FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP was of the view that patients with pulmonary veno-occlusive disease could benefit from treatment with Flolan and that for hypotension and angina it was more appropriate to include relevant warnings in section 4.4.
Slovenian: Menil je, da bi lahko bolniki s pljučno venookluzivno boleznijo imeli koristi od zdravljenja z zdravilom Flolan ter da je v zvezi s hipotenzijo in angino pektoris ustrezneje vključiti zadevna opozorila v poglavje 4.4.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Flolan in the elderly and patients with reduced kidney and liver function.
Slovenian: Odbor CHMP je po uskladitvi indikacij uskladil tudi priporočila v zvezi z uporabo zdravila Flolan pri starejših in bolnikih z zmanjšanim delovanjem ledvic in jeter.
English: After reviewing the available data supporting the use of the medicine, the CHMP agreed that Flolan should be used for the following:
Slovenian: Odbor CHMP se je po proučitvi razpoložljivih podatkov, ki podpirajo uporabo zdravila, strinjal, da se zdravilo Flolan uporablja za:
English: Epoprostenol also widens the blood vessels which helps to lower the blood pressure in the lungs.
Slovenian: Poleg tega razširi krvne žile, kar pripomore k znižanju krvnega tlaka v pljučih.
English: In harmonising the contraindications, the CHMP decided to remove three contraindications that were in the SmPCs of some EU countries: pulmonary veno-occlusive disease, hypotension and angina.
Slovenian: Odbor CHMP se je med usklajevanjem kontraindikacij odločil, da izloči tri kontraindikacije, ki so bile navedene v povzetkih glavnih značilnosti zdravila v nekaterih državah EU: pljučno venookluzivno bolezen, hipotenzijo in angino pektoris.
English: It is used to prevent blood clotting during haemodialysis (technique for removing waste products from the blood used in patients with kidney disease).
Slovenian: Uporablja se za preprečevanje strjevanja krvi med hemodializo (tehniko odstranjevanja presnovkov in strupov iz krvi pri bolnikih z ledvičnim obolenjem).
English: The active substance in Flolan, epoprostenol, is a natural occurring prostaglandin that works by stopping the blood from clotting.
Slovenian: Zdravilna učinkovina v zdravilu Flolan, epoprostenol, je naravno prisoten prostaglandin, ki preprečuje strjevanje krvi.
English: Flolan is also used to treat a lung condition called ‘pulmonary arterial hypertension' (high blood pressure in the lungs).
Slovenian: Uporablja se tudi za zdravljenje pljučne bolezni, imenovane pljučna arterijska hipertenzija (visok krvni tlak v pljučih).
English: It stops the activation of the blood clotting mechanism by preventing platelets (components that help the blood to clot) from sticking together.
Slovenian: Ustavi aktivacijo mehanizma za strjevanje krvi s preprečevanjem lepljenja krvnih ploščic (sestavin, ki pripomorejo k strjevanju krvi).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je ob upoštevanju predloženih podatkov in interne znanstvene razprave menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v vsej EU.
English: • treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH
Slovenian: • zdravljenje pljučne arterijske hipertenzije (idiopatske ali podedovane pljučne arterijske hipertenzije in pljučne arterijske hipertenzije, povezane z boleznimi vezivnega tkiva) pri bolnikih z bolezenskimi znaki iz funkcionalnih razredov SZO III in IV za izboljšanje vadbene sposobnosti;
English: Flolan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Flolan potrebna uskladitev.
English: This might be every 6 to 12 months.
Slovenian: To je lahko vsake 6 do 12 mesecev.
English: Date of first authorisation: 17 November 1997 Date of latest renewal: 17 September 2007
Slovenian: Datum pridobitve dovoljenja za promet: 17. november 1997 Datum zadnjega podaljšanja: 17/09/2007
English: Therefore no special dosage regimen can be recommended.
Slovenian: Zato ne moremo priporočiti posebnega režima odmerjanja.
English: Your doctor will work out your dose based on how severe your symptoms are, and other factors.
Slovenian: Zdravnik bo odmerek določil na podlagi resnosti vaših simptomov in drugih dejavnikov.
English: The current medical standards for emergency treatment are to be observed.
Slovenian: Upoštevati je treba najnovejše zdravstvene standarde za urgentno zdravljenje.
English: The usual frequency of infusion is once every 2 weeks (see section 4.2).
Slovenian: Običajna pogostost infundiranja je enkrat na vsaka 2 tedna (glejte poglavje 4.2).
English: Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose.
Slovenian: Ko najde ustrezen odmerek, bo zdravnik še vedno preverjal vaš odziv, da se prepriča, da uporabljate pravilen odmerek.
English: Patient data will be anonymously collected in this Registry.
Slovenian: V registru bodo podatke o pacientih zbirali anonimno.
English: A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
Slovenian: Vrsta odmernih režimov se je izkazala za učinkovito zoper nekatere ali vse izmed ne-nevroloških manifestacij bolezni.
English: You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).
Slovenian: Morda boste prejeli dodatna zdravila, ki bodo preprečila alergijsko reakcijo (npr. antihistaminike in/ali kortikosteroide).
English: - if you are allergic to imiglucerase or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - Če ste alergični na imiglucerazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The cause can be unknown, or it can be due to heart, lung or liver problems.
Slovenian: Vzrok je lahko neznan ali pa nastane zaradi težav s srcem, pljuči ali jetri.
English: Subsequent infusions may need to occur in a clinical setting.
Slovenian: Nadaljnje infuzije bodo morda morali prejemati v kliničnem okolju.
English: Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.
Slovenian: Zdravnik bo skrbno spremljal vaš odziv na zdravljenje in morda odmerek spreminjal (poviševal ali zmanjševal), dokler ne najde odmerka, ki najbolje obvladuje vaše simptome.
English: This will not lead to any loss of imiglucerase activity.
Slovenian: To ne povzroči zmanjšanja aktivnosti imigluceraze.
English: Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes.
Slovenian: Po infundiranju se je encimska aktivnost v plazmi hitro zmanjšala z razpolovno dobo od 3,6 do 10,4 minute.
English: It is recommended that the diluted solution be administered within 3 hours.
Slovenian: Razredčeno raztopino je priporočljivo uporabiti v 3 urah.
English: These variables do not appear to be influenced by dose or duration of infusion, however, only 1 or 2 patients were studied at each dose level and infusion rate.
Slovenian: Kaže, da na te spremenljivke velikost odmerka ali trajanje infundiranja ne vplivata, vendar pa sta doslej v študiji o posameznih odmerkih in hitrosti infundiranja sodelovala samo 1 ali 2 bolnika.
English: Cerezyme has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Cerezyme nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly.
Slovenian: Kot z vsemi intravenskimi proteinskimi proizvodi so možne resne preobčutljivostne reakcije alergijske vrste, vendar se pojavijo samo občasno.
English: The reconstituted solution must be further diluted.
Slovenian: Rekonstituirano raztopino je treba razredčiti.
English: Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Slovenian: Zdravila Cerezyme se ne sme dajati kot mešanico z drugimi zdravili v isti infuziji (kapalna infuzija).
English: • bone disease after exclusion of other causes such as Vitamin D deficiency
Slovenian: • bolezen kosti, ko smo izključili druge vzroke zanjo, kot npr. pomanjkanje vitamina D,
English: Occasionally, small dosage adjustments may be made to avoid discarding partially used vials.
Slovenian: Občasno lahko odmerek nekoliko spremenite, da ne bi bilo potrebno zavreči delno izpraznjenih vial.
English: These symptoms generally respond to treatment with antihistamines and/or corticosteroids.
Slovenian: Ti simptomi se običajno odzovejo na zdravljenje z antihistaminiki in/ali kortikosteroidi.
English: If you forget to use Cerezyme
Slovenian: Če ste pozabili uporabiti zdravilo Cerezyme
English: Paediatric population No dose adjustment is necessary for the paediatric population.
Slovenian: Pediatrična populacija Za pediatrično populacijo ni potrebno prilagajanje odmerka
English: Once individual patient response for all relevant clinical manifestations is wellestablished, dosages and frequency of administration may be adjusted with the goal to either maintain already reached optimal parameters for all clinical manifestations or further improve those clinical parameters which have not yet been normalised.
Slovenian: Ko se odziv posameznega bolnika na vse poglavitne bolezenske znake ustali, se lahko odmerke in pogostost dajanja zdravila prilagodi z namenom, da se vzdržujejo že doseženi optimalni parametri za vse bolezenske znake ali pa da se izboljšajo klinični parametri, ki se še niso normalizirali.
English: Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health.
Slovenian: Nezdravljenim ženskam je treba svetovati, da razmislijo o pričetku zdravljenja pred zanositvijo, da bi dosegle optimalno zdravje.
English: Intravenous use Read the package leaflet before use.
Slovenian: intravenska uporaba Pred uporabo preberite priloženo navodilo.
English: Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying Gaucher disease in pregnancy.
Slovenian: Na voljo so omejene izkušnje, pridobljene na podlagi izidov 150 nosečnosti (osnovane prvenstveno na spontanih poročanjih in pregledu literature), ki nakazujejo, da je uporaba zdravila Cerezyme med nosečnostjo koristna za nadzorovanje osnovne Gaucherjeve bolezni.
English: If these reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated.
Slovenian: Če se reakcije pojavijo, se priporoča takojšnja ustavitev infuzije zdravila Cerezyme in uvedba ustreznega zdravljenja.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Slovenian: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: - some patients with Gaucher disease have high blood pressure in the lungs (pulmonary hypertension).
Slovenian: - Nekateri bolniki z Gaucherjevo boleznijo imajo visok krvni pritisk v pljučih (pljučna hipertenzija).
English: From a microbiological safety point of view, the product should be used immediately.
Slovenian: Razredčena raztopina: Z vidika mikrobiološke varnosti je priporočeno, da zdravilo uporabite takoj.
English: Symptoms suggestive of hypersensitivity (* marked in the table above) have been noted, overall in approximately 3% of the patients.
Slovenian: O simptomih, ki kažejo na preobčutljivostno reakcijo (v zgornji preglednici so označeni z znakom *), poročajo pri vsega skupaj približno 3 % bolnikov.
English: The clinical manifestations of Gaucher disease can adversely affect quality of life.
Slovenian: Bolezenski znaki Gaucherjeve bolezni lahko negativno vplivajo na kakovost življenja.
English: Each vial of Cerezyme is for single use only.
Slovenian: Ena viala zdravila Cerezyme je namenjena samo enkratni uporabi.
English: Generally, improvements in organ systems with a faster turnover rate, such as the haematological, can be noted far more rapidly than in those with a slower turnover, such as the bone.
Slovenian: Na splošno se izboljšave opazijo veliko hitreje v organskih sistemih s hitrim obnavljanjem, kot je hematološki, kot pri organskih sistemih s počasnim obnavljanjem, kot je skelet.
English: The natural history of Gaucher disease usually shows progression, with the risk of irreversible complications arising in various organs over time.
Slovenian: Anamneza Gaucherjeve bolezni navadno kaže napredovanje, tekom časa pa se lahko v različnih organih pojavi tveganje nepopravljivih zapletov.
English: Your doctor may test if you have an allergic reaction to imiglucerase.
Slovenian: Vaš zdravnik lahko testira, ali se na imiglucerazo alergijsko odzovete.
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake: "EXP".
English: The usual frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
Slovenian: Običajna pogostost infundiranja je enkrat na vsaka 2 tedna; večina podatkov, ki so na voljo, se nanašajo na navedeno pogostost odmerjanja.
English: It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.
Slovenian: Priporoča se, da zdravilo Cerezyme uporabite takoj po tem, ko ga zmešate s sterilno vodo.
English: A Q4 infusion regimen may be a therapeutic option for some adult patients with stable residual Gaucher disease type 1, but clinical data are limited.
Slovenian: Q4 režim infundiranja lahko predstavlja možnost zdravljenja za nekatere odrasle bolnike s stabilno rezidualno Gaucherjevo boleznijo tipa 1, vendar so klinični podatki omejeni.
English: Signs and symptoms presenting in childhood typically represent more severe Gaucher disease.
Slovenian: Znaki in simptomi, ki se pojavijo v otroštvu, navadno kažejo na bolj resno obliko Gaucherjeve bolezni.
English: Educational materials for the use of Cerezyme in home infusion, consisting of:
Slovenian: Izobraževalno gradivo za infundiranje zdravila Cerezyme na domu, sestavljeno iz:
English: Clinically, Gaucher disease is a heterogeneous phenotypic spectrum.
Slovenian: Klinično je Gaucherjeva bolezen heterogeni fenotipski spekter.
English: No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/foetal development, parturition and postnatal development.
Slovenian: Študije na živalih, za oceno učinkov zdravila Cerezyme na nosečnost, razvoj zarodka/plodu, porod in postnatalni razvoj, niso bile izvedene.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands
Slovenian: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
English: The rate and extent of response to Cerezyme treatment is dose-dependent.
Slovenian: Stopnja in obseg odziva na zdravilo Cerezyme sta odvisna od velikosti odmerka.
English: Other medicines and Cerezyme
Slovenian: Druga zdravila in zdravilo Cerezyme
English: Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see section 4.8).
Slovenian: Pri bolnikih s protitelesi za imiglucerazo se poveča tveganje za preobčutljivostne reakcije (glejte poglavje 4.8).
English: • Manual for patients with Gaucher disease who receive home infusion;
Slovenian: • Priročnik za bolnike z Gaucherjevo boleznijo, ki doma prejemajo infuzije zdravila
English: In addition, Gaucher disease has been associated with an increased risk of immunoglobulin abnormalities such as hyperimmunoglobulinemia, polyclonal gammopathy, monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma.
Slovenian: Poleg tega je Gaucherjeva bolezen povezana s povišanim tveganjem za imunoglobulinske nepravilnosti, kot so hiperimunoglobulinemija, poliklonska gamopatija, monoklonska gamopatija nedoločenega pomena (monoclonal gammopathy of undetermined significance, MGUS) in multipli mielom.
English: Maintenance therapy every 4 weeks (Q4) at the same cumulative dose as the bi-weekly (Q2) dose has been studied in adult patients with stable residual Gaucher disease type 1.
Slovenian: Vzdrževalno zdravljenje na vsake 4 tedne (Q4) z enakim kumulativnim odmerkom kot pri dvotedenskem odmerku (Q2) so proučevali pri odraslih bolnikih s stabilno rezidualno Gaucherjevo boleznijo tipa 1.
English: Gaucher disease is associated with increased morbidity and early mortality.
Slovenian: Gaucherjeva bolezen je povezana z zvišano stopnjo pojavnosti bolezni in zgodnjo umrljivostjo.
English: It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy.
Slovenian: Kaže, da se pri bolnikih, pri katerih se protitelesa IgG razvijejo, le-ta zelo verjetno razvijejo v 6 mesecih in le redko po 12 mesecih zdravljenja.
English: This may contribute to skeletal disease burden in Gaucher disease.
Slovenian: To lahko prispeva k obremenitvi bolezni skeleta pri Gaucherjevi bolezni.
English: It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child's gastrointestinal tract
Slovenian: Ni znano, ali se ta zdravilna učinkovina izloča v materino mleko, vendar se bo encim verjetno presnovil v otrokovih prebavilih.
English: Tachycardia*, cyanosis*
Slovenian: Tahikardija*, cianoza*
English: Pharmacotherapeutic group: Enzymes-Imiglucerase (recombinant macrophage targeted βglucocerebrosidase), ATC code: A16AB02.
Slovenian: Farmakoterapevtska skupina: Encimi - imigluceraza (rekombinantna, na makrofage usmerjena βglukocerebrozidaza), ATC koda A16AB02.
English: Some side effects were seen primarily while patients were being given the medicine or shortly after.
Slovenian: Nekateri neželeni učinki so se primarno pojavili pri bolnikih med prejemanjem zdravila ali tik po tem.
English: This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion.
Slovenian: To vključuje povečano tveganje za skeletne manifestacije, poslabšanje citopenije, krvavitve in večje potrebe po transfuziji.
English: Cerezyme therapy reduces the requirement for splenectomy in most cases and early treatment with Cerezyme has been associated with a reduced risk of pulmonary hypertension.
Slovenian: Zdravljenje z zdravilom Cerezyme zniža potrebo po izvajanju splenektomije v večini primerov, zgodnje zdravljenje z zdravilom Cerezyme pa povezujejo z znižanim tveganjem za pljučno hipertenzijo.
English: You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”.
Slovenian: Register “ICGG Gaucher Registry” Zdravnika lahko prosite, da vpiše vaše podatke o bolniku v „ICGG Gaucher Registry“.
English: Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients.
Slovenian: Po sedanjih podatkih, na osnovi presejalnega preizkusa ELISA, kateremu je sledil potrdilni preizkus radioimunskega obarjanja, se pri približno 15 % bolnikov prvo leto zdravljenja razvijejo protitelesa IgG za imiglucerazo.
English: In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy.
Slovenian: Pri nosečnicah z Gaucherjevo boleznijo in tistih, ki nameravajo zanositi, je treba oceniti tveganje in koristi zdravljenja za vsako nosečnost.
English: The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Slovenian: Informacija na teh navodilih za uporabo se nanaša na vse skupine bolnikov, vključno z otroci,
English: Furthermore, these data indicate no malformative toxicity for the foetus by Cerezyme, although the statistical evidence is low.
Slovenian: Ti podatki kažejo, da Cerezyme ne povzroča toksičnih deformacij plodu, čeprav je statističnih dokazov malo.
English: In women receiving Cerezyme treatment continuation throughout pregnancy should be considered.
Slovenian: Pri ženskah, ki prejemajo zdravilo Cerezyme, bi morali premisliti o nadaljevanju zdravljenja v času nosečnosti.
English: Cerezyme has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease.
Slovenian: Izkazalo se je, da zdravilo Cerezyme izboljša duševne in fizične vidike kakovosti življenja bolnikov z Gaucherjevo boleznijo.
English: Rare (may affect up to 1 in 1,000 people): - anaphylactoid reactions
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov) - anafilaktične reakcije
English: Gaucher disease is associated with increased glucose production and increased resting energy expenditure rate, which may contribute to fatigue and cachexia.
Slovenian: Gaucherjeva bolezen je povezana z zvišano tvorbo glukoze in zvišano stopnjo porabe energije v mirovanju, kar lahko prispeva k utrujenosti in kaheksiji.
English: The patient or caregiver will be instructed in infusion technique and the keeping of a treatment diary.
Slovenian: Bolnik ali njegov negovalec se bosta poučila o tehniki infuzije, vodila pa bosta tudi dnevnik zdravljenja.
English: During 1 hour intravenous infusions of 4 doses (7.5, 15, 30, 60 U/kg) of imiglucerase, steady-state enzymatic activity was achieved by 30 minutes.
Slovenian: Med enournim intravenskim infundiranjem 4 odmerkov (7,5, 15, 30 in 60 enot/kg) imigluceraze se je pojavila ravnotežna encimska aktivnost po 30 minutah.
English: Name and address of the manufacturer of the biological active substance Genzyme Corporation, 500 Soldiers Field Road, Allston, MA 02134, USA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, USA Name and address of the manufacturers responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: 500 Soldiers Field Road - Allston, MA 02134, ZDA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, ZDA Ime in naslov izdelovalcev, odgovornih za sproščanje serij Genzyme Ltd., 37 Hollands Road - Haverhill, Suffolk CB9 8PU, Velika Britanija Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska V natisnjenem navodilu za uporabo morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: Patients treated with 60 U/kg body weight every 2 weeks showed a faster improvement and a greater maximum treatment effect as compared to patients receiving the lower doses.
Slovenian: Pri bolnikih, ki so prejemali 60 enot/kg telesne mase na vsaka 2 tedna, je prišlo do hitrejšega izboljšanja in večjega največjega učinka zdravljenja v primerjavi z bolniki, ki so prejemali nižje odmerke.
English: What Cerezyme is and what it is used for.
Slovenian: Kaj je zdravilo Cerezyme in za kaj ga uporabljamo