natgillin/translations-raw huggingface dataset:
In patients with a fractured tibia, using Inductos in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Pri bolnikih z zlomom golenice je bila uporaba zdravila Inductos v kombinaciji s standardno oskrbo z vidika zmanjševanja tveganja za neuspeh zdravljenja učinkovitejša od uporabe zgolj standardne oskrbe.
Why has Inductos been approved?
Zakaj je bilo zdravilo Inductos odobreno?
For the full list of all side effects reported with Inductos, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Inductos, glejte navodilo za uporabo.
The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Nadomestni dibotermin alfa deluje enako kot naravna beljakovina za morfogenezo kosti 2 (BMP-2), ki nastaja v telesu.
Inductos is used to help new bone develop.
Zdravilo Inductos se uporablja za spodbujanje tvorbe nove kosti.
The main measure of effectiveness was the number of patients who did not need further treatment for their fractured tibia (such as a bone graft or changes to the nail used to fix the bones together) in the year following surgery.
Primerjali so ga s standardno oskrbo, glavno merilo učinkovitosti pa je bilo število bolnikov, ki v letu po kirurškem posegu niso potrebovali nadaljnjega zdravljenja zloma golenice (kot npr. kostnega presadka ali menjave vijaka, uporabljenega za učvrstitev kosti).
In spinal fusion, Inductos was as effective as bone grafts.
Pri fuziji hrbtenice je bilo zdravilo Inductos enako učinkovito kot kostni presadek.
The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
Vsebuje prašek z zdravilno učinkovino dibotermin alfa, vehikel in matriks (kolagensko gobico).
For a fractured tibia, Inductos is placed around the broken bone to aid healing.
Pri zlomu golenice se zdravilo Inductos namesti okrog zlomljene kosti, da bi tako spodbudili celjenje.
Inductos is a kit for implant.
Zdravilo Inductos je komplet za vsaditev.
How has Inductos been studied?
Kako je bilo zdravilo Inductos raziskano?
What is Inductos used for?
Za kaj se zdravilo Inductos uporablja?
• treating a fracture that is related to a disease such as Paget's disease or cancer.
• za zdravljenje zloma, ki je povezan z boleznijo, kot je Pagetova bolezen ali rak. Za celoten seznam omejitev pri uporabi zdravila Inductos glejte navodilo za uporabo.
What is Inductos?
Kaj je zdravilo Inductos?
How is Inductos used?
Kako se zdravilo Inductos uporablja?
• surgery to heal fractures (breaks) of the tibia (shin bone).
• pri kirurških posegih za fuzijo (spajanje) v ledvenem delu hrbtenice.
How does Inductos work?
Kako zdravilo Inductos deluje?
Doctors will also be given information on the EU registry.
Zdravniki bodo prav tako prejeli informacije o registru EU.
The number of implants per year depends on how much protection from the sun is needed.
Število implantatov na leto je odvisno od tega, kolikšna zaščita pred soncem je potrebna.
The European Commission granted a marketing authorisation valid throughout the European Union for Scenesse on 22 December 2014.
Evropska komisija je dovoljenje za promet z zdravilom Scenesse, veljavno po vsej Evropski uniji, izdala 22. decembra 2014.
These affected around 1 in 5 patients and were generally mild in severity.
Ti so prizadeli približno 1 od 5 bolnikov in so bili v splošnem blagi.
The Committee also consulted individual patients and experts on their experience with Scenesse.
Odbor se je prav tako posvetoval s posameznimi bolniki in strokovnjaki o njihovih izkušnjah z zdravilom Scenesse.
What measures are being taken to ensure the safe and effective use of Scenesse?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Scenesse?
Other information about Scenesse
Druge informacije o zdravilu Scenesse
Scenesse has been authorised under ‘exceptional circumstances'.
Zdravilo Scenesse je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
It is not intended to provide practical advice on how to use Scenesse.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
A risk management plan has been developed to ensure that Scenesse is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Scenesse je bil pripravljen načrt obvladovanja tveganj.
Scenesse is used to help prevent or reduce these symptoms so that these patients can lead more normal lives.
Zdravilo Scenesse pomaga preprečiti ali zmanjšati te simptome, da bi tako bolnikom omogočili bolj normalno življenje.
Patients with EPP have high levels of a substance called protoporphyrin IX in the body.
Bolniki z EPP imajo v telesu visoke ravni snovi, imenovane protoporfirin IX.
The summary of the opinion of the Committee for Orphan Medicinal Products for Scenesse 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 Scenesse 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 Scenesse.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Scenesse.
What is Scenesse and what is it used for?
Kaj je zdravilo Scenesse in za kaj se uporablja?
Why is Scenesse approved?
Zakaj je bilo zdravilo Scenesse odobreno?
Because the number of patients with EPP is low, the disease is considered ‘rare', and Scenesse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 May 2008.
Ker je bolnikov z EPP malo, velja ta bolezen za redko, zato je bilo zdravilo Scenesse 8. maja 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Scenesse is only prescribed by specialist doctors in recognised centres for treating EPP and should only be used by doctors who have been properly trained.
Zdravilo Scenesse predpisujejo le specialisti v priznanih centrih za zdravljenje EPP, uporabljajo pa ga lahko samo zdravniki, ki so ustrezno usposobljeni.
What are the risks associated with Scenesse?
Kakšna tveganja so povezana z zdravilom Scenesse?
What benefits of Scenesse have been shown in studies?
Kakšne koristi je zdravilo Scenesse izkazalo v študijah?
One Scenesse implant is injected under the patient's skin once every 2 months, before and during periods of high sunlight exposure, e.g. from spring to autumn.
En implantat zdravila Scenesse se injicira bolniku pod kožo vsaka 2 meseca, pred obdobji visoke izpostavljenosti soncu in med njimi, npr. od pomladi do jeseni.
In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine.
Poleg tega bo družba, ki trži zdravilo Scenesse, zagotovila, da bodo zdravniki prejeli izobraževalno gradivo in bodo deležni usposabljanja za uporabo zdravila.
The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness).
Najpogostejši neželeni učinki, opaženi v študijah z zdravilom Scenesse, so bili navzea (slabost), glavobol in reakcije na mestu implantata (kot so sprememba barve, bolečina in rdečica).
What information is still awaited for Scenesse?
Katere informacije o zdravilu Scenesse še pričakujemo?
Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.
Dnevno beleženje izpostavljenosti sončni svetlobi med 10. in 16. uro v obdobju šestih mesecev je pokazalo, da so bolniki, ki so prejemali zdravilo Scenesse, na neposredni sončni svetlobi v povprečju prebili 116 ur, ne da bi občutili bolečino, v primerjavi z 61 urami pri bolnikih, ki so prejemali placebo.
In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light.
Pri bolnikih z EPP lahko izpostavljenost svetlobi povzroči simptome, kot sta bolečina in otekanje kože, zaradi česar bolniki ne morejo preživljati časa na prostem ali v prostorih z močno svetlobo.
Three implants per year are recommended;
Priporočeni so trije implantati letno, dovoljeni pa največ štirje.
Scenesse must not be used in patients with reduced liver or kidney function.
Zdravila Scenesse ne smejo uporabljati bolniki z zmanjšanim delovanjem jeter ali ledvic.
Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.
Zdravilo Scenesse je implantat, ki se uporablja za zdravljenje bolnikov z eritropoetsko protoporfirijo (EPP), redko boleznijo, ki povzroča preobčutljivost za svetlobo.
For more information on how to use Scenesse, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Scenesse glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition.
Protoporfirin IX je fototoksičen in pri ljudeh s to boleznijo ob izpostavljenosti svetlobi povzroča boleče reakcije.
The full EPAR and risk management plan summary for Scenesse 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) in povzetek načrta obvladovanja tveganj za zdravilo Scenesse sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Scenesse večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease.
Do tega je prišlo zato, ker - med drugim zaradi redkosti bolezni - ni bilo mogoče pridobiti vseh informacij o njegovih koristih.
This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.
Ta pigment, imenovan evmelanin, se tvori med izpostavljenostjo sončni svetlobi, da prepreči prodiranje svetlobe v celice.
In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period.
V njej je sodelovalo 93 bolnikov z EPP, ki so šest mesecev prejemali bodisi zdravilo Scenesse bodisi placebo (zdravilo brez zdravilne učinkovine).
Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.
Bolnike je treba po injiciranju posameznega implantata opazovati še 30 minut, saj se v tem času lahko razvije alergijska reakcija.
For the full list of all side effects and restrictions with Scenesse, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri zdravilu Scenesse glejte navodilo za uporabo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scenesse, including information on the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Scenesse in navodilo za njegovo uporabo vključene informacije o varnosti, vključno z informacijami o previdnostnih ukrepih, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Scenesse contains the active substance afamelanotide.
Zdravilo Scenesse vsebuje zdravilno učinkovino afamelanotid.
Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.
Ker je zdravilo Scenesse pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, zagotovila dolgoročne podatke o koristih in varnosti zdravila iz registra bolnikov v EU, ki prejemajo zdravilo.
By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.
Zdravilo Scenesse spodbuja tvorbo evmelanina v koži ter posledično zmanjšuje prodiranje svetlobe skozi kožo in tako pomaga preprečiti boleče reakcije.
The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alphamelanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin.
Zdravilna učinkovina zdravila Scenesse, afamelanotid, je podobna telesnemu hormonu, imenovanemu alfa-melanocit stimulirajoči hormon, ki spodbuja tvorbo rjavo-črnega pigmenta v koži.
For practical information about using Scenesse, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Scenesse naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
How does Scenesse work?
Kako zdravilo Scenesse deluje?
For more information about treatment with Scenesse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Scenesse preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU.
Čeprav je bil dodaten čas, preživet na sončni svetlobi, kratek, je Odbor pri odločitvi, da priporoči odobritev uporabe zdravila Scenesse v EU, upošteval možno izboljšanje kakovosti življenja, neizpolnjene zdravstvene potrebe pri bolnikih z EPP in blage neželene učinke, opažene med kratkotrajnim zdravljenjem z zdravilom.
The CHMP noted that Scenesse led to an increase in the amount of time patients could spend in direct sunlight without experiencing pain.
CHMP je ugotovil, da je zdravilo Scenesse bolnikom omogočilo daljše preživljanje časa na neposredni sončni svetlobi, ne da bi občutili bolečino.
Scenesse has been shown in a study to lead to an increase in the amount of time patients can spend in sunlight.
Študija je pokazala, da zdravilo Scenesse podaljšuje čas, ki ga bolniki lahko preživijo na sončni svetlobi.
How is Scenesse used?
Kako se zdravilo Scenesse uporablja?
Over 24 weeks
V obdobju 24 tednov
However, Cmax increases by 15-23%.
Vendar pa se Cmax poveča za 15-23 %.
Date of first authorisation: 20 July 2011 Date of latest renewal: 18 May 2017
Datum prve odobritve: 20. julij 2011 Datum zadnjega podaljšanja: 18. maj 2017
≥20% improvement
≥20 % izboljšanje
The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Ne pričakuje se, da bi majhno zmanjšanje AUC zmanjšalo terapevtsko učinkovitost.
There is limited safety information in these patients.
Informacij o varnosti za te bolnike je malo.
− The other ingredients are:
− Druge sestavine zdravila so:
The usual dosing regimen should always be followed.
Vedno je treba upoštevati običajni režim odmerjanja.
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); not known (cannot be estimated from the available data).
Pogostnosti so opredeljene 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established.
Varnosti in učinkovitosti zdravila Fampyra pri otrocih, starih med 0 in 18 let, niso ugotavljali.
• Feeling weak and tired
• občutek oslabelosti in utrujenosti
Creatinine clearance can be estimated using the Cockroft-Gault formula.
Očistek kreatinina se lahko oceni s formulo Cockroft-Gault.
− if you are prone to infections
− če ste nagnjeni k okužbam.
You may also notice other effects not listed here.
Opazite lahko tudi druge učinke, ki tukaj niso našteti.
Do not give Fampyra to children or adolescents under the age of 18 years.
Zdravila Fampyra ne dajajte otrokom ali mladostnikom, starim manj kot 18 let.
In animal studies no effects on fertility were seen.
V študijah na živalih niso opazili vpliva na plodnost.
43% Risk difference: 10.4%
43 % razlika tveganja: 10,4 %
Children and in adolescents
Otroci in mladostniki
Do not take more than two tablets in a day.
Ne jemljite več kot dveh tablet na dan.
Fampridine has a volume of distribution of approximately 2.6 l/kg.
Volumen porazdelitve fampridina je približno 2,6 l/kg.
• Upset stomach
• vznemirjen želodec
Reports of hypertension have also been received.
Obstajajo tudi poročila o hipertenziji.
− if you are taking a medicine called cimetidine
− če jemljete zdravilo, imenovano cimetidin.
However, no increased risk for malformations or adverse effects on fertility was noted.
Vendar pa niso opazili večjega tveganja za malformacije ali neželene učinke na plodnost.
Athlone, Co. Westmeath Ireland
Athlone, Co. Westmeath
Duration of double-blind treatment was 24 weeks with a 2 week post-treatment follow-up.
Dvojno slepo zdravljenje je trajalo 24 tednov z 2-tedenskim spremljanjem po zdravljenju.
It is unknown whether fampridine is excreted in human or animal milk.
Ni znano, ali se fampridin izloča v materino mleko pri človeku ali pri živali.
Fampridine has a narrow therapeutic index.
Fampridin ima ozek terapevtski indeks.
Do not take the tablets more often than every 12 hours.
Tablet ne jemljite pogosteje kot vsakih 12 ur.
The improvement appeared rapidly (within weeks) after starting Fampyra.
Izboljšanje se je pojavilo hitro (v nekaj tednih) po začetku jemanja zdravila
After 2 to 4 weeks the treatment will be reassessed.
Po 2 do 4 tednih bo učinke zdravljenja ponovno ocenil.
Fampridine is not a substrate for P-glycoprotein.
Fampridin ni substrat za P-glikoprotein.
A responder was defined as a patient who consistently had a faster walking speed for at least three visits out of a possible four during the double blind period as compared to the maximum value among five off-treatment visits.
Odzivna oseba je bila opredeljena kot bolnik, ki je konsistentno hodil hitreje vsaj v treh od možnih štirih obiskov v dvojno slepem obdobju preskušanja v primerjavi z največjo hitrostjo, doseženo med petimi obiski, ki niso sodili v obdobje zdravljenja.
Clinical studies of Fampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
V klinične študije z zdravilom Fampyra ni bilo vključenih dovolj bolnikov, starih 65 let in več, da bi se ugotovilo, ali je njihov odziv drugačen kot pri mlajših bolnikih.
*Intent to treat population = 633; LSM = Least square mean
*Populacija z namenom zdravljenja = 633; LSM = povprečje najmanjših kvadratov (Least Squares Mean)
Older people:
Starejši ljudje:
OCT2 is the transporter responsible for the active secretion of fampridine.
OCT2 je prenašalec, odgovoren za aktivno izločanje fampridina.
Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX07.
Farmakoterapevtska skupina: druga zdravila za živčevje, oznaka ATC: N07XX07.
Fampyra with food and drink
Zdravilo Fampyra skupaj s hrano in pijačo
The difference in the Berg Balance Scale (BBS; a measure of static balance), was not statistically significant.
Medtem ko razlika v rezultatu glede na Bergovo lestvico ravnotežja (Berg Balance Scale - BBS; merilo statičnega ravnotežja) ni bila statistično značilna.
Particular attention should be given to patients with a previous history of allergic reactions.
Posebno pozornost je treba nameniti bolnikom z alergijskimi reakcijami v anamnezi.
These clinical signs were not unexpected and represent exaggerated pharmacology of fampridine.
Ti klinični znaki niso bili nepričakovani in predstavljajo pretiran farmakološki odziv na fampridin.
Before starting treatment and during treatment your doctor may check that your kidneys are working properly.
Pred začetkom zdravljenja in med njim bo morda zdravnik preveril, ali vaše ledvice pravilno delujejo.
This is consistent with fampridine's pharmacological activity.
To je v skladu s farmakološko aktivnostjo fampridina.
If an anaphylactic or other serious allergic reaction occurs, Fampyra should be discontinued and not restarted.
Če se pojavi anafilaktična ali druga resna alergijska reakcija, je treba uporabo zdravila Fampyra prekiniti in z njo ne nadaljevati.
Study 218MS305 was conducted in 636 subjects with multiple sclerosis and walking disability.
Študijo 218MS305 so opravili pri 636 bolnikih z multiplo sklerozo in nezmožnostjo hoje.
Renal clearance (CLR 370 ml/min) is substantially greater than glomerular filtration rate due to combined glomerular filtration and active excretion by the renal OCT2 transporter.
Ledvični očistek (CLR 370 ml/min) je znatno višji kot stopnja glomerularne filtracije zaradi kombinirane glomerularne filtracije in aktivnega izločanja prek ledvičnega transporterja OCT2.
What Fampyra is and what it is used for
Kaj je zdravilo Fampyra in za kaj ga uporabljamo
• Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra
• Na začetku je treba zdravljenje omejiti na dva do štiri tedne, saj se klinične koristi praviloma pokažejo v roku dveh do štirih tednov po uvedbi zdravila Fampyra.
− if you feel aware of your heartbeat (palpitations)
− če se zavedate bitja svojega srca (palpitacije).
− if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
− če ste alergični na fampridin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting.
Varnost zdravila Fampyra so ocenili v randomiziranih kontroliranih kliničnih študijah, v odprtih dolgoročnih študijah in po začetku trženja.
• Worsening of nerve pain in the face (trigeminal neuralgia)
• poslabšanje bolečine živca na obrazu (nevralgija trigeminalnega živca)
This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.
Zdravilo deluje tako, da omogoča normalnejši pretok signala po živcu, kar vam omogoča, da bolje hodite.
The clinical relevance of these findings remains to be elucidated, but a causal relationship with fampridine treatment cannot be excluded.
Klinični pomen teh izsledkov je treba še pojasniti, toda vzročnega razmerja z zdravljenjem s fampridinom ni mogoče izključiti.
Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Ireland
Proizvajalec: Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Irska
Presumably, by enhancing action potential formation, more impulses might be conducted in the central nervous system.
Domneva se, da se lahko s povečanim nastajanjem akcijskega potenciala v osrednji živčni sistem prevede več impulzov.
Your doctor will give you an initial prescription for 2 to 4 weeks.
Zdravnik vam lahko na začetku predpiše zdravilo za 2 do 4 tedne.
Viral infection1
virusna infekcija1
Side effects are listed below by frequency:
Neželeni učinki so našteti spodaj po pogostnosti:
See section 4.
1Glejte poglavje 4.4.
Adverse reactions are presented below by system organ class and absolute frequency.
Neželeni učinki so spodaj razvrščeni po organskih sistemih in absolutni pogostnosti.