natgillin/translations-raw huggingface dataset:
For the full list of all side effects reported with Aubagio, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aubagio, glejte navodilo za uporabo.
The studies also looked at the effect of Aubagio on the changes in the patients' level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.
V študijah so proučevali tudi učinek zdravila Aubagio na spremembo stopnje nezmožnosti bolnikov in ugotovili, da se je po dveh letih in pol (132 tednih) zdravljenja tveganje za poslabšanje nezmožnosti zmanjšalo za 30 % v primerjavi s placebom.
Aubagio must also not be used in pregnant women or during breast-feeding.
Prav tako ga ne smejo uporabljati nosečnice in ženske, ki dojijo.
Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a.
Zdravilo Aubagio se daje peroralno, kar je njegova prednost v primerjavi z drugimi zdravili, na primer interferonom beta-1a.
Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo).
Ugotovili so, da je zdravilo Aubagio učinkovitejše od placeba: pri bolnikih, ki so jemali zdravilo Aubagio, so zabeležili za približno 30 % večje zmanjšanje števila recidivov kot pri bolnikih, ki so jemali placebo (letna stopnja recidivov pri zdravilu Aubagio je bila 0,35, pri placebu pa 0,53).
With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.
Z zmanjšanjem števila limfocitov se zmanjša tudi vnetje, kar pripomore k obvladovanju simptomov multiple skleroze.
Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Zdravilo Aubagio se uporablja pri vrsti multiple skleroze, imenovane recidivno remitentna multipla skleroza, pri kateri ima bolnik napade (recidive) simptomov, ki jim sledijo obdobja izboljšanja (remisije).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aubagio, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.
Ugotovili so, da je zdravilo Aubagio učinkovitejše od placeba: po približno devetih mesecih (36 tednih) so pri bolnikih, ki so jemali zdravilo Aubagio, opazili približno eno aktivno lezijo na sliko, pri bolnikih, ki so jemali placebo, pa približno 2,7.
How does Aubagio work?
Kako zdravilo Aubagio deluje?
A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a.
Pri bolnikih, ki so jemali zdravilo Aubagio, je bila stopnja trajne prekinitve zdravljenja 13,5 %, pri bolnikih, ki so jemali interferon beta-1a, pa 24 %.
How is Aubagio used?
Kako se zdravilo Aubagio uporablja?
• severe liver disease;
• s hudim obolenjem jeter;
In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsingremitting MS.
V študijah je zdravilo Aubagio pri bolnikih z recidivno remitentno multiplo sklerozo zmanjšalo število recidivov in upočasnilo napredovanje njihove nezmožnosti.
You may watch television.
Lahko gledate televizijo.
Date of first authorisation: 24 October 2001 Date of latest renewal: 22 September 2011
Datum prve odobritve: 24. oktober 2001 Datum zadnjega podaljšanja: 22. september 2011
Your doctor will also tell you what to do.
Tudi vaš zdravnik vam bo povedal, kako morate ravnati.
No other interactions have been observed.
Drugih interakcij niso opazili.
Of these, 6 had a complete local response according to WHO criteria.
Od teh jih je 6 doseglo popoln lokalni odziv po kriterijih Svetovne zdravstvene organizacije.
Plasma protein binding is at 85-87 %.
Vezava na plazemske proteine je okoli 85 -87 %.
Tel.: +49 3641 5195330 Fax: +49 3641 5195331
Tel.: +49 49 3641 5195330 Faks: +49 3641 5195331
The use of headlamps is recommended instead.
Namesto njih priporočajo uporabo naglavnih svetilk.
You must follow these instructions carefully.
Teh navodil se morate natančno držati.
The following information is intended for medical or healthcare professionals only
Naslednje informacije so namenjene samo zdravstvenemu osebju
The type of clothes you must wear are:
Nositi morate sledeče vrste oblačil:
Start on Day 8 with 10-15 minutes outdoors.
Začnite 8. dan z 10-15 minutami na prostem.
For treatment of other types of pain listed in this section, please see section 4.4.
Za zdravljenje drugih vrst bolečine, ki so navedene v tem poglavju, glejte poglavje 4.4.
• You will gradually become less sensitive to light.
• Postopoma boste postali manj občutljivi za svetlobo.
You must get out of the light immediately.
Takoj se morate umakniti s svetlobe.
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, ki so navedene spodaj, so opredeljene z naslednjim dogovorom: 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), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
• Sunscreen creams will not prevent this sensitivity.
• Kreme za sončenje ne bodo pomagale pri tej vrsti občutljivosti.
Wait 24 hours to see if there is any redness.
Počakajte 24 ur, da vidite, ali se pojavi rdečina.
The laser light is not hot and will not burn.
Laserska svetloba ni vroča in ne peče.
Days 8-14
Dnevi 8-14
Appropriate precaution must be taken when handling this medicinal product.
Pri ravnanju s tem zdravilom je potrebna ustrezna previdnost.
Oximeters must be repositioned at least every 10-15 minutes to avoid the risk of local skin burns.
Oksimetre je potrebno prestavljati vsaj vsakih 10 do 15 minut, da se izognemo tveganju za lokalne opekline na koži.
Your eyes may be very sensitive to bright lights during this week.
Vaše oči so lahko v tem tednu zelo občutljive na močno svetlobo.
The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Srednja vrednost trajanja odziva tumorja za vse bolnike je bila 57 dni za celoten odziv in 84 dni za popoln odziv.
• Do not wear very thin clothing because it will not protect you from strong light.
• Ne nosite zelo tankih oblačil, saj vas ne bodo zaščitila pred močno svetlobo.
What should I do to prevent burns?
Kaj moram storiti, da se izognem opeklinam?
You can increase your exposure by another 15 minutes each day i.e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on.
Vsak dan lahko povečate izpostavljenost neposredni sončni svetlobi za 15 minut, to pomeni 30 minut drugi dan, 45 minut tretji dan, 60 minut četrti dan in tako naprej.
Days 2-7
Dnevi 2-7
If you have this problem, wear dark glasses.
Če boste imeli takšne težave, nosite sončna očala.
These effects may make it difficult to eat and drink.
Zaradi teh neželenih učinkov boste mogoče s težavo jedli in pili.
Do not use this medicine after the expiry date which is stated on the label and the carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki in škatli.
Stay in shaded areas or go out when it is cloudy.
Zadržujte se v senci ali pojdite ven v oblačnem vremenu.
Pain occurs the day after illumination and usually lasts 2 to 4 weeks.
Bolečine se pojavijo naslednji dan po obsevanju in navadno trajajo 2 do 4 tedne.
The amount of alcohol in this product may alter the effects of other medicines.
Količina alkohola v tem zdravilu lahko spremeni učinke drugih zdravil.
Do not stay in the sunlight for more than 15 minutes the first time.
Prvič ne ostanite na sončni svetlobi več kot 15 minut.
Furthermore you will probably notice swelling and reddening around the area that has been treated.
Poleg tega boste verjetno opazili otekanje in pordečitev okrog zdravljenega predela.
• Please speak to your doctor about this before you go home after being injected with Foscan.
• Prosimo, da se o tem pogovorite z zdravnikom, še preden greste domov po injiciranju zdravila Foscan.
Women of childbearing potential have to use effective contraception during and up 3 months after treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 3 mesece po njem.
This product is also harmful for those suffering from alcoholism.
To zdravilo je tudi škodljivo za tiste, ki trpijo za alkoholizmom.
A WHO local complete response was observed in 14 % of patients.
Popoln lokalni odziv po WHO (Svetovna zdravstvena organizacija) so opazili pri 14 % bolnikov.
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Stay in the shade.
Zadržujte se v senci.
Proactively managing the local effects and diminishing photoactivation in non-tumour areas is important to manage the risks.
Aktivno zdravljenje lokalnih učinkov in zmanjševanje fotoaktivacije v netumorskih območjih je pomembno pri upravljanju tveganj.
• These instructions are written in this leaflet.
• Navodila so napisana v tem Navodilu za uporabo.
You may be given some medicine to reduce the swelling.
Mogoče boste dobili kakšno zdravilo za zmanjšanje otekline.
Events occurring at a frequency not known (frequency cannot be estimated from the available data):
Neželeni učinki, ki se pojavljajo z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
Single dose.
Enojni odmerek.
5 years Once opened, the solution must be used immediately.
5 let Odprto raztopino je treba takoj uporabiti.
It is important that patients are re-introduced to normal light gradually (see the light protection guidelines for patients at the end of this section).
Pomembno je, da se bolniki spet postopoma ponovno privajajo na normalno svetlobo (glejte smernice za zaščito pred svetlobo za bolnike na koncu tega poglavja).
Thirty-seven patients received at least 2 treatments with Foscan.
37 bolnikov je prejelo vsaj 2 odmerka zdravila Foscan.
Foscan will be stored at the hospital pharmacy.
Zdravilo Foscan bo shranjeno v bolnišnični lekarni.
Most people will be able to go back to their normal routine by Day 22.
Večina ljudi se bo lahko po 22. dnevu vrnila v normalni ritem življenja.
Please let your doctor or nurse know if you have pain or if the painkillers you have been given are not taking the pain away.
Povejte zdravniku ali medicinski sestri, če vas boli ali če zdravila proti bolečinam, ki ste jih prejeli, niso odpravila bolečine.
No specific systemic symptoms are known to be associated with overdose.
Ni znanih specifičnih sistemskih simptomov, povezanih s prevelikim odmerjanjem.
Harmful for those suffering from alcoholism.
Škodljivo za osebe z alkoholizmom.
You must test this carefully by exposing the back of your hand to the sun for 5 minutes.
To morate previdno preizkusiti tako, da hrbtno stran roke za 5 minut izpostavite sončni svetlobi.
If it is absolutely necessary to go outdoors during the hours of daylight, you must be careful to cover up all your skin including your face and hands and wear dark glasses.
Če se morate nujno odpraviti iz hiše v času dnevne svetlobe, si morate pazljivo pokriti vso kožo, vključno z obrazom in dlanmi, in nositi sončna očala.
You can then repeat the test.
Po teh 24-ih urah lahko ponovite preizkus.
Treatment should be supportive.
Uvesti je treba podporno zdravljenje.
On the first day after the skin test, you can stay in direct sunlight for 15 minutes.
Prvi dan po kožnem preizkusu lahko ostanete na neposredni sončni svetlobi 15 minut.
The effects of Foscan on fertility in humans have not been studied.
Učinkov zdravila Foscan na plodnost pri ljudeh niso raziskali.
Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/kg were reduced by one third relative to a dose of 0.3 mg/kg.
Objavljene klinične raziskave so pokazale, da sta bila trajanje in intenzivnost fotosenzitivnosti pri predpisanem odmerku 0,15 mg/kg manjša za tretjino v primerjavi z odmerkom 0,3 mg/kg.
There is no enterohepatic recirculation of these metabolites.
Enterohepatična recirkulacija teh metabolitov ne obstaja.
This means that normal daylight or bright indoor lighting could give you skin burns.
To pomeni, da vam normalna dnevna svetloba ali močna svetloba v notranjem prostoru lahko povzroči opekline na koži.
Day 15 onward Your sensitivity to light is gradually getting back to normal.
15. dan in naprej Vaša občutljivost za svetlobo se postopoma vrača na normalno raven.
Each field is to be illuminated once only at each treatment.
Vsako polje mora biti pri posameznem zdravljenju obsevano le enkrat.
If you do not follow these instructions, you may get severe sunburn that leads to permanent scarring.
Če se teh navodil ne boste držali, lahko dobite hude sončne opekline, kar bo pustilo trajne brazgotine.
Illumination of the tumour should only be carried out if the potential benefit justifies the potential risk of excessive necrosis.
Obsevanje tumorja naj se izvaja le, če potencialna korist upravičuje potencialno tveganje za prekomerno nekrozo.
This risk can be controlled in the clinical situation by minimising direct exposure to light (see section 4.4).
To tveganje je v klinični situaciji mogoče nadzorovati z minimaliziranjem neposredne izpostavljenosti svetlobi (glejte poglavje 4.4).
Foscan contains ethanol (alcohol):
Zdravilo Foscan vsebuje etanol (alkohol):
Although no other developmental effects were observed, the applied doses were not sufficiently in excess of the human therapeutic dose to provide an adequate margin of safety.
Čeprav drugih učinkov na razvoj niso opazili, uporabljeni odmerki niso dovolj prekoračili terapevtskega odmerka za ljudi, da bi zagotovil primerno mejo varnosti.
Normally, people are able to begin to return to normal outdoor lighting after 15 days.
Običajno se ljudje lahko pričnejo vračati na normalno zunanjo svetlobo po 15 dneh.
Increased damage to tissue was noted.
Opazili so porast poškodb tkiva.
In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose.
V primeru prevelikega odmerka bi lasersko zdravljenje povzročilo globljo nekrozo tumorja, kot bi bilo pričakovano pri predpisanem odmerku.
Temoporfin does not concentrate in the tissues.
Temoporfin se ne koncentrira v tkivih.
Keep the curtains drawn and use light bulbs of 60 W or less.
Zavese naj bodo zagrnjene, uporabljajte svetilke z močjo 60 W ali manj.
Foscan should not be used during pregnancy unless the clinical condition of the woman requires treatment with temoporfin.
Zdravila Foscan ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje s temoporfinom.
Injection site pain is transient and can be reduced by slowing the injection rate.
Bolečina na mestu injiciranja je prehodna in jo lahko zmanjšamo z upočasitvijo hitrosti injiciranja.
Animal studies have shown some haematological and blood chemistry changes (decreased platelets, erythrocytes and haemoglobin, increased neutrophils, fibrinogen, bilirubin, triglyceride and cholesterol).
Študije na živalih so pokazale nekatere hematološke spremembe in spremembe v sestavi krvi (zmanjšano število trombocitov, eritrocitov in hemoglobina; povečano število nevtrofilcev, fibrinogena, bilirubina, trigliceridov in holesterola).
Calculate the required dose of Foscan according to the bodyweight of the patient.
Potrebni odmerek zdravila Foscan izračunajte glede na telesno maso bolnika.
If you do not see any skin redness in the next 24 hours, you can gradually increase your time outdoors during the week.
Če se v naslednjih 24-ih urah ne pojavijo rdečine na koži, lahko v tem tednu postopoma povečujete svoj čas na prostem.
An extensive volume of distribution is observed that is intermediate between total and extracellular body water.
Opazili so obsežen volumen porazdelitve, ki je vmesen med celotno in zunajcelično telesno tekočino.
Each pack contains 1 glass vial and a filter.
Vsaka škatla vsebuje 1 stekleno vialo in filter.
In a clinical trial of 147 patients with advanced head and neck squamous cell carcinoma, tumour response, defined as a reduction of a minimum of 50 % of the tumour mass for a minimum of four weeks, was observed in 25 % after a single treatment.
V kliničnem preskušanju, izvedenem na 147 bolnikih z napredovalim ploščatoceličnim karcinomom glave in vratu, se je odzivnost tumorja, definirana kot 50-odstotno zmanjšanje mase tumorja za najmanj 4 tedne, pokazala pri 25 % bolnikov po enem zdravljenju.
You can now begin to go outside during daylight hours.
Zdaj lahko začnete hoditi iz hiše tudi v času dnevne svetlobe.
If there is no redness, you can gradually increase your exposure to sunlight day by day.
Če se rdečina ne pojavi, lahko postopoma, dan za dnem, povečujete svojo izpostavljenost sončni svetlobi.
Do not sunbathe.
Ne sončite se.
Prophylactic treatment with corticosteroids should be considered.
V poštev pride profilaktično zdravljenje s kortikosteroidi.
The resulting complications (i.e. dyspnoea or even airway obstruction leading to, for instance, intubation or tracheotomy) should be anticipated.
dispnea ali celo obstrukcija zračnih poti, zaradi katere je potrebna na primer intubacija ali traheotomija) moramo predvideti.
Unplanned or emergency surgical procedures where Foscan has been administered within the previous 30 days must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient.
Nenačrtovani ali nujni kirurški posegi v primerih, kjer je bilo v preteklih 30 dneh injicirano zdravilo Foscan, naj se izvajajo le, če je to absolutno potrebno in če možne koristi odtehtajo tveganje za bolnika.
Tissue outside the target area must be shielded completely to avoid photoactivation by scattered or reflected light.
Tkivo zunaj ciljnega področja mora biti v celoti zaščiteno, da ne pride do fotoaktivacije zaradi razpršene ali odbite svetlobe.
Ten patients achieved a tumour response due to re-treatment.
Pri 10 bolnikih so dosegli odziv tumorja po ponovnem zdravljenju.
Remove the intravenous cannula immediately following the injection.
Intravensko kanilo odstranite takoj po injiciranju.
What you need to know before you use Foscan
Kaj morate vedeti, preden boste uporabili zdravilo Foscan
Attach the filter to the syringe (Figure 2).
Pritrdite filter na brizgo (slika 2).
What Foscan is and what it is used for
Kaj je zdravilo Foscan in za kaj ga uporabljamo
CALCULATION OF DOSE
IZRAČUN ODMERKA
Illumination of airways may lead to local inflammation and oedema.
Obsevanje zračnih poti lahko povzroči lokalno vnetje in edem.
• The amount of alcohol in this medicine may impair your ability to drive or use machines for a few hours after injection.
• Količina alkohola v tem zdravilu lahko za nekaj ur po injekciji zmanjša vašo sposobnost vožnje ali upravljanja s stroji.
Tumour responses are enhanced in patients with fully illuminated lesions of 10 mm or less in depth.
Odziv tumorja je povečan pri bolnikih s popolnoma obsevanimi lezijami, globokimi 10 mm ali manj.
Attach the syringe and filter to the cannula.
Pritrdite brizgo in filter na kanilo.
Due to the generation of reactive oxygen species, temoporfin poses a minor risk of mutagenicity.
Zaradi generiranja reaktivnih kisikovih spojin temoporfin predstavlja manjše tveganje za mutagenezo.
You can gradually return to normal indoor lighting.
Postopoma se lahko vrnete na normalno razsvetljavo v hiši.
The dose is 0.15 mg/kg body weight.
Odmerek je 0,15 mg/kg telesne mase.
The genotoxicity of temoporfin has been investigated to a limited extent.
Genotoksičnost temoporfina je bila le delno preučena.
Do NOT flush with aqueous solutions such as sodium chloride 9 mg/ml (0.9 %) solution for injection or water for injections.
NE izpirajte z vodnimi raztopinami, npr. z raztopino natrijevega klorida za injiciranje 9 mg/ml (0,9 %) ali vodo za injekcije.
Do not use Foscan - if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6), - if you are hypersensitive (allergic) to porphyrins, - if you have porphyria, or any other disease that is made worse by light, - if the tumour being treated goes through a large blood vessel, - if you are going to have an operation in the next 30 days, - if you have an eye disease which needs examination with bright light in the next 30 days, - if you are already being treated with a photosensitising agent.
Ne uporabljajte zdravila Foscan: - če ste alergični na temoporfin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6), - če ste preobčutljivi (alergični) na porfirine, - če imate porfirijo ali katero koli drugo bolezen, katere stanje se na svetlobi lahko poslabša, - če tumor, ki ga zdravite, sega skozi večjo žilo v telesu, - če boste v naslednjih 30 dneh imeli operacijo, - če imate očesno bolezen, zaradi katere boste v naslednjih 30 dneh imeli pregled z močno lučjo, - če se že zdravite z zdravilom, ki povzroča preobčutljivost za svetlobo.
Foscan is used for the treatment of head and neck cancer in patients who cannot be treated with other therapies.
Zdravilo Foscan se uporablja za zdravljenje raka glave in vratu pri bolnikih, ki jih ni mogoče zdraviti z drugimi načini zdravljenja.
Such a reaction has been reported with topical 5-fluorouracil.
Takšne vrste reakcija je znana pri topikalni uporabi 5-fluorouracila.
If at any time you notice a prickly or burning feeling or see skin reddening after exposure to sun, wait until this disappears before exposing your skin to light for this length of time again.
Če kadarkoli na koži občutite ščemeč ali žareč občutek ali opazite, da koža po izpostavljenosti sončni svetlobi postaja rdeča, počakajte, da ti znaki izginejo, preden svojo kožo ponovno izpostavite sončni svetlobi za enako obdobje.
Photoactivation induces local tissue damage resulting in acute inflammatory response.
Fotoaktivacija sproži lokalno tkivno okvaro, ki povzroči akutni vnetni odziv.
• Sunglasses with side panels: for eyes and skin around eyes.
• Sončna očala s stransko zaščito: za oči in kožo okrog oči.
Remember to avoid direct sunlight coming through the window or direct light from household appliances such as reading lamps.
Ne pozabite se izogibati neposredni sončni svetlobi, ki prihaja skozi okno, ali neposredni svetlobi iz gospodinjskih aparatov, na primer bralnih luči.
Temoporfin is bound to plasma lipoproteins and high density proteins such as albumin in the blood.
Temoporfin se veže na plazemske lipoproteine in na proteine z visoko gostoto, npr. na albumin v krvi.
Two major metabolites of temoporfin are eliminated into the bile.
Dva glavna metabolita temoporfina se izločata v žolč.
LASER ILLUMINATION OF TREATMENT SITE
LASERSKO OBSEVANJE MESTA ZDRAVLJENJA