FrancophonIA/ELRC3.0 huggingface dataset:
English: By reducing these impulses, tolperisone is believed to reduce muscle contraction, helping to relieve the stiffness.
Slovenian: Z onemogočanjem teh impulzov naj bi tolperizon onemogočil krčenje mišic in s tem olajšal togost.
English: In addition, since extremely limited data are available to support the safety and dosing recommendations of injectable tolperisone, the CHMP concluded that the benefits of this formulation do not outweigh the identified risks, and that the marketing authorisations for tolperisone-containing medicines given by injection should be revoked.
Slovenian: Poleg tega je zaradi dejstva, da so v podporo varnosti in priporočilom za odmerjanje tolperizona za injiciranje na voljo le izjemno omejeni podatki, je odbor CHMP zaključil, da koristi te oblike niso večje od ugotovljenih tveganj in da je treba dovoljenja za promet z zdravili za injiciranje, ki vsebujejo tolperizon, preklicati.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of tolperisone-containing medicines given orally (by mouth) continue to outweigh their risks, but that their use should be restricted to the treatment of adults with post-stroke spasticity (stiffness).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi peroralnih zdravil (zdravil, ki jih bolniki zaužijejo), ki vsebujejo tolperizon, še vedno večje od z njimi povezanih tveganj, vendar pa je treba njihovo uporabo omejiti na zdravljenje odraslih s spastičnostjo (togostjo)po možganski kapi.
English: • Patients should be informed of the possibility of hypersensitivity reactions during treatment with tolperisone.
Slovenian: • Bolnike je treba obvestiti, da med zdravljenjem s tolperizonom obstaja možnost za preobčutljivostne reakcije.
English: Therefore, based on the evaluation of the currently available data and considering that the risk of hypersensitivity reactions is more significant than previously identified, the CHMP concluded that the benefits of oral tolperisone-containing medicines continue to outweigh its risks only when used in the treatment of post-stroke spasticity in adults.
Slovenian: Zato je odbor CHMP na podlagi ocene trenutno razpoložljivih podatkov in ob upoštevanju, da je tveganje za preobčutljivostne reakcije bistveno večje od tveganja, ugotovljenega v preteklosti, zaključil, da so koristi peroralnih zdravil, ki vsebujejo tolperizon, še vedno večje od z njimi povezanih tveganj, vendar le pri uporabi za zdravljenje odraslih s spastičnostjo po možganski kapi.
English: • Patients should be aware that the benefits of oral tolperisone continue to outweigh its risks only for the treatment of post-stroke spasticity in adults.
Slovenian: • Bolniki se morajo zavedati, da so koristi peroralnega tolperizona še vedno večje od z njim povezanih tveganj le pri zdravljenju odraslih s spastičnostjo po možganski kapi.
English: • Prescribers are advised that the indication for oral tolperisone has been restricted to the treatment of post-stroke spasticity in adults.
Slovenian: • Zdravnike je treba obvestiti, da je bila indikacija za peroralni tolperizon omejena na zdravljenje spastičnosti po možganski kapi pri odraslih.
English: Patients should stop taking tolperisone and inform their doctor if they experience any of these symptoms.
Slovenian: Če bolniki zaznajo katerega koli od teh simptomov, naj nemudoma prenehajo jemati tolperizon in obvestijo svojega zdravnika.
English: This overview was last updated in 02-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 02-2019.
English: Rubraca (rucaparib)
Slovenian: Rubraca (rukaparib)
English: Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in po potrebi posodobila ta povzetek.
English: Regarding safety, side effects occur frequently but are generally not serious and are manageable with appropriate treatment.
Slovenian: Kar zadeva varnost, se neželeni učinki pojavljajo pogosto, vendar običajno niso hudi in so z ustreznim zdravljenjem obvladljivi.
English: What measures are being taken to ensure the safe and effective use of Rubraca?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rubraca?
English: Further information on Rubraca can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rubraca.
Slovenian: Nadaljnje informacije za zdravilo Rubraca so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Rubraca.
English: The European Medicines Agency decided that although further study was needed to better understand the size of the benefit, Rubraca's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da je sicer potrebna dodatna študija, ki bo omogočila boljše razumevanje obsega koristi, vendar so koristi zdravila Rubraca večje od z njim povezanih tveganj, in se lahko odobri za uporabo v EU.
English: Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018.
Slovenian: Za zdravilo Rubraca je bilo 24. maja 2018 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: An overview of Rubraca and why it is authorised in the EU
Slovenian: Pregled zdravila Rubraca in zakaj je odobreno v EU
English: Why is Rubraca authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Rubraca odobreno v EU?
English: In addition, fewer liver and blood-related problems occur with Rubraca than with other existing treatments for these patients.
Slovenian: Poleg tega se pri zdravilu Rubraca pojavlja manj težav z jetri in krvjo kot pri drugih obstoječih zdravljenjih za te bolnice.
English: Of the 79 patients whose disease had responded in the past to platinumbased medicines, 65% (51 patients) had a response to treatment with Rubraca and the response lasted on average 294 days (around 10 months).
Slovenian: Od 79 bolnic, katerih bolezen se je v preteklosti odzvala na zdravila na osnovi platine, se je 65 % (51 bolnic) odzvalo na zdravljenje z zdravilom Rubraca, odziv pa je trajal povprečno 294 dni (približno 10 mesecev).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rubraca upoštevati zdravstveni delavci in bolnice, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What is Rubraca and what is it used for?
Slovenian: Kaj je zdravilo Rubraca in za kaj se uporablja?
English: The company will also provide further data on maintenance treatment, including data on how long patients survived with Rubraca.
Slovenian: Podjetje bo zagotovilo tudi dodatne podatke o vzdrževalnem zdravljenju, vključno s podatki o času preživetja bolnic, ki prejemajo zdravilo Rubraca.
English: What benefits of Rubraca have been shown in studies?
Slovenian: Kakšne koristi zdravila Rubraca so se pokazale v študijah?
English: As for all medicines, data on the use of Rubraca are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rubraca stalno spremljajo.
English: Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment.
Slovenian: Ženske med zdravljenjem z zdravilom Rubraca in še vsaj dva tedna po zdravljenju ne smejo dojiti.
English: Rubraca has been given ‘conditional authorisation'.
Slovenian: Zdravilo Rubraca je pridobilo „pogojno dovoljenje za promet“.
English: For such patients, tests for a genetic mutation (BRCA mutation) should be carried out first to see if Rubraca is likely to work for them.
Slovenian: Pri teh bolnicah je treba najprej opraviti testiranje za gensko mutacijo (mutacija v genu BRCA), da se ugotovi, ali je verjetno, da bo zdravilo Rubraca zanje primerno.
English: The most common side effects with Rubraca (which may affect more than 1 in 5 people) are tiredness or weakness, nausea (feeling sick), increased levels of creatinine (which may indicate kidney problems) and liver enzymes in the blood (which may indicate liver damage), vomiting, anaemia (low red blood cell counts), decreased appetite, dysgeusia (taste disturbances), diarrhoea, thrombocytopenia (low levels of platelets) and abdominal pain (belly ache).
Slovenian: Najpogostejši neželeni učinki zdravila Rubraca (ki se lahko pojavijo pri več kot 1 od 5 bolnic) so utrujenost ali oslabelost, navzeja (siljenje na bruhanje), zvišane ravni kreatinina (kar lahko kaže na težave z ledvicami) in jetrnih encimov v krvi (kar lahko kaže na poškodbo jeter), bruhanje, anemija (nizko število rdečih krvnih celic), zmanjšan tek, disgevzija (spremembe v okušanju hrane), driska, trombocitopenija (nizko število krvnih ploščic) ter bolečine v trebuhu.
English: For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Rubraca glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Rubraca are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Rubraca, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnic.
English: It can also be used if the patient's cancer has returned or is worsening after two treatments with platinum-based medicines and they can no longer have these medicines.
Slovenian: Uporablja se lahko tudi, če se je rak pri bolnici ponovil ali poslabšal po dveh zdravljenjih z zdravili na osnovi platine in teh zdravil ne more več uporabljati.
English: Rubraca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer.
Slovenian: Predpisovanje in izdaja zdravila Rubraca je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: In normal cells there is an alternative mechanism for repairing DNA but this alternative mechanism does not work properly in cancer cells with mutations in the BRCA genes.
Slovenian: V normalnih celicah obstaja alternativni mehanizem popravljanja DNK, ki pa v rakavih celicah z mutacijami v genu BRCA ne deluje pravilno.
English: Other information about Rubraca
Slovenian: Druge informacije o zdravilu Rubraca
English: What are the risks associated with Rubraca?
Slovenian: Kakšna tveganja so povezana z zdravilom Rubraca?
English: Two other studies looked at 106 patients with ovarian cancer and BRCA mutation whose cancer had come back following at least 2 previous cancer treatments, including in many cases treatment with platinum-based medicines.
Slovenian: V drugih dveh študijah so proučevali 106 bolnic z rakom jajčnikov in mutacijo v genu BRCA, pri katerih se je rak po vsaj dveh predhodnih zdravljenjih ponovil, v številnih primerih tudi po zdravljenju z zdravili na osnovi platine.
English: The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADPribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells).
Slovenian: Učinkovina v zdravilu Rubraca, rukaparib, zavira aktivnost družine beljakovin, imenovanih poli (ADPriboza) polimeraze (PARP), ki pomagajo popravljati poškodovano DNK v (normalnih in rakavih) celicah.
English: What information is still awaited for Rubraca?
Slovenian: Katere informacije o zdravilu Rubraca še pričakujemo?
English: proteins are blocked, the damaged DNA in these cancer cells cannot be repaired, and, as a result, the cancer cells die.
Slovenian: Z zaviranjem beljakovin PARP se poškodovana DNK v teh rakavih celicah torej ne more popraviti in zato rakave celice odmrejo.
English: Patients given Rubraca lived for 11 months without the disease coming back or getting worse compared with 5 months in patients given placebo (a dummy treatment).
Slovenian: Bolnice, ki so prejemale zdravilo Rubraca, so živele 11 mesecev brez ponovnega pojava ali poslabšanja bolezni, tiste, ki so prejemale placebo (zdravilo brez učinkovine), pa pet mesecev.
English: Since Rubraca has been given conditional authorisation, the company that markets the medicine will provide the results from an ongoing study comparing Rubraca with chemotherapy (another cancer medicine) in patients with high-grade epithelial cancer of the ovary, of the fallopian tubes or of the peritoneum with BRCA mutation whose cancer has come back after chemotherapy treatments.
Slovenian: Ker je zdravilo Rubraca pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo rezultate iz študije, ki poteka in v kateri primerjajo zdravilo Rubraca s kemoterapijo (drugim zdravilom za zdravljenje raka) pri bolnicah z epitelijskim rakom jajčnikov, jajcevodov ali peritonealnega raka visoke stonje z mutacijo v genu BRCA, pri katerih se je rak po zdravljenju s kemoterapijo ponovil.
English: Rubraca was also beneficial to patients whose cancer had come back after 2 previous cancer treatments, although these benefits have only been shown in patients with a BRCA mutation.
Slovenian: Zdravilo Rubraca je koristilo tudi bolnicam, katerih rak se je ponovil po dveh predhodnih zdravljenjih raka, vendar so se ti učinki pokazali le pri bolnicah z mutacijo v genu BRCA.
English: For maintenance treatment, Rubraca should be used no later than 8 weeks after the patient has finished their treatment with platinum-based medicine.
Slovenian: Pri vzdrževalnem zdravljenju je treba zdravilo Rubraca uporabiti najpozneje osem tednov po končanem zdravljenju z zdravilom na osnovi platine.
English: Rubraca as maintenance treatment was investigated in a study of 564 patients with ovarian cancer which had cleared (partially or completely) after treatment with platinum-based cancer medicines.
Slovenian: Zdravilo Rubraca so kot vzdrževalno zdravljenje proučevali v študiji s 564 bolnicami z rakom jajčnikov, ki je (delno ali v celoti) izginil po zdravljenju z zdravili za zdravljenje raka na osnovi platine.
English: How is Rubraca used?
Slovenian: Kako se zdravilo Rubraca uporablja?
English: It can be used as maintenance treatment in patients whose recurring cancer has cleared (partially or completely) after treatment with platinum-based cancer medicines.
Slovenian: Zdravilo Rubraca se lahko uporablja za vzdrževalno zdravljenje pri bolnicah, pri katerih je ponovljeni rak (delno ali v celoti) izginil po zdravljenju z zdravili za zdravljenje raka na osnovi platine.
English: This benefit was seen in patients with or without the BRCA mutation.
Slovenian: Ta učinek je bil viden pri bolnicah z mutacijo v genu BRCA ali brez nje.
English: Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
Slovenian: Rubraca je zdravilo za zdravljenje raka jajčnikov, jajcevodov (cevastih organov, ki povezujejo jajčnike z maternico) in peritonealnega (mrena v trebušni votlini) raka visoke stopnje.
English: This benefit with Rubraca was seen in patients with or without the BRCA mutation.
Slovenian: Ta učinek zdravila Rubraca je bil viden pri bolnicah z mutacijo v genu BRCA ali brez nje.
English: How does Rubraca work?
Slovenian: Kako zdravilo Rubraca deluje?
English: Treatment may be interrupted and doses may be reduced in patients who have certain side effects.
Slovenian: Pri bolnicah, ki imajo določene neželene učinke, bo morda treba zdravljenje prekiniti ali zmanjšati odmerek.
English: For the full list of side effects of Rubraca, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rubraca, glejte navodilo za uporabo.
English: The recommended dose of Rubraca is 600 mg twice a day.
Slovenian: Zdravilo Rubraca je na voljo v obliki tablet po 200, 250 in 300 mg. Priporočeni odmerek zdravila Rubraca je 600 mg dvakrat na dan. Zdravljenje je treba nadaljevati, dokler rak napreduje ali se pri bolnici pojavijo nesprejemljivi neželeni učinki.
English: Rubraca has been shown to delay worsening or return of the disease in patients whose cancer had cleared partially or completely after treatment with platinum-based medicines.
Slovenian: Pri bolnicah, pri katerih je rak po zdravljenju z zdravili na osnovi platine delno ali v celoti izginil, se je pokazalo, da zdravilo Rubraca upočasni poslabšanje ali ponovitev bolezni.
English: It is available as tablets (400 and 800 mg).
Slovenian: Na voljo je v tabletah (400 in 800 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Renagel on 28 January 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Renagel, veljavno po vsej Evropski uniji, izdala 28. januarja 2000.
English: The full EPAR for Renagel 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 Renagel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease.
Slovenian: To povzroča hiperfosfatemijo, ki lahko dolgoročno vodi do zapletov, na primer do bolezni srca in okostja.
English: What measures are being taken to ensure the safe and effective use of Renagel?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Renagel?
English: This is a summary of the European public assessment report (EPAR) for Renagel.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Renagel.
English: In the third, there was an average fall of 0.71 mmol/l over 44 weeks.
Slovenian: V tretji študiji je bilo v 44 tednih ugotovljeno povprečno znižanje za 0,71 mmol/l.
English: In all of the studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti sprememba ravni fosfatov v krvi od začetka do konca zdravljenja.
English: Patients should take Renagel tablets whole with meals and stick to their prescribed diets.
Slovenian: Bolniki morajo tablete zdravila jemati cele ob obroku in se držati predpisane diete.
English: Other information about Renagel
Slovenian: Druge informacije o zdravilu Renagel
English: For more information about treatment with Renagel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Renagel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: A risk management plan has been developed to ensure that Renagel is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Renagel je bil pripravljen načrt obvladovanja tveganj.
English: Patients with long-term kidney disease cannot eliminate phosphate from their bodies.
Slovenian: Bolniki z dolgotrajno boleznijo ledvic iz telesa ne morejo izločati fosfatov.
English: When taken with meals, it attaches to phosphate from food within the gut, preventing it from being absorbed into the body.
Slovenian: Če se zdravilo jemlje ob obrokih, se v črevesju veže na fosfate iz hrane, s čimer preprečuje njihovo absorpcijo v telo.
English: Renagel should be used with other treatments such as calcium or vitamin D supplements to control the development of bone disease.
Slovenian: Zdravilo Renagel je treba uporabljati skupaj z drugimi načini zdravljenja, na primer z dodatki kalcija in vitamina D za nadzor razvoja obolenja kosti.
English: In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks.
Slovenian: Pri hemodializi so zdravilo Renagel proučili v dveh kratkotrajnih študijah (8 tednov) in eni daljši študiji (44 tednov).
English: The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day.
Slovenian: Priporočeni začetni odmerek zdravila Renagel je odvisen od koncentracije fosfatov v krvi in znaša od 800 do 1 600 mg trikrat dnevno.
English: The longer study looked at the use of Renagel in 192 patients, the majority of whom had taken Renagel in previous studies.
Slovenian: V daljši študiji so proučevali uporabo zdravila Renagel pri 192 bolnikih, od katerih ga je večina jemala v predhodnih študijah.
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 Renagel.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Renagel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Renagel večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Renagel, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The second, which did not compare Renagel with any other medicines, included 172 patients.
Slovenian: V drugi študiji, v kateri zdravila Renagel niso primerjali z nobenim drugim zdravilom, je sodelovalo 172 bolnikov.
English: What benefit has Renagel shown during the studies?
Slovenian: Kakšne koristi je zdravilo Renagel izkazalo med raziskavami?
English: The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Slovenian: Najpogostejša neželena učinka zdravila Renagel (opažena pri enem bolniku od desetih) sta navzeja (slabost) in bruhanje.
English: The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/l.
Slovenian: Odmerek zdravila je treba prilagoditi tako, da koncentracija fosfatov v krvi ostane pod 1,76 mmol/l.
English: It can be used in patients undergoing haemodialysis (dialysis using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Slovenian: Lahko se uporablja pri bolnikih, ki prejemajo hemodializo (dializo z uporabo naprave za filtriranje krvi) ali peritonealno dializo (pri čemer se tekočina črpa v trebuh, notranja telesna membrana pa filtrira kri).
English: In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/l over the eight weeks of Renagel treatment, compared with 0.68 mmol/l when the patients were taking calcium acetate.
Slovenian: V primerjalni študiji bolnikov, ki so prejemali hemodializo, je bilo povprečno znižanje v osmih tednih zdravljenja z zdravilom Renagel 0,65 mmol/l, medtem ko je bilo znižanje pri bolnikih, ki so prejemali kalcijev acetat, 0,68 mmol/l.