natgillin/translations-raw huggingface dataset:
• Inspect the TYSABRI vial for particles prior to dilution and administration.
• Pred razredčitvijo in dajanjem zdravila TYSABRI preverite, ali so v viali delci.
EXP
CHMP.
More frequent MRIs (e.g. on a 3 to 6 monthly basis) using an abbreviated protocol should be considered for patients at higher risk of PML.
Za bolnike, pri katerih je tveganje za PML večje, je treba razmisliti o pogostejšem MRS (npr. vsake 3 do
EDSS-baseline, median (range)
mediana (razpon)
Inspect the TYSABRI vial for particles prior to dilution and administration.
Pred razredčitvijo in dajanjem zdravila TYSABRI preverite, ali so v viali delci.
In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
2 leti (placebo: 1.135) je prišlo do neželenih učinkov, zaradi katerih je bilo zdravljenje prekinjeno, pri
Mean number of Gd-enhancing lesions
Povprečno število lezij, vidnih z gadolinijem
− Listlessness
• slabost
− Prolonged dizziness
Brez recidiva
The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom Optimark, veljavno po vsej Evropski uniji, izdala 23. julija 2007.
The recommended dose is 0.2 ml per kilogram body weight.
Priporočeni odmerek je 0,2 ml na kilogram telesne mase.
Other information about Optimark:
Druge informacije o zdravilu Optimark:
What measures are being taken to ensure the safe and effective use of Optimark?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Optimark?
In addition, the company will provide annual reviews of cases of NSF and conduct a study on the accumulation of gadolinium in the bone.
Poleg tega bo zagotovila letna poročila primerov NSF in izvedla študijo o kopičenju gadolinija v kosteh.
The full EPAR for Optimark 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 Optimark je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Each scan's clarity was scored on a four-point scale.
Jasnost vsake slike je bila ocenjena s štiristopenjsko lestvico.
The company that markets Optimark will ensure that all healthcare professionals who are expected to use this medicine are informed that it should not be used in children below 2 years as the effect of the medicine in this age group, such as its effect on immature kidneys, has not been studied.
Družba, ki trži zdravilo Optimark, bo poskrbela, da bodo vsi zdravstveni delavci, ki naj bi predpisovali to zdravilo, obveščeni, da se ne sme uporabljati pri otrocih, mlajših od dveh let, saj učinek zdravila pri tej starostni skupini, kot na primer učinek zdravila na nezrele ledvice, ni bil raziskan.
The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body).
Slike so analizirali trije radiologi (zdravniki, specializirani za slikanje telesa in tolmačenje slik).
In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped' until it is eliminated from the body in the urine.
V zdravilu Optimark je gadolinij vezan na drugo kemijsko spojino, tako da se kovina v telesu ne sprosti, ampak ostane „ujeta“, dokler se z urinom ne izloči iz telesa.
This is a summary of the European public assessment report (EPAR) for Optimark.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Optimark.
As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Zaradi tega vpliva začnejo vodne molekule oddajati močnejši signal, kar omogoča jasnejšo sliko.
It is given as an injection into a vein, usually a vein in an arm.
Daje se z injekcijo v veno, po navadi v veno roke.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Optimark have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Optimark, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The CHMP decided that Optimark's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Optimark večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What benefit has Optimark shown during the studies?
Kakšne koristi je zdravilo Optimark izkazalo med študijami?
Patients who have moderate problems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it.
Bolniki z zmernimi težavami z ledvicami lahko zdravilo Optimark prejmejo le, če je zdravnik pazljivo pretehtal koristi in tveganja njegove uporabe.
For more information about treatment with Optimark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Optimark preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Optimark is for diagnostic use.
Zdravilo Optimark je namenjeno diagnostični uporabi.
A repeated dose is not recommended in children, in patients with kidney problems or in elderly patients.
Ponavljajoč odmerek ni priporočljiv za otroke, bolnike z obolenji ledvic in starejše bolnike.
It is used in adults and in children from two years of age who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Uporablja se pri odraslih in otrocih, starejših od dveh let, pri katerih se izvaja magnetnoresonančno slikanje (MRS), tj. vrsta slikanja notranjih organov.
When looking at certain abnormalities in the brain, Optimark may need to be used at a higher dose, or the dose may need to be repeated.
Pri proučevanju določenih nepravilnosti v možganih bo morda treba uporabiti večji odmerek zdravila Optimark ali pa odmerek ponoviti.
Optimark has been studied in four main studies involving a total of 804 patients who had or were thought to have abnormalities in the brain or spine (two studies in 401 patients) or in the liver (two studies in 403 patients).
Zdravilo Optimark so proučevali v štirih glavnih študijah s skupno 804 bolniki z znanimi ali domnevnimi nepravilnostmi v možganih ali hrbtenjači (dve študiji s skupno 401 bolnikom) ali jetrih (dve študiji s skupno 403 bolniki).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Optimark.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Optimark allows images to be taken for up to an hour after it has been injected, although the best time to take a scan depends on the location and type of abnormality that is being examined.
Zdravilo Optimark omogoča slikanje največ eno uro po injiciranju, čeprav je najboljši čas za slikanje odvisen od predela in vrste obravnavane nepravilnosti.
It is available in prefilled syringes and in vials.
Na voljo je v napolnjenih injekcijskih brizgah in vialah.
Optimark must not be used in people who are hypersensitive (allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium.
Zdravila Optimark ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) gadoversetamid, katero koli drugo sestavino zdravila ali druga zdravila, ki vsebuje gadolinij.
MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body.
Magnetnoresonančno slikanje je metoda slikanja in temelji na majhnih magnetnih poljih, ki jih ustvarjajo vodne molekule v telesu.
Once injected, gadolinium interacts with the water molecules.
Gadolinij po injiciranju vpliva na vodne molekule.
In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.
V študijah nepravilnosti v jetrih se je rezultat pri obeh zdravilih izboljšal za povprečno 0,38 točke glede na izhodiščno vrednost 1,82 točke.
Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.
Zdravilo Optimark se uporablja za doseganje jasnejše slike pri bolnikih z znanimi ali domnevnimi nepravilnostmi v možganih, hrbtenici ali jetrih.
The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent.
Glavno merilo učinkovitosti je bila razlika v razločljivosti nepravilnosti na magnetnoresonančnih slikah, posnetih s kontrastnim sredstvom oziroma brez njega.
The radiologists did not know what treatment the patient had received beforehand, to make sure that the studies' findings were as accurate as possible.
Da bi bili izsledki študije čim bolj natančni, radiologi niso vedeli, kakšno zdravljenje je bolnik pred tem prejel.
What is the risk associated with Optimark?
Kakšna tveganja so povezana z zdravilom Optimark?
Optimark should only be given by a doctor who has experience in using MRI.
Zdravilo Optimark sme dajati samo zdravnik, ki ima izkušnje z uporabo magnetnoresonančnega slikanja.
In all of the studies, the effects of Optimark were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium).
Učinke zdravila Optimark so v vseh študijah primerjali z učinki gadopentetat dimeglumina (drugega kontrastnega sredstva, ki vsebuje gadolinij).
NSF causes thickening of the skin and connective tissues.
Nefrogena sistemska fibroza povzroča odebelitev kože in veznih tkiv.
These patients should receive no more than one dose of Optimark during each MRI scan, and there should be a gap of at least a week between each Optimark injection.
Med vsakim magnetnoresonančnim slikanjem lahko ti bolniki prejmejo samo en odmerek zdravila Optimark, med dvema injiciranjema pa mora preteči najmanj en teden.
In the two studies of brain and spine abnormalities taken together, scans taken with Optimark had a score increase of 0.63 points on average from a ‘baseline' of 1.58 points without Optimark.
V dveh študijah nepravilnosti v možganih in hrbtenici je bilo na slikah, posnetih ob jemanju zdravila Optimark, doseženo povprečno izboljšanje rezultata za 0,63 točke (izhodiščna vrednost brez zdravila Optimark je bila 1,58 točke).
Why has Optimark been approved?
Zakaj je bilo zdravilo Optimark odobreno?
This compared with an increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.
Pri primerjalnem kontrastnem sredstvu je bilo opaženo izboljšanje za 0,66 točke, pri čemer je bila izhodiščna vrednost 1,60 točke.
Optimark is a solution for injection that contains the active substance gadoversetamide.
Zdravilo Optimark je raztopina za injiciranje, ki vsebuje zdravilno učinkovino gadoversetamid.
The most common side effects with Optimark (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances) and feeling hot. For the full list of all side effects reported with Optimark, see the package leaflet.
Najpogostejši neželeni učinki zdravila Optimark (opaženi pri 1 do 10 bolnikih od 100) so glavobol, disgevzija (motnje okušanja) in občutek vročine.
The active substance in Optimark, gadoversetamide, contains gadolinium, a ‘rare-earth' metal element.
Zdravilna učinkovina zdravila Optimark, gadoversetamid, vsebuje redko zemeljsko kovino gadolinij.
It must not be used in patients who have severely reduced kidney function, in patients who have had or are about to have a liver transplant, or in babies aged less than four weeks, due to a risk of a condition called nephrogenic systemic fibrosis (NSF).
Zaradi tveganja za nefrogeno sistemsko fibrozo (NSF) se ne sme uporabljati pri bolnikih s hudo okvaro delovanja ledvic, pri bolnikih, pri katerih so ali bodo presadili jetra, ali pri dojenčkih, mlajših od štirih tednov.
How has Optimark been studied?
Kako je bilo zdravilo Optimark raziskano?
In all of the studies, Optimark was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.
Zdravilo Optimark je bilo pri izboljšanju razločljivosti nepravilnosti na slikah v vseh študijah enako učinkovito kot primerjalno kontrastno sredstvo.
How does Optimark work?
Kako zdravilo Optimark deluje?
What is Optimark used for?
Za kaj se zdravilo Optimark uporablja?
What is Optimark?
Kaj je zdravilo Optimark?
How is Optimark used?
Kako se zdravilo Optimark uporablja?
Gadolinium is used as a ‘contrast agent' to help obtain better images with MRI scans.
Ta se uporablja kot kontrastno sredstvo, ki zagotavlja boljše slike, izdelane z magnetnoresonančnim slikanjem.
Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika Pot uporabe Stična ovojnina
90 (3 x 30) tablets
Peroralna uporaba Plastenka (HDPE) 90 (3 x 30) tablet
MA (EU) number Invented name Strength Pharmaceutical form
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
30 tablets
Peroralna uporaba Plastenka (HDPE) 30 tablet
Route of administration
Številka (EU) dovoljenja za promet
Take it as soon as you remember.
Uporabite ga, čim se spomnite.
Date of first authorisation: 18 December 2018
Datum prve odobritve: 18.december 2018
Always tell your doctor about other health problems.
Zdravniku morate vedno povedati tudi za druge zdravstvene težave.
These symptoms may be signs of an allergic reaction which may become serious.
Navedeni simptomi so lahko znaki alergijske reakcije, ki lahko postane resna.
Treatment difference (95% confidence intervals, p-value)
Razlika zdravljenj (95 % interval zaupanja, vrednost p)
If this occurs, do not drive or use machines.
Če pride do tega, ne upravljajte vozil in strojev.
It will help to reduce the effects of COPD on your everyday life.
Pomagalo vam bo zmanjšati vpliv KOPB na vaše vsakdanje življenje.
It is important to instruct the patient to:
Bolniku morate naročiti:
• difficulty sleeping
• težave s spanjem
This medicine is for long-term use.
To zdravilo je namenjeno za dolgotrajno uporabo.
• medicines which can prolong ‘QT interval' (a change in the electrical activity of the heart).
• zdravila, ki lahko podaljšajo trajanje "intervala QT" (gre za spremembo električnega delovanja srca).
• you have asthma.
• če imate astmo.
Other antimuscarinics and sympatomimetics
Drugi antimuskariniki in simpatikomimetiki
These patients should be monitored for potential adverse reactions.
Te bolnike je treba spremljati glede možnih neželenih učinkov.
White suspension.
bela suspenzija
The frequency of adverse reactions is defined using the following convention: 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) and not known (cannot be estimated from available data).
Pogostnost neželenih učinkov je opredeljena upoštevaje naslednji dogovor: 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) ter neznana (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
The recommended dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening).
Priporočeni odmerek sta dve inhalaciji dvakrat na dan (dve inhalaciji zjutraj in dve inhalaciji zvečer).
Do not expose to temperatures higher than 50°C.
Ne izpostavljajte temperaturam nad 50 °C.
Note: Patients should be instructed on the correct inhalation technique.
Opomba: Bolnike je treba poučiti o pravilnem načinu inhaliranja.
Date pouch opened:__________
Datum odprtja vrečke: __________
Your inhaler is now ready to use.
Inhalator je zdaj pripravljen za uporabo.
It will only be effective as long as you are using it. Do not stop unless your doctor tells you to, even if you feel better, as your symptoms may get worse.
Ne nehajte ga uporabljati, če vam tega ne naroči zdravnik, tudi če se počutite bolje, kajti simptomi se vam lahko poslabšajo.
• When the arrow reaches ‘0', you must stop using your inhaler.
• Ko kazalec doseže oznako "0", morate prenehati z uporabo inhalatorja.
The individual studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the studies if a severe exacerbation or more than 2 moderate exacerbations occurred.
Posamezne študije niso bile posebej načrtovane za oceno učinka zdravljenja na poslabšanja KOPB in bolnike so iz študij umaknili, če se je pri njih pojavilo hudo poslabšanje ali več kot dve zmerni poslabšanji.
If you want to stop treatment, first talk to your doctor.
Če želite zdravljenje prenehati, se najprej posvetujte z zdravnikom.
Then stop pressing the dose indicator.
Potem nehajte pritiskati kazalnik odmerka.
Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Bolniki s klinično pomembnimi neurejenimi srčno-žilnimi boleznimi niso bili vključeni v klinične študije.
• shaking or tremor
• tresenje ali tremor
Press here
Pritisnite tukaj
Clean the inhaler once each week for the first 3 weeks.
Prve 3 tedne očistite inhalator enkrat na teden.
Hold your breath as long as you comfortably can, up to 10 seconds (See Figure 11).
Zadržite dih, kolikor dolgo lahko, ne da bi vam bilo neprijetno, do 10 sekund (glejte sliko 11).
• you have heart problems
• če imate težave s srcem.
The combination of these substances with different mechanisms of action results in additive efficacy compared to use with either component alone.
Kombinacija teh učinkovin z različnima mehanizmoma delovanja doseže dodatno učinkovitost v primerjavi z vsako učinkovino posamezno.
• After priming 4 times, the dose indicator should be pointing to the right of “120” and your inhaler is now ready to use.
• Potem ko ste 4-krat izvedli osnovno pripravo, mora kazalnik odmerka kazati desno od oznake "120" in vaš inhalator je zdaj pripravljen za uporabo.
• fast or irregular heart beat
• hitro ali neredno bitje srca
It is important to use Bevespi Aerosphere every day, even if you have no COPD symptoms at the time.
Pomembno je, da zdravilo Bevespi Aerosphere uporabljate vsak dan, tudi če trenutno nimate simptomov KOPB.
Daily rescue Ventolin (inhalations/day)
Dnevno rešilno zdravilo Ventolin (št. inhalacij/dan)
- you are allergic to glycopyrronium, formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
- ste alergični na glikopironij, formoterolijev fumarat dihidrat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Step 4: Shake off as much water from the actuator as you can.
4. korak: S sprožilnika otresite toliko vode, kot je le lahko.
Component of a multipack, cannot be sold separately.
Del skupnega pakiranja, ni za ločeno prodajo.
• high blood sugar levels
• visoka koncentracija sladkorja v krvi
Step 6: When you have finished breathing in, remove the mouthpiece from your mouth.
6. korak: Ko končate vdih, vzemite ustnik iz ust.
If paradoxical bronchospasm does occur, treatment with the medicinal product should be stopped and other treatments considered.
Če se paradoksni bronhospazem pojavi, je treba zdravljenje s tem zdravilom prenehati in razmisliti o drugih zdravilih.
If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
Če bolnik izpusti odmerek, ga mora uporabiti čim prej, naslednji odmerek pa mora uporabiti ob običajnem času.
If there is any built-up medicine, repeat Steps 3 to 5 in the section.
Če ostane še kaj obloge zdravila, ponovite postopek od 3. do 5. koraka iz tega poglavja.
• Repeat the priming steps 3 more times (See Figure 4 and Figure 5).
• Še 3-krat ponovite korake osnovne priprave (glejte sliko 4 in sliko 5).
Do not take more than two puffs twice a day.
Ne uporabite več kot dveh vpihov dvakrat na dan.
Both central and peripheral deposition were observed.
Opažali so tako osrednje kot periferno odlaganje.
Stop using Bevespi Aerosphere and seek immediate medical care if you notice any of the following symptoms:
Prenehajte uporabljati zdravilo Bevespi Aerosphere in nemudoma poiščite zdravniško pomoč, če opazite katerega koli od naslednjih simptomov:
You may hear a soft click from the dose indicator as it counts down during use.
Iz kazalnika odmerka lahko slišite tih klik, ko med uporabo odšteva.
Do not use this medicine after the expiry date which is stated on the carton, pouch and pressurised container after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, vrečki in tlačnem vsebniku poleg oznake "EXP".
The decrease in serum potassium is usually transient, not requiring supplementation.
Znižanje kalija v serumu je po navadi prehodno in ne zahteva dodajanja kalija.
In that study, 62% of the radiolabelled formoterol was excreted in the urine while 24% was eliminated in the faeces.
V tej študiji se je 62 % radioaktivno označenega formoterola izločilo v urinu, 24 % pa v blatu.
Patients should be advised not to take more than 2 inhalations twice daily.
Bolnikom morate naročiti, naj ne uporabijo več kot 2 inhalaciji dvakrat na dan.
Some medicines may affect how this medicine works, or make it more likely that you will have side effects.
Nekatera zdravila lahko vplivajo na delovanje tega zdravila ali povečajo verjetnost za pojav neželenih učinkov.
• difficulty passing urine (urinary retention)
• težave pri odvajanju urina (zastoj urina)
For pharmacokinetic purposes each component can therefore be considered separately.
Kar zadeva farmakokinetiko, je torej mogoče vsako od obeh sestavin obravnavati posebej.
It is very important to keep your inhaler clean so that medicine does not build-up and block the spray through the mouthpiece (See Figure 14).
Zelo pomembno je, da inhalator vzdržujete čist, tako da se zdravilo ne nalaga v njem in ne ovira razprševanja skozi ustnik (glejte sliko 14).
The most common adverse reactions reported in the clinical development program (comprised of 1,588 patients receiving Bevespi Aerosphere) were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).
Najpogostejši neželeni učinki, o katerih so poročali v kliničnem razvojnem programu (v katerem je bilo 1588 bolnikov, ki so prejemali zdravilo Bevespi Aerosphere), so bili glavobol (1,9 %), navzea (1,4 %), mišični spazmi (1,4 %) in omotica (1,3 %).
Do not use this medicine for asthma
Tega zdravila ne uporabljajte za zdravljenje astme.
A puff of medicine is released each time you press the centre of the dose indicator.
Vpih zdravila se sprosti vsakič, ko pritisnete na sredino kazalnika odmerka.
These belong to a group of medicines called long-acting bronchodilators.
Ti učinkovini spadata v skupino zdravil, ki jih imenujemo dolgodelujoči bronhodilatatorji.
The number in the dose indicator display window will change after every 20 puffs.
Številka v okencu kazalnika odmerka se bo spremenila na vsakih 20 vpihov.
There were improvements in trough FEV1 irrespective of age, sex, degree of airflow limitation, baseline symptoms, smoking status, or inhaled corticosteroid use.
Najnižji FEV1 se je izboljšal ne glede na starost, spol, stopnjo omejitve pretoka zraka, izhodiščne simptome, kadilsko stanje ali uporabo inhalacijskih kortikosteroidov.
• medicines that lower potassium in your blood.
• zdravila, ki znižujejo vrednost kalija v krvi.
Elderly No dose adjustments are required in elderly patients (see section 5.2).
Starejši Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
The inhaler can be used for up to 3 months after first opening the pouch.
Inhalator lahko uporabljate do 3 mesece po prvem odprtju vrečke.