FrancophonIA/ELRC3.0 huggingface dataset:
English: - severe hypernatraemia or severe hyperchloraemia - severely impaired hepatic function
Slovenian: • huda hipernatriemija ali huda hiperkloridemija
English: Package Leaflet <This medicine is subject to additional monitoring.
Slovenian: <Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: • blood clotting (coagulation) disorders
Slovenian: • motnje v strjevanju krvi (koagulaciji)
English: Surgery and trauma: Your doctor will consider carefully if this medicine is suitable for you.
Slovenian: Zdravnik bo skrbno preučil, če je zdravilo za vas ustrezno.
English: Discontinue the use of HES at the first sign of coagulopathy.
Slovenian: Ob prvem znaku koagulopatije prekinite uporabo HES.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujete se tudi, če opazite neželene učinke, ki so navedeni v tem navodilu.
English: • Liver injury
Slovenian: • poškodba ledvic
English: Severe haemodilution resulting from high doses of HES solutions must also be avoided in the treatment of hypovolaemic patients.
Slovenian: Pri zdravljenju hipovolemičnih bolnikov se izogibajte tudi hudi hemodiluciji, ki je posledica visokih odmerkov raztopine HES.
English: Your doctor will adjust the dose of <Product name> carefully in order to prevent fluid overload.
Slovenian: Zdravnik bo natančno prilagodil odmerek zdravila <Ime zdravila>, da se prepreči preobremenitev s tekočino, še posebno, če imate težave s pljuči, srcem ali krvnim obtokom.
English: • have severely impaired liver function
Slovenian: • hudo okvarjeno delovanje jeter
English: The indication for volume replacement with HES has to be considered carefully, and haemodynamic monitoring is required for volume and dose control.
Slovenian: Indikacijo za nadomeščanje volumna s HES je treba skrbno preučiti.
English: • have severe liver disease
Slovenian: • če imate hudo bolezen jeter
English: • have severe heart failure
Slovenian: • če imate hudo popuščanje srca
English: There is a lack of robust long term safety data in patients undergoing surgical procedures and in patients with trauma.
Slovenian: Pri bolnikih s predvidenimi kirurškimi posegi in bolnikih s poškodbami so realni podatki o dolgoročni varnosti pomanjkljivi.
English: Use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h.
Slovenian: Poglavje 4.2 Odmerjanje in način uporabe [To poglavje je treba spremeniti, da odraža naslednje besedilo] Uporabo HES moramo omejiti na začetno fazo nadomeščanja volumna, najdaljši čas uporabe je 24 ur.
English: • suffer from burn injury
Slovenian: • opekline
English: • impairment of your liver function
Slovenian: • okvarjeno delovanje jeter
English: - severe coagulopathy - organ transplant patients
Slovenian: • huda koagulopatija
English: (Invented) name Strength Pharmaceutical form Route of administration
Slovenian: Farmacevtska oblika Pot uporabe
English: 2.5 mg/ml
Slovenian: 2,5 mg/ml prašek za raztopino za infundiranje intravenska uporaba viala (steklo)
English: Immediate packaging Pack size
Slovenian: Velikost pakiranja
English: 2013 [cited April 2014].
Slovenian: 2013 [citirano aprila 2014].
English: National approval was obtained in most of the European countries.
Slovenian: Nacionalna odobritev je bila pridobljena v večini evropskih držav.
English: is approved in all EU Member States except Latvia, Malta and Slovenia.
Slovenian: je bilo odobreno v vseh državah članicah EU, razen v Latviji, na Malti in v Sloveniji.
English: There were no major discrepancies between the existing wordings in the individual Member States.
Slovenian: Ni bilo bistvenih razlik med obstoječimi besedili v posameznih državah članicah.
English: 2 Department of Health and Human Services.
Slovenian: Ameriško ministrstvo za zdravje in človeške vire.
English: was first approved in United Kingdom on 15 June 1988, which marks its International Birth Date (IBD).
Slovenian: je bilo najprej odobreno v Združenem kraljestvu 15. junija 1988; ta datum označuje njegov mednarodni datum rojstva (International Birth Date - IBD).
English: Additional data in this population need to be submitted in the future via the appropriate regulatory procedure.
Slovenian: Dodatne podatke za to populacijo bo treba predložiti v skladu z ustreznim regulativnim postopkom.
English: Some of the studies are conducted predominantly in adults, but also included children.
Slovenian: Nekatere študije se izvajajo prvenstveno na odraslih, vendar vključujejo tudi otroke.
English: and associated names is considered to be favourable.
Slovenian: in povezanih imen šteje za ugodno.
English: The only strength of 500 mg is available.
Slovenian: Edina razpoložljiva jakost je 500 mg.
English: The majority of these studies were open-label controlled studies.
Slovenian: Večinoma je šlo za odprte nadzorovane študije.
English: Ten clinical studies were conducted during the period from 1986 till 1996 in patients with AIDS.
Slovenian: V obdobju od 1986 do 1996 je bilo pri bolnikih z AIDS-om izvedenih deset kliničnih študij.
English: In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity.
Slovenian: Pri študijah na živalih je bil ganciklovir povezan z reproduktivno toksičnostjo in teratogenostjo.
English: In most of the studies efficacy of ganciclovir 2.5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
Slovenian: V večini študij učinkovitosti ganciklovirja so preučevali odmerke 2,5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
English: Cymevene i.v.
Slovenian: Zdravilo Cymevene i.v.
English: Consideration should be given to official guidance on the appropriate use of antiviral agents.
Slovenian: Upoštevati je treba uradne smernice za ustrezno uporabo protivirusnih zdravil.
English: Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Slovenian: Občutljivi humani virusi vključujejo humani citomegalovirus (HCMV), virus herpesa simpleksa tip 1 in tip 2 (HSV-1 in HSV-2), humani virus herpesa tip 6, tip 7 in tip 8 (HHV-6, HHV-7, HHV-8), virus Epstein-Barr (EBV), virus varicella zoster (VZV) in virus hepatitisa B.
English: On 15 September 2014 the European Commission on behalf of all marketing authorisation holders presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics, labelling and package leaflet of the medicinal products, Cymevene i.v.
Slovenian: 15. septembra 2014 je Evropska komisija v imenu vseh imetnikov dovoljenja za promet z zdravilom Evropski agenciji za zdravila predložila napotitev v skladu s členom 30 Direktive 2001/83/ES z namenom uskladitve nacionalnega povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo zdravila Cymevene i.v.
English: Results of these studies demonstrated beneficial effect on progression of disease, relapse of CMV infections and incidence of the disease.
Slovenian: Rezultati teh študij so pokazali ugodne učinke na napredovanje bolezni, ponovitve okužb CMV in pojavnost bolezni.
English: The safety and efficacy of ganciclovir in children under 12 years of age has not been established.
Slovenian: Varnost in učinkovitost ganciklovirja pri otrocih, mlajših od 12 let, še nista bili dokazani.
English: Therefore, ganciclovir should not be used in pregnant women unless the clinical need for treatment of the woman outweighs the potential teratogenic risk to the foetus.
Slovenian: Ganciklovir se zato ne sme uporabljati pri nosečnicah, razen če klinična potreba po zdravljenju ženske odtehta potencialno teratogeno tveganje za plod.
English: and associated names (see Annex I)
Slovenian: in povezanih imen (glejte Prilogo I)
English: The safety of ganciclovir for use in pregnant women has not been established.
Slovenian: Varnost ganciklovirja za uporabo pri nosečnicah ni bila dokazana.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Slovenian: Na podlagi pregleda podatkov je odbor CHMP sprejel usklajen modul 3.
English: Therefore, breastfeeding must be discontinued during treatment with ganciclovir.
Slovenian: Zato je treba med zdravljenjem z ganciklovirjem prekiniti dojenje.
English: contains ganciclovir, a synthetic analogue of 2'-deoxyguanosine which inhibits replication of herpes viruses.
Slovenian: vsebuje ganciklovir, sintetični analog 2'-deoksigvanozina, ki zavira replikacijo virusov herpesa.
English: The high pH of ganciclovir can result in severe tissue irritation if the product is given by intramuscular or subcutaneous injection and toxicity may be increased if intravenous administration is rapid.
Slovenian: Visok pH ganciklovirja lahko povzroči močno draženje tkiv, če se zdravilo daje z intramuskularno ali subkutano injekcijo, poleg tega se lahko poveča toksičnost, če intravensko dajanje poteka hitro.
English: However, ganciclovir readily diffuses across the human placenta.
Slovenian: Vendar pa ganciklovir zlahka pronica skozi človeško posteljico.
English: It is unknown if ganciclovir is excreted in human breast milk, but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the breastfed infant cannot be excluded.
Slovenian: Ni znano, ali se ganciklovir izloča v materino mleko, vendar možnosti, da se ganciklovir izloča v materino mleko in da utegne povzročiti resne neželene učinke na dojenem otroku, ni mogoče izključiti.
English: The medicinal product is available in vials of 10 ml as powder for concentrate for solution for infusion.
Slovenian: Zdravilo je na voljo v 10 ml vialah kot prašek za koncentrat za pripravo raztopine za infundiranje.
English: and associated names (see Annex I).
Slovenian: in povezanih imenih (glejte Prilogo I).
English: Cymevene is indicated for use in adults and adolescents from 12 years of age.
Slovenian: Zdravilo Cymevene je indicirano za uporabo pri odraslih in mladostnikih od 12. leta dalje.
English: Special dosage instructions for patients with renal impairment, older people and paediatric patients are provided.
Slovenian: Na voljo so navodila za posebno odmerjanje pri bolnikih z okvaro ledvic, starejših ljudeh in pediatričnih bolnikih.
English: Overall summary of the scientific evaluation of Cymevene i.v.
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Cymevene i.v.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil predlog za uskladitev modula kakovosti.
English: Panel on Opportunistic Infections in HIV-exposed and HIV-Infected Children.
Slovenian: Odbor za opurtunistične okužbe pri otrocih, ki so izpostavljeni virusu HIV in okuženi z njim.
English: These additions to the safety information were considered relevant and were accepted by the CHMP.
Slovenian: Odbor CHMP je menil, da so ti dodatki k informacijam o varnosti pomembni, in jih je sprejel.
English: Two contraindications were finally in this section regarding the cross-hypersensitivity and the breast-feeding.
Slovenian: Dve kontraindikaciji sta bili vendarle umeščeni v to poglavje, in sicer navzkrižna preobčutljivost in dojenje.
English: The CHMP agreed on a common wording.
Slovenian: Odbor CHMP je potrdil skupno besedilo.
English: In addition the wording on precautions of handling the product has been harmonised.
Slovenian: Usklajeno je bilo tudi besedilo o previdnostnih ukrepih pri ravnanju z zdravilom.
English: In allogenic HSCT recipients, the review concluded that CMV disease should be treated with antiviral agents such as ganciclovir or foscarnet with 2-3 weeks of induction therapy followed by 3-4 weeks of maintenance therapy.
Slovenian: Pri prejemnikih alogenskih HSCT so rezultati pregleda pokazali, da je treba bolezen CMV zdraviti s protivirusnimi zdravili, kot sta ganciklovir ali foskarnet, z 2−3 tedni indukcijskega zdravljenja, čemur sledijo 3−4 tedni vzdrževalnega zdravljenja.
English: Clinical trials included only patients with haematological malignancy.
Slovenian: Klinične študije so vključevale le bolnike s hematološkimi malignostmi.
English: In patients with AIDS prevention of CMV disease is no longer recommended because the highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with AIDS.
Slovenian: Pri bolnikih z AIDS-om preprečevanje bolezni CMV ni več priporočljivo, saj je pri njih visokoaktivna antiretrovirusna terapija (HAART) zmanjšala tveganje za bolezni CMV.
English: Safety and efficacy data from valganciclovir studies conducted in children were also presented as relevant to the safety and efficacy of ganciclovir (clinical use of valganciclovir, the pro-drug of ganciclovir, has been approved in EU for paediatric SOT recipients for prevention of CMV disease.)
Slovenian: Predloženi so bili tudi podatki o varnosti in učinkovitosti iz študij valganciklovirja pri otrocih, kolikor so bili ustrezni za varnost in učinkovitost ganciklovirja (klinična uporaba valganciklovirja, predzdravila ganciklovirja, je bila odobrena v EU za pediatrične prejemnike presajenih čvrstih organov za preprečevanje bolezni CMV).
English: Before the introduction of HAART, approximately 30% of patients with AIDS experienced CMV retinitis, making CMV prophylaxis necessary.
Slovenian: Pred uvedbo terapije HAART se je pri približno 30 % bolnikov z AIDS-om pojavil CMV-retinitis, zaradi česar je bila profilaksa CMV nujna.
English: The CHMP adopted a positive opinion recommending the variation to the terms of the marketing authorisations for which the summary of products characteristics, labelling and package leaflet as set out in Annex III of the CHMP opinion for Cymevene i.v.
Slovenian: Odbor CHMP je sprejel pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet z zdravili, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo opredeljeni v Prilogi III k mnenju odbora CHMP o zdravilu Cymevene i.v.
English: The amended therapeutic indication (and posology) for adolescents from 12 years of age is based on noncompany sponsored ganciclovir studies and treatment guidelines2.
Slovenian: Dopolnjena terapevtska indikacija (in odmerjanje) pri mladostnikih od 12. leta dalje temelji na študijah ganciklovirja, ki jih niso sponzorirala podjetja, in smernicah za zdravljenje2.
English: The inclusion criteria regarding the age of eligible patients in ganciclovir studies are variable.
Slovenian: Merila za vključevanje v študije ganciklovirja na podlagi starosti ustreznih bolnikov so spremenljiva.
English: The labelling was reviewed during this procedure and changes were introduced, mainly to align with the QRD template.
Slovenian: V okviru postopka je bilo pregledano označevanje in uvedene so bile spremembe, predvsem zaradi uskladitve s predlogo za pregled kakovosti dokumentov.
English: The final PL wording was agreed by the CHMP.
Slovenian: Končno besedilo navodila za uporabo je potrdil odbor CHMP.
English: Clinical studies, pharmacodynamics data, and treatment guidelines are provided to support the use of the same dose in adults and adolescents for treatment and prevention of CMV disease.
Slovenian: Predloženi so klinične študije, farmakodinamični podatki in smernice za zdravljenje v podporo uporabi enakega odmerka pri odraslih in mladostnikih za zdravljenje in preprečevanje bolezni CMV.
English: doses used for 2 weeks (induction treatment) and later 5 mg/kg or 6 mg/kg maintenance doses were evaluated for treatment of CMV retinitis in AIDS patients.
Slovenian: dvakrat dnevno 2 tedna (indukcijsko zdravljenje) in poznejše vzdrževalne odmerke 5 mg/kg ali 6 mg/kg za zdravljenje CMV-retinitisa pri bolnikih z AIDS-om.
English: The CHMP after assessing all the currently available data they concluded that the harmonised therapeutic indication for Cymevene i.v.
Slovenian: Odbor CHMP je po oceni vseh trenutno razpoložljivih podatkov zaključil, da je treba usklajeno terapevtsko indikacijo za zdravilo Cymevene i.v.
English: The use of ganciclovir in paediatric transplant recipients and patients with AIDS/HIV is recommended in current authoritative treatment guidelines.
Slovenian: Uporabo ganciklovirja pri pediatričnih bolnikih s presaditvijo in bolnikih z AIDS-om/virusom HIV priporočajo veljavne smernice za zdravljenje.
English: The MAH has not conducted formal studies in the paediatric patient population.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni izvedel formalnih študij v populaciji pediatričnih bolnikov.
English: The harmonised information on posology was presented by the MAH per indication, i.e. standard dosage for treatment of CMV disease in adults and adolescents from 12 years of age with normal renal function and standard dosage for prevention of CMV disease in adults and adolescents from 12 years of age with normal renal function using prophylaxis or pre-emptive therapy.
Slovenian: Usklajene informacije o odmerjanju je imetnik dovoljenja za promet z zdravilom predstavil za vsako indikacijo posebej, tj. standardni odmerek za zdravljenje bolezni CMV pri odraslih in mladostnikih od 12. leta dalje z normalnim delovanjem ledvic in standardni odmerek za preprečevanje bolezni CMV pri odraslih in mladostnikih od 12. leta dalje z normalnim delovanjem ledvic, ki uporabljajo profilakso ali preventivno zdravljenje.
English: MAH state that other oncology patients receiving chemotherapy do not routinely require CMV prophylaxis but certain high-risk patients, such as Asian patients, particularly those receiving rituximab or hyper-CVAD chemotherapy, may benefit.
Slovenian: Imetnik dovoljenja za promet z zdravilom navaja, da pri drugih onkoloških bolnikih, ki prejemajo kemoterapijo, ni rutinske potrebe po profilaksi CMV, lahko pa ta koristi nekaterim bolnikom z visokim tveganjem, kot so azijski bolniki, zlasti tisti, ki prejemajo rituksimab ali kemoterapijo hiperCVAD.
English: the CHMP was of the opinion that the benefit/risk ratio of Cymevene i.v.
Slovenian: odbor CHMP je menil, da se razmerje med tveganji in koristmi zdravila Cymevene i.v.
English: should be amended as follows: Cymevene is indicated in adults and adolescents from 12 years of age for the: treatment of cytomegalovirus (CMV) disease in immunocompromised patients; prevention of CMV disease in patients with drug-induced immunosuppression (for example following organ transplantation or cancer chemotherapy).
Slovenian: Zdravilo Cymevene je indicirano pri odraslih in mladostnikih od 12. leta dalje za: - zdravljenje citomegalovirusne bolezni (CMV) pri bolnikih z oslabljenim imunskim sistemom; - preprečevanje bolezni CMV pri bolnikih z imunosupresijo kot posledico jemanja zdravil (na primer po presaditvi organa ali kemoterapiji za zdravljenje raka).
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Slovenian: • namen napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: Grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Podlaga za spremembo pogojev dovoljenj(-a) za promet z zdravilom
English: Section 4.8 - Adverse events
Slovenian: Poglavje 4.8 - Neželeni učinki
English: The treatment of CMV disease in stem cell transplant (SCT) and solid organ transplant (SOT) recipient is recommended by guidelines, the data supporting the proposed indication are obtained from published literature.
Slovenian: Smernice priporočajo zdravljenje bolezni CMV pri prejemnikih presajenih matičnih celic (SCT) in presajenih čvrstih organov (SOT), podatki v podporo predlagani indikaciji so pridobljeni iz objavljene literature.
English: For the prevention of CMV disease, ganciclovir is only indicated in transplant recipients and patients receiving cancer chemotherapy.
Slovenian: Za preprečevanje bolezni CMV je ganciklovir indiciran le pri bolnikih s presaditvijo in bolnikih, ki prejemajo kemoterapijo za zdravljenje raka.
English: Cymevene must only be given by intravenous infusion over 1 hour.
Slovenian: Zdravilo Cymevene se sme dajati samo z enourno intravensko infuzijo.
English: Caution regarding the need to administer Cymevene by intravenous infusion over 1 hour and the hazards associated with other routes or rates of administration were provided.
Slovenian: Podana so bila opozorila glede potrebe po dajanju zdravila Cymevene z enourno intravensko infuzijo in glede nevarnosti, povezanih z drugimi načini ali hitrostmi dajanja.
English: Although data are scarce the benefit-risk conclusion and posology can in the CHMP view, be extrapolated to adolescents of 12 years and older considering the very serious nature of the disease it is indicated for.
Slovenian: Kljub omejenim podatkom je po mnenju odbora CHMP oceno razmerja med tveganji in koristmi ter odmerjanje mogoče razširiti tudi na mladostnike, stare 12 let in več, saj je treba upoštevati veliko resnost bolezni, za katero je zdravilo indicirano.
English: One non-systematic review of CMV disease diagnosis, prevention, and treatment in hematopoietic stem cell transplant (HSCT) recipients was conducted.
Slovenian: Izveden je bil en nesistematičen pregled diagnoze, preprečevanja in zdravljenja bolezni CMV pri prejemnikih presajenih hematopoetskih matičnih celic (HSCT).
English: For treatment in adults, the studies have been conducted by MAH in patients with AIDS.
Slovenian: Glede zdravljenja odraslih je imetnik dovoljenja za promet z zdravilom izvedel študije pri bolnikih z AIDS-om.
English: There are no MAH-sponsored studies of CMV treatment in stem cell transplant recipients but various clinical treatment guidelines advise on appropriate treatment and prevention of CMV disease in these patients.
Slovenian: Ni študij zdravljenja CMV pri prejemnikih presajenih matičnih celic, ki bi jih sponzoriral imetnik dovoljenja za promet z zdravilom, vendar različne smernice za klinično zdravljenje svetujejo ustrezno zdravljenje in preprečevanje bolezni CMV pri teh bolnikih.
English: The MAH submitted documentation to support both indications of treatment and prevention of the CMV disease.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil dokumentacijo v podporo obema indikacijama zdravljenja in preprečevanja bolezni CMV.
English: Various clinical treatment guidelines advise on appropriate treatment and prevention of CMV disease in stem cell transplant recipients.
Slovenian: Različne smernice za klinično zdravljenje priporočajo ustrezno zdravljenje in preprečevanje bolezni CMV pri prejemnikih presajenih matičnih celic.
English: is administered parenterally by intravenous infusion over 1 hour.
Slovenian: se daje parenteralno z enourno intravensko infuzijo.
English: The dosage recommendations proposed by MAH are in line with the indications.
Slovenian: Priporočila za odmerjanje, ki jih je priporočil imetnik dovoljenja za promet z zdravilom, so v skladu z indikacijami.
English: In conclusion, based on the assessment of the MAH's proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of product information documents of Cymevene i.v.
Slovenian: Odbor CHMP je na podlagi ocene predlogov in odgovorov imetnikov dovoljenja za promet z zdravilom ter razprav v odboru potrdil usklajene sklope dokumentov z informacijami o zdravilu za zdravilo Cymevene i.v.
English: The information on pregnancy and breastfeeding was different in the individual Member States.
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in dojenje Informacije o nosečnosti in dojenju so se razlikovale med posameznimi državami članicami.
English: Treatment guidelines1 recommend using ganciclovir for CMV prophylaxis in allogenic stem cell transplant recipients and in patients receiving alemtuzumab therapy.
Slovenian: Smernice za zdravljenje1 priporočajo uporabo ganciklovirja za profilakso CMV pri prejemnikih presajenih alogenskih matičnih celic in pri bolnikih, ki se zdravijo z alemtuzumabom.
English: Summary of product characteristics (SmPC)
Slovenian: Povzetek glavnih značilnosti zdravila