FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, to address the potential signal of an increased risk with increased dose as suggested by the results of the French SAGHE study, it was agreed to emphasize in the product information of all somatropin-containing medicinal products that the maximum recommended daily dose should not be exceeded.
Slovenian: Nazadnje, za preučitev morebitnega opozorila glede povečanega tveganja pri večjih odmerkih, na katero kažejo izsledki francoske študije SAGHE, je bilo dogovorjeno, da se v informacijah o zdravilu pri vseh zdravilih, ki vsebujejo somatropin, poudari, da se največji priporočeni dnevni odmerek ne sme preseči.
English: All other data reviewed by the CHMP did not corroborate the results of the SAGHE study or did provide new or additional safety concerns.
Slovenian: Drugi podatki, ki jih je pregledal odbor CHMP, niso potrdili izsledkov študije SAGHE in niso vzbudili novih ali dodatnih skrbi glede varnosti.
English: In view of the above, the CHMP has recommended the variation to the terms of the Marketing Authorisations for somatropin-containing medicinal products (see Annex I), for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III and subject to the conditions set out in Annex IV of this Opinion.
Slovenian: Ob upoštevanju naslednjega je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo somatropin (glejte Prilogo I), katerih ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so določena v Prilogi III, zanjo pa veljajo pogoji, določeni v Prilogi IV tega mnenja.
English: Considering previously published data and information already included in the Product Information for some somatropins, the Committee considered that it is justified to harmonise existing contraindications for all somatropin containing medicines when there is any evidence of activity of a tumour.
Slovenian: Glede na predhodno objavljene podatke in informacije, ki so pri nekaterih zdravilih s somatropinom že vključene v informacije o zdravilu, je Odbor menil, da je upravičeno uskladiti obstoječe kontraindikacije za vsa zdravila, ki vsebujejo somatropin, če obstaja kakršen koli dokaz o aktivnosti tumorja.
English: Somatropin is a recombinant human growth hormone (rhGH) acting on the metabolism of lipids, carbohydrates and proteins.
Slovenian: Somatropin je rekombinantni humani rastni hormon (rhGH), ki vpliva na presnovo maščob, ogljikovih hidratov in beljakovin.
English: • Other data reviewed did not corroborate the results of the SAGHE study, or provided additional safety concerns.
Slovenian: • Drugi preučeni podatki niso potrdili izsledkov študije SAGHE in niso vzbudili dodatnih skrbi glede varnosti.
English: In adults, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
Slovenian: Pri odraslih vzdržuje normalno zgradbo organizma, tako da povečuje retencijo dušika, spodbuja rast skeletnih mišic in mobilizira telesno maščobo.
English: • The Committee considered the results of the French SAGHE study and all available data submitted from clinical trials, registries, cohorts and safety databases in relation to the cardiovascular risk and risk of neoplasm associated with somatropin-treatment.
Slovenian: • Odbor je preučil izsledke francoske študije SAGHE ter vse predložene podatke iz kliničnih preskušanj, registrov, kohortnih študij in podatkovnih zbirk o varnosti zdravil v zvezi s kardiovaskularnim tveganjem in tveganjem novotvorb, ki se povezujeta z zdravljenjem s somatropinom.
English: In view of all the above discussed, the Committee considered justified to harmonise or include , as appropriate, contraindications for all somatropin containing medicinal products with regards the potential for tumour-promoting associated with treatment.
Slovenian: Glede na zgoraj navedeno je Odbor menil, da je upravičeno uskladiti ali po potrebi vključiti kontraindikacije za vsa zdravila, ki vsebujejo somatropin, kar zadeva možnost za pospešeno rast tumorjev, ki se povezuje z zdravljenjem.
English: This also needs to be reflected in the Risk Management Plans as well as the potential risk linked to subarachnoid or intracerebral haemorrhage.
Slovenian: To je treba navesti tudi v načrtih za obvladovanje tveganj skupaj z možnim tveganjem, povezanim s subarahnoidno ali intracerebralno krvavitvijo.
English: No data on the occurrence of non-fatal neoplasms in patients of the SAGHE study is, at the moment, available and the morbidity results are still is on-going.
Slovenian: Za bolnike iz študije SAGHE trenutno ni na voljo podatkov o pogostnosti nesmrtnih novotvorb, izsledki glede obolevnosti pa so še v pripravi.
English: Currently there are nine approved somatropin-medicinal products in the Union: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton approved via Mutual Recognition procedure (MRP) or Nationally (NAP) and Omnitrope, NutropinAq and Valtropin approved centrally (CAP).
Slovenian: Trenutno je v Uniji odobrenih devet zdravil, ki vsebujejo somatropin: zdravila Genotropin, Humatrope, Maxomat, Norditropin, Saizen in Zomacton so bila odobrena po postopku z medsebojnim priznavanjem ali nacionalnem postopku, zdravila Omnitrope, NutropinAq in Valtropin pa po centraliziranem postopku.
English: 3 Ergun Longmire B, Mertens AC, Mitby P, Qin J, Heller G, Shi W et al. Growth hormone treated and risk of second malignant neoplasms in the childhood cancer survivor.
Slovenian: 3 Ergun-Longmire, B., Mertens, A. C., Mitby, P., Qin, J., Heller, G., Shi, W. in drugi, Growth hormone treated and risk of second malignant neoplasms in the childhood cancer survivor, J. Clin.
English: In the Union, somatropin is approved to be used in children for growth hormone deficiency (including idiopathic growth hormone deficiency), growth failure in patients with Turner syndrome, chronic renal insufficiency or short stature homebox-containing gene (SHOX) deficiency, PraderWilli syndrome and in patients born small for gestational age (SGA).
Slovenian: V Uniji je uporaba somatropina dovoljena pri otrocih s pomanjkanjem rastnega hormona (vključno z idiopatskim pomanjkanjem rastnega hormona), bolnikih z zaostankom v rasti zaradi Turnerjevega sindroma, kronične ledvične insuficience, haploinsuficience gena SHOX ali Prader-Willijevega sindroma in bolnikih, ki so se za svojo gestacijsko starost rodili majhni (MGS).
English: The CHMP reviewed all data submitted including data from the French SAGHE study and from clinical trials, registries, cohorts and safety databases (pharmacovigilance) as well as data available in the literature relating to the cardiovascular risk and risk of neoplasm associated with somatropin-treatment.
Slovenian: Odbor CHMP je pregledal vse predložene podatke, vključno s podatki iz francoske študije SAGHE in iz kliničnih preskušanj, registrov, kohortnih študij in podatkovnih zbirk o varnosti zdravil (farmakovigilanca) ter podatki iz literature v zvezi s kardiovaskularnim tveganjem in tveganjem novotvorb pri zdravljenju s somatropinom.
English: Somatropin-treatment has been associated with tumour-promoting potential and this is currently reflected in the product information of all somatropin-containing medicinal products.
Slovenian: Zdravljenje s somatropinom se povezuje z možnostjo za pospešeno rast tumorjev, kar se trenutno navaja v informacijah o zdravilu pri vseh zdravilih, ki vsebujejo somatropin.
English: 2 Sklar CA, Mertens AC, Mitby P, et al. Risk of disease recurrence and second neoplasms in survivors of childhood cancer treated with growth hormone: A report from the Childhood Cancer Survivor Study.
Slovenian: 2 Sklar, C. A., Mertens, A. C., Mitby, P. in drugi, Risk of disease recurrence and second neoplasms in survivors of childhood cancer treated with growth hormone: A report from the Childhood Cancer Survivor Study, J. Clin.
English: Results of the French SAGHE study, a long-term surveillance study in a high number of patients and with a mean follow up of 17 years suggested an overall increase of mortality in patients treated with somatropin for isolated growth hormone deficiency (GDH), idiopathic short stature (ISS) and short for gestational age (SGA) compared to the general population.
Slovenian: Izsledki francoske študije SAHGE, tj. dolgoročne spremljevalne študije na velikem številu bolnikov in s povprečnim 17-letnim spremljanjem, so v primerjavi s splošno populacijo pokazali splošno povečanje umrljivosti pri bolnikih, zdravljenih s somatropinom zaradi izoliranega pomanjkanja rastnega hormona, idiopatske nizke rasti in majhnosti za gestacijsko starost (MGS).
English: The specific wording to be include in section 4.3 of the SmPCs and reflected in the package leaflets of all somatropin-containing medicinal products was agreed (see Annex II).
Slovenian: Dogovorjeno je bilo natančno besedilo, ki mora biti vključeno v poglavje 4.3 povzetkov glavnih značilnosti in v navodila za uporabo vseh zdravil, ki vsebujejo somatropin (glejte Prilogo II).
English: Scientific conclusions and grounds for the amendment of the summaries of product characteristics and package leaflets presented by the EMA
Slovenian: Priloga II Znanstveni zaključki in podlaga za dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: The low risk population defined as treatment for idiopathic growth hormone deficiency, idiopathic short stature, short stature in children born short for gestational age, or isolated growth hormone deficiency was included in the mortality analysis (n=6,892 patients corresponding to 116,403 person-years of observation).
Slovenian: V analizo umrljivosti je bila vključena populacija z majhnim tveganjem, opredeljena kot zdravljenje zaradi idiopatskega pomanjkanja rastnega hormona, idiopatske nizke rasti, nizke rasti pri otrocih, ki so se za svojo gestacijsko starost rodili majhni, ali izoliranega pomanjkanja rastnega hormona (n = 6 892 bolnikov, kar je 116 403 oseb-let opazovanja).
English: Increased mortality was apparent when higher doses were used and due to subarachnoid or intracerebral haemorrhage and bone tumours.
Slovenian: Povečana umrljivost je bila razvidna pri uporabi večjih odmerkov ter zaradi subarahnoidne ali intracerebralne krvavitve in kostnih tumorjev.
English: These results suggested an increased mortality with higher doses and due to diseases of the circulatory system (subarachnoid or intracerebral haemorrhage) and bone tumours.
Slovenian: Navedeni izsledki so kazali na povečano umrljivost pri večjih odmerkih ter zaradi bolezni cirkulacijskega sistema (subarahnoidna ali intracerebralna krvavitev) in kostnih tumorjev.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Grounds for amendment of the summaries of product characteristics and Package Leaflets
Slovenian: Podlaga za dopolnilo povzetkov glavnih značilnosti zdravil in navodila za uporabo
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: - Treatment of acute alcohol intoxication
Slovenian: - zdravljenje akutne zastrupitve z alkoholom;
English: 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.
Slovenian: Haldol je bil odobren na nacionalni ravni v Evropski uniji (EU) z mnogimi razlikami v besedilu povzetka glavnih značilnosti zdravila v posameznih državah članicah.
English: 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.
Slovenian: 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.
English: Paediatric indications were agreed only for the oral formulations for the treatment of:
Slovenian: Pediatrične indikacije so usklajene le za peroralne formulacije za zdravljenje:
English: 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.
Slovenian: 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.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC for Haldol and associated names;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES za zdravilo Haldol in povezana imena;
English: It is advised that measurement of haloperidol concentrations may be considered in individual cases.
Slovenian: Priporočljivo je, da se lahko v posameznih primerih izvede merjenje koncentracij haloperidola.
English: - Tic disorders including Tourette's syndrome
Slovenian: - motnje tikov, vključno s Tourettovim sindromom;
English: - Agitation, aggression and psychotic symptoms associated with dementia
Slovenian: - vznemirjenost, agresivnost in psihotični simptomi, povezani z demenco;
English: Section 4.3 was also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Slovenian: Poglavje 4.3 je bilo spremenjeno, da vključuje tudi besedilo v zvezi s kontraindikacijo glede tveganja kardiotoksičnosti haloperidola.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • The Committee considered the divergences identified in the notification for Haldol and associated names, as well as the remaining sections of the product information;
Slovenian: • odbor je obravnaval razlike, ugotovljene v obvestilu za zdravilo Haldol in povezana imena, ter preostala poglavja informacij o zdravilu;
English: 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):
Slovenian: 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):
English: 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).
Slovenian: 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).
English: Caution is also recommended when using Haldol in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours
Slovenian: Previdnost je priporočljiva tudi pri uporabi zdravila Haldol pri bolnikih z obstoječo hiperprolaktinemijo in bolnikih s sumom na tumorje, odvisne od prolaktina.
English: • The Committee agreed on a harmonised product information for Haldol and associated names.
Slovenian: • odbor se je strinjal z usklajenimi informacijami o zdravilu Haldol in povezanih imenih.
English: Scientific conclusions Haldol, which contains the active substance haloperidol, is an antipsychotic belonging to the butyrophenone group.
Slovenian: Haldol, ki vsebuje zdravilno učinkovino haloperidol, je antipsihotik, ki spada v skupino butirofenonov.
English: The information under the subheading extrapyramidal symptoms was further elaborated to include the symptoms and time to onset of acute dystonia and akathisia.
Slovenian: Informacije pod podnaslovom o ekstrapiramidnih simptomih so bile dopolnjene s simptomi in časom do pojava akutne distonije in akatizije.
English: In addition, the committee considered the advice of the consulted Healthcare Professionals Organisations (HCPOs) and SAG Psychiatry.
Slovenian: Poleg tega je odbor upošteval nasvet iz posvetovanj organizacij zdravstvenih delavcev in svetovalne skupine za psihiatrijo;
English: 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.
Slovenian: 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.