FrancophonIA/ELRC3.0 huggingface dataset:
English: When taken on their own, Tesavel and metformin produced similar reductions in HbA1c levels, but the effectiveness of Tesavel seemed to be slightly lower than that of metformin.
Slovenian: Ob samostojnem jemanju zdravila Tesavel ali metformina so bila znižanja ravni HbA1c podobna, vendar je bilo zdravilo Tesavel malenkost slabše učinkovito kot metformin.
English: The other study compared Tesavel with metformin, used on their own, in 1,058 patients;
Slovenian: V drugi študiji so zdravilo Tesavel primerjali z metforminom pri 1 058 bolnikih, ki so obe zdravili jemali samostojno;
English: • in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Slovenian: • v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR-gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor;
English: • on its own, in patients who are not satisfactorily controlled on diet and exercise and in whom metformin (an antidiabetes medicine) is not suitable;
Slovenian: • kot samostojno zdravilo pri bolnikih, katerih bolezen samo z dieto in telesno vadbo ni zadovoljivo nadzorovana in pri katerih metformin (zdravilo za zdravljenje sladkorne bolezni) ni primeren;
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Tesavel to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Slovenian: Ravni HbA1c so bile po 18 tednih znižane za 1,03 % pri bolnikih, ki so zdravilo Tesavel dodajali metforminu in rosiglitazonu, v primerjavi z znižanjem za 0,31 % pri tistih, ki so kot dodatek prejemali placebo.
English: Finally, they were reduced by 0.59% in patients adding Tesavel to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Slovenian: Ravni so se znižale za 0,59 % pri bolnikih, ki so zdravilo Tesavel dodajali insulinu (z metforminom ali brez njega) v primerjavi z zmanjšanjem za 0,03 % pri tistih, ki so kot dodatek jemali placebo.
English: Tesavel or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Slovenian: • v štirih študijah so zdravilo Tesavel primerjali s placebom (zdravilom brez zdravilne učinkovine): zdravilo Tesavel ali placebo so bolniki jemali samostojno v dveh študijah, ki sta vključevali 1 262 bolnikov, kot dodatek metforminu v eni študiji s 701 bolnikom in kot dodatek pioglitazonu (agonistu PPAR-gama) v eni študiji s 353 bolniki;
English: How does Tesavel work?
Slovenian: Kako zdravilo Tesavel deluje?
English: In the additional studies, adding Tesavel to glimepiride (with and without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
Slovenian: V dodatnih študijah je dodajanje zdravila Tesavel glimepiridu (z metforminom ali brez njega) po 24 tednih znižalo ravni HbA1c za 0,45 % v primerjavi s povečanjem za 0,28 % pri bolnikih, pri katerih so dodajali placebo.
English: What is Tesavel used for?
Slovenian: Za kaj se zdravilo Tesavel uporablja?
English: How has Tesavel been studied?
Slovenian: Kako je bilo zdravilo Tesavel raziskano?
English: What is Tesavel?
Slovenian: Kaj je zdravilo Tesavel?
English: One study compared Tesavel with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Slovenian: V eni študiji so pri 1 172 bolnikih primerjali zdravilo Tesavel z glipizidom (sulfonilsečnino), obe zdravili pa so dodajali metforminu.
English: When added to pioglitazone, Tesavel reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Slovenian: Če je bilo zdravilo Tesavel dodano pioglitazonu, je po 24 tednih znižalo ravni HbA1c za 0,85 % v primerjavi z znižanjem za 0,15 % pri bolnikih, ki so kot dodatek jemali placebo.
English: Adding Tesavel to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Slovenian: Če je bilo zdravilo Tesavel dodano metforminu, je po 24 tednih znižalo ravni HbA1c za 0,67 % v primerjavi z znižanjem za 0,02 % pri bolnikih, ki so kot dodatek jemali placebo.
English: How is Tesavel used?
Slovenian: Kako se zdravilo Tesavel uporablja?
English: This may limit the damage to nearby healthy tissues.
Slovenian: To lahko omeji poškodbo na bližnja zdrava tkiva.
English: 1 See outcome of safety review carried out in 2018 here.
Slovenian: 1 Izid varnostnega pregleda, opravljenega v letu 2018, si lahko ogledate tukaj.
English: Further information on Xofigo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Xofigo so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It should be used only for patients who have had at least two previous treatments for prostate cancer or who cannot receive other treatments.
Slovenian: Uporabljati se sme samo pri bolnikih, pri katerih sta bili neuspešni vsaj dve predhodni zdravljenji raka prostate ali ki ne morejo prejeti drugih zdravil.
English: The bones in the body take up radium in the same way as calcium.
Slovenian: Kosti v telesu radij privzemajo enako kot kalcij.
English: What measures are being taken to ensure the safe and effective use of Xofigo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xofigo?
English: The European Medicines Agency decided that Xofigo'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 so koristi zdravila Xofigo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Xofigo received a marketing authorisation valid throughout the EU on 13 November 2013.
Slovenian: Za zdravilo Xofigo je bilo 13. novembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: Other information about Xofigo
Slovenian: Druge informacije o zdravilu Xofigo
English: Patients given Xofigo lived on average for 14.9 months, compared with 11.3 months for those given placebo.
Slovenian: Bolniki, ki so prejemali Xofigo, so preživeli 14,9 meseca, tisti, ki so prejemali placebo, pa 11,3 meseca.
English: Patients were given up to 6 injections at 1-month intervals and were followed up for 3 years from the first injection.
Slovenian: Bolniki so v enomesečnih razmikih prejeli do šest injekcij, spremljali pa so jih do tri leta od prvega injiciranja.
English: Injections are repeated every 4 weeks for a total of 6 injections.
Slovenian: Injiciranje je treba ponavljati vsake štiri tedne, bolnik pa skupno prejme šest injekcij.
English: As for all medicines, data on the use of Xofigo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xofigo stalno spremljajo.
English: The medicine is slowly injected into a vein usually for up to one minute.
Slovenian: Zdravilo se počasi, običajno do največ eno minuto, injicira v veno.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xofigo have also 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 Xofigo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Xofigo must not be used with the medicine abiraterone acetate and the corticosteroids prednisone or prednisolone.
Slovenian: Zdravilo Xofigo se ne sme uporabljati z abirateron acetatom ali kortikosteroidom prednizonom ali prednizolonom.
English: The radioactive radium builds up in bone tissues where the cancer has spread, and the alpha particles destroy surrounding cancer cells and help to control the associated symptoms.
Slovenian: Radioaktivni radij se kopiči v kostnih tkivih, v katere se je razširil rak, delci alfa pa uničujejo okoliške rakave celice in pomagajo nadzorovati simptome bolezni.
English: The most serious side effects were thrombocytopenia and neutropenia (low levels of neutrophils, a type of white blood cell that fights infection).
Slovenian: Najresnejša neželena učinka sta bila trombocitopenija in nevtropenija (nizko število nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam).
English: Side effects reported with Xofigo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Xofigo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Xofigo have been shown in studies?
Slovenian: Kakšne koristi zdravila Xofigo so se pokazale v študijah?
English: Why is Xofigo authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Xofigo odobreno v EU?
English: An overview of Xofigo and why it is authorised in the EU
Slovenian: Pregled zdravila Xofigo in zakaj je odobreno v EU
English: The dose of Xofigo is calculated to provide a specific dose of radioactivity based on the patient's body weight.
Slovenian: Odmerek zdravila Xofigo se izračuna za zagotovitev točnega odmerka radioaktivnosti na podlagi bolnikove telesne mase.
English: Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue'.
Slovenian: Zdravilo Xofigo se uporablja samostojno ali v kombinaciji z zdravilom, imenovanim analog LHRH.
English: Xofigo has been shown to prolong life and delaying signs and symptoms of progressive disease.
Slovenian: Dokazano je, da zdravilo Xofigo podaljša življenje in odloži pojav znakov in simptomov napredujoče bolezni.
English: The company that markets Xofigo will have to conduct studies to further characterise the safety profile of the medicine, in particular with regard to the risk of fractures and the risk of new metastases that do not affect the bone in patients treated with Xofigo.
Slovenian: Podjetje, ki trži zdravilo Xofigo, bo moralo izvesti študije za nadaljnjo opredelitev varnostnega profila tega zdravila, zlasti kar zadeva tveganje za zlome in tveganje za nove zasevke, ki ne prizadenejo kosti, pri bolnikih, zdravljenih s tem zdravilom.
English: For more information about using Xofigo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Xofigo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).
Slovenian: Zdravilo Xofigo je radiofarmak (zdravilo, ki vsebuje radioaktivno snov), ki se uporablja za zdravljenje odraslih z rakom prostate (žleze moškega reproduktivnega sistema).
English: What are the risks associated with Xofigo?
Slovenian: Kakšna tveganja so povezana z zdravilom Xofigo?
English: Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs.
Slovenian: Zdravilo Xofigo se uporablja, kadar je kastracija (za prenehanje tvorbe moških hormonov) s kirurškim posegom ali zdravili neučinkovita ali kadar se je rak razširil na kosti (kostne metastaze) in povzroča simptome, kot je bolečina, ni pa se razširil na druge notranje organe.
English: Xofigo can only be obtained with a prescription and should only be handled and given by someone who is authorised to use radioactive medicines and after evaluation of the patient by a qualified doctor.
Slovenian: Predpisovanje in izdaja zdravila Xofigo je le na recept, z njim pa sme ravnati in ga dajati samo oseba, ki je pooblaščena za uporabo radioaktivnih zdravil, in sicer po tem, ko je bolnika pregledal usposobljeni zdravnik.
English: What is Xofigo and what is it used for?
Slovenian: Kaj je zdravilo Xofigo in za kaj se uporablja?
English: Xofigo can increase the risk of having fractures.
Slovenian: Zdravilo Xofigo lahko poveča tveganje za pojav zlomov.
English: Xofigo (radium-223 dichloride)
Slovenian: Xofigo ([223Ra]radijev klorid)
English: Xofigo was compared with placebo (a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work.
Slovenian: Zdravilo Xofigo so s placebom (zdravilom brez učinkovine) poleg standardne nege primerjali v glavni študiji, v katero je bilo vključenih 921 moških z rakom prostate, ki se je razširil na kosti, pri katerih supresija moških hormonov z zdravili ali kirurškim posegom ni bila učinkovita.
English: The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (low blood-platelet counts) and bone fractures.
Slovenian: Najpogostejši neželeni učinki zdravila Xofigo (ki se lahko pojavijo pri več kot 1 bolniku od 10) so driska, navzeja (slabost), bruhanje, trombocitopenija (nizko število trombocitov) in zlomi kosti.
English: The active substance in Xofigo, radium-223, emits short-range radiation known as alpha particles.
Slovenian: Učinkovina v zdravilu Xofigo, [223Ra]radij, oddaja sevanje kratkega dosega, imenovano delci alfa.
English: How does Xofigo work?
Slovenian: Kako zdravilo Xofigo deluje?
English: How is Xofigo used?
Slovenian: Kako se zdravilo Xofigo uporablja?
English: For the full list of side effects of Xofigo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xofigo, glejte navodilo za uporabo.
English: Regarding its safety, several measures have been put in place to minimise the risks of the medicine such as bone fractures1 The radiation emitted by Xofigo has a shorter range than the radiation of currently available radiopharmaceuticals.
Slovenian: Kar zadeva njegovo varnost, je bilo sprejetih več ukrepov za zmanjšanje tveganj pri tem zdravilu, na primer zlomov kosti1.
English: Xofigo contains the active substance radium-223 dichloride.
Slovenian: Zdravilo Xofigo vsebuje učinkovino [223Ra]radijev klorid.
English: The signs and symptoms of progressive disease such as bone pain also took longer to develop in patients given Xofigo.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Xofigo, je trajalo dalj tudi do pojava znakov in simptomov napredujoče bolezni, na primer bolečine v kosteh.
English: Take your dose once a day.
Slovenian: Odmerek vzemite enkrat na dan.
English: These changes were each in the direction of improved lipid responses and were sustained over 2 years.
Slovenian: Vse te spremembe so bile v smeri izboljšanih odzivov lipidov in so se ohranile v obdobju 2 let.
English: Children younger than 6 years
Slovenian: Otroci, mlajši od 6 let
English: Your doctor may increase your dose to find the right amount of CRESTOR for you.
Slovenian: Vaš zdravnik lahko poveča vaš odmerek, da bi našel ustrezen odmerek zdravila CRESTOR za vas.
English: This trial (n=176) was not suited for comparison of rare adverse drug events.
Slovenian: To preskušanje (n = 176) ni bilo primerno za primerjavo redkih neželenih učinkov zdravila.
English: This means you are at risk from a heart attack or stroke.
Slovenian: To pomeni, da vas ogroža srčni infarkt ali možganska kap.
English: What you need to know before you take CRESTOR
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo CRESTOR
English: • You have other factors that increase your risk of having a heart attack, stroke or related health problems.
Slovenian: • imate druge dejavnike, ki povečajo tveganje za srčni infarkt, možgansko kap ali podobne zdravstvene težave.
English: Treatment of hypercholesterolaemia
Slovenian: Zdravljenje hiperholesterolemije
English: Rosuvastatin exposure was predictable with respect to dose and time over a 2-year period.
Slovenian: Izpostavljenost rosuvastatinu je bila v 2-letnem obdobju predvidljiva, kar zadeva odmerek in čas.
English: You have been prescribed CRESTOR because:
Slovenian: Zdravnik vam je predpisal zdravilo CRESTOR, ker imate:
English: • You have a high cholesterol level.
Slovenian: • visok holesterol.
English: The 40 mg tablet is not suitable for use in paediatric patients.
Slovenian: 40 mg tablete niso primerne za uporabo pri pediatričnih bolnikih.
English: Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol.
Slovenian: Zdravilo CRESTOR se uporablja pri odraslih, mladostnikih in otrocih, starih 6 let ali več, za zdravljenje visokega holesterola.
English: The safety and efficacy of use in children younger than 6 years has not been studied.
Slovenian: Varnost in učinkovitost uporabe pri otrocih, mlajših od 6 let, nista raziskani.
English: The starting dose for all patients was 5 mg rosuvastatin once daily.
Slovenian: Začetni odmerek je bil za vse bolnike 5 mg rosuvastatina enkrat na dan.
English: • If the patient is under 6 years old: CRESTOR should not be given to children younger than 6 years.
Slovenian: • Če je bolnik mlajši od 6 let: Zdravila CRESTOR ne smemo dajati otrokom mlajšim od 6 let.
English: You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels.
Slovenian: Zdravnik vam je svetoval jemanje statina, ker sprememba prehrane in povečanje telesne dejavnosti pri vas nista zadoščala za ureditev koncentracije holesterola.
English: Experience in children with homozygous familial hypercholesterolaemia is limited to a small number of children aged between 8 and 17 years.
Slovenian: Izkušnje pri otrocih s homozigotno družinsko hiperholesterolemijo so omejene na majhno število otrok, starih od 8 do 17 let.
English: • If the patient is below 18 years of age: The CRESTOR 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
Slovenian: • Če je bolnik mlajši od 18 let: Zdravilo CRESTOR 40 mg tablete niso primerne za uporabo pri otrocih in mladostnikih mlajših od 18 let.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rosuvastatin in all subsets of the paediatric population in the treatment of homozygous familial hypercholesterolaemia, primary combined (mixed) dyslipidaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rosuvastatinom za vse podskupine pediatrične populacije, za zdravljenje homozigotne družinske hiperholesterolemije, primarne kombinirane (mešane) dislipidemije in preprečevanje kardiovaskularnih dogodkov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Therefore, Crestor is not recommended for use in children younger than 6 years.
Slovenian: Zato zdravila CRESTOR ni priporočljivo uporabljati za otroke, mlajše od 6 let.
English: Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations (see Section 4.4).
Slovenian: Prilagajanje je treba pri pediatričnih bolnikih narediti v skladu z odzivom in prenašanjem posameznika, tako kot svetujejo priporočila za pediatrično zdravljenje (glejte poglavje 4.4).
English: CRESTOR 40 mg tablet should not be used by children.
Slovenian: Zdravila CRESTOR 40 mg tablete otroci ne smejo uporabljati.
English: Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Slovenian: Varnost in učinkovitost odmerkov nad 20 mg v tej populaciji nista raziskani.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure and valid at the time of the Commission Decision.
Slovenian: Ta Povzetek glavnih značilnosti zdravila in Navodilo za uporabo sta rezultat napotitvenega postopka.
English: In a clinical trial of children and adolescents receiving rosuvastatin for 52 weeks, CK elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently compared to observations in clinical trials in adults (see Section 4.8).
Slovenian: V kliničnih preskušanjih pri otrocih in mladostnikih, ki so prejemali rosuvastatin 52 tednov, so zvišanje kreatin-kinaze > 10-kratno ULN in mišične simptome po telesni vadbi ali intenzivnejši telesni dejavnosti opažali pogosteje kot v kliničnih preskušanjih pri odraslih (glejte poglavje 4.8).
English: Safety and efficacy of doses greater than 10 mg have not been studied in this population.
Slovenian: Varnost in učinkovitost odmerkov nad 10 mg v tej populaciji nista raziskani.
English: The maximum daily dose of CRESTOR is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years.
Slovenian: Največji dnevni odmerek zdravila CRESTOR je 10 mg za otroke, stare od 6 do 9 let, in 20 mg za otroke, stare od 10 do 17 let.
English: The evaluation of linear growth (height), weight, BMI (body mass index), and secondary characteristics of sexual maturation by Tanner staging in paediatric patients 6 to 17 years of age taking rosuvastatin is limited to a two-year period.
Slovenian: Ocena linearne rasti (telesne višine), telesne mase, ITM (indeksa telesne mase) in sekundarnih značilnosti spolnega dozorevanja po Tannerjevi razvrstitvi pri pediatričnih bolnikih v starosti od 6 do 17 let, ki jemljejo rosuvastatin, je omejena na dvoletno obdobje.
English: Rosuvastatin was also studied in a 2-year open-label, titration-to-goal study in 198 children with heterozygous familial hypercholesterolaemia aged 6 to 17 years (88 male and 110 female, Tanner stage <II-V).
Slovenian: Rosuvastatin so raziskali tudi v 2-letni odprti, do cilja titrirani študiji pri 198 otrocih s heterozigotno družinsko hiperholesterolemijo, starih od 6 do 17 let (88 fantov in 110 deklet, stopnja po Tannerju < II-V).
English: [The wording of the indication for treatment of hypercholesterolaemia should be replaced with the following:]
Slovenian: [Obstoječe informacije glede indikacije zdravljenja hiperholesterolemije se zamenjajo s sledečimi:]
English: Rosuvastatin 5 mg, 10 mg, and 20 mg also achieved statistically significant mean changes from baseline for the following secondary lipid and lipoprotein variables: HDL-C, TC, non-HDL-C,LDL-C/HDLC, TC/HDL-C, TG/HDL-C, non HDL C/HDL-C, ApoB, ApoB/ApoA-1.
Slovenian: Rosuvastatin v odmerkih 5 mg, 10 mg in 20 mg je v primerjavi z izhodiščem dosegel tudi statistično značilne povprečne spremembe naslednjih sekundarnih lipidnih in lipoproteinskih spremenljivk: HDLholesterol, trigliceridi, ne-HDL-holesterol, LDL-holesterol/HDL-holesterol, trigliceridi/HDL-holesterol, trigliceridi/HDL-holesterol, ne-HDL-holesterol/HDL-holesterol, ApoB, ApoB/ApoA-1.
English: Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Slovenian: Odrasli, mladostniki in otroci, stari 6 let ali več s primarno hiperholesterolemijo (tipa IIa vključno s heterozigotno družinsko hiperholesterolemijo) in mešano dislipidemijo (tipa IIb) - kot dodatek dieti, kadar odziv nanjo ali druge nefarmakološke ukrepe (npr. telesna vadba, hujšanje) ni bil zadovoljiv.