FrancophonIA/ELRC3.0 huggingface dataset:
English: Viani Evohaler and associated names (see Annex I) 25/250 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Slovenian: Viani Evohaler in povezana imena (Glejte Dodatek I) 25/250 mikrogramov/odmerek, inhalacijska suspenzija pod tlakom [Glejte Dodatek I - Izpolni država članica]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 25 micrograms of salmeterol (as xinafoate) and 250 micrograms of fluticasone propionate per actuation
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN v enem odmerku je 25 mikrogramov salmeterola (kot ksinafoat) in 250 mikrogramov flutikazonijevega propionata
English: The initial starting dose is 2 inhalations of 25 mcg salmeterol and 50 mcg FP twice daily.
Slovenian: Začetni odmerek sta 2 vdiha 25 µg salmeterola in 50 µg flutikazon propionata dvakrat na dan.
English: Viani 25/50 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
Slovenian: Pri bolnikih s hudo astmo je pred uvedbo katere koli fiksne kombinacije priporočljivo določiti ustrezni odmerek inhalacijskega kortikosteroida.
English: GlaxoSmithKline GmbH & Co. KG Theresienhohe 11
Slovenian: KG Theresienhohe 11
English: Keep out of the reach and sight of children
Slovenian: POGLEDA OTROK
English: What Viani looks like and contents of the pack Pressurised inhalation, suspension.
Slovenian: Izgled zdravila Viani in vsebina pakiranja
English: Patients should breathe out as far as is comfortable and then place the mouthpiece in your mouth between their teeth and close their lips around it, Patients should be instructed not to bite the mouth piece.
Slovenian: Potem naj ustnik da v usta med zobe in okrog njega stisne ustnice.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 puffs
Slovenian: 1 inhalator s 120 sprožitvami ali
English: Respiratory, Thoracic & Mediastinal Disorders
Slovenian: Salmeterolijev ksinafoat in flutikazonijev propanoat Za inhalacijo
English: The study was completed on 31 July 2016.
Slovenian: Študija je bila zaključena 31. julija 2016.
English: The dose should be adjusted accordingly, as described above.
Slovenian: Odmerek je treba ustrezno prilagoditi, kakor je opisano zgoraj.
English: If not, the next higher dose should be selected.
Slovenian: Če ni, je treba izbrati naslednji večji odmerek.
English: DATE OF FIRST AUTHORISATION 20 November 2015
Slovenian: DATUM PRVE PRIDOBITVE 20. november 2015
English: The physician's educational material should contain the following key elements:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključne elemente:
English: Use within 3 months of opening.
Slovenian: Uporabite v 3 mesecih po odprtju.
English: Elderly patients (older than 65 years)
Slovenian: Starejši bolniki (> 65 let)
English: Liver parameters should also be monitored.
Slovenian: Spremljati je treba tudi jetrne parametre.
English: Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose.
Slovenian: Vzemite naslednji odmerek, takoj ko se spomnite, če je do naslednjega odmerka preostalo še več kot 12 ur.
English: Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
Slovenian: Tel: +353 86 803 8014 info@retrophin.com
English: This medicine is intended for long-term use.
Slovenian: To zdravilo je namenjeno dolgotrajni uporabi.
English: In the event of overdose the patient should be monitored and treated symptomatically.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika spremljati in simptomatsko zdraviti.
English: Ask your doctor for advice.
Slovenian: Za nasvet se obrnite na zdravnika.
English: Do not take more capsules than your doctor has advised you.
Slovenian: Ne vzemite več kapsul, kot vam je naročil zdravnik.
English: For additional information, see section 6.6.
Slovenian: Za dodatne informacije glejte poglavje 6.6.
English: The mixture should be given immediately after preparation.
Slovenian: Mešanico je treba uporabiti takoj po pripravi.
English: A total of 85 patients took part in the clinical study.
Slovenian: V klinični študiji je sodelovalo skupno 85 bolnikov.
English: What you need to know before you use Kolbam 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Kolbam 3.
English: Patients should be monitored initially every 3 months during the first year then 6 monthly during the subsequent three years and annually thereafter.
Slovenian: V prvem letu je treba bolnike spremljati vsake tri mesece, v naslednjih treh letih vsakih šest mesecev, potem pa enkrat na leto.
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Slovenian: Zdravnik vam bo povedal, koliko kapsul morate vzeti in kdaj.
English: It is recommended that cholic acid is taken with food (see section 4.5) at approximately the same time each day, in the morning and/or evening.
Slovenian: Priporočeno je, da se holna kislina jemlje s hrano (glejte poglavje 4.5) ob približno istem času vsak dan, zjutraj in/ali zvečer.
English: Some of the primary defects include but are not limited to:
Slovenian: Nekatere od primarnih okvar med drugim vključujejo:
English: Cholic acid also promotes normal growth of children.
Slovenian: Holna kislina spodbuja tudi normalno rast pri otrocih.
English: Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Slovenian: Dodatne ali pogostejše preiskave je treba opraviti za spremljanje zdravljenja v obdobju hitre rasti, sočasne bolezni ali nosečnosti (glejte poglavje 4.6).
English: The dose should be subsequently titrated to the desired effect but should not exceed a maximum of 15 mg/kg/day.
Slovenian: Potem je treba odmerek titrirati do želenega učinka, vendar ne sme preseči največjega odmerka 15 mg/kg/dan.
English: In all studies, a dose of 10-15 mg/kg/day was administered.
Slovenian: V vseh študijah so uporabili odmerek od 10 do 15 mg/kg/dan.
English: • oral contraceptives,
Slovenian: • peroralna kontracepcijska sredstva,
English: Try to ensure that if any of the dose is spat out or refused, it is given again.
Slovenian: Poskušajte zagotoviti, da odmerek, ki ga otrok izpljune ali zavrne, daste znova.
English: <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: - PSURs - Annual Reassessments
Slovenian: PSUR - letne ponovne ocene
English: Side effects of unknown frequency (cannot be estimated from the available data):
Slovenian: Neželeni učinki z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov):
English: • oestrogen,
Slovenian: • estrogen,
English: • Information on: o Calculation of the correct dose and the need to instruct caregivers on how to administer the product correctly o Symptoms and signs of an overdose and the management of this
Slovenian: • informacije o: o izračunu pravilnega odmerka in potrebi po dajanju navodil skrbnikom, kako pravilno uporabljati zdravilo, o simptomih in znakih prevelikega odmerjanja ter njegovi obravnavi.
English: There are several enzyme defects described in the literature.
Slovenian: V literaturi je opisanih več okvar encimov.
English: Co-administration should be avoided.
Slovenian: Sočasnemu jemanju se je treba izogniti.
English: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu France
Slovenian: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Francija
English: To monitor the long term safety and efficacy in patients treated with Kolbam from a patient registry for which details are reflected in the risk management plan.
Slovenian: Spremljati dolgoročno varnost in učinkovitost pri bolnikih, zdravljenih z zdravilom Kolbam, v registru bolnikov, katerega podrobnosti so navedene v načrtu za obvladovanje tveganja.
English: Once the bottle is opened, the medicinal product must be used within 3 months.
Slovenian: Po odprtju plastenke je treba zdravilo uporabiti v 3 mesecih.
English: In this set of patients, about one quarter were below or at most 6 months of age at diagnosis, and about one third were between 7 and 36 months.
Slovenian: Pri tem nizu bolnikov jih je bila približno četrtina v času diagnoze mlajših od šest mesecev ali starih šest mesecev, približno tretjina pa od sedem do 36 mesecev.
English: During your treatment, your doctor will carry out various blood and urine tests at different times to see how your body is handling this medicine and to help work out the dose that you need.
Slovenian: Med zdravljenjem bo zdravnik opravil različne krvne in urinske preiskave v različnih obdobjih, s katerimi bo ugotovil, kako vaše telo prenaša to zdravilo in kakšen odmerek potrebujete.
English: Kolbam can be used from the age of one month and patients affected by these conditions will need treatment for the rest of their life.
Slovenian: Zdravilo Kolbam se lahko uporablja od starosti enega meseca naprej, bolniki s temi okvarami pa bodo zdravljenje potrebovali do konca življenja.
English: • AMACR deficiency
Slovenian: • pomanjkanje AMACR;
English: Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.
Slovenian: Zdravljenje je treba prekiniti prej, če obstajajo jasni pokazatelji hude odpovedi jeter.
English: Clinical features were limited to pruritus and diarrhoea.
Slovenian: Klinični znaki so bili omejeni na pruritus in diarejo.
English: In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.1 to 35.6 years.
Slovenian: V študiji CAC-002-01 je bila povprečna starost bolnikov 9,0 leta z razponom od 0,1 do 35,6 let.
English: Cholic acid is one of the primary bile acids in man on which essential physiological functions depend.
Slovenian: Holna kislina je ena od primarnih žolčnih kislin pri človeku, od katere so odvisne esencialne fiziološke funkcije.
English: In the absence of clinical experience in such patients, no recommendations on dosage adjustment can be made.
Slovenian: Ker ni kliničnih izkušenj s temi bolniki, ni mogoče priporočiti prilagoditve odmerka.
English: Your doctor will advise you if for any reason you have to stop treatment with cholic acid.
Slovenian: Zdravnik vam bo svetoval, če morate zaradi kakršnega koli razloga prekiniti zdravljenje s holno kislino.
English: Do not chew the capsule.
Slovenian: Kapsule ne žvečite.
English: Of these 85 patients, 52 presented with disorders in primary bile acid synthesis including the following 3 single enzymes:
Slovenian: Od teh 85 bolnikov jih je imelo 52 motnje v sintezi primarnih žolčnih kislin, vključno z naslednjimi tremi posamičnimi encimimi:
English: Progress and results from the registry will form the basis of the annual reassessments of the benefit/risk profile of Kolbam.
Slovenian: Napredek in rezultati v zvezi z registrom bodo podlaga za letno ponovno oceno profila razmerja med tveganji in koristmi zdravila Kolbam.
English: Swallow each capsule whole with water, either just before or just after food.
Slovenian: Kapsule pogoltnite cele z vodo, tik pred obrokom ali tik po njem.
English: Where the dose calculated is not a multiple of 50, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to suppress urinary bile acids.
Slovenian: Kadar izračunani odmerek ni večkratnik števila 50, je treba izbrati najbližji odmerek pod največjim odmerkom 15 mg/kg/dan, če je to zadostno za zaviranje žolčnih kislin v urinu.
English: What Kolbam is and what it is used for 2.
Slovenian: Kaj je zdravilo Kolbam in za kaj ga uporabljamo 2.
English: The recommended dose is based on your body weight (10-15 mg per kg) taken either as a single dose, once a day, or divided into two doses, one in the morning and one in the evening.
Slovenian: Priporočeni odmerek temelji na vaši telesni masi (od 10 do 15 mg na kg), vzame pa se kot enkratni odmerek enkrat na dan ali razdeljen v dva odmerka, eden zjutraj in eden zvečer.
English: Should the use of a preparation containing one of these substances be necessary, it must be taken at least 5 hours before or after cholic acid.
Slovenian: Če je uporaba pripravka, ki vsebuje te učinkovine, nujna, ga je treba uporabiti vsaj pet ur pred zaužitjem holne kisline ali po njem.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: Your doctor will advise you to take cholic acid at least 5 hours before or after taking the other medicine.
Slovenian: Zdravnik vam bo svetoval, da holno kislino vzamete vsaj pet ur pred uporabo drugega zdravila ali pet ur po njej.
English: The dose of cholic acid should be adjusted individually.
Slovenian: Odmerek holne kisline je treba prilagajati individualno.
English: The remaining 5 patients were treatment naïve.
Slovenian: Preostalih 5 bolnikov je bilo predhodno nezdravljenih.
English: See above under ‘Do not take Kolbam'.
Slovenian: Glejte zgornje poglavje „Ne jemljite zdravila Kolbam“.
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State.
Slovenian: Pred prihodom zdravila na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom v zadevni državi članici dogovoriti glede končnega izobraževalnega gradiva.
English: Mixing of the capsule contents is designed to mask any unpleasant taste which results from the capsules being opened but no data on the compatibility or palatability are available.
Slovenian: Vsebina kapsule je zasnovana tako, da ob mešanju prikrije neprijeten okus, ki je posledica odprtja kapsule, vendar podatki o združljivosti ali okusnosti niso na voljo.
English: This mixing of the capsule contents with food should mask any unpleasant taste of the medicine.
Slovenian: Mešanje vsebine kapsule s hrano prikrije neprijeten okus zdravila.
English: The relevance of animal data with regards to cholic acid therapy safety is uncertain due to the known high inter-animal variability of bile acid homeostasis.
Slovenian: Pomembnost podatkov o živalih glede varnosti zdravljenja s holno kislino je negotova zaradi znane velike variabilnosti homeostaze žolčnih kislin med živalmi.
English: Other medicines and Kolbam
Slovenian: Druga zdravila in zdravilo Kolbam
English: Never take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Available data in animals have shown excretion of cholic acid in milk (see section 5.3).
Slovenian: Razpoložljivi podatki pri živalih so pokazali izločanje holne kisline v mleko (glejte poglavje 5.3).
English: The MAH shall ensure that at launch all physicians expected to prescribe the product are provided with information on the correct and safe use of the product.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora ob prihodu zdravila na trg zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali to zdravilo, prejeli informacije o njegovi pravilni in varni uporabi.
English: The events were transitory and generally did not interfere with the therapy.
Slovenian: Neželeni učinki so bili prehodni in navadno niso ovirali zdravljenja.
English: If you stop taking it the abnormal substances in your bile may build up again to the levels before treatment was started, potentially causing damage to your liver.
Slovenian: Če ga prenehate jemati, se lahko nenormalne snovi v žolču ponovno nakopičijo do ravni pred začetkom zdravljenja, kar lahko poškoduje jetra.
English: At therapeutic doses, no effects on the breastfed newborn infant are anticipated since the systemic exposure of the breastfeeding mother to cholic acid is negligible (see section 5.2).
Slovenian: Pri terapevtskih odmerkih ni pričakovati učinkov na dojenega novorojenčka, saj je sistemska izpostavljenost matere holni kislini zanemarljiva (glejte poglavje 5.2).
English: Episodes of symptomatic overdose (or excessive dosing regimen) have been reported, including accidental overdose.
Slovenian: Poročali so o epizodah simptomatskega prevelikega odmerjanja (ali režimu čezmernega odmerjanja), vključno z nenamernim prevelikim odmerjanjem.
English: • AMACR deficiency (n=1)
Slovenian: • pomanjkanje AMACR (n = 1);
English: Gallstones have been reported after long-term therapy.
Slovenian: O žolčnih kamnih so poročali po dolgotrajnem zdravljenju.
English: No interaction studies with cholic acid and concomitantly administered medicinal products or food have been carried out.
Slovenian: Študij medsebojnega delovanja med holno kislino in sočasnimi zdravili ali hrano niso izvedli.
English: WHAT KOLBAM IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO KOLBAM IN ZA KAJ GA UPORABLJAMO
English: • CYP7A1 deficiency
Slovenian: • pomanjkanje CYP7A1.
English: The clinical experience reported is from a patient population with disorders in primary bile acid synthesis that includes principally infants from the age of one month, children and adolescents.
Slovenian: Klinične izkušnje, o katerih so poročali, izhajajo iz populacije bolnikov z motnjami sinteze primarnih žolčnih kislin, ki vključuje predvsem dojenčke, stare en mesec ali več, otroke in mladostnike.
English: No formal preclinical safety studies have been conducted; however, data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Slovenian: Opravili niso nobenih uradnih predkliničnih varnostnih študij, vendar podatki v literaturi na podlagi študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti,
English: On average, patients in this subgroup were 3 years at treatment start, minimum and maximum ages were 0 and 14 years, respectively.
Slovenian: Bolniki v tej podskupini so bili povprečno stari tri leta, pri čemer je bila najmanjša starost 0 let, največja pa 14 let.
English: Printing ink
Slovenian: Tiskarsko črnilo:
English: These are some of the medicines that may affect the way in which Kolbam works:
Slovenian: Nekatera zdravila, ki lahko vplivajo na delovanje zdravila Kolbam, so:
English: If you stop taking Kolbam
Slovenian: Če ste prenehali jemati zdravilo Kolbam
English: 90 capsules.
Slovenian: 90 kapsul
English: By replacing the missing cholic acid it stimulates the production of normal bile and helps prevent the build-up of the abnormal substances in the liver.
Slovenian: Z nadomeščanjem manjkajoče holne kisline spodbuja tvorbo normalnega žolča in pomaga preprečevati kopičenje nenormalnih snovi v jetrih.
English: The capsule contents will remain as fine granules in the milk or food.
Slovenian: Vsebina kapsule bo v mleku ali hrani ohranila obliko zrnc.
English: There is a theoretical possibility that administration of food may increase cholic acid bioavailability and improve tolerability.
Slovenian: Obstaja teoretična možnost, da lahko jemanje s hrano poveča biološko uporabnost holne kisline in izboljša prenašanje zdravila.
English: It is recommended that cholic acid is taken with food (see section 4.2).
Slovenian: Priporočeno je, da se holna kislina jemlje s hrano (glejte poglavje 4.2).
English: The capsules contain a white powder.
Slovenian: Kapsule vsebujejo bel prašek.
English: The effect of food on the bioavailability of cholic acid has not been studied.
Slovenian: Učinka hrane na biološko uporabnost holne kisline niso proučili.
English: You can continue to breastfeed your baby whilst being treated with cholic acid, as levels in breast milk are considered too low to harm your baby.
Slovenian: Med zdravljenjem s holno kislino lahko nadaljujete dojenje, saj so ravni v materinem mleku prenizke, da bi lahko škodovale vašemu otroku.
English: In the liver, cholic acid is extracted from portal blood by multiple mechanisms, including passive diffusion and transporters.
Slovenian: V jetrih se holna kislina iz portalne krvi izloči z več mehanizmi, vključno s pasivno difuzijo in prenašalci.
English: Pack sizes: 90 capsules.
Slovenian: Velikost pakiranja: 90 kapsul.
English: More frequent tests will be needed if you are growing fast, if you are ill (e.g., if you have liver problems) or if you are pregnant.
Slovenian: Če hitro rastete, ste bolni (npr. če imate težave z jetri) ali noseči, bodo potrebne pogostejše preiskave.
English: A total of 79 patients received cholic acid treatment, 49 of these suffered from a primary enzyme defect.
Slovenian: Zdravljenje s holno kislino je prejelo skupno 79 bolnikov, od katerih jih je 49 imelo okvaro primarnih encimov.
English: At therapeutic doses, no effect on fertility is anticipated.
Slovenian: Pri terapevtskih odmerkih se ne pričakujejo učinki na plodnost.
English: • lipid-lowering medicines such as clofibrate
Slovenian: • zdravila za zniževanje ravni lipidov, kot je klofibrat.
English: Height and weight showed similar improvements.
Slovenian: Rezultati za telesno višino in maso so se podobno izboljšali.
English: Do not use after the expiry date which is stated on the carton and bottle label after “EXP''.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na plastenki poleg oznake „Uporabno do:“.
English: There are limited safety data from the use of cholic acid in pregnant women.
Slovenian: Varnostni podatki o uporabi holne kisline pri nosečnicah so omejeni.
English: No data are available for patients with renal impairment.
Slovenian: Podatki o bolnikih z ledvično okvaro niso na voljo.
English: If you have a condition called familial hypertriglyceridaemia, your doctor may have to increase your dose of cholic acid.
Slovenian: Če imate bolezen, imenovano družinska hipertrigliceridemija, bo zdravnik morda moral povečati odmerek holne kisline.
English: Ciclosporin may affect the levels of cholic acid.
Slovenian: Ciklosporin lahko vpliva na ravni holne kisline.
English: General improvements in the degree of atypical urine bile acids were also seen in individual defect groups.
Slovenian: Splošno izboljšanje ravni atipičnih žolčnih kislin v urinu so prav tako opazili pri skupinah s posameznimi okvarami.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: For young infants the contents may be mixed with infant formula, expressed breast milk or fruit puree and for infants and children under 6 years, mixed with soft food such as mashed potatoes or apple puree.
Slovenian: Pri majhnih dojenčkih se lahko vsebina zmeša z otroško formulo, iztisnjenim materinim mlekom ali sadno kašico, pri dojenčkih in otrocih, mlajših od šest let, pa z mehko hrano, kot je krompirjev pire ali jabolčna čežana.
English: Slightly increased blood pressure was evident in rats after 30 days of cholic acid at approximately 4-fold therapeutic dose with increased vasoconstrictor responses to noradrenaline, together with decreased levels of aldosterone and increased corticosterone, but no adverse clinical signs were observed.
Slovenian: Pri podganah so po 30 dneh uporabe holne kisline v odmerkih, približno 4-krat večjih od terapevtskega, ugotovili rahlo povišan krvni tlak s povečanimi vazokonstriktornimi odzivi na noradrenalin, skupaj z znižanimi ravnmi aldosterona in povišanimi ravnmi kortikosterona, vendar niso opazili nobenih neželenih kliničnih znakov.