FrancophonIA/ELRC3.0 huggingface dataset:
English: Esperoct (turoctocog alfa pegol)
Slovenian: Esperoct (turoktokog alfa pegol)
English: When bleeding episodes occurred, they were successfully treated with one or two further injections in 94% of cases.
Slovenian: Ko so se epizode krvavitve pojavile, so bile v 94 % primerov uspešno zdravljene z eno ali dvema dodatnima injekcijama.
English: These include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest, tingling and wheezing.
Slovenian: Te vključujejo: oteklost, pekoč občutek in zbadanje na mestu injiciranja, mrzlico, vročinske oblive, srbeč izpuščaj, glavobol, koprivnico, nizek krvni tlak, letargijo, siljenje na bruhanje in bruhanje, nemir, hiter srčni utrip, tiščanje v prsih, mravljinčenje in piskajoče dihanje.
English: Patients or their carers may be able to inject Esperoct themselves at home once they have been trained appropriately.
Slovenian: Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Esperoct injicirajo sami doma.
English: Twelve further patients in this study did not receive preventive treatment but were given Esperoct for treating bleeding ‘on demand'.
Slovenian: Dvanajst dodatnih bolnikov v tej študiji ni prejelo preventivnega zdravljenja, ampak so zdravilo Esperoct za zdravljenje krvavitev prejeli „na zahtevo“.
English: The dose, frequency and duration of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Slovenian: Odmerek, pogostnost in trajanje zdravljenja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev, ter od resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
English: Esperoct can be used in adults and children from 12 years of age.
Slovenian: Zdravilo Esperoct se lahko uporablja pri odraslih in otrocih, starih 12 let in več.
English: What benefits of Esperoct have been shown in studies?
Slovenian: Kakšne koristi zdravila Esperoct so se pokazale v študijah?
English: Side effects reported with Esperoct are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Esperoct, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Esperoct authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Esperoct odobreno v EU?
English: The company that markets Esperoct will carry out a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues and organs.
Slovenian: Podjetje , ki trži zdravilo Esperoct, bo izvedlo študijo za proučitev morebitnega učinka kopičenja PEG v horoidnem pletežu možganov in drugih tkivih in organih.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esperoct 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 Esperoct upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Slovenian: Nadomešča manjkajoči faktor VIII ter tako pripomore k strjevanju krvi in omogoči začasen nadzor nad motnjo strjevanja krvi.
English: In a study involving patients between 12 and 66 years of age, 175 patients given Esperoct every 4 days or twice weekly as preventive treatment had, on average, around 4 bleeding episodes a year, achieving the target of the study, which was less than 8.5 episodes a year.
Slovenian: V študiji, ki je vključevala bolnike med 12. in 66. letom starosti, je 175 bolnikov, ki so vsake štiri dni ali dvakrat tedensko prejemali preventivno zdravljenje, v povprečju imelo približno 4 epizode krvavitev na leto, s čimer je bil dosežen cilj študije, tj. manj kot 8,5 epizode na leto.
English: An overview of Esperoct and why it is authorised in the EU
Slovenian: Pregled zdravila Esperoct in zakaj je odobreno v EU
English: What are the risks associated with Esperoct?
Slovenian: Kakšna tveganja so povezana z zdravilom Esperoct?
English: The active substance in Esperoct, turoctocog alfa pegol, works in the body in the same way as human factor VIII.
Slovenian: Učinkovina v zdravilu Esperoct , turoktokog alfa pegol, deluje v telesu enako kot humani faktor VIII.
English: These patients had on average around 32 bleeding episodes a year and Esperoct was successful at stopping the bleeds 97% of the time after 1 or 2 injections.
Slovenian: Ti bolniki so imeli v povprečju približno 32 epizod krvavitev na leto, zdravilo Esperoct pa je bilo uspešno pri zaustavljanju krvavitev v 97 % primerov po eni ali dveh injekcijah.
English: For more information about using Esperoct, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Esperoct glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Esperoct and what is it used for?
Slovenian: Kaj je zdravilo Esperoct in za kaj se uporablja?
English: In a second study in 68 children aged below 12 years, Esperoct given as preventive treatment reduced the number of bleeding episodes to around 2 episodes a year.
Slovenian: V drugi študiji, ki je vključevala 68 otrok, mlajših od 12 let, je zdravilo Esperoct kot preventivno zdravljenje zmanjšalo število krvavitev na približno dve epizodi na leto.
English: Hypersensitivity (allergic) reactions can occur with Esperoct and are uncommon (affecting up to 1 in 100 people).
Slovenian: Pri zdravilu Esperoct se lahko pojavijo preobčutljivostne (alergijske) reakcije, ki so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov).
English: Following treatment with factor VIII products, including Esperoct, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Slovenian: Po zdravljenju z zdravili s faktorjem VIII, vključno z zdravilom Esperoct, se lahko pri nekaterih bolnikih pojavijo zaviralci (protitelesa) faktorja VIII, ki izničijo delovanje zdravila in tako povzročijo izgubo nadzora nad krvavitvijo.
English: Very rarely, patients may develop antibodies against hamster protein in the medicine and have allergic reactions.
Slovenian: Zelo redko lahko bolnik razvije protitelesa proti beljakovinam hrčka, ki jih vsebuje zdravilo, kar povzroči alergijsko reakcijo.
English: Part of the active substance is a chemical called polyethylene glycol (PEG), which is added to help the medicine remain in the body for longer and thereby prolong its action.
Slovenian: Del učinkovine je kemična snov z imenom polietilenglikol (PEG), ki pripomore k počasnejšemu izločanju zdravila iz telesa in s tem podaljša njegovo delovanje.
English: Esperoct must not be used in patients with allergy to hamster proteins.
Slovenian: Zdravilo Esperoct se ne sme uporabljati pri bolnikih z alergijo na beljakovine hrčkov.
English: Studies have found that Esperoct is effective at preventing and treating bleeding in patients with haemophilia A. Because Esperoct is ‘pegylated', patients on this medicine could also have fewer or less frequent injections than they would on conventional FVIII products.
Slovenian: Študije so pokazale, da je zdravilo Esperoct učinkovito pri preprečevanju in zdravljenju krvavitev pri bolnikih s hemofilijo A. Ker je zdravilo „pegilirano“, potrebujejo bolniki, ki ga jemljejo, manj ali manj pogoste injekcije, kot bi jih pri standardnih zdravilih s faktorjem VIII.
English: Esperoct is given as an injection into a vein.
Slovenian: Zdravilo Esperoct se daje z injiciranjem v veno.
English: Esperoct can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of haemophilia.
Slovenian: Predpisovanje in izdaja zdravila Esperoct je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
English: For the full list of side effects and restrictions with Esperoct, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Esperoct glejte navodilo za uporabo.
English: Esperoct has been shown to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Slovenian: Zdravilo Esperoct se je izkazalo za učinkovito pri preprečevanju in zdravljenju epizod krvavitev pri bolnikih s hudo hemofilijo, ki so bili prej zdravljeni z drugimi zdravili s faktorjem VIII.
English: How does Esperoct work?
Slovenian: Kako zdravilo Esperoct deluje?
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Slovenian: Bolnikom s hemofilijo A primanjkuje faktorja VIII, tj. beljakovine, potrebne za normalno strjevanje krvi, zato hitro zakrvavijo.
English: However, part of the active substance in Esperoct (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Slovenian: Vendar pa se lahko del učinkovine zdravila Esperoct (imenovan PEG) po dolgotrajnem zdravljenju kopiči v telesu, tudi v strukturi v možganih, imenovani horoidni pletež.
English: Esperoct is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by the lack of a clotting protein known as factor VIII.
Slovenian: Esperoct je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A, tj. prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, znane kot faktor VIII.
English: How is Esperoct used?
Slovenian: Kako se zdravilo Esperoct uporablja?
English: Esperoct contains the active substance turoctocog alfa pegol.
Slovenian: Zdravilo Esperoct vsebuje učinkovino turoktokog alfa pegol.
English: 18 months.
Slovenian: 18 mesecev
English: Date of first authorisation: 16 October 2009 Date of latest renewal: 18 September 2014
Slovenian: Datum prve odobritve: 16. oktober 2009 Datum zadnjega podaljšanja: 18. september 2014
English: • you have cancer,
Slovenian: • če imate raka,
English: • you are or have been a smoker (as this may increase the risk of dental problems).
Slovenian: • če ste ali ste bili kadilec (ker to lahko poveča tveganje za težave z zobmi).
English: Continue your morning activities.
Slovenian: Nadaljujte z običajnimi jutranjimi opravili.
English: What is vitamin D?
Slovenian: Kaj je vitamin D?
English: Total body BMD also increased significantly.
Slovenian: Pomembno se je zvišala tudi MKG celotnega telesa.
English: The relevance to humans is unknown.
Slovenian: Pomen le-tega za ljudi ni znan.
English: • Do not take with coffee or tea.
Slovenian: • Ne vzemite s kavo ali čajem.
English: You can sit, stand or walk - just stay fully upright.
Slovenian: Lahko sedite, stojite ali hodite - pomembno je le, da ostanete pokonci.
English: Do not take two tablets on the same day.
Slovenian: Ne smejo vzeti dveh tablet na isti dan.
English: If you think any of these apply to you, do not take the tablets.
Slovenian: Če mislite, da kar koli od naštetega velja za vas, tablet ne jemljite.
English: Please read it carefully.
Slovenian: Prosimo, da jih natančno preberete.
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Slovenian: Čas do pojava simptomov je bil od enega dneva do več mesecev po začetku zdravljenja.
English: These are usually small and asymptomatic.
Slovenian: Običajno so ta znižanja majhna in asimptomatska.
English: If you experience any of these side effects you should not drive until you feel better.
Slovenian: Če se pri vas pojavi kateri od teh neželenih učinkov, ne smete voziti, dokler se ne počutite bolje.
English: Therefore, it is important that you follow the advice given in section 3.
Slovenian: Zato je pomembno, da upoštevate navodila, opisana v poglavju 3.
English: Talk to your doctor first and follow the advice given.
Slovenian: Prej se pogovorite z zdravnikom in upoštevajte njegov nasvet.
English: To permit adequate absorption of alendronate:
Slovenian: Za zadostno absorpcijo alendronata:
English: The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Slovenian: Prej ko nastopi menopavza, večje je tveganje za pojav osteoporoze.
English: - Hypocalcaemia.
Slovenian: - Hipokalciemija.
English: Protein binding in human plasma is approximately 78 %.
Slovenian: Vezava na plazemske proteine je pri ljudeh približno 78 %.
English: VANTAVO with food and drink
Slovenian: Zdravilo VANTAVO skupaj s hrano in pijačo
English: • if your doctor has told you that you have low blood calcium.
Slovenian: • če vam je zdravnik povedal, da imate nizko vrednost kalcija v krvi.
English: Follow these instructions carefully.
Slovenian: Natančno upoštevajte naslednja navodila.
English: Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Many of these patients were also receiving chemotherapy and corticosteroids.
Slovenian: Veliko teh bolnikov je prejemalo tudi kemoterapijo in kortikosteroide.
English: The frequency of rare was estimated based on relevant clinical trials.
Slovenian: Pogostnost redko je bila ocenjena na podlagi ustreznih kliničnih preskušanj.
English: Supplemental vitamin D reduces these risks and their consequences.
Slovenian: Dodatek vitamina D zmanjša našteta tveganja in njihove posledice.
English: The two treatment groups were also similar with regard to BMD increases at other skeletal sites.
Slovenian: Obe skupini sta si bili podobni tudi glede zvišanja MKG na drugih mestih skeleta.
English: Do not lie down until after your first food of the day.
Slovenian: Ne ulezite se, dokler ne pojeste prvega dnevnega obroka hrane.
English: *See sections 4.2 and 4.4
Slovenian: Glejte poglavji 4.2 in 4.4
English: • if you cannot stand or sit upright for at least 30 minutes,
Slovenian: • če ne morete stati ali pokončno sedeti vsaj 30 minut,
English: Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years.
Slovenian: Bisfosfonati se vgradijo v kostni matriks, iz katerega se nato postopoma sproščajo v obdobju nekaj let.
English: • Do not take with juice or milk.
Slovenian: • Ne vzemite s sokom ali z mlekom.
English: Therefore no dose adjustment is necessary for the elderly.
Slovenian: Zato pri starejših prilagoditev odmerkov ni potrebna.
English: - Inability to stand or sit upright for at least 30 minutes.
Slovenian: - Nesposobnost stati ali sedeti vzravnano vsaj 30 minut.
English: The bone formed during treatment with alendronate is of normal quality.
Slovenian: Kost, ki se tvori med zdravljenjem z alendronatom, je normalne kakovosti.
English: What is alendronate?
Slovenian: Kaj je alendronat?
English: Due to the nature of the disease process in osteoporosis, VANTAVO is intended for long-term use.
Slovenian: Zaradi narave bolezenskega procesa osteoporoze je zdravilo VANTAVO namenjeno za dolgotrajno uporabo.
English: Therefore, it is important that you follow the advice given in section 3 and wait at least 30 minutes before taking any other oral medicines or supplements.
Slovenian: Zato je pomembno, da upoštevate navodila v poglavju 3 in počakate vsaj 30 minut, preden zaužijete katera koli druga zdravila ali dodatke.
English: Currently available data for alendronic acid in the paediatric population is described in section 5.1.
Slovenian: Trenutno razpoložljivi podatki o uporabi alendronske kisline pri pediatrični populaciji so opisani v poglavju 5.1.
English: Plasma concentrations fell by more than 95 % within six hours following intravenous administration.
Slovenian: Za več kot 95 % so plazemske koncentracije padle v 6 urah po intravenski aplikaciji.
English: Children and adolescents VANTAVO should not be given to children and adolescents less than 18 years of age.
Slovenian: Otroci in mladostniki Zdravila VANTAVO se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let.
English: In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
Slovenian: V študijah osteoporoze je bil alendronat učinkovit pri jemanju vsaj 30 minut pred prvim dnevnim obrokom hrane ali pijače.
English: Don't lie down, eat, drink or take other medicines for at least 30 minutes.
Slovenian: Ne ulezite se, ne jejte, ne pijte in ne jemljite drugih zdravil vsaj še 30 minut.
English: Laboratory test findings
Slovenian: Izvidi laboratorijskih preiskav
English: Like muscles, bones need exercise to stay strong and healthy.
Slovenian: Tako kot za mišice je tudi za kosti potrebna telesna aktivnost, da ostanejo močne in zdrave.
English: What is osteoporosis?
Slovenian: Kaj je osteoporoza?
English: Most patients had relief of symptoms after stopping treatment.
Slovenian: Pri večini bolnikov so se težave zmanjšale po prenehanju zdravljenja.
English: The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Slovenian: Terminalni razpolovni čas pri ljudeh po oceni presega 10 let, kar odraža sproščanje alendronata iz okostja.
English: Store in the original blister in order to protect from moisture and light.
Slovenian: Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred vlago in svetlobo.
English: Hypocalcaemia must be corrected before initiating therapy with VANTAVO (see section 4.3).
Slovenian: Hipokalciemijo je treba korigirati pred začetkom zdravljenja z zdravilom VANTAVO (glejte poglavje 4.3).
English: As a result, bone loss occurs and bones become weaker.
Slovenian: Kot posledica se pojavi izguba kostnine in kosti postanejo šibkejše.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Slovenian: Med zdravljenjem naj se ti bolniki, če je mogoče, izognejo invazivnim zobozdravniškim posegom.
English: • rash made worse by sunlight,
Slovenian: • izpuščaj, ki se poslabša na soncu
English: Rare symptomatic hypocalcaemia, often in association with predisposing conditions.
Slovenian: Redki simptomatska hipokalciemija, pogosto v povezavi s predisponirajočimi stanji
English: Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
Slovenian: Bolnikom je treba povedati, da neupoštevanje teh navodil lahko poveča tveganje za težave s požiralnikom.
English: • if you are allergic to alendronic acid, colecalciferol or any of the other ingredients of this medicine (listed in section 6),
Slovenian: • če ste alergični na alendronsko kislino, holekalciferol ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Read the Package Leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo!
English: The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use (see section 5.2).
Slovenian: Količina bisfosfonata, vgrajenega v kostnino odraslega, in zato tudi količina, ki je na voljo za sprostitev nazaj v sistemsko cirkulacijo, sta neposredno odvisni od odmerka in časa uporabe bisfosfonatov (glejte poglavje 5.2).
English: Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60 %.
Slovenian: Zaradi sočasnega zaužitja alendronata in kave ali pomarančnega soka se je biološka uporabnost zmanjšala za približno 60 %.
English: Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function.
Slovenian: Čeprav kliničnih informacij ni na voljo, je verjetno, da se, kot pri živalih, izločanje alendronata preko ledvic pri bolnikih z okvaro ledvične funkcije zmanjša.
English: Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Slovenian: Alendronat spada v razred nehormonskih zdravil, ki jih imenujemo bisfosfonati.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bisphosphonates, combinations, ATC code: M05BB03
Slovenian: Farmakoterapevtska skupina: Zdravila za zdravljenje bolezni kosti, Difosfonati, kombinacije, oznaka ATC: M05BB03
English: Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5 and section 4.8).
Slovenian: Druge pijače (vključno z mineralno vodo), hrana in nekatera zdravila lahko zmanjšajo absorpcijo alendronata (glejte poglavje 4.5 in poglavje 4.8).
English: In both cases, the excreted radioactivity was almost exclusively as metabolites of the parent.
Slovenian: V obeh primerih je bila izločena radioaktivnost skoraj v celoti v obliki presnovkov.
English: Since it is not known how long you should take VANTAVO, you should discuss the need to stay on this medicine with your doctor periodically to determine if VANTAVO is still right for you.
Slovenian: Ker ni znano kako dolgo je treba jemati zdravilo VANTAVO, se morate glede nadaljevanja zdravljenja s tem zdravilom redno posvetovati z zdravnikom, ki bo odločil ali je zdravljenje z zdravilom VANTAVO za vas še vedno primerno.
English: It contains important information reminding you how to take VANTAVO properly.
Slovenian: Ta vsebuje pomembne informacije, ki vas spomnijo, kako pravilno jemati zdravilo VANTAVO.
English: • Do not take with mineral water (still or sparkling).
Slovenian: • Ne vzemite z mineralno vodo (z mehurčki ali brez).
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of VANTAVO on an individual patient basis, particularly after 5 or more years of use.
Slovenian: Potrebo po nadaljevanju zdravljenja z zdravilom VANTAVO je treba ponovno periodično oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
English: The optimal duration of bisphosphonate treatment for osteoporosis has not been established.
Slovenian: Optimalno trajanje zdravljenja osteoporoze z bisfosfonati še ni določeno.
English: • you are undergoing chemotherapy or radiotherapy,
Slovenian: • če prejemate kemoterapijo ali radioterapijo,
English: If you take more VANTAVO than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila VANTAVO, kot bi smeli Če po pomoti vzamete preveč tablet, popijte poln kozarec mleka in nemudoma pokličite zdravnika.
English: C]alendronate, approximately 50 % of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Slovenian: C]alendronata se je približno 50 % radioaktivnosti izločilo z urinom v 72 urah; v blatu so našli le malo ali nič radioaktivnosti.
English: It is common in women after the menopause.
Slovenian: Pogosta je pri ženskah po menopavzi.
English: Early on, osteoporosis usually has no symptoms.
Slovenian: Osteoporoza je v začetni fazi običajno brez simptomov.
English: Further hydroxylation occurs prior to elimination.
Slovenian: Pred izločanjem pride še do nadaljnje hidroksilacije.
English: The safety and efficacy of VANTAVO in children less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila VANTAVO pri otrocih, mlajših od 18 let, nista bili dokazani.