FrancophonIA/ELRC3.0 huggingface dataset:
English: The composite endpoint of all-cause mortality or first CHF hospitalisation was also significantly reduced with candesartan, HR 0.80 (95%CI: 0.70 to 0.92, p=0.001).
Slovenian: Sestavljena končna točka umrljivosti zaradi vseh vzrokov ali prve hospitalizacije zaradi kroničnega srčnega popuščanja se je s kandesartanom prav tako značilno zmanjšala, HR 0,80 (95 % IZ: od 0,70 do 0,92, p = 0,001).
English: The active ingredient is candesartan cilexetil.
Slovenian: Zdravilna učinkovina je cileksetilkandesartanat.
English: In CHARM-Alternative, the composite endpoint of cardiovascular mortality or first CHF hospitalisation was significantly reduced with candesartan in comparison with placebo, hazard ratio (HR) 0.77 (95%CI: 0.67 to 0.89, p< 0.001).
Slovenian: V študiji CHARM-Alternative se je sestavljena končna točka kardiovaskularne umrljivosti ali prve hospitalizacije zaradi kroničnega srčnega popuščanja s kandesartanom v primerjavi s placebom statistično značilno zmanjšala, razmerje ogroženosti (HR) 0,77 (95 % IZ: od 0,67 do 0,89, p < 0,001).
English: Patients with hepatic impairment
Slovenian: Bolniki s hipovolemijo
English: In CHARM-Preserved, no statistically significant reduction was achieved in the composite endpoint of cardiovascular mortality or first CHF hospitalisation, HR 0.89 (95%CI: 0.77 to 1.03, p=0.118).
Slovenian: V študiji CHARM-Preserved se sestavljena končna točka kardiovaskularne umrljivosti in prve hospitalizacije zaradi kroničnega srčnega popuščanja ni statistično značilno zmanjšala, HR 0,89 (95 % IZ: od 0,77 do 1,03, p = 0,118).
English: Blopress 2 mg Tabletten 2 mg
Slovenian: Blopress 2 mg 2 mg Tablete
English: Both the mortality and morbidity (CHF hospitalisation) components of these composite endpoints contributed to the favourable effects of candesartan.
Slovenian: K ugodnemu učinku kandesartana sta pripomogla oba elementa te sestavljene končne točke: umrljivost in obolevnost (hospitalizacija zaradi kroničnega srčnega popuščanja).
English: This may make you feel faint or dizzy.
Slovenian: Posledici sta lahko omotica ali omedlevica.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Slovenian: Med hkratno uporabo litija in zaviralcev ACE je opisano reverzibilno povečanje koncentracije litija v serumu in povečanje njegovih toksičnih učinkov.
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Slovenian: Pri nekaterih bolnikih sta žilni tonus in delovanje ledvic odvisna predvsem od delovanja sistema reninangiotenzin-aldosteron; to velja npr. za bolnike s hudim kongestivnim srčnim popuščanjem ali osnovno boleznijo ledvic, vključno s stenozo ledvične arterije.
English: Atacand 16, tabletten 16 mg 16 mg Tablet
Slovenian: Atacand 16, tabletten 16 mg
English: HOW TO STORE ATACAND
Slovenian: SHRANJEVANJE ZDRAVILA ATACAND
English: When Atacand is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Slovenian: Hipertenzivnim bolnikom z okvaro ledvic je med uporabo Atacanda priporočljivo redno kontrolirati koncentracijo kalija in kreatinina v serumu.
English: Biotransformation and elimination
Slovenian: Presnova in izločanje
English: In CHARM-Added, the composite endpoint of cardiovascular mortality or first CHF hospitalisation was significantly reduced with candesartan in comparison with placebo, HR 0.85 (95%CI: 0.75 to 0.96, p=0.011).
Slovenian: V študiji CHARM-Added se je sestavljena končna točka kardiovaskularne umrljivosti ali prve hospitalizacije zaradi kroničnega srčnega popuščanja s kandesartanom v primerjavi s placebom statistično značilno zmanjšala, HR 0,85 (95 % IZ: od 0,75 do 0,96, p < p = 0,011).
English: Atacand 32, tabletten 32 mg 32 mg Tablet
Slovenian: Atacand 32, tabletten 32 mg
English: Of candesartan patients 36.6% (95%CI: 33.7 to 39.7) and of placebo patients 42.7% (95%CI: 39.6 to 45.8) experienced this endpoint, absolute difference 6.0% (95%CI: 10.3 to 1.8).
Slovenian: Ta končna točka se je pojavila pri 36,6 % bolnikov, ki so prejemali kandesartan (95 % IZ: od 33,7 do 39,7), in pri 42,7 % bolnikov, ki so prejemali placebo (95 % IZ: od 39,6 do 45,8), absolutna razlika 6,0 % (95 % IZ: od 10,3 do 1,8).
English: Other sections of the SPC were harmonised accordingly.
Slovenian: Skladno s tem so bila usklajena tudi druga poglavja povzetka glavnih značilnosti zdravila.
English: The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis.
Slovenian: Začetni odmerek za bolnike z okvaro ledvic (vključno z bolniki na hemodializi) je 4 mg. Odmerek je treba prilagoditi glede na odziv.
English: Of candesartan patients 33.0% (95%CI: 30.1 to 36.0) and of placebo patients 40.0% (95%CI: 37.0 to 43.1) experienced this endpoint, absolute difference 7.0% (95%CI: 11.2 to 2.8).
Slovenian: Ta končna točka se je pojavila pri 33,0% bolnikov, ki so prejemali kandesartan (95 % IZ: od 30,1 do 36,0), in pri 40,0 % bolnikov, ki so prejemali placebo (95 % IZ: od 37,0 do 43,1), absolutna razlika 7,0 % (95 % IZ: od 11,2 do 2,8).
English: Very rare Hyperkalaemia, hyponatraemia
Slovenian: Presnovne in prehranske motnje Zelo redki hiperkaliemija, hiponatriemija
English: Strength Pharmaceutical Form Route of administration
Slovenian: Imetnik dovoljenja za promet z zdravilom Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe zdravila
English: Of candesartan patients 42.2% (95%CI: 39.5 to 45.0) and of placebo patients 46.1% (95%CI: 43.4 to 48.9) experienced this endpoint, absolute difference 3.9% (95%CI: 7.8 to 0.1).
Slovenian: Ta končna točka se je pojavila pri 42,2 % bolnikov, ki so prejemali kandesartan (95 % IZ: od 39,5 do 45,0), in pri 46,1 % bolnikov, ki so prejemali placebo (95 % IZ: od 43,4 do 48,9), absolutna razlika 3,9 % (95 % IZ: 7,8 do 0,1).
English: Heart Failure
Slovenian: Srčno popuščanje
English: Blopress 4 mg Tabletten 4 mg
Slovenian: Blopress 4 mg 4 mg Tablete
English: Atacand PROTECT 32 mg Tabletten
Slovenian: PROTECT 32 mg Tabletten
English: Blopress 8 mg Tabletten 8 mg
Slovenian: Blopress 8 mg 8 mg Tablete
English: Of candesartan patients 37.9% (95%CI: 35.2 to 40.6) and of placebo patients 42.3% (95%CI: 39.6 to 45.1) experienced this endpoint, absolute difference 4.4% (95%CI: 8.2 to 0.6).
Slovenian: Ta končna točka se je pojavila pri 37,9 % bolnikov, ki so prejemali kandesartan (95 % IZ: od 35,2 do 40,6), in pri 42,3 % bolnikov, ki so prejemali placebo (95 % IZ: od 39,6 do 45,1), absolutna razlika 4,4 % (95 % IZ: od 8,2 do 0,6).
English: Amias 2 mg
Slovenian: Amias 2 mg 2 mg Tablete
English: Atacand 8 mg comprimidos 8mg
Slovenian: Atacand 8 mg 8mg Tablete
English: Atacand 4 mg comprimidos 4 mg
Slovenian: Atacand 4 mg 4 mg Tablete
English: As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen.
Slovenian: Opazili so majhno znižanje hemoglobina, tako kot pri drugih zaviralcih sistema renin-angiotenzin-aldosteron.
English: Candesartan cilexetil is a prodrug suitable for oral use.
Slovenian: Cileksetilkandesartanat je predzdravilo, primerno za peroralno uporabo.
English: Blopress 32 mg Tabletten 32 mg Tablet
Slovenian: Blopress 32 mg 32 mg Tablete
English: Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Slovenian: Zdravilo Atacand je indicirano za: zdravljenje esencialne hipertenzije pri odraslih bolnikih, zdravljenje odraslih bolnikov s srčnim popuščanjem in zmanjšano sistolično funkcijo levega prekata (iztisni delež levega prekata ≤ 40 %) kot dodatek zdravljenju poleg zaviralcev ACE ali kadar bolniki zaviralce ACE slabo prenašajo.
English: Sweden AstraZeneca AB 151 85 Södertälje, Sweden
Slovenian: AstraZeneca AB 151 85 Södertälje, Sweden
English: Blopress 16 mg Tabletten 16 mg Tablet
Slovenian: Blopress 16 mg 16 mg Tablete
English: Common Dizziness/vertigo, headache
Slovenian: Pogosti omotica/vrtoglavica, glavobol
English: You must tell your doctor if you think you are (or might become) pregnant.
Slovenian: Zdravniku morate povedati, če mislite, da ste noseči (ali da bi lahko zanosili).
English: Before you take, or whilst you are taking Atacand, tell your doctor.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Atacand Preden uporabite zdravilo Atacand in med jemanjem tega zdravila morate zdravniku povedati:
English: Amias 32 mg
Slovenian: Amias 32 mg 32 mg Tablete
English: Parapres 4 mg comprimidos 4 mg
Slovenian: Parapres 4 mg comprimidos
English: Patients with intravascular volume depletion
Slovenian: Bolniki z okvaro jeter
English: Atacand 32 mg - Tabletten 32 mg Tablet
Slovenian: Atacand 32 mg 32 mg Tablete
English: Amias 16 mg
Slovenian: Amias 16 mg 16 mg Tablete
English: Amias 8 mg
Slovenian: Amias 8 mg 8 mg Tablete
English: Atacand 16 mg - Tabletten 16 mg Tablet
Slovenian: Atacand 16 mg 16 mg Tablete
English: Blopress 8 mg comprimidos 8 mg
Slovenian: Blopress 8 mg comprimidos
English: Parapres 8 mg comprimidos 8 mg
Slovenian: Parapres 8 mg comprimidos
English: Amias 4 mg
Slovenian: Amias 4 mg 4 mg Tablete
English: Blopress 4 mg comprimidos 4 mg
Slovenian: Blopress 4 mg comprimidos
English: Common Hypotension
Slovenian: Pogosti hipotenzija
English: Section 4.2 Posology and method of administration
Slovenian: Poglavje 4.2 Odmerjanjeinnačinuporabe
English: indicates that a contraindication during the first trimester of pregnancy is not justified; the use of AIIRAs in the first trimester of pregnancy is not recommended.
Slovenian: Ker ni na voljo informacij glede uporabe zdravila Atacand med dojenjem, zdravila Atacand ne priporočamo.
English: BEFORE YOU TAKE ATACAND
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ATACAND
English: This is usually achieved within a month.
Slovenian: To stanje je običajno doseženo v enem mesecu.
English: This summary was last updated in 10-2016
Slovenian: Povzetek je bil nazadnje posodobljen 10-2016.
English: This helps to improve the symptoms of the disease.
Slovenian: To prispeva k izboljšanju simptomov bolezni.
English: It should be dissolved fully in water, juice, milk, formula or food immediately before being taken.
Slovenian: Prašek je treba neposredno pred zaužitjem popolnoma raztopiti v vodi, soku, mleku, otroški formuli ali hrani.
English: The information from these studies was compared to published reports describing the outcome of untreated patients with the disease.
Slovenian: Podatke iz teh študij so primerjali z objavljenimi poročili, ki opisujejo izid pri nezdravljenih bolnikih s to boleznijo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cystadane on 15 February 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Cystadane, veljavno po vsej Evropski uniji, izdala 15. februarja 2007.
English: For 140 patients, information was also provided on their symptoms, the dose and duration of treatment, and other medicines being taken.
Slovenian: Za 140 bolnikov so bile podane tudi informacije o njihovih simptomih, odmerkih in trajanju zdravljenja ter drugih uporabljenih zdravilih.
English: What measures are being taken to ensure the safe and effective use of Cystadane?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cystadane?
English: The aim of the treatment is to keep blood levels of homocysteine below 15 micromoles or as low as possible.
Slovenian: Namen zdravljenja je vzdrževanje ravni homocisteina pod 15 mikromolov ali na čim nižji ravni.
English: This causes a wide range of symptoms, including impaired vision, weak bones and circulatory problems.
Slovenian: To povzroča številne simptome, vključno z okvaro vida, krhkimi kostmi in težavami z obtočili.
English: Most patients were also taking vitamins B6 or B12, or folate.
Slovenian: Večina bolnikov je jemala tudi vitamina B6 ali B12 ali folat.
English: This is a summary of the European public assessment report (EPAR) for Cystadane.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cystadane.
English: Betaine is a natural substance that is extracted from sugar beet.
Slovenian: Betain je naravna snov, ki se pridobiva iz sladkorne pese.
English: This was associated with an improvement in symptoms affecting the cardiovascular system (heart and blood vessels) as well as an improvement in developmental problems in around three quarters of the patients taking Cystadane.
Slovenian: To je bilo povezano z izboljšanjem simptomov v zvezi s kardiovaskularnim sistemom (srcem in ožiljem) ter izboljšanjem razvojnih težav pri približno treh četrtinah bolnikov, ki so prejemali zdravilo Cystadane.
English: In particular, the company will monitor cases of cerebral oedema, which was seen in a small number of patients during the testing of the medicine.
Slovenian: Zlasti bo spremljala primere možganskega edema, ki so ga pri majhnem številu bolnikov opazili med testiranjem zdravila.
English: It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet.
Slovenian: Uporablja se kot dodatek drugim zdravilom, na primer vitaminu B6 (piridoksin), vitaminu B12 (kobalamin), folatu in posebni dieti.
English: Cystadane is supplied with 3 measuring spoons to measure 100 mg, 150 mg and 1 g of the powder.
Slovenian: Zdravilo Cystadane se dobavlja s tremi merilnimi žličkami za odmerjanje 100 mg, 150 mg in 1 g praška.
English: The company presented information on Cystadane from the scientific literature.
Slovenian: Družba je predložila informacije o zdravilu Cystadane iz znanstvene literature.
English: Other information about Cystadane
Slovenian: Druge informacije o zdravilu Cystadane
English: The medicine was effective in patients with all three types of homocystinuria.
Slovenian: Zdravilo je bilo učinkovito pri bolnikih z vsemi tremi vrstami homocistinurije.
English: The standard dose of Cystadane is 100 mg per kilogram of body weight a day, divided into two equal doses.
Slovenian: Običajni odmerek zdravila Cystadane je 100 mg na kilogram telesne mase vsak dan, razdeljen v dva ločena odmerka.
English: The dose can be adjusted depending on the response to treatment (monitored by measuring the level of homocysteine in the blood).
Slovenian: Odmerek je mogoče prilagoditi glede na odziv bolnika na zdravljenje (kar se nadzoruje z merjenjem ravni homocisteina v krvi).
English: The company that makes Cystadane will set up a register of patients taking the medicine to monitor its safety.
Slovenian: Družba, ki izdeluje zdravilo Cystadane, bo vzpostavila register bolnikov, ki jemljejo zdravilo, da bi tako nadzorovala njegovo varnost.
English: The Committee noted that Cystadane is not a substitute for other treatments.
Slovenian: Ugotovil je, da zdravilo Cystadane ne more nadomestiti drugih načinov zdravljenja.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Cystadane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Patients with symptoms of cerebral oedema, such as morning headaches with vomiting, or changes in vision, should speak to their doctor, as treatment with Cystadane may have to be interrupted.
Slovenian: Bolniki s simptomi možganskega edema, kot so jutranji glavobol z bruhanjem, ali spremembami vida, naj se posvetujejo z zdravnikom, saj bo mogoče treba zdravljenje z zdravilom Cystadane prekiniti.
English: The most common side effect when taking Cystadane (seen in more than 1 patient in 10) is elevated levels of methionine in the blood.
Slovenian: Najpogostejši neželeni učinek zdravila Cystadane (opažen pri več kot 1 bolniku od 10) so povišane ravni metionina v krvi.
English: Because the number of patients with homocystinuria is low, the disease is considered ‘rare', and Cystadane was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Slovenian: Ker je bolnikov s homocistinurijo malo, velja ta bolezen za redko, zato je bilo zdravilo Cystadane 9. julija 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: This included 202 reports that described the effects of Cystadane, given at a variety of doses, on homocysteine levels in homocystinuria patients of various ages.
Slovenian: Te so obsegale 202 poročili, ki opisujejo učinke zdravila Cystadane, uporabljenega v različnih odmerkih, na raven homocisteina pri bolnikih različnih starosti, ki imajo homocistinurijo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cystadane have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cystadane upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Treatment with Cystadane should be supervised by a doctor who has experience in the treatment of patients with homocystinuria.
Slovenian: Zdravljenje z zdravilom Cystadane mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s homocistinurijo.
English: What are the risks associated with Cystadane?
Slovenian: Kakšna tveganja so povezana z zdravilom Cystadane?
English: What is Cystadane and what is it used for?
Slovenian: Kaj je zdravilo Cystadane in za kaj se uporablja?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je navkljub maloštevilnim sistematičnim študijam zdravila Cystadane sklenil, da je zdravilo koristno kot dodatek k obstoječim načinom zdravljenja homocistinurije, kot so dodajanje vitaminov in posebna dieta.
English: Patients taking Cystadane appeared to have greater reductions in homocysteine levels than untreated patients.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Cystadane, je očitno prišlo do večjega znižanja ravni homocisteina kot pri nezdravljenih bolnikih.
English: In homocystinuria, betaine reduces homocysteine levels in the blood by transforming homocysteine into the amino acid methionine.
Slovenian: Pri homocistinuriji betain znižuje raven homocisteina v krvi tako, da homocistein ponovno pretvarja v aminokislino metionin.
English: It is not intended to provide practical advice on how to use Cystadane.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For more information about treatment with Cystadane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cystadane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Cystadane is a medicine used to treat homocystinuria, an inherited disease where the amino acid homocysteine cannot be broken down and therefore builds up in the body.
Slovenian: Zdravilo Cystadane je namenjeno za zdravljenje homocistinurije, tj. dedne bolezni, pri kateri se aminokislina homocistein, ne more razgraditi in se zato kopiči v telesu.
English: What benefits of Cystadane have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cystadane izkazalo v študijah?
English: The full EPAR for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cystadane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Cystadane approved?
Slovenian: Zakaj je bilo zdravilo Cystadane odobreno?
English: It recommended that Cystadane be given marketing authorisation.
Slovenian: Priporočil je, da se zanj izda dovoljenje za promet.
English: Methionine levels should be monitored in patients taking Cystadane, as it might lead to cerebral oedema (swelling in the brain).
Slovenian: Pri bolnikih, ki jemljejo zdravilo Cystadane, je treba nadzorovati raven metionina, saj lahko povzroči možganski edem (otekanje v možganih).
English: For practical information about using Cystadane, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cystadane naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Cystadane betaine anhydrous
Slovenian: Cystadane brezvodni betain
English: Cystadane is available as a powder to be taken by mouth.
Slovenian: Zdravilo Cystadane je na voljo v obliki praška, ki se jemljejo peroralno.
English: Cystadane contains the active substance betaine anhydrous.
Slovenian: Zdravilo Cystadane vsebuje zdravilno učinkovino brezvodni betain.
English: How is Cystadane used?
Slovenian: Kako se zdravilo Cystadane uporablja?
English: How does Cystadane work?
Slovenian: Kako zdravilo Cystadane deluje?
English: The Committee decided that Cystadane's benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Slovenian: Zato je sklenil, da so koristi zdravila Cystadane, če se uporablja v skladu z indikacijo, večje od z njim povezanih tveganj pri dopolnilnem zdravljenju homocistinurije.
English: This dose is expected to be used in only a limited number of the treatments (less than 1%).
Slovenian: Ta odmerek naj bi se po pričakovanjih uporabil le pri zelo majhnem številu zdravljenj (manj kot 1 %).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bridion on 25 July 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Bridion, veljavno po vsej Evropski uniji, izdala 25. julija 2008.
English: This might be necessary if patients need to be able to start to breathe on their own again during the operation.
Slovenian: To utegne biti potrebno pri bolnikih, ki morajo že med operacijo začeti znova dihati samostojno.
English: What measures are being taken to ensure the safe and effective use of Bridion?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bridion?
English: The full EPAR for Bridion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bridion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Bridion
Slovenian: Druge informacije o zdravilu Bridion
English: This is a summary of the European public assessment report (EPAR) for Bridion.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bridion.
English: Bridion sugammadex
Slovenian: Bridion sugamadeks
English: There were too few children aged below two years to determine the safety and effectiveness of Bridion in this age group.
Slovenian: Otrok, mlajših od dveh let, je bilo premalo za določitev varnosti in učinkovitosti zdravila Bridion v tej starostni skupini.