natgillin/translations-raw huggingface dataset:
Since Raxone has been approved under exceptional circumstances, the company that markets Raxone will conduct additional studies on the long-term effects and safety of Raxone, and will establish and maintain a registry of LHON patients treated with Raxone.
Ker je zdravilo Raxone pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, zagotovila izvedbo dodatnih študij o dolgoročnih učinkih in varnosti zdravila Raxone ter vzpostavila in vzdrževala register bolnikov z LKON, zdravljenih z zdravilom Raxone.
Why is Raxone approved?
Zakaj je bilo zdravilo Raxone odobreno?
Additional supportive data on the benefits of Raxone came from an expanded access program through which Raxone was made available to individual patients not participating in a clinical study, and from a case record survey, which included data from patients with LHON who did not receive any treatment.
Dodatni podporni podatki o koristih zdravila Raxone izhajajo iz programa razširjenega dostopa, v katerem je bilo zdravilo Raxone na voljo posameznim bolnikom, ki niso sodelovali v klinični študiji, in raziskave primerov v evidenci, ki je vključila podatke bolnikov z LKON, ki niso prejeli nobenega zdravljenja.
The full EPAR and risk management plan summary for Raxone 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 Raxone sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefits of Raxone have been shown in studies?
Kakšne koristi je zdravilo Raxone izkazalo v študijah?
This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.
To pomeni, da mitohondriji niso zmožni pravilno ustvarjati energije, zato tvorijo strupene oblike kisika (proste radikale), ki poškodujejo živčne celice v očesu, potrebne za vid.
What are the risks associated with Raxone?
Kakšna tveganja so povezana z zdravilom Raxone?
The most common side effects with Raxone (which may affect more than 1 in 10 people) are nasopharyngitis and cough; mild to moderate diarrhoea and back pain are also common (affecting up to 1 in 10 people).
Najpogostejša neželena učinka zdravila Raxone (ki lahko prizadeneta več kot 1 osebo od 10) sta nazofaringitis in kašelj, pogosta (ki lahko prizadeneta največ 1 osebo od 10) pa sta tudi blaga do zmerna driska in bolečina v hrbtu.
Idebenone is thought to help improve production of energy by restoring mitochondrial function, thereby preventing the cellular damage and the loss of sight seen in LHON.
Menijo, da idebenon pomaga izboljšati tvorbo energije, tako da ponovno vzpostavi delovanje mitohondrijev, kar preprečuje celično poškodbo in izgubo vida, povezano z LKON.
For the full list of all side effects and restrictions with Raxone, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Raxone glejte navodilo za uporabo.
Raxone can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in LHON.
Izdaja zdravila Raxone je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z LKON.
What information is still awaited for Raxone?
Katere informacije o zdravilu Raxone še pričakujemo?
Raxone has been investigated in one main study involving 85 patients with LHON, in which it was compared with placebo (a dummy treatment) over 24 weeks.
Zdravilo Raxone so raziskali v eni glavni študiji, ki je vključila 85 bolnikov z LKON, v kateri so ga 24 tednov primerjali s placebom (zdravilom brez zdravilne učinkovine).
For practical information about using Raxone, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Raxone naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Raxone, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Raxone in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
With regard to the safety of Raxone, the majority of side effects seen with the medicine were mild or moderate in intensity.
Z varnostnega vidika je bila resnost večine neželenih učinkov zdravila Raxone blaga ali zmerna.
Analyses of all these data showed a consistent pattern whereby generally a larger proportion of patients treated with Raxone had vision improvement compared with untreated or placebo-treated patients.
Analize vseh teh podatkov so pokazale dosleden vzorec, pri katerem je na splošno izboljšanje vida doseglo več bolnikov, zdravljenih z zdravilom Raxone, kot nezdravljenih bolnikov ali bolnikov, ki so prejemali placebo.
How does Raxone work?
Kako zdravilo Raxone deluje?
Raxone contains the active substance idebenone.
Zdravilo Raxone vsebuje zdravilno učinkovino idebenon.
How is Raxone used?
Kako se zdravilo Raxone uporablja?
The results of the main study showed an improvement in vision in patients treated with Raxone, and this trend towards a beneficial effect was confirmed by additional data from an expanded access program and a case record survey.
Ta koristen učinek so potrdili tudi z dodatnimi podatki iz programa z razširjenim dostopom in raziskave primerov iz evidence.
10 (2 x 5) pre-filled pens
10 (2 x 5) napolnjenih injekcijskih peresnikov
Route of Administration
Farmacevtska oblika Pot uporabe Stična ovojnina
EU Procedure number Invented name Strength Pharmaceutical Form
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
Package size
Številka EU
Date of first authorisation: 20 September 2006 Date of latest renewal: 15 July 2016
Datum pridobitve dovoljenja za promet: 20. september 2006 Datum zadnjega podaljšanja: 15. julij 2016
They will calculate the right dose for you.
Izračunal bo za vas primeren odmerek.
No interaction studies have been performed and no other forms of interaction have been identified.
Študij medsebojnega delovanja niso izvedli niti niso ugotovili drugih oblik interakcij.
• altered taste,
• spremenjen okus,
In the case of overdose the doctor will take appropriate action.
V primeru prevelikega odmerjanja bo zdravnik uvedel ustrezne ukrepe.
Pack sizes of 1 or 4 vials.
Pakiranji z 1 ali 4 vialami.
Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied in these groups
Zdravilo Luminity se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let), saj se ni preučevalo pri teh skupinah.
The safety and efficacy of Luminity in children and adolescents below 18 years have not been established.
Učinkovitost in varnost zdravila Luminity pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The contents of the vial are intended for single use only.
Vsebina viale je namenjena le za enkratno uporabo.
In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
V nekaterih primerih se lahko zdravnik za dokončanje ultrazvočne preiskave odloči za uporabo dveh injiciranj.
This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
S tem se zagotovi, da se zdravilo stresa na pravilen način in dovolj dolgo, da nastane »disperzija« mikrosfer s plinom perflutrenom ustrezne velikosti, da se pridobi kakovostna slika.
Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.
Zdravljenje prevelikega odmerjanja mora biti usmerjeno v podporo vseh vitalnih funkcij in takojšnjo uvedbo simptomatskega zdravljenja.
EU/1/06/361/001 4 single-dose vials EU/1/06/361/002 1 single-dose vial
EU/1/06/361/001 4 viale z enim odmerkom EU/1/06/361/002 1 viala z enim odmerkom
Patients on mechanical ventilation
Bolniki na mehanični ventilaciji
These levels are substantially above the recommended maximal clinical dose.
Te koncentracije so bistveno nad priporočenim največjim kliničnim odmerkom.
It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests).
Je kontrastno sredstvo (zdravilo, ki pomaga pri pregledovanju struktur v telesu med preiskavami s slikanjem).
EXP After activation: use within 12 hours
EXP: Po aktiviranju: uporabite v 12 urah.
The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
Najpogosteje opisani neželeni učinki so glavobol (2,0 %), zardevanje (1,0 %) in bolečine v hrbtu (0,9 %).
In addition, some patients may experience convulsions, which may be associated with these allergic reactions.
Razen tega se pri nekaterih bolnikih lahko pojavijo tudi epileptični krči, ki so lahko povezani s temi alergijskimi reakcijami.
It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Prav tako je programiran, da se izključi in odda vidno in slišno opozorilo, če frekvenca stresanja preseže ciljno frekvenco za 5 % ali se zmanjša za 10 % pod njo.
In clinical trials these reactions were reported rarely and for post-marketing reports the frequency is not known.
V kliničnih preskušanjih so o teh reakcijah poročali redko, pri poročilih po pridobitvi dovoljenja za promet pa pogostnost ni znana.
Higher doses of the product, typically ≥ 1 ml/kg, resulted in more severe signs including unresponsiveness and occasionally death.
Večji odmerki zdravila, praviloma ≥ 1 ml/kg, so povzročili hujše znake, vključno z neodzivnostjo in, občasno, s smrtjo.
No air should be injected into the vial.
V vialo ne smete injicirati zraka.
Fertility Animal studies do not indicate direct or indirect harmful effects on fertility.
Plodnost Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na plodnost.
Emergency equipment and personnel trained in its use must be readily available.
Oprema za nujne primere in osebje, usposobljeno za njeno uporabo, mora biti vedno nemudoma na voljo.
Pharmacokinetics in special population groups
Farmakokinetika pri posebnih skupinah bolnikov
A strict dose/response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
Natančnega razmerja med odmerkom in odzivom ni mogoče opredeliti, je pa ugotovljeno, da imajo veliki odmerki dolgotrajnejši kontrasten učinek.
These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use.
Te učinke so opazili samo pri izpostavljenostih, ki so presegale največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Vialmix operaterja opozori, če je frekvenca stresanja 5 % ali več pod ciljno frekvenco.
For perflutren, no clinical data on exposed pregnancies are available.
Za perflutren ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood.
Intenzivnost dopplerskega signala se je dobro ujemala z izmerjenimi in ekstrapoliranimi koncentracijami perflutrena v krvi.
Adverse reactions were reported with the following frequencies (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).
< 1/10; občasni ≥ 1/1.000 do < 1/100; redki ≥ 1/10.000 do < 1/1.000; zelo redki < 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
It is not known whether Luminity is excreted in human breast milk.
Ni znano, ali se zdravilo Luminity pri človeku izloča v materinem mleku.
Note: if the product is allowed to stand for more than 5 minutes after activation, it should be resuspended with 10 seconds of hand agitation prior to syringe withdrawal from the vial.
Opomba: če izdelek stoji več kot 5 minut po aktiviranju, ga morate resuspendirati tako, da ga 10 sekund ročno tresete, preden ga z brizgo potegnete iz viale.
Other medicines and Luminity
Druga zdravila in zdravilo Luminity
• reduced blood pressure,
• znižan krvni tlak,
Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration.
Bolnike z nestabilnim kardiopulmonalnim stanjem je treba nadzirati med in še najmanj 30 minut po uporabi zdravila Luminity.
CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Izkazalo pa se je, da je CLpljučni bistveno manjši (51 %) pri ženskah kot pri moških (vsi preiskovanci).
Some patients may experience allergic type reactions such as swelling of the face.
Pri nekaterih bolnikih se lahko pojavijo alergijske reakcije, npr. otekanje obraza.
There is however a risk that these allergic type reactions become severe and may include anaphylactic shock (a serious, potentially life-threatening allergic response).
Te alergijske reakcije lahko postanejo resne in lahko vključujejo tudi anafilaktični šok (resen, morebitno smrtno nevaren alergijski odziv).
The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Čas do največje intenzivnosti dopplerskega signala tmax je bil podoben tmax perflutrena v krvi (1,13 minute v primerjavi z 1,77 minute).
These side effects usually go away quickly without any treatment.
• sprememba vida Ti neželeni učinki ponavadi minejo hitro brez kakršnegakoli zdravljenja.
The observed 99% drop in Doppler signal intensity within 10 minutes (t1/2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
Opaženi 99 % padec intenzivnosti dopplerskega signala v 10 minutah (t1/2 približno 2 minuti) se sklada z upadanjem merljive koncentracije perflutrena v krvi.
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Irska
The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs.
Perflutrenska sestavina zdravila Luminity se je iz sistemskega obtoka hitro odstranila skozi pljuča.
Use in this patient group should be on the basis of a benefit risk assessment by the physician.
Uporaba pri tej skupini bolnikov mora temeljiti na zdravnikovi oceni razmerja med tveganji in koristmi.
The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans.
Farmakokinetika in presnova MPEG5000 DPPE pri človeku nista ugotovljeni.
These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects.
Ti izsledki kažejo, da je celokupna sistemska eliminacija perflutrena hitra in da pri bolnikih s KOPB ni bistveno manjša kot pri zdravih preiskovancih.
Pulmonary disease
Pljučna bolezen
Resuscitation equipment and trained personnel must always be readily available.
Ves čas mora biti nemudoma na voljo oprema za oživljanje in ustrezno usposobljeno osebje.
The safety of microspheres in patients on mechanical ventilation has not been established.
Varnost mikrosfer pri bolnikih na mehanični ventilaciji ni ugotovljena.
If you are given more Luminity than you should
Če ste dobili večji odmerek zdravila Luminity, kot bi smeli
Excipient(s) with known effect Each ml contains 2.679 mg sodium
Pomožna(e) snov(i) z znanim učinkom: En ml vsebuje 2,679 mg natrija.
Luminity is for intravenous use (direct injection into the vein).
Zdravilo Luminity je namenjeno intravenski uporabi (neposrednemu injiciranju v veno).
The product should be used immediately after its withdrawal from the vial.
Zdravilo morate uporabiti takoj, ko ga potegnete iz viale.
Luminity has no effect on the ability to drive and use machines.
Zdravilo Luminity nima vpliva na sposobnost vožnje in upravljanja s stroji.
The percentage of the perflutren dose excreted in expired air was approximately 50% of the administered dose due to the small quantities of perflutren given and the inability to quantify low levels of perflutren by gas chromatography.
Odstotek odmerka perflutrena, ki se je izločil v izdihanem zraku, je bil približno 50 % apliciranega odmerka; to je posledica majhne količine apliciranega perflutrena in nemožnosti za kvantificiranje nizkih koncentracij perflutrena s plinsko kromatografijo.
Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds.
Zdravilo Luminity aktivirate z Vialmixom, ki ima programiran čas stresanja 45 sekund.
The naturally occurring phospholipids in Luminity (see section 6.1) are distributed in the endogenous lipid pools in the body (for example, liver) whereas the synthetic component (MPEG5000) has been shown to be excreted in the urine in preclinical studies.
Naravni fosfolipidi, ki jih vsebuje zdravilo Luminity (glejte poglavje 6.1), se porazdelijo v endogenih zbirih lipidov v telesu (npr. v jetrih), za sintetično sestavino (MPEG5000) pa so v predkliničnih študijah ugotovili, da se izloči v urinu.
What you need to know before you use Luminity Do not use Luminity
Kaj morate vedeti, preden boste uporabili zdravilo Luminity Ne uporabljajte zdravila Luminity
It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Nujno morate upoštevati navodila za uporabo in ravnanje z zdravilom Luminity, med pripravo pa strogo skrbeti za aseptičnost postopka.
The ultrasound echoes from blood and biological soft tissues such as fat and muscles are generated at interfaces due to small differences in the ultrasonic properties of the tissues.
Ultrazvočni odboji od krvi in bioloških mehkih tkiv, npr. maščevja in mišic, nastanejo na mejni površini zaradi majhnih razlik v ultrazvočnih lastnostih teh tkiv.
What Luminity is and what it is used for
Kaj je zdravilo Luminity in za kaj ga uporabljamo
Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Irska
Contents of the pack and other information What Luminity contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Luminity
The way Luminity is given and the dose depend on the technique used for the echocardiography.
Način dajanja zdravila Luminity in njegov odmerek sta odvisna od tehnike, ki se uporabi pri ehokardiografiji,
- The active substance is perflutren.
Učinkovina je perflutren.
Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.
Previdnost je potrebna pri bolnikih s klinično pomembno boleznijo pljuč, vključno z difuzno intersticijsko pljučno fibrozo in hudo kronično obstruktivno pljučno boleznijo, saj študije pri teh bolnikih niso bile izvedene.
It is available in a pack containing one or four single-use 1.5 ml vials.
Na voljo je v pakiranjih, ki vsebujejo eno in štiri 1,5-ml viale za enkratno uporabo.
The clinical consequences of overdose with Luminity are not known.
Klinične posledice prevelikega odmerka zdravila Luminity niso znane.
The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Vialmix ni priložen pakiranju zdravila Luminity, a ga bodo zdravniki dobili, ko bodo naročili pakiranje.
The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute.
Potem jo prilagodite, kot je potrebno za optimalno ojačitev slike, ne sme pa preseči 10 ml/minuto.
Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of perflutren.
Dopplerske ultrazvočne meritve z zdravilom Luminity so opravili hkrati s farmakokinetično analizo perflutrena.
Before use, this medicine must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
To zdravilo je treba aktivirati s stresanjem v mehaničnem pripomočku, imenovanem Vialmix, ki se dobavi zdravnikom, ki ga potrebujejo za pripravo zdravila.
This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
To zdravilo vsebuje 103,5 mg/ml propilenglikola, kar ustreza 182,2 mg propilenglikola na vialo.
Immediately after activation, Luminity appears as a milky white dispersion.
Takoj po aktiviranju je zdravilo Luminity videti kot mlečno bela disperzija.
Rare: Abnormal electrocardiogram
Preiskave redki: nenormalen elektrokardiogram
Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Zdravilo Luminity se ne sme uporabljati pri osnovnih načinih slikanja med obremenitveno ehokardiografijo, saj učinkovitost in varnost nista bili dokazani.
Luminity contains propylene glycol.
Luminity vsebuje propilenglikol.
In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation.
Pri takšnih bolnikih lahko fosfolipidno inkapsulirane mikrosfere obidejo pljuča in pridejo neposredno v arterijski obtok.
Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management.
Kontrastna ehokardiografija se sme izvesti le pri bolnikih, pri katerih bi rezultati tovrstne preiskave lahko bistveno vplivali na potek zdravljenja posameznega bolnika.
Activation process and administration
Postopek aktiviranja in apliciranja
1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.
1,5 ml tekočine v viali iz bistrega borosilikatnega stekla tipa I, zaprti s klorobutilnim elastomernim liofilizacijskim zamaškom, zapečateni z aluminijsko obrobo in pokriti s plastičnim dvižnim gumbom.
If Luminity is administered directly to the patient without undergoing the mechanical activation procedure using the Vialmix (see section 6.6), the product will not produce its intended effect.
Če zdravilo Luminity aplicirate, ne da bi ga pred tem mehanično aktivirali z Vialmixom (glejte poglavje 6.6), ne bo imel želenega učinka.
• and abnormal electrocardiogram.
• nenormalen elektrokardiogram.
The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored under refrigeration or at room temperature.
Zdravilo lahko reaktivirate do 48 ur po prvem aktiviranju in ga uporabite do 12 ur po drugem aktiviranju, ne glede na to, ali je shranjeno v hladilniku ali pri sobni temperaturi.
Heart or breathing problems including cardiac arrest have occurred in some patients.
Pri nekaterih bolnikih so se pojavile težave s srcem ali dihanjem, vključno z zastojem srca.
- The vial should be activated using the Vialmix.
- Vialo morate aktivirati z Vialmixom.
When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial.
Če uporabljate iglo, mora biti zabodena tako, da disperzijo vlečete iz sredine tekočine v viali, obrnjeni na glavo.