FrancophonIA/ELRC3.0 huggingface dataset:
English: • infections of the respiratory tract (airways and lungs) such as tonsillitis, sinusitis, otitis media
Slovenian: • okužb dihal (dihalnih poti in pljuč), kot so tonzilitis, sinuzitis, vnetje srednjega ušesa, poslabšanje bronhitisa in pljučnica;
English: The Committee agreed that the tablets and oral suspensions containing amoxicillin and clavulanic acid as a 2:1 ratio should not be used in lower respiratory tract infections or in otitis media.
Slovenian: Odbor se je strinjal, da se tablete in peroralne suspenzije z amoksicilinom in klavulansko kislino v razmerju 2:1 ne smejo uporabljati za okužbe spodnjih dihal ali vnetje srednjega ušesa, ker skupni dnevni odmerek amoksicilina, ki ga zagotavljajo te formulacije ob standardnem odmerjanju, ni zadosten za učinkovito uničenje bakterij, pri velikih odmerkih pa lahko bolnik prejme preveč klavulanske kisline.
English: It was to be available as 150 mg tablets.
Slovenian: Na voljo naj bi bilo v obliki 150miligramskih tablet.
English: The company had requested a re-examination of the negative opinion, but withdrew before this re-examination had started.
Slovenian: Družba je zahtevala ponoven pregled negativnega mnenja, vendar je zahtevek umaknila še pred začetkom postopka.
English: However, the CHMP concluded that the new subgroup of patients proposed for treatment was not well represented in the study (28 patients) and the reliability of the results is questionable.
Slovenian: Vendar pa je CHMP zaključil, da je bila nova podskupina bolnikov, predlagana za zdravljenje, v študiji premajhna (28 bolnikov) in da je zanesljivost rezultatov vprašljiva.
English: The company informed the CHMP that there are no ongoing clinical trials.
Slovenian: Družba je CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja.
English: In its letter notifying the Agency of the withdrawal of application, the company state that it was withdrawing the application for strategic reasons.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila iz strateških razlogov.
English: The main measure of effectiveness was the change in vision after six months of treatment measured using a standard eye test with a letter chart.
Slovenian: Glavno merilo učinkovitosti je bila sprememba vida po šestih mesecih zdravljenja, ki so jo ocenili s standardnim očesnim testom s tabelo s črkovnimi znaki.
English: Patients in compassionate use programmes can continue using Raxone.
Slovenian: Bolniki, ki sodelujejo v programih sočutne uporabe, lahko še naprej jemljejo zdravilo Raxone.
English: The effects of Raxone were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Raxone so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Raxone is a medicine that contains the active substance idebenone.
Slovenian: Raxone je zdravilo, ki vsebuje zdravilno učinkovino idebenon.
English: The way idebenone works in LHON is not fully understood but it is thought to reduce the formation of free radicals and to help improve production of energy, thereby preventing the cellular damage and the loss of sight seen in LHON.
Slovenian: Način delovanja idebenona pri LHON ni povsem pojasnjen, vendar se domneva, da zavira tvorjenje prostih radikalov in pomaga izboljšati proizvodnjo energije ter posledično preprečiti okvaro celic in izgubo vida, ki jo povzroča LHON.
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Slovenian: Za bolnike z LHON so značilne spremembe (okvare) genskega materiala mitohondrijev.
English: In addition, the CHMP considered that the data supporting the mode of action for idebenone in LHON are not sufficient.
Slovenian: Poleg tega je menil, da so podatki, s katerimi naj bi utemeljili način delovanja idebenona pri LHON, pomanjkljivi.
English: Withdrawal of the marketing authorisation application for Raxone (idebenone)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Raxone (idebenon)
English: Raxone was expected to be used for the treatment of LHON, which is an inherited disease characterised by progressive loss of sight.
Slovenian: Zdravilo Raxone naj bi se uporabljalo za zdravljenje LHON, tj. dedne bolezni, za katero je značilna postopna izguba vida.
English: At the time of the negative opinion, the CHMP was concerned that in patients with LHON whose symptoms started in the previous five years, taking Raxone for six months did not lead to a significant improvement in vision compared with placebo (patients taking Raxone were able to distinguish three more letters on the letter chart compared with patients taking placebo).
Slovenian: V času izdaje negativnega mnenja je CHMP menil, da po 6-mesečnem zdravljenju z zdravilom Raxone pri bolnikih z LHON, pri katerih so se simptomi pojavili v zadnjih petih letih, niso opazili pomembnega izboljšanja vida v primerjavi s skupino, ki je prejemala placebo (bolniki, ki so jemali zdravilo Raxone, so na tabeli s črkovnimi znaki razločili tri črke več kot bolniki, ki so jemali placebo).
English: Given the small size of this sub-group, the CHMP considered that a spontaneous improvement could not be ruled out.
Slovenian: Menil je, da zaradi majhne podskupine pri teh bolnikov ni mogoče izključiti spontanega izboljšanja.
English: The active substance in Raxone, idebenone, acts on structures inside cells known as mitochondria, which produce the energy necessary for cells to function.
Slovenian: Zdravilna učinkovina v zdravilu Raxone, idebenon, deluje na strukture znotraj celic, imenovane mitohondriji, ki proizvajajo energijo, potrebno za delovanje celic.
English: The company presented the results from one main study with Raxone involving 85 patients with LHON whose symptoms started in the previous five years.
Slovenian: Družba je predstavila rezultate iz ene glavne študije z zdravilom Raxone, v katero je bilo vključenih 85 bolnikov z LHON, pri katerih so se simptomi pojavili v preteklih petih letih.
English: In the study, patients received Raxone or placebo (a dummy treatment) for six months.
Slovenian: V študiji so bolniki šest mesecev prejemali zdravilo Raxone ali placebo (zdravilo brez zdravilne učinkovine).
English: What is Raxone?
Slovenian: Kaj je zdravilo Raxone?
English: On 21 March 2013, Santhera Pharmaceuticals (Deutschland) GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raxone, for the treatment of Leber's hereditary optic neuropathy (LHON).
Slovenian: Družba Santhera Pharmaceuticals (Deutschland) GmbH je 21. marca 2013 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Raxone, namenjenim zdravljenju Leberjeve hereditarne optične nevropatije (LHON).
English: 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.
Slovenian: To pomeni, da mitohondriji ne morejo pravilno ustvarjati energije in proizvajajo strupene oblike kisika (proste radikale), ki poškodujejo živčne celice v očesu, ki nam omogočajo, da vidimo.
English: These patients showed an improvement of 17 letters on the letter chart compared with placebo.
Slovenian: Ti bolniki so na tabeli s črkovnimi znaki prepoznali 17 črk več kot bolniki, ki so jemali placebo.
English: Based on the same study, the company later proposed to restrict the use of Raxone to patients with LHON whose symptoms started in the previous year.
Slovenian: Družba je na podlagi iste študije kasneje predlagala omejitev uporabe zdravila Raxone na bolnike z LHON, pri katerih so se simptomi pojavili v preteklem letu.
English: The CHMP did not consider this benefit to be significant.
Slovenian: Zato je CHMP menil, da zdravilo ni izkazalo pomembnih koristi.
English: What was Raxone expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Raxone uporabljalo?
English: Raxone was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 February 2007 for the treatment of LHON.
Slovenian: Zdravilo Raxone je bilo 15. februarja 2007 določeno kot „zdravilo sirota‟ (zdravilo za zdravljenje redkih bolezni) za zdravljenje LHON.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Raxone did not outweigh its risks.
Slovenian: Zato je v času umika menil, da koristi zdravila Raxone ne odtehtajo z njim povezanih tveganj.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion recommending that the marketing authorisation be refused for Raxone for the treatment of Leber's hereditary optic neuropathy (LHON).
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika vloge izrazil negativno mnenje in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Raxone za zdravljenje Leberjeve hereditarne optične nevropatije (LHON).
English: How is Raxone expected to work?
Slovenian: Kako naj bi zdravilo Raxone delovalo?
English: Patients should be monitored for signs and symptoms and managed as recommended in section 4.2.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov ter ukrepati, kot je priporočeno v poglavju 4.2.
English: Adopted at the 30 September-3 October 2019 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 30. septembrom in 3. oktobrom 2019
English: Corticosteroid treatment unless otherwise specified
Slovenian: Zdravljenje s kortikosteroidi, če ni določeno drugače
English: • Inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
Slovenian: • vnetje mišic ali težave z njimi: med simptomi so lahko bolečine v mišicah, ali šibkost ali hitra utrujenost mišic;
English: Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:
Slovenian: Zdravnik lahko odloži uporabo naslednjega odmerka zdravila IMFINZI ali preneha vaše zdravljenje z zdravilom IMFINZI, če imate:
English: Summary of product characteristics 4.2.
Slovenian: Povzetek glavnih značilnosti zdravila 4.2.
English: Durvalumab - Myasthenia gravis (EPITT no 19451)
Slovenian: Durvalumab - miastenija gravis (št. EPITT 19451)
English: Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Slovenian: Glede na mehanizem delovanja zdravila IMFINZI se lahko pojavijo še drugi morebitno imunsko pogojeni neželeni učinki.
English: IMFINZI treatment modification
Slovenian: Prilagoditev zdravljenja z zdravilom IMFINZI
English: treated with IMFINZI monotherapy in clinical trials (n = 1889): myasthenia gravis, myocarditis, myositis, polymyositis.
Slovenian: Naslednji imunsko pogojeni neželeni učinki so bili v kliničnih preskušanjih (n = 1889) zabeleženi pri manj kot 1 % bolnikov, ki so prejemali samostojno zdravljenje z zdravilom IMFINZI: miastenija gravis, miokarditis, miozitis, polimiozitis.
English: Undesirable effects Nervous system disorders Rare: Myasthenia gravis
Slovenian: Neželeni učinki Bolezni živčevja Redki: miastenija gravis
English: Frequency not known: eruption of the skin or mucous membranes (lichenoid drug reaction)
Slovenian: Neznana pogostnost: izpuščaj na koži ali sluznicah (lihenoidna reakcija na zdravilo)
English: Rare: a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Slovenian: Možni neželeni učinki Redki: stanje, pri katerem mišice postanejo oslabele in se hitro utrudijo (miastenija gravis).
English: Permanently discontinue d d) For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Slovenian: Drugi imunsko pogojeni neželeni učinki prekinite uporabo odmerka razmislite o začetnem odmerku od 1 do 4 mg/kg/dan prednizona ali ekvivalenta in nato postopoma zmanjšujte trajno prenehajte uporabljati d d) Če se pri miasteniji gravis pojavijo znaki mišične oslabelosti ali respiratorne insuficience, morate zdravilo IMFINZI trajno prenehati uporabljati.
English: Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: lichenoid drug reaction
Slovenian: Seznam neželenih učinkov v preglednici Bolezni kože in podkožja
English: Lithium - Drug-induced lichenoid reaction (EPITT no
Slovenian: Litij - lihenoidna reakcija na zdravilo (št. EPITT 19389)
English: Other immunemediated adverse reactions
Slovenian: Neželeni učinki
English: Special warnings and precautions for use
Slovenian: Posebna opozorila in previdnostni ukrepi Drugi imunsko pogojeni neželeni učinki
English: B - 1000 Brussels Belgium
Slovenian: B - 1000 Brussels Belgija
English: ATC code: H02AB09.
Slovenian: Oznaka ATC: H02AB09.
English: • You should preferably be in an upright position.
Slovenian: • Najbolje je, da ste v pokončnem položaju.
English: The binding is about 90%.
Slovenian: Stopnja vezave je okoli 90-odstotna.
English: • Difficulty sleeping
Slovenian: • težave s spanjem
English: The lowest possible maintenance dosage should be used.
Slovenian: Uporablja naj se najmanjši možni vzdrževalni odmerek.
English: Side effects of this medicine are:
Slovenian: Neželeni učinki tega zdravila so:
English: Frequencies of these possible side effects are not known (frequency cannot be estimated from the available data).
Slovenian: Pogostost teh možnih neželenih učinkov ni znana (pogostosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Risks may be higher when high doses are given.
Slovenian: Tveganje je večje, kadar se dajejo visoki odmerki.
English: The effect of corticosteroids may be reduced for 3-4 days after treatment with mifepristone.
Slovenian: Učinek kortikosteroidov se lahko zmanjša za 3 do 4 dni po zdravljenju z mifepristonom.
English: This leaflet was last revised in .
Slovenian: Navodilo je bilo nazadnje revidirano .
English: A too high dose of this medicine for more than a few days may be harmful to your health.
Slovenian: Če več kot nekaj dni jemljete prevelik odmerek tega zdravila, lahko to škoduje vašemu zdravju.
English: The safety and efficacy of Plenadren in children/adolescents aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Plenadren pri otrocih/mladostnikih, mlajših od 18 let, še ni bila dokazana.
English: Very common (1/10); Common (1/100 to <1/10).
Slovenian: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10).
English: In which case, symptomatic treatment should be instituted as necessary.
Slovenian: V tem primeru je po potrebi treba začeti simptomatično zdravljenje.
English: This regimen has been documented in over 300 intercurrent illness episodes within the clinical study programme.
Slovenian: Ta režim zdravljenja je bil dokumentiran pri več kot 300 epizodah sočasne bolezni v okviru programa klinične študije.
English: • Mood changes such as feelings of overexcitement or losing touch with reality
Slovenian: • nihanje razpoloženja, kot so občutja prekomernega navdušenja ali izguba stika z resničnostjo
English: If you experience any signs or symptoms listed in the section “The need for additional doses of Plenadren”, contact your doctor immediately.
Slovenian: Če opazite kateri koli znak ali simptom, naveden v poglavju “Potreba po dodatnih odmerkih zdravila Plenadren”, takoj obvestite zdravnika.
English: In addition they modify the body's immune responses to diverse stimuli.
Slovenian: Poleg tega spreminjajo imunski odziv telesa na različne dražljaje.
English: Plenadren with food and drink
Slovenian: Zdravilo Plenadren skupaj s hrano in pijačo
English: If you have forgotten to take your tablet in the morning, take it as soon as possible thereafter.
Slovenian: Če ste pozabili vzeti zdravilo Plenadren Če ste pozabili zjutraj vzeti tableto, jo vzemite takoj, ko je mogoče.
English: This may occur during commencement of treatment and during dose adjustments.
Slovenian: Pojavijo se lahko na začetku zdravljenja in med prilagajanjem odmerka.
English: Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare.
Slovenian: Poročila o akutni toksičnosti in/ali smrti po prevelikem odmerjanju hidrokortizona so redka.
English: Glucocorticoids occur naturally in the body, and help to maintain your general health and well-being.
Slovenian: Glukokortikoidi so naravno prisotni v telesu, ter pomagajo ohranjati splošno zdravje in dobro počutje.
English: Do not stop taking it without consulting your doctor.
Slovenian: Ne prenehajte jemati tega zdravila, ne da bi se posvetovali s svojim zdravnikom.
English: Plenadren is not recommended for use in children and adolescents under 18 years old as it has not been studied in these patients.
Slovenian: Uporabe zdravila Plenadren pri otrocih in mladostnikih, mlajših od 18 let, ne priporočajo, ker je pri teh bolnikih niso preučevali.
English: - if for any other reason your general health is declining although you take your medicine as prescribed; seek immediate medical care.
Slovenian: - če se zaradi kakršnegakoli drugega razloga vaše splošno zdravje poslabšuje navkljub jemanju zdravila po navodilih, nemudoma poiščite zdravniško pomoč;
English: Not all pack sizes may be available in your country.
Slovenian: V vaši državi morda ni na voljo vseh navedenih pakiranj.
English: • Diabetes or problems with blood sugar levels (shown in blood tests)
Slovenian: • sladkorna bolezen ali težave z ravnjo sladkorja v krvi (rezultati krvnih preiskav)
English: You should then take the second dose of this medicine 6 to 10 hours after the morning dose.
Slovenian: Drugi odmerek tega zdravila vzemite od 6 do 10 ur po jutranjem odmerku.
English: Please discuss this with your doctor and follow the instructions on how to act in these situations.
Slovenian: O tem se pogovorite z zdravnikom in upoštevajte njegova navodila glede ravnanja v teh primerih.
English: It belongs to a group of medicines called corticosteroids.
Slovenian: Sodi v skupino zdravil, imenovanih kortikosteroidi.
English: A common maintenance dose is 20-30 mg per day, given once daily in the morning.
Slovenian: Običajni vzdrževalni odmerek je 20-30 mg na dan, ki se daje enkrat na dan, in sicer zjutraj.
English: They will normally disappear with time, if not contact your doctor.
Slovenian: Sčasoma običajno izginejo, v nasprotnem primeru se posvetujte z zdravnikom.
English: This may happen when you have stomach problems involving vomiting and/or diarrhoea.
Slovenian: To se lahko zgodi, če imate težave z želodcem, ki vključujejo bruhanje in/ali drisko.
English: They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Slovenian: Uporabljajo se tudi zaradi močnih protivnetnih učinkov pri boleznih različnih organskih sistemov.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
English: Do not take this medicine with grapefruit juice as the juice will conflict with the action of this medicine.
Slovenian: Ne jemljite tega zdravila skupaj s sokom grenivke, saj bo sok negativno vplival na delovanje zdravila.
English: If more than one daily administration is required the morning dose should be given as instructed, additional doses given later during the day can be given with or without food.
Slovenian: Če je potreben več kot en odmerek na dan, je treba jutranji odmerek dati po navodilih, dodatne odmerke kasneje čez dan pa s hrano ali brez nje.
English: However, talk to your doctor if you plan to breast-feed your baby.
Slovenian: Vendar pa zdravnika obvestite, če nameravate dojiti otroka.
English: The need for additional doses of Plenadren
Slovenian: Potreba po dodatnih odmerkih zdravila Plenadren
English: If it is not enough to double the daily dose, you should take a third dose 6 to 10 hours after the second dose (6-10 hour intervals between doses).
Slovenian: Če podvojeni dnevni odmerek ne zadošča, vzemite še tretji odmerek, in sicer od 6 do 10 ur po drugem odmerku (od 6- do 10-urni razmik med odmerki).
English: It is important that you continue treatment with Plenadren during pregnancy.
Slovenian: Pomembno je, da med nosečnostjo nadaljujete zdravljenje z zdravilom Plenadren.
English: Therefore, patients should be advised of the signs and symptoms of acute adrenal insufficiency and of adrenal crisis and the need to seek immediate medical attention.
Slovenian: Zato je treba bolnikom razložiti znake in simptome akutne adrenalne insuficience in adrenalne krize in potrebo, da takoj poiščejo zdravniško pomoč.
English: Concomitant infections
Slovenian: Sočasne okužbe
English: Shire Services BVBA Rue Montoyer 47 B - 1000 Brussels Belgium
Slovenian: Shire Services BVBA Rue Montoyer 47 B - 1000 Brussels Belgija
English: A small amount of cortisol is excreted in the urine unchanged (<0.5% of the daily production), meaning that cortisol is eliminated completely by metabolism.
Slovenian: Majhna količina kortizola se v urinu izloča v nespremenjeni obliki (< 0,5 % dnevne količine), kar pomeni, da se kortizol v celoti izloča s presnavljanjem.
English: Therefore, there is no reason to believe that replacement doses of hydrocortisone will exacerbate any systemic infection or worsen the outcome of such an infection.
Slovenian: Zato ni razloga, da bi domnevali, da bodo nadomestni odmerki hidrokortizona poslabšali kakršnokoli sistemsko okužbo ali izid take okužbe.
English: Talk to your doctor or pharmacist before taking Plenadren - when you have a condition that makes you unable to take this medicine or when the medicine is not absorbed properly from your stomach.
Slovenian: Pred začetkom jemanja zdravila Plenadren se posvetujte z zdravnikom ali farmacevtom: - kadar imate bolezen, zaradi katere ne morete jemati tega zdravila ali kadar se zdravilo iz vašega želodca ne absorbira pravilno.
English: If you are affected do not drive or use machines, until you have discussed the issue with your doctor.
Slovenian: Če zdravilo na vas vpliva, ne upravljajte vozil ali strojev, dokler se o težavi ne pogovorite z zdravnikom.
English: On the other hand, the extent of absorption and bioavailability was approximately 30% higher for the 20 mg tablet after food intake compared to fasting and there was no absorption failure or dose dumping.
Slovenian: Po drugi strani pa je bil pri 20 mg tabletah obseg absorpcije in biološke razpoložljivosti za okoli 30 % večji po vnosu hrane v primerjavi z jemanjem zdravila na tešče, pri čemer tudi ni prišlo do neuspešne absorpcije ali prekomernega sproščanja.
English: An increased dose is necessary occasionally in order for the body to cope with increased stress such as fever.
Slovenian: Povečan odmerek je občasno potreben, da se lahko telo spopade s povečanim naporom, na primer zvišano telesno temperaturo.
English: This may require dose adjustment of hydrocortisone.
Slovenian: Zaradi tega bo morda potrebna prilagoditev odmerka hidrokortizona.
English: Paediatric population No pharmacokinetic data are available in children or adolescents.
Slovenian: Pri otrocih ali mladostnikih ni na voljo nobenih farmakokinetičnih podatkov.
English: Most reactions resolve after dose reduction, although specific treatment may be necessary.
Slovenian: Večina učinkov po zmanjšanju odmerka izzveni, čeprav je včasih potrebno posebno zdravljenje.
English: It is therefore important to continue taking this medicine as prescribed by your doctor.
Slovenian: Zato je pomembno, da nadaljujete z jemanjem tega zdravila v skladu z zdravnikovimi navodili.
English: • When you wake up in the morning swallow Plenadren tablets whole with a glass of water at least 30 minutes before your breakfast, preferable between 6.00 am and 8.00 am in the morning.
Slovenian: • Ko se zjutraj zbudite, pogoltnite celo tableto zdravila Plenadren s kozarcem vode, vsaj 30 minut pred zajtrkom, najbolje med 6. in 8. uro zjutraj.