FrancophonIA/ELRC3.0 huggingface dataset:
English: Advagraf 5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Slovenian: Advagraf 5 mg trde kapsule s podaljšanim sproščanjem Velikost pakiranja: 30, 50 in 100 trdih kapsul s podaljšanim sproščanjem v pretisnih omotih ali 30×1, 50×1 in 100×1 trdih kapsul s podaljšanim sproščanjem v perforiranih pretisnih omotih za enkratni odmerek.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Slovenian: ALUMINIJASTI OVOJ Advagraf 5 mg trde kapsule s podaljšanim sproščanjem (30, 50, 100, aluminijasti ovoj)
English: Advagraf 3 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Slovenian: Advagraf 3 mg trde kapsule s podaljšanim sproščanjem Velikost pakiranja: 30, 50 in 100 trdih kapsul s podaljšanim sproščanjem v pretisnih omotih ali 30×1, 50×1 in 100×1 trdih kapsul s podaljšanim sproščanjem v perforiranih pretisnih omotih za enkratni odmerek.
English: Prophylaxis of kidney transplant rejection
Slovenian: Zdravljenje zavrnitve alogenskega presadka po presaditvi drugih alogenskih presadkov
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Advagraf 0.5 mg prolonged-release hard capsules
Slovenian: PRETISNI OMOT Advagraf 0,5 mg trde kapsule s podaljšanim sproščanjem
English: - Herbal preparations containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
Slovenian: Med jemanjem zdravila Advagraf bolniki ne smejo uporabljati zdravil rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum) ali drugih zdravil rastlinskega izvora.
English: Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Slovenian: Zdravnik bo z njimi preverjal ustreznost odmerka in ga po potrebi prilagodil.
English: Advagraf 5 mg prolonged-release hard capsules Tacrolimus
Slovenian: Advagraf 5 mg trde kapsule s podaljšanim sproščanjem takrolimus peroralna uporaba
English: EMA/300585/2012 EMEA/H/C/002622
Slovenian: EMA/CHMP/158913/2012 EMEA/H/C/002622
English: This medicine is the same as Rilutek, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Rilutek, ki je že odobreno v Evropski uniji (EU).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Riluzole Zentiva on 7 May 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Riluzole Zentiva, veljavno po vsej Evropski uniji, odobrila dne 7. maja 2012.
English: One of these studies was in older patients (over 75) and in patients with advanced disease.
Slovenian: V eni od teh študij so sodelovali starejši bolniki (starejši od 75 let) in bolniki z napredovalo boleznijo.
English: The full EPAR for Riluzole Zentiva 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 Riluzole Zentiva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adult and elderly patients, it is given as 100 mg a day (50 mg every 12 hours).
Slovenian: Odraslim in starejšim bolnikom se daje v odmerku 100 mg dnevno (50 mg vsakih 12 ur).
English: For more information about treatment with Riluzole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Riluzole Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: EPAR summary for the public riluzole
Slovenian: Povzetek EPAR za javnost riluzol
English: Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Slovenian: Riluzol ustavi sproščanje glutamata, kar morda pomaga preprečevati okvare živčnih celic.
English: This is a summary of the European public assessment report (EPAR) for Riluzole Zentiva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Riluzole Zentiva.
English: The exact way in which it works in ALS is not known.
Slovenian: Natančen način delovanja pri ALS še ni znan.
English: Riluzole Zentiva 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Slovenian: Zdravilo Riluzole Zentiva v odmerku 50 mg/dan ni bilo učinkovitejše od placeba, odmerek 200 mg/dan pa ni bil učinkovitejši od odmerka 100 mg/dan.
English: The effectiveness of Riluzole Zentiva has been compared with that of placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Slovenian: Učinkovitost zdravila Riluzole Zentiva so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh študijah, ki so skupaj zajele 1 282 bolnikov.
English: For more information please see the package leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: They noted that there is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms, and that it has not been shown to be effective in the late stages of ALS.
Slovenian: Ugotovil je, da ni dokazov o terapevtskem učinku zdravila Riluzole Zentiva na motorično funkcijo, delovanje pljuč, fascikulacije, mišično moč in motorične simptome ter da zdravilo ni izkazalo učinkovitosti v poznih stadijih ALS.
English: ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Slovenian: ALS je ena od oblik bolezni motoričnega nevrona, pri kateri pride do napada živčnih celic, ki so odgovorne za pošiljanje navodil mišicam, s čimer povzroči šibkost, mišično oslabelost in paralizo.
English: The average survival time was significantly longer for patients who received Riluzole Zentiva compared with patients who received placebo.
Slovenian: Povprečni čas preživetja je bil bistveno daljši pri bolnikih, ki so dobivali zdravilo Riluzole Zentiva, v primerjavi z bolniki, ki so dobivali placebo.
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 Riluzole Zentiva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Riluzole Zentiva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It is thought that the destruction of nerve cells in motor neurone disease may be caused by too much glutamate, a neurotransmitter (chemical messenger).
Slovenian: Domnevajo, da uničenje živčnih celic pri bolezni motoričnega nevrona povzroča prevelika količina živčnega prenašalca glutamata (kemičnega prenašalca).
English: Across the studies, Riluzole Zentiva was given as 50, 100 or 200 mg per day, and for up to 18 months.
Slovenian: V teh študijah so zdravilo Riluzole Zentiva dajali v odmerkih po 50, 100 ali 200 mg dnevno, in sicer do 18 mesecev.
English: Riluzole Zentiva is used to extend the patient's life, or the time before they need to use mechanical ventilation.
Slovenian: Zdravilo Riluzole Zentiva se uporablja za podaljšanje bolnikovega življenja ali podaljšanje časa, preden mora bolnik začeti uporabljati mehansko ventilacijo.
English: The most common side effects seen with Riluzole Zentiva (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests (increased in liver enzymes levels).
Slovenian: Najpogostejši neželeni učinki zdravila Riluzole Zentiva (opaženi pri več kot 1 bolniku od 10) so navzeja (slabost), astenija (šibkost) in nenormalni rezultati testov delovanja jeter (povišane ravni jetrnih encimov).
English: Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Slovenian: Zdravilo Riluzole Zentiva se uporablja pri bolnikih z amiotrofično lateralno sklerozo (ALS).
English: Treatment with Riluzole Zentiva should only be started by a specialist doctor with experience in the management of motor neurone diseases.
Slovenian: Zdravljenje z zdravilom Riluzole Zentiva sme uvesti samo zdravnik specialist z izkušnjami v zdravljenju bolezni motoričnega nevrona.
English: Other information about Riluzole Zentiva
Slovenian: Druge informacije o zdravilu Riluzole Zentiva
English: Looking at the results of the three studies together, over 18 months, patients who received Riluzole Zentiva 100 mg/day had an average survival time that was about two months longer than the survival time for patients who received placebo.
Slovenian: Ob upoštevanju rezultatov vseh treh študij, ki so trajale 18 mesecev, je bil povprečni čas preživetja bolnikov, ki so dobivali zdravilo Riluzole Zentiva v odmerkih 100 mg/dan, za približno dva meseca daljši v primerjavi z bolniki, ki so dobivali placebo.
English: The Committee recommended that Riluzole Zentiva be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Riluzole Zentiva odobri dovoljenje za promet.
English: What benefit has Riluzole Zentiva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Riluzole Zentiva izkazalo med študijami?
English: The company that makes Rilutek has agreed that its scientific data can be used for Riluzole Zentiva (‘informed consent').
Slovenian: Družba, ki proizvaja zdravilo Rilutek, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Riluzole Zentiva („uporaba dokumentacije s soglasjem“).
English: Riluzole Zentiva must not be used in people who are hypersensitive (allergic) to riluzole or any of the other ingredients.
Slovenian: Zdravila Riluzole Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) riluzol ali katero koli drugo sestavino zdravila.
English: Riluzole Zentiva must also not be given to women who are pregnant or breast-feeding.
Slovenian: Zdravilo se tudi ne sme uporabljati pri nosečnicah in ženskah, ki dojijo.
English: The CHMP decided that Riluzole Zentiva's benefits are greater than its risks to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis.
Slovenian: Odbor CHMP je zaključil, da so koristi zdravila Riluzole Zentiva večje od z njim povezanih tveganj, kar zadeva podaljšanje življenja ali podaljšanje časa do mehanske ventilacije pri bolnikih z amiotrofično lateralno sklerozo.
English: For the full list of all side effects reported with Riluzole Zentiva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Riluzole Zentiva, glejte navodilo za uporabo.
English: Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
Slovenian: Zdravilo Riluzole Zentiva se ne sme uporabljati pri bolnikih z drugimi oblikami bolezni motoričnega nevrona.
English: Riluzole Zentiva is a medicine containing the active substance riluzole.
Slovenian: Riluzole Zentiva je zdravilo, ki vsebuje zdravilno učinkovino riluzol.
English: What is the risk associated with Riluzole Zentiva?
Slovenian: Kakšna tveganja so povezana z zdravilom Riluzole Zentiva?
English: Riluzole Zentiva must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Slovenian: Ne smejo ga uporabljati bolniki, ki imajo bolezen jeter ali nenormalno visoke ravni jetrnih encimov.
English: The medicine was not more effective than placebo in the late stages of ALS.
Slovenian: V poznih stadijih ALS ni bilo zdravilo nič učinkovitejše od placeba.
English: The active substance in Riluzole Zentiva, riluzole, acts on the nervous system.
Slovenian: Zdravilna učinkovina v zdravilu Riluzole Zentiva, riluzol, deluje na živčevje.
English: Why has Riluzole Zentiva been approved?
Slovenian: Zakaj je bilo zdravilo Riluzole Zentiva odobreno?
English: How has Riluzole Zentiva been studied?
Slovenian: Kako je bilo zdravilo Riluzole Zentiva raziskano?
English: What is Riluzole Zentiva used for?
Slovenian: Za kaj se zdravilo Riluzole Zentiva uporablja?
English: How is Riluzole Zentiva used?
Slovenian: Kako se zdravilo Riluzole Zentiva uporablja?
English: What is Riluzole Zentiva?
Slovenian: Kaj je zdravilo Riluzole Zentiva?
English: How does Riluzole Zentiva work?
Slovenian: Kako zdravilo Riluzole Zentiva deluje?
English: 19 May 2011
Slovenian: 19. maj 2011
English: The European Commission issued a decision on 19 May 2011.
Slovenian: Evropska komisija je odločbo izdala dne 19. maja 2011.
English: The medicine is available in all Member States of the European Union as well as Iceland and Norway.
Slovenian: Zdravilo je na voljo v vseh državah članicah Evropske unije ter na Islandiji in Norveškem.
English: The recommended dose for adults, including elderly patients, is one 1 mg tablet once a day.
Slovenian: Priporočeni odmerek za odrasle, vključno s starejšimi bolnicami, je ena 1-miligramska tableta enkrat na dan.
English: Arimidex is authorised in the EU via mutual recognition and national procedures.
Slovenian: Zdravilo Arimidex je v EU odobreno s postopkoma medsebojnega priznavanja in nacionalnimi postopki.
English: 4.3 Contra-indications
Slovenian: 4. 3 Kontraindikacije
English: Why was Arimidex reviewed?
Slovenian: Zakaj je bilo zdravilo Arimidex pregledano?
English: Arimidex must not be used in:
Slovenian: Zdravilo Arimidex se ne sme uporabljati pri:
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je v državah članicah privedlo do razhajanj glede uporabe zdravila, kar je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo v državah, kjer se zdravilo trži.
English: Questions and answers on Arimidex (anastrozole, 1 mg tablets)
Slovenian: Vprašanja in odgovori o zdravilu Arimidex (anastrozol, 1 mg tablete)
English: On 22 July 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Arimidex in the EU.
Slovenian: Evropska komisija je dne 22. julija 2010 zadevo napotila na CHMP, da se uskladijo dovoljenja za promet z zdravilom Arimidex v EU.
English: The European Medicines Agency has completed a review of Arimidex.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Arimidex.
English: Arimidex is a medicine that contains the active substance anastrozole.
Slovenian: Arimidex je zdravilo, ki vsebuje zdravilno učinkovino anastrozol.
English: The Committee also harmonised other sections of the SmPC, including the Special Warnings, which state that tamoxifen and oestrogen-containing therapies should not be given with Arimidex and that Arimidex should be used with caution in patients with severe kidney problems or moderate to severe liver problems.
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s posebnimi opozorili, kjer je navedeno, da bolniki, ki prejemajo zdravilo Arimidex, ne smejo sočasno jemati drugih zdravil, ki vsebujejo tamoksifen in estrogen, ter da je zdravilo Arimidex treba previdno uporabljati pri bolnicah s hudimi težavami z ledvicami ali zmernimi do hudimi težavami z jetri.
English: The same dose is recommended in patients with mild liver problems or with mild to moderate kidney problems.
Slovenian: Enak odmerek se priporoča za bolnice z blagimi težavami z jetri ali z blagimi do zmernimi težavami z ledvicami.
English: What is Arimidex?
Slovenian: Kaj je zdravilo Arimidex?
English: • Patients known to be hypersensitive (allergic) to the active substance anastrozole, or to any of the other ingredients.
Slovenian: • bolnicah z znano preobčutljivostjo za (alergijo na) zdravilno učinkovino anastrozol ali katerokoli drugo sestavino zdravila.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v Odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo uskladiti v celotni EU.
English: The CHMP agreed that Arimidex should be used for:
Slovenian: CHMP je potrdil, da se zdravilo Arimidex lahko uporablja za:
English: Decreasing the production of oestrogen is a way of suppressing the growth of the breast cancer because the growth of breast tissue is stimulated by oestrogen.
Slovenian: Zmanjšanje tvorjenja estrogena je način zaviranja rasti raka dojke, saj estrogen spodbuja rast tkiva dojk.
English: The company that markets Arimidex is AstraZeneca.
Slovenian: Družba, ki trži zdravilo Arimidex, je AstraZeneca.
English: Questions and answers on Arimidex (anastrozole, 1 mg tablets) EMA/405019/2011
Slovenian: Vprašanja in odgovori o zdravilu Arimidex (anastrozol, 1 mg tablete) EMA/211634/2011
English: • Adjuvant (add-on) treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women, including those who have received two to three years of adjuvant tamoxifen (another anti-cancer medicine).
Slovenian: • Adjuvantno (dodatno) zdravljenje zgodnjega invazivnega raka dojke, pozitivnega na hormonske receptorje, pri ženskah po menopavzi, vključno s tistimi, ki so dve do tri leta prejemale dodatni tamoksifen (drugo zdravilo proti raku).
English: ‘Hormone receptor-positive' means that the cancer depends on the presence of oestrogen in order to grow.
Slovenian: „Pozitiven na hormonske receptorje“ pomeni, da je rast raka odvisna od prisotnosti estrogena.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Arimidex in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Arimidex.
English: Arimidex belongs to a group of medicines called ‘aromatase inhibitors' which reduce the amount of the hormone oestrogen made in the body by blocking the action of an enzyme in the body called ‘aromatase'.
Slovenian: Zdravilo Arimidex sodi v skupino zdravil, imenovanih „zaviralci aromataze“, ki z zaviranjem encima v telesu, imenovanega „aromataza“, zmanjšujejo količino hormona estrogena, ki se tvori v telesu.
English: For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is five years.
Slovenian: Za ženske po menopavzi z zgodnjim invazivnim rakom dojke, pozitivnim na hormonske receptorje, je priporočeno trajanje dodatnega endokrinega zdravljenja pet let.
English: It is used to treat breast cancer in women who have already gone through the menopause.
Slovenian: Uporablja se za zdravljenje raka dojke pri ženskah po menopavzi.
English: • Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Slovenian: • Zdravljenje žensk po menopavzi z napredovalim rakom dojke, pozitivnim na hormonske receptorje.
English: Arimidex was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke - humana zdravila (CMD(h)) je ugotovila, da je za zdravilo Arimidex potrebno usklajevanje.
English: The European Commission issued a decision on 13 July 2011.
Slovenian: Evropska komisija je odločbo izdala dne 13. julija 2011.
English: Outcome of nine procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended1
Slovenian: Izid devetih postopkov v skladu s členom 20 Uredbe (ES) št. 726/2004 in enega postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena1
English: 2 Bisphosphonates can be authorised nationally or centrally.
Slovenian: 2 Bisfosfonati so lahko odobreni z nacionalnim ali centraliziranim postopkom.
English: The working party concluded that there was a need to conduct a further review to determine if any regulatory action was necessary.
Slovenian: Delovna skupina je sklenila, da je treba izvesti nadaljnje preglede, s katerimi bi ugotovili, ali so potrebni kakršni koli regulativni ukrepi.
English: If an atypical fracture is suspected in one leg then the other leg should also be examined.
Slovenian: Če obstaja sum, da je v eni nogi prišlo do atipičnega zloma, je treba pregledati tudi drugo nogo.
English: The Committee has also looked at epidemiological studies (studies of the causes and distribution of diseases in the population).
Slovenian: Odbor je preučil tudi epidemiološke študije (študije vzrokov in porazdelitve bolezni pri prebivalstvu).
English: The full changes made to the information to doctors and patients are available on the Agency's website.
Slovenian: Celoten seznam sprememb v informacijah za zdravnike in bolnike je na voljno na spletni strani agencije.
English: Procedure numbers: EMEA/H/C/000595/A-20/0026, EMEA/H/C/000336/A-20/0036, EMEA/H/C/000101/A-20/0051, EMEA/H/C/000502/A-20/0025, EMEA/H/C/000501/A-20/0024, EMEA/H/C/000759/A-20/0012, EMEA/H/C/000619/A-20/0015, EMEA/H/C/001180/A-20/0005, EMEA/H/C/001195/A-20/0001 and EMEA/H/A-31/001279
Slovenian: 1 Številke postopkov: EMEA/H/C/000595/A-20/0026, EMEA/H/C/000336/A-20/0036, EMEA/H/C/000101/A-20/0051, EMEA/H/C/000502/A-20/0025, EMEA/H/C/000501/A-20/0024, EMEA/H/C/000759/A-20/0012, EMEA/H/C/000619/A-20/0015, EMEA/H/C/001180/A-20/0005, EMEA/H/C/001195/A-20/0001 in EMEA/H/A-31/001279
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršnakoli vprašanja, naj se o njih posvetujejo s svojim zdravnikom ali farmacevtom.
English: Questions and answers on the review of bisphosphonates and atypical stress fractures
Slovenian: Vprašanja in odgovori v zvezi s pregledom bisfosfonatov in atipičnih stresnih zlomov
English: What are the recommendations for prescribers and patients?
Slovenian: Kakšna so priporočila za bolnike in zdravnike, ki predpisujejo zdravila?
English: What are bisphosphonates?
Slovenian: Kaj so bisfosfonati?
English: They should report to their doctor any pain, weakness or discomfort in the thigh or groin area, as this may be an indication of a possible fracture.
Slovenian: Zdravniku morajo poročati o morebitni bolečini, šibkosti ali neugodju v stegnu ali dimljah, saj je to lahko znak možnega zloma.
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised medicines.
Slovenian: Hkrati je Evropska komisija zaprosila CHMP, naj izvede enako oceno za zdravila, ki so bila odobrena po centraliziranem postopku.
English: Why were bisphosphonates reviewed?
Slovenian: Zakaj so bili bisfosfonati pregledani?
English: They have been authorised in the EU since the early 1990s for hypercalcaemia (high levels of calcium in the blood) and the prevention of bone problems in patients with cancer.
Slovenian: V EU so odobreni od začetka devetdesetih let za hiperkalcemijo (visoka vsebnost kalcija v krvi) in preprečevanje težav s kostmi pri bolnikih z rakom.
English: Bisphosphonates are medicines that are used to treat and prevent bone disorders.
Slovenian: Bisfosfonati so zdravila, ki se uporabljajo za zdravljenje in preprečevanje kostnih bolezni.