FrancophonIA/ELRC3.0 huggingface dataset:
English: These findings were made available to EU national authorities in November 2010.
Slovenian: Izsledki študij so bili nacionalnim pristojnim organom EU na voljo novembra 2010.
English: After a re-examination, the Committee confirmed its recommendation on 15 November 2012.
Slovenian: Po ponovnem pregledu je Odbor potrdil svoja priporočila z dne 15. novembra 2012.
English: What is calcitonin?
Slovenian: Kaj je kalcitonin?
English: − hypercalcaemia caused by cancer.
Slovenian: − zdravljenje hiperkalcemije zaradi raka.
English: The Committee maintained its recommendations after re-examination.
Slovenian: Po ponovnem pregledu Odbor ohranja svoja priporočila.
English: Why were calcitonin-containing medicines reviewed?
Slovenian: Zakaj so bila zdravila, ki vsebujejo kalcitonin, pregledana?
English: • Calcitonin will only be available as a solution for injection and infusion, and should only be used for:
Slovenian: • Kalcitonin bo na voljo samo kot raztopina za injiciranje in infundiranje in se lahko uporablja samo za:
English: The issue was also investigated in 2009 and 2010 by the EMA's Pharmacovigilance Working Party (PhVWP), but there was insufficient evidence at the time for any regulatory action.
Slovenian: To vprašanje je leta 2009 in 2010 preiskovala tudi delovna skupina za farmakovigilanco Evropske agencije za zdravila, vendar je bilo dokazov za kakršen koli ureditveni ukrep premalo.
English: The CHMP also reviewed post-marketing safety data, randomised controlled studies and experimental cancer studies.
Slovenian: Odbor je prav tako pregledal podatke o varnosti zdravila iz obdobja trženja, randomizirane nadzorovane študije in eksperimentalne študije raka.
English: The CHMP noted that the available data suggest that a higher proportion of patients treated with calcitonin for long periods of time may develop cancer of various types, compared with patients taking placebo.
Slovenian: Odbor CHMP je ugotovil, da razpoložljivi podatki nakazujejo, da se lahko pri več bolnikih, ki dlje časa prejemajo zdravljenje s kalcitoninom, razvijejo različne vrste raka v primerjavi z bolniki, ki prejemajo placebo.
English: • Treatment with calcitonin should be limited to the shortest possible time using the smallest effective dose.
Slovenian: • Zdravljenje s kalcitoninom je treba omejiti na najkrajši možni čas z najnižjim, še učinkovitim odmerkom.
English: Although the cancer rates reported in the studies were low, the increase in cancer rates seen with calcitonin varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation.
Slovenian: Čeprav so bili deleži raka, o katerih so poročali v študijah, nizki, je povišanje pojavnosti raka pri kalcitoninu znašalo med 0,7 % v študijah s peroralnim pripravkom in 2,4 % v študijah s pripravkom za nos.
English: Calcitonin is a hormone that increases the amount of calcium in the bones and lowers the calcium level in the blood.
Slovenian: Kalcitonin je hormon, ki poveča količino kalcija v kosteh in zniža raven kalcija v krvi.
English: − prevention of acute bone loss due to sudden immobilisation, with a recommended treatment period of two weeks and a maximum treatment period of four weeks;
Slovenian: − preprečevanje akutne izgube kostne mase zaradi nenadne imobilizacije, s priporočenim trajanjem zdravljenja dva tedna in najdaljšim trajanjem zdravljenja štiri tedne;
English: − Paget's disease, restricted to patients who do not respond to alternative treatments or for whom such treatments are not suitable, and with treatment normally limited to three months (longer treatment and periodic retreatment may be considered taking into account the benefits and risks);
Slovenian: − zdravljenje Pagetove bolezni, izključno pri bolnikih, ki se ne odzivajo na alternativna zdravljenja ali za katere tovrstna zdravljenja niso primerna, s trajanjem zdravljenja, običajno omejenim na tri mesece (daljše zdravljenje in periodično zdravljenje je mogoče ob upoštevanju koristi in tveganj);
English: • Calcitonin will no longer be used for the treatment of osteoporosis.
Slovenian: • Kalcitonin se ne bo več uporabljal za zdravljenje osteoporoze.
English: On 19 July 2012, the European Medicines Agency completed a review of the benefits and risks of calcitonin-containing medicines, concluding that there was evidence of a small increased risk of cancer with long-term use of these medicines.
Slovenian: Evropska agencija za zdravila je 19. julija 2012 zaključila pregled koristi in tveganj zdravil, ki vsebujejo kalcitonin, ter sklenila, da je dolgotrajna uporaba omenjenih zdravil povezana z rahlo povečanim tveganjem za nastanek raka.
English: Calcitonin, manufactured in the laboratory, is used in medicines to treat or prevent conditions that involve the loss of calcium from the bones.
Slovenian: Kalcitonin, proizveden v laboratoriju, se v zdravilih uporablja za zdravljenje ali preprečevanje stanj, pri katerih se med drugim izloča kalcij iz kosti.
English: In addition to the two studies of the unlicensed oral calcitonin medicine, the CHMP reviewed available data on the benefits and risks of calcitonin-containing medicines provided by the companies that market these medicines as well as data from the scientific literature and from third parties.
Slovenian: Odbor CHMP je poleg omenjenih dveh študij z neregistrirano peroralno obliko kalcitonina pregledal tudi razpoložljive podatke o koristih in tveganjih zdravil, ki vsebujejo kalcitonin, ki so jih predložile družbe, ki tržijo ta zdravila, ter podatke iz znanstvene literature in tretjih strani.
English: • Patients receiving injectable calcitonin who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki prejemajo kalcitonin v obliki raztopine za injiciranje, naj se v primeru vprašanj posvetujejo s svojim zdravnikom ali farmacevtom.
English: This review was initiated following preliminary findings from two studies of an unlicensed oral calcitonin medicine, which pointed to a possible association with prostate cancer.
Slovenian: Pregled je bil sprožen po predhodnih ugotovitvah dveh študij z neregistrirano peroralno obliko kalcitonina, ki sta nakazali morebitno povezavo z rakom prostate.
English: Following the receipt of the data from the studies on the unlicensed oral medicine, the UK medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of calcitonincontaining medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Po prejetju podatkov študij z neregistrirano peroralno obliko zdravila je britanska agencija za zdravila odbor CHMP prosila, naj izvede popolno oceno razmerja med koristmi in tveganji zdravil, ki vsebujejo kalcitonin, in poda mnenje, ali je treba dovoljenja za promet z zdravili v EU ohraniti, spremeniti, začasno umakniti ali preklicati.
English: A possible association between calcitonin and prostate cancer was first investigated by the UK medicines regulatory agency in 2004, but a causal association could not be established with the evidence available at the time.
Slovenian: Morebitno povezavo med kalcitoninom in rakom prostate je prvič preiskovala britanska regulatorna agencija za zdravila leta 2004, vendar s takrat razpoložljivimi dokazi vzročne povezanosti niso dokazali.
English: It has been used in the EU for treating osteoporosis (a disease that makes bones fragile), Paget's disease (a bone disease that involves bone remodelling and can cause deformity), and hypercalcaemia (increased blood calcium) caused by cancer.
Slovenian: V EU se kalcitonin uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti), Pagetove bolezni (kostne bolezni, ki vključuje prestrukturiranje kostnega tkiva in lahko povzroči deformacijo) in hiperkalcemije (povišane vrednosti kalcija v krvi) zaradi raka.
English: Calcitonin-containing medicines have been available in the EU as solutions for injection or infusion (drip into a vein) since 1973, and as a nasal spray since 1987.
Slovenian: Zdravila, ki vsebujejo kalcitonin, so v EU od leta 1973 na voljo v obliki raztopine za injiciranje ali infundiranje (kapalne infuzije v veno), od leta 1987 pa v obliki pršila za nos.
English: • Prescribers should note that calcitonin should no longer be used for the treatment of osteoporosis.
Slovenian: • Zdravniki naj upoštevajo, da se kalcitonin ne uporablja več za zdravljenje osteoporoze.
English: As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation should no longer be used.
Slovenian: Ker se pršilo za nos uporablja samo pri osteoporozi, CHMP priporoča prekinitev uporabe tega pripravka.
English: However, the CHMP recommended that even for these uses calcitonin treatment should be given for the shortest possible time using the smallest effective dose.
Slovenian: CHMP kljub temu priporoča, naj tudi v navedenih primerih zdravljenje s kalcitoninom traja najkrajši možni čas z najnižjim, še učinkovitim odmerkom.
English: It is also used to prevent acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.
Slovenian: Kalcitonin se uporablja tudi za preprečevanje akutne izgube kostne mase zaradi nenadne imobilizacije, na primer pri bolnikih z nedavnimi osteoporotičnimi zlomi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that they should only be authorised for short-term use in Paget's disease, acute bone loss due to sudden immobilisation and hypercalcaemia caused by cancer.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila priporoča, da se zdravila predpišejo samo za kratkotrajno uporabo pri Pagetovi bolezni, akutni izgubi kostne mase zaradi nenadne imobilizacije ter hiperkalcemiji zaradi raka.
English: Patients being treated for osteoporosis with calcitonin nasal sprays or other formulations are advised to speak to their doctor at a routine appointment, who will recommend suitable alternative treatment.
Slovenian: Bolniki, ki se zdravijo za osteoporozo s kalcitoninom v obliki pršila za nos ali drugih pripravkov, naj se ob rednem pregledu posvetujejo s svojim zdravnikom, ki jim bo predpisal primerno alternativno zdravljenje.
English: Taking into account the limited benefit of calcitonin when used to treat postmenopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin did not outweigh the risks in this condition.
Slovenian: Odbor CHMP je ob upoštevanju omejenih koristi kalcitonina pri zdravljenju pomenopavzne osteoporoze za zmanjšanje tveganja vretenčnih zlomov zaključil, da v tem stanju koristi kalcitonina ne odtehtajo z njim povezanih tveganj.
English: The benefit-risk balance remains positive only for the following uses: treatment of Paget's disease for patients who cannot be treated with alternative treatments, prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, and the treatment of hypercalcaemia caused by cancer.
Slovenian: Razmerje med koristmi in tveganji ostaja pozitivno samo za naslednje uporabe: zdravljenje Pagetove bolezni pri bolnikih, ki jih ni mogoče zdraviti z alternativnimi zdravljenji, preprečevanje akutne izgube kostne mase zaradi nenadne imobilizacije, na primer pri bolnikih z nedavnimi osteoporotičnimi zlomi, in zdravljenje hiperkalcemije zaradi raka.
English: The Committee also concluded that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
Slovenian: Odbor je prav tako zaključil, da pri zdravljenju osteoporoze koristi zdravil, ki vsebujejo kalcitotin, ne odtehtajo z njimi povezanih tveganj in da je treba z njihovo uporabo za zdravljenje tega stanja prenehati.
English: The response was maintained for up to 5 years.
Slovenian: Tak odziv se je ohranil do pet let.
English: This summary was last updated in 04-2017.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2017.
English: PML is a very serious condition that may result in severe disability or death.
Slovenian: PML je zelo resna bolezen, ki lahko povzroči hudo invalidnost ali smrt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri on 27 June 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tysabri, veljavno po vsej Evropski uniji, izdala 27. junija 2006.
English: Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for one hour afterwards.
Slovenian: Ker lahko infuzija izzove alergijsko reakcijo, je treba bolnika opazovati med infundiranjem in eno uro po njem.
English: The pack will also include information about other risks of this medicine for patients.
Slovenian: Izobraževalno gradivo bo vključevalo tudi informacije o drugih tveganjih tega zdravila za bolnike.
English: This is a summary of the European public assessment report (EPAR) for Tysabri.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tysabri.
English: The full EPAR for Tysabri 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 Tysabri je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Tysabri?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tysabri?
English: If there is no clear benefit for the patient after six months, the doctor should re-assess the treatment.
Slovenian: Če po šestih mesecih zdravljenja pri bolniku ni vidnega izboljšanja stanja, mora zdravnik zdravljenje ponovno pretehtati.
English: About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine's effectiveness.
Slovenian: Pri približno 6 % bolnikov, ki so sodelovali v študijah, so se razvila obstojna protitelesa proti natalizumabu, ki zmanjšujejo učinkovitost zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tysabri's benefits in this restricted population are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Tysabri pri tej omejeni populaciji večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: It must not be given in combination with other disease-modifying medicines or to patients who have cancer (unless it is a type of skin cancer called basal cell carcinoma).
Slovenian: Ne sme se dajati v kombinaciji z drugimi zdravili za spreminjanje poteka bolezni ali bolnikom, ki imajo raka (razen če gre za kožni rak, imenovan bazocelularni karcinom kože).
English: Patients should make sure their partner or carer, as well as other doctors treating them, are aware of its content.
Slovenian: Poskrbeti morajo za to, da bodo njihov partner ali negovalec ter vsi zdravniki, ki so vključeni v njihovo zdravljenje, seznanjeni z njeno vsebino.
English: If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
Slovenian: Če obstaja sum na PML, mora zdravnik prekiniti zdravljenje, dokler ni jasno, da bolnik nima okužbe.
English: However, because of its safety risks, it should only be used in patients who have a real need for the medicine either because their disease has failed to respond to at least one other disease-modifying therapy or is rapidly getting worse.
Slovenian: Vendar se zaradi njegovih tveganj za varnost sme uporabljati samo pri bolnikih, ki zdravilo resnično potrebujejo, ker se bodisi niso odzvali na vsaj eno drugo zdravljenje z zdravili za spreminjaje poteka bolezni bodisi ker se njihova bolezen hitro poslabšuje.
English: A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses.
Slovenian: Druga študija je pokazala, da je dodajanje zdravila Tysabri zdravljenju z drugim zdravilom, interferonom beta-1a, učinkovitejše od dodajanja placeba, saj zmanjšuje tveganje za poslabšanje prizadetosti in število napadov.
English: The most common side effects seen in studies with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), joint pain, rigors (shaking chills), fever and tiredness.
Slovenian: Najpogostejši neželeni učinki, zabeleženi v študijah zdravila Tysabri (opaženi pri 1 do 10 bolnikih od 100), so okužbe sečil (okužbe struktur za odvajanje urina), nazofaringitis (okužbe nosu in žrela), urtikarija (srbeč izpuščaj), glavobol, omotica, bruhanje, navzeja (slabost), bolečine v sklepih, mrzlica (drgetanje), povišana telesna temperatura in utrujenost.
English: Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Slovenian: Bolniki, ki prejemajo zdravilo Tysabri, morajo prejeti posebno opozorilno izkaznico, ki povzema ključne informacije o varnosti zdravila.
English: Patients should read this card carefully and keep it with them.
Slovenian: Skrbno jo morajo prebrati in jo vedno imeti vedno s seboj.
English: The company that markets Tysabri will agree on measures to further enhance the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri.
Slovenian: Družba, ki trži zdravilo Tysabri, se bo dogovorila o ukrepih za nadaljnje izboljšanje spremljanja bolnikov v posameznih državah članicah, kot so registri in študije bolnikov, ki prejemajo to zdravilo.
English: Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.
Slovenian: Bolniki morajo te informacije dobiti na začetku zdravljenja z zdravilom Tysabri, če zdravljenje traja več kot dve leti, in ob prenehanju zdravljenja, saj tveganje za pojav PML obstaja še šest mesecev po prenehanju zdravljenja.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Slovenian: Multipla skleroza je obolenje živcev, pri kateri vnetje uniči zaščitni ovoj okoli živčnih celic.
English: Other information about Tysabri
Slovenian: Druge informacije o zdravilu Tysabri
English: Tysabri is a medicine for treating adults with multiple sclerosis (MS) that has failed to respond to another disease-modifying therapy or is rapidly getting worse.
Slovenian: Tysabri je zdravilo za zdravljenje odraslih z multiplo sklerozo (MS), ki se ni odzvala na drugo zdravilo za spreminjanje poteka bolezni oziroma se hitro poslabšuje.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called ‘α4β1 integrin' found on the surface of white blood cells involved in inflammation.
Slovenian: Zdravilna učinkovina v zdravilu Tysabri, natalizumab, je monoklonsko protitelo, ki se ciljno veže na beljakovino, imenovano „integrin α4β1“, ki se nahaja na površini belih krvnih celic, povezanih z vnetjem.
English: Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from 1.99 to 0.22 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used),.
Slovenian: Tretja študija, ki še vedno poteka, pa je pokazala, da se je pri bolnikih, zdravljenih z zdravilom Tysabri, povprečno število napadov multiple skleroze na leto zmanjšalo z 1,99 na 0,22 (ne glede na to, katero zdravilo za spreminjanje poteka bolezni so uporabljali predhodno).
English: The risk is also higher if the patient used medicines that supress the immune system before starting Tysabri, or if the patient has antibodies against the virus that causes PML.
Slovenian: Tveganje je večje tudi, če je bolnik jemal zdravila za zaviranje imunskega sistema, preden je začel jemati zdravilo Tysabri, ali če ima protitelesa zoper virus, ki povzroča PML.
English: In addition, the risk of disability getting worse was reduced by 42% over two years with Tysabri in comparison with placebo.
Slovenian: Poleg tega se je tveganje za poslabšanje prizadetosti v dveh letih zmanjšalo za 42 % pri bolnikih, ki so prejemali zdravilo Tysabri, v primerjavi s placebom.
English: This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to the brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with Tysabri and other MS medicines.
Slovenian: Ta naprava zdravniku omogoča, da spremlja spremembe v možganih ali hrbtenjači, povezane z multiplo sklerozo, in opazi okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML), ki je povezana z zdravilom Tysabri in drugimi zdravili za zdravljenje multiple skleroze.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tysabri have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tysabri upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Tysabri is given as a one-hour infusion (drip) into a vein once every four weeks.
Slovenian: Zdravilo Tysabri se daje z enournim infundiranjem (kapalno infuzijo) v veno enkrat vsake štiri tedne.
English: What are the risks associated with Tysabri?
Slovenian: Kakšna tveganja so povezana z zdravilom Tysabri?
English: Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).
Slovenian: Zdravilo Tysabri je bilo učinkovito pri zmanjševanju števila recidivov in poslabšanja prizadetosti (izmerjene z razširjeno lestvico stopnje prizadetosti).
English: In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabritreated patients fell by about 68% after a year, compared with the patients who received placebo.
Slovenian: V študiji, v kateri so zdravilo Tysabri primerjali s placebom (zdravilom brez zdravilne učinkovine), je po enem letu število napadov multiple skleroze pri bolnikih, ki so prejemali zdravilo Tysabri, padlo za približno 68 % v primerjavi z bolniki, ki so prejemali placebo.
English: It will also supply all doctors who prescribe Tysabri with an educational pack that includes information on the safety of Tysabri, including information on which patients may be at a higher or lower risk of PML.
Slovenian: Prav tako bo za vse zdravnike, ki predpisujejo zdravilo Tysabri, pripravila izobraževalno gradivo z vsemi informacijami o njegovi varnosti, vključno z informacijami o tem, pri katerih bolnikih obstaja večje ali manjše tveganje za pojav PML.
English: What is Tysabri and what is it used for?
Slovenian: Kaj je zdravilo Tysabri in za kaj se uporablja?
English: Tysabri must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune system is weakened.
Slovenian: Zdravilo Tysabri se ne sme dajati bolnikom, ki imajo PML ali pri katerih obstaja tveganje za pojav te okužbe, kot so npr. bolniki z oslabljenim imunskim sistemom.
English: What benefits of Tysabri have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Tysabri izkazalo v študijah?