natgillin/translations-raw huggingface dataset:
These results suggested an increased mortality with higher doses and due to diseases of the circulatory system (subarachnoid or intracerebral haemorrhage) and bone tumours.
Navedeni izsledki so kazali na povečano umrljivost pri večjih odmerkih ter zaradi bolezni cirkulacijskega sistema (subarahnoidna ali intracerebralna krvavitev) in kostnih tumorjev.
Overall, in view of the limitations of the French SAGHE study the findings of an apparent increased risk of mortality in children treated with somatropin (increased risk with higher doses and relating to subarachnoid or intracerebral haemorrhage and bone tumours) cannot be regarded as robust data.
Glede na omejitve francoske študije SAGHE se na splošno ugotovitve o očitnem povečanem tveganju umrljivosti pri otrocih, zdravljenih s somatropinom (povečano tveganje pri večjih odmerkih ter v povezavi s subarahnoidno ali intracerebralno krvavitvijo in kostnimi tumorji), ne morejo šteti za zanesljive podatke.
In view of these limitations, the Committee concluded that the study findings of an apparent increased risk of mortality in children treated with somatropin (increased risk with higher doses and relating to subarachnoid or intracerebral haemorrhage and bone tumours) cannot be regarded as robust.
Glede na te omejitve je Odbor sklenil, da se ugotovitve o očitnem povečanem tveganju umrljivosti pri otrocih, zdravljenih s somatropinom (povečano tveganje pri večjih odmerkih ter v zvezi s subarahnoidno ali intracerebralno krvavitvijo in kostnimi tumorji), ne morejo šteti za zanesljive podatke.
1 Swerdlow AJ, Higgins CD, Adlard P, et al. Risk of cancer in patients treated with pituitary growth hormone in the UK, 195985: a cohort study.
1 Swerdlow, A. J., Higgins, C. D., Adlard, P. in drugi, Risk of cancer in patients treated with pituitary growth hormone in the UK, 1959-85: a cohort study, Lancet 2002, 360: 273-277.
Grounds for amendment of the summaries of product characteristics and Package Leaflets
Podlaga za dopolnilo povzetkov glavnih značilnosti zdravil in navodila za uporabo
Secondly, due to several published studies that reported a higher risk of tumour and/or tumour related mortality for patients treated with growth hormone (Swerdlow et al. 20021, Sklar et al. 20022 and by Ergun-Longmire et al. 20063).
Ta povezava izhaja iz, prvič, biološke verjetnosti na podlagi ugotovljene možnosti, da insulinu podoben rastni dejavnik-1 (IGF-1), ki je ključni mediator delovanja rastnega hormona in ki se izloča v odziv na aktivacijo receptorjev rastnega hormona, povzroča tumorje, ter drugič, iz več objavljenih študij, ki so pokazale večje tveganje tumorjev in/ali s tumorji povezane umrljivosti pri bolnikih, zdravljenih z rastnim hormonom (Swerdlow in drugi 20021, Sklar in drugi 20022 ter Ergun-Longmire in drugi 20063).
This potential risk should also be reflected in the Risk Management Plan for all somatropin products as well as the potential risk of subarachnoid or intracerebral haemorrhage.
To možno tveganje in možno tveganje subarahnoidne ali intracerebralne krvavitve je treba navesti tudi v načrtu za obvladovanje tveganj za vsa zdravila, ki vsebujejo somatropin.
Also, the characteristics of the treated patients that per se may be associated with increased mortality, even if in a low risk group (i.e. treated for isolated GHD, ISS and SGA).
Med temi omejitvami so uporaba splošne populacije kot referenčne skupine za izračun standardiziranih stopenj umrljivosti, kar vodi do neizmerljivih zavajajočih dejavnikov, ter značilnosti zdravljenih bolnikov, ki bi bile lahko same po sebi povezane s povečano umrljivostjo, tudi če so ti bolniki v skupini z majhnim tveganjem (tj. so zdravljeni zaradi izoliranega pomanjkanja rastnega hormona, idiopatske nizke rasti ali MGS).
- Treatment of acute alcohol intoxication
- zdravljenje akutne zastrupitve z alkoholom;
Haldol has been approved nationally in the European Union (EU) with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Haldol je bil odobren na nacionalni ravni v Evropski uniji (EU) z mnogimi razlikami v besedilu povzetka glavnih značilnosti zdravila v posameznih državah članicah.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission (EC) notified the European Medicines Agency's secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenega zdravila (in povezanih imen), je Evropska komisija obvestila sekretariat Evropske agencije za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES z namenom razrešitve razhajanj med nacionalno odobrenimi povzetki glavnih značilnosti zdravila in uskladitve razhajajočih se informacij po vsej EU.
Paediatric indications were agreed only for the oral formulations for the treatment of:
Pediatrične indikacije so usklajene le za peroralne formulacije za zdravljenje:
It was agreed that the maximum dose in elderly patients should be 5 mg/day, while higher doses should only be considered in patients who have tolerated higher doses and after reassessment of the patient's individual benefit-risk profile.
Dogovorjeno je bilo, da bi moral biti največji odmerek pri starejših bolnikih 5 mg/dan, medtem ko se večji odmerki upoštevajo le pri bolnikih, ki so prenesli večje odmerke, in po ponovni oceni bolnikovega razmerja med koristmi in tveganjem.
• The Committee considered the referral under Article 30 of Directive 2001/83/EC for Haldol and associated names;
• odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES za zdravilo Haldol in povezana imena;
It is advised that measurement of haloperidol concentrations may be considered in individual cases.
Priporočljivo je, da se lahko v posameznih primerih izvede merjenje koncentracij haloperidola.
- Tic disorders including Tourette's syndrome
- motnje tikov, vključno s Tourettovim sindromom;
- Agitation, aggression and psychotic symptoms associated with dementia
- vznemirjenost, agresivnost in psihotični simptomi, povezani z demenco;
Section 4.3 was also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Poglavje 4.3 je bilo spremenjeno, da vključuje tudi besedilo v zvezi s kontraindikacijo glede tveganja kardiotoksičnosti haloperidola.
The list of examples of contraindicated combinations considered essential for the prescriber to be informed of the risk of an additive QT prolonging effect of two or more QT prolonging antipsychotics, was moved to section 4.4.
Seznam primerov kontraindiciranih kombinacij, ki se štejejo za bistvene za informiranost zdravnika o tveganju aditivnega učinka podaljševanja intervala QT dveh ali več antipsihotikov, ki podaljšujejo interval QT, je premaknjen v poglavje 4.4.
The discussion and conclusions reached by the HCPOs and SAG Psychiatry were taken into account in the evaluation by the CHMP, and are reflected in the relevant sections above.
Razprava in sklepi organizacij zdravstvenih delavcev in znanstvene svetovalne skupine za psihiatrijo so bili upoštevani pri oceni odbora CHMP in se odražajo v ustreznih poglavjih zgoraj.
As regards the posology, section 4.2 of the SmPC, the initial and maximum doses were clarified and listed for each indication, for all patient populations - adult, elderly and paediatric.
Kar zadeva odmerjanje, sta bila v poglavju 4.2 povzetka glavnih značilnosti zdravila pojasnjena začetni in največji odmerek za vsako indikacijo za vse populacije bolnikov - odrasle, starejše in pediatrične.
In view of the above, the Committee concluded that the benefit-risk balance of Haldol and associated names remains favourable, subject to the agreed amendments to the product information.
Odbor je glede na zgoraj navedeno menil, da je razmerje med tveganji in koristmi zdravila Haldol in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
In section 4.4; Special warnings and precautions for use, the following changes have been included: the risk of a rapid switch to depression in patient populations with bipolar disorder was added under a separate subheading, also advising close supervision of patients and in particular those at high risk.
V poglavje 4.4 Posebna opozorila in previdnostni ukrepi so bile vključene naslednje spremembe: v ločeno podpoglavje sta bila dodana tveganje hitrega prehoda v depresijo v skupini bolnikov z bipolarno motnjo ter nasvet glede strožjega nadzora nad bolniki, zlasti tistimi z visokim tveganjem.
In section 5.2 Pharmacokinetic properties, a statement that back-conversion to haloperidol cannot be fully excluded has been included although it is not possible to quantitate the role of back-oxidation of reduced haloperidol to haloperidol on haloperidol half-life, clearance and activity.
V poglavje 5.2 Farmakokinetične lastnosti je bila dodana izjava, da pretvorbe nazaj v haloperidol ni mogoče povsem izključiti, čeprav ni mogoče kvantitativno opredeliti vloge povratne oksidacije reduciranega haloperidola v haloperidol na razpolovno dobo, očistek in aktivnost haloperidola.
The questions to the HCPOs mainly pertained to the clinical value of the indications (section 4.1) and dosing recommendations in clinical practice (section 4.2), as well as the contraindication for haloperidol due to central nervous system depression, and whether it was possible to define the severity/degree of central nervous system depression due to alcohol or other depressant medicinal products, and whether there specific cases where the use of haloperidol should be contraindicated.
Vprašanja za organizacije zdravstvenih delavcev so se v glavnem nanašala na klinični pomen indikacij (poglavje 4.1) in priporočila za odmerjanje v klinični praksi (poglavje 4.2), kontraindikacije za haloperidol zaradi depresije centralnega živčnega sistema, ali je mogoče določiti resnost/stopnjo depresije centralnega živčnega sistema zaradi alkohola ali drugih depresijskih zdravil, in ali obstajajo posebni primeri, v katerih je treba uporabo haloperidola kontraindicirati.
• The Committee considered the divergences identified in the notification for Haldol and associated names, as well as the remaining sections of the product information;
• odbor je obravnaval razlike, ugotovljene v obvestilu za zdravilo Haldol in povezana imena, ter preostala poglavja informacij o zdravilu;
The SAG Psychiatry was consulted on the clinical value of the following adult and paediatric indications (section 4.1) and also on dosing recommendations in clinical practice (section 4.2):
Izvedeno je bilo posvetovanje z znanstveno svetovalno skupino za psihiatrijo o klinični vrednosti upoštevanja naslednjih indikacij za odrasle in pediatrične bolnike (poglavje 4.1) ter o priporočilih za odmerjanje v klinični praksi (poglavje 4.2):
The Committee as a consequence, recommends the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Haldol and associated names (see Annex I).
Odbor je posledično priporočil spremembo pogojev dovoljenj za promet z zdravilom Haldol in povezanimi imeni, za katera so v Prilogi III navedene informacije o zdravilu (glejte Prilogo I).
Caution is also recommended when using Haldol in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours
Previdnost je priporočljiva tudi pri uporabi zdravila Haldol pri bolnikih z obstoječo hiperprolaktinemijo in bolnikih s sumom na tumorje, odvisne od prolaktina.
• The Committee agreed on a harmonised product information for Haldol and associated names.
• odbor se je strinjal z usklajenimi informacijami o zdravilu Haldol in povezanih imenih.
Scientific conclusions Haldol, which contains the active substance haloperidol, is an antipsychotic belonging to the butyrophenone group.
Haldol, ki vsebuje zdravilno učinkovino haloperidol, je antipsihotik, ki spada v skupino butirofenonov.
The information under the subheading extrapyramidal symptoms was further elaborated to include the symptoms and time to onset of acute dystonia and akathisia.
Informacije pod podnaslovom o ekstrapiramidnih simptomih so bile dopolnjene s simptomi in časom do pojava akutne distonije in akatizije.
In addition, the committee considered the advice of the consulted Healthcare Professionals Organisations (HCPOs) and SAG Psychiatry.
Poleg tega je odbor upošteval nasvet iz posvetovanj organizacij zdravstvenih delavcev in svetovalne skupine za psihiatrijo;
Section 4.6 has been harmonised and the information presented under the separate subheadings of Pregnancy, Lactation and Fertility in compliance with the SmPC guideline.
Poglavje 4.6 je bilo usklajeno in informacije so bile predstavljene v ločenih podpoglavjih Nosečnost, Dojenje in Plodnost v skladu s smernico o povzetku glavnih značilnosti zdravila.
Overall summary of the scientific evaluation by the CHMP Based on the review of all available data, the consultations with the Healthcare Professionals Organisations (HCPOs) and Scientific Advisory Group (SAG) Psychiatry, the CHMP recommended the following revisions to harmonise the product information for Haldol oral and injectable formulations.
Na podlagi pregleda vseh razpoložljivih podatkov ter posvetovanja z organizacijami zdravstvenih delavcev in znanstveno svetovalno skupino za psihiatrijo je odbor CHMP predlagal naslednje popravke za uskladitev informacij o zdravilu Haldol v formulacijah za peroralno uporabo in injiciranje.
As CYP3A4 and, to a lesser extent, CYP2D6 are involved in the metabolism of haloperidol, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to 40%, although in some cases, increases of up to 100% have been reported, and has been added in section 4.5 Interaction with other medicinal products and other forms of interaction.
Ker CYP3A4 in v manjši meri tudi CYP2D6 sodelujeta pri presnovi haloperidola, je morebitno povečanje koncentracije haloperidola v plazmi ob sočasni uporabi zaviralca CYP3A4 in/ali CYP2D6 v razponu od 20 do 40 %, čeprav so v nekaterih primerih ugotovili povečanje do 100 %.
• The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
• odbor CHMP je pregledal vse podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom.
Minor changes were included in the remaining sections of the SmPC.
V preostale dele povzetka glavnih značilnosti zdravila so bile vključene manjše spremembe.
Grounds for the CHMP opinion Whereas
Podlaga za mnenje odbora CHMP Ob upoštevanju naslednjega:
The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Spremembe povzetka glavnih značilnosti zdravila, ki so pomembne za uporabnika, so bile prenesene tudi v navodilo za uporabo in potrjene s strani odbora CHMP.
It is a potent central dopamine type 2 receptor antagonist, and at recommended dosages, has no antihistaminergic or anticholinergic activity and minimal alpha 1 adrenergic activity.
V priporočenih odmerkih nima antihistaminergičnega ali antiholinergičnega delovanja in ima minimalno adrenergično delovanje alfa 1.
- Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.
- zdravljenje perzistentne agresivnosti in psihotičnih simptomov pri bolnikih z zmerno do hudo Alzheimerjevo demenco in vaskularno demenco, če nefarmakološko zdravljenje ni uspelo ali obstaja tveganje poškodovanja sebe ali drugih;
Furthermore, observational studies have consistently reported an increased mortality in elderly haloperidol users - the highest mortality risk with haloperidol was in the first 30 days and persists for at least 6 months.
Največje tveganje umrljivosti zaradi haloperidola je bilo v prvih 30 dneh in je trajalo najmanj 6 mesecev.
- Symptoms of persistent aggression in children with autism or pervasive developmental disorders
- simptomi perzistentne agresivnosti pri otrocih z avtizmom in prodornimi motnjami v razvoju.
- Tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.
- motnje tikov, vključno s Tourettovim sindromom, pri otrocih in mladostnikih, starih od 10 do 17 let, s hudo okvaro po neuspešnih izobraževalnih, psiholoških in drugih farmakoloških zdravljenjih.
- Treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
- zdravljenje motnje tikov, vključno s Tourettovim sindromom, pri bolnikih s hudo okvaro po neuspešnih izobraževalnih, psiholoških in drugih farmakoloških zdravljenjih;
- Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.
- perzistentne, hude agresije pri otrocih in mladostnikih, starih od 6 do 17 let, z avtizmom ali prodorno razvojno motnjo, če druge oblike zdravljenja niso bile uspešne ali pa jih bolnik ne prenaša;
Angioedema was added to section 4.8 Undesirable effects and additional information on the site of action of injectable haloperidol in the treatment and prophylaxis of nausea and vomiting has been included in section 5.1 Pharmacodynamic properties.
V poglavje 4.8 Neželeni učinki je bil dodan angioedem, v poglavje 5.1 Farmakodinamične lastnosti pa dodatne informacije o mestu delovanja haloperidola za injiciranje za zdravljenje in preprečevanje siljenja na bruhanje in bruhanja.
- Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.
- shizofrenije pri mladostnikih, starih od 13 do 17 let, če druga farmakološka zdravljenja niso bila uspešna ali pa jih bolnik ne prenaša;
A SAG and HCPOs consultations were carried out during this procedure at the request of the CHMP.
Na zahtevo odbora CHMP so bila v tem postopku opravljena posvetovanja z znanstveno svetovalno skupino in organizacijami zdravstvenih delavcev.
- Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.
- zdravljenje akutne psihomotorične agitacije, povezane s psihotično motnjo ali z maničnimi epizodami bipolarne motnje I;
- Treatment of moderate to severe manic episodes associated with bipolar I disorder.
- zdravljenje zmernih do hudih maničnih epizod, povezanih z bipolarno motnjo I;
- Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.
- posamezna ali kombinirana profilaksa pri bolnikih z zmernim do visokim tveganjem za pooperativno siljenje na bruhanje in bruhanje, če so druga zdravila neučinkovita ali jih bolnik ne prenaša;
- Treatment of schizophrenia in paediatric population
- zdravljenje shizofrenije pri otrocih;
- Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated.
- kombinirano zdravljenje pooperativnega siljenja na bruhanje in bruhanja, če so druga zdravila neučinkovita ali jih bolnik ne prenaša.
- Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
- zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, če druga zdravila niso učinkovita, jih bolnik ne prenaša ali peroralno zdravljenje ni primerno;
For the injectable formulations: - Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
- hitro obvladanje akutne psihomotorične agitacije, povezane s psihotično motnjo ali z maničnimi epizodami bipolarne motnje I, če peroralno zdravljenje ni primerno;
- Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated.
- zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, če druga zdravila niso učinkovita ali jih bolnik ne prenaša.
Pharmaceutical Form Route of Administration Packaging
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
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Številka EU
MA (EU) number (Invented) name Strength Pharmaceutical Form
Izmišljeno ime
These improvements were not statistically significant.
Omenjeno izboljšanje ni bilo statistično značilno.
Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/09/2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 08.09.2015
About 4% of an oral dose is excreted unchanged in urine.
4 % peroralnega odmerka se izloča nespremenjenega z urinom.
If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Če se to zgodi vam, bodite previdni pri vožnji ali upravljanju strojev v času, ko bi lahko prihajalo do nenadnih sprememb jakosti svetlobe, zlasti ko vozite ponoči.
Children Ivabradine Anpharm is not intended for use in children and adolescents younger than 18 years.
Ivabradine Anpharm ni namenjen za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Vsi fosfeni so ponehali med zdravljenjem ali po njem, in sicer večina med zdravljenjem (77,5 %).
(see section 5.1)
(glejte poglavje 5.1).
In this way Ivabradine Anpharm helps to control and reduce the number of angina attacks.
Na ta način Ivabradine Anpharm pripomore k nadzoru in zmanjševanju anginoznih napadov.
If you forget to take a dose of Ivabradine Anpharm, take the next dose at the usual time.
Če ste pozabili vzeti odmerek zdravila Ivabradine Anpharm, vzemite naslednji odmerek ob običajnem času.
The long-term effects of ivabradine on growth, puberty and general development as well as the longterm efficacy of therapy with ivabradine in childhood to reduce cardiovascular morbidity and mortality have not been studied.
Dolgoročni učinki ivabradina na rast, puberteto in splošen razvoj, kakor tudi dolgoročna učinkovitost terapije z ivabradinom za zmanjševanje srčno-žilne umrljivosti in umrljivosti v otroški dobi niso bili preučevani.
If you think that the effect of Ivabradine Anpharm is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila Ivabradine Anpharm premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in all subsets of the paediatric population for the treatment of angina pectoris.
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z ivabradinom za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
74 received ivabradine (ratio 2:1).
74 bolnikov je prejemalo ivabradin (razmerje 2:1).
It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Uporablja se pri odraslih bolnikih, ki ne prenašajo ali ne morejo jemati zdravil za srce, imenovanih antagonisti receptorjev beta.
The most common adverse reactions with this medicine are dose dependent and related to its mode of action:
Najpogostejši neželeni učinki tega zdravila so odvisni od odmerka ter so povezani z njegovim mehanizmom delovanja: Zelo pogosti: