FrancophonIA/ELRC3.0 huggingface dataset:
English: The relative risk reduction of proximal femur and hip area fractures with strontium ranelate over 3 years (FAS population from TROPOS) was not statistically significant compared with placebo: 15% (RR=0.85, 95% CI [0.61; 1.19], p=0.333) and 21% (RR=0.79, 95% CI [0.59; 1.06], p=0.112), respectively.
Slovenian: Rezultati so pokazali povečano tveganje za miokardni infarkt pri uporabi zdravila Protelos/Osseor v primerjavi s placebom (1,7 % v primerjavi z 1,1 %) z relativnim tveganjem 1,6 (95-odstotni IZ, 1,07 do 2,38) in povečano tveganje za venske trombotične in embolične dogodke1,9 % v primerjavi z 1,3 %, z relativnim tveganjem 1,5 (95-odstotni IZ, 1,04 do 2,19).
English: Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Slovenian: „Odbor CHMP se je strinjal s splošno oceno tveganj, povezanih z zdravilom Protelos/Osseor, ki jo je podal odbor PRAC.
English: In view of the data provided and other treatment alternatives available, some experts, in particular the experts in osteoporosis were of the opinion that a patient population could benefit from the product.
Slovenian: Pri sprejemanju odločitve glede uporabe zdravila Protelos/Osseor je odbor CHMP upošteval analizo koristi in tveganj, ki jo je izvedel odbor PRAC, ter mnenje strokovnjakov za osteoporozo, da obstaja skupina bolnikov, ki bi jim zdravilo lahko koristilo.
English: In order to assess the impact of the restrictions introduced in the product information, namely the restriction to patients with severe osteoporosis and patients without the contraindications (current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism; temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest; established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or uncontrolled hypertension), post-hoc subgroup analyses of the existing clinical trial data were performed.
Slovenian: Razpoložljivi podatki ne kažejo povečanega srčno-žilnega tveganja pri bolnikih brez ugotovljene obstoječe ali pretekle ishemične bolezni srca, periferne arterijske bolezni in/ali možgansko-žilne bolezni ter pri bolnikih z nenadzorovano hipertenzijo.
English: Scientific conclusions
Slovenian: Informacije za zdravstvene delavce
English: Overall conclusion
Slovenian: Več o postopku
English: Strontium ranelate has a different mechanism of action from other available products; this might be a valuable alternative, particularly in long-term treatment of osteoporosis and for patients for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Slovenian: • Zdravilo Protelos/Osseor se lahko uporablja samo za zdravljenje hude osteoporoze pri ženskah po menopavzi in moških z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, odobrenimi za zdravljenje osteoporoze, ni mogoče, na primer zaradi kontraindikacij ali intolerance.
English: The CHMP, having considered the PRAC recommendation dated January 2014 and the totality of the information provided by the MAH, is of the opinion that the benefit-risk balance of strontium ranelate remains positive in the restricted population, taking into account the agreed risk minimisation measures, including changes to the product information and additional pharmacovigilance activities.
Slovenian: „Odbor PRAC je med celotnim postopkom tesno sodeloval z odborom CHMP in čeprav se zavedamo, da se priporočila obeh odborov razlikujejo, je naše razumevanje razmerja med tveganji in koristmi zdravila zelo usklajeno, imamo pa tudi enako mnenje o pomembnosti učinkovitega spremljanja srčno-žilnega tveganja,“ je dejala June Raine, predsednica odbora PRAC.
English: This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Slovenian: Pomembno je, da družba izvede dodatne raziskave, s katerimi bo potrdila učinkovitost novih ukrepov.
English: The risk minimisation measures included reducing the target population by excluding patients with high risk for ischemic cardiac disorders, and restricting the indication to patients with severe osteoporosis, who are most likely to benefit from treatment.
Slovenian: Odbor CHMP je menil, da je srčno-žilno tveganje pri bolnikih, ki uporabljajo zdravilo Protelos/Osseor, mogoče obvladati tako, da se uporaba zdravila omeji na bolnike, ki v anamnezi nimajo bolezni srca in ožilja, ter dodatno na tiste, ki ne morejo uporabljati drugih zdravil, ki so odobrena za zdravljenje osteoporoze.
English: The PRAC, having considered the matter, recommended the suspension of the marketing authorisation for Protelos and Osseor.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ta končna priporočila izdal, potem ko je Odbor za oceno tveganja na področju farmakovigilance (PRAC) najprej priporočil začasni umik dovoljenja za promet z zdravilom zaradi z njim povezanega srčno-žilnega tveganja.
English: • The Committee considered that, when the fracture data from randomised, placebo-controlled studies in postmenopausal women are reviewed, the magnitude of the benefit in fracture prevention was found to be modest, particularly for the most serious types of fractures.
Slovenian: Pri sprejemanju zaključkov je odbor CHMP upošteval, da so podatki iz študij pokazali ugoden učinek pri preprečevanju zlomov, med drugim tudi pri bolnikih z velikim tveganjem za zlome.
English: The CHMP agreed with the conclusions of the PRAC that the use of strontium ranelate in a broad osteoporosis population (postmenopausal population) is associated with a number of serious risks; namely serious cardiac disorders (including myocardial infarction), thromboembolic events (including VTE), serious skin reactions (including DRESS syndrome, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis), disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Slovenian: Zdravilo Protelos/Osseor (stroncijev ranelat) je v EU odobreno za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah, pri katerih je že nastopila menopavza in pri katerih obstaja veliko tveganje za zlome (zlomljene kosti), da se zmanjša tveganje za zlome hrbtenice in kolka.
English: In order to address the concern that cardiovascular risk may increase considerably over time in the predominantly elderly target population, the MAH proposed regular assessment of the patients' cardiovascular risk.
Slovenian: Tveganje za razvoj srčno-žilne bolezni pri bolniku je treba oceniti pred začetkom zdravljenja in nato še v rednih časovnih presledkih, praviloma na vsakih 6 do 12 mesecev.
English: However the CHMP took the view that assessment of cardiovascular risk is a primary task for practising physicians, mainly relying on accessible information (such as family and patient history, smoking status, body mass index, waist circumference, blood pressure) and commonly investigated laboratory values (such as blood glucose and lipids).
Slovenian: Poleg tega morajo zdravniki te bolnike še naprej redno spremljati in zdravljenje prekiniti, če se pri njih pojavijo težave s srcem ali ožiljem, na primer nenadzorovan visok krvni tlak ali angina.
English: Together with the comprehensive risk communication and the educational material consisting of a new DHPC, prescribers' checklists and patient alert cards, it can be reasonably assumed that such prominent restrictions of use will accordingly raise the awareness of both physicians and patients for a cautious exposure to this medicinal product.
Slovenian: Dodatni ukrepi za zmanjšanje tveganja vključujejo razdelitev izobraževalnega gradiva zdravstvenim delavcem, ki predpisujejo to zdravilo, da se zagotovi, da se bo uporabljalo samo pri ustrezni skupini bolnikov.
English: Points of differences with the PRAC recommendation and scientific rationale of the CHMP position
Slovenian: Podrobnejše informacije o priporočilu odbora PRAC in ozadju tega pregleda so na voljo na spletni strani agencije.
English: • The Committee considered that the exclusion of patients with contraindications relating to cardiovascular and thromboembolic risks impacted on the statistical significance of the observed increased risks.
Slovenian: • Odločitev zdravnikov, ali bodo predpisali zdravilo Protelos/Osseor, mora še naprej temeljiti na oceni tveganj za posameznega bolnika.
English: When fracture data from randomised, placebo-controlled studies in postmenopausal women were reviewed, the magnitude of the benefit of fracture prevention was found to be modest, particularly regarding the most serious types of fractures.
Slovenian: Kar zadeva koristi zdravila, so podatki o učinkovitosti pokazali učinek pri preprečevanju zlomov, med drugim tudi pri bolnikih z velikim tveganjem za zlome.
English: Strontium ranelate is associated with a number of serious adverse events including serious cardiac disorders, thromboembolic events, serious skin reactions, disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Slovenian: • Zdravljenje z zdravilom Protelos/Osseor je treba prekiniti, če se pri bolniku pojavi ishemična bolezen srca, periferna arterijska bolezen ali možgansko-žilna bolezen, ter v primeru nenadzorovane hipertenzije.
English: In addition, other relevant changes have been implemented in the product information of strontium ranelate, strengthening the contraindications and warnings as well as restricting the indication for strontium ranelate to patients at high risk of fracture for whom treatment with other medicinal products is not possible due to, for example, contraindications or intolerance.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Protelos/Osseor ter priporočila dodatno omejitev uporabe zdravila, in sicer na bolnike, ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
English: The CHMP considered the PRAC recommendation and the additional information provided by the MAH both in writing and at an oral explanation.
Slovenian: Odbor CHMP je priporočila predložil Evropski komisiji, ki jih je potrdila in izdala končni pravno zavezujoči sklep, ki velja za celotno EU.
English: Study CLE-12911-021, for example, was an observational international prospective cohort survey (non-interventional) performed in seven EU countries with the main objective to follow-up during 3 years a cohort of post-menopausal women treated with strontium ranelate with a special focus on all potential safety concerns.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom velikim tveganjem, zaključil, da mora zdravilo Protelos/Osseor ostati dostopno bolnikom, ki v anamnezi nimajo srčno-žilnih bolezni in ne morejo uporabljati drugih zdravil.
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: The recommended starting dose depends on the patient's height and weight.
Slovenian: Priporočeni odmerek je odvisen od bolnikove telesne mase in višine.
English: For more information on generic medicines, see the question-andanswer document here.
Slovenian: Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
English: Patients with moderately or severely impaired liver function should be treated with lower doses.
Slovenian: Bolnike z zmernimi ali hudimi okvarami delovanja jeter je treba zdraviti z manjšimi odmerki.
English: Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Slovenian: Nadaljnje informacije o zdravilu Bortezomib Fresenius Kabi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Velcade, and do not need to be repeated for Bortezomib Fresenius Kabi.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Velcade, zato jih ni treba ponoviti za zdravilo Bortezomib Fresenius Kabi.
English: When injected under the skin, it is given in the thigh or abdomen (belly).
Slovenian: Pri injiciranju v podkožje se zdravilo daje v stegno ali abdomen (trebuh).
English: Because Bortezomib Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Bortezomib Fresenius Kabi generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Slovenian: Zdravilo Bortezomib Fresenius Kabi je na voljo v vialah (3,5 mg) v obliki praška za pripravo raztopine za injiciranje.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Bortezomib Fresenius Kabi has been shown to be comparable to Velcade.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Bortezomib Fresenius Kabi primerljivo z zdravilom Velcade.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Fresenius Kabi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Bortezomib Fresenius Kabi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Fresenius Kabi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bortezomib Fresenius Kabi?
English: Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Slovenian: Bortezomib Fresenius Kabi je zdravilo proti raku, ki se uporablja za zdravljenje multiplega mieloma, tj. krvnega raka, pri naslednjih skupinah bolnikov:
English: As for every medicine, the company provided studies on the quality of Bortezomib Fresenius Kabi.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Bortezomib Fresenius Kabi.
English: Side effects reported with Bortezomib Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Bortezomib Fresenius Kabi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Bortezomib Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Bortezomib Fresenius Kabi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Slovenian: Pri injiciranju v veno se raztopina tri do pet minut vbrizgava skozi kateter (ozko sterilno cevko).
English: There was no need for ‘bioequivalence' studies to investigate whether Bortezomib Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Slovenian: Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Bortezomib Fresenius Kabi absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
English: Doses of Bortezomib Fresenius Kabi are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Fresenius Kabi is given alone or in combination with other medicines.
Slovenian: Odmerki zdravila Bortezomib Fresenius Kabi se dajejo v časovnih razmikih, pri čemer mora biti med dvema zaporednima odmerkoma premor, cikli zdravljenja pa trajajo od tri od šest tednov, kar je odvisno od tega, ali se zdravilo daje samostojno ali v kombinaciji z drugimi zdravili.
English: This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine' already authorised in the EU called Velcade.
Slovenian: To pomeni, da vsebuje enako učinkovino, bortezomib, in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Velcade.
English: The company that markets Bortezomib Fresenius Kabi will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Slovenian: Podjetje, ki trži zdravilo Velcade, bo zagotovilo, da bodo zdravstveni delavci prejeli izobraževalno gradivo, ki vsebuje pojasnila o izračunavanju ustreznega odmerka ter pripravi in dajanju zdravila.
English: An overview of Bortezomib Fresenius Kabi and why it is authorised in the EU
Slovenian: Pregled zdravila Bortezomib Fresenius Kabi in zakaj je odobreno v EU
English: Additionally, when Bortezomib Fresenius Kabi is given under the skin, the active substance in both products, which have the same composition, is expected to be absorbed in the same way.
Slovenian: Kadar se zdravilo Bortezomib Fresenius Kabi injicira v podkožje, se pričakuje, da se bo učinkovina, ki ima v obeh primerih enako sestavo, absorbirala na enak način.
English: Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Slovenian: Zdravilo Bortezomib Fresenius Kabi se uporablja tudi za zdravljenje limfoma plaščnih celic, tj. še ene vrste krvnega raka, pri predhodno nezdravljenih odraslih, pri katerih presaditev krvotvornih matičnih celic ni mogoča.
English: What are the benefits and risks of Bortezomib Fresenius Kabi?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Bortezomib Fresenius Kabi?
English: The active substance in Bortezomib Fresenius Kabi, bortezomib, is a proteasome inhibitor.
Slovenian: Učinkovina v zdravilu Bortezomib Fresenius Kabi, bortezomib, je zaviralec proteasoma.
English: Other information about Bortezomib Fresenius Kabi
Slovenian: Druge informacije o zdravilu Bortezomib Fresenius Kabi
English: Why is Bortezomib Fresenius Kabi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Bortezomib Fresenius Kabi odobreno v EU?
English: Bortezomib Fresenius Kabi is a ‘generic medicine'.
Slovenian: Zdravilo Bortezomib Fresenius Kabi je generično zdravilo.
English: What is Bortezomib Fresenius Kabi and what is it used for?
Slovenian: Kaj je zdravilo Bortezomib Fresenius Kabi in za kaj se uporablja?
English: In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone;
Slovenian: Pri teh bolnikih se zdravilo Bortezomib Fresenius Kabi uporablja v kombinaciji z melfalanom in prednizonom;
English: As for all medicines, data on the use of Bortezomib Fresenius Kabi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bortezomib Fresenius Kabi stalno spremljajo.
English: Fresenius Kabi is only given by injection into a vein or under the skin.
Slovenian: Bortezomib Fresenius Kabi se lahko dajo samo z injiciranjem v veno ali podkožje.
English: Therefore, the Agency's view was that, as for Velcade, the benefits of Bortezomib Fresenius Kabi outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Bortezomib Fresenius Kabi enako kot pri zdravilu Velcade odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
English: Bortezomib Fresenius Kabi is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Slovenian: Zdravilo Bortezomib Fresenius Kabi se pri teh bolnikih uporablja samostojno ali v kombinaciji s pegiliranim liposomalnim doksorubicinom ali deksametazonom;
English: This is because when Bortezomib Fresenius Kabi is given by injection into a vein the active substance is delivered straight into the bloodstream.
Slovenian: Zdravilo Bortezomib Fresenius Kabi se namreč daje z injiciranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
English: For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Slovenian: Za zdravljenje limfoma plaščnih celic se zdravilo Bortezomib Fresenius Kabi uporablja v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom.
English: In this group of patients, Bortezomib Fresenius Kabi is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
Slovenian: Pri tej skupini bolnikov se zdravilo Bortezomib Fresenius Kabi uporablja v kombinaciji z deksametazonom ali pa z deksametazonom in talidomidom;
English: How has Bortezomib Fresenius Kabi been studied?
Slovenian: Kako je bilo zdravilo Bortezomib Fresenius Kabi raziskano?
English: How does Bortezomib Fresenius Kabi work?
Slovenian: Kako zdravilo Bortezomib Fresenius Kabi deluje?
English: Bortezomib
Slovenian: Zdravilo
English: How is Bortezomib Fresenius Kabi used?
Slovenian: Kako se zdravilo Bortezomib Fresenius Kabi uporablja?
English: Don't drive or use machines unless you're feeling well.
Slovenian: Ne vozite in ne upravljajte strojev, če se ne počutite dobro.
English: A risk to the breastfeeding child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: The safety and efficacy of epoprostenol in children younger than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost epoprostenola pri otrocih, mlajših od 18 let, še nista ugotovljeni .
English: They will also advise you how to stop treatment if necessary.
Slovenian: Pojasnila vam bosta tudi, kako prenehati z zdravljenjem, če je to potrebno.
English: The procedure given below should be closely followed.
Slovenian: Natančno je treba upoštevati spodaj navedeni postopek.
English: This procedure should be conducted in a hospital with adequate resuscitation equipment.
Slovenian: Ta postopek je treba opraviti v bolnišnici in z dosegljivo ustrezno reanimacijsko opremo.
English: It is very important that you follow all of their instructions carefully.
Slovenian: Zelo pomembno je, da natančno upoštevate vsa njuna navodila.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 4.2.
English: • You have more frequent, or longer periods of bleeding.
Slovenian: • Imate pogostejše ali dolgotrajnejše krvavitve.
English: If it does, the skin could be damaged.
Slovenian: Če se to zgodi, lahko pride do poškodbe kože.
English: • digoxin (used to treat heart disease).
Slovenian: • digoksin (uporablja se za zdravljenje bolezni srca).
English: The amount you are given is based on your body weight, and your type of illness.
Slovenian: Količina, ki jo boste dobili, bo odvisna od vaše telesne mase in vrste vaše bolezni.
English: It is not known how many people are affected:
Slovenian: Ni znano, pri kolikšnem številu ljudi se pojavijo naslednji neželeni učinki:
English: • for up to 12 hours at 25oC, if it has just been made up
Slovenian: • do 12 ur pri temperaturi 25 oC, če je bila pravkar pripravljena,
English: N=4/25).
Slovenian: s 5/24).
English: • You feel dizzy or feel faint, especially on standing.
Slovenian: • Občutite omotico ali omedlevico, zlasti ko vstanete.
English: Also your blood pressure can become too low.
Slovenian: Tudi krvni tlak se lahko preveč zniža.