FrancophonIA/ELRC3.0 huggingface dataset:
English: Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Slovenian: Za rekonstitucijo in dajanje zdravila se sme uporabiti samo priloženi pribor (vialo s praškom, z vehiklom napolnjeno injekcijsko brizgo, adapter za vialo in pribor za vensko punkcijo).
English: This summary was last updated in 02-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 02-2019.
English: This means that Silapo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: What measures are being taken to ensure the safe and effective use of Silapo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silapo?
English: Silapo received a marketing authorisation valid throughout the EU on 18 December 2007.
Slovenian: Za zdravilo Silapo je bilo 18. decembra 2007 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: The iron levels of all patients should be checked and iron supplements given if necessary.
Slovenian: Pri vseh bolnikih je treba preveriti raven železa in jim po potrebi predpisati dodatke železa.
English: After that, the two groups switched to receiving the other medicine for a further 12 weeks.
Slovenian: Zatem sta obe skupini bolnikov za nadaljnjih 12 tednov prešli na zdravljenje z drugim zdravilom.
English: Further information on Silapo can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/Silapo
Slovenian: Nadaljnje informacije o zdravilu Silapo so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/Silapo
English: • patients who cannot receive medicines to prevent blood clots;
Slovenian: bolnikih, ki ne morejo prejemati zdravil za preprečevanje krvnih strdkov;
English: An overview of Silapo and why it is authorised in the EU
Slovenian: Pregled zdravila Silapo in zakaj je odobreno v EU
English: What is Silapo and what is it used for?
Slovenian: Kaj je zdravilo Silapo in za kaj se uporablja?
English: Haemoglobin levels were maintained at around 11.4 g/dl in both groups.
Slovenian: Ravni hemoglobina so bile v obeh skupinah bolnikov ohranjene na približno 11,4 g/dl.
English: For these patients, the lowest dose that controls the symptoms well enough should be used.
Slovenian: Pri teh bolnikih je treba uporabiti najnižji odmerek, ki še zagotavlja dovolj dober nadzor nad simptomi.
English: During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment.
Slovenian: V zadnjih štirih tednih študije so bile ravni hemoglobina okoli 11,6 g/dl, kar pomeni, da so narasle z ravni okoli 8,0 g/dl pred zdravljenjem.
English: The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure.
Slovenian: Najpogostejša neželena učinka zdravila Silapo (ki se lahko pojavita pri več kot 1 bolniku od 100) sta glavobol in povišan krvni tlak.
English: Why is Silapo authorised in the EU?
Slovenian: Zakaj je zdravilo Silapo odobreno v EU?
English: What benefits of Silapo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Silapo izkazalo v študijah?
English: Silapo must not be used in the following groups:
Slovenian: Zdravilo Silapo se ne sme uporabljati pri naslednjih skupinah bolnikov:
English: As for all medicines, data on the use of Silapo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Silapo stalno spremljajo.
English: Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Silapo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What are the risks associated with Silapo?
Slovenian: Kakšna tveganja so povezana z zdravilom Silapo?
English: For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Silapo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: • patients with hypertension (high blood pressure) that is not controlled;
Slovenian: bolnikih z nenadzorovano hipertenzijo (visokim krvnim tlakom);
English: Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Slovenian: Epoetin zeta se uporablja tudi pred kirurškimi posegi za povečanje števila rdečih krvnih celic in kot pomoč pri zmanjšanju posledic izgube krvi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have 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 Silapo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: • patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Slovenian: bolnikih, ki so tik pred kirurškim posegom, vključno pred zahtevnejšim ortopedskim kirurškim posegom, in imajo resne kardiovaskularne (srčnožilne) težave, vključno z nedavnim srčnim napadom ali možgansko kapjo.
English: In these cases, epoetin zeta is used to increase red blood cell counts.
Slovenian: V teh primerih se za povečanje števila rdečih krvnih celic uporablja epoetin zeta.
English: The dose, how often it is given and how long it is used for also depend on why Silapo is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Slovenian: Odmerek, pogostost injiciranja in trajanje uporabe zdravila Silapo so odvisni od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
English: For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range.
Slovenian: Pri bolnikih z odpovedjo ledvic ali mielodisplastičnimi sindromi ali pri tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati znotraj priporočenega območja.
English: All of the patients in the second study had received treatment with Eprex/Erypo for at least 3 months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks.
Slovenian: Vsi bolniki v drugi študiji so bili vsaj tri mesece zdravljeni z zdravilom Eprex/Erypo, preden so za 12 tednov bodisi prešli na zdravilo Silapo bodisi ostali pri zdravljenju z zdravilom Eprex/Erypo.
English: The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.
Slovenian: Referenčno zdravilo za zdravilo Silapo je zdravilo Eprex/Erypo, ki vsebuje epoetin alfa.
English: The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Slovenian: Podjetje je predstavilo tudi rezultate dveh študij, ki sta pokazali, da je zdravilo Silapo, injicirano v podkožje, enako učinkovito kot druga zdravila, ki vsebujejo epoetin: v eni študiji je sodelovalo 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi študiji pa so zdravilo Silapo primerjali z zdravilom Eprex/Erypo pri 462 bolnikih s slabokrvnostjo kot posledico težav z ledvicami.
English: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
Slovenian: bolnikih, pri katerih se je po zdravljenju z epoetinom razvila aplazija rdečih krvnih celic (zmanjšano ali zaustavljeno tvorjenje rdečih krvnih celic);
English: Silapo can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Silapo is approved for.
Slovenian: Predpisovanje in izdaja zdravila Silapo je le na recept, zdravljenje z njim pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z boleznimi, za katere je to zdravilo odobreno.
English: Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Slovenian: Zdravilo Silapo se uporablja pri bolnikih, pri katerih obstaja majhno ali srednje tveganje za pojav akutne mieloične levkemije in ki imajo nizke ravni naravnega hormona eritropoetina.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo, ali tistih z ledvičnimi težavami lahko slabokrvnost povzroči pomanjkanje eritropoetina ali nezadostna odzivnost telesa na naravno prisotni eritropoetin.
English: The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Slovenian: Učinkovina v zdravilu Silapo, epoetin zeta, je kopija hormona eritropoetina in deluje popolnoma enako kot naravni hormon pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu.
English: Because Silapo is a biosimilar medicine, the studies on effectiveness and safety of epoetin carried out with Eprex/Erypo do not all need to be repeated for Silapo.
Slovenian: Ker je zdravilo Silapo podobno biološko zdravilo, študij o učinkovitosti in varnosti epoetina, ki so že bile izvedene z zdravilom Eprex/Erypo, za zdravilo Silapo ni treba ponavljati.
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Slovenian: Zdravilo se uporablja pri bolnikih z normalnimi ravnmi železa, pri katerih lahko pride do zapletov pri transfuziji krvi, če pred kirurškim posegom ne darujejo lastne krvi, pričakovane izgube pa znašajo od 900 do 1 800 ml; za zdravljenje slabokrvnosti pri odraslih z mielodisplastičnimi sindromi (obolenji, pri katerih je okvarjeno nastajanje zdravih krvnih celic).
English: Other information about Silapo:
Slovenian: Druge informacije o zdravilu Silapo:
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Silapo po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Eprex/Erypo in da se po telesu enako porazdeli.
English: All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Silapo pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Eprex/Erypo.
English: How does Silapo work?
Slovenian: Kako zdravilo Silapo deluje?
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Silapo outweighs the identified risk and it can be authorised.
Slovenian: Agencija je zato menila, da koristi zdravila Silapo enako kot pri zdravilu Eprex/Erypo odtehtajo znana tveganja in da se zdravilo lahko odobri.
English: The injection under the skin may be given by the patient or a carer if they have been trained.
Slovenian: Bolnik si zdravilo lahko v podkožje injicira sam ali mu ga injicira negovalec, če sta bila za to ustrezno usposobljena.
English: Silapo is available in pre-filled syringes and is injected either into a vein or under the skin, depending on the condition for which the patient is being treated.
Slovenian: Zdravilo Silapo je na voljo v napolnjenih injekcijskih brizgah, daje pa se z injiciranjem v veno ali podkožje, kar je odvisno od bolezni, ki se zdravi.
English: Silapo contains the active substance epoetin zeta and is a ‘biosimilar' medicine.
Slovenian: Zdravilo Silapo vsebuje učinkovino epoetin zeta in je „podobno biološko zdravilo“.
English: Studies have also shown that giving Silapo produces similar levels of the active substance in the body to giving Eprex/Erypo.
Slovenian: Študije so pokazale tudi, da zdravilo Silapo vzpostavi podobne ravni učinkovine v telesu kot zdravilo Eprex/Erypo.
English: In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy.
Slovenian: Poleg tega so študije pokazale še, da so učinki tega zdravila pri zviševanju in ohranjanju ravni krvnih celic pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, enakovredni učinkom zdravila Eprex/Erypo.
English: For the full list of side effects of Silapo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Silapo, glejte navodilo za uporabo.
English: Laboratory studies comparing Silapo with Eprex/Erypo have shown that the active substance in Silapo is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Silapo primerjali z referenčnim zdravilom Eprex/Erypo, so pokazale, da je učinkovina v zdravilu Silapo po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Eprex/Erypo.
English: Silapo, injected into a vein, was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a procedure for removing waste products from the blood).
Slovenian: Zdravilo Silapo, injicirano v veno, je bilo v dveh glavnih študijah, v katere je bilo vključenih 922 bolnikov s slabokrvnostjo, povezano s kronično ledvično odpovedjo, ki potrebujejo hemodializo (postopek za odstranjevanje odpadnih snovi iz krvi), enako učinkovito kot zdravilo Eprex/Erypo pri popravljanju in ohranjanju števila rdečih krvnih celic.
English: The first study compared the effects of Silapo with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Slovenian: V prvi študiji so pri 609 bolnikih učinke zdravila Silapo pri popravljanju števila rdečih krvnih celic 24 tednov primerjali z učinki zdravila Eprex/Erypo.
English: The second study compared the effects of Silapo with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients.
Slovenian: V drugi študiji so pri 313 bolnikih učinke zdravila Silapo pri ohranjanju števila rdečih krvnih celic primerjali z učinki zdravila Eprex/Erypo.
English: How is Silapo used?
Slovenian: Kako se zdravilo Silapo uporablja?
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, decreasing ability of the kidneys to work properly) or other kidney problems;
Slovenian: Silapo je zdravilo, ki se uporablja v naslednjih primerih: za zdravljenje slabokrvnosti (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim upadanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami; za zdravljenje slabokrvnosti pri odraslih, ki prejemajo kemoterapijo za zdravljenje določenih vrst raka, in za zmanjšanje potrebe po transfuziji krvi; za povečanje količine lastne krvi, ki jo lahko bolniki z zmerno slabokrvnostjo darujejo zase pred kirurškim posegom in ki jo nato med posegom ali po njem prejmejo nazaj; za zmanjšanje potrebe po transfuziji krvi pri odraslih z blago obliko slabokrvnosti pred zahtevnejšim ortopedskim kirurškim posegom (na kosteh), na primer operacijo kolkov.
English: Special warnings and precautions for use Dyskinesia
Slovenian: Posebna opozorila in previdnostni ukrepi Diskinezija
English: Pramipexole - Dystonia (EPITT no 18866)
Slovenian: Pramipeksol - distonija (št. EPITT 18866)
English: Adopted at the 29 August-1 September 2017 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 29. avgustom in 1. septembrom 2017
English: Rare side effects • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
Slovenian: Redki neželeni učinki • Povečana občutljivost kože na sonce in ultravijolične žarke (fotosenzitivnost).
English: Talk to your doctor before taking <product name>.
Slovenian: Pred začetkom jemanja zdravila <ime zdravila> se posvetujte z zdravnikom.
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Slovenian: Če imate (ste imeli) ali se pri vas pojavijo zdravstvena stanja ali simptomi, zlasti kaj od spodaj naštetega, to povejte zdravniku:
English: Package leaflet 4.
Slovenian: Navodilo za uporabo 4.
English: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Slovenian: Pri bolnikih z obstoječimi kožnimi obolenji, kot sta atopijski dermatitis in atopični ekcem, so poročali o resnejših reakcijah.
English: - Dystonia2 (inability of keeping your body and neck straight and upright (axial dystonia)).
Slovenian: - Distonija2 (nezmožnost pokončne drže telesa in vratu (aksialna distonija)).
English: Undesirable effects Skin and subcutaneous tissue disorders Frequency ‘rare': Photosensitivity* *see section c)
Slovenian: Pogostnost: „redki“: fotosenzitivnost* *Glejte poglavje c).
English: Dystonia
Slovenian: - Diskinezija
English: Mesalazine - Risk of photosensitivity reactions (EPITT no
Slovenian: Mesalazin - tveganje za fotosenzitivnostne reakcije (št. EPITT 18869)
English: - Dyskinesia
Slovenian: Distonija
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/406998/2017
Slovenian: EMA/PRAC/600974/2017
English: The patch should be replaced every 3 days.
Slovenian: Obliž je treba zamenjati vsake tri dni.
English: The European Commission issued a decision on this opinion on 22/9/16.
Slovenian: Evropska komisija je o tem mnenju izdala odločbo dne 22/9/16.
English: The age and general condition of the patient should also be taken into account.
Slovenian: Upoštevati je treba tudi starost in splošno bolnikovo stanje.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway
Slovenian: Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn in Norveško.
English: The appropriate starting dose should be chosen according to the patient's current use of opioid medicines.
Slovenian: Ustrezni začetni odmerek je treba izbrati skladno z bolnikovo trenutno uporabo opioidnih zdravil.
English: This section also contains other warnings, including warnings about the risk of respiratory depression, dependence and potential for abuse, and use in children and elderly patients.
Slovenian: To poglavje vsebuje tudi druga opozorila, vključno z opozorili o tveganjih za respiratorno depresijo, odvisnost in možnost zlorabe ter o uporabi pri otrocih in starejših bolnikih.
English: The company that markets these medicines is Janssen-Cilag and associated companies.
Slovenian: Ta zdravila tržijo družba Janssen-Cilag in povezana podjetja.
English: These patients should be closely monitored for side effects.
Slovenian: Bolnike je treba glede teh neželenih učinkov skrbno spremljati.
English: The dose should be re-assessed regularly during treatment and the lowest effective dose should be used.
Slovenian: Odmerek je treba v času zdravljenja redno vrednotiti in uporabljati najmanjši še učinkovit odmerek.
English: Durogesic has been authorised in the EU via national procedures.
Slovenian: Zdravilo Durogesic je bilo v EU odobreno po nacionalnih postopkih.
English: The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 4.9 (overdose).
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.6 (plodnost, nosečnost in laktacija), 4.8 (neželeni učinki) in 4.9 (preveliko odmerjanje).
English: Durogesic is available in the EU under various trade names including Durogesic DTrans and Durogesic Matrix.
Slovenian: Zdravilo Durogesic je v EU na voljo pod različnimi tržnimi imeni, vključno z imenoma Durogesic DTrans in Durogesic Matrix.
English: Fentanyl is an opioid (a pain medicine related to morphine).
Slovenian: Fentanil je opioid (morfinu sorodno protibolečinsko zdravilo).
English: Why was Durogesic reviewed?
Slovenian: Zakaj je bilo zdravilo Durogesic pregledano?
English: Patients who have serious side effects with Durogesic should be monitored for at least 24 hours after removal of the patch, depending on their symptoms, because the active substance fentanyl remains in the blood for some time and its level only declines slowly (by about half after 24 hours).
Slovenian: Bolnike, ki imajo ob uporabi zdravila Durogesic resne neželene učinke, je treba po odstranitvi obliža spremljati vsaj 24 ur, odvisno od njihovih simptomov, saj ostane zdravilna učinkovina fentanil v krvi še nekaj časa in se njena raven le počasi zmanjšuje (za približno polovico po 24 urah).
English: On 21 July 2016, the European Medicines Agency completed a review of Durogesic.
Slovenian: Evropska agencija za zdravila je 21. julija 2016 zaključila pregled zdravila Durogesic.
English: What is Durogesic?
Slovenian: Kaj je zdravilo Durogesic?
English: Also, it must not be used in patients with severe respiratory depression (breathing problems), or in those allergic to fentanyl or any other ingredients of Durogesic.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih s hudo respiratorno depresijo (težavami z dihanjem) ter bolnikih, ki so alergični na fentanil ali katero drugo sestavino zdravila Durogesic.
English: Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Durogesic.
Slovenian: Po uskladitvi indikacij je odbor CHMP uskladil tudi priporočila o načinu uporabe zdravila Durogesic.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Durogesic in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Durogesic v Evropski uniji (EU).
English: The CHMP agreed that Durogesic can be used in adults to treat severe long-term pain that requires continuous treatment with opioid medicines, whether or not the pain is caused by cancer.
Slovenian: Odbor CHMP je soglašal, da se zdravilo Durogesic lahko uporablja pri odraslih za zdravljenje hude dolgotrajne bolečine, ki zahteva stalno zdravljenje z opioidnimi zdravili, ne glede na to, ali je vzrok bolečine rak ali ne.
English: In children treated with Durogesic, the patch should be applied on the upper back to prevent the child from removing the patch.
Slovenian: Pri otrocih, zdravljenih z zdravilom Durogesic, je treba obliž namestiti na zgornji del hrbta, da se otroku prepreči odstranitev obliža.