natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Besponsa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Besponsa večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Besponsa is given as an infusion (drip) into a vein lasting for at least one hour.
Zdravilo Besponsa se daje kot (kapalna) infuzija v veno v trajanju vsaj ene ure.
The summary of the opinion of the Committee for Orphan Medicinal Products for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Besponsa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
This is a summary of the European public assessment report (EPAR) for Besponsa.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Besponsa.
Why is Besponsa approved?
Zakaj je bilo zdravilo Besponsa odobreno?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besponsa 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 Besponsa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What are the risks associated with Besponsa?
Kakšna tveganja so povezana z zdravilom Besponsa?
With regard to safety, the side effects with Besponsa are similar to those of other chemotherapy medicines and can usually be managed by dose reduction or treatment interruption.
Kar zadeva varnost, so neželeni učinki zdravila Besponsa podobni učinkom drugih kemoterapevtskih zdravil in se jih običajno lahko obvlada z zmanjševanjem odmerka ali prekinitvijo zdravljenja.
In patients who do not respond to treatment, Besponsa should be stopped after 3 cycles.
Pri bolnikih, ki se na zdravljenje ne odzivajo, je treba zdravljenje po treh ciklih ustaviti.
For more information about treatment with Besponsa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Besponsa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Besponsa is used on its own in adults whose cancer has come back or did not respond to previous treatment.
Zdravilo Besponsa se samostojno uporablja pri odraslih, pri katerih se je rak ponovil ali ki se na prejšnje zdravljenje niso odzvali.
The full EPAR for Besponsa 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 Besponsa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare', and Besponsa was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 June 2013.
Ker je bolnikov s prekurzorsko B-celično ALL malo, velja ta bolezen za redko, zato je bilo zdravilo Besponsa 7. junija 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment.
Bolniki, pri katerih je zdravljenje učinkovito, vendar pri njih matične celice ne bodo presajene, lahko prejmejo do največ 6 ciklov zdravljenja.
Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment.
Bolniki, pri katerih je zdravilo Besponsa učinkovito, morajo prejeti dva ali tri cikle, čemur lahko sledi presaditev matičnih celic za zamenjavo kostnega mozga, kar je edino kurativno zdravljenje.
The most common side effects with Besponsa (which may affect more than 1 in 5 people) are thrombocytopenia (low blood platelet counts), neutropenia and leucopenia (low white blood cell counts), infection, anaemia (low red blood cell counts), tiredness, haemorrhage (bleeding), fever, nausea (feeling sick), headache, febrile neutropenia (low white cell count with fever), abdominal pain (stomach ache), increased levels of liver enzymes called transaminases and gammaglutamyltransferase, and hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells).
Najpogostejši neželeni učinki zdravila Besponsa (ki se lahko pojavijo pri več kot 1 bolniku od 5) so trombocitopenija (nizko število krvnih ploščic), nevtropenija in levkopenija (nizko število belih krvnih celic), okužba, anemija (nizko število rdečih krvnih celic), utrujenost, krvavitev, zvišana telesna temperatura, navzeja (siljenje na bruhanje), glavobol, febrilna nevtropenija (nizko število belih krvnih celic in povišana telesna temperatura), bolečine v trebuhu, zvišane ravni jetrnih encimov (transaminaz in gama-glutamiltransferaze) ter hiperbilirubinemija (visoke ravni bilirubina, razgradnega produkta rdečih krvnih celic).
Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL).
Zdravilo Besponsa je zdravilo proti raku, ki se uporablja za zdravljenje krvnega raka, ki prizadene celice B (vrsta belih krvnih celic) in se imenuje prekurzorska B-celična akutna limfoblastna levkemija (ALL).
For the full list of all side effects and restrictions reported with Besponsa, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Besponsa, glejte navodilo za uporabo.
Other information aboutBesponsa
Druge informacije o zdravilu Besponsa
Besponsa can only be obtained with a prescription, and treatment should be given under the supervision of a doctor who has experience in the use of cancer treatments.
Predpisovanje in izdaja zdravila Besponsa je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika z izkušnjami z zdravljenjem raka.
For practical information about using Besponsa, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Besponsa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The most serious side effects are infection, febrile neutropenia, haemorrhage, abdominal pain, fever, tiredness and veno-occlusive liver disease/sinusoidal obstruction syndrome (VOD/SOS, a serious liver disease).
Najresnejši neželeni učinki so okužba, febrilna nevtropenija, krvavitev, bolečine v trebuhu, vročina, utrujenost in venookluzivna bolezen jeter/sindrom obstrukcije sinusoidov (VOD/SOS, resna bolezen jeter).
This means that patients' have a particular protein (CD22) on the surface of their white blood cells.
To pomeni, da imajo bolniki na površini belih krvnih celic posebno beljakovino (CD22).
How is Besponsa used?
Kako se zdravilo Besponsa uporablja?
The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule, N-acetyl-gamma-calicheamicin dimethylhydrazide.
Zdravilna učinkovina v zdravilu Besponsa, inotuzumab ozogamicin, je monoklonsko protitelo (vrsta beljakovine), ki je vezano na majhno molekulo, N-acetil-gama-kaliheamicin dimetilhidrazid.
The CHMP considered that although there have been recent advances in the treatment of B-cell precursor ALL, treatment options for patients remain limited.
Odbor CHMP je ocenil, da ostajajo možnosti zdravljenja prekurzorske B-celične ALL kljub nedavnemu napredku omejene.
In patients who have a type of chromosome known as Philadelphia-chromosome, treatment with a cancer medicine called a tyrosine kinase inhibitor should have been tried before starting Besponsa.
Pri bolnikih z vrsto kromosoma, imenovano kromosom Philadelphia, je treba pred začetkom zdravljenja z zdravilom Besponsa poskusiti z zdravljenjem z zdravilom proti raku, imenovanim zaviralec tirozin-kinaze.
Besponsa must not be used in patients who have VOD/SOS or have had severe VOD/SOS or have other serious liver diseases.
Pri bolnikih, ki imajo VOD/SOS ali so imeli resno VOD/SOS ali drugo resno bolezen jeter, se zdravila Besponsa ne sme uporabljati.
Patients were considered to have responded if they had no remaining cancerous B cells in their blood and bone marrow after treatment.
Pri bolnikih je bil odziv ugotovljen, če po zdravljenju v krvi in kostnem mozgu niso imeli rakavih celic B.
Patients who responded to treatment could proceed to have a stem cell transplant.
Bolniki, ki so sodelovali v zdravljenju, so lahko prejeli presadek matičnih celic.
The main study showed that Besponsa was better than other commonly used chemotherapy medicines at inducing a response in patients and allowing them to have a curative stem cell transplant.
Glavna študija je pokazala, da v primerjavi z drugimi pogosto uporabljanimi kemoterapevtskimi zdravili zdravilo Besponsa pri bolnikih bolje inducira odziv in omogoči kurativno zdravljenje z matičnimi celicami.
Besponsa is only used in patients with ‘CD22-positive B-cell precursor ALL'.
Zdravilo Besponsa se uporablja samo pri bolnikih s prekurzorsko B-celično ALL, pozitivno na CD22.
Besponsa contains the active substance inotuzumab ozogamicin.
Zdravilo Besponsa vsebuje zdravilno učinkovino inotuzumab ozogamicin.
Besponsa was shown to be more effective than other chemotherapy (medicines to treat cancer) in one main study involving 326 adults with CD22-positive B-cell precursor ALL, which had come back or had not responded to previous treatment.
Zdravilo Besponsa se je v glavni študiji, v katero je bilo vključenih 326 odraslih s prekurzorsko Bcelično ALL, pri katerih je prišlo do ponovitve bolezni ali ki se niso odzvali na predhodno zdravljenje, pokazalo kot učinkovitejše od druge kemoterapije (zdravil za zdravljenje raka).
Once attached, the medicine is taken up by the cell where calicheamicin becomes active, causing breaks in the cell's DNA and thereby killing the cancer cell.
Monoklonsko telo je bilo zasnovano, da prepozna beljakovino CD22 in se veže nanjo na rakavih celicah B. Po vezavi zdravilo vstopi v celico, kjer se kaliheamicin aktivira in povzroči prekinitev celične DNK ter s tem uniči rakavo celico.
The doctor may interrupt treatment or reduce the dose, if the patient develops certain serious side effects.
Če se pri bolniku pojavijo nekateri resni neželeni učinki, bo zdravnik morda moral začasno prekiniti zdravljenje oziroma zmanjšati odmerek.
How does Besponsa work?
Kako zdravilo Besponsa deluje?
3 bottles
3 stekleničke
Invented name Strength Pharmaceutical form Route of administration Packaging
Številka EU Izmišljeno ime Jakost
EU Number
Vsebina
Strength Pharmaceutical Form
ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
This summary was last updated in November 2012.
Povzetek je bil nazadnje posodobljen novembra 2012.
This medicine is the same as Axura, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Axura, ki je že odobreno v Evropski uniji (EU).
Memantine Merz should be given once a day, at the same time every day.
Zdravilo Memantine Merz se daje enkrat dnevno, vsak dan ob istem času.
The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Merz on 22 November 2012.
Evropska komisija je dovoljenje za promet z zdravilom Memantine Merz, veljavno po vsej Evropski uniji, odobrila dne 22. novembra 2012.
To prevent side effects, the dose of Memantine Merz is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Da se preprečijo neželeni učinki, se odmerek zdravila Memantine Merz v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg, drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
The full EPAR for Memantine Merz 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 Memantine Merz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The most common side effects with Memantine Merz (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, balance disorders, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache, raised liver function test results and drug hypersensitivity (allergy to the medicine).
Najpogostejši neželeni učinki zdravila Memantine Merz (opaženi pri 1 do 10 bolnikih od 100) so somnolenca (zaspanost), omotica, motnje ravnotežja, hipertenzija (visok krvni tlak), dispneja (oteženo dihanje), zaprtje, glavobol, povišane vrednosti jetrnih funkcijskih testov in preobčutljivost (alergija na zdravilo).
This is a summary of the European public assessment report (EPAR) for Memantine Merz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Memantine Merz.
For more information about treatment with Memantine Merz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Memantine Merz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Memantine Merz's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Memantine Merz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Memantine Merz has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Zdravilo Memantine Merz so proučevali v treh glavnih študijah, ki so vključevale skupno 1 125 bolnikov z Alzheimerjevo boleznijo, pri čemer so nekateri izmed njih v preteklosti prejemali druga zdravila za zdravljenje te bolezni.
The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Memantine Merz should be re-assessed on a regular basis.
Prenašanje in odmerek zdravila je treba oceniti v 3 mesecih od začetka zdravljenja, od takrat naprej pa je treba koristi zdravljenja z zdravilom Memantine Merz ponovno ocenjevati v rednih intervalih.
However, when these results were considered along with those of the three additional studies, it was noted that the effect of Memantine Merz was smaller in patients with mild disease.
Vendar pa je primerjava teh rezultatov z rezultati treh dodatnih študij pokazala, da je bil učinek zdravila Memantine Merz manjši pri bolnikih z blago boleznijo.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Merz by the patient.
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Memantine Merz.
Memantine Merz is used to treat patients with moderate to severe Alzheimer's disease.
Zdravilo Memantine Merz se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
Memantine Merz was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Zdravilo Memantine Merz je bilo pri nadzorovanju simptomov Alzheimerjeve bolezni učinkovitejše od placeba.
Memantine Merz was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Zdravilo Memantine Merz so primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 24 do 28 tednov.
Memantine Merz was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Zdravilo Memantine Merz so proučevali še v treh dodatnih študijah, ki so vključevale skupno 1 186 bolnikov z blago do hudo boleznijo.
Memantine Merz must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Zdravila Memantine Merz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) memantinijev klorid ali katero koli drugo sestavino zdravila.
The company that makes Axura has agreed that its scientific data can be used for Memantine Merz (‘informed consent').
Družba, ki izdeluje zdravilo Axura, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Memantine Merz („uporaba dokumentacije s soglasjem“).
In the two studies of mild to moderate disease, patients on Memantine Merz had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
V dveh študijah blage do zmerne bolezni so imeli bolniki, ki so prejemali zdravilo Memantine Merz, po 24 tednih manj hudih simptomov, merjeno z globalnimi in kognitivnimi merili.
Memantine Merz memantine hydrochloride
Memantine Merz memantinijev klorid
Memantine Merz is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Zdravilo Memantine Merz je na voljo tudi kot peroralna raztopina z dodano črpalko, ki dovede 5 mg memantinijevega klorida ob vsakem črpanju.
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 Memantine Merz.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Memantine Merz, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In the study of moderately severe to severe disease, patients taking Memantine Merz had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
V študiji z bolniki z zmerno hudo do hudo boleznijo je bilo po 28 tednih pri bolnikih, ki so jemali zdravilo Memantine Merz, ugotovljenih manj simptomov kot pri bolnikih, ki so jemali placebo, merjeno z globalnimi in funkcionalnimi merili.
Other information about Memantine Merz
Druge informacije o zdravilu Memantine Merz
What benefit has Memantine Merz shown during the studies?
Kakšne koristi je zdravilo Memantine Merz izkazalo med študijami?
Memantine Merz is a medicine that contains the active substance memantine hydrochloride.
Memantine Merz je zdravilo, ki vsebuje zdravilno učinkovino memantinijev klorid.
For the full list of all side effects reported with Memantine Merz, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Memantine Merz, glejte navodilo za uporabo.
The active substance in Memantine Merz, memantine hydrochloride, is an antidementia medicine.
Zdravilna učinkovina zdravila Memantine Merz, memantinijev klorid, je zdravilo za zdravljenje demence.
What is the risk associated with Memantine Merz?
Kakšna tveganja so povezana z zdravilom Memantine Merz?
Why has Memantine Merz been approved?
Zakaj je bilo zdravilo Memantine Merz odobreno?
What is Memantine Merz?
Kaj je zdravilo Memantine Merz?
What is Memantine Merz used for?
Za kaj se zdravilo Memantine Merz uporablja?
How has Memantine Merz been studied?
Kako je bilo zdravilo Memantine Merz raziskano?
How does Memantine Merz work?
Kako zdravilo Memantine Merz deluje?
How is Memantine Merz used?
Kako se zdravilo Memantine Merz uporablja?
Most of them occurred during the first months of treatment.
Večinoma so se pojavili v prvih nekaj mesecih zdravljenja.
Patients with such form of the disease may derive less benefit from treatment.
Bolniki s tovrstno obliko bolezni imajo od zdravljenja manjšo korist.
Diacerein is not recommended in patients older than 65 years.
Diacereina ne priporočamo bolnikom, starejšim od 65 let.
The capsules must be swallowed intact, without opening them, together with a glass of water.
Kapsule je treba pogoltniti cele, ne da bi jih odpirali, skupaj s kozarcem vode.
As some patients may experience loose stools or diarrhoea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily.
Ker imajo lahko nekateri bolniki mehko blato ali drisko, je priporočeni začetni odmerek prva dva do štiri tedne zdravljenja 50 mg enkrat dnevno z večernim obrokom, nato je priporočeni odmerek 50 mg dvakrat dnevno.
As a rule, these effects abate with continuing treatment.
Praviloma ti učinki z nadaljevanjem zdravljenja izzvenijo.
How to take [Invented Name]
Kako jemati zdravilo [izmišljeno ime]
The treatment should be taken with food, one with breakfast and the other with evening meal.
Zdravilo je treba jemati s hrano, prvi odmerek z zajtrkom in drugega z večernim obrokom.
• Current and/or history of liver disease
• Trenutna jetrna bolezen in/ali jetrna bolezen v anamnezi
Your doctor may ask you to undergo blood tests to check your liver function.
Zdravnik vas bo morda napotil na krvne preiskave, s katerimi bo preveril delovanje jeter.
From post-marketing surveillance
Podatki iz obdobja spremljanja po pridobitvi dovoljenja za promet
[The dose recommendation for adults should be as follows]
Odmerjanje [Priporočeno odmerjanje za odrasle mora biti, kot sledi]
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Priloga III Spremembe relevantnih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo
Intake of diacerein frequently leads to diarrhoea (see section 4.8) that can consequently lead to dehydration and hypokalaemia.
Jemanje diacereina pogosto povzroči drisko (glejte poglavje 4.8), kar lahko privede do dehidracije in hipokaliemije.
What you need to know before you take [Invented Name] Do not take [Invented Name]: [The following contraindication should be added here and replace any existing wording on hepatic insufficiency]
Kaj morate vedeti, preden boste vzeli zdravilo [izmišljeno ime] Ne jemljite zdravila [izmišljeno ime]: [Tu je treba dodati naslednje kontraindikacije, ki morajo nadomestiti obstoječe besedilo o jetrni insuficienci]
4.1 Therapeutic indications [This section should be read as follows]
4.1 Terapevtske indikacije [To poglavje se mora glasiti, kot sledi]
Treatment of symptoms in patients with osteoarthritis of the hip or knee, with delayed effect.
Zdravljenje simptomov pri bolnikih z osteoartritisom kolka ali kolena z zapoznelim učinkom.
In some cases, diarrhoea was severe with complications such as dehydration and disorders of fluid and electrolyte balance.
V nekaterih primerih je bila driska huda, z zapleti, kot so dehidracija in motnje ravnovesja tekočin in elektrolitov.
Treatment with [Invented Name] is therefore not recommended for a specific form of hip osteoarthritis called rapidly progressive (worsening) hip osteoarthritis.
Zdravljenja z zdravilom [izmišljeno ime] zato ne priporočamo pri posebni obliki osteoartritisa kolka, ki se imenuje hitro napredujoči osteoartritis kolka.
Before treatment with diacerein is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease.
Pred uvedbo zdravljenja z diacereinom je treba bolnika izprašati o morebitnih soobolevnostih in preteklih ali trenutnih jetrnih boleznih ter preveriti prisotnost večjih vzrokov za aktivno jetrno bolezen.
If you have diarrhoea while taking this medicine, stop taking [Invented Name] and contact your doctor to discuss which other treatments you can take.
Če imate po jemanju zdravila [izmišljeno ime] drisko, ga prenehajte jemati in se posvetujte z zdravnikom glede drugih zdravil, ki jih lahko jemljete.