natgillin/translations-raw huggingface dataset:
What is the risk associated with Suboxone?
Kakšna tveganja so povezana z zdravilom Suboxone?
The most common side effects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome.
Najpogostejši neželeni učinki zdravila Suboxone (opaženi pri več kot 1 bolniku od 10) so nespečnost, zaprtje, slabost, potenje, glavobol in odtegnitveni sindrom.
Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Zdravilo Suboxone se uporablja za zdravljenje odvisnosti od opioidnih (narkotičnih) drog, kot sta heroin ali morfij, pri odvisnikih, ki so privolili v zdravljenje.
The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo.
Rezultat glede želje po drogi je pred zdravljenjem znašal med 62,4 in 65,6, ob koncu študije pa 29,8 ob jemanju zdravila Suboxone in 55,1 ob jemanju placeba.
Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with 5.8% of the patients receiving placebo.
Zdravilo Suboxone je bilo kot samostojno zdravilo enako učinkovito kot buprenorfin in učinkovitejše od placeba: negativen rezultat preiskave urina ob koncu študije je imelo 17,8 % bolnikov, ki so jemali zdravilo Suboxone, in 5,8 % bolnikov, ki so jemali placebo.
For the full list of all side effects reported with Suboxone, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Suboxone, glejte navodilo za uporabo.
In patients who have mild to moderately reduced liver function lower starting doses are recommended.
Pri bolnikih z delno ali srednje okrnjenim delovanjem jeter se priporočajo nižji začetni odmerki.
Suboxone contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs).
Zdravilo Suboxone vsebuje dve zdravilni učinkovini: buprenorfin, ki je opioidni agonist (deluje kot opioidna droga), in nalokson, ki je opioidni antagonist (izniči učinke opioidnih drog).
It is recommended that the patient's liver be checked before starting treatment with Suboxone and should also be monitored regularly during treatment.
Pred začetkom zdravljenja z zdravilom Suboxone je priporočljivo opraviti preiskave delovanja bolnikovih jeter, redno pa je treba pregledovati njihovo delovanje tudi med samim zdravljenjem.
One main study compared Suboxone with buprenorphine on its own or with placebo (a dummy treatment) in 326 heroin-dependent patients for four weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study.
V eni glavni študiji so pri 326 odvisnikih od heroina v obdobju štirih tednov zdravilo Suboxone primerjali z buprenorfinom kot samostojnim zdravilom ali s placebom in merili delež bolnikov, pri katerih ob koncu študije ni bilo mogoče zaznati nobenih sledi opioidov v urinu.
Why has Suboxone been approved?
Zakaj je bilo zdravilo Suboxone odobreno?
The full EPAR for Suboxone can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports For more information about treatment with Suboxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Suboxone je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Suboxone is a medicine that contains two active substances, buprenorphine and naloxone.
Zdravilo Suboxone vsebuje dve zdravilni učinkovini: buprenorfin in nalokson.
How has Suboxone been studied?
Kako je bilo zdravilo Suboxone raziskano?
What is Suboxone?
Kaj je zdravilo Suboxone?
What is Suboxone used for?
Za kaj se zdravilo Suboxone uporablja?
How does Suboxone work?
Kako zdravilo Suboxone deluje?
How is Suboxone used?
Kako se zdravilo Suboxone uporablja?
This summary was last updated in 08-2008.
Povzetek je bil nazadnje posodobljen 8-2008.
The marketing authorisation was renewed on 22 September 2003 and on 22 September 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 22. septembra 2003 in 22. septembra 2008.
Other information about Comtan:
Druge informacije o zdravilu Comtan:
The European Commission granted a marketing authorisation valid throughout the European Union for Comtan to Novartis Europharm Limited on 22 September 1998.
Evropska komisija je dovoljenje za promet z zdravilom Comtan, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limted dne 22. septembra 1998.
The Committee recommended that Comtan be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Comtan odobri dovoljenje za promet.
It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours).
Ne sme se ga uporabljati skupaj v kombinacijah s „prilagojenim sproščanjem“ (kjer se levodopa počasi sprošča v obdobju več ur).
Comtan is used to treat patients with Parkinson's disease.
Zdravilo Comtan se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
What benefit has Comtan shown during the studies?
Kakšne koristi je zdravilo Comtan izkazalo med študijami?
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTAN EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) COMTAN Povzetek EPAR za javnost
Comtan should not be used in patients with:
Zdravila Comtan ne smejo uporabljati bolniki:
When patients first add Comtan to their exiting medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Ko bolnik prvič doda zdravilo Comtan svojim obstoječim zdravilom, bo morda moral vzeti manjši dnevni odmerek levodope, kar lahko doseže tako, da bodisi spremeni pogostost jemanja levodope ali pa zmanjša količino levodope, zaužite v vsakem odmerku.
The main measure of effectiveness was the time spent in the ‘on' state (the time when levodopa is controlling the symptoms of Parkinson's disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Glavno merilo učinkovitosti je bil čas, ko je bilo bolnikovo stanje dobro (stanje „vklopa“, ko je levodopa nadzorovala simptome Parkinsonove bolezni), in sicer po prvem jutranjem odmerku levodope v prvi študiji in v teku celega dne v drugi študiji.
What is the risk associated with Comtan?
Kakšna tveganja so povezana z zdravilom Comtan?
Comtan was more effective than placebo in both studies.
V obeh študijah je bilo zdravilo Comtan učinkovitejše od placeba.
It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Bolnik zaužije eno tableto zdravila Comtan skupaj z vsakim odmerkom drugega zdravila, vendar največ 10 tablet na dan.
Comtan should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Zdravila Comtan ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) entakapon ali katero koli drugo sestavino zdravila.
Comtan is a medicine that contains the active substance entacapone.
Comtan je zdravilo, ki vsebuje zdravilno učinkovino entakapon.
In the first study, adding Comtan increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
V prvi študiji je dodajanje zdravila Comtan podaljšalo trajanje stanja „vklopa“ za 1 uro in 18 minut v primerjavi s placebom.
The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Najpogostejši neželeni učinki zdravila Comtan (opaženi pri 1 do 10 bolnikih izmed 100) so diskinezija (nekontrolirani gibi), navzeja (občutek slabosti) in nenevarna sprememba barve urina.
For the full list of all side effects reported with Comtan, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Comtan, glejte navodilo za uporabo.
The active substance in Comtan, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Zdravilna učinkovina v zdravilu Comtan, entakapon, deluje tako, da ponovno vzpostavi ravni dopamina v delih možganov, ki nadzorujejo gibe in njihovo usklajenost.
Comtan has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Zdravilo Comtan so preučevali pri skupno 376 bolnikih s Parkinsonovo boleznijo v dveh šestmesečnih študijah, v katerih so merili učinke dodajanja zdravila Comtan ali placeba (zdravila brez zdravilne učinkovine) bolnikovi kombinaciji levodope in karbidope oziroma levodope in benserazida.
Why has Comtan been approved?
Zakaj je bilo zdravilo Comtan odobreno?
Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called catechol-O-methyl transferase (COMT).
Entakapon blokira encim, imenovan katehol-O-metiltransferaza (COMT), ki sodeluje pri razgradnji levodope v telesu.
Comtan should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Zdravilo Comtan se ne sme jemati hkrati z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrste antidepresivov).
The full EPAR for Comtan is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) z zdravilo Comtan je na voljo tukaj.
Comtan can only be used with conventional combinations of levodopa.
Zdravilo Comtan se lahko uporablja le s standardnimi kombinacijami levodope.
Comtan is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Zdravilo Comtan se uporablja, kadar nihanj ne moremo zdraviti samo s standardno kombinacijo, ki vsebuje levodopo.
Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Zdravilo Comtan se uporablja skupaj z levodopo (bodisi v kombinaciji z levodopo in benserazidom ali kombinaciji z levodopo in karbidopo), kadar bolnik doživlja „nihanja“ proti koncu obdobja med dvema odmerkoma zdravil.
Comtan is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Zdravilo Comtan se uporablja samo v kombinaciji z levodopo in benserazidom oziroma levodopo in karbidopo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtan kot dodatka k standardnima kombinacijama levodope/benserazida oziroma levodope/karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
What is Comtan used for?
Za kaj se zdravilo Comtan uporablja?
How does Comtan work?
Kako zdravilo Comtan deluje?
What is Comtan?
Kaj je zdravilo Comtan?
How has Comtan been studied?
Kako je bilo zdravilo Comtan raziskano?
How is Comtan used?
Kako se zdravilo Comtan uporablja?
* Antigenic mass ELISA units.
* ELISA enote mase antigena
- L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
--1 - serološka skupina L. interrogans serovar Canicola Portland-vere (sev Ca-12-000)
- L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
- serološka skupina L. interrogans Grippotyphosa serovar Dadas (sev Gr-01-005)
EMEA Number
EMEA številka Izmišljeno ime Jakost
Not applicable
Ovojnina
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Ocular use vial (glass)
Okularna uporaba viala (steklena)
The improvement in patients' vision was maintained for at least three years.
Izboljšanje vida bolnikov se je ohranilo vsaj tri leta.
An information package for patients and their carers will also be provided.
Na voljo bo tudi informacijsko gradivo za bolnike in njihove negovalce.
The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.
Vrsta virusa, uporabljenega v tem zdravilu (adeno-povezan virus), ne povzroča bolezni pri ljudeh.
Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.
Bolniki so preskus opravili, če so pot končali v treh minutah in se niso zaleteli v več kot tri ovire.
What measures are being taken to ensure the safe and effective use of Luxturna?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Luxturna?
Luxturna will only be available from centres where the educational programme is in place.
Zdravilo Luxturna bo na voljo samo v centrih, kjer se izvaja izobraževalni program.
This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition.
To je bilo ocenjeno kot pomembna klinična korist, pri čemer se je upoštevalo pomanjkanje odobrenih zdravljenj za to napredujoče degenerativno stanje.
Therefore, the European Medicines Agency decided that Luxturna's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Luxturna večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.
Poleg tega bo morala družba spremljati vse bolnike, ki so v glavnih študijah prejemali zdravilo Luxturna 15 let, da bi opredelila dolgoročno učinkovitost in varnost zdravila ter vzpostavila register za zbiranje dolgoročnih podatkov o varnosti pri bolnikih, ki so bili zdravljeni z zdravilom Luxturna.
Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila ema.europa.eu/medicines/human/orphan-designations.
As for all medicines, data on the use of Luxturna are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Luxturna stalno spremljajo.
This helps the cells in the retina to function better, slowing down the progression of the disease.
To pripomore k boljšemu delovanju celic v mrežnici, kar upočasnjuje napredovanje bolezni.
Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012).
Dedna mrežnična distrofija je redka, zato je bilo zdravilo Luxturna določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za dve obliki bolezni na dva različna datuma (za retinitis pigmentoso: 28. julija 2015 in za Leberjevo kongenitalno amavrozo:2. aprila 2012).
Other information about Luxturna
Druge informacije o zdravilu Luxturna
Further information on Luxturna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/luxturna.
Nadaljnje informacije o zdravilu Luxturna so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/luxturna.
The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings.
Glavno merilo učinkovitosti je bilo, kako dobro so bolniki opravili preskus mobilnosti, pri katerem so morali krmariti po poti z zavoji in ovirami pri različnih nastavitvah svetlobe.
Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so.
Poleg tega je 13 od 21 (62 %) bolnikov, zdravljenjih z zdravilom Luxturna, uspešno opravilo preskus mobilnosti na najnižji stopnji osvetljenosti en luks (podobno kot pri slabo osvetljenem pločniku ponoči), medtem ko nobeden od bolnikov, ki niso prejemali tega zdravila, tega ni mogel storiti.
Why is Luxturna authorised in the EU?
Zakaj je zdravilo Luxturna odobreno v EU?
What is Luxturna and what is it used for?
Kaj je zdravilo Luxturna in za kaj se uporablja?
Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Luxturna, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Luxturna have been shown in studies?
Kakšne koristi je zdravilo Luxturna izkazalo v študijah?
An overview of Luxturna and why it is authorised in the EU
Pregled zdravila Luxturna in zakaj je odobreno v EU
Luxturna has been shown to improve patients' vision and ability to move around obstacles, particularly in dim light, and is expected to improve their quality of life.
Za zdravilo Luxturna je bilo dokazano, da izboljšuje vid bolnikov in njihovo sposobnost, da se premikajo okoli ovir, zlasti pri šibki svetlobi, in se pričakuje, da bo izboljšalo njihovo kakovost življenja.
The safety of Luxturna was considered acceptable and side effects manageable.
Varnost zdravila Luxturna je bila ocenjena kot sprejemljiva, neželeni učinki pa obvladljivi.
Luxturna must not be used in patients with eye infection or inflammation.
Zdravilo Luxturna ne sme uporabljati pri bolnikih z očesno okužbo ali vnetjem očesa.
Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.
Bolniki morajo začeti prejemati imunosupresivna zdravila (zdravila, ki zavirajo delovanje imunskega sistema, naravnega obrambnega mehanizma telesa) tri dni preden se zdravilo Luxturna injicira v prvo oko, da se zmanjša tveganje, da telo zavrne zdravilo.
What are the risks associated with Luxturna?
Kakšna tveganja so povezana z zdravilom Luxturna?
For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Luxturna glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luxturna have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Luxturna upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The second eye should be treated at least 6 days after the first.
V drugo oko se injicira najmanj 6 dni po injiciranju v prvo.
Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).
Luxturna je zdravilo, ki se uporablja za zdravljenje odraslih in otrok z izgubo vida zaradi dedne mrežnične distrofije, tj. redke genetske okvare mrežnice (na svetlobo občutljive membrane na očesnem ozadju).
Luxturna is given as a single injection into the back of each eye, under the retina.
Zdravilo Luxturna se daje kot enkratna injekcija v zadnji del vsakega očesa pod mrežnico.
After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route.
Po enem letu zdravljenja so bolniki, zdravljeni z zdravilom Luxturna, izboljšali svoje rezultate za 1,8 točke, medtem ko so bolniki, ki tega zdravila niso prejemali, svoj rezultat izboljšali za 0,2 točke.
Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product'.
Zdravilo Luxturna vsebuje učinkovino voretigen neparvovek in je vrsta zdravila za napredno zdravljenje, imenovano „zdravilo za gensko zdravljenje“.
The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet.
Najpogostejši neželeni učinki zdravila Luxturna (ki lahko prizadenejo več kot 1 osebo od 20) so veznična hiperemija (povečana oskrba očesa s krvjo, ki povzroča pordelost očesa), katarakta (zamegljenost očesne leče) in povečan pritisk znotraj očesa.
Luxturna can only be used while patients still have enough functioning cells left in the retina and when the disease is caused by mutations (changes) in the gene RPE65.
Zdravilo Luxturna se lahko uporablja samo, če imajo bolniki še vedno dovolj delujočih celic v mrežnici in če so bolezen povzročile mutacije (spremembe) gena RPE65.
RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.
Gen RPE65 je odgovoren za tvorjenje encima, imenovanega vse-trans-retinil izomeraza, ki je potreben za normalno delovanje celic mrežnice.
Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations.
Zdravilo Luxturna je bilo raziskano v eni glavni študiji, v katero je bilo vključenih 31 bolnikov z dedno mrežnično distrofijo zaradi mutacij gena RPE65.
When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme.
Ko se zdravilo Luxturna injicira v oko, virus prenese gen RPE65 v celice mrežnice in jim omogoči tvorjenje manjkajočega encima.
Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.
Predpisovanje in izdaja zdravila Luxturna je le na recept, zdravljenje z njim pa mora uvesti kirurg z izkušnjami z izvajanjem operativnih posegov na očeh.
Luxturna consists of a virus that contains normal copies of the RPE65 gene.
Zdravilo Luxturna sestoji iz virusa, ki vsebuje normalne kopije gena RPE65.
The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration.
Družba, ki trži zdravilo Luxturna, bo za zagotovitev njegove pravilne uporabe in zmanjšanje tveganja, povezanega s tem zdravilom in njegovo uporabo, vzpostavila izobraževalni program in pripravila izobraževalno gradivo za zdravnike in farmacevte, za katere se pričakuje, da bodo uporabljali zdravilo Luxturna in rokovali z njim.