FrancophonIA/ELRC3.0 huggingface dataset:
English: Fluticasone Propionate 250mcg/Dose Inhalation Powder
Slovenian: Flutikazon propionat, 250 mcg/odmerek
English: Budesonide 160µg Dose, Formoterol Fumarate Dihydrate Ph.Eur.
Slovenian: Budezonid, odmerek 160 µg, formoterol fumarat dihidrat Ph.Eur., odmerek 4,5 µg
English: Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed
Slovenian: Flutikazon propionat, odmerek 250 µg Prašek za inhaliranje, odmerjeni
English: Fluticasone Propionate 500µg Dose Inhalation Powder
Slovenian: Flutikazon propionat, odmerek 500 µg Prašek za inhaliranje
English: Glaxosmithkline Gmbh & Co. Kg Flutide Diskus
Slovenian: Glaxosmithkline Gmbh & Co.
English: Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed
Slovenian: Flutikazon propionat, odmerek 500 µg Prašek za inhaliranje, odmerjeni
English: Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 500µg Dose
Slovenian: Salmeterol ksinafoat, odmerek 50 µg, flutikazon propionat, odmerek 500 µg
English: Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose
Slovenian: Salmeterol ksinafoat, odmerek 50 µg, flutikazon, odmerek 500 µg
English: Fluticasone Propionate 250mcg/Dose Pressurised Inhalation,
Slovenian: Flutikazon propionat, 250 µg/odmerek Inhalacijska suspenzija pod tlakom
English: Salmeterol 50µg Dose, Fluticasone Propionate 500µg Dose
Slovenian: Salmeterol, odmerek 50 µg; flutikazon propionat, odmerek 500 µg
English: This may take 5-10 minutes.
Slovenian: To lahko traja 5-10 minut.
English: Below is a list of examples of these types of medicines:
Slovenian: Spodaj je seznam primerov tovrstnih zdravil:
English: • Additional monitoring
Slovenian: • Dodatno spremljanje
English: Povidone K 30
Slovenian: Povidon K 30
English: You may be more closely monitored by your doctor if you are below the age of 18 or over the age of 65.
Slovenian: Zdravnik vas bo morda skrbneje spremljal, če ste mlajši od 18 let ali starejši od 65 let.
English: This medicine should not be taken by those under 15 years of age.
Slovenian: Tega zdravila ne smejo jemati tisti, ki so mlajši od 15 let.
English: • seeing or hearing things that are not there (hallucinations).
Slovenian: • če slišite ali vidite stvari, ki jih ni (halucinacije).
English: Similar to control
Slovenian: Podobno kot kontrola
English: When a hepatic event is suspected, further biological and etiological evaluation is required.
Slovenian: Če sumite na jetrni dogodek, je potrebno nadaljnje biološko in etiološko ovrednotenje.
English: The patient should be transferred to an environment within which full resuscitation facilities are available.
Slovenian: Bolnika je treba prenesti v okolje, kjer so na voljo vsi pripomočki za oživljanje.
English: Email: PatientSafetyRoW@indivior.com
Slovenian: E-pošta: PatientSafetyRoW@indivior.com
English: • recently suffered a head injury or brain disease
Slovenian: • nedavnih poškodb glave ali bolezni možganov,
English: Important things to be aware of:
Slovenian: Pomembne informacije, ki jih morate poznati:
English: • Take the dose once a day by placing the tablets under the tongue.
Slovenian: • Odmerek vzemite enkrat dnevno, tako da tablete namestite pod jezik.
English: Date of latest renewal: 26 September 2011
Slovenian: Datum prve odobritve: 26. september 2006 Datum zadnjega podaljšanja: 26. september 2011
English: Due to the lack of data in adolescents (age 15-<18), patients in this age group should be more closely monitored during treatment.
Slovenian: Zaradi pomanjkanja podatkov o uporabi pri mladostnikih (starost 15 do <18) je treba bolnike v tej skupini med zdravljenjem spremljati bolj natančno.
English: • Dependence This product can cause dependence.
Slovenian: • Odvisnost To zdravilo lahko povzroča odvisnost.
English: • some medicines may decrease the effect of Suboxone.
Slovenian: • Nekatera zdravila lahko zmanjšajo učinek zdravila Suboxone.
English: You may be unable to think clearly, and may breathe much slower than is normal for you.
Slovenian: Morda ne boste mogli trezno razmišljati, vaše dihanje pa bo morda veliko počasnejše, kot je za vas normalno.
English: Use in adolescents (Age 15-<18)
Slovenian: Uporaba pri mladostnikih (starost 15 do <18)
English: • Misuse and abuse
Slovenian: • Napačna uporaba in zloraba
English: No synergistic enhancement of toxicity has been observed.
Slovenian: Sinergijske okrepitve toksičnosti niso opazili.
English: They may also cause central nervous system depression, which is very serious.
Slovenian: Povzročajo tudi depresijo osrednjega živčnega sistema, ki je zelo nevarna.
English: In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
Slovenian: Pri nekaterih bolnikih lahko po zadovoljivi stabilizaciji zmanjšate pogostnost odmerjanja na 3-krat tedensko (na primer ponedeljek, sreda in petek).
English: These may be signs of a life-threatening allergic reaction.
Slovenian: To so lahko znaki življenjsko nevarnih alergijskih reakcij.
English: Your doctor will decide if your treatment should be continued with an alternative medicine.
Slovenian: Vaš zdravnik se bo odločil, ali naj se zdravljenje nadaljuje z nadomestnim zdravilom.
English: The maximum daily dose is 24 mg.
Slovenian: Največji dnevni odmerek je 24 mg.
English: General supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient.
Slovenian: Uvesti je treba splošne podporne ukrepe, ki vključujejo pozorno spremljanje stanja dihanja in srčnega utripa bolnika.
English: Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Slovenian: Neželeni učinki so temeljili na znani farmakološki aktivnosti opioidnih agonističnih in/ali antagonističnih snoveh.
English: A patent airway and assisted or controlled ventilation must be assured.
Slovenian: Zagotoviti morate prehodne dihalne poti in asistirano ali nadzorovano ventilacijo.
English: • Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases.
Slovenian: • Diagnoza ali nepovezana zdravstvena stanja To zdravilo lahko zakrije simptome bolečine, ki lahko pomagajo pri diagnozi nekaterih bolezni.
English: Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Slovenian: Zaradi tega je treba odmerke prilagoditi, in se izogniti tej kombinaciji, ko obstaja tveganje za napačno uporabo.
English: Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Slovenian: Buprenorfin se lahko uporablja napačno ali zlorablja podobno kot druge opioide, zakonite ali nezakonite.
English: Patients with rare hereditary problems of galactose intolerance, should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo tega zdravila ne smejo jemati.
English: o benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Slovenian: o Benzodiazepini: ta kombinacija lahko povzroči smrt zaradi respiratorne depresije centralnega izvora.
English: Depending on your condition, the dose of Suboxone may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Slovenian: Glede na vaše stanje lahko odmerek zdravila Suboxone še naprej zmanjšujete pod skrbnim zdravniškim nadzorom, dokler ga na koncu ne prenehate jemati.
English: These may be symptoms of liver damage.
Slovenian: To so lahko simptomi poškodb jeter.
English: The absorption of buprenorphine is followed by a rapid distribution phase (distribution half-life of 2 to 5 hours).
Slovenian: Porazdelitev Absorpciji buprenorfina sledi faza hitre porazdelitve (porazdelitveni razpolovni čas 2 do 5 ur).
English: However, Suboxone can be a target for people who abuse prescription medicine.
Slovenian: Vendar je lahko zdravilo Suboxone tarča ljudi, ki zlorabljajo zdravila na recept.
English: However, the dose given on any one day should not exceed 24 mg buprenorphine.
Slovenian: Vendar odmerek na kateri koli posamezen dan ne sme presegati 24 mg buprenorfina.
English: • alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).
Slovenian: • alkoholnimi pijačami ali zdravili, ki vsebujejo alkohol, ker alkohol okrepi sedativni učinek buprenorfina (glejte poglavje 4.7).
English: • Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms.
Slovenian: • Tablet ne žvečite ali pogoltnite, ker zdravilo ne bo delovalo, lahko pa se pojavijo odtegnitveni simptomi.
English: A doctor's assessment of your readiness for treatment will guide the timing of your first Suboxone dose.
Slovenian: Zdravnikova ocena vaše primernosti za zdravljenje bo narekovala čas za vaš prvi odmerek zdravila Suboxone.
English: This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Suboxone.
Slovenian: To se lahko pogosteje zgodi v prvih nekaj tednih zdravljenja, ko se vaš odmerek spreminja, lahko pa se tudi med uživanjem alkohola ali jemanjem drugih pomirjeval sočasno z zdravilom Suboxone.
English: Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Slovenian: Zdravilo Suboxone se uporablja pri odraslih ali mladostnikih, starih 15 let ali več, ki prejemajo tudi medicinsko, socialno in psihološko podporo.
English: Indivior Europe Limited
Slovenian: Slovenija Indivior Europe Limited
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Slovenian: Farmakoterapevtska skupina: druga zdravila za živčni sistem, zdravila, ki se uporabljajo pri motnjah odvisnosti, oznaka ATC: N07BC51.
English: Your doctor will determine the best dose for you.
Slovenian: Vaš zdravnik bo določil najprimernejši odmerek za vas.
English: • asthma or other breathing problems
Slovenian: • astme ali drugih težav z dihanjem,
English: Keep this medicine in a safe place to protect it from theft.
Slovenian: Zdravilo shranjujte na varnem mestu, zaščitenega pred krajo.
English: Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Slovenian: Buprenorfin so prilagodili na vzdrževalni odmerek do 3. dne; aktivne kontrolne odmerke so titrirali bolj postopoma.
English: The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Slovenian: Učinkovitost buprenorfina, 8 mg na dan, je bil podoben učinku zmernega aktivnega kontrolnega učinka, vendar enakovrednosti niso dokazali.
English: Do not take Suboxone together with alcohol.
Slovenian: Zdravila Suboxone ne smete vzeti skupaj z alkoholom.
English: 28 sublingual tablets
Slovenian: 28 podjezičnih tablet
English: PHARMACEUTICAL FORM AND CONTENTS 7 sublingual tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7 podjezičnih tablet
English: Renal elimination plays a relatively small role (~30 %) in the overall clearance of buprenorphine/naloxone.
Slovenian: Renalna eliminacija ima relativno majhno vlogo (~30 %) pri celotnem očistku buprenorfina/naloksona.
English: PK Parameter
Slovenian: FK parameter
English: Some medicines may increase the side effects of Suboxone and may sometimes cause very serious reactions.
Slovenian: Nekatera zdravila lahko povečajo neželene učinke zdravila Suboxone in imajo lahko včasih zelo hude neželene učinke.
English: Content of the pack and other Information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Also tell your doctor immediately if you experience side effects such as:
Slovenian: Svojemu zdravniku tudi takoj povejte, če izkusite neželene učinke, kot so:
English: Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments.
Slovenian: Osebe so bili vsak dan pregledani na kliniki (od ponedeljka do petka), kjer so jim odmerjali zdravilo in ocenili njegovo učinkovitost.
English: This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft.
Slovenian: To zdravilo je lahko tarča ljudi, ki zlorabljajo zdravila na recept, zato ga je treba hraniti na varnem mestu, zaščitenega pred krajo.
English: The risks of using Suboxone in pregnant women are not known.
Slovenian: Tveganja uporabe zdravila Suboxone pri nosečnicah niso znana.
English: Therefore, breastfeeding should be discontinued during treatment with Suboxone.
Slovenian: Zato je treba med zdravljenjem z zdravilom Suboxone prenehati z dojenjem.
English: What Suboxone is and what it is used for
Slovenian: Kaj je zdravilo Suboxone in za kaj ga uporabljamo
English: • This medicine has been prescribed for you Do not pass it on to others.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Slovenian: Poročali so o številnih primerih smrti zaradi respiratorne depresije, še zlasti pri uporabi buprenorfina v kombinaciji z benzodiazepini (glejte poglavje 4.5) ali kadar se buprenorfina ni uporabljalo v skladu z navodili za predpisovanje.
English: Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist e.g. morphine.
Slovenian: Študije na živalih kot tudi klinične izkušnje so dokazale, da buprenorfin lahko povzroči odvisnost, ki pa ni tako močna kot pri popolnih agonistih, npr. morfiju.
English: Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes until a satisfactory response is achieved, but should not exceed a 10 mg starting dose.
Slovenian: Začetni odmerki naloksona lahko znašajo do 2 mg in jih je treba ponavljati vsake 2-3 minute, dokler se ne doseže zadosten odziv, vendar začetni odmerek ne sme preseči 10 mg.
English: These underlying factors must be taken into consideration before prescribing buprenorphine/naloxone and during treatment.
Slovenian: Te osnovne dejavnike je treba upoštevati pred predpisovanjem buprenorfina/naloksona in med zdravljenjem.
English: Following intravenous administration, naloxone is rapidly distributed (distribution halflife ~ 4 minutes).
Slovenian: Po intravenski administraciji se nalokson hitro porazdeli (porazdelitveni razpolovni čas ~ 4 minute).
English: Initiation therapy (induction)
Slovenian: Začetek zdravljenja (indukcija)
English: Naloxone has a mean half-life from plasma of 1.2 hours.
Slovenian: Nalokson ima povprečni razpolovni čas v plazmi 1,2 ure.
English: How to remove the tablet from the blister 1 - Do not push the tablet through the foil.
Slovenian: Kako vzeti tableto iz pretisnega omota 1 - Tablete ne potiskajte skozi folijo.
English: Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Slovenian: Zdravljenje je namenjeno odraslim in mladostnikom nad 15 leti starosti, ki so privolili v zdravljenje svoje odvisnosti.
English: 1 - Do not push the tablet through the foil.
Slovenian: 1 - Tablete ne potiskajte skozi folijo.
English: During the days after you start treatment, your doctor may increase the dose of Suboxone you take according to your needs.
Slovenian: V dneh po začetku zdravljenja bo vaš zdravnik morda povečal odmerek zdravila Suboxone glede na vaše potrebe.
English: Both Cmax and AUC of buprenorphine increased with the increase in dose (in the range of 4-16 mg), although the increase was less than dose-proportional.
Slovenian: Vrednosti Cmax in AUC buprenorfina sta se povečali s povečanjem odmerka (v razponu od 4-16 mg), čeprav povečanje ni bilo odvisno od odmerka.
English: Elimination of buprenorphine is bi- or tri-exponential, and has a mean half-life from plasma of 32 hours.
Slovenian: Eliminacija buprenorfina je dvojno ali trikratno eksponentna in ima v plazmi razpolovni čas 32 ur.
English: If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če imate občutek, da je zdravilo Suboxone premočno ali prešibko, se posvetujte s svojim zdravnikom ali farmacevtom.
English: After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Slovenian: Ko pri bolniku dosežete zadovoljivo stabilizacijo, lahko, če se bolnik strinja, odmerek počasi zmanjšate na nižji vzdrževalni odmerek; v nekaterih ugodnih primerih lahko zdravljenje prekinete.
English: The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days.
Slovenian: Odmerek zdravila v ponedeljek in sredo mora biti dvakrat večji od individualno prilagojenega dnevnega odmerka, odmerek v petek pa trikrat večji od individualno prilagojenega dnevnega odmerka, na vmesne dni pa bolnik ne sme prejeti nobenega odmerka.
English: Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities.
Slovenian: Bolniki morajo biti previdni pri vožnji ali upravljanju nevarnih strojev, ker lahko buprenorfin/nalokson vpliva na njihovo sposobnost delovanja pri takih dejavnostih.
English: When taken during pregnancy, particularly late pregnancy, medicines like Suboxone may cause drug withdrawal symptoms including problems with breathing in your newborn baby.
Slovenian: Pri jemanju v nosečnosti, še posebej v pozni nosečnosti, lahko zdravila, kot je Suboxone, povzročijo odtegnitvene simptome, vključno s težavami z dihanjem pri novorojenčkih.
English: There are no adequate data from the use of Suboxone in pregnant women.
Slovenian: Ustreznih podatkov o uporabi zdravila Suboxone pri nosečnicah ni.
English: Respiratory depression as a result of central nervous system depression is the primary symptom requiring intervention in the case of overdose because it may lead to respiratory arrest and death.
Slovenian: Respiratorna depresija, ki je poglavitni simptom posledice depresije osrednjega živčnega sistema, zahteva ukrepanje, če pride do prevelikega odmerjanja, saj lahko povzroči zastoj dihanja in smrt.
English: Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Slovenian: Nekateri ljudje so umrli zaradi odpovedi dihanja (nesposobnost dihanja), ker so zlorabili to zdravilo ali so ga vzeli v kombinaciji z drugimi depresivi osrednjega živčnega sistema, kot so alkohol, benzodiazepini (pomirjevala) ali drugi opioidi.
English: Dose titration in steps of 2-8 mg buprenorphine is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 24 mg buprenorphine.
Slovenian: Prilagajanje odmerka v korakih od 2 do 8 mg buprenorfina se vodi s pomočjo ponovnega ocenjevanja kliničnega in psihološkega stanja bolnika in ne sme preseči največjega posameznega odmerka 24 mg buprenorfina.
English: Taking the wrong dose of benzodiazepines may cause death due to respiratory failure (inability to breathe).
Slovenian: Napačen odmerek benzodiazepinov lahko povzroči smrt zaradi dihalne odpovedi (nezmožnosti dihanja).
English: Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
Slovenian: Odvisno od ugotovitev lahko zdravnik prekine uporabo zdravila, tako da ne povzročite sindroma odtegnitve in prepreči povratek bolnika k uporabi nezakonitih drog.
English: • a urinary disorder (especially linked to enlarged prostrate in men)
Slovenian: • motenj uriniranja (pri moških še zlasti v povezavi s povečano prostato),
English: If taken together with alcohol or central nervous system depressants, the effect is likely to be more pronounced (see sections 4.4 and 4.5).
Slovenian: Če se zdravilo jemlje skupaj z alkoholom ali depresivi osrednjega živčnega sistema, bo učinek verjetno bolj izrazit (glejte poglavji 4.4 in 4.5).
English: Symptomatic treatment of respiratory depression, and standard intensive care measures, should be implemented.
Slovenian: Uvesti je treba simptomsko zdravljenje respiratorne depresije in standardno intenzivno nego.
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.
Slovenian: To zdravilo lahko povzroči hudo, morda celo usodno, depresijo dihanja (zmanjšana zmožnost dihanja) pri otrocih in tistih, ki niso odvisniki, in to zdravilo vzamejo nenamerno ali namerno.
English: Packed in packs of 7 and 28 tablets.
Slovenian: Pakirano v paketih 7 in 28 tablet.
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).
Slovenian: Ta zdravila vključujejo zdravila za zdravljenje epilepsije (kot sta karbamazepin in fenitoin) in zdravila za zdravljenje tuberkuloze (rifampicin).
English: Table 1 summarises adverse reactions reported from pivotal clinical trials in which, 342 of 472 patients (72.5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.
Slovenian: Preglednica 1 podaja povzetek neželenih učinkov, o katerih so poročali v glavnih kliničnih raziskavah, v katerih je 342 od 472 bolnikov (72,5 %) poročalo o neželenih učinkih, in tistih, o katerih so poročali po prihodu zdravila na trg.
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Slovenian: O smrti so poročali tudi v povezavi s sočasnim dajanjem buprenorfina in drugih depresivov, kot so alkohol ali drugi opioidi.
English: Do not forget to advise your doctor if you take this medicine.
Slovenian: Obvestite svojega zdravnika, če jemljete to zdravilo.
English: • clonidine (used to treat high blood pressure) may extend the effects of this medicine.
Slovenian: • Klondin (za zdravljenje visokega krvnega tlaka) lahko podaljša čas učinkovanja tega zdravila.
English: Opioid-induced miosis, changes in the level of consciousness, or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease.
Slovenian: Mioza zaradi opioidov, spremembe v stopnji zavesti in spremembe v občutenju bolečine kot simptoma bolezni lahko vplivajo na oceno bolnika ter otežijo diagnozo oziroma zakrijejo klinični potek druge bolezni.
English: Peak plasma concentrations are achieved 90 minutes after sublingual administration.
Slovenian: Najvišja plazemska koncentracija se doseže 90 minut po uporabi pod jezikom.
English: Patients must be warned to store the blister safely, to never open the blister in advance, to keep them out of the reach of children and other household members, and not to take this medicine in front of children.
Slovenian: Bolnike posvarite, naj pretisni omot shranjujejo na varnem mestu in ga ne odpirajo vnaprej, zdravila naj shranjujejo zunaj dosega otrok in drugih članov gospodinjstva ter naj zdravila ne jemljejo v prisotnosti otrok.