FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertavid contains a recombinant FSH.
Slovenian: Zdravilo Fertavid vsebuje rekombinantni FSH, ki ga pridobivajo s tehnologijo rekombinantne DNK.
English: Infertile women undergoing ART have an increased incidence of ectopic pregnancies.
Slovenian: Pri neplodnih ženskah v postopku oploditve z biomedicinsko pomočjo je pogostnost zunajmaternične nosečnosti večja.
English: Fertavid 150 IU/0.18 mL solution for injection Fertavid 300 IU/0.36 mL solution for injection Fertavid 600 IU/0.72 mL solution for injection Fertavid 900 IU/1.08 mL solution for injection follitropin beta
Slovenian: Fertavid 150 i.e./0,18 ml raztopina za injiciranje Fertavid 300 i.e./0,36 ml raztopina za injiciranje Fertavid 600 i.e./0,72 ml raztopina za injiciranje Fertavid 900 i.e./1,08 ml raztopina za injiciranje folitropin beta
English: Fertavid 600 IU/0.72 mL solution for injection
Slovenian: Fertavid 600 i.e./0,72 ml raztopina za injiciranje
English: One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in 1.08 mL aqueous solution.
Slovenian: En vložek vsebuje neto skupni odmerek 900 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 1,08 ml vodne raztopine.
English: OUTER CARTON TEXT Fertavid 600 IU/0.72 mL 1 cartridge
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 600 i.e./0,72 ml 1 vložek
English: OUTER CARTON TEXT Fertavid 300 IU/0.36 mL 1 cartridge
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 300 i.e./0,36 ml 1 vložek
English: 2 packs with 3 pen needles
Slovenian: 2 pakiranji s 3 iglami za peresnik
English: Fertavid 300 IU/0.36 mL solution for injection EU/1/09/510/017
Slovenian: Fertavid 300 i.e./0,36 ml raztopina za injiciranje EU/1/09/510/017
English: Fertavid 600 IU/0.72 mL solution for injection EU/1/09/510/018
Slovenian: Fertavid 600 i.e./0,72 ml raztopina za injiciranje EU/1/09/510/018
English: Fertavid 75 IU/0.5 mL solution for injection
Slovenian: Fertavid 75 i.e./0,5 ml raztopina za injiciranje
English: CARTRIDGE TEXT Fertavid 150 IU/0.18 mL
Slovenian: BESEDILO NA VLOŽKU FERTAVID 150 i.e./0,18 ml
English: One cartridge contains a net total dose of 600 IU recombinant follicle-stimulating hormone (FSH) in 0.72 mL aqueous solution.
Slovenian: En vložek vsebuje neto skupni odmerek 600 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,72 ml vodne raztopine.
English: Fertavid 900 IU/1.08 mL solution for injection
Slovenian: Fertavid 900 i.e./1,08 ml raztopina za injiciranje
English: OUTER CARTON TEXT Fertavid 900 IU/1.08 mL 1 cartridge
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 900 i.e./1,08 ml 1 vložek
English: Fertavid solution for injection in cartridges has been developed for use in the Puregon Pen.
Slovenian: Fertavid raztopina za injiciranje v vložkih je namenjena za uporabo s peresnikom Puregon Pen.
English: 1 pack with 3 pen needles
Slovenian: 1 pakiranje s 3 iglami za peresnik
English: One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 0.36 mL aqueous solution.
Slovenian: En vložek vsebuje neto skupni odmerek 300 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,36 ml vodne raztopine.
English: Dosage in the male
Slovenian: OHSS bolečine v medenici
English: Ovarian torsion has occurred after treatment with gonadotropins including Fertavid.
Slovenian: Med zdravljenjem z gonadotropini, vključno z zdravilom Fertavid, so se pojavili primeri torzije jajčnikov.
English: Fertavid 75 IU/0.5 mL solution for injection EU/1/09/510/004
Slovenian: Fertavid 75 i.e./0,5 ml raztopina za injiciranje EU/1/09/510/004
English: OUTER CARTON TEXT Fertavid 150 IU/0.18 mL 1 cartridge
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 150 i.e./0,18 ml 1 vložek
English: VIAL TEXT Fertavid 50 IU/0.5 mL
Slovenian: BESEDILO NA VIALI Fertavid 50 i.e./0,5 ml
English: Fertavid 300 IU/0.36 mL injection follitropin beta
Slovenian: Fertavid 300 i.e./0,36 ml injekcija folitropin beta s.c.
English: Nervous system disorders
Slovenian: Razvrstitev po organskih sistemih
English: Fertavid 150 IU/0.18 mL solution for injection EU/1/09/510/016
Slovenian: Fertavid 150 i.e./0,18 ml raztopina za injiciranje EU/1/09/510/016
English: Talk to your doctor before using Fertavid if you:
Slovenian: Pred začetkom uporabe zdravila Fertavid se posvetujte z zdravnikom:
English: 3 packs with 3 pen needles
Slovenian: 3 pakiranja s 3 iglami za peresnik
English: Fertavid 600 IU/0.72 mL injection follitropin beta
Slovenian: Fertavid 600 i.e./0,72 ml injekcija folitropin beta s.c.
English: OUTER CARTON TEXT Fertavid 75 IU/0.5 mL 1, 5 or 10 vials
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 75 i.e./0,5 ml 1, 5 ali 10 vial
English: Treatment with Fertavid and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Slovenian: Moškim dajte 450 i.e. zdravila Fertavid na teden, najbolje v 3 odmerkih po 150 i.e., skupaj s hCG. Zdravljenje z zdravilom Fertavid in hCG mora trajati najmanj 3 do 4 mesece, preden lahko pričakujete izboljšanje spermatogeneze.
English: Breast complaints Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage
Slovenian: OHSS bolečine v medenici občasni težave z dojkami metroragija ciste na jajčnikih povečanje jajčnikov torzija jajčnika povečanje maternice krvavitev iz nožnice
English: Fertavid 150 IU/0.18 mL solution for injection
Slovenian: Fertavid 150 i.e./0,18 ml raztopina za injiciranje
English: Step 6 - Injecting the solution
Slovenian: Šesti korak - injiciranje raztopine
English: One cartridge contains a net total dose of 150 IU recombinant follicle-stimulating hormone (FSH) in 0.18 mL aqueous solution.
Slovenian: En vložek vsebuje neto skupni odmerek 150 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,18 ml vodne raztopine.
English: PC:
Slovenian: (PCOS),
English: Ovarian torsion has been reported after treatment with gonadotropins, including follitropin beta.
Slovenian: Po zdravljenju z gonadotropini, vključno z zdravilom Fertavid, so poročali o torziji jajčnikov.
English: VIAL TEXT Fertavid 100 IU/0.5 mL
Slovenian: BESEDILO NA VIALI Fertavid 100 i.e./0,5 ml
English: Fertavid 200 IU/0.5 mL solution for injection EU/1/09/510/013
Slovenian: Fertavid 200 i.e./0,5 ml raztopina za injiciranje EU/1/09/510/013
English: Fertavid 100 IU/0.5 mL solution for injection EU/1/09/510/007
Slovenian: Fertavid 100 i.e./0,5 ml raztopina za injiciranje EU/1/09/510/007
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 75 IU (150 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Slovenian: 1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 75 i.e. (150 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
English: Fertavid 900 IU/1.08 mL injection follitropin beta
Slovenian: Fertavid 900 i.e./1,08 ml injekcija folitropin beta s.c.
English: Fertavid 150 IU/0.18 mL injection follitropin beta
Slovenian: Fertavid 150 i.e./0,18 ml injekcija folitropin beta s.c.
English: • Anovulation
Slovenian: • Odsotnost ovulacije
English: Fertavid 75 IU/0.5 mL injection follitropin beta
Slovenian: Fertavid 75 i.e./0,5 ml raztopina za injiciranje folitropin beta
English: Fertavid 900 IU/1.08 mL solution for injection EU/1/09/510/019
Slovenian: Fertavid 900 i.e./1,08 ml raztopina za injiciranje EU/1/09/510/019
English: Fertavid 200 IU/0.5 mL solution for injection
Slovenian: Fertavid 200 i.e./0,5 ml raztopina za injiciranje
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 200 IU (400 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Slovenian: 1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 200 i.e. (400 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
English: One vial contains 7,5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Slovenian: Ena viala vsebuje 7,5 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
English: Solution for injection (injection).
Slovenian: raztopina za injiciranje (injekcija) Bistra in brezbarvna raztopina.
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 150 IU (300 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Slovenian: 1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 150 i.e. (300 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
English: One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Slovenian: Ena viala vsebuje 75 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 150 i.e./ml.
English: Fertavid 300 IU/0.36 mL solution for injection follitropin beta
Slovenian: Fertavid 300 i.e./0,36 ml raztopina za injiciranje folitropin beta
English: After intramuscular or subcutaneous administration of Fertavid, maximum concentrations of FSH are reached within about 12 hours.
Slovenian: Največje koncentracije FSH so dosežene približno 12 ur po intramuskularnem ali subkutanem dajanju zdravila Fertavid.
English: Fertavid 50 IU/0.5 mL solution for injection EU/1/09/510/001
Slovenian: Fertavid 50 i.e./0,5 ml raztopina za injiciranje EU/1/09/510/001
English: Fertavid 150 IU/0.5 mL solution for injection EU/1/09/510/010
Slovenian: Fertavid 150 i.e./0,5 ml raztopina za injiciranje EU/1/09/510/010
English: 0.36 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Slovenian: 0,36 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
English: Fertavid 150 IU/0.5 mL solution for injection
Slovenian: Fertavid 150 i.e./0,5 ml raztopina za injiciranje
English: Fertavid 75 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 75 IU in 0.5 mL aqueous solution per vial.
Slovenian: Fertavid 75 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
English: OUTER CARTON TEXT Fertavid 150 IU/0.5 mL 1, 5 or 10 vials
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 150 i.e./0,5 ml 1, 5 ali 10 vial
English: One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Slovenian: Ena viala vsebuje 150 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 300 i.e./ml.
English: One vial contains 200 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Slovenian: Ena viala vsebuje 200 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 400 i.e./ml.
English: OUTER CARTON TEXT Fertavid 100 IU/0.5 mL 1, 5 or 10 vials
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 100 i.e./0,5 ml 1, 5 ali 10 vial
English: OUTER CARTON TEXT Fertavid 50 IU/0.5 mL 1, 5 or 10 vials
Slovenian: BESEDILO NA ZUNANJI OVOJNINI Fertavid 50 i.e./0,5 ml 1, 5 ali 10 vial
English: Step 4 - Inserting the needle
Slovenian: Četrti korak - vbod igle
English: VIAL TEXT Fertavid 75 IU/0.5 mL
Slovenian: BESEDILO NA VIALI Fertavid 75 i.e./0,5 ml
English: Fertavid 50 IU/0.5 mL solution for injection
Slovenian: Fertavid 50 i.e./0,5 ml raztopina za injiciranje
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 100 IU (200 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Slovenian: 1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 100 i.e. (200 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 50 IU (100 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Slovenian: 1 viala vsebuje 0,5 ml folitropina beta, ki ustreza: 50 i.e. (100 i.e./ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
English: Fertavid 200 IU/0.5 mL injection follitropin beta
Slovenian: Fertavid 200 i.e./0,5 ml raztopina za injiciranje folitropin beta
English: Abdominal discomfort Constipation Diarrhoea
Slovenian: Bolezni živčevja pogosti glavobol
English: The injection site should be alternated to prevent lipoatrophy.
Slovenian: Menjajte mesto injiciranja, da ne pride do atrofije maščevja.
English: 0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Slovenian: 0,72 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
English: Fertavid 100 IU/0.5 mL solution for injection
Slovenian: Fertavid 100 i.e./0,5 ml raztopina za injiciranje
English: Fertavid 600 IU/0.72 mL solution for injection follitropin beta
Slovenian: Fertavid 600 i.e./0,72 ml raztopina za injiciranje folitropin beta
English: One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Slovenian: Ena viala vsebuje 5 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
English: Fertavid 50 IU/0.5 mL injection follitropin beta
Slovenian: Fertavid 50 i.e./0,5 ml raztopina za injiciranje folitropin beta
English: Fertavid 150 IU/0.5 mL injection follitropin beta
Slovenian: Fertavid 150 i.e./0,5 ml raztopina za injiciranje folitropin beta
English: One vial contains 20 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Slovenian: Ena viala vsebuje 20 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
English: One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Slovenian: Ena viala vsebuje 50 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 100 i.e./ml.
English: Fertavid 200 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 200 IU in 0.5 mL aqueous solution per vial.
Slovenian: Fertavid 200 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
English: Fertavid 900 IU/1.08 mL solution for injection follitropin beta
Slovenian: Fertavid 900 i.e./1,08 ml raztopina za injiciranje folitropin beta
English: 0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Slovenian: 0,18 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
English: Fertavid 100 IU/0.5 mL injection follitropin beta
Slovenian: Fertavid 100 i.e./0,5 ml raztopina za injiciranje folitropin beta
English: Fertavid 150 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 150 IU in 0.5 mL aqueous solution per vial.
Slovenian: Fertavid 150 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
English: 1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Slovenian: 1,08 ml raztopine v 1,5 ml vložku (iz stekla tipa I) s sivim gumijastim batom in aluminijasto zgubano zaporko z gumijasto oblogo.
English: One vial contains 15 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Slovenian: Ena viala vsebuje 15 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
English: Fertavid 100 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 100 IU in 0.5 mL aqueous solution per vial.
Slovenian: Fertavid 100 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
English: This is thought to be due to differences in parental characteristics (e.g., maternal age, sperm characteristics) and multiple gestations.
Slovenian: Pogostnost prirojenih malformacij je pri postopkih oploditve z biomedicinsko pomočjo morda nekoliko večja kot pri naravnih zanositvah, kar je verjetno posledica različnih lastnosti staršev (npr. materina starost, značilnosti sperme) in večplodnih nosečnosti.
English: Fertavid 50 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 50 IU in 0.5 mL aqueous solution per vial.
Slovenian: Fertavid 50 i.e./0,5 ml raztopina za injiciranje: Ena viala vsebuje učinkovino folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
English: Fertavid 150 IU/0.18 mL solution for injection follitropin beta
Slovenian: Fertavid 150 i.e./0,18 ml raztopina za injiciranje folitropin beta
English: One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Slovenian: Ena viala vsebuje 100 i.e. rekombinantnega folikle stimulirajočega hormona (FSH) v 0,5 ml vodne raztopine, kar ustreza 200 i.e./ml.
English: For use only with a pen injector called Puregon Pen.
Slovenian: subkutana (s.c.) uporaba Za uporabo le s peresnikom Puregon Pen.
English: One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Slovenian: Ena viala vsebuje 10 mikrogramov beljakovin (specifična biološka aktivnost in vivo ustreza približno 10.000 i.e. FSH / mg beljakovin).
English: Step 3 - Preparing the area
Slovenian: Tretji korak - priprava mesta injiciranja
English: • Primary gonadal failure
Slovenian: • primarna odpoved spolnih žlez.
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Slovenian: Poročevalec je bil dr. Karl Broich, soporočevalec pa je bil dr. Eric Abadie.
English: The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
Slovenian: Referenčna država članica je bila Nemčija, zadevne države članice pa so bile Avstrija, Francija, Nizozemska, Španija in Združeno kraljestvo.
English: London, 23 October 2007 EMEA/331678/2007
Slovenian: London, 23. oktober 2007 EMEA/331678/2007
English: International Non-Proprietary Name (INN): fentanyl
Slovenian: Mednarodno nelastniško ime (INN): fentanil
English: The Mutual Recognition Procedure started on 06 July 2006.
Slovenian: Postopek medsebojnega priznavanja se je začel 6. julija 2006.
English: Germany referred the reasons for disagreement to the EMEA on 20 December 2006.
Slovenian: Nemčija je razloge za nesoglasje predložila agenciji EMEA dne 20. decembra 2006.
English: The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Slovenian: Postopek arbitraže se je začel 24. januarja 2007 s sprejemom seznama vprašanj.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Te države članice niso mogle priti do sporazuma glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: The final opinion was converted into a Decision by the European Commission on 23 October 2007.
Slovenian: Evropska komisija je končno mnenje spremenila v odločbo dne 23. oktobra 2007.
English: The Marketing Authorisation Holder provided written explanations on 13 April 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila dne 13. aprila 2007.
English: A positive opinion was adopted by consensus 19 July 2007.
Slovenian: Odbor je dne 19. julija 2007 soglasno izdal pozitivno mnenje.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Slovenian: Ta se nanaša na razširitev indikacije na bolnike brez raka, izbiro pretvornih tabel, vprašanje, ali bi bilo treba podati v podatkih o zdravilu tudi kontraindikacije za doječe matere in za medsebojna delovanja z opioidi z delnim agonističnim delovanjem, ter študije, ki so potrebne za dokazovanje biološke enakovrednosti z referenčnim zdravilom.
English: Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Slovenian: Glede predlagane indikacije, odmerjanja in kontraindikacij so bile v podatkih o zdravilu in pri dokazovanju biološke enakovrednosti odkrite znatne razlike, kar predstavlja resen zadržek glede javnega zdravja.
English: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Slovenian: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS in z njim povezana imena so opioidni analgetiki, indicirani za hude kronične bolečine, ki jih je mogoče primerno blažiti le z opioidnimi analgetiki.
English: During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h TTS and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem julija 2007 je bil CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Fentanyl-ratiopharm 25/50/75/100 µg/h TTS in z njim povezana imena ugodno, da ugovori, ki jih je imela Francija, ne bi smeli preprečiti izdaje dovoljenja za promet z zdravilom in da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo dopolniti.
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4) 1 ZA Fentanyl-ratiopharm 25/50/75/100 µg/h TTS in z njim povezana imena
English: Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Slovenian: Družba Ratiopharm GmbH je predložila vlogo za postopek medsebojnega priznavanja zdravila Fentanylratiopharm 25/50/75/100 µg/h TTS in z njim povezanih imen v obliki transdermalnega obliža na osnovi dovoljenja za promet z zdravilom, ki ga je Nemčija odobrila dne 4. aprila 2006.
English: Number of responders at end of treatment
Slovenian: Število odzivnih oseb ob koncu zdravljenja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 November 2014
Slovenian: Datum prve odobritve: 17. november 2014
English: Ribavirin was discontinued in 19% of the patients.
Slovenian: Zdravljenje z ribavirinom so prekinili pri 19 % bolnikov.
English: Race: Black/ African American
Slovenian: Rasa: Črnci/afriški Američani