natgillin/translations-raw huggingface dataset:
Why is Febuxostat Mylan approved?
Zakaj je bilo zdravilo Febuksostat Mylan odobreno?
The active substance in Febuxostat Mylan, febuxostat, reduces the formation of uric acid.
Zdravilna učinkovina zdravila Febuksostat Mylan, febuksostat, zmanjša tvorjenje sečne kisline.
How is Febuxostat Mylan used?
Kako se zdravilo Febuksostat Mylan uporablja?
Febuxostat Mylan treatment should not be stopped if an attack of gout occurs.
V primeru zagona protina se zdravljenje z zdravilom Febuksostat Mylan ne sme prekiniti.
How does Febuxostat Mylan work?
Kako zdravilo Febuksostat Mylan deluje?
How has Febuxostat Mylan been studied?
Kako je bilo zdravilo Febuksostat Mylan raziskano?
The procedure should be carried out under sterile conditions.
Postopek je treba izvajati v sterilnih pogojih.
What measures are being taken to ensure the safe and effective use of Jetrea?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jetrea?
The European Commission granted a marketing authorisation valid throughout the European Union for Jetrea on 13 March 2013.
Evropska komisija je dovoljenje za promet z zdravilom Jetrea, veljavno po vsej Evropski uniji, izdala 13. marca 2013.
The other eye should not be treated with Jetrea for at least 7 days.
Drugo oko se z zdravilom Jetrea ne sme zdraviti najmanj sedem dni.
The full EPAR for Jetrea 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 Jetrea 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 Jetrea.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jetrea.
After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81).
Po 28 dneh so rezultati pokazali odpravo adhezije pri 25 % oziroma 28 % (61 od 219 oziroma 62 od 245) bolnikov, ki so prejeli injekcijo zdravila Jetrea, v primerjavi s 13 % oziroma 6 % (14 od 107 oziroma 5 od 81) bolnikov, ki so prejeli placebo.
What benefits of Jetrea have been shown in studies?
Kakšne koristi je zdravilo Jetrea izkazalo v študijah?
What is Jetrea and what is it used for?
Kaj je zdravilo Jetrea in za kaj se uporablja?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh 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 Jetrea večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated.
Priporočeni odmerek je 0,125 mg, ki se daje z enkratnim injiciranjem v prizadeto oko in se ne sme ponoviti.
Other information about Jetrea
Druge informacije o zdravilu Jetrea
Although the effects shown were modest (resolution of vitreomacular adhesion in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery.
Čeprav so bili učinki zdravila skromni (odprava vitreaomakularne adhezije pri četrtini bolnikov), so bili ocenjeni kot pomembni, saj lahko zdravljenje izboljša vid in odpravi potrebo po kirurškem posegu.
Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself.
Kar zadeva varnost zdravila, so bili najpogostejši neželeni učinki kratkotrajni in ocenjeni kot obvladljivi ter so se pogosto pojavili kot odziv na injiciranje ali pa so bili povezani z odpravo same bolezni.
In two main studies involving 652 adults with vitreomacular adhesion and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment).
V dveh glavnih študijah, ki sta vključevali 652 odraslih z vitreomakularno adhezijo in poslabšanim vidom, so bolniki prejeli eno intravitrealno injekcijo 0,125 mg zdravila Jetrea ali injekcijo placeba (zdravila brez zdravilne učinkovine).
What are the risks associated with Jetrea?
Kakšna tveganja so povezana z zdravilom Jetrea?
Why is Jetrea approved?
Zakaj je bilo zdravilo Jetrea odobreno?
Jetrea must not be used in patients who have or are thought to have infections in or around the eyes.
Zdravila Jetrea ne smejo uporabljati bolniki, ki imajo ali utegnejo imeti okužbo v očesu ali okoli njega.
It is not intended to provide practical advice on how to use Jetrea.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It contains the active substance ocriplasmin.
Vsebuje zdravilno učinkovino okriplazmin.
The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain, photopsia (flashes of light in the field of vision) and chromatopsia (changes in colour perception), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye).
Najpogostejši neželeni učinki so delci v steklovini (majhne, temne pike, pogosto nepravilnih oblik, v vidnem polju), bolečina v očesu, fotopsija (utrinki svetlobe v vidnem polju) in kromatopsija (spremembe v zaznavanju barv) ter krvavitev v očesni veznici (krvavitev v membrani, ki prekriva beli del očesa).
Jetrea is a solution for injection into the eye.
Zdravilo Jetrea je raztopina za injiciranje v oko.
For more information about treatment with Jetrea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Jetrea preberite navodilo za uporabo (ki je prav tako del EPAR) 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 Jetrea have also 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 Jetrea upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.
Tveganje za resnejše neželene učinke, kot so trajno poslabšanje vida, druge spremembe delovanja mrežnice ali podpornih struktur leče, je majhno.
For practical information about using Jetrea, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Jetrea naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients.
Družba, ki trži zdravilo Jetrea, mora zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi to zdravilo uporabljali, prejeli povzetek glavnih značilnosti zdravila in informativno gradivo za bolnike.
The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.
Zdravilna učinkovina zdravila Jetrea, okriplazmin, je podobna humanemu plazminu, tj. encimu, ki je naravno prisoten v očesu in ima sposobnost razgradnje beljakovin med steklovino in mrežnico, ki so odgovorne za adhezijo, s čimer zmanjšuje otekanje mrežnice in izboljšuje vid.
The side effects seen with Jetrea affect the eye.
Neželeni učinki, opaženi pri uporabi zdravila Jetrea, prizadenejo oko.
Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye).
Vitreomakularno trakcijo povzroča vitreomakularna adhezija, pri kateri je steklovina nenormalno tesno vezana na osrednji del mrežnice (na svetlobo občutljive membrane v ozadju očesa).
Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction.
Študije so pokazale, da je bilo zdravilo Jetrea učinkovito pri zdravljenju vitreomakularne adhezije, zato naj bi bilo učinkovito tudi pri preprečevanju poslabšanja vida, do katerega lahko pride zaradi nezdravljene in napredovale vitreomakularne trakcije.
Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina.
Uspešno zdravljenje vitreomakularne adhezije lahko pomaga odpraviti motnje vida zaradi vitreomakularne trakcije in preprečiti nadaljnjo izgubo vida zaradi nezdravljene in napredovale trakcije mrežnice.
The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections.
Oftalmolog lahko pred zdravljenjem z zdravilom Jetrea in po njem predpiše antibiotične kapljice za oko za preprečevanje očesnih okužb.
Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance.
Zdravilo Jetrea se uporablja za zdravljenje odraslih z vitreomakularno trakcijo, tj. očesno boleznijo, ki lahko povzroči hude motnje vida.
It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye).
Predpisovanje in izdaja zdravila je le na recept, injicirati pa ga mora ustrezno usposobljeni oftalmolog (specialist za oči), ki ima izkušnje z dajanjem intravitrealnih injekcij (injiciranjem v steklovino, tj. želatini podobno tekočino v očesu).
Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.
Zdravilo Jetrea se je med študijami izkazalo za učinkovito pri odpravi adhezije med steklovino in mrežnico, s čimer se je zmanjšala potreba po kirurškem posegu.
For the full list of all side effects reported with Jetrea, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jetrea, glejte navodilo za uporabo.
When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.
Ko se steklovina z leti skrči, zaradi tesne vezave za seboj povleče tudi mrežnico, kar povzroči otekanje mrežnice in privede do zamegljenega ali popačenega vida.
How does Jetrea work?
Kako zdravilo Jetrea deluje?
How is Jetrea used?
Kako se zdravilo Jetrea uporablja?
Member State (in EEA)
Država članica (v EGP)
(Invented) Name Strength
(Izmišljeno) Ime Jakost
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
4 mg/40 mg tablet
4 mg/40 mg tableta peroralna uporaba
0.10 g/1 g per 100 ml oral solution
0.10 g/1 g na 100 ml peroralna raztopina peroralna uporaba
VASOBRAL, solution buvable en flacon
VASOBRAL, peroralna raztopina v viali
VASOBRAL, comprimé sécable
VASOBRAL, zarezo tableta
Marketing Authorisaton Holder
Imetnik dovoljenja za promet z zdravilom
The Committee also noted that the last study performed in infants below one year was completed in 2001.
Prav tako je bil Odbor seznanjen, da je bila zadnja raziskava, opravljena na dojenčkih, mlajših od enega leta, zaključena leta 2001.
There is no evidence that either short or long term protection has been impacted.
Nikakršnih dokazov ni o vplivu na kratkoročno ali dolgoročno zaščito.
It was considered that a decision will be taken according to the responses given on quality and clinical concerns.
Sklenil je, da bo odločitev temeljila na odgovorih o kakovosti in kliničnih zadržkih.
These changes, in principle, address the concerns raised by the CHMP and its Working Parties.
Te spremembe se načeloma naslavljajo na zadržke, ki so se pojavili pri CHMP in njegovih delovnih skupinah.
In the past experience, there has never been an instance when high performance in adolescents and young adults did not correspond with high performance in infants.
V preteklih izkušnjah se še ni zgodilo, da bi velik učinek pri mladostnikih in mladih odraslih ne odgovarjal velikemu učinku pri dojenčkih.
Therefore, the results of this study provide evidence that the currently available product is providing the expected level of protective antibodies in all populations for which it is indicated.
Zato rezultati te raziskave dokazujejo, da daje trenutno razpoložljiv izdelek pričakovano raven zaščitnih protiteles v vseh populacijah, za katere je indiciran.
There are some indications that the Hep B vaccine currently produced is less immunogenic than the vaccine produced in the 1990's.
Nekaj indikacij kaže na to, da je cepivo Hep B, ki se trenutno izdeluje, manj imunogeno kot cepivo, izdelano v 90-ih letih prejšnjega stoletja.
Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows:
V pričakovanju izida raziskav se imetnik dovoljenja za promet zavezuje k dopolnitvi poglavij 4.2, 4.4, 4.5 (kjer je primerno) in 5.1 v SPC z naslednjim besedilom:
The CHMP endorsed the new product information and agreed to finalise the article 20 procedure without any further regulatory action.
CHMP je potrdil nove podatke o izdelku in sklenil brez nadaljnjih regulatornih ukrepov dokončati postopek iz člena 20.
Information will be provided to health care professionals and will ensure that the vaccine will be correctly used in the different age and risk categories.
Podatki bodo na voljo zdravnikom in bodo zagotavljali pravilno uporabo cepiva v različnih starostnih kategorijah in kategorijah tveganja.
The reason for decreasing immunogenicity over several years remains still unidentified.
Razlog za večletno padajočo imunogenost še ni znan.
These trials were carried out in different risk groups and age categories, i.e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.
Preizkušanje so izvedli v različnih skupinah tveganja in starostnih kategorijah, npr. otrocih, rojenih hepatitis B pozitivnim materam, dojenčkih, zdravih mladih odraslih in zdravih osebah, starih od 16 do 35 let.
The results from these three trials with product manufactured in the current facility, confirm solid, reproducible performance based on these recent historical data and should also predict performance as expected in other populations as well.
Rezultati teh treh preizkušanj, kjer je izdelek proizveden v trenutni ustanovi, potrjujejo trdno, ponovljivo delovanje, ki temelji na teh nedavnih historičnih podatkih in prav tako napoveduje pričakovano delovanje v drugih populacijah.
The most recent immunogenicity data comes from the interim analysis of the V232-054 trial, this is the third trial in the past few years to study the current product (from the BTMC manufacturing facility) in young adults using the same dosing schedule (the other two trials are V501-011 and V232052).
Najnovejši podatki imunogenosti prihajajo iz vmesne analize preizkušanja V232-054, to je tretjega preizkušanja v zadnjih nekaj letih, ki preučuje trenutni proizvod (iz proizvodne ustanove BTMC) na mladih odraslih z enakim urnikom odmerjanja (drugi dve preizkušanji sta V501-011 in V232-052).
The CHMP debated the current lack of knowledge about the clinical significance of the findings and immune memory in general and agreed that these issues needed to be carefully explored before deciding on regulatory action.
CHMP je razpravljal o trenutnem pomanjkanju znanja o kliničnem pomenu izsledkov in o imunološkem spominu na splošno ter je sklenil, da je potrebno pred uvedbo regulatornih ukrepov ta vprašanja temeljito proučiti.
As a consequence the data obtained so far must be interpreted with caution since they were generated using the paediatric (5µg) dose of Hep B vaccine produced before 2001.
Zato je treba do sedaj zbrane podatke pazljivo razlagati, saj so bili sproženi z otroškim (5µg ) odmerkom cepiva Hep B, izdelanim pred letom 2001.
Although the root cause for reduced immunogenicity during the past 5 years is still not ascertained, evidence was provided that the manufacturing process seems now to be better controlled.
Kljub temu, da temeljni razlog za znižano imunogenost v zadnjih petih letih še vedno ni ugotovljen, dokazi kažejo, da je proizvodni postopek danes bolje nadzorovan.
• The use of this vaccine will not pose an immediate risk to any of the target groups the vaccine is indicated for.
• Uporaba tega cepiva ne bo predstavljala neposrednega tveganja za katerokoli ciljno skupino, kateri je cepivo namenjeno.
Due to the relatively high risk of infection, the group of infants born to Hepatitis B positive mothers represents the population, which would be most vulnerable to a possible insufficient immunogenicity of the vaccine.
Zaradi relativno visokega tveganja za okužbo predstavlja skupina dojenčkov, rojenih hepatitis B pozitivnim materam, populacijo, ki bi bila najbolj občutljiva za nezadostno imunogenost cepiva.
The CHMP concluded that the use of this vaccine will not pose an immediate risk to any of the target groups the vaccine is indicated for.
CHMP je zaključil, da uporaba tega cepiva ne bo predstavljala neposrednega tveganja za katerokoli ciljno skupino, kateri je cepivo namenjeno.
The MAH developed an upgraded manufacturing process to increase immunogenicity.
Imetnik dovoljenja za promet je razvil posodobljen proizvodni postopek za povečanje imunogenosti.
• The need of the 4th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used
• Pri skrčeni shemi odmerjanja pri 0, 1, 2 in 12 mesecih se je povečala potreba po četrtem odmerku pri 12-ih mesecih.
• The recommendations for serologic testing, and administration of additional doses if needed, in immunocompromised patients, in non-responders of other high risk groups, and in the case of presumed exposure to hepatitis B, have been strengthened.
• Priporočila za serološko testiranje in odmerjanje dodatnih odmerkov, če so potrebni, pri imunsko oslabljenih bolnikih, pri bolnikih drugih tveganih skupin, ki se ne odzivajo, in v primeru predpostavljene izpostavljenosti hepatitisu B, so bili ojačani.
As there are currently no reports on increased numbers of Hepatitis B breakthrough cases after HBVAXPRO vaccination, considering that the EU is a low endemic region, no immediate safety signal could be identified by the CHMP.
Ker trenutno ne poročajo o povečanem številu primerov izbruha hepatitisa B po cepljenju s cepivom HBVAXPRO in ob upoštevanju, da je EU nizko endemično območje, CHMP ne vidi nikakršnega takojšnjega opozorilnega signala.
• The concomitant administration of pneumococcal conjugate vaccine is not recommended since this has not been sufficiently studied for HBVAXPRO.
• Sočasno uporaba pnevmokoknega konjugiranega cepiva ni priporočena, saj tovrstne raziskave za HBVAXPRO niso bile opravljene.
In addition, a review of clinical performance as assessed by protection against disease as noted in the V121-018 trial supports the conclusion that the hepatitis B vaccines remain effective in decreasing hepatitis B infection and its serious sequelae.
Poleg tega pregled kliničnih učinkov, opredeljenih kot zaščita pred boleznijo, kot je navedeno v preizkušanju V121-018, podpira zaključek, da ostajajo cepiva proti hepatitisu B učinkovita pri zmanjševanju okužb s hepatitisom B in njihovih resnih posledic.
Revised SPCs and PLs provide updated information in relation to best use of the product considering latest clinical data.
Spremenjen Povzetek glavnih značilnosti zdravila (SPC) in Navodila za uporabo vsebujeta posodobljene podatke o najboljši uporabi izdelka, upoštevajoč najnovejše klinične podatke.
The clinical issues were discussed with the MAH at the Vaccine Working Party (VWP) during its February 2006 meeting, while the quality issues were discussed at the February 2006 BWP meeting.
Na zasedanju delovne skupine za cepiva (VWP) februarja 2006 je z imetnikom dovoljenja za promet obravnaval klinična vprašanja, medtem ko so vprašanja o kakovosti obravnavali na zasedanju delovne skupine za biotehnologijo (BWP) februarja 2006.
Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with HBVAXPRO and further to the assessment of the data provided by the MAH, the CHMP concluded that the MA of HBVAXPRO should be varied in accordance with Article 5(1) of Regulation (EC) No. 726/2004.
Ob upoštevanju vseh različnih točk, vključno s časovno razporeditvijo, potrebno za pregled vseh vprašanj glede nizke imunogenosti HepB po cepljenju s HBVAXPRO, do ocene podatkov, ki jih je podal imetnik dovoljenja za promet, je CHMP zaključil, da mora biti dovoljenje za promet s cepivom HBVAXPRO spremenjeno v skladu s členom 5(1) Uredbe (ES) št. 726/2004.
Potential remaining risks will be minimised to an acceptable level by the fundamentally revised SPC.
Bistveno spremenjen SPC bo ostala možna tveganja zmanjšal na sprejemljivo stopnjo.
The CHMP also considered the commitments given by the MAH in response to CHMP's requests to meticulously control the performance of HBVAXPRO from now on in a broad array of appropriate clinical trials including all age and risk categories.
Prav tako je CHMP upošteval obljubo imetnika dovoljenja za promet, kot odgovor na prošnjo odbora CHMP, naj od sedaj dalje temeljito preverja delovanje cepiva HBVAXPRO v širokem spektru primernih kliničnih preizkušanj, vključno z vsemi starostnimi kategorijami in kategorijami tveganja.
In addition to the immunogenicity data generated in the past 5 years from clinical trials with the HBVAXPRO and PROCOMVAX data, the acceptable performance of these vaccines are supported from findings of surveillance for hepatitis B cases in the United States and New Zealand and from an analysis of the trend in vaccine failures reported to the MAH safety database.
Poleg podatkov o imunogenosti, zbranih v zadnjih petih letih iz kliničnih preizkušanj s podatki cepiv HBVAXPRO in PROCOMVAX, je sprejemljivo delovanje teh cepiv podprto z ugotovitvami nadzora nad primeri hepatitisa B v ZDA in Novi Zelandiji ter iz analize trenda neuspešnega cepljenja, podanega varnostni podatkovni bazi imetnika dovoljenja za promet.
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component and that following extensive review of the manufacturing process the MAH has identified the current adjuvantation process as a potential root cause for decreased immunogenicity of the HepB vaccine component.
• CHMP je ugotovil, da je vzrok za zmanjšano imunogenost sestavine HepB, ki jo je izdal imetnik dovoljenja za promet, v spremenljivosti proizvodnega postopka za to sestavino in da je po temeljitem pregledu proizvodnega postopka imetnik dovoljenja za promet ugotovil, da je možni temeljni vzrok za zmanjšano imunogenost sestavine HepB cepiva sedanji pomožni postopek.