAZIDA CODRAMOL 320/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Finnish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 320/12.5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
English: Escitalopram SAVANDRA 20 mg comprimate filmate
Finnish: SAVANDRA 20 mg comprimate filmate
English: 37,5 mg Prolongedreleased capsule, hard
Finnish: 37,5 mg Pitkään vapauttava kapseli, kova
English: Telmisartan/Hydrochlorothi azide 80mg/25mg Tablets
Finnish: Telmisartan/Hydrochlorot hiazide 80mg/25mg Tablets
English: Valsartan/HCTZ Fair-Med Healthcare 160 mg/12.5 mg Filmtabletten mg/12,5 mg
Finnish: Valsartan/HCTZ Fair-Med Healthcare 160 mg/12.5 mg Filmtabletten
English: Alendronic acid Alendronic Acid 70mg Tablets
Finnish: Alendronic Acid 70mg Tablets
English: Alendronic acid Alendroninezuur Accord 10mg Tabletten
Finnish: Alendroninezuur Accord 10mg Tabletten
English: Ropinirole 1mg film-coated tablets
Finnish: Ropinirole 1mg filmcoated tablets
English: Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/25 mg film-coated tablets
Finnish: Valsartan/Hydrochlorothi azide Fair-Med 320 mg/25 mg film-coated tablets
English: Teva UK Limited Brampton Road Hampden Park Sussex BN22 9AG United Kingdom
Finnish: Sussex BN22 9AG United Kingdom
English: Hydrochlorothiazide 150mg/12.5mg Filmcoated tablets mg/12,5 mg
Finnish: Hydrochlorothiazide 150mg/12.5mg Filmcoated tablets
English: Venlafaxina Eurogenus 37,5 mg Prolongedreleased capsule, hard
Finnish: Venlafaxina Eurogenus 37,5 mg Pitkään vapauttava kapseli, kova
English: Escitalopram Escitalopram-Micro Labs 5 mg Filmtabletten
Finnish: Escitalopram-Micro Labs 5 mg Filmtabletten
English: Hydrochloorthiazide Torrent 150 mg/12,5 mg filmomhulde tabletten mg/12,5 mg
Finnish: Hydrochloorthiazide Torrent 150 mg/12,5 mg filmomhulde tabletten
English: Escitalopram ESCITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable
English: NEBIVOLOLRATIOPHARM 5mg
Finnish: NEBIVOLOL-RATIOPHARM 5mg
English: Escitalopram Escitalopram-Micro Labs 10 mg Filmtabletten
Finnish: Escitalopram-Micro Labs 10 mg Filmtabletten
English: Escitalopram Escitalopram-Micro Labs 15 mg Filmtabletten
Finnish: Escitalopram-Micro Labs 15 mg Filmtabletten
English: Telmisartan/Hydrochlorothi azide 80mg/12.5mg Tablets
Finnish: Telmisartan/Hydrochlorot hiazide 80mg/12.5mg Tablets
English: Valsartan/HCTZ Fair-Med 160 mg/12,5 mg, filmomhulde tabletten mg/12,5 mg
Finnish: Valsartan/HCTZ Fair-Med 160 mg/12,5 mg, filmomhulde tabletten
English: Hydrochloorthiazide Torrent 300 mg/12,5 mg filmomhulde tabletten mg/12,5 mg
Finnish: Hydrochloorthiazide Torrent 300 mg/12,5 mg filmomhulde tabletten
English: VALSARTAN/HIDROCLORO TIAZIDA CODRAMOL 160/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Finnish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 160 MG/12.5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
English: Welding GmbH & Co. KG Esplanade 39
Finnish: KG Esplanade 39
English: Escitalopram ESCITALOPRAM ZYDUS 5 mg, comprimé pelliculé
Finnish: ESCITALOPRAM ZYDUS 5 mg, comprimé pelliculé
English: Ropinirole 2mg film-coated tablets
Finnish: Ropinirole 2mg filmcoated tablets
English: Escitalopram ESCITALOPRAM ABBOTT 20mg, comprimé pelliculé
Finnish: ESCITALOPRAM ABBOTT 20mg, comprimé pelliculé
English: Levetiracetam Levetiracetam Dr. Reddy's, 1000 mg, comprimate filmate
Finnish: Reddy's, 1000 mg, comprimate filmate
English: Kandrozid tablet
Finnish: Kalvopäällysteinen tabletti
English: Irbesartan Torrent Hidrochlorotiazida 150/12,5mg comprimate filmate mg/12,5 mg
Finnish: Irbesartan Torrent Hidrochlorotiazida 150/12,5mg comprimate filmate
English: Alendronic acid ALENDRONIC ACID ACCORD 70mg
Finnish: ALENDRONIC ACID ACCORD 70MG
English: Irbesartan/Hydrochlorothia zide Fairmed 300mg/25mg film-coated tablets
Finnish: Irbesartan/Hydrochlorothi azide Fairmed 300mg/25mg film-coated tablets
English: Escitalopram ESCITALOPRAM BROWN 20 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM BROWN 20 mg, comprimé pelliculé sécable
English: Escitalopram SAVANDRA 5 mg comprimate filmate
Finnish: SAVANDRA 5 mg comprimate filmate
English: Escitalopram SAVANDRA 15 mg comprimate filmate
Finnish: SAVANDRA 15 mg comprimate filmate
English: Ropinirole 5mg film-coated tablets
Finnish: Ropinirole 5mg filmcoated tablets
English: Hydrochlorothiazide 300mg/12.5mg Filmcoated tablets mg/12,5 mg
Finnish: Hydrochlorothiazide 300mg/12.5mg Filmcoated tablets
English: Levetiracetam Levetiracetam Dr. Reddy's, 750 mg, comprimate filmate
Finnish: Reddy's, 750 mg, comprimate filmate
English: Valsartan/HCTZ Fair-Med Healthcare 320 mg/12,5 mg Filmtabletten mg/12,5 mg
Finnish: Valsartan/HCTZ Fair-Med Healthcare 320 mg/12,5 mg Filmtabletten
English: Trimetazidina Mylan
Finnish: Trimetazidina Pharmakern
English: Alendronic acid Alendroninezuur Accord 70mg Tabletten
Finnish: Alendroninezuur Accord 70mg Tabletten
English: Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg
Finnish: Valsartan/Hydrochlorothi azide Fair-Med 320 mg/12.5 mg film-coated tablets
English: VALSARTAN/HIDROCLORO TIAZIDA CODRAMOL 160 MG/12,5 mg
Finnish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 160/25 MG
English: Escitalopram SAVANDRA 10 mg comprimate filmate
Finnish: SAVANDRA 10 mg comprimate filmate
English: Valsartan/HCTZ Fair-Med 320 mg/12,5 mg, filmomhulde tabletten mg/12,5 mg
Finnish: Valsartan/HCTZ Fair-Med 320 mg/12,5 mg, filmomhulde tabletten
English: Farmaprojects 150 mg, capsules met verlengde afgifte, hard
Finnish: Venlafaxine Farmaprojects 150 mg, capsules met verlengde afgifte, hard
English: Escitalopram ESCITALOPRAM ZYDUS 15 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM ZYDUS 15 mg, comprimé pelliculé sécable
English: Desloratadine
Finnish: Deksametasoni
English: 150 mg Capsule, hard Oral use
Finnish: 150 mg Kapseli, kova Suun kautta
English: 750 mg Prolongedrelease tablet
Finnish: 750 mg Depottabletti
English: Farmaprojects 75 mg, capsules met verlengde afgifte, hard
Finnish: Venlafaxine Farmaprojects 75 mg, capsules met verlengde afgifte, hard
English: Irbesartan HCTZ Fair-Med 150+12,5 mg Filmtabletten mg/12,5 mg
Finnish: Irbesartan HCTZ FairMed 150+12,5 mg Filmtabletten
English: Telmisartan/ hydrochlorothiazide
Finnish: Telmisartaani/hydrokl ooritiatsidi
English: 37,5 mg Prolongedrelease capsule
Finnish: 37,5 mg Pitkään vapauttava kapseli
English: Irbesartan Torrent Hidrochlorotiazida 300/12,5mg comprimate filmate mg/12,5 mg
Finnish: Irbesartan Torrent Hidrochlorotiazida 300/12,5mg comprimate filmate
English: Irbesartan/Hydrochlorothia zide 300mg/25mg filmcoated tablets
Finnish: Irbesartan/Hydrochlorothi azide 300mg/25mg filmcoated tablets
English: Escitalopram ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable
English: Hydrochlorothiazide 300mg/25mg Film-coated tablets
Finnish: Irbesartan Hydrochlorothiazide 300mg/25mg Filmcoated tablets
English: Escitalopram ESCITALOPRAM ABBOTT 15mg, comprimé pelliculé
Finnish: ESCITALOPRAM ABBOTT 15mg, comprimé pelliculé
English: Donepezil Odis Mylan
Finnish: DONEPEZILO FLAS MYLAN
English: Escitalopram ESCITALOPRAM ABBOTT 5mg, comprimé pelliculé
Finnish: ESCITALOPRAM ABBOTT 5mg, comprimé pelliculé
English: Escitalopram ESCITALOPRAM ABBOTT 10mg, comprimé pelliculé
Finnish: ESCITALOPRAM ABBOTT 10mg, comprimé pelliculé
English: Escitalopram ESCITALOPRAM ZYDUS 10 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM ZYDUS 10 mg, comprimé pelliculé sécable
English: Alendronic acid Ácido alendrónico Accord 70 mg tablet
Finnish: Ácido alendrónico Accord 70 mg Tabletti
English: 0,24 mg Orodispersible tablet
Finnish: 0,24 mg Tabletti, suussa hajoava
English: VENLAFAXIN ORION 37,5 mg Prolongedreleased capsule, hard
Finnish: VENLAFAXIN ORION 37,5 mg Pitkään vapauttava kapseli, kova
English: Esomeprazole/ Generics 40 mg
Finnish: ESOMEPRAZOLE/ GENERICS
English: Levetiracetam Levetiracetam Dr. Reddy's, 500mg, comprimate filmate
Finnish: Reddy's, 500mg, comprimate filmate
English: Escitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable
English: Venlafaxina Bluepharma 37,5 mg Prolongedreleased capsule, hard
Finnish: Venlafaxina Bluepharma 37,5 mg Pitkään vapauttava kapseli, kova
English: ESOMEPRAZOLO MYLAN 20 mg
Finnish: Fexofenadina Mylan 120 mg
English: 0,06 mg Orodispersible tablet
Finnish: 0,06 mg Tabletti, suussa hajoava
English: Escitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable
Finnish: ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable
English: Fexofenadine 120 mg filmcoated tablets
Finnish: Fexofenadine 120 mg film-coated tablets
English: 200 mg Modified - release capsule, hard
Finnish: 200 mg Säädellysti vapauttava kapseli, kova
English: Irbesartan HCTZ Fair-Med 300+12,5 mg Filmtabletten mg/12,5 mg
Finnish: Irbesartan HCTZ FairMed 300+12,5 mg Filmtabletten
English: Farmaprojects 37,5 mg, capsules met verlengde afgifte, hard
Finnish: Venlafaxine Farmaprojects 37,5 mg, capsules met verlengde afgifte, hard
English: Metformin "Actavis PTC"
Finnish: Metformin "Actavis PTC" 500 mg Depottabletti
English: Levetiracetam Levetiracetam Dr. Reddy's, 250 mg, comprimate filmate
Finnish: Reddy's, 250 mg, comprimate filmate
English: Metoclopramide METOCLOPRAMIDA ACCORD 10 mg
Finnish: METOCLOPRAMIDA ACCORD 10 MG COMPRIMIDOS EFG
English: Fexofenadine 180 mg filmcoated tablets
Finnish: Fexofenadine 180 mg film-coated tablets
English: VENLAFAXINE ORION 37,5 mg Prolongedreleased capsule, hard
Finnish: VENLAFAXINE ORION 37,5 mg Pitkään vapauttava kapseli, kova
English: Portugal"
Finnish: Portugali
English: 150 mg Prolongedrelease tablet
Finnish: 150 mg Depottabletti
English: Levetiracetam Levetiracetam-Generics 750 mg Film - coated tablet
Finnish: Levetiracetam 750mg film-coated tablets
English: Irbesartan/Hydrochlorothia zide 150mg/12.5mg filmcoated tablets mg/12,5 mg
Finnish: Irbesartan/Hydrochlorothi azide 150mg/12.5mg film-coated tablets
English: Auden McKenzie Limited McKenzie House Bury Street, Ruislip Middlesex HA4 7TL United Kingdom
Finnish: Iso-Britannia Auden McKenzie Limited McKenzie House
English: 92707 Colombes Cedex
Finnish: 15, boulevard Charles de Gaulle 92707 Colombes Cedex
English: Venlafaxine Bluefish 37,5 mg Prolongedreleased capsule, hard
Finnish: Venlafaxine Bluefish 37,5 mg Pitkään vapauttava kapseli, kova
English: Farmaprojects 75 mg Hartkapseln, retardiert
Finnish: Venlafaxin Farmaprojects 75 mg Hartkapseln, retardiert
English: Farmaprojects 37,5 mg Hartkapseln, retardiert
Finnish: Venlafaxin Farmaprojects 37,5 mg Hartkapseln, retardiert
English: 1000 mg Prolongedrelease tablet
Finnish: 1000 mg Depottabletti
English: 0,12 mg Orodispersible tablet
Finnish: 0,12 mg Tabletti, suussa hajoava
English: Irbesartan/Hydrochlorothia zide 300mg/12.5mg filmcoated tablets mg/12,5 mg
Finnish: Irbesartan/Hydrochlorothi azide 300mg/12.5mg film-coated tablets
English: 100 mg Tablet
Finnish: 10 mg Tabletti
English: Desloratadine Apotex
Finnish: Desloratadine Apotex 5 mg
English: Esomeprazole
Finnish: Esomepratsoli
English: Norway ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Finnish: Norja ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: IRBESARTAN/HIDROCLOR OTIAZIDA WELDING 300 mg/12.5 mg
Finnish: Irbesartan/Hydrochlorothi azid Heumann 300 mg/12.5 mg
English: Iceland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Finnish: Islanti ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: IRBESARTAN/HIDROCLOR OTIAZIDA WELDING 150 mg/12.5 mg
Finnish: Irbesartan/Hydrochlorothi azid Heumann 150 mg/12.5 mg
English: Scored tablet
Finnish: Uurrettu tabletti
English: Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use
Finnish: Tacpan 0.5 mg Hartkapseln
English: Ropinirole 0.25 mg Filmcoated Tablets
Finnish: Ropinirolihydrokloridi Ropinirole 0.25 mg Filmcoated Tablets
English: Farmaprojects 150 mg Hartkapseln, retardiert
Finnish: Venlafaxin Farmaprojects 150 mg Hartkapseln, retardiert
English: Prolongedrelease tablet
Finnish: Pitkään vapauttava tabletti
English: Ropinirole 0.5 mg Filmcoated Tablets
Finnish: Ropinirolihydrokloridi Ropinirole 0.5 mg Filmcoated Tablets
English: 75 mg Prolongedrelease tablet
Finnish: 75 mg Tabletti, kalvopäällysteinen
English: 200 mg Prolongedrelease tablet
Finnish: 200 mg Depottabletti
English: Ropinirole 1 mg Filmcoated Tablets
Finnish: Ropinirolihydrokloridi Ropinirole 1 mg Filmcoated Tablets
English: Levocetirizine
Finnish: Kefpodoksiimi
English: Escitalopram Escitalopram Brown
Finnish: Escitalopram Brown 5 mg
English: Fluconazole 150mg capsule 150 mg Capsule, hard Oral use
Finnish: Fluconazol Bluefish 150 mg Kapseli, kova Suun kautta
English: Germany ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Finnish: Saksa ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: Ropinirole 2 mg Filmcoated Tablets
Finnish: Ropinirolihydrokloridi Ropinirole 2 mg Filmcoated Tablets
English: Desloratadin Ratiopharm 2,5 mg Orodispersible tablet
Finnish: Desloratadin Ratiopharm 2,5 mg Tabletti, suussa hajoava
English: 100 mg Prolongedrelease tablet
Finnish: 100 mg Depottabletti
English: ESOMEPRAZOLO MYLAN 40 mg
Finnish: ESOMEPRAZOLO MYLAN 40 mg Enterokapseli, kova
English: Cefpodoxime
Finnish: Enterokapseli
English: VENLAFAXINE FAIR-MED 75 mg
Finnish: Venlafaxina Eurogenus 75 mg
English: Donepezil Mylan 10 mg 10 mg
Finnish: Donepezil Odis Mylan 5 mg
English: Finland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Finnish: Suomi ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: Potactasol topotecan
Finnish: Potactasol topotekaani
English: The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011.
Finnish: Euroopan komissio myönsi koko Euroopan unionin alueella voimassa olevan myyntiluvan Potactasolia varten 6. tammikuuta 2011.
English: The full EPAR for Potactasol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Finnish: Potactasolia koskeva EPAR-arviointilausunto on kokonaisuudessaan viraston verkkosivustolla osoitteessa ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Potactasol.
Finnish: Tämä asiakirja on tiivistelmä Euroopan julkisesta arviointilausunnosta (EPAR), joka koskee Potactasolvalmistetta.
English: The company has provided data from the published literature on topotecan.
Finnish: Yhtiö on toimittanut tietoa topotekaania koskevasta julkaistusta kirjallisuudesta.
English: Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects.
Finnish: Potactasol-annosta voi olla syytä tarkistaa tai hoitoa lykätä sivuvaikutuksista riippuen.
English: The Committee recommended that Potactasol be given marketing authorisation.
Finnish: Komitea suositteli, että Potactasolille annetaan myyntilupa.
English: 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.
Finnish: Tekstissä selitetään, miten lääkevalmistekomitea (CHMP) on arvioinut lääkevalmistetta ja päätynyt myyntiluvan myöntämistä puoltavaan lausuntoon ja suosituksiin Potactasolin käytön ehdoista.
English: The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin.
Finnish: Lääkevalmistekomitea katsoi, että EU:n vaatimusten mukaisesti Potactasolin on osoitettu olevan verrattavissa Hycamtiniin.
English: It is used on its own to treat patients with:
Finnish: Sitä annetaan ainoana lääkehoitona potilaille, joilla on
English: Potactasol also affects non-cancer cells, which causes side effects.
Finnish: Potactasol vaikuttaa syöpäsolujen lisäksi myös muihin soluihin, mistä aiheutuu sivuvaikutuksia.
English: 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.
Finnish: Koska Potactasol on geneerinen lääkevalmiste ja biologisesti samanarvoinen alkuperäislääkkeeseen nähden, sen etujen ja riskien katsotaan olevan samat kuin alkuperäislääkkeen.
English: 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.
Finnish: Sekä munasarja- että keuhkosyövän hoidossa Potactasolia annetaan joka päivä viiden päivän ajan, mitä seuraa kolmen viikon tauko ennen seuraavan hoitojakson aloittamista.
English: 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).
Finnish: Sitä käytetään myös yhdessä sisplatiinin (toinen syöpälääke) kanssa naisilla, joilla kohdunkaulansyöpä on uusiutunut sädehoidon jälkeen tai kun tauti on pitkälle edennyt (syöpä on levinnyt kohdunkaulan ulkopuolelle).
English: Other information about Potactasol
Finnish: Muita tietoja Potactasolista
English: 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.
Finnish: Mitään lisätutkimuksia ei tarvittu, koska Potactasol on geneerinen lääke, jota annetaan infuusiona ja jonka vaikuttava aine on sama kuin alkuperäislääkkeellä, Hycamtinilla.
English: 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).
Finnish: Kun Potactasolia annetaan sisplatiinin kanssa kohdunkaulansyövän hoitoon, sitä annetaan infuusiona päivinä 1, 2 ja 3 (sisplatiini annetaan 1. päivänä).
English: When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes.
Finnish: Kun pelkkää Potactasolia käytetään munasarjasyövän hoitoon, sitä annetaan infuusiona yli 30 minuutin ajan.
English: Potactasol is a cancer medicine.
Finnish: Potactasol on syöpälääke.
English: 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.
Finnish: Potactasol-annos määräytyy hoidettavan syöpätyypin sekä potilaan painon ja pituuden mukaan.
English: This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Finnish: Se tarkoittaa, että Potactasol on samanlainen kuin alkuperäislääke Hycamtin, jolla on jo voimassaoleva myyntilupa Euroopan unionin (EU) alueella.
English: Why has Potactasol been approved?
Finnish: Miksi Potactasol on hyväksytty?
English: For more information about treatment with Potactasol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Finnish: Lisätietoja Potactasol-hoidosta saat pakkausselosteesta (sisältyy myös EPAR-lausuntoon) tai lääkäriltä tai apteekista.
English: What are the benefits and risks of Potactasol?
Finnish: Mitkä ovat Potactasolin edut ja haitat?
English: Potactasol is a ‘generic medicine'.
Finnish: Potactasol on geneerinen lääke.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Finnish: Näin ollen se katsoi, että sen edut ovat Hycamtinin tapaan havaittuja riskejä suuremmat.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Finnish: Sitä saa jauheena, josta valmistetaan infuusioliuos (suonensisäistä tiputusta varten).
English: Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Finnish: Potactasolia annetaan vain syöpälääkitykseen perehtyneen lääkärin valvonnassa.
English: What is Potactasol?
Finnish: Mitä Potactasol on?
English: Potactasol is a medicine that contains the active substance topotecan.
Finnish: Potactasol on lääke, jonka vaikuttava aine on topotekaani.
English: The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Finnish: Potactasolin vaikuttava aine topotekaani on ns. topoisomeraasin estäjiin kuuluva syöpälääke.
English: How has Potactasol been studied?
Finnish: Miten Potactasolia on tutkittu?
English: How is Potactasol used?
Finnish: Miten Potactasolia käytetään?
English: What is Potactasol used for?
Finnish: Mihin Potactasolia käytetään?
English: How does Potactasol work?
Finnish: Miten Potactasol vaikuttaa?
English: MA (EU) number
Finnish: EU-myyntilupa numero
English: • The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Finnish: • Opportunististen infektioiden riski, erityisesti CMV-viremia • Suositus elävien rokotteiden välttämiseksi ainakin 12 kuukauden ajan MabCampath-hoidon o yliherkkyysreaktioiden hoitoon (elvytys mukaan lukien) on varauduttava lääkkeen o infuusioreaktioriski on suurin ensimmäisellä hoitoviikolla o jos reaktio on kohtalainen tai vaikea, annos on pidettävä samana (ts. sitä ei saa suurentaa), kunnes potilas sietää hyvin annoksen o jos hoito keskeytetään yli 7 päiväksi, MabCampath-hoito tulisi aloittaa uudelleen
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Finnish: JÄSENVALTIOIDEN TOIMEENPANTAVAT LÄÄKEVALMISTEEN TURVALLISEEN JA TEHOKKAASEEN KÄYTTÄMISEEN LIITTYVÄT EHDOT TAI RAJOITUKSET
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Finnish: • valmisteyhteenveto ja pakkausseloste sekä myyntipäällysmerkinnät.
English: 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:
Finnish: Jäsenvaltioiden on varmistettava, että kaikki alla kuvatut lääkevalmisteen turvalliseen ja tehokkaaseen käyttämiseen liittyvät ehdot ja rajoitukset pannaan toimeen:
English: The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the
Finnish: Jäsenvaltioiden on varmistettava, että myyntiluvan haltija toimittaa kaikille MabCambathvalmistetta määrääville lääkäreille hoitohenkilökunnan tietopaketin, joka sisältää seuraavan materiaalin:
English: - To agree the details of an educational brochure with the MAH.
Finnish: Sovittava myyntiluvan haltijan kanssa tietolehtisen yksityiskohdista.
English: This summary was last updated on 30/08/2012.
Finnish: Tämä yhteenveto on päivitetty viimeksi 30/08/2012.
English: The marketing authorisation was renewed on 2 August 2007.
Finnish: Myyntilupa uusittiin 2. elokuuta 2007.
English: It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).
Finnish: Sitä saa injektionesteenä, liuoksena (0,1 mg/ml ja 0,5 mg/ml).
English: In addition, the blood pressure will increase before returning to normal or below normal.
Finnish: Myös verenpaine nousee ensin, mutta palautuu sitten normaaliksi tai normaalia matalammaksi.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Finnish: Jos tarvitset lisätietoja eläimen sairaudesta tai hoidosta, ota yhteyttä eläinlääkäriin.