natgillin/translations-raw huggingface dataset:
Riluzole Zentiva must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Ne smejo ga uporabljati bolniki, ki imajo bolezen jeter ali nenormalno visoke ravni jetrnih encimov.
The medicine was not more effective than placebo in the late stages of ALS.
V poznih stadijih ALS ni bilo zdravilo nič učinkovitejše od placeba.
The active substance in Riluzole Zentiva, riluzole, acts on the nervous system.
Zdravilna učinkovina v zdravilu Riluzole Zentiva, riluzol, deluje na živčevje.
Why has Riluzole Zentiva been approved?
Zakaj je bilo zdravilo Riluzole Zentiva odobreno?
How has Riluzole Zentiva been studied?
Kako je bilo zdravilo Riluzole Zentiva raziskano?
What is Riluzole Zentiva used for?
Za kaj se zdravilo Riluzole Zentiva uporablja?
How is Riluzole Zentiva used?
Kako se zdravilo Riluzole Zentiva uporablja?
What is Riluzole Zentiva?
Kaj je zdravilo Riluzole Zentiva?
How does Riluzole Zentiva work?
Kako zdravilo Riluzole Zentiva deluje?
19 May 2011
19. maj 2011
The European Commission issued a decision on 19 May 2011.
Evropska komisija je odločbo izdala dne 19. maja 2011.
The medicine is available in all Member States of the European Union as well as Iceland and Norway.
Zdravilo je na voljo v vseh državah članicah Evropske unije ter na Islandiji in Norveškem.
The recommended dose for adults, including elderly patients, is one 1 mg tablet once a day.
Priporočeni odmerek za odrasle, vključno s starejšimi bolnicami, je ena 1-miligramska tableta enkrat na dan.
Arimidex is authorised in the EU via mutual recognition and national procedures.
Zdravilo Arimidex je v EU odobreno s postopkoma medsebojnega priznavanja in nacionalnimi postopki.
4.3 Contra-indications
4. 3 Kontraindikacije
Why was Arimidex reviewed?
Zakaj je bilo zdravilo Arimidex pregledano?
Arimidex must not be used in:
Zdravilo Arimidex se ne sme uporabljati pri:
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.
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.
Questions and answers on Arimidex (anastrozole, 1 mg tablets)
Vprašanja in odgovori o zdravilu Arimidex (anastrozol, 1 mg tablete)
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.
Evropska komisija je dne 22. julija 2010 zadevo napotila na CHMP, da se uskladijo dovoljenja za promet z zdravilom Arimidex v EU.
The European Medicines Agency has completed a review of Arimidex.
Evropska agencija za zdravila je zaključila pregled zdravila Arimidex.
Arimidex is a medicine that contains the active substance anastrozole.
Arimidex je zdravilo, ki vsebuje zdravilno učinkovino anastrozol.
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.
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.
The same dose is recommended in patients with mild liver problems or with mild to moderate kidney problems.
Enak odmerek se priporoča za bolnice z blagimi težavami z jetri ali z blagimi do zmernimi težavami z ledvicami.
What is Arimidex?
Kaj je zdravilo Arimidex?
• Patients known to be hypersensitive (allergic) to the active substance anastrozole, or to any of the other ingredients.
• bolnicah z znano preobčutljivostjo za (alergijo na) zdravilno učinkovino anastrozol ali katerokoli drugo sestavino zdravila.
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.
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.
The CHMP agreed that Arimidex should be used for:
CHMP je potrdil, da se zdravilo Arimidex lahko uporablja za:
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.
Zmanjšanje tvorjenja estrogena je način zaviranja rasti raka dojke, saj estrogen spodbuja rast tkiva dojk.
The company that markets Arimidex is AstraZeneca.
Družba, ki trži zdravilo Arimidex, je AstraZeneca.
Questions and answers on Arimidex (anastrozole, 1 mg tablets) EMA/405019/2011
Vprašanja in odgovori o zdravilu Arimidex (anastrozol, 1 mg tablete) EMA/211634/2011
• 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).
• 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).
‘Hormone receptor-positive' means that the cancer depends on the presence of oestrogen in order to grow.
„Pozitiven na hormonske receptorje“ pomeni, da je rast raka odvisna od prisotnosti estrogena.
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).
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.
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'.
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.
For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is five years.
Za ženske po menopavzi z zgodnjim invazivnim rakom dojke, pozitivnim na hormonske receptorje, je priporočeno trajanje dodatnega endokrinega zdravljenja pet let.
It is used to treat breast cancer in women who have already gone through the menopause.
Uporablja se za zdravljenje raka dojke pri ženskah po menopavzi.
• Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
• Zdravljenje žensk po menopavzi z napredovalim rakom dojke, pozitivnim na hormonske receptorje.
Arimidex was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke - humana zdravila (CMD(h)) je ugotovila, da je za zdravilo Arimidex potrebno usklajevanje.
The European Commission issued a decision on 13 July 2011.
Evropska komisija je odločbo izdala dne 13. julija 2011.
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
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
2 Bisphosphonates can be authorised nationally or centrally.
2 Bisfosfonati so lahko odobreni z nacionalnim ali centraliziranim postopkom.
The working party concluded that there was a need to conduct a further review to determine if any regulatory action was necessary.
Delovna skupina je sklenila, da je treba izvesti nadaljnje preglede, s katerimi bi ugotovili, ali so potrebni kakršni koli regulativni ukrepi.
If an atypical fracture is suspected in one leg then the other leg should also be examined.
Če obstaja sum, da je v eni nogi prišlo do atipičnega zloma, je treba pregledati tudi drugo nogo.
The Committee has also looked at epidemiological studies (studies of the causes and distribution of diseases in the population).
Odbor je preučil tudi epidemiološke študije (študije vzrokov in porazdelitve bolezni pri prebivalstvu).
The full changes made to the information to doctors and patients are available on the Agency's website.
Celoten seznam sprememb v informacijah za zdravnike in bolnike je na voljno na spletni strani agencije.
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
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
• Patients who have any questions should speak to their doctor or pharmacist.
• Bolniki, ki imajo kakršnakoli vprašanja, naj se o njih posvetujejo s svojim zdravnikom ali farmacevtom.
Questions and answers on the review of bisphosphonates and atypical stress fractures
Vprašanja in odgovori v zvezi s pregledom bisfosfonatov in atipičnih stresnih zlomov
What are the recommendations for prescribers and patients?
Kakšna so priporočila za bolnike in zdravnike, ki predpisujejo zdravila?
What are bisphosphonates?
Kaj so bisfosfonati?
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.
Zdravniku morajo poročati o morebitni bolečini, šibkosti ali neugodju v stegnu ali dimljah, saj je to lahko znak možnega zloma.
At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised medicines.
Hkrati je Evropska komisija zaprosila CHMP, naj izvede enako oceno za zdravila, ki so bila odobrena po centraliziranem postopku.
Why were bisphosphonates reviewed?
Zakaj so bili bisfosfonati pregledani?
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.
V EU so odobreni od začetka devetdesetih let za hiperkalcemijo (visoka vsebnost kalcija v krvi) in preprečevanje težav s kostmi pri bolnikih z rakom.
Bisphosphonates are medicines that are used to treat and prevent bone disorders.
Bisfosfonati so zdravila, ki se uporabljajo za zdravljenje in preprečevanje kostnih bolezni.
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.
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.
The Committee noted that the number of reports of atypical fractures of the femur in users of bisphosphonates had increased since the 2008 review.
Odbor je ugotovil, da se je število poročil o atipičnih zlomih stegnenice pri uporabnikih bisfosfonatov od pregleda leta 2008 povečalo.
As a result, a warning was added to the product information of alendronic acidcontaining medicines across Europe.
Posledično je bilo po vsej Evropi v informacije o zdravilih, ki vsebujejo alendronsko kislino, vključeno opozorilo.
They work by stopping the action of the osteoclasts, the cells that are involved in breaking the bone down.
Delujejo tako, da zavirajo delovanje osteoklastov, celic, ki sodelujejo pri razgradnji kosti.
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.
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.
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.
V EU so na voljo v obliki tablet in raztopin za infundiranje (kapalne infuzije v veno) pod različnimi tržnimi imeni in kot generična zdravila2.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Bisphosphonates include alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid.
Bisfosfonati vključujejo alendronsko kislino, klodronsko kislino, etidronsko kislino, ibandronsko kislino, neridronsko kislino, pamidronsko kislino, rizedronsko kislino, tiludronsko kislino in zoledronsko kislino.
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.
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.
• 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.
• 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.
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.
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.
• Patients who are taking bisphosphonate-containing medicines need to be aware of the risk of atypical fracture of the thigh bone.
• Bolniki, ki jemljejo zdravila, ki vsebujejo bisfosfonate, se morajo zavedati tveganja za atipične zlome stegnenice.
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.
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.
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).
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.
• 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.
• Zdravniki, ki predpisujejo zdravila, ki vsebujejo bisfosfonat, se morajo zavedati, da se lahko občasno pojavljajo atipični zlomi stegnenice (kost stegna), zlasti po dolgotrajni uporabi.
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.
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.
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).
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).
The European Commission granted a marketing authorisation valid throughout the European Union for Alimta on 20 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom Alimta, veljavno po vsej Evropski uniji, odobrila dne 20. septembra 2004.
The full EPAR for Alimta can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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.
Alimta affects fertility, so both men and women who receive it need to be made aware of this.
Zdravilo Alimta vpliva na plodnost, zato je treba moške in ženske, ki ga prejemajo, o tem obvestiti.
Other information about Alimta
Druge informacije o zdravilu Alimta
The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Priporočeni odmerek zdravila je 500 mg na kvadratni meter telesne površine (izračunano glede na bolnikovo višino in maso).
Alimta is used to treat two types of lung cancer:
Zdravilo Alimta se uporablja za zdravljenje dveh vrst pljučnega raka:
It must not be used during breast-feeding or at the same time as the vaccine for yellow fever.
Zdravilo se ne sme uporabljati med dojenjem ali hkrati s cepivom proti rumeni mrzlici.
This is a summary of the European public assessment report (EPAR) for Alimta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alimta.
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.
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.
What is the risk associated with Alimta?
Kakšna tveganja so povezana z zdravilom Alimta?
What benefit has Alimta shown during the studies?
Kakšne koristi je zdravilo Alimta izkazalo med študijami?
The CHMP concluded that Alimta's benefits are greater than its risks and recommended that it be given marketing authorisation.
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.
For more information about treatment with Alimta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Zdravilo Alimta se sme dajati samo pod nadzorom zdravnika, ki je usposobljen za uporabo kemoterapije.
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.
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.