FrancophonIA/ELRC3.0 huggingface dataset:
English: During the study period, the main adverse events occurred generally in the SOCs nervous system disorders (34%), procedure-related lesions/intoxications and complications (8%) and general disorders (8%).
Slovenian: V času trajanja študije so se po organskih sistemih glavni neželeni učinki pojavljali kot bolezni živčevja (34 %) in lezije/zastrupitve in zapleti, povezani s postopkom (8 %) ter kot splošne težave (8 %).
English: In summary, the CHMP noted the 52 fatal cases identified (including 30 cases of overdoses) in the two French pharmacovigilance analyses, for which an association with meprobamate was considered possible.
Slovenian: Skupno je CHMP v dveh francoskih farmakovigilančnih analizah zabeležil 52 primerov s smrtnim izidom (vključno s 30 primeri prevelikih odmerkov), za katere je bila kot možna upoštevana povezava z meprobamatom.
English: Therefore, in order to assess the safety profile of meprobamate, mainly neurological and psychiatric adverse events, including pharmacodependence and serious withdrawal symptoms under normal conditions of use, particularly in the elderly, the CHMP reviewed the data from the two pharmacovigilance analyses of safety data on meprobamate conducted by the Lille CRPV, which were the basis of the Afssaps decision to suspend the marketing authorisations for the products concerned.
Slovenian: Zato je z namenom ocenitve varnostnega profila meprobamata, predvsem nevroloških in psihiatričnih neželenih učinkov, vključno s farmakološko odvisnostjo in z resnimi odtegnitvenimi simptomi pri običajnih pogojih uporabe, še posebej pri starejših osebah, pregledal podatke dveh farmakovigilančnih analiz o varnosti meprobamata, ki ju je izvedla agencija Lille CRPV in ki sta predstavljali podlago za odločitev organa Afssaps za začasen umik dovoljenj za promet z zadevnimi zdravili.
English: In conclusion, taking into account the serious neurological and psychiatric adverse events associated with the use of meprobamate, including under normal conditions of use, the risk of accidental overdoses and of pharmacodependence associated with withdrawal symptoms, the very limited clinical evidence of meprobamate and the lack of effectiveness of the implemented and proposed risk minimisation measures, the CHMP was of the opinion that the risk-benefit balance of meprobamatecontaining medicinal products for oral use is not positive under normal conditions of use.
Slovenian: Ob upoštevanju resnih nevroloških in psihiatričnih neželenih učinkov, povezanih z uporabo meprobamata, tudi pri običajnih pogojih uporabe, tveganj za naključna prevelika odmerjanja in farmakološko odvisnost, povezanih z odtegnitvenimi simptomi, zelo omejenih kliničnih dokazov o meprobamatu in pomanjkanju učinkovitosti uvedenih in predlaganih ukrepov za zmanjševanje tveganja, je bil CHMP mnenja, da razmerje med tveganji in koristmi zdravil, ki vsebujejo meprobamat, za peroralno uporabo, pri običajnih pogojih uporabe ni pozitivno.
English: This analysis assessed the impact of the implementation of risk minimisation measures (restriction of the indication and the posology as well as a reduction of the pack size) on its risk profile.
Slovenian: Pri tej analizi je bil ocenjen vpliv uvedbe ukrepov za zmanjšanje tveganja (omejitev indikacije in odmerjanja kot tudi omejitev velikosti pakiranja) v profilu tveganja.
English: The CHMP also noted the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France, which did not result in a significant nor sufficient reduction of the incidence of adverse reactions associated with meprobamate, including in cases of normal conditions of use.
Slovenian: CHMP je opozoril tudi na farmakovigilančne analize vpliva ukrepov za zmanjšanje tveganja za zdravila z meprobamatom in zdravila s kombinacijo meprobamata in aceprometazina, uvedenih v Franciji, ki niso prikazali bistvenega ali zadostnega zmanjšanja pojavnosti neželenih učinkov, povezanih z meprobamatom, vključno s primeri običajnih pogojev uporabe.
English: The CHMP reviewed the available data submitted by the MAHs but considered that this limited data was insufficient to conclude on the safety of meprobamate and the predictability of any associated risks.
Slovenian: CHMP je pregledal razpoložljive podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom, a je te omejene podatke imel za nezadostne, da bi na njihovi podlagi lahko sklepal o varnosti meprobamata ter o predvidljivosti morebitnih povezanih tveganj.
English: The CHMP therefore concluded that accidental overdoses are a serious risk with meprobamate.
Slovenian: CHMP je zato sklenil, da naključna prevelika odmerjanja predstavljajo resno tveganje pri uporabi meprobamata.
English: • The Committee noted that meprobamate has a relatively narrow therapeutic index and therefore considered that accidental overdoses, which are often serious and can be fatal, are a serious risk with meprobamate.
Slovenian: • Odbor je opozoril, da ima meprobamat relativno ozek terapevtski indeks in je zato menil, da naključna prevelika odmerjanja, ki so pogosto resna in lahko imajo smrtni izid, predstavljajo resno tveganje pri uporabi meprobamata.
English: The CHMP concluded that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level, especially with regard to elderly patients and the risk of pharmacodependence.
Slovenian: CHMP je sklenil, da ni mogoče določiti nobenih ukrepov za zmanjšanje tveganja, ki bi v zadostni meri zmanjšali ugotovljena tveganja, povezana z uporabo meprobamata, na klinično sprejemljivo raven, še posebej za starejše bolnike, ter tveganje za farmakološko odvisnost.
English: The CHMP noted that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, as supported by the available data which identified a number of accidental overdoses which were often serious, including fatalities.
Slovenian: CHMP je opozoril, da ima meprobamat relativno ozek terapevtski indeks s strmo krivuljo odmerek/odziv, kot dokazujejo razpoložljivi podatki, ki so pokazali številna naključna prevelika odmerjanja, ki so bila pogosto resna, vključno s smrtnimi izidi.
English: With regards to safety, the CHMP considered that a number of serious neurological (coma, loss of consciousness) and psychiatric (pharmacodependence and withdrawal symptoms) adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Slovenian: V zvezi z varnostjo je CHMP menil, da so pri uporabi meprobamata poročali o številnih resnih nevroloških (koma, izguba zavesti) in psihiatričnih (farmakološka odvisnost in odtegnitveni simptomi) neželenih učinkih, ki so lahko resni in s potencialnim smrtnim izidom tudi pri običajnih pogojih uporabe.
English: With regard to risk minimisation measures, the CHMP reviewed the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France and the limited additional risk minimisation measures proposed by the MAHs.
Slovenian: V zvezi z ukrepi za zmanjšanje tveganja je CHMP pregledal farmakovigilančne analize vpliva ukrepov za zmanjšanje tveganja za meprobamat in kombinacijo meprobamata in aceprometazina, ki so bili uvedeni v Franciji, ter omejene dodatne ukrepe za zmanjšanje tveganja, ki so jih predlagali imetniki dovoljenja za promet z zdravilom.
English: 7 fatalities associated with meprobamate were reported during the study period (including 2 due to overdoses).
Slovenian: V času trajanja študije so poročali o 7 smrtnih izidih, povezanih z meprobamatom (vključno z 2 zaradi prevelikega odmerka).
English: The CHMP was of the opinion that patients who are being treated for alcohol withdrawal are at risk of serious adverse reactions, given that liver function is likely to be affected in most patients with chronic alcohol problems.
Slovenian: CHMP je bil mnenja, da pri bolnikih, ki so zdravljeni zaradi odtegnitve alkohola, obstaja tveganje za resne neželene učinke, glede na to, da utegne biti pri večini bolnikov s kroničnimi težavami z alkoholom prizadeto delovanje jeter.
English: • The CHMP considered, based on the assessment of the impact of the risk minimisation measures implemented in France and of the limited additional risk minimisation measures proposed by the MAHs, that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level.
Slovenian: • Na podlagi ocene vpliva ukrepov za zmanjšanje tveganja, ki so bili uvedeni v Franciji, ter omejenih dodatnih ukrepov za zmanjšanje tveganja, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, je CHMP menil, da ni mogoče določiti nikakršnih ukrepov za zmanjšanje tveganja, ki bi v zadostni meri zmanjšali ugotovljena tveganja, povezana z uporabo meprobamata, na klinično sprejemljivo raven.
English: The analysis concluded that the reporting rate for meprobamate/aceprometazine did not decrease following the implementation of the risk minimisation measures.
Slovenian: V analizi je bilo ugotovljeno, da pogostnost navedb za kombinirana zdravila meprobamata in aceprometazina po uvedbi ukrepov za zmanjšanje tveganja ni upadla.
English: In conclusion, the CHMP was of the opinion that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level within normal conditions of use.
Slovenian: CHMP je bil v zaključku mnenja, da ni mogoče določiti nobenih ukrepov za minimiziranje tveganja, ki bi v zadostni meri zmanjšali ugotovljena tveganja, povezana z uporabo meprobamata, na klinično sprejemljivo raven pri običajnih pogojih uporabe.
English: In addition, while the efficacy remains largely unchanged since the granting of the initial marketing authorisation, the CHMP was of the opinion that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
Slovenian: Ker torej učinkovitost ostaja skoraj nespremenjena od odobritve prvega dovoljenja za promet z zdravili, je bil CHMP mnenja, da razpoložljivi podatki prikazujejo le zelo omejeno klinično učinkovitost meprobamata za njegove odobrene indikacije.
English: The CHMP reviewed the MAH proposals but considered them insufficient to reduce the identified risk of meprobamate.
Slovenian: CHMP je pregledal predloge imetnikov dovoljenja za promet z zdravilom in menil, da ne zadoščajo za zmanjšanje ugotovljenega tveganja pri uporabi meprobamata.
English: • The CHMP considered that meprobamate has a potential for pharmacodependence under normal conditions of use and that as a consequence, meprobamate is also associated with a risk of serious withdrawal symptoms.
Slovenian: • CHMP je menil, da ima meprobamat pri običajnih pogojih uporabe potencial za farmakološko odvisnost in da je posledično lahko povezan s tveganjem za resne odtegnitvene simptome.
English: System Organ Classes (SOCs) nervous system disorders (29%) and procedure-related lesions/intoxications and complications (12%).
Slovenian: V času trajanja študije so se po organskih sistemih glavni neželeni učinki, o katerih so poročali, pojavljali kot bolezni živčevja (29 %) in lezije/zastrupitve in zapleti, povezani s postopkom (12 %).
English: Noting that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, the CHMP therefore concluded that accidental overdoses are a serious risk with meprobamate.
Slovenian: Ob upoštevanju, da ima meprobamat relativno ozek terapevtski indeks s strmo krivuljo odmerek/odziv, je CHMP zaključil, da pri uporabi meprobamata naključna prevelika odmerjanja predstavljajo resno tveganje.
English: Finally, the CHMP noted a non-fatal case of coma, following severe liver failure, in a cirrhotic patient.
Slovenian: CHMP je zabeležil tudi primer kome brez smrtnega izida, ki mu je sledila huda jetrna odpoved pri bolniku s cirozo.
English: • The Committee considered that a number of neurological and psychiatric adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Slovenian: • Odbor je bil mnenja, da so v zvezi z uporabo meprobamata poročali o številnih nevroloških in psihiatričnih neželenih učinkih, ki so lahko resni in imajo potencialno smrtni izid tudi pri običajnih pogojih uporabe.
English: The CHMP also considered that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
Slovenian: CHMP je prav tako mnenja, da ima meprobamat potencial za farmakološko odvisnost po daljši uporabi, kar povzroča tveganje za odtegnitvene simptome, ki so resni in lahko imajo smrten izid.
English: The CHMP therefore concluded that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
Slovenian: CHMP je zato zaključil, da po daljši uporabi meprobamata obstaja možnost za razvoj farmakološke odvisnosti, kar povzroča tveganje za odtegnitvene simptome, ki so resni in lahko imajo smrten izid.
English: • The CHMP is of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
Slovenian: • CHMP je bil mnenja, da pri bolnikih, ki so zdravljeni zaradi odtegnitve alkohola, zaradi okvarjenega delovanja jeter obstaja tveganje za potencialno resne neželene učinke.
English: The CHMP considered that the data identified a risk of pharmacodependence, based on utilization data issued from a claims database showing prolonged use of meprobamate.
Slovenian: CHMP je na podlagi podatkov o uporabi, ki so izhajali iz baze podatkov zavarovalniških zahtevkov ter so prikazovali daljšo uporabo meprobamata, menil, da so podatki pokazali tveganje za farmakološko odvisnost.
English: Finally, the CHMP was of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
Slovenian: CHMP je tudi menil, da pri bolnikih, ki so zdravljeni zaradi odtegnitve alkohola, zaradi okvarjenega delovanja jeter obstaja tveganje za potencialno resne neželene učinke.
English: Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Slovenian: Zdravljenje z zdravilom Azomyr je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti bolnika, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Azomyr therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Azomyr, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: There are no known interactions of Azomyr with other medicines.
Slovenian: Ni znanih interakcij med zdravilom Azomyr in drugimi zdravili.
English: In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2).
Slovenian: V primeru hude ledvične insuficience morate zdravilo Azomyr uporabljati previdno (glejte poglavje 5.2).
English: Azomyr effectively controlled symptoms for 24 hours.
Slovenian: Zdravilo Azomyr učinkovito obvladuje te simptome za čas 24 ur.
English: As a precautionary measure, it is preferable to avoid the use of Azomyr during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Azomyr bolje izogibati.
English: The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Azomyr.
Slovenian: Zdravnik, ki predpiše zdravilo, naj se zaveda, da je pri otrocih, mlajših od 2 let, večina primerov rinitisa infekcijskega izvora (glejte poglavje 4.4) in da ni nobenih podatkov, ki bi govorili v prid zdravljenju infekcijskega rinitisa z zdravilom Azomyr.
English: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Azomyr was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Slovenian: V dveh s placebom kontroliranih šesttedenskih preskušanjih pri bolnikih s kronično idiopatsko urtikarijo je zdravilo Azomyr učinkovito blažilo srbenje in zmanjšalo velikost in število izpuščajev koprivnice že do konca prvega intervala odmerjanja.
English: The dose of orodispersible tablet is placed in the mouth where it will disperse immediately.
Slovenian: Odmerek orodisperzibilne tablete dajte v usta, kjer bo takoj razpadel.
English: However, the safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as Azomyr oral solution, was demonstrated in three paediatric trials.
Slovenian: Varnost desloratadina v obliki sirupa, ki vsebuje isto koncentracijo desloratadina kot Azomyr peroralna raztopina, pa so dokazali v treh preskušanjih pri pediatričnih bolnikih.
English: Azomyr 2.5 mg tablets has not been evaluated in paediatric patients however in conjunction with the dose finding studies in paediatrics, the pharmacokinetics data for Azomyr orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Slovenian: Uporabe zdravila Azomyr 2,5 mg tablete niso ovrednotili pri pediatričnih bolnikih, vendar pa skupaj s študijami za ugotavljanje pediatričnega odmerka tudi farmakokinetični podatki za zdravilo Azomyr orodisperzibilne tablete govorijo v prid uporabi 2,5 mg odmerka pri pediatričnih bolnikih starih 6 do 11 let.
English: Water had no effect on the bioavailability of Azomyr orodispersible tablets.
Slovenian: Voda ni vplivala na biološko uporabnost zdravila Azomyr orodisperzibilne tablete.
English: During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Slovenian: Med trženjem zdravila Azomyr so zelo redko poročali o primerih hudih alergijskih reakcij (težave z dihanjem, piskanje, srbenje, koprivnica in otekanje).
English: What Azomyr is Azomyr contains desloratadine which is an antihistamine.
Slovenian: Kaj je zdravilo Azomyr Zdravilo Azomyr vsebuje desloratadin, ki je antihistaminik.
English: Other medicines and Azomyr
Slovenian: Druga zdravila in zdravilo Azomyr
English: Do not use this medicine if you notice any change in the appearance of Azomyr orodispersible tablet.
Slovenian: Ne uporabljajte tega zdravila, če opazite kakršne koli spremembe videza zdravila Azomyr orodisperzibilna tableta.
English: If you forget to take Azomyr orodispersible tablet If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Slovenian: Če ste pozabili vzeti zdravilo Azomyr orodisperzibilna tableta Če ste pozabili vzeti odmerek pravočasno, ga vzemite čimprej in potem nadaljujte z ustaljenim režimom odmerjanja.
English: The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Slovenian: Učinkovitosti tablet Azomyr niso jasno dokazali v preskušanjih pri mladostnikih, starih od 12 do 17 let.
English: Azomyr orodispersible tablet contains aspartame This product contains aspartame.
Slovenian: Zdravilo Azomyr orodisperzibilna tableta vsebuje aspartam To zdravilo vsebuje aspartam.
English: Taking Azomyr is not recommended if you are pregnant or nursing a baby.
Slovenian: Jemanja zdravila Azomyr vam ne priporočamo, če ste noseči ali če dojite.
English: ● liver inflammation ● abnormal liver function tests body movement
Slovenian: ● nenormalni izvidi preiskav telesnimi gibi delovanja jeter
English: Efficacy of Azomyr syrup has not been investigated in paediatric trials in children less than 12 years of age.
Slovenian: Učinkovitosti zdravila Azomyr sirup niso raziskovali v pediatričnih preskušanjih pri otrocih, mlajših od 12 let.
English: Efficacy of Azomyr oral solution has not been investigated in separate paediatric trials.
Slovenian: Učinkovitosti zdravila Azomyr peroralna raztopina niso raziskovali v ločenih pediatričnih preskušanjih.
English: A. MANUFACTURIERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Therefore, the efficacy of Azomyr orodispersible tablet is expected to be the same as with the Azomyr tablet formulation.
Slovenian: Zato je pričakovana učinkovitost zdravila Azomyr orodisperzibilne tablete enaka učinkovitosti tablet Azomyr.
English: Azomyr orodispersible tablet with food, drink and alcohol Azomyr orodispersible tablet does not need to be taken with water or liquid.
Slovenian: Zdravilo Azomyr orodisperzibilna tableta skupaj s hrano, pijačo in alkoholom Zdravila Azomyr orodisperzibilna tableta vam ni treba jemati z vodo ali tekočino.
English: Azomyr tablets contain lactose.
Slovenian: Zdravilo Azomyr tablete vsebuje laktozo.
English: The recommended dose of Azomyr is one 5 mg orodispersible tablet placed in the mouth once a day.
Slovenian: Priporočeni odmerek zdravila Azomyr je ena 5 mg orodisperzibilna tableta v usta enkrat na dan.
English: In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Slovenian: V klinični farmakološki raziskavi pri sočasnem jemanju tablet Azomyr in uživanju alkohola ni bilo okrepljenih škodljivih učinkov alkohola (glejte poglavje 5.1).
English: In clinical studies with Azomyr, the following side effects were reported as:
Slovenian: V kliničnih študijah z zdravilom Azomyr so poročali o naslednjih neželenih učinkih:
English: Talk to your doctor, pharmacist or nurse before taking Azomyr: - if you have poor kidney function.
Slovenian: Pred začetkom jemanja zdravila Azomyr se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če vam ledvice slabo delujejo.
English: Azomyr oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylenefaced liner.
Slovenian: Zdravilo Azomyr peroralna raztopina je na voljo v rjavih stekleničkah iz stekla tipa III velikosti 30, 50, 60, 100, 120, 150, 225 ali 300 ml. Stekleničke so zaprte s plastično zaporko, varno za otroke (C/R) z navojem, z večplastno oblogo s polietilenom na vrhu.
English: In clinical studies in most children and adults, side effects with Azomyr were about the same as with a dummy solution or tablet.
Slovenian: V kliničnih študijah so bili pri večini otrok in odraslih neželeni učinki pri jemanju zdravila Azomyr približno enaki kot pri jemanju peroralne suspenzije placeba ali tablet.
English: EU/1/00/157/001 1 tablet EU/1/00/157/002 2 tablets EU/1/00/157/003 3 tablets EU/1/00/157/004 5 tablets EU/1/00/157/005 7 tablets EU/1/00/157/006 10 tablets EU/1/00/157/007 14 tablets EU/1/00/157/008 15 tablets EU/1/00/157/009 20 tablets EU/1/00/157/010 21 tablets EU/1/00/157/011 30 tablets EU/1/00/157/012 50 tablets EU/1/00/157/013 100 tablets
Slovenian: EU/1/00/157/001 1 tableta EU/1/00/157/002 2 tableti EU/1/00/157/003 3 tablete EU/1/00/157/004 5 tablet EU/1/00/157/005 7 tablet EU/1/00/157/006 10 tablet EU/1/00/157/007 14 tablet EU/1/00/157/008 15 tablet EU/1/00/157/009 20 tablet EU/1/00/157/010 21 tablet EU/1/00/157/011 30 tablet EU/1/00/157/012 50 tablet EU/1/00/157/013 100 tablet
English: If you forget to take Azomyr
Slovenian: Če ste pozabili vzeti zdravilo Azomyr
English: Adults During the marketing of Azomyr, the following side effects were reported as:
Slovenian: Odrasli Med trženjem zdravila Azomyr so poročali o naslednjih neželenih učinkih: