FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains the active substance fentanyl and is available as a transdermal patch (a patch that gradually delivers the medicine through the skin).
Slovenian: Vsebuje zdravilno učinkovino fentanil in je na voljo v obliki transdermalnega obliža (obliža, ki postopoma dovaja zdravilo skozi kožo).
English: Durogesic patches release enough fentanyl to be fatal if not used appropriately, especially for a child; sufficient fentanyl remains in the patch to cause severe effects even after it has been used.
Slovenian: Obliži zdravila Durogesic sproščajo dovolj fentanila, da bi bili lahko ob neustrezni uporabi smrtni, še zlasti za otroka; v obližu ostane dovolj fentanila, da bi lahko povzročil hude učinke tudi potem, ko je bil že uporabljen.
English: 2 This referral procedure did not cover other fentanyl formulations such as tablets, nasal sprays or solutions for injection
Slovenian: Ta napotitveni postopek ni vključeval drugih pripravkov s fentanilom, npr. v obliki tablet, nosnih pršil ali raztopin za injiciranje.
English: Durogesic must not be used to relieve severe short-term pain or pain resulting from an operation.
Slovenian: Zdravilo Durogesic se ne sme uporabljati za lajšanje hude kratkotrajne bolečine in pooperacijske bolečine.
English: Durogesic is a medicine used to relieve severe long-term pain in adults and children from 2 years of age.
Slovenian: Durogesic je zdravilo, ki se uporablja za lajšanje hude dolgotrajne bolečine pri odraslih in otrocih, starih dve leti ali več.
English: Durogesic can also be used to treat severe long-term pain in children from 2 years of age who are already being treated with opioids.
Slovenian: Zdravilo Durogesic se lahko uporablja tudi za zdravljenje hude dolgotrajne bolečine pri otrocih, starih dve leti ali več, ki so se že zdravili z opioidi.
English: On 15 September 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Durogesic in the EU2.
Slovenian: Da bi uskladili dovoljenja za promet z zdravilom Durogesic v EU, je Evropska komisija 15. septembra 2015 napotila zadevo na odbor CHMP.2
English: The use of Durogesic is not recommended in patients who have not taken opioid medicines before.
Slovenian: Pri bolnikih, ki pred tem niso jemali drugih opioidov, uporaba zdravila Durogesic ni priporočljiva.
English: However, adult patients who cannot take opioids by mouth and for whom Durogesic is considered the only option could be given the patch with the lowest dose.
Slovenian: Obliž z najmanjšim odmerkom lahko vseeno prejmejo odrasli, ki opioidov ne morejo jemati peroralno in pri katerih je zdravilo Durogesic edina možnost.
English: Therefore, the patches must be kept out of the sight and reach of children, before and after use.
Slovenian: Obliže je treba zato pred uporabo in po njej hraniti nedosegljivo otrokom.
English: Tables to work out the appropriate dose of Durogesic when switching from other opioids taken by mouth or given by injection have been included in the harmonised SmPC.
Slovenian: V usklajeni povzetek glavnih značilnosti zdravila so vključene preglednice za določanje ustreznega odmerka zdravila Durogesic pri prehodu z drugih opioidov, ki se jemljejo peroralno ali injicirajo.
English: Durogesic was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1.
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Durogesic potrebno usklajevanje.1
English: Immediate Packaging
Slovenian: Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: • Other medicines you are taking.
Slovenian: • drugih zdravil, ki jih jemljete.
English: This means you should be careful how much alcohol you drink.
Slovenian: To pomeni, da morate paziti, koliko alkohola spijete.
English: It remains unclear whether this represents a distinct clinical entity.
Slovenian: Še vedno ni jasno, ali to lahko predstavlja posebno klinično entiteto.
English: Consequently, it is recommended that newborn infants be monitored carefully.
Slovenian: Zato je priporočljivo novorojenčke skrbno spremljati.
English: Iceland, Norway, Sweden:
Slovenian: Islandija, Norveška, Švedska:
English: An increased risk cannot be excluded for other patient populations.
Slovenian: Povečanega tveganja tudi pri drugih skupinah bolnikov ni mogoče izključiti.
English: The mechanism for this increased risk is not known.
Slovenian: Mehanizem za navedeno povečanje tveganja ni znan.
English: • Lack of normal facial expression that sometimes looks like a mask.
Slovenian: • odsotnost normalnega obraznega izražanja, obraz je včasih videti kot maska.
English: Severe allergic reaction that may include:
Slovenian: Hude alergijske reakcije, ki lahko vključujejo:
English: Adults aged 18 years and above
Slovenian: Odrasli, stari 18 let ali več
English: Problems with the heart:
Slovenian: Težave s srcem:
English: This is most likely to occur within the first few weeks of treatment.
Slovenian: To se najpogosteje pojavi v prvih tednih zdravljenja.
English: These are signs of a serious condition.
Slovenian: To so znaki resne bolezni.
English: • You will not be given more than 300 mg every 4 weeks.
Slovenian: • Zagotovo ne boste prejeli več kot 300 mg vsake 4 tedne.
English: You may need urgent medical treatment.
Slovenian: Morda boste potrebovali nujno medicinsko pomoč in zdravljenje.
English: A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much.
Slovenian: To zdravilo vam bosta dajala zdravnik ali medicinska sestra, zato ni zelo verjetno, da bi ga prejeli preveč.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pristojne oblasti držav članici posodobijo v sodelovanju z referenčno državo članico, skladno s postopki, navedenimi v poglavju 4 nasova III Direktive 2001/83/ES
English: Males and younger age groups are at higher risk of experiencing such reactions.
Slovenian: Pri moških in v mlajših starostnih skupinah so opazili večje tveganje za take reakcije.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria:
Slovenian: Zdravilo je v državah članicah Evropskega gospodarskega prostora pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija:
English: (based on individual patient response) until an optimal therapeutic effect is obtained.
Slovenian: (na osnovi odziva pri posameznem bolniku), dokler ni dosežen optimalni terapevtski učinek.
English: Patients must always be maintained on the lowest effective dose.
Slovenian: Za vzdrževalno zdravljenje mora bolnik vedno prejeti najmanjši še učinkovit odmerek.
English: • See, hear, feel or smell things that are not there (hallucinations)
Slovenian: • lahko vidite, slišite, tipate ali vohate stvari, ki ne obstajajo (halucinacije),
English: • Difficulty getting and keeping an erection (impotence)
Slovenian: • težave z doseganjem in vzdrževanjem erekcije (impotenca)
English: Do not drive or use any tools or machines without discussing this with your doctor first.
Slovenian: Ne upravljajte vozil in ne uporabljajte naprav in strojev, ne da bi se prej o tem posvetovali z zdravnikom.
English: • Problems with vision, such as blurred vision.
Slovenian: • težave z vidom, kot je zamegljen vid.
English: • Being unable to move
Slovenian: • nezmožnost premikanja,
English: Most of these symptoms were reversible.
Slovenian: Navedeni simptomi so bili večinoma reverzibilni.
English: Elderly people and people with dementia
Slovenian: Starejše osebe in osebe z demenco
English: It can also cause severe allergic reactions and blood clots.
Slovenian: Lahko povzroči tudi hudo alergijsko reakcijo in nastanek krvnih strdkov.
English: cannot be estimated from the available data.
Slovenian: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
English: • Severe allergic reactions (adrenaline)
Slovenian: • za hude alergijske reakcije (adrenalin),
English: See ‘Look out for serious side effects' in section 4.
Slovenian: Glejte besedilo pod naslovom »Bodite pozorni na resne neželene učinke« v poglavju 4.
English: Mean haloperidol plasma protein binding in adults is approximately 88 to 92%.
Slovenian: Povprečna vezava haloperidola na beljakovine v plazmi pri odraslih znaša približno 88% do 92%.
English: This belongs to a group of medicines called ‘antipsychotics'.
Slovenian: Sodi v skupino zdravil, ki jih imenujemo »antipsihotiki«.
English: • Excessive sweating
Slovenian: • prekomerno znojenje
English: Respiratory depression may necessitate artificial respiration.
Slovenian: V primeru depresije dihanja je lahko potrebna umetna ventilacija.
English: [To be completed nationally] <Other sources of information> <Detailed information on this medicine is available on the website of {MS/Agency}> [To be completed nationally]
Slovenian: <Drugi viri informacij> <Podrobne informacije o zdravilu so objavljene na spletni strani {MS/Agency}>
English: The manifestations may be permanent in some patients.
Slovenian: Ti znaki so lahko pri nekaterih bolnikih stalno prisotni.
English: • Bupropion (for depression or to help you stop smoking)
Slovenian: • bupropion (za zdravljenje depresije ali v pomoč pri opuščanju kajenja),
English: Pregnancy - if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice.
Slovenian: Nosečnost - Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY}
Slovenian: Datum prve odobritve: {DD mesec LLLL} Datum zadnjega podaljšanja: {DD mesec LLLL}
English: Sudden deaths have occurred in patients using this medicine, but the exact frequency of these deaths is unknown.
Slovenian: Pri bolnikih, ki so uporabljali to zdravilo, je prišlo do primerov nenadne smrti, vendar pogostnost teh primerov ni točno znana.
English: • Abnormal heart rhythm - this stops the heart working normally and may cause loss of consciousness
Slovenian: • motnje srčnega ritma - zaradi njih srce preneha normalno delovati in lahko izgubite zavest,
English: Patients with depression
Slovenian: Bolniki z depresijo
English: The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in po padajoči resnosti v okviru posamezne kategorije pogostnosti.
English: • Feel unusually suspicious (paranoia)
Slovenian: • ste lahko neobičajno sumničavi (paranoja),
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Te informacije o zdravilu so rezultat odločbe Komisije v napotitvenem postopku.
English: • Believe things that are not true (delusions)
Slovenian: • lahko verjamete v stvari, ki niso resnične (blodnje),
English: • You are less aware of things around you or your reactions become unusually slow
Slovenian: • če imate motnje zavesti (zmanjšano dojemanje dogajanja v okolici) ali so vaše reakcije neobičajno počasne
English: Enzyme induction may be observed after a few days of treatment.
Slovenian: Indukcijo encimov je lahko opazimo po nekaj dneh zdravljenja.
English: In extreme cases, the patient would appear comatose with respiratory depression and hypotension that could be severe enough to produce a shock-like state.
Slovenian: V ekstremnih primerih je lahko bolnik komatozen z depresijo dihanja in hipotenzijo, ki sta lahko tako hudi, da povzročita stanje, podobno šoku.
English: • You are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na haloperidol ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: This is because small amounts of the medicine may pass into the mother's milk and on to the baby.
Slovenian: To je pomembno zato, ker lahko nekaj zdravila prehaja v materino mleko in ga otrok zaužije.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Slovenian: Bolnikom, pri katerih se razvijejo simptomi, lahko zvečevanje odmerka škodi.
English: Effect of haloperidol on other medicinal products
Slovenian: Vpliv haloperidola na druga zdravila
English: If you miss an appointment, contact your doctor right away to make a new appointment.
Slovenian: Če zamudite obisk pri zdravniku, ga takoj pokličite in se dogovorite za nov termin.
English: These include mental health problems (such as schizophrenia).
Slovenian: To vključuje duševne motnje (kot je shizofrenija).
English: • Verapamil (for blood pressure or heart problems).
Slovenian: • verapamil (za nadzorovanje krvnega tlaka ali zdravljenje težav s srcem).
English: • Abnormal muscle tension
Slovenian: • neobičajna mišična napetost
English: Tell your doctor straight away and stop taking both medicines if you get:
Slovenian: Takoj obvestite zdravnika in prenehajte uporabljati obe zdravili, če opazite:
English: The safety and efficacy of HALDOL Decanoate in children and adolescents below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila HALDOL Decanoate pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: • How you have reacted to haloperidol in the past
Slovenian: • vašega odziva na haloperidol v preteklosti,
English: The ECG measures the electrical activity of your heart.
Slovenian: EKG je posnetek električne aktivnosti srca.
English: • You have progressive supranuclear palsy (PSP)
Slovenian: • če imate progresivno supranuklearno paralizo (PSP)
English: • Ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
Slovenian: • če ste imeli kdaj krvavitev v možganih ali če vam je zdravnik povedal, da je pri vas tveganje za možgansko kap večje kot pri drugih ljudeh,
English: • Confused, disoriented, a headache, balance problems and feel sleepy.
Slovenian: • da ste zmedeni, dezorientirani, vas boli glava, imate težave z ravnotežjem in ste zaspani.
English: Therapeutic concentrations
Slovenian: Terapevtske koncentracije
English: • A swollen face, lips, mouth, tongue or throat
Slovenian: • otekanje obraza, ustnic, ust, jezika ali grla oziroma žrela,
English: • A maximum dose of 300 mg every 4 weeks must not be exceeded because the safety concerns outweigh the clinical benefits of treatment.
Slovenian: • Največjega odmerka 300 mg vsake 4 tedne se ne sme preseči, saj varnostni pomisleki pretehtajo klinične koristi zdravljenja s takim odmerkom.
English: It is used for illnesses affecting the way you think, feel or behave.
Slovenian: Zdravilo uporabljamo za zdravljenje bolezni, ki vplivajo na mišljenje, občutke in vedenje.
English: • Problems walking
Slovenian: • težave s hojo
English: • Problems having sex
Slovenian: • težave pri spolnih odnosih
English: • You will only be given a higher dose than 75 mg every 4 weeks if your doctor decides it is safe to do so.
Slovenian: • Več kot 75 mg odmerek vsake 4 tedne boste prejeli le, če vaš zdravnik odloči, da je to za vas varno.
English: Examples of medicinal products that may increase haloperidol plasma concentrations (based on clinical experience or drug interaction mechanism) include:
Slovenian: Primeri zdravil, ki bi lahko zvišali koncentracijo haloperidola v plazmi (na osnovi kliničnih izkušenj ali mehanizma interakcij) so med drugim lahko:
English: Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (14%), tremor (8%), parkinsonism (7%), muscle rigidity (6%) and somnolence (5%).
Slovenian: Po združenih podatkih o varnosti iz teh kliničnih študij so najbolj pogosto poročali o naslednjih neželenih učinkih: ekstrapiramidne motnje (14%), tremor (8%), parkinsonizem (7%), mišična rigidnost (6%) in somnolenca (5%).
English: These intravenous doses, which prolonged QTc, did not cause arrhythmias.
Slovenian: Navedeni intravenski odmerki, ki so podaljšali interval QTc, niso povzročali aritmij.
English: • You have heart failure or recently had a heart attack
Slovenian: • če imate srčno popuščanje ali ste pred kratkim preboleli srčni infarkt
English: • A slow heart beat, heart disease or anyone in your close family has died suddenly of heart problems
Slovenian: • če imate počasen srčni utrip, katero od bolezni srca ali če je kdo v vaši ožji družini nenadoma umrl zaradi težav s srcem,
English: • You have a low level of potassium in your blood, which has not been treated
Slovenian: • če imate znižano raven kalija v krvi, ki ni bila zdravljena
English: If you get any of these effects, you may be given an additional medicine.
Slovenian: Če se bo pri vas pojavil kateri od navedenih učinkov, boste verjetno prejeli še druga zdravila.
English: • You have a type of dementia called ‘Lewy body dementia'
Slovenian: • če imate vrsto demence, ki jo imenujemo »demenca z Lewyjevimi telesci«
English: Observational studies suggest that treatment of elderly patients with haloperidol is also associated with increased mortality.
Slovenian: Rezultati opazovalnih študij kažejo, da je tudi zdravljenje starejših bolnikov s haloperidolom povezano s povečano umrljivostjo.
English: Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Slovenian: Vzroki smrti so bili sicer različni, vendar je bila, kot kaže, večina smrti kardiovaskularne (na primer srčno popuščanje, nenadna smrt) ali infekcijske narave (na primer pljučnica).
English: Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
Slovenian: Težave z nadzorovanjem premikanja trupa ali okončin (ekstrapiramidne motnje), kot so:
English: Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Slovenian: Zdravnika obvestite tudi, če jemljete katero od drugih zdravil za zniževanje krvnega tlaka, kot so zdravila za odvajanje vode (diuretiki).
English: Cerebrovascular events
Slovenian: Cerebrovaskularni dogodki
English: The exact frequency of these problems is unknown.
Slovenian: Pogostnost pojavljanja teh težav ni točno znana.
English: This causes a high fever, severe muscle stiffness, confusion and loss of consciousness.
Slovenian: Povzroča zvišano telesno temperaturo, hudo okorelost mišic, zmedenost in izgubo zavesti.
English: It is for intramuscular use, and is given as an injection deep into a muscle.
Slovenian: Namenjeno je za intramuskularno uporabo in ga prejmete v obliki injekcije globoko v mišico.
English: Hyperthermia is often an early sign of this syndrome.
Slovenian: Zgodnji znak tega sindroma je pogosto hipertermija.
English: It also crosses the placenta and is excreted in breast milk.
Slovenian: Prehaja tudi preko placente in se izloča v materino mleko.
English: • You have Parkinson's disease
Slovenian: • če imate Parkinsonovo bolezen
English: These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not use Haldol Decanoate (see ‘Do not use Haldol Decanoate if').
Slovenian: Navedena zdravila povečujejo verjetnost za težave s srcem, zato se pogovorite z zdravnikom, če jemljete katero od njih, in ne uporabljajte zdravila Haldol Decanoate (glejte 'Ne uporabljajte zdravila Haldol Decanoate').
English: This association may be stronger for haloperidol than for atypical antipsychotic medicinal products, is most pronounced in the first 30 days after the start of treatment, and persists for at least 6 months.
Slovenian: Ta povezanost, ki je pri haloperidolu lahko močnejša kot pri atipičnih antipsihotičnih zdravilih, je najbolj izrazita v prvih 30 dneh po začetku zdravljenja in je prisotna najmanj 6 mesecev.
English: • Dementia with Lewy bodies.
Slovenian: • demenca z Lewyjevimi telesci
English: Haloperidol crosses the blood-brain barrier easily.
Slovenian: Haloperidol zlahka prehaja krvnomožgansko bariero.
English: • Parkinson's disease.
Slovenian: • Parkinsonova bolezen
English: Pharmacotherapeutic group: psycholeptics; antipsychotics; butyrophenone derivatives, ATC code: N05AD01.
Slovenian: Farmakoterapevtska skupina: psiholeptiki; antipsihotiki; derivati butirofenona, oznaka ATC: N05AD01.
English: A serious problem called ‘neuroleptic malignant syndrome'.
Slovenian: Resen zaplet, ki ga imenujemo »nevroleptični maligni sindrom«.
English: Haloperidol causes efficient psychomotor sedation, which explains the favourable effect on mania and other agitation syndromes.
Slovenian: Haloperidol povzroči učinkovito psihomotorično sedacijo, kar pojasni ugodno delovanje v primeru manije in drugih sindromov z agitacijo.
English: • Elderly people will normally start on a lower dose, usually 12.5 mg to 25 mg every 4 weeks.
Slovenian: • Starejši ljudje običajno začnejo z manjšim odmerkom, običajno od 12,5 mg do 25 mg vsake
English: An extrapyramidal reaction is manifest by muscular rigidity and a generalised or localised tremor.
Slovenian: Ekstrapiramidne reakcije se kažejo kot mišična rigidnost in generaliziran ali lokaliziran tremor.
English: The extent to which this association is attributable to the medicinal product, as opposed to being confounded by patient characteristics, has not yet been elucidated.
Slovenian: V kolikšni meri je to povezanost mogoče pripisati samemu zdravilu in v kolikšni meri nanjo begajoče vplivajo lastnosti bolnika še ni bilo pojasnjeno.
English: The plasma concentrations rise gradually, usually peaking within 3 to 9 days after injection.
Slovenian: Koncentracija v plazmi postopoma narašča in je najvišja od 3. do 9. dne po injiciranju.
English: The syndrome may be masked when treatment is reinstituted, when the dose is increased or when a switch is made to a different antipsychotic.
Slovenian: Sindrom se lahko prikrije pri ponovni uvedbi zdravljenja, pri zvečevanju odmerka ali pri prehodu na drugo antipsihotično zdravilo.
English: The most prominent symptoms are severe extrapyramidal reactions, hypotension and sedation.
Slovenian: Najbolj opazni simptomi so hude ekstrapiramidne reakcije, hipotenzija in sedacija.
English: Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for ventricular arrhythmias and must be corrected before treatment with haloperidol is started.
Slovenian: Elektrolitske motnje, kot sta hipokaliemija in hipomagneziemija, povečujejo tveganje za ventrikularne aritmije in jih je treba odpraviti pred začetkom zdravljenja s haloperidolom.
English: A decision must be made whether to discontinue breastfeeding or to discontinue HALDOL Decanoate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja ali za prekinitev zdravljenja z zdravilom HALDOL Decanoate in pri tem upoštevati koristi dojenja za otroka in koristi zdravljenja za mater.
English: Acute dystonia may necessitate stopping the medicinal product.
Slovenian: Zaradi akutne distonije bo morda potrebno prekiniti uporabo zdravila.
English: In cases of severe extrapyramidal reactions, it is recommended that an antiparkinson medicinal product be administered, and continued for several weeks.
Slovenian: V primeru hudih ekstrapiramidnih reakcij je priporočljivo bolniku dajati antiparkinsonike in z njimi nadaljevati še nekaj tednov.
English: • You have a heart condition called ‘prolonged QT interval', or any other problem with your heart rhythm that shows as an abnormal tracing on an ECG (electrocardiogram)
Slovenian: • če imate srčno motnjo z imenom »podaljšanje intervala QT« ali katero od drugih motenj srčnega ritma, ki se kaže kot nenormalen zapis na EKG posnetku (elektrokardiogramu)