FrancophonIA/ELRC3.0 huggingface dataset:
English: Rydapt must not be given to patients taking certain other medicines that affect the way it is handled in the body.
Slovenian: Zdravilo Rydapt se ne sme dajati bolnikom, ki jemljejo nekatera druga zdravila, ki vplivajo na način njegove presnove v telesu.
English: For mast cell disorders, the starting dose is 100 mg (four capsules) twice daily; treatment is continued for as long as the patient benefits.
Slovenian: Pri boleznih mastocitov je začetni odmerek 100 mg (štiri kapsule) dvakrat na dan; zdravljenje se nadaljuje, dokler bolniku koristi.
English: Why is Rydapt approved?
Slovenian: Zakaj je bilo zdravilo Rydapt odobreno?
English: What benefits of Rydapt have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Rydapt izkazalo v študijah?
English: What are the risks associated with Rydapt?
Slovenian: Kakšna tveganja so povezana z zdravilom Rydapt?
English: The European Medicines Agency therefore decided that Rydapt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Rydapt večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Rydapt is available as capsules containing 25 mg of midostaurin.
Slovenian: Zdravilo Rydapt je na voljo v obliki kapsul, ki vsebujejo 25 mg midostavrina.
English: For more information about treatment with Rydapt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rydapt preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rydapt have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rydapt upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Rydapt can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Rydapt je le na recept, zdravljenje pa mora začeti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: In mast cell disorders there was also important evidence of effectiveness.
Slovenian: Tudi za bolezni mastocitov obstajajo pomembni dokazi o učinkovitosti.
English: One main study, involving 717 such patients, compared Rydapt with placebo (a dummy treatment) initially as an addition to other cancer medicines, followed by treatment with Rydapt or placebo alone in those whose disease responded.
Slovenian: V eni glavni študiji, ki je vključevala 717 takih bolnikov, so primerjali zdravilo Rydapt s placebom (zdravilom brez zdravilne učinkovine), na začetku kot dodatek drugim zdravilom proti raku, nato pa v obliki samostojnega zdravljenja z zdravilom Rydapt ali placebom pri bolnikih, pri katerih se je bolezen odzvala.
English: This means that it blocks the action of certain enzymes known as receptor tyrosine kinases.
Slovenian: To pomeni, da zavira delovanje encimov, imenovanih receptorji tirozin kinaze.
English: It is used with other cancer medicines (chemotherapy) initially and on its own once the chemotherapy is completed if the disease has responded to treatment.
Slovenian: Na začetku se uporablja skupaj z drugimi zdravili za zdravljenje raka (kemoterapijo), nato pa samostojno, ko je kemoterapija zaključena, če se je bolezen odzvala na zdravljenje.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and Rydapt was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates (see below).
Slovenian: Ker je bolnikov s temi boleznimi malo, veljajo za redke, zato je bilo zdravilo Rydapt večkrat (glejte datume spodaj) določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Although Rydapt had not been compared with other treatments, given the rarity of the conditions and the unmet medical need of patients who have them, the clinical benefits were clear, and the adverse effects acceptable.
Slovenian: Čeprav zdravila Rydapt niso primerjali z nobenim drugim zdravilom, so klinične koristi glede na redkost bolezni in neizpolnjene zdravstvene potrebe bolnikov, ki imajo te bolezni, jasne, neželeni učinki pa sprejemljivi.
English: For practical information about using Rydapt, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Rydapt naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Rydapt is only given when the AML has a particular genetic change called an FLT3 mutation.
Slovenian: Zdravilo Rydapt se daje le, kadar ima AML posebno genetsko spremembo, imenovano mutacija FLT3.
English: In patients with an FLT3 mutation, an abnormal form of the FLT3 tyrosine kinase stimulates the survival and growth of AML cells.
Slovenian: Pri bolnikih z mutacijo FLT3, nenormalno obliko tirozin kinaze FLT3, spodbuja preživetje in rast celic AML.
English: How is Rydapt used?
Slovenian: Kako se zdravilo Rydapt uporablja?
English: The active substance in Rydapt, midostaurin, is a ‘tyrosine kinase inhibitor'.
Slovenian: Zdravilna učinkovina v zdravilu Rydapt, midostavrin, je „zaviralec tirozin kinaze“.
English: The study looked at the response to Rydapt treatment in patients with aggressive systemic mastocytosis, systemic mastocytosis associated with blood cancer, or mast cell leukaemia.
Slovenian: V študiji so preučevali odziv na zdravljenje z zdravilom Rydapt pri bolnikih z agresivno sistemsko mastocitozo, sistemsko mastocitozo, povezano s krvnim rakom, ali mastocitno levkemijo.
English: Rydapt also blocks a mutated form of another enzyme, KIT kinase, which plays an important role in stimulating the abnormal growth of mast cells in patients with mast cell disorders.
Slovenian: Zdravilo Rydapt tudi zavira mutirano obliko drugega encima, KIT-kinaze, ki ima pomembno vlogo pri spodbujanju nenormalne rasti mastocitov pri bolnikih z boleznimi mastocitov.
English: For the full list of all side effects reported with Rydapt, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rydapt, glejte navodilo za uporabo.
English: Rydapt is a cancer medicine used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a cancer of white blood cells.
Slovenian: Rydapt je zdravilo za zdravljenje raka, ki se uporablja pri odraslih z novo diagnosticirano akutno mieloično levkemijo (AML), vrsto raka, ki prizadene bele krvne celice.
English: The commonest severe side effects were tiredness, sepsis (blood poisoning), pneumonia (lung infection), febrile neutropenia and diarrhoea.
Slovenian: Najpogostejši resni neželeni učinki so bili utrujenost, sepsa (zastrupitev krvi), pljučnica (okužba pljuč), febrilna nevtropenija in driska.
English: Another main study involving 116 patients with mast cell disorders also showed benefit.
Slovenian: Koristi so dokazali tudi v drugi glavni študiji, ki je vključevala 116 bolnikov z boleznimi mastocitov.
English: By blocking the abnormal FLT3 enzyme, Rydapt helps to bring about the death of the abnormal cells and control the spread of the cancer.
Slovenian: Zdravilo Rydapt z zaviranjem nenormalnega encima FLT3 pripomore k uničenju nenormalnih celic in nadzoru širjenja raka.
English: Rydapt is also used on its own in adults with the following disorders of a type of white blood cell known as mast cell: aggressive systemic mastocytosis, systemic mastocytosis associated with a haematological neoplasm (blood cancer), and mast cell leukaemia.
Slovenian: Zdravilo Rydapt se samostojno uporablja tudi pri odraslih z naslednjimi boleznimi vrste belih krvnih celic, imenovanih mastociti: agresivno sistemsko mastocitozo, sistemsko mastocitozo, povezano s hematološko neoplazmo (krvnim rakom), in mastocitno levkemijo.
English: The most frequent severe side effects were febrile neutropenia, lymphopenia (low counts of lymphocytes, a particular type of white blood cell), infections at the site of a catheter (a tube inserted in a vein), exfoliative dermatitis, high blood sugar and nausea (feeling sick).
Slovenian: Najpogostejši resni neželeni učinki so bili febrilna nevtropenija, limfopenija (nizko število limfocitov, posebne vrste belih krvnih celic), okužbe na mestu katetra (cevke, vstavljene v veno), eksfoliativni dermatitis, visoka raven sladkorja v krvi in navzea (siljenje na bruhanje).
English: When used to treat AML, the most common side effects with Rydapt (which may affect more than 1 in 10 people) are febrile neutropenia (fever and low white blood cell count, seen in nearly all patients), exfoliative dermatitis (inflamed, peeling skin), vomiting, headache, petechiae (tiny blood spots under the skin) and fever.
Slovenian: Kadar se zdravilo Rydapt uporablja za zdravljenje AML, so najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 10) febrilna nevtropenija (zvišana telesna temperatura in nizko število belih krvnih celic, kar se pojavi pri skoraj vseh bolnikih), eksfoliativni dermatitis (vneta koža, ki se lušči), bruhanje, glavobol, petehije (drobne krvave pike pod kožo) in zvišana telesna temperatura.
English: When used for mast cell disorders, the commonest side effects (affecting one third or more of all patients) were nausea, vomiting, diarrhoea, peripheral oedema (swelling of the ankles and feet) and tiredness.
Slovenian: Kadar se je zdravilo uporabljalo za zdravljenje bolezni mastocitov, so bili najpogostejši neželeni učinki (ki se pojavijo pri eni tretjini bolnikov ali več) navzea, bruhanje, driska, periferni edem (otekanje gležnjev in stopal) ter utrujenost.
English: Rydapt has been shown to be of benefit in patients with AML associated with an FTL3 mutation.
Slovenian: Dokazano je bilo, da zdravilo Rydapt koristi bolnikom z AML, povezano z mutacijo FTL3.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Rydapt can be found on the Agency's website:
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Rydapt je na voljo na spletni strani agencije: akutna mieloična levkemija, mastocitoza.
English: The usual starting dose is 50 mg (two capsules) twice a day for AML, on days 8 to 21 of a 28-day treatment cycle, and then every day once the disease has responded.
Slovenian: Pri AML je običajni začetni odmerek 50 mg (dve kapsuli) dvakrat na dan od 8. do
English: Rydapt has been shown to improve survival in patients with AML associated with an FLT3 mutation.
Slovenian: Dokazali so, da zdravilo Rydapt podaljša preživetje pri bolnikih z AML, povezano z mutacijo FLT3.
English: acute myeloid leukaemia mastocytosis.
Slovenian: Zdravilo Rydapt vsebuje zdravilno učinkovino midostavrin.
English: How does Rydapt work?
Slovenian: Kako zdravilo Rydapt deluje?
English: --1 Influenza virus (inactivated, split) of the following strains*:
Slovenian: Virusi influence (inaktivirani, razcepljeni) naslednjih sevov*:
English: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) ....... 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .
Slovenian: A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09 ....... 15 mikrogramov HA** A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) .
English: 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ............................................ 15 micrograms HA**
Slovenian: 15 mikrogramov HA** B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ............................................. 15 mikrogramov HA**
English: Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin l t o r
Slovenian: na 0,1 ml odmerka * razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat ** hemaglutinin o č
English: 1 pre-filled syringe
Slovenian: 0,1 ml 1 napolnjena injekcijska brizga
English: Invented name Strength
Slovenian: Številka EU Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
English: PritorPlus must not be used in women who are more than three months pregnant.
Slovenian: Zdravila PritorPlus ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
English: The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom PritorPlus, veljavno po vsej Evropski uniji, izdala 22. aprila 2002.
English: The full EPAR for PritorPlus 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 PritorPlus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of PritorPlus?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila PritorPlus?
English: This is a summary of the European public assessment report (EPAR) for PritorPlus.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo PritorPlus.
English: Other information about PritorPlus
Slovenian: Druge informacije o zdravilu PritorPlus
English: The most common side effect with PritorPlus (seen in between 1 and 10 patients in 100) is dizziness.
Slovenian: Najpogostejši neželeni učinek zdravila PritorPlus (opažen pri 1 do 10 bolnikih od 100) je omotica.
English: A risk management plan has been developed to ensure that PritorPlus is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila PritorPlus je bil pripravljen načrt obvladovanja tveganj.
English: PritorPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Slovenian: Zdravilo PritorPlus so preučevali v petih glavnih študijah, v katerih je sodelovalo skupno 2 985 bolnikov z blago do zmerno hipertenzijo.
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 PritorPlus.
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: For more information about treatment with PritorPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom PritorPlus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: PritorPlus is taken by mouth once a day with liquid, with or without food.
Slovenian: Zdravilo PritorPlus se jemlje peroralno enkrat na dan s tekočino, sočasno s hrano ali brez nje.
English: What benefit has PritorPlus shown during the studies?
Slovenian: Kakšne koristi je zdravilo PritorPlus izkazalo med študijami?
English: PritorPlus telmisartan / hydrochlorothiazide
Slovenian: PritorPlus telmisartan/hidroklorotiazid
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for PritorPlus, 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: What is the risk associated with PritorPlus?
Slovenian: Kakšna tveganja so povezana z zdravilom PritorPlus?
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, PritorPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 ali bolnikih z zmerno ali hudo okvaro ledvic se zdravilo PritorPlus ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (zdravilo za zdravljenje esencialne hipertenzije).
English: It is available as tablets (40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Slovenian: Na voljo je v obliki tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida).
English: The Committee recommended that PritorPlus be given marketing authorisation.
Slovenian: Zato je priporočil, da se za zdravilo PritorPlus izda dovoljenje za promet.
English: Care must be taken when using PritorPlus with other medicines that have an effect on blood potassium levels.
Slovenian: Posebna pozornost je potrebna, kadar se zdravilo PritorPlus jemlje sočasno z drugimi zdravili, ki vplivajo na ravni kalija v krvi.
English: PritorPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Slovenian: Zdravilo PritorPlus se prav tako ne sme uporabljati pri osebah, ki imajo huda obolenja jeter, ledvic ali žolčnika, ter osebah s prenizkimi ravnmi kalija v krvi ali previsokimi ravnmi kalcija v krvi.
English: For the full list of all side effects reported with PritorPlus, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PritorPlus, glejte navodilo za uporabo.
English: PritorPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Slovenian: Zdravilo PritorPlus se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak) in pri katerih samo s telmisartanom krvnega tlaka ni mogoče ustrezno uravnavati.
English: PritorPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Slovenian: PritorPlus je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
English: In four of these studies, PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Slovenian: V štirih študijah so zdravilo PritorPlus pri skupno 2 272 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine) in telmisartanom kot samostojnim zdravilom.
English: Why has PritorPlus been approved?
Slovenian: Zakaj je bilo zdravilo PritorPlus odobreno?
English: PritorPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Slovenian: Zdravilo PritorPlus je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in telmisartana, uporabljenega kot samostojno zdravilo.
English: The CHMP decided that PritorPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Slovenian: CHMP je zaključil, da so koristi zdravila PritorPlus pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvni tlak ni zadostno uravnan samo s telmisartanom, večje od z njim povezanih tveganj.
English: PritorPlus contains two active substances, telmisartan and hydrochlorothiazide.
Slovenian: Zdravilo PritorPlus vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
English: The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Slovenian: Odmerek zdravila PritorPlus, ki ga je treba uporabiti, je odvisen od odmerka telmisartana, ki ga je bolnik jemal pred tem: bolniki, ki so predhodno jemali 40 mg telmisartana, morajo uporabljati tablete v odmerku 40 mg/12,5 mg, medtem ko morajo bolniki, ki so predhodno jemali 80 mg telmisartana, jemati tablete v odmerku 80 mg/12,5 mg. Tablete v odmerku 80 mg/25 mg se dajejo bolnikom, pri katerih krvnega tlaka ni mogoče uravnati z jemanjem tablet v odmerku 80 mg/12,5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo PritorPlus.
English: What is PritorPlus used for?
Slovenian: Za kaj se zdravilo PritorPlus uporablja?
English: How has PritorPlus been studied?
Slovenian: Kako je bilo zdravilo PritorPlus raziskano?
English: What is PritorPlus?
Slovenian: Kaj je zdravilo PritorPlus?
English: How is PritorPlus used?
Slovenian: Kako se zdravilo PritorPlus uporablja?
English: How does PritorPlus work?
Slovenian: Kako zdravilo PritorPlus deluje?
English: Treatment can be repeated every three months if necessary.
Slovenian: Zdravljenje se po potrebi lahko ponovi vsake tri mesece.
English: This was followed by a confirmatory study in a further 364 patients that was carried out at the request of the CHMP.
Slovenian: Temu je sledila potrdilna študija na nadaljnjih 364 bolnikih, ki so jo izvedli na zahtevo odbora CHMP.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Visudyne on 27 July 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Visudyne, veljavno po vsej Evropski uniji, izdala 27. julija 2000.
English: Although the first study in occult disease showed some effectiveness, this was not confirmed in the second study.
Slovenian: Čeprav je prva študija pri prikriti bolezni pokazala določeno stopnjo učinkovitosti, druga študija tega ni potrdila.
English: The full EPAR for Visudyne can be found 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 Visudyne je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If necessary, the other eye can be treated with the laser immediately afterwards.
Slovenian: Po potrebi se lahko drugo oko z laserskim žarkom obseva takoj po prvem.
English: Visudyne is used to treat adults with:
Slovenian: Zdravilo Visydyne se uporablja za zdravljenje odraslih z: