FrancophonIA/ELRC3.0 huggingface dataset:
English: In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
Slovenian: Pri dializnih bolnikih s hudim obolenjem ledvic je imelo približno 40 % bolnikov, ki so jemali zdravilo Parareg, ob koncu študije ravni paratiroidnega hormona pod 250 mikrogramov na liter, v primerjavi s 6 % bolnikov, ki so prejemali placebo.
English: For oral use Read the package leaflet before use.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Parareg, glejte navodilo za uporabo.
English: In this leaflet What Parareg is and what it is used for
Slovenian: Za kaj se zdravilo Parareg uporablja ?
English: B CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: Odbor je priporočil, da se za zdravilo Parareg odobri dovoljenje za promet.
English: PTH levels in Parareg clinical trials were measured at the end of the dosing interval.
Slovenian: Kakšne koristi je zdravilo Parareg izkazalo med študijami?
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Parareg je na voljo tukaj.
English: During treatment with Parareg, tell your doctor:
Slovenian: Zdravilo Parareg se uporablja pri odraslih in starostnikih:
English: In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
Slovenian: Zdravilo Parareg je zmanjšalo ravni paratiroidnega hormona za 42 % v primerjavi s povečanjem za 8 % pri bolnikih, ki so jemali placebo.
English: Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n=1136).
Slovenian: Zdravilo Parareg so preučevali v treh glavnih študijah, ki so vključevale 1136 dializnih bolnikov s hudim obolenjem ledvic.
English: Parareg works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Slovenian: To pomeni, da posnema učinkovanje kalcija v telesu.
English: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Slovenian: Rezultati dodatnih študij so podprli uporabo zdravila Parareg pri zdravljenju hiperkalciemije pri bolnikih s primarnim hiperparatiroidizmom.
English: Parareg should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).
Slovenian: Zdravilo Parareg se uporablja pri bolnikih s hudim obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi potrebujejo dializo.
English: Parareg has not been tested in pregnant women.
Slovenian: Kako je bilo zdravilo Parareg raziskano?
English: Cataracts are known to occur in rodents as a result of hypocalcaemia.
Slovenian: „Sekundarni“ pomeni, da hiperparatiroidizem nastane kot posledica drugega bolezenskega stanja.
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli ob koncu študije raven paratiroidnega hormona pod 250 mikrogramov na liter.
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Slovenian: Cinakalcet s povečanjem občutljivosti teh receptorjev zmanjša tvorbo paratiroidnega hormona v obščitnicah.
English: Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT receiving dialysis.
Slovenian: Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom so neželeni učinki podobni tistim, opaženim pri bolnikih z dolgotrajnim obolenjem ledvic: najpogostejša neželena učinka sta navzeja (slabost) in bruhanje.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Slovenian: To pomeni, da obstajajo podatki v literaturi z znanstvenimi dokazi o njihovi učinkovitosti in varnosti, če se uporabljajo, kot je navedeno, in ki v EU zajemajo obdobje vsaj 10 let.
English: It should be taken during the day at least half an hour to one hour before or after taking other medicines and not immediately before bedtime.
Slovenian: Jemati jo je treba čez dan, vsaj pol ure do eno uro pred ali po jemanju drugih zdravil, in ne neposredno pred spanjem.
English: The plant is cultivated or gathered to obtain the seeds for medicinal use.
Slovenian: Rastlino se goji ali nabira za pridobivanje semen za medicinsko uporabo.
English: EMA/HMPC/313600/2013
Slovenian: EMA/HMPC/313600/2013 Odbor za zdravila rastlinskega izvora (HMPC)
English: If constipation does not resolve after three days, a doctor or pharmacist should be consulted.
Slovenian: Če se zaprtosti ne odpravi v treh dneh, se je treba posvetovati z zdravnikom ali farmacevtom.
English: When handling the powder preparation, inhalation of the powder should be avoided as this may lead to allergic sensitization and the potential development of allergies.
Slovenian: Pri uporabi pripravka v obliki praška je treba preprečiti vdihavanje praška, ker lahko to povzroči alergijsko občutljivost in morebitni razvoj alergij.
English: Studies that were carried out in patients with irritable bowel disease did not show an effect on the disease itself but showed benefits in those patients who were also suffering from constipation.
Slovenian: Študije, ki so bile izvedene na bolnikih z boleznijo razdražljivega črevesja, niso pokazale učinka na bolezen samo, vendar so zabeležili koristi pri bolnikih, ki so istočasno trpeli za zaprtostjo.
English: The HMPC conclusions on the use of ispaghula husk medicines are based on their ‘well-established use' in these conditions.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo semensko lupino jajčastega trpotca, temeljijo na njihovi „dobro uveljavljeni uporabi“ pri teh stanjih.
English: It can be used in adults and children above the age of 6 years for the treatment of constipation and to soften the stools but should only be used in adults and children over the age of 12 years when used to increase the fibre intake.
Slovenian: Za zdravljenje zaprtosti in omehčanje blata se lahko uporablja pri odraslih in otrocih, starejših od 6 let, , za povečanje vnosa vlaknin pa se lahko uporablja samo pri odraslih in otrocih, starejših od 12 let.
English: It should also not be used in patients with conditions that involve a narrowing of the stomach and gut, and patients who have difficulty swallowing or have problems with their throat.
Slovenian: Prav tako se jih ne sme uporabljati pri bolnikih s stanji, ki vključujejo zoženje želodca in črevesja, ter pri bolnikih, ki imajo težave s požiranjem ali z žrelom.
English: There is a risk of a build-up of hard, dry stool, particularly if Ispaghula husk is swallowed without enough liquid.
Slovenian: Obstaja tveganje za kopičenje trdega, suhega blata, zlasti kadar se lupina jajčastega trpotca ne zaužije z dovolj tekočine.
English: The way ispaghula husk works in reducing blood cholesterol levels is not fully understood.
Slovenian: Delovanje semenske lupine jajčastega trpotca pri zmanjšanju ravni holesterola v krvi ni povsem pojasnjeno.
English: Further information on the risks associated with ispaghula husk medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The use of ispaghula husk in hypercholesterolaemia always requires medical supervision.
Slovenian: Uporaba semenske lupine jajčastega trpotca pri hiperholesterolemiji mora vedno potekati pod zdravniškim nadzorom.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ispaghula husk.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo semenske lupine jajčastega trpotca.
English: This summary is not intended to provide practical advice on how to use medicines containing ispaghula husk.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo semensko lupino jajčastega trpotca.
English: By increasing the stool bulk it also increases the tension in the bowel wall which will trigger bowel movements.
Slovenian: S povečanjem prostornine blata poveča tudi napetost črevesne stene, kar sproži odvajanje blata.
English: Allergic reactions including rhinitis (runny nose), conjunctivitis (reddening and inflammation of the white of the eye), bronchospasm (excessive and prolonged contraction of the airway muscles) and anaphylaxis (severe allergic reaction) may also occur.
Slovenian: Pojavijo se lahko tudi alergijske reakcije, vključno z rinitisom (izcejanjem iz nosu), konjunktivitisom (pordečitvijo in vnetjem očesne beločnice), bronhospazmom (čezmernim in dolgotrajnim krčenjem mišic v dihalnih poteh) in anafilaksijo (hudo alergijsko reakcijo).
English: Ispaghula husk is the common name for the seed coats of the plant Plantago ovata Forssk.
Slovenian: Semenska lupina jajčastega trpotca je splošno ime za ovojnice semen rastline Plantago ovata Forssk.
English: Any applications for the licensing of medicines containing ispaghula husk have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: The HMPC also concluded that ispaghula husk can be used in people where an increase in the daily intake of dietary fibre may be advisable, such as patients with irritable bowel syndrome who are suffering from constipation or in combination with diet in patients with hypercholesterolaemia (high blood cholesterol levels).
Slovenian: Odbor HMPC je prav tako zaključil, da se lahko semenska lupina jajčastega trpotca uporablja pri osebah, pri katerih bi bil priporočljiv povečan dnevni vnos prehranskih vlaknin, na primer pri bolnikih s sindromom razdražljivega črevesja, ki trpijo za zaprtostjo, ali v kombinaciji s prehrano pri bolnikih s hiperholesterolemijo (visokimi ravnmi holesterolav krvi).
English: Further information on the HMPC assessment of ispaghula husk medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo semensko lupino jajčastega trpotca, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ispaghula husk.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo semensko lupino jajčastega trpotca.
English: Information on the use and licensing of ispaghula husk medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Its effectiveness in softening stools has been shown in a number of studies comparing ispaghula husk with placebo (a dummy treatment) in patients with haemorrhoids.
Slovenian: Njegova učinkovitost pri mehčanju blata je bila dokazana v številnih študijah, v katerih so semensko lupino jajčastega trpotca primerjali s placebom (zdravilom brez zdravilne učinkovine) pri bolnikih s hemoroidi.
English: Ispaghula husk is used without further processing or as preparations obtained by powdering the seed coats.
Slovenian: Semenska lupina jajčastega trpotca se uporablja brez nadaljnje obdelave ali v obliki pripravkov, izdelanih z drobljenjem ovojnic semen v prašek.
English: How are ispaghula husk medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo semensko lupino jajčastega trpotca, odobrena v EU?
English: In its assessment of ispaghula husk to treat constipation, the HMPC considered a number of clinical studies involving over 900 patients that showed the effectiveness of ispaghula husk as a mild laxative.
Slovenian: Odbor HMPC je pri oceni semenske lupine jajčastega trpotca za zdravljenje zaprtosti preučil številne klinične študije, v katerih je sodelovalo več kot 900 bolnikov, ki so pokazale učinkovitost semenske lupine jajčastega trpotca kot blagega odvajala.
English: Several studies investigated the effects of ispaghula husk on blood cholesterol levels and found that treatment with ispaghula husk led to small reductions in blood cholesterol levels.
Slovenian: Učinke semenske lupine jajčastega trpotca na raven holesterola v krvi so preučevali v več študijah in ugotovili, da je zdravljenje s semensko lupino jajčastega trpotca povzročilo manjša znižanja ravni holesterola v krvi.
English: Detailed instruction on how to take ispaghula husk medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo semensko lupino jajčastega trpotca, in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: The HMPC concluded that ispaghula husk can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Slovenian: Odbor HMPC je zaključil, da se lahko semenska lupina jajčastega trpotca uporablja za zdravljenje habitualne (ponavljajoče) zaprtosti (zaprtost, ki ni posledica organskih sprememb) in pri stanjih, ko je želeno omehčanje blata, da se zmanjša bolečine pri njegovem odvajanju, na primer pri analnih fisurah (zadnjičnih razpokah), hemoroidih (zlati žili) in po kirurškem posegu na anusu (zadnjiku) ali rektumu (danki).
English: Ispaghula husk contains dietary fibre, which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Slovenian: Semenska lupina jajčastega trpotca vsebuje prehranske vlaknine, ki pomešane z vodo tvorijo gelu podobno zmes, ki deluje kot blago odvajalo (zdravilo za zdravljenje zaprtosti).
English: The HMPC recommended that ispaghula husk should not be used in patients with a sudden change in bowel habit that persists for more than two weeks, and in patients with undiagnosed bleeding of the rectum and failure to pass stools following the use of a laxative.
Slovenian: Odbor HMPC je priporočil, da se zdravil, ki vsebujejo semensko lupino jajčastega trpotca, ne sme uporabljati pri bolnikih z nenadno spremembo pri odvajanju blata, ki traja več kot dva tedna, ter pri bolnikih z nediagnosticirano krvavitvijo iz rektuma (danke) in nezmožnostjo izločanja blata po jemanju odvajal.
English: Herbal medicines containing ispaghula husk are usually available in solid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo semensko lupino jajčastega trpotca, so navadno na voljo v trdnih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
English: For more information about treatment with ispaghula husk 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 semensko lupino jajčastega trpotca, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: It moves down the digestive system and makes the stools softer by increasing their water content.
Slovenian: Zmes se pomika navzdol po prebavilih in poveča vsebnost vode v blatu ter ga tako omehča.
English: For practical information about using ispaghula husk 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: Ispaghula husk should be taken with plenty of liquid.
Slovenian: Semensko lupino jajčastega trpotca je treba zaužiti z veliko tekočine.
English: Side effects have been reported with ispaghula husk medicines, including flatulence and abdominal distension (swelling of the belly).
Slovenian: Pri zdravilih, ki vsebujejo semensko lupino jajčastega trpotca, so poročali o neželenih učinkih, vključno s flatulenco (nabiranje plinov v želodcu in črevesju, vetrovi) in abdominalno distenzijo (napihnjenostjo trebuha).
English: How does ispaghula husk work as a medicine?
Slovenian: Kako semenska lupina jajčastega trpotca deluje kot zdravilo?
English: What are the risks associated with Ispaghula husk medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo semensko lupino
English: What evidence supports the use of ispaghula husk medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo semensko lupino
English: At the same time ispaghula husk lubricates the intestine which improves the transit of stools.
Slovenian: Semenska lupina jajčastega trpotca obenem podmaže črevo, s čimer se izboljša prehajanje blata.
English: Other information about ispaghula husk medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo semensko lupino jajčastega trpotca
English: What is Ispaghula husk?
Slovenian: Kaj je lupina jajčastega trpotca?
English: 15 March 2012
Slovenian: 15. marec 2012
English: The withdrawal letter is available here.
Slovenian: Dopis o umiku je na voljo tukaj.
English: The application was withdrawn after ‘day 90'.
Slovenian: Vlogo so umaknili po „90.
English: Tyverb has been authorised in the EU since June 2008.
Slovenian: Zdravila Tyverb je v EU odobreno od junija 2008.
English: A comparative study would have addressed this issue.
Slovenian: To vprašanje bi lahko obravnavali v primerjalni študiji.
English: The main measure of effectiveness was overall survival (the length of time the patients lived).
Slovenian: Glavno merilo učinkovitosti je bilo celokupno preživetje (koliko časa so bolnice živele).
English: What was the recommendation of the CHMP at that time?
Slovenian: Kakšno je bilo takrat priporočilo odbora CHMP?
English: Tyverb is available in all EU Member States.
Slovenian: Zdravilo Tyverb je na voljo v vseh državah članicah EU.
English: The full European Public Assessment Report for Tyverb 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 Tyverb je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets.
Slovenian: Na voljo je v obliki tablet.
English: It has been granted ‘conditional' marketing authorisation because there is more evidence to come about the medicine.
Slovenian: Zdravilo je pridobilo „pogojno dovoljenje za promet“, ker se pričakujejo dodatni dokazi o njegovem delovanju.
English: HER2 is a receptor for epidermal growth factor and is involved in stimulating the cells to divide uncontrollably.
Slovenian: HER2 je receptor za epidermalni rastni faktor in sodeluje pri stimulaciji nenadzorovane delitve celic.
English: ‘Advanced' means that the cancer has started to spread and ‘metastatic' means that the cancer has already spread to other parts of the body.
Slovenian: „Napredoval“ pomeni, da se je rak začel širiti, „metastatski“ pa, da se je že razširil na druge dele telesa.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: To pomeni, da je odbor CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: The company presented data from one main study involving a total of 444 patients with metastatic breast cancer that was expressing large quantities of HER2.
Slovenian: Družba je predložila podatke iz ene glavne študije, v kateri je sodelovalo 444 bolnic z metastatskim rakom dojke, ki je izražal velike količine HER2.
English: What is Tyverb?
Slovenian: Kaj je zdravilo Tyverb?
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Slovenian: Kakšne so posledice umika za bolnice, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
English: There are no consequences on the use of Tyverb in its authorised indications.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Tyverb pri odobrenih indikacijah.
English: Tyverb in combination with paclitaxel is expected to work in the same way as it does in its existing indication.
Slovenian: Zdravilo Tyverb naj bi v kombinaciji s paklitakselom delovalo enako kot pri obstoječi indikaciji.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: Potem ko je ocenil odgovore družbe na vprašanja, so nekatera vprašanja še vedno ostala nerešena.
English: On 15 February 2012, Glaxo Group Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Tyverb, to add the use in combination with paclitaxel for the treatment of metastatic breast cancer.
Slovenian: Družba Glaxo Group Ltd. je dne 15. februarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Tyverb, s katero bi dodala uporabo zdravila v kombinaciji s paklitakselom za zdravljenje metastatskega raka dojke.
English: What was Tyverb expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Tyverb uporabljalo?
English: Tyverb is used when the cancer is advanced or metastatic.
Slovenian: Zdravilo Tyverb se uporablja pri napredovalem ali metastatskem raku.
English: These compounds work by blocking enzymes known as protein kinases, which can be found in some receptors on the surface of cancer cells including HER2.
Slovenian: Te učinkovine delujejo tako, da zavirajo encime proteinske kinaze, ki jih najdemo v nekaterih receptorjih na površini rakavih celic, vključno s HER2.
English: Tyverb is a medicine that contains the active substance lapatinib.
Slovenian: Tyverb je zdravilo, ki vsebuje zdravilno učinkovino lapatinib.