FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently, on 20 September 2010, the UK Medicines Regulatory Agency asked the CHMP to issue an opinion on bisphosphonate-containing medicines and atypical stress fractures and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Regulativna agencija za zdravila Združenega kraljestva je tako 20. Septembra 2010 zaprosila CHMP, naj izda mnenje o zdravilih, ki vsebujejo bisfosfonat, in atipičnih stresnih zlomih ter o tem, ali naj se dovoljenja za promet s temi zdravili po vsej EU ohranijo, spremenijo, začasno umaknejo ali ukinejo.
English: The Committee noted that the number of reports of atypical fractures of the femur in users of bisphosphonates had increased since the 2008 review.
Slovenian: Odbor je ugotovil, da se je število poročil o atipičnih zlomih stegnenice pri uporabnikih bisfosfonatov od pregleda leta 2008 povečalo.
English: As a result, a warning was added to the product information of alendronic acidcontaining medicines across Europe.
Slovenian: Posledično je bilo po vsej Evropi v informacije o zdravilih, ki vsebujejo alendronsko kislino, vključeno opozorilo.
English: They work by stopping the action of the osteoclasts, the cells that are involved in breaking the bone down.
Slovenian: Delujejo tako, da zavirajo delovanje osteoklastov, celic, ki sodelujejo pri razgradnji kosti.
English: The CHMP has reviewed all case reports of stress fractures in patients treated with bisphosphonates, relevant data from the published literature and data provided by the companies that make bisphosphonates.
Slovenian: CHMP je pregledal vsa poročila primerov stresnih zlomov pri bolnikih, ki so se zdravili z bisfosfonati, zadevne podatke iz objavljene literature in podatke, ki so jih predložile družbe, ki bisfosfonate izdelujejo.
English: They are available in the EU as tablets and as solutions for infusion (drip into a vein) under various trade names and as generic medicines2.
Slovenian: V EU so na voljo v obliki tablet in raztopin za infundiranje (kapalne infuzije v veno) pod različnimi tržnimi imeni in kot generična zdravila2.
English: The CHMP also noted that these fractures had a distinct pattern on X-rays and may be related to bisphosphonate use, especially during long-term use in osteoporosis.
Slovenian: CHMP je tudi ugotovil, da imajo ti zlomi pri rentgenskem slikanju poseben vzorec in so lahko povezani z uporabo bisfosfonatov, še posebno pri dolgotrajni uporabi pri osteoporozi.
English: They have also been available since the mid 1990s for the treatment of osteoporosis (a disease that makes bones fragile) and Paget's disease (a disease involving bone growth that causes bone deformity).
Slovenian: Od sredine devetdesetih so na voljo tudi za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) in Pagetove bolezni (bolezni, pri kateri rast kosti povzroča kostne nepravilnosti).
English: However, the product information should be amended to add a warning concerning this risk, and, for bisphosphonates used in osteoporosis, to advise doctors to periodically review treatment, in particular after five or more years of treatment.
Slovenian: Kljub temu pa je treba spremeniti informacije o zdravilu in vključiti opozorilo glede tega tveganja; za bisfosfonate, ki se uporabljajo pri osteoporozi, pa zdravnikom svetovati, naj redno spremljajo zdravljenje, še posebej po petih ali več letih zdravljenja.
English: The European Medicines Agency has completed a review of bisphosphonate-containing medicines at the request of the United Kingdom and the European Commission, following reports of an increased risk of atypical stress fractures of the femur associated with these medicines.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravil, ki vsebujejo bisfosfonate, na zahtevo Združenega kraljestva in Evropske komisije po poročilih o povečanem tveganju za atipične stresne zlome stegnenice, povezane z uporabo teh zdravil.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that atypical femoral fractures are likely to be a class effect of bisphosphonates but that such fractures occur only rarely and the benefits of bisphosphonatecontaining medicines continue to outweigh their risks.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP sklenil, da so atipični zlomi stegnenice verjetno učinek skupine bisfosfonatov, vendar pa se ti zlomi le redko pojavljajo in koristi zdravil, ki vsebujejo bisfosfonat, še naprej odtehtajo z njim povezana tveganja.
English: The Committee agreed that this could be related to the mode of action of bisphosphonates, which could lead to a delay in the repair of naturally occurring stress fractures although the exact mechanism is not known.
Slovenian: Odbor se je strinjal, da je to lahko povezano z načinom delovanja bisfosfonatov in bi lahko povzročilo zakasnelost pri celjenju običajnih stresnih zlomov, čeprav točen mehanizem ni znan.
English: Bisphosphonates include alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid.
Slovenian: Bisfosfonati vključujejo alendronsko kislino, klodronsko kislino, etidronsko kislino, ibandronsko kislino, neridronsko kislino, pamidronsko kislino, rizedronsko kislino, tiludronsko kislino in zoledronsko kislino.
English: The current European public assessment reports for the nine centrally authorised medicines containing bisphosphonates concerned by these referrals (Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic acid Teva, Vantavo and Zometa) can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Veljavna evropska javna poročila za devet zdravil, ki vsebujejo bisfosfonat in so bila odobrena po centraliziranem postopku ter so jih te napotitve zadevale (Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronska kislina Teva, Vantavo in Zometa), so na voljo na spletni strani Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • Doctors who are prescribing these medicines for the prevention or treatment of osteoporosis should regularly review the need for continued treatment, especially after five or more years of use.
Slovenian: • Zdravniki, ki predpisujejo ta zdravila za preprečevanje ali zdravljenje osteoporoze, morajo redno spremljati, ali še obstaja potreba po nadaljnjem zdravljenju, zlasti po petih ali več letih uporabe zdravila.
English: The PhVWP also concluded at the time that it was not possible to rule out the possibility that the effect could be a class effect (an effect common to all bisphosphonates), and decided to keep the issue under close review.
Slovenian: Delovna skupina za farmakovigilanco je ugotovila, da takrat ni bilo mogoče izključiti možnosti, da gre za učinek skupine (učinek skupen vsem bisfosfonatom), in se odločila, da bo zadevo pozorno spremljala.
English: • Patients who are taking bisphosphonate-containing medicines need to be aware of the risk of atypical fracture of the thigh bone.
Slovenian: • Bolniki, ki jemljejo zdravila, ki vsebujejo bisfosfonate, se morajo zavedati tveganja za atipične zlome stegnenice.
English: In April 2010, the PhVWP noted that further data from both the published literature and postmarketing reports were now available that suggested that atypical stress fractures of the femur may be a class effect.
Slovenian: Aprila 2010 je Delovna skupina za farmakovigilanco upoštevala, da so bili na voljo novi podatki tako iz objavljene literature kot iz poročil, nastalih v obdobju trženja, ki so kazali, da so atipični stresni zlomi lahko učinek skupine.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bisphosphonates continue to outweigh their risks but that warnings of the risk of atypical femoral fractures should be added to the prescribing information for all bisphosphonate-containing medicines in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi bisfosfonatov še naprej odtehtajo z njim povezana tveganja, vendar pa je v informacije o predpisovanju zdravil v Evropski uniji (EU), ki vsebujejo bisfosfonate, treba vključiti opozorila o tveganju za atipične zlome stegnenice.
English: • Doctors who prescribe bisphosphonate-containing medicines should be aware that atypical fractures may occur rarely in the femur (thigh bone), especially after long term use.
Slovenian: • Zdravniki, ki predpisujejo zdravila, ki vsebujejo bisfosfonat, se morajo zavedati, da se lahko občasno pojavljajo atipični zlomi stegnenice (kost stegna), zlasti po dolgotrajni uporabi.
English: In 2008, the CHMP's Pharmacovigilance Working Party (PhVWP) noted that alendronic acid was associated with an increased risk of atypical fracture of the femur (thigh bone) that developed with low or no trauma.
Slovenian: Delovna skupina za farmakovigilanco je leta 2008 ugotovila, da je alendronska kislina povezana s povečanim tveganjem za atipični zlom stegnenice (kost v stegnu), ki se je pojavil pri majhni poškodbi ali pa ni bil povezan s poškodbo.
English: The centrally authorised bisphosphonate-containing medicines concerned by these referrals are Aclasta and Zometa (zoledronic acid), Bondenza, Bonviva, Bondronat and Ibandronic acid Teva (ibandronic acid), and Adrovance and Fosavance (alendronic acid and vitamin D3).
Slovenian: Zdravila, ki vsebujejo bisfosfonat in so bila odobrena po centraliziranem postopku ter jih ta napotitev zadeva, so Aclasta in Zometa (zoledronska kislina), Bondenza, Bonviva, Bondronat in Ibandronska kislina Teva (ibandronska kislina) ter Adrovance in Fosavance (alendronska kislina in vitamin D3).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Alimta on 20 September 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Alimta, veljavno po vsej Evropski uniji, odobrila dne 20. septembra 2004.
English: The full EPAR for Alimta 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 Alimta je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Alimta affects fertility, so both men and women who receive it need to be made aware of this.
Slovenian: Zdravilo Alimta vpliva na plodnost, zato je treba moške in ženske, ki ga prejemajo, o tem obvestiti.
English: Other information about Alimta
Slovenian: Druge informacije o zdravilu Alimta
English: The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Slovenian: Priporočeni odmerek zdravila je 500 mg na kvadratni meter telesne površine (izračunano glede na bolnikovo višino in maso).
English: Alimta is used to treat two types of lung cancer:
Slovenian: Zdravilo Alimta se uporablja za zdravljenje dveh vrst pljučnega raka:
English: It must not be used during breast-feeding or at the same time as the vaccine for yellow fever.
Slovenian: Zdravilo se ne sme uporabljati med dojenjem ali hkrati s cepivom proti rumeni mrzlici.
English: This is a summary of the European public assessment report (EPAR) for Alimta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alimta.
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 Alimta.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What is the risk associated with Alimta?
Slovenian: Kakšna tveganja so povezana z zdravilom Alimta?
English: What benefit has Alimta shown during the studies?
Slovenian: Kakšne koristi je zdravilo Alimta izkazalo med študijami?
English: The CHMP concluded that Alimta'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 Alimta večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For more information about treatment with Alimta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Alimta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Slovenian: Zdravilo Alimta se sme dajati samo pod nadzorom zdravnika, ki je usposobljen za uporabo kemoterapije.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Slovenian: Pretvorba pemetrekseda v njegovo aktivno obliko laže poteka v rakavih celicah kot v normalnih celicah, kar privede do višje koncentracije aktivne oblike zdravila in njegovega daljšega učinkovanja v rakavih celicah.
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Slovenian: Tako se množenje rakavih celic zmanjša, medtem ko je vpliv na normalne celice zelo majhen.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Slovenian: V telesu se pemetreksed pretvori v aktivno obliko, ki zavira aktivnost encimov, vključenih v tvorbo nukleotidov (gradnikov DNK in RNK, genskega materiala celic).
English: Alimta must not be used in people who are hypersensitive (allergic) to pemetrexed or any of the other ingredients.
Slovenian: Zdravila Alimta ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pemetreksed ali katero koli drugo sestavino zdravila.
English: For the full list of all side effects reported with Alimta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Alimta, glejte navodilo za uporabo.
English: Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Alimta in cisplatin, je bil čas preživetja v povprečju 12,1 meseca, pri bolnikih, ki so prejemali samo cisplatin, pa 9,3 meseca.
English: Why has Alimta been approved?
Slovenian: Zakaj je bilo zdravilo Alimta odobreno?
English: The main measures of effectiveness were how long the patients survived and how long they lived without their cancer getting worse.
Slovenian: Glavno merilo učinkovitosti je bil čas preživetja bolnikov in čas do poslabšanja bolezni.
English: Bone marrow suppression causes decreased levels in the blood of white blood cells (the cells that fight infection), platelets (components that help the blood to clot) and haemoglobin (the protein found in red blood cells that carries oxygen around the body).
Slovenian: Supresija kostnega mozga povzroči znižane ravni belih krvnih celic (celic, ki se spopadajo z okužbami), krvnih ploščic (ki pomagajo pri strjevanju krvi) in hemoglobina (beljakovine, ki se nahaja v rdečih krvnih celicah in prenaša kisik po telesu) v krvi.
English: It contains the active substance pemetrexed.
Slovenian: Vsebuje zdravilno učinkovino pemetreksed.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta.
Slovenian: Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Alimta jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
English: The most common side effects with Alimta, used on its own or with other anticancer medicines, are bone marrow suppression (when the bone marrow produces less blood cells than normal) and gastrointestinal toxicities (side effects affecting the stomach and gut).
Slovenian: Najpogostejši neželeni učinki zdravila Alimta, uporabljenega samostojno ali sočasno z drugimi zdravili proti raku, sta bili supresija kostnega mozga (ko kostni mozeg proizvaja manj krvnih celic, kot je običajno) in gastrointestinalna toksičnost (neželeni učinki, ki prizadenejo želodec in črevesje).
English: The gastrointestinal toxicities seen with Alimta are loss of appetite, nausea (feeling sick), vomiting, diarrhoea, constipation, pharyngitis (sore throat), and mucositis or stomatitis (inflammation of the lining of the digestive system and mouth).
Slovenian: Gastrointestinalne toksičnosti, opažene pri jemanju zdravila Alimta, so bile izguba apetita, slabost, bruhanje, driska, zaprtje, faringitis (vneto žrelo) ter mukozitis ali stomatitis (vnetje sluznice prebavnega trakta ali ust).
English: Alimta increased the survival time of patients with malignant pleural mesothelioma.
Slovenian: Zdravilo Alimta je podaljšalo čas preživetja bolnikov z malignim plevralnim mezoteliomom.
English: In the treatment of non small cell lung cancer, Alimta was as effective as the comparators, with survival times around 10.3 months in patients who had not received chemotherapy in the past, and around 8.1 months in those who had received chemotherapy in the past.
Slovenian: Pri zdravljenju nedrobnoceličnega pljučnega raka je bilo zdravilo Alimta tako učinkovito kot primerjalna zdravila s časom preživetja 10,3 meseca pri bolnikih, ki predhodno še niso bili zdravljeni s kemoterapijo, in približno 8,1 meseca pri tistih, ki so bili že zdravljeni s kemoterapijo v preteklosti.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos),where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Slovenian: • malignega plevralnega mezotelioma (raka pljučne sluznice, ki ga običajno povzroči izpostavljenosti azbestu), pri čemer se uporablja skupaj s cisplatinom pri bolnikih, ki pred tem niso bili zdravljeni s kemoterapijo, ali pri tistih, pri katerih raka ni mogoče odstraniti s kirurškim posegom;
English: The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Slovenian: Zdravilna učinkovina zdravila Alimta, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine antimetabolitov.
English: In one maintenance treatment study, patients receiving Alimta lived for a further 4.3 months from the start of maintenance treatment without their cancer getting worse, compared with 2.6 months in those receiving placebo.
Slovenian: V študiji vzdrževalnega zdravljenja so bolniki, ki so prejemali zdravilo Alimta živeli še 4,3 meseca od začetka vzdrževalnega zdravljenja, ne da bi rak napredoval, tisti, ki so prejemali placebo pa le 2,6 meseca.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Slovenian: Pri bolnikih, ki so bili zdravljeni s kemoterapijo na osnovi platine, se lahko uporablja tudi kot vzdrževalno zdravljenje.
English: For the treatment of locally advanced or metastatic non small cell lung cancer, Alimta was compared with gemcitabine (another anticancer medicine), in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy before.
Slovenian: Pri zdravljenju lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka so zdravilo Alimta primerjali s gemcitabinom (drugim zdravilom proti raku), v kombinaciji s cisplatinom, v študiji s 1 725 bolniki, ki predhodno še niso bili zdravljeni s kemoterapijo.
English: • advanced ‘non small cell' lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received anticancer treatment.
Slovenian: • napredovalega nedrobnoceličnega pljučnega raka, znanega kot neskvamozni tip, pri čemer se uporablja bodisi v kombinaciji s cisplatinom pri predhodno nezdravljenih bolnikih bodisi samostojno pri bolnikih, katerih rak je bil predhodno zdravljen.
English: How has Alimta been studied?
Slovenian: Kako je bilo zdravilo Alimta raziskano?
English: Alimta is a powder that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Alimta je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: Alimta was also compared with docetaxel (another anticancer medicine) in one study involving 571 patients who had received chemotherapy in the past.
Slovenian: Zdravilo Alimta so primerjali tudi z docetakselom (drugim zdravilom proti raku) v eni študiji s 571 bolniki, ki so v preteklosti že bili zdravljeni s kemoterapijo.
English: Alimta pemetrexed
Slovenian: Alimta pemetreksed
English: For the treatment of malignant pleural mesothelioma, Alimta in combination with cisplatin has been compared with cisplatin alone in one main study in 456 patients who had not received chemotherapy for their disease before.
Slovenian: Pri zdravljenju malignega plevralnega mezotelioma so zdravilo Alimta v kombinaciji s cisplatinom primerjali s cisplatinom, uporabljenim samostojno, v eni glavni študiji s 456 bolniki, pri katerih bolezen predhodno ni bila zdravljena s kemoterapijo.
English: Improved survival times with Alimta were only seen in patients with non small cell lung cancer of the non-squamous type.
Slovenian: Zdravilo Alimta je podaljšalo čas preživetja le pri bolnikih z nedrobnoceličnim pljučnim rakom neskvamoznega tipa.
English: When Alimta is given with cisplatin, an ‘anti emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Slovenian: Kadar se zdravilo Alimta daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem vzeti tudi antiemetično zdravilo (za preprečevanje bruhanja) in zaužiti tekočino (za preprečevanje dehidracije).Pri bolnikih z nenormalno krvno sliko ali določenimi drugimi neželenimi učinki je treba zdravljenje odložiti ali prekiniti oziroma zmanjšati odmerek.
English: For maintenance treatment, Alimta was compared with placebo (a dummy treatment) in two main studies involving 1,202 patients whose cancer had not got worse during platinum-based chemotherapy.
Slovenian: Kot vzdrževalno zdravljenje so zdravilo Alimta primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji s 1 202 bolniki, pri katerih se rak med zdravljenjem s kemoterapijo na osnovi platine ni poslabšal.
English: In the second maintenance study, the figures were 4.1 months in the Alimta and 2.8 months in the placebo group.
Slovenian: Dolžina preživetja brez poslabšanja stanja je bila pri drugem vzdrževalnem zdravljenju 4,1 meseca pri bolnikih, ki so jemali zdravilo Alimta, in 2,8 meseca pri tistih, ki so jemali placebo.
English: How is Alimta used?
Slovenian: Kako se zdravilo Alimta uporablja?
English: What is Alimta used for?
Slovenian: Za kaj se zdravilo Alimta uporablja?
English: What is Alimta?
Slovenian: Kaj je zdravilo Alimta?
English: 11 February 2015
Slovenian: 11. februar 2015
English: The final opinion was converted into a Decision by the European Commission on 11 February 2015.
Slovenian: Končno mnenje je bilo 11. februarja 2015 spremenjeno v sklep Evropske komisije.