FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of SABAs in emergency conditions and to enable external cephalic version is supported as this reflects limited duration of use and minimal dosing, and from a safety perspective these indications should be maintained, where authorised.
Slovenian: Uporaba kratkodelujočih beta agonistov v nujnih primerih in za zunanji obrat otroka v glavično vstavo je še naprej ustrezna, saj gre za kratkotrajno uporabo pri najmanjših odmerkih, zato je treba z varnostnega vidika te indikacije tam, kjer so že odobrene, ohraniti.
English: The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for short-acting beta-agonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products in the obstetric indications (see Annex I).
Slovenian: PRAC je obravnaval postopek po členu 31 Direktive 2001/83/ES, sprožen na podlagi farmakovigilančnih podatkov, za zdravila, ki vsebujejo kratkodelujoče beta agoniste (SABA) (salbutamol, terbutalin, fenoterol, ritodrin, heksoprenalin in izoksuprin) in so odobrena za indikacije v porodništvu (glejte Prilogo I);
English: Data available from clinical trials, post-marketing reports and literature were considered in this review.
Slovenian: V tem pregledu so proučili razpoložljive podatke iz kliničnih preskušanj, poročil iz obdobja trženja in literature.
English: Products for which the oral and suppository formulations are only used in obstetric indications should have their licenses revoked and recalled from the market.
Slovenian: Dovoljenja za promet z zdravili, katerih peroralne oblike in svečke se uporabljajo samo za indikacije v porodništvu, je treba razveljaviti in zadevna zdravila odpoklicati s trga.
English: With injectable formulations there are safety issues during prolonged use of these active substances in the context of the obstetric indications, however there may be benefit in administering parental formulations in the obstetric indication of tocolysis in the short-term (maximum 48 hours).
Slovenian: Pri farmacevtskih oblikah za injiciranje je vprašljiva varnost ob daljši uporabi teh zdravilnih učinkovin v okviru indikacij v porodništvu, vendar pa lahko obstajajo koristi, če se parenteralne oblike dajejo za tokolizo samo za kratek čas (največ 48 ur).
English: The Committee is of the opinion that the benefits of the parenteral formulations of short-acting beta-agonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products continue to outweigh the risks in the obstetric indications of short term management of uncomplicated tocolysis.
Slovenian: odbor meni, da so koristi parenteralnih oblik zdravil, ki vsebujejo kratkodelujoče beta agoniste (SABA) (salbutamol, terbutalin, fenoterol, ritodrin, heksoprenalin in izoksuprin), še vedno večje od tveganj pri zdravljenju indikacije v porodništvu kratkotrajno vodenje nezapletene tokolize;
English: Eight cases of neonatal/foetal death including abortions have been identified by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zabeležil osem primerov neonatalnih/fetalnih smrti, vključno s splavi.
English: The Committee in addition stressed that the parenteral products should only be administered for short term management (up to 48 hours) of the obstetric indications in patients between 22 and 37 weeks of gestation.
Slovenian: poleg tega je odbor poudaril, da se lahko parenteralna zdravila dajejo samo za kratkotrajno zdravljenje (za največ 48 ur) indikacij v porodništvu pri bolnicah med 22. in 37. tednom nosečnosti.
English: One case report of uterine haemorrhage exists however it is confounded by concomitant uterine pathology.
Slovenian: Obstaja eno poročilo o primeru maternične krvavitve, vendar je k temu pripomogla sočasna patologija maternice.
English: Having noted the above, the PRAC concluded that the benefit-risk balance is not favourable for the oral formulations and suppositories in view of the overall available safety data, in particular in relation to the risk of serious cardiovascular events, and limited efficacy.
Slovenian: Ob upoštevanju vsega zgoraj omenjenega je PRAC zaključil, da glede na vse razpoložljive podatke o varnosti, še zlasti podatke o tveganju za resne srčno-žilne dogodke, in omejeno učinkovitost razmerje med tveganji in koristmi peroralnih farmacevtskih oblik in svečk ni ugodno.
English: The use should be contraindicated in patients at a gestational age less than 22 weeks, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
Slovenian: Uporabo je treba kontraindicirati pri bolnicah z gestacijsko starostjo ploda manj kot 22 tednov, pri bolnicah z obstoječo ishemično boleznijo srca in bolnicah z izrazitimi dejavniki tveganja za ishemično bolezen srca ter pri bolnicah, pri katerih obstaja nevarnost za splav v prvem in drugem trimesečju nosečnosti.
English: Four patients with no pre-existing cardiac pathology developed peripartum cardiomyopathy while on prolonged oral terbutaline for various treatment durations (9.5-53 days).
Slovenian: Po dolgotrajnem zdravljenju s peroralnim terbutalinom, ki je trajalo različno dolgo (9,5-53 dni), se je peripartalna kardiomiopatija razvila pri štirih bolnicah, ki prej niso imele nobenih težav s srcem.
English: In addition, blood pressure and heart rate, electrolyte and fluid balance, glucose and lactate levels and potassium levels should be continuously monitored.
Slovenian: Prav tako je treba stalno preverjati krvni tlak in srčno frekvenco, ravnovesje elektrolitov in tekočin, koncentracijo glukoze in laktata ter koncentracijo kalija.
English: The PRAC concluded that the benefits of injectable forms outweighed the cardiovascular risks in restricted conditions of use: these active substances should be given for short term management (up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Slovenian: PRAC je zaključil, da so koristi farmacevtskih oblik za injiciranje večje od srčno-žilnih tveganj, če se upoštevajo strožji pogoji uporabe: te zdravilne učinkovine se lahko dajejo za kratkotrajno zdravljenje (največ 48 ur) med 22. in 37. tednom nosečnosti pri bolnicah, pri katerih zdravljenje s tokolitiki ni zdravstveno ali porodniško kontraindicirano.
English: For the parenteral formulations, the PRAC having considered all the available data and specifically for the management of uncomplicated premature labour recommends that these active substances should be given for short term management (up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Slovenian: V zvezi s parenteralnimi oblikami je PRAC, potem ko je pregledal vse razpoložljive podatke in še posebej podatke v zvezi z vodenjem nezapletenega prezgodnjega poroda, priporočil, da naj se te zdravilne učinkovine dajejo samo za kratek čas (največ 48 ur) med 22. in 37. tednom nosečnosti pri bolnicah, pri katerih zdravljenje s tokolitiki ni zdravstveno ali porodniško kontraindicirano.
English: The committee also stressed that in the patients receiving these parenteral medicinal products the blood pressure and heart rate, electrolyte and fluid balance, glucose and lactate levels and potassium levels should be continuous monitored.
Slovenian: Odbor je poudaril še, da je treba pri bolnicah, ki prejemajo ta parenteralna zdravila, stalno preverjati krvni tlak in srčno frekvenco, ravnovesje elektrolitov in tekočin, koncentracijo glukoze in laktata ter koncentracijo kalija.
English: In contrast to other SABAs, no maternal fatality and no case of myocardial infarction have been reported following hexoprenaline administration for tocolysis.
Slovenian: V nasprotju z drugimi kratkodelujočimi beta agonisti po dajanju heksoprenalina za tokolizo niso poročali o maternalni smrti ali primerih srčnega infarkta.
English: Two cases of tocolysis maintained with suppositories only were also reported to develop pulmonary oedema.
Slovenian: Prav tako so poročali o dveh primerih pljučnega edema, ki se je razvil pri zaviranju popadkov s samimi svečkami.
English: The CMDh considered the below PRAC recommendation dated 5 September 2013 with regards to the terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products:
Slovenian: Skupina za postopek medsebojnega priznavanja in decentralizirani postopek (CMDh) je proučila spodnje priporočilo, ki ga je izdal odbor PRAC dne 5. septembra 2013 v zvezi z zdravili, ki vsebujejo terbutalin, salbutamol, heksoprenalin, ritodrin, fenoterol in izoksuprin:
English: The committee also stressed that in the patients receiving these parenteral medicinal products the blood pressure and heart rate, electrolyte and fluid balance, glucose and lactate levels and potassium levels should be monitored throughout treatment.
Slovenian: Odbor je poudaril še, da je treba pri bolnicah, ki prejemajo ta parenteralna zdravila, v času zdravljenja preverjati krvni tlak in srčno frekvenco, ravnovesje elektrolitov in tekočin, koncentracijo glukoze in laktata ter koncentracijo kalija;
English: Maternal tachycardia is the most commonly reported adverse reaction following intravenous hexoprenaline administration.
Slovenian: Neželeni učinek, o katerem so najpogosteje poročali po intravenskem dajanju heksoprenalina, je maternalna tahikardija.
English: Parenteral medicinal SABA products should be contraindicated in patients at less than 22 weeks of gestation, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
Slovenian: Parenteralna zdravila, ki vsebujejo kratkodelujoče beta agoniste, je treba kontraindicirati pri bolnicah v manj kot 22. tednu nosečnosti, pri bolnicah z obstoječo ishemično boleznijo srca in bolnicah z izrazitimi dejavniki tveganja za ishemično bolezen srca ter pri bolnicah, ki jim grozi splav v prvem in drugem trimesečju nosečnosti.
English: For these indications which include short term management of uncomplicated tocolysis the PRAC recommended the parenteral products should only be administered for short term management (up to 48 hours) in patients between 22 and 37 weeks of gestation.
Slovenian: Pri teh indikacijah, ki vključujejo kratkotrajno vodenje nezapletene tokolize, je PRAC priporočil, naj se parenteralne oblike zdravil dajejo samo za kratkotrajno zdravljenje (največ 48 ur) pri bolnicah med 22. in 37. tednom nosečnosti.
English: Tachycardia, palpitations, and changes of blood pressure accounted for about 2/3 of the adverse events associated with the oral formulation.
Slovenian: Približno dve tretjini neželenih dogodkov, povezanih s peroralno obliko, so predstavljale tahikardija, palpitacije in spremembe krvnega tlaka.
English: For these indications which include short term management of uncomplicated tocolysis the PRAC recommended the parenteral products should only be administered for short term management (up to 48 hours) of the obstetric indications in patients between 22 and 37 weeks of gestation.
Slovenian: Pri teh indikacijah, ki vključujejo kratkotrajno vodenje nezapletene tokolize, je PRAC priporočil, naj se parenteralne oblike zdravil dajejo samo za kratkotrajno zdravljenje (največ 48 ur) indikacij v porodništvu pri bolnicah med 22. in 37. tednom nosečnosti.
English: Myocardial infarction or serious arrhythmias were not reported in the clinical trial reports available to the MAH.
Slovenian: V poročilih o kliničnih preskušanjih, s katerimi razpolaga imetnik dovoljenja za promet z zdravilom, ni poročil o srčnem infarktu ali resnih aritmijah.
English: • epilepsy.
Slovenian: • epilepsijo.
English: The studies lasted up to 12 weeks.
Slovenian: Študije so trajale do 12 tednov.
English: The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;
Slovenian: Glavno merilo učinkovitosti je bila sprememba števila napadov po 11 do 12 tednih;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Lyrica, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 6. julija 2004.
English: Patients who have kidney problems need to take lower doses.
Slovenian: Bolniki, ki imajo težave z ledvicami, morajo jemati nižje odmerke.
English: It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).
Slovenian: Na voljo je v obliki kapsul (belih: 25, 50 in 150 mg; belih in oranžnih: 75, 225 in 300 mg; oranžnih: 100 mg; svetlo oranžnih: 200 mg) ali kot peroralna raztopina (20 mg/ml).
English: This document is a summary of the European Public Assessment Report (EPAR) for Lyrica.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lyrica.
English: Other information about Lyrica:
Slovenian: Druge informacije o zdravilu Lyrica:
English: Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks.
Slovenian: Učinkovitost so merili s standardnim vprašalnikom za merjenje tesnobe po štirih do osmih tednih.
English: Lyrica is used to treat adults with the following conditions:
Slovenian: Zdravilo Lyrica se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The CHMP decided that Lyrica's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Lyrica večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The effectiveness of Lyrica was measured using a standard pain questionnaire;
Slovenian: Učinkovitost zdravila Lyrica so merili s standardnim vprašalnikom za točkovanje bolečine;
English: The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses.
Slovenian: Priporočeni začetni odmerek zdravila Lyrica je 150 mg na dan, ki se porazdeli na dva ali tri odmerke.
English: What benefit has Lyrica shown during the studies?
Slovenian: Kakšne koristi je zdravilo Lyrica izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lyrica.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Lyrica, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Slovenian: Najpogostejša neželena učinka zdravila Lyrica (opažena pri več kot 1 bolniku od 10) sta omotica in zaspanost.
English: Lyrica is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Slovenian: Zdravilo Lyrica se uporablja kot dodatek k obstoječim zdravljenjem pri bolnikih s parcialnimi napadi (epileptični napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
English: Lyrica has been compared with placebo (a dummy treatment) in 22 studies:
Slovenian: Zdravilo Lyrica so primerjali s placebom (zdravilom brez zdravilne učinkovine) v 22 študijah:
English: Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or any of the other ingredients.
Slovenian: Zdravila Lyrica ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pregabalin ali katero koli drugo sestavino zdravila.
English: A further study was carried out in 137 patients with central neuropathic pain due to a spinal cord injury.
Slovenian: Nadaljnja študija je bila izvedena s približno 137 bolniki z osrednjo nevropatsko bolečino, ki je bila posledica poškodbe hrbtenjače.
English: In neuropathic pain, Lyrica was more effective than placebo in decreasing pain.
Slovenian: Pri nevropatski bolečini je bilo zdravilo Lyrica učinkovitejše od placeba pri zmanjšanju bolečine.
English: • neuropathic pain (pain due to nerve damage).
Slovenian: • nevropatsko bolečino (bolečino zaradi poškodbe živcev).
English: What is the risk associated with Lyrica?
Slovenian: Kakšna tveganja so povezana z zdravilom Lyrica?
English: Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Slovenian: Zdravilo Lyrica se lahko uporablja pri periferni nevropatski bolečini, kot je bolečina pri bolnikih s sladkorno boleznijo, ali pri bolnikih, ki so imeli herpes zoster (pasovec), in osrednji nevropatski bolečini, kot je bolečina pri bolnikih s poškodbo hrbtenjače;
English: After three to seven days, the dose can be increased to 300 mg per day.
Slovenian: Po treh do sedmih dneh se lahko odmerek poveča na 300 mg na dan. Količina odmerkov se lahko poveča do dvakrat, dokler ni dosežen najučinkovitejši odmerek.
English: • for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles.
Slovenian: • v desetih študijah so proučevali periferno nevropatsko bolečino pri več kot 3 000 bolnikih, od katerih jih je približno polovica imela diabetično nevropatijo, druga polovica pa bolečine po pasovcu.
English: Stopping treatment with Lyrica should also be done gradually, over at least a week.
Slovenian: Največji odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Lyrica mora potekati postopno, in sicer mora trajati najmanj en teden.
English: In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more.
Slovenian: Pri epilepsiji se je ob jemanju zdravila Lyrica zmanjšalo število napadov: pri približno 45 % bolnikov, ki so jemali 600 mg zdravila Lyrica, in pri približno 35 % bolnikov, ki so dnevno jemali 300 mg zdravila Lyrica, se je število napadov zmanjšalo za 50 % ali več.
English: For the full list of all side effects reported with Lyrica, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lyrica, glejte navodilo za uporabo.
English: • for generalised anxiety disorder, there were eight studies involving over 3,000 patients.
Slovenian: • v osmih študijah so proučevali generalizirano anksiozno motnjo pri več kot 3 000 bolnikih.
English: Why has Lyrica been approved?
Slovenian: Zakaj je bilo zdravilo Lyrica odobreno?
English: For more information about treatment with Lyrica, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lyrica preberite navodilo za uporabo (ki je prav tako del EPAR).
English: • for epilepsy, there were three studies involving over 1,000 patients.
Slovenian: • V treh študijah so proučevali več kot 1 000 bolnikov z epilepsijo.
English: In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.
Slovenian: Pri generalizirani anksiozni motnji je bilo zdravilo Lyrica učinkovitejše od placeba: pri 52 % bolnikov, ki so jemali zdravilo Lyrica, je bilo izboljšanje 50- ali večodstotno v primerjavi z 38 % bolnikov, ki so jemali placebo.
English: The full EPAR for Lyrica can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lyrica je na voljo tukaj.
English: What is Lyrica used for?
Slovenian: Za kaj se zdravilo Lyrica uporablja?
English: In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Slovenian: Pri osrednji nevropatski bolečini je bilo pri 22 % bolnikov, zdravljenih z zdravilom Lyrica, doseženo izboljšanje točkovanja bolečine za 50 % ali več v primerjavi z 8 % bolnikov, ki so se zdravili s placebom.
English: How does Lyrica work?
Slovenian: Kako zdravilo Lyrica deluje?
English: In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
Slovenian: Pri periferni nevropatski bolečini je bilo pri 35 % bolnikov, zdravljenih z zdravilom Lyrica, doseženo izboljšanje točkovanja bolečine za 50 % ali več v primerjavi z 18 % bolnikov, ki so se zdravili s placebom.
English: How has Lyrica been studied?
Slovenian: Kako je bilo zdravilo Lyrica raziskano?
English: How is Lyrica used?
Slovenian: Kako se zdravilo Lyrica uporablja?
English: The company presented results of five key studies from the published literature.
Slovenian: Družba je predstavila rezultate petih glavnih študij iz objavljene literature.
English: If necessary, the dose can be divided between both sides of the mouth.
Slovenian: Po potrebi se lahko odmerek porazdeli med obe strani ust.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Buccolam on 5 September 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Buccolam, veljavno po vsej Evropski uniji, odobrila dne 5. septembra 2011.
English: Each syringe contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of midazolam.
Slovenian: Ena brizga vsebuje 2,5 mg, 5 mg, 7,5 mg ali 10 mg midazolama.
English: The full EPAR for Buccolam 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 Buccolam je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose ranges from 2.5.mg to 10 mg, depending on the child's age.
Slovenian: Priporočeni odmerek znaša od 2,5 mg do 10 mg glede na starost otroka.
English: With regard to side effects, the medicine may cause respiratory depression, as is the case with other comparable medicines, but is generally well tolerated.
Slovenian: Kar zadeva stranske učinke, lahko zdravilo povzroča respiratorno depresijo tako kot druga primerljiva zdravila, vendar ga bolniki na splošno dobro prenašajo.
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Slovenian: Živčni prenašalci, kot je GABA, so kemične snovi, ki živčnim celicam omogočajo medsebojno komunikacijo.
English: Convulsions are caused by excessive electrical activity in the brain.
Slovenian: Konvulzije povzroča prekomerna električna aktivnost v možganih.
English: This is a summary of the European public assessment report (EPAR) for Buccolam.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Buccolam.
English: For more information about treatment with Buccolam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Buccolam preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Carers should only administer one dose.
Slovenian: Negovalci smejo dati samo en odmerek.