FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with saw palmetto fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo plod palmeta, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What is saw palmetto fruit?
Slovenian: Kaj je plod palmeta?
English: What are the risks associated with saw palmetto fruit medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo plod palmeta?
English: Saw palmetto fruit preparations may be obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (hexane or ethanol), which is then partially evaporated to obtain a soft extract.
Slovenian: Pripravki s plodom palmeta se pridobivajo z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se svež rastlinski material najprej namoči v topilo (heksan ali etanol), v katerem se raztopijo spojine.
English: The HMPC conclusions on the use of ethanol-extracted saw palmetto fruit medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo z etanolom ekstrahiran plod palmeta, za lajšanje simptomov v spodnjih sečilih, povezanih z BHP, temeljijo na njihovi „tradicionalni uporabi“ pri tej bolezni.
English: Therefore, the HMPC conclusions on the use of saw palmetto medicines are based on their long-standing use.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo plod palmeta, zato temeljijo na njihovi dolgotrajni uporabi.
English: The HMPC conclusions on the use of hexane-extracted saw palmetto fruit medicines for the symptomatic treatment of BPH are based on their ‘well-established use' in this condition.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo s heksanom ekstrahiran plod palmeta, za simptomatsko zdravljenje BHP temeljijo na njihovi „dobro uveljavljeni medicinski uporabi“ pri tej bolezni.
English: For practical information about using saw palmetto fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: 23 January 2015
Slovenian: 23. januar 2015
English: The withdrawal letter is available here.
Slovenian: Dopisu o umiku je na voljo tukaj.
English: Teysuno has been authorised in the EU since March 2011.
Slovenian: Zdravilo Teysuno je v EU odobreno od marca 2011.
English: The full European Public Assessment Report for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Teysuno je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: As a result, it prevents the growth of cancer cells and eventually kills them.
Slovenian: Posledično preprečuje rast rakavih celih in jih nazadnje uniči.
English: On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno.
Slovenian: Družba Nordic Group BV je 6. januarja 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo indikacije zdravila Teysuno.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: 5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
Slovenian: 5-FU je podoben pirimidinu, tj. snovi, ki se nahaja v genskem materialu celic (DNK in RNK).
English: Tegafur is a ‘prodrug' that is converted in the body to another medicine called 5-fluorouracil (5-FU).
Slovenian: Zdravilo Tegafur je „predzdravilo“, ki se v telesu pretvori v drugo zdravilo, imenovano 5-fluorouracil (5-FU).
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU, and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Slovenian: Drugi dve zdravilni učinkovini zdravila Teysuno zagotavljata učinkovitost tegafurja pri manjših odmerkih in z manj neželenimi učinki: gimeracil preprečuje razgradnjo 5-FU, oteracil pa zmanjšuje delovanje 5-FU v normalnem, nerakavem tkivu v črevesju.
English: There are no consequences on the use of Teysuno in its authorised indication.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Teysuno pri njegovi odobreni indikaciji.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe.
English: It is used in combination with cisplatin (a platinum-based cancer medicine).
Slovenian: Uporablja se v kombinaciji s cisplatinom (zdravilom proti raku na osnovi platine).
English: Teysuno contains the active substances tegafur, gimeracil and oteracil.
Slovenian: Zdravilo Teysuno vsebuje zdravilne učinkovine tegafur, gimeracil in oteracil.
English: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Slovenian: Glavna zdravilna učinkovina zdravila Teysuno, tegafur, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine antimetabolitov.
English: The company presented data from two studies involving a total of 43 patients with advanced gastric cancer or other tumours, in which Teysuno was used in combination with oxaliplatin and other cancer medicines.
Slovenian: Družba je predložila podatke iz dveh študij, v katerih je sodelovalo skupno 43 bolnikov z napredovalim rakom želodca ali drugimi tumorji, ki so prejemali zdravilo Teysuno v kombinaciji z oksaliplatinom in drugimi zdravili proti raku.
English: What was Teysuno expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Teysuno uporabljalo?
English: Data from published studies on the use of Teysuno in combination with platinum-based medicines were also provided.
Slovenian: Zagotovila je tudi podatke iz objavljenih študij o uporabi zdravila Teysuno v kombinaciji z zdravili na osnovi platine.
English: In particular very limited data were provided on the combination of Teysuno with oxaliplatin and no data were provided on the use with carboplatin.
Slovenian: O kombinaciji zdravila Teysuno in oksaliplatina so bili predloženi zelo omejeni podatki, o uporabi zdravila Teysuno skupaj s karboplatinom pa niso bili predloženi nobeni podatki.
English: How is Teysuno expected to work?
Slovenian: Kako naj bi zdravilo Teysuno delovalo?
English: Teysuno is a cancer medicine that is used to treat adults with advanced gastric (stomach) cancer.
Slovenian: Zdravilo Teysuno je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z napredovalim rakom želodca.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application because, in its preliminary assessment report, the CHMP considered that the data provided were insufficient to conclude that the benefits outweigh the risks when Teysuno is used in combination with other platinum-based cancer medicines.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da vlogo umika, ker je CHMP v svojem predhodnem poročilu o oceni zdravila menil, da predloženi podatki ne zadostujejo za zaključek, da so koristi uporabe zdravila Teysuno v kombinaciji z drugimi zdravili proti raku na osnovi platine večje od z njo povezanih tveganj.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Teysuno could not have been approved for the treatment of advanced gastric cancer in combination with platinumbased medicines other than cisplatin.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Teysuno ni mogoče odobriti za zdravljenje napredovalega raka želodca v kombinaciji z zdravili na osnovi platine, ki ne vključujejo cisplatina.
English: Teysuno was also expected to be used in combination with platinum-based cancer medicines other than cisplatin, such as oxaliplatin.
Slovenian: Zdravilo Teysuno naj bi se uporabljalo tudi v kombinaciji z drugimi zdravili proti raku na osnovi platine, kot je oksaliplatin, in ne le s cisplatinom.
English: What is happening with Teysuno for the treatment of patients with advanced gastric cancer in combination with cisplatin?
Slovenian: Kakšne so posledice za zdravilo Teysuno, indicirano za zdravljenje bolnikov z napredovalim rakom želodca v kombinaciji s cisplatinom?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the data provided were too scarce to allow adequate evaluation of the benefits and risks of Teysuno in combination with platinumbased medicines other than cisplatin in patients with advanced gastric cancer.
Slovenian: Zato je CHMP v času umika menil, da so bili predloženi podatki preveč omejeni, da bi omogočali ustrezno oceno koristi in tveganj uporabe zdravila Teysuno v kombinaciji z zdravili na osnovi platine, ki ne vključujejo cisplatina, pri bolnikih z napredovalim rakom želodca.
English: The change concerned extending the use of Teysuno to treat advanced gastric cancer in combination with platinum-based cancer medicines other than cisplatin.
Slovenian: Sprememba je zadevala razširitev uporabe zdravila Teysuno na zdravljenje napredovalega raka želodca v kombinaciji z zdravili proti raku na osnovi platine, ki ne vključujejo cisplatina.
English: The data provided were too limited to allow a benefit-risk evaluation of Teysuno in combination with other platinum-based medicines in patients with advanced gastric cancer.
Slovenian: Predloženi podatki so bili preveč omejeni, da bi omogočali oceno razmerja med koristmi in tveganji uporabe zdravila Teysuno v kombinaciji z drugimi zdravili na osnovi platine pri bolnikih z napredovalim rakom želodca.
English: Send a question via our website www.ema.europa.eu/contact the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Slovenian: 5-FU v telesu zavzame mesto pirimidina in ovira encime, vključene v tvorjenju nove DNK.
English: Page 6/6
Slovenian: Stran 5/5
English: Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Slovenian: Pred preklicem začasnega umika dovoljenj za promet z zdravilom bodo nacionalni pristojni organi, ki jih usklajuje referenčna država članica, zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednji pogoj:
English: The marketing authorisation holder demonstrates bioequivalence in the fed state, in compliance with the guidance on the investigation of bioequivalence in place at the time of lifting the suspension.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora ob preklicu začasnega umika dokazati biološko enakovrednost pri jemanju zdravila s hrano v skladu s smernicami za proučevanje biološke enakovrednosti.
English: Conditions for the lifting of the marketing authorisations suspension
Slovenian: Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
English: Long term effects are not yet known.
Slovenian: Dolgoročni učinki še niso znani.
English: Long term safety
Slovenian: Dolgoročna varnost
English: Peri- and postnatal development has not been studied.
Slovenian: Peri- in postnatalnega razvoja niso proučevali.
English: 5550 Airport Boulevard Boulder, Colorado 80301 United States of America
Slovenian: 5550 Airport Boulevard Boulder, Colorado 80301 ZDA
English: Not known (frequency cannot be estimated from available data):
Slovenian: Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti):
English: It is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or - plan to have a baby.
Slovenian: Zdravniku morate povedati, če: - ste noseči, - mislite, da ste morda noseči, ali
English: For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet.
Slovenian: Za informacije o pripravi in dajanju zdravila Kepivance glejte informacije za zdravstveno osebje na koncu teh navodil.
English: The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies.
Slovenian: Dolgoročna varnost zdravila Kepivance ni povsem ugotovljena, kar zadeva celotno preživetje, preživetje brez napredovanja in sekundarne malignome.
English: These events were consistent with those observed at the recommended dose but were generally more severe.
Slovenian: Ti dogodki so se skladali z dogodki, zabeleženimi ob priporočenih odmerkih, a so bili na splošno hujši.
English: Safety and efficacy has not been evaluated in older people.
Slovenian: Varnost in učinkovitost pri starejših osebah nista bili ovrednoteni.
English: Palifermin (60 micrograms/kg/day) n = 106
Slovenian: Palifermin (60 mikrogramov/kg/dan) n = 106
English: Generally, dissolution of Kepivance takes less than 5 minutes.
Slovenian: Praviloma traja raztapljanje zdravila Kepivance manj kot 5 minut.
English: Systemic exposure did not appear to increase with the dose.
Slovenian: Prav tako ni bilo videti, da bi se sistemska izpostavljenost povečevala z odmerkom.
English: Adverse reactions from clinical trials and spontaneous reporting
Slovenian: Neželeni učinki iz kliničnih preskušanj in spontanega poročanja
English: Once reconstituted, store in a refrigerator and use within 24 hours.
Slovenian: Ko je zdravilo pripravljeno, ga shranjujte v hladilniku in porabite v 24 urah.
English: Kepivance should only be used in adults over the age of 18 years.
Slovenian: Zdravilo Kepivance smejo dobivati le odrasli, starejši od 18 let.
English: Each pack contains 6 vials.
Slovenian: Eno pakiranje vsebuje 6 vial.
English: Please inform your doctor if you are receiving or have recently received heparin.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali heparin.
English: These reactions were primarily mild to moderate in severity and were reversible.
Slovenian: Učinki so bili predvsem blagi do zmerni in so bili reverzibilni.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to Kepivance neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Date of latest renewal: 23 September 2010
Slovenian: Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 23. september 2010
English: The safety and efficacy of Kepivance in children aged 0 to 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Kepivance pri otrocih, starih od 0 do 18 let, še nista bili dokazani.
English: Although palifermin was safe at all doses tested the incidence of skin reactions increased with the dose.
Slovenian: Čeprav je bil palifermin varen pri vseh testiranih odmerkih, je incidenca kožnih reakcij naraščala z odmerkom.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other
Slovenian: Zaradi pomanjkanja študij o kompatibilnosti zdravila ne smete mešati z drugimi zdravili.
English: What Kepivance is and what it is used for
Slovenian: Kaj je zdravilo Kepivance in za kaj ga uporabljamo
English: If you are pregnant you should not use Kepivance unless clearly necessary.
Slovenian: Če ste noseči, zdravila Kepivance ne uporabljajte, razen če je to nujno potrebno.
English: Lack of efficacy and risk of infection with high dose melphalan conditioning regimen
Slovenian: Pomanjkanje učinkovitosti in tveganje za okužbo ob pripravljalnem režimu z visokimi odmerki melfalana
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
English: Neither of the two dosing regimens demonstrated statistically significant results versus placebo.
Slovenian: Nobena od zgornjih dveh shem odmerjanja ni pokazala statistično značilnih rezultatov v primerjavi s placebom.
English: Visual acuity was not affected at 6 or 12 months in either treatment group.
Slovenian: Ostrina vida po 6 ali 12 mesecih v nobeni skupini ni bila prizadeta.
English: In this study, 212 patients were randomised and received either palifermin or placebo.
Slovenian: V študiji je bilo randomiziranih 212 bolnikov, ki so dobivali palifermin ali placebo.
English: What Kepivance is and what it is used for What you need to know before you use Kepivance
Slovenian: Kaj je zdravilo Kepivance in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Kepivance
English: Other medicines and Kepivance
Slovenian: Druga zdravila in zdravilo Kepivance
English: It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve
Slovenian: Od endogenega humanega KGF se razlikuje po tem, da ima za izboljšanje stabilnosti odstranjenih prvih 23 N-terminalnih aminokislin.
English: Due to limited data in patients, heparins should be used with care in patients receiving palifermin and appropriate blood coagulation tests should be carried out to monitor their treatment.
Slovenian: Zaradi omejenih podatkov pri bolnikih je treba heparine uporabljati previdno pri bolnikih, ki prejemajo palifermin in opraviti ustrezne teste koagulacije krvi za spremljanje njihovega zdravljenja.
English: • increase in lipase and amylase levels (digestive enzymes) in the blood (which do not require treatment and usually return to normal after stopping treatment with Kepivance).
Slovenian: • motnje okušanja in • zvišana raven lipaze in amilaze (prebavnih encimov) v krvi (ki ne zahteva zdravljenja in se običajno povrne na normalno raven po prenehanju zdravljenja z zdravilom Kepivance).
English: Based on these limited data no recommendation on dose adjustment can be
Slovenian: Na podlagi teh omejenih podatkov ni mogoče dati priporočil o prilagajanju odmerka.
English: As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low.
Slovenian: Ker je zdravilo Kepivance beljakovinsko zdravilo, je tveganje za medsebojno delovanje z drugimi zdravili majhno.
English: However, the administration of palifermin did not affect heparin´s anticoagulant effect in the experimental conditions (single dose, subtherapeutic dose regimen).
Slovenian: Dajanje palifermina pa ni vplivalo na antikoagulacijski učinek heparina v eksperimentalnih pogojih (enkratni odmerek, subterapevtski režim odmerjanja).
English: After reconstitution: 24 hours at 2 °C - 8 °C, protected from light.
Slovenian: 6 let Po pripravi: 24 ur pri temperaturi med 2 °C in 8 °C, zaščiteno pred svetlobo.
English: MARKETING AUTHORISATION HOLDER Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
Slovenian: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Švedska
English: The potential risk to the human embryo or foetus is unknown.
Slovenian: Možno tveganje za človeški zarodek in plod ni znano.
English: Currently available data are described in section 5.2 but no recommendation on dose adjustment can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o prilagajanju odmerka ni mogoče dati.
English: Kepivance is a sterile but unpreserved product and is intended for single use only.
Slovenian: Zdravilo Kepivance je sterilno, vendar ne vsebuje konzervansov in je namenjeno samo za enkratno uporabo.
English: Kepivance has not been tested in pregnant women.
Slovenian: Zdravilo Kepivance ni preizkušeno pri nosečnicah.
English: The pharmacodynamic effect of palifermin, as measured by the change in Ki67 expression, tended to be lower when administered with heparin but the clinical relevance of this finding is unclear.
Slovenian: Farmakodinamični učinek palifermina, izmerjen s spremembo izraženosti Ki67, je bil nižji ob dajanju s heparinom, vendar pa klinični pomen te ugotovitve ni jasen.
English: Other endpoints included the incidence, duration and severity of oral mucositis and the requirement for opioid analgesia.
Slovenian: Med drugimi končnimi točkami so bile incidenca, trajanje in izrazitost oralnega mukozitisa in potreba po opioidni analgeziji.
English: For information on dose limiting toxicities see section 4.8.
Slovenian: Za informacije o toksičnih učinkih, ki omejujejo odmerek, glejte poglavje 4.8.
English: Studies in animals have shown reproductive and developmental toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja in razvoj (glejte poglavje 5.3).
English: It is not known whether Kepivance is excreted in human milk, therefore Kepivance should not be administered to women who are breast-feeding.
Slovenian: Ni znano, ali se zdravilo Kepivance izloča v materinem mleku, zato ženske, ki dojijo, ne smejo dobiti zdravila Kepivance.
English: In two studies in healthy volunteers, co-administration of Kepivance and heparin resulted in approximately 5 times higher systemic exposure to palifermin, due to a lower volume of distribution.
Slovenian: V dveh študijah z zdravimi prostovoljci je sočasno dajanje zdravila Kepivance in heparina povzročilo približno petkrat večjo sistemsko izpostavljenost paliferminu zaradi manjšega volumna porazdelitve.
English: No overt cases of pancreatitis have been reported in this patient population.
Slovenian: V tej populaciji bolnikov ni bilo manifestnih primerov pankreatitisa.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label, after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali, z oznako "Upor.
English: Kepivance might interact with a medicine called heparin.
Slovenian: Zdravilo Kepivance lahko vpliva na zdravilno učinkovino, imenovano heparin.
English: To treat your blood cancer you may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells).
Slovenian: Za zdravljenje vašega krvnega raka morda dobivate kemoterapijo, radioterapijo in presaditev avtolognih hematopoetskih matičnih celic (krvotvornih celic iz vašega lastnega organizma).
English: The contents should be swirled gently during dissolution.
Slovenian: Vsebino morate med raztapljanjem previdno vrteti.
English: In a study to assess potential carcinogenicity in transgenic rasH2 mice, no treatment related increases in the incidence of neoplastic lesions were observed.
Slovenian: V študiji za presojo potencialne kancerogenosti na transgenskih rasH miših niso opažali, da bi se incidence neoplastičnih lezij povečale v zvezi z zdravljenjem.
English: Kepivance will be given to you by a doctor or nurse with experience in cancer treatment.
Slovenian: Zdravilo Kepivance vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo zdravil proti raku.