natgillin/translations-raw huggingface dataset:
The third compared one infusion of Aclasta with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, and looked at the change in the density of the bones in the spine over a year.
Zdravilo Aclasta so za zdravljenje osteoporoze proučevali v treh glavnih študijah: v prvi so zdravilo Aclasta primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 8 000 starejših ženskah z osteoporozo, in sicer so beležili število zlomov hrbtenice in kolka v obdobju treh let; v drugi so zdravilo Aclasta primerjali s placebom pri 2 127 moških in ženskah z osteoporozo, ki so si nedavno zlomili kolk, in beležili število zlomov v obdobju do pet let; v tretji pa so primerjali enojno infuzijo zdravila Aclasta z dnevnim odmerjanjem rizedronata (drugega difosfonata) pri 833 moških in ženskah z osteoporozo, ki so jo povzročili glukokortikoidi, ter opazovali spremembe v gostoti kosti hrbtenice v enem letu.
Strength Pharmaceutical Form Route of Administration
izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
2 vials + 1 vial
2 viali + 1 viala
Solution: 5 ml (30 mg/ml) + Flushing solution 5ml
raztopina: 5 ml (30 mg/ml) + raztopina za izpiranje 5 ml
Intracerebroventr icular use vial (glass)
150 mg raztopina za infundiranje intracerebroventri kularna uporaba viala (steklena)
If other eye drops are also being used, they should be given at least 5 minutes apart.
Če se uporabljajo tudi druge očesne kapljice, jih je treba dati v razmiku vsaj pet minut.
The European Commission granted a marketing authorisation valid throughout the European Union, for Travatan on 27 November 2001.
Evropska komisija je dovoljenje za promet z zdravilom Travatan, veljavno po vsej Evropski uniji, izdala 27. novembra 2001.
Side effects reported in children are similar to those seen in adults.
Neželeni učinki pri otrocih so podobni tistim, ki se pojavijo pri odraslih.
The main measure of effectiveness in all studies was the reduction in intraocular pressure
Glavno merilo učinkovitosti v vseh študijah je bilo znižanje očesnega tlaka.
The full EPAR for Travatan can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Travatan je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Travatan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Travatan.
Travatan has been studied in 1,989 adult patients in three main studies, lasting between six and 12 months.
Zdravilo Travatan so raziskali pri 1 989 odraslih bolnikih v treh glavnih študijah, ki so trajale od šest do 12 mesecev.
For more information about treatment with Travatan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Travatan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A fourth study also compared the effectiveness of adding Travatan to treatment with timolol (427 patients, six-month duration).
Tudi v četrti študiji so primerjali učinkovitost dodajanja zdravila Travatan zdravljenju s timololom (pri 427 bolnikih v šestmesečnem obdobju).
What benefit has Travatan shown during the studies?
Kakšne koristi je zdravilo Travatan izkazalo med študijami?
There may also be changes to the patient's eyelashes, including increased length, thickness, colour or number of lashes.
Spremenijo se lahko tudi bolnikove trepalnice: te lahko postanejo daljše ali debelejše ali se spremeni njihova barva ali število.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Travatan.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Travatan?
Kakšna tveganja so povezana z zdravilom Travatan?
For the full list of all side effects and restrictions with Travatan, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Travatan glejte navodilo za uporabo.
The dose is one drop of Travatan in the affected eye(s) once a day, preferably in the evening.
Odmerek je ena kapljica zdravila Travatan v prizadeto oko (prizadeti očesi) enkrat dnevno, najbolje zvečer.
In addition, Travatan was compared with timolol in a fifth main study over 3 months, involving 152 children between 2 months and 18 years of age.
Poleg tega so zdravilo Travatan v peti glavni študiji tri mesece primerjali s timololom, zajemala pa je 152 otrok, starih od dveh mesecev do 18 let.
The CHMP decided that Travatan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicine (CHMP) je zaključil, da so koristi zdravila Travatan večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
It is used in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal).
Uporablja se pri odraslih, ki imajo glavkom z odprtim zakotjem (bolezen, pri kateri se očesni tlak zviša, ker tekočina ne more iztekati iz očesa), in pri odraslih z okularno hipertenzijo (očesni tlak je višji od običajnega).
Other information about Travatan
Druge informacije o zdravilu Travatan:
The combined treatment with Travatan plus timolol produced an additional decrease of intraocular pressure in patients who were not controlled with timolol alone.
Kombinirano zdravljenje z zdraviloma Travatan in timololom je povzročilo dodatno znižanje očesnega tlaka pri bolnikih, pri katerih s samim timololom očesni tlak ni bil ustrezno nadzorovan.
The most common side effects when using Travatan (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to eye irritation and redness) and iris hyperpigmentation (darkening of the colour of the iris).
Najpogostejši neželeni učinki pri uporabi zdravila Travatan (opaženi pri več kot 1 bolniku od 10) so očesna hiperemija (povečan dotok krvi v oko, ki povzroči draženje in pordenje očesa) in hiperpigmentacija šarenice (potemnitev njene barve).
It can also be used in children from two months of age who have ocular hypertension or childhood glaucoma.
Lahko se uporablja tudi pri otrocih, starejših od dveh mesecev, ki imajo visok očesni tlak ali otroški glavkom.
Why has Travatan been approved?
Zakaj je bilo zdravilo Travatan odobreno?
All three studies compared travoprost with timolol, which is the standard treatment for glaucoma.
V vseh treh študijah so travoprost primerjali s timololom, ki se uporablja pri standardnem načinu zdravljenja glavkoma.
One of the three trials also included a comparison with latanoprost (another prostaglandin analogue used for glaucoma).
V eni od treh študij so zdravilo primerjali tudi z latanoprostom (še enim analogom prostaglandina, ki se uporablja pri zdravljenju glavkoma).
When intraocular pressure is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Zvišan očesni tlak poškoduje mrežnico (za svetlobo občutljivo membrano na zadnji steni zrkla) in vidni živec, ki pošilja signale iz očesa v možgane.
In the eye, prostaglandins increase the drainage of the watery fluid (aqueous humour) out of the eyeball.
Prostaglandin v očesu poveča odvajanje vodene tekočine (prekatne vodke) iz zrkla.
The active substance in Travatan, travoprost, is a prostaglandin analogue (a man-made copy of a prostaglandin, one of a group of substances naturally found in the body).
Zdravilna učinkovina zdravila Travatan, travoprost, je analog prostaglandina (umetno izdelane kopije v človeškem telesu
By lowering the pressure, Travatan reduces the risk of
Zdravilo Travatan z zniževanjem tlaka zmanjša nevarnost poškodb.
Travatan was at least as effective as timolol and as effective as latanoprost in reducing intraocular pressure.
Zdravilo Travatan je bilo pri zniževanju očesnega tlaka vsaj tako učinkovito kot timolol in enako učinkovito kot latanoprost.
How has Travatan been studied?
Kako je bilo zdravilo Travatan raziskano?
Travatan is used to reduce intraocular pressure (pressure inside the eye).
Zdravilo Travatan se uporablja za zniževanje očesnega tlaka.
Travatan is a clear eye drop solution that contains the active substance travoprost.
Zdravilo Travatan je bistra raztopina v obliki kapljic za oko, ki vsebuje zdravilno učinkovino travoprost.
What is Travatan used for?
Za kaj se zdravilo Travatan uporablja?
How is Travatan used?
Kako se zdravilo Travatan uporablja?
What is Travatan?
Kaj je zdravilo Travatan?
Travatan acts in the same way and increases the flow of fluid out of the eye.
Zdravilo Travatan deluje enako in poveča odtok tekočine iz očesa, s čimer pomaga znižati očesni tlak.
50 mg Powder for concentrate for solution for injection / infusion
50 mg prašek za koncentrat za raztopino za injiciranje / infundiranje intravenska uporaba
Invented name
Številka EU Izmišljeno ime
Intravenous use Vial (glass)
Viala (steklo)
The remaining 16 patients did not fall into either group.
Preostalih 16 bolnikov ni spadalo v nobeno od omenjenih skupin.
This was switched to a full marketing authorisation on 24 April 2015.
To je bilo 24. aprila 2015 spremenjeno v običajno dovoljenje za promet.
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Arzerra on 19 April 2010.
Evropska komisija je pogojno dovoljenje za promet z zdravilom Arzerra, veljavno po vsej Evropski uniji, izdala 19. aprila 2010.
What measures are being taken to ensure the safe and effective use of Arzerra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Arzerra?
The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Glavno merilo učinkovitosti je bil število bolnikov, ki so se odzvali na zdravljenje.
It is given using an infusion pump.
Daje se s pomočjo infuzijske črpalke.
To reduce the risk of these reactions, infusions are started slowly (particularly when first starting treatment) and then speeded up every 30 minutes if no reactions occur.
Da bi zmanjšali tveganje za pojav teh neželenih učinkov, je infundiranje sprva počasno (zlasti na začetku zdravljenja), nato pa se vsakih 30 minut pospeši, če ni reakcij.
This is a summary of the European Public Assessment Report (EPAR) for Arzerra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Arzerra.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Ko je družba predložila dodatne zahtevane podatke, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
Other information about Arzerra
Druge informacije o zdravilu Arzerra
Arzerra was originally given ‘conditional approval', because there was more evidence to come about the medicine.
Zdravilo Arzerra je prvotno pridobilo „pogojno dovoljenje za promet“, ker so bili pričakovani dodatni dokazi o zdravilu.
If reactions occur, treatment is interrupted and may be restarted at a slower rate when the patient has recovered or stopped permanently if a serious allergic reaction occurs.
Če pride do reakcij, se zdravljenje prekine in se lahko ponovno začne počasneje, ko si bolnik opomore, ali se trajno prekine, če pride do resnih alergijskih reakcij.
The dosing schedule depends on whether the patient has been treated before and whether the patient's disease has come back.
Shema odmerjanja je odvisna od tega, ali je bil bolnik predhodno že zdravljen in ali se je bolezen ponovila.
The European Medicines Agency decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Evropska agencija za zdravila je sklenila, da so koristi zdravila Arzerra večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
The summary of the opinion of the Committee for Orphan Medicinal Products for Arzerra can also be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Arzerra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
What benefits of Arzerra have been shown in studies?
Kakšne koristi je zdravilo Arzerra izkazalo v študijah?
It is not intended to provide practical advice on how to use of Arzerra.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the risks associated with Arzerra?
Kakšna tveganja so povezana z zdravilom Arzerra?
What is Arzerra and what is it used for?
Kaj je zdravilo Arzerra in za kaj se uporablja?
Arzerra was not compared with any other treatments in this study.
V tej študiji zdravila Arzerra niso primerjali z drugimi zdravili.
For practical information about using Arzerra, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Arzerra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arzerra have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Arzerra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Arzerra approved?
Zakaj je bilo zdravilo Arzerra odobreno?
The full EPAR for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Arzerra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna določeno strukturo (imenovano antigen), ki je prisotna v nekaterih celicah v telesu, in se veže nanjo.
Because the number of patients with CLL is low, the disease is considered ‘rare', and Arzerra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Ker je bolnikov s kronično limfocitno levkemijo malo, velja ta bolezen za redko, zato je bilo zdravilo Arzerra 7. novembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The response rate was slightly lower in patients whose treatment with fludarabine had failed but who were not suitable for treatment with alemtuzumab (43%).
Stopnja odzivnosti je bila nekoliko nižja pri bolnikih, pri katerih je bilo zdravljenje s fludarabinom neuspešno in ki niso bili primerni za zdravljenje z alemtuzumabom (43 %).
Arzerra can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in treating cancer and in a place where facilities for resuscitating patients are readily available.
Predpisovanje in izdaja zdravila Arzerra je le na recept, dajati pa ga je treba pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem raka, v ustanovi, v kateri je nemudoma na voljo oprema za oživljanje.
In patients whose previous treatment with both fludarabine and alemtuzumab had failed, 49% (47 out of 95) responded to treatment with Arzerra.
Pri bolnikih, katerih predhodno zdravljenje s fludarabinom in alemtuzumabom ni bilo uspešno, se jih je 49 % (47 od 95) odzvalo na zdravljenje z zdravilom Arzerra.
The Agency also noted that patients with CLL who had not responded to previous treatment have limited treatment options.
Prav tako je ugotovila, da imajo bolniki s kronično limfocitno levkemijo, ki se niso odzvali na predhodno zdravljenje, omejene možnosti zdravljenja.
In 95 of these patients, the disease had not responded to both fludarabine and alemtuzumab, and in 112, treatment with fludarabine had failed but the patients had not been treated with alemtuzumab because this medicine was not suitable for them.
Od teh bolnikov se jih 95 ni odzvalo na zdravljenje s fludarabinom in alemtuzumabom, pri 112 pa je bilo zdravljenje s fludarabinom neuspešno, z alemtuzumabom pa jih niso zdravili, saj to zdravilo zanje ni bilo primerno.
In these patients Arzerra is used together with fludarabine and cyclophosphamide.
Pri teh bolnikih se zdravilo Arzerra uporablja skupaj s fludarabinom in ciklofosfamidom.
The most common side effects with Arzerra (seen in more than 1 patient in 10) are lower respiratory tract infection (infection of the lungs such as pneumonia), upper respiratory tract infection (nose and throat infection), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), nausea (feeling sick), fever, rash, dyspnoea (difficulty breathing), cough, diarrhoea and tiredness.
Najpogostejši neželeni učinki zdravila Arzerra (opaženi pri več kot 1 bolniku od 10) so okužba spodnjih dihal (okužba pljuč, kot je pljučnica), okužbe zgornjih dihal (okužbe nosu in grla), nevtropenija (nizko število nevtrofilcev, vrste belih krvnih celic), anemija (nizko število rdečih krvnih celic), navzeja (slabost), povišana telesna temperatura, izpuščaji, dispneja (oteženo dihanje), kašelj, driska in utrujenost.
By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease.
Ofatumumab z vezavo na CD20 spodbudi imunski sistem, da napade rakave celice, kar pripomore k obvladovanju bolezni.
• in patients whose disease has come back after previous treatment (known as relapsed disease).
• pri bolnikih, katerih bolezen se je po predhodnem zdravljenju ponovno pojavila (ponovljena bolezen).
Before each infusion, the patient receives medicines, such as a corticosteroid, an antihistamine and paracetamol, to help to prevent infusion reactions (such as rash, fever, allergic reactions and difficulty breathing).
Pred vsako infuzijo mora bolnik prejeti zdravila, kot je kortikosteroid, antihistaminik in paracetamol, kar pripomore k preprečevanju neželenih učinkov pri infundiranju (kot so izpuščaji, povišana telesna temperatura, alergijske reakcije in oteženo dihanje).
Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Arzerra je zdravilo za zdravljenje raka, ki se uporablja pri odraslih s kronično limfocitno levkemijo (KLL), tj. rakom vrste belih krvnih celic, imenovanih limfociti.
The response to treatment was assessed by looking at the patients' symptoms, the number of lymphocytes in their blood, results of blood and bone marrow tests and the size of their lymph nodes, liver and spleen.
Odziv na zdravljenje so ocenili glede na simptome bolnikov, število limfocitov v krvi, rezultate krvnih preiskav in preiskav kostnega mozga ter velikost bezgavk, jeter in vranice.
For more information on how Arzerra is used, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Arzerra glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
• in previously untreated patients who cannot be treated with fludarabine; in these patients it is used together with chlorambucil or bendamustine (other cancer medicines);
• pri predhodno nezdravljenih bolnikih, ki jih ni mogoče zdraviti s fludarabinom; pri teh bolnikih se zdravilo Arzerra uporablja skupaj s klorambucilom ali bendamustinom (drugima zdraviloma za zdravljenje raka);
The Agency noted that Arzerra was shown to be effective at treating patients with CLL (previously untreated patients, patients who had not responded to previous treatment with fludarabine and alemtuzumab and patients whose cancer had come back after previous treatment).
Ugotovila je, da se je zdravilo Arzerra izkazalo kot učinkovito pri zdravljenju bolnikov s kronično limfocitno levkemijo (predhodno nezdravljenih bolnikov, bolnikov, ki se niso odzvali na zdravljenje s fludarabinom in alemtuzumabom, in bolnikov, pri katerih se je rak po predhodnem zdravljenju ponovil).
For the full list of side effects and restrictions with Arzerra, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Arzerra glejte navodilo za uporabo.
Arzerra is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Zdravilo Arzerra je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
For more information about treatment with Arzerra, read the Package Leaflet (also part of the EPAR).
Za več informacij o zdravljenju z zdravilom Arzerra preberite navodilo za uporabo (ki je prav tako del EPAR).
Ofatumumab has been designed to attach to a protein called CD20 that is found on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Ofatumumab je bil zasnovan tako, da se veže na beljakovino, imenovano CD20, ki jo najdemo na površini limfocitov, vključno z rakavimi limfociti, prisotnimi pri kronični limfocitni levkemiji.
The active substance in Arzerra, ofatumumab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Arzerra, ofatumumab, je monoklonsko protitelo.
Arzerra has been investigated in one main study involving 223 patients with CLL whose disease had not responded to previous treatment.
Zdravilo Arzerra so proučevali v eni glavni študiji, v katero je bilo vključenih 223 bolnikov s kronično limfocitno levkemijo, ki se ni odzvala na predhodno zdravljenje.
Arzerra plus fludarabine and cyclophosphamide was effective at increasing progression-free survival, with patients living on average for 28.9 months without their disease getting worse, compared with 18.8 months in patients given fludarabine and cyclophosphamide alone.
Zdravilo Arzerra v kombinaciji s fludarabinom in ciklofosfamidom je bilo učinkovito pri podaljševanju časa preživetja bolnikov brez napredovanja bolezni, pri čemer so bolniki brez poslabšanja bolezni v povprečju živeli 28,9 meseca, medtem ko je to obdobje pri bolnikih, ki so prejemali fludarabin in ciklofosfamid, znašalo 18,8 meseca.
One main study involving 365 patients whose cancer had come back compared the combination of Arzerra plus fludarabine and cyclophosphamide with fludarabine and cyclophosphamide used alone.
V glavni študiji, v katero je bilo vključenih 365 bolnikov, pri katerih se je rak ponovil, so kombinacijo zdravila Arzerra in fludarabina ter ciklofosfamida primerjali s kombinacijo fludarabina in ciklofosfamida kot samostojnima zdraviloma.
Arzerra plus chlorambucil was effective at increasing progression-free survival (how long the patients lived without their disease getting worse), with patients living on average for 22.4 months without their disease getting worse, compared with 13.1 months in patients given chlorambucil alone.
Kombinacija zdravila Arzerra in klorambucila je bila učinkovita pri podaljševanju časa preživetja brez napredovanja bolezni (obdobja preživetja bolnikov brez poslabšanja bolezni), pri čemer so bolniki v povprečju živeli 22,4 meseca brez poslabšanja bolezni, medtem ko je bilo to obdobje pri bolnikih, ki so jemali samo klorambucil, 13,1.
How does Arzerra work?
Kako zdravilo Arzerra deluje?