FrancophonIA/ELRC3.0 huggingface dataset:
English: • children who are less than six months old and were born five or more weeks prematurely (at 35
Slovenian: • pri otrocih, mlajših od šest mesecev, ki so se rodili pet ali več tednov prezgodaj (s 35 tedni gestacijske starosti ali manj);
English: • children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
Slovenian: • pri otrocih, mlajših od dveh let, ki so se v zadnjih šestih mesecih zdravili zaradi bronhopulmonalne displazije (nenormalnega pljučnega tkiva, ki se navadno pojavi pri prezgodaj rojenih otrocih);
English: Palivizumab has been designed to attach to a protein called ‘fusion protein A' on the surface of RSV.
Slovenian: Palivizumab je zasnovan tako, da se veže na beljakovino imenovano „fuzijski protein A“ na površini RSV.
English: The CHMP decided that Synagis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Synagis večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Other information about Synagis
Slovenian: Druge informacije o zdravilu Synagis
English: Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Slovenian: Zdravilo Synagis se uporablja za preprečevanje hude bolezni spodnjih dihal (pljuč), ki jo povzroča respiratorni sincicijski virus (RSV) in zahteva hospitalizacijo.
English: Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Slovenian: Zdravilo Synagis se daje enkrat mesečno, če v otrokovem okolju obstaja nevarnost za okužbo z RSV: na področju severne poloble traja obdobje tveganja od novembra do aprila.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Synagis.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Synagis, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease.
Slovenian: V drugi opravljeni študiji so zdravilo Synagis primerjali s placebom pri 1 287 otrocih s prirojenimi boleznimi srca.
English: Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo.
Slovenian: Zdravilo Synagis je bilo pri zmanjšanju števila hospitalizacij zaradi RSV učinkovitejše od placeba: v času trajanja študije so v bolnišnico zaradi okužbe z RSV sprejeli 5 % otrok, ki so prejemali zdravilo Synagis, v primerjavi z 11 % otrok, ki so prejemali placebo.
English: What benefit has Synagis shown during the studies?
Slovenian: Kakšne koristi je zdravilo Synagis izkazalo med študijami?
English: The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash.
Slovenian: Najpogostejša neželena učinka zdravila Synagis (opažena pri 1 do 10 bolnikih od 100) sta povišana telesna temperatura in izpuščaj.
English: Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised' monoclonal antibodies.
Slovenian: Zdravila Synagis ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) palivizumab, katero koli drugo sestavino zdravila ali druge vrste humaniziranih monoklonskih protiteles.
English: It contains the active substance palivizumab.
Slovenian: Vsebuje zdravilno učinkovino palivizumab.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
Slovenian: To je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen), ki se nahaja v telesu, in se veže nanjo.
English: For the full list of all side effects reported with Synagis, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Synagis, glejte navodilo za uporabo.
English: Synagis is a powder and solvent that are made up into a solution for injection.
Slovenian: Zdravilo Synagis je prašek in vehikel za pripravo raztopine za injiciranje.
English: What is the risk associated with Synagis?
Slovenian: Kakšna tveganja so povezana z zdravilom Synagis?
English: Why has Synagis been approved?
Slovenian: Zakaj je bilo zdravilo Synagis odobreno?
English: The active substance in Synagis, palivizumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila Synagis, palivizumab, je monoklonsko protitelo.
English: The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season.
Slovenian: V glavni študiji zdravila Synagis, ki so jo izvedli pri 1 502 otrocih z visokim tveganjem za okužbo, so učinkovitost tega zdravila primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine) v obdobju ene sezone razsajanja RSV.
English: In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti število otrok, ki so jih sprejeli v bolnišnico zaradi okužbe z RSV.
English: How does Synagis work?
Slovenian: Kako zdravilo Synagis deluje?
English: What is Synagis?
Slovenian: Kaj je zdravilo Synagis?
English: What is Synagis used for?
Slovenian: Za kaj se zdravilo Synagis uporablja?
English: How has Synagis been studied?
Slovenian: Kako je bilo zdravilo Synagis raziskano?
English: How is Synagis used?
Slovenian: Kako se zdravilo Synagis uporablja?
English: Extension Study 044
Slovenian: Podaljšanje študije 044
English: Some solution will remain in the vial:
Slovenian: Nekaj raztopine bo ostalo v viali:
English: There are also links to other websites about rare diseases and treatments.
Slovenian: kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: - You may be given additional medicines to treat or help prevent future reactions.
Slovenian: - Mogoče boste dobili dodatna zdravila za zdravljenje ali preprečevanje prihodnjih reakcij.
English: The results are presented in Table 2.
Slovenian: Rezultati so predstavljeni v preglednici 2.
English: An IRR often appears as a hypersensitivity reaction.
Slovenian: IRR se pogosto pojavi kot preobčutljivostna reakcija.
English: There are 5 potential N-linked glycosylation sites, four of which are occupied.
Slovenian: Obstaja pet potencialnih N-vezavnih glikozilacijskih mest, od katerih so štiri zasedena.
English: Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals.
Slovenian: Prilagoditve odmerka se lahko izvedejo za vsakega posameznika posebej na podlagi doseganja in vzdrževanja terapevtskih ciljev.
English: From a microbiological point of view, the medicine should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
English: However, no data are available for children under the age of 4 years.
Slovenian: Vendar o otrocih, mlajših od 4 let, ni podatkov.
English: • Patient evaluation and selection;
Slovenian: • ovrednotenje in izbira bolnikov;
English: In some cases vomiting can be serious (reported from post-marketing experience).
Slovenian: V nekaterih primerih je lahko bruhanje resno (o tem so poročali v obdobju trženja).
English: 400 Units
Slovenian: 400 enot
English: Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
Slovenian: Datum zadnjega podaljšanja: 19. junij 2015
English: The majority of hypersensitivity reactions usually occur up to 12 hours post infusion.
Slovenian: Večina preobčutljivostnih reakcij se navadno pojavi do 12 ur po infuziji.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2C to 8C.
Slovenian: Če se ne porabi takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri temperaturi od 2 °C do 8 °C.
English: The effect on height was assessed in the study 044 (see section 5.1, Extension Study 044).
Slovenian: V študiji 044 so ocenili učinek na višino (glejte poglavje 5.1, Podaljšanje študije 044).
English: VPRIV should not be used in children under the age of 2 years.
Slovenian: Zdravilo VPRIV se ne sme uporabljati pri otrocih, mlajših od 2 let.
English: • Infusion diary;
Slovenian: • dnevnik infuzij;
English: Read all of this leaflet carefully before this medicine is used because it contains important information for you.
Slovenian: Pred uporabo zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials.
Slovenian: Odvzemite izračunan volumen zdravila iz ustreznega števila vial.
English: • Requirements for home infusion (home condition, patient assessment, emergency treatment);
Slovenian: • zahteve za infuzije na domu (pogoji v domačem okolju, ocena bolnika, urgentno zdravljenje);
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Slovenian: Predhodno zdravljenje z antihistaminiki in/ali kortikosteroidi lahko prepreči poznejše reakcije, če je bilo potrebno simptomatsko zdravljenje.
English: The studies allowed the inclusion of patients 2 years and older and the safety and efficacy profiles are expected to be similar down to the age of 2 years.
Slovenian: Študije so omogočale vključitev bolnikov, starih 2 leti in več, za profila varnosti in učinkovitosti pa se pričakuje, da bosta podobna pri bolnikih, starih od 2 let naprej.
English: Use aseptic technique.
Slovenian: Uporabite aseptično tehniko.
English: Home administration under the supervision of a healthcare professional may be considered only for those patients who have received at least three infusions and were tolerating their infusions well.
Slovenian: O možnosti uporabe doma pod nadzorom zdravstvenega delavca lahko razmišljamo samo pri bolnikih, ki so prejeli vsaj tri infuzije in ki dobro prenašajo infundiranje.
English: In contrast, no significant change in femoral neck BMD was observed.
Slovenian: V nasprotju s tem niso opazili nobene pomembne spremembe v BMD stegneničnega vratu.
English: Response to treatment
Slovenian: Odziv na zdravljenje
English: • Safety information;
Slovenian: • podatki o varnosti;
English: *Liver and spleen volume is normalized as a percentage of body weight.
Slovenian: *Prostornina jeter in vranice je normalizirana kot odstotek telesne mase.
English: If the dates of submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
English: There was no indication of significant improvements of the neurological manifestations of type 3 Gaucher disease except for one patient in this study.
Slovenian: Nič ni kazalo na pomembno izboljšanje nevroloških manifestacij Gaucherjeve bolezni tipa 3, razen pri enem bolniku v tej študiji.
English: • Description on how to prepare and administer the infusion including safety information;
Slovenian: • opis načina priprave in dajanja infuzij, vključno s podatki o varnosti;
English: What VPRIV is and what it is used for
Slovenian: Kaj je zdravilo VPRIV in za kaj ga uporabljamo
English: Investigations activated partial thromboplastin time prolonged, neutralizing antibody positive
Slovenian: Preiskave podaljšan aktivirani parcialni tromboplastinski čas, pozitivna nevtralizirajoča protitelesa
English: • Emergency plan provided by the prescriber including who to call and what to do in the case of a serious hypersensitivity reaction.
Slovenian: • načrt za nujne primere, ki ga bo posredoval zdravnik, ki predpisuje zdravilo, in bo vključeval podatke o tem, koga je treba poklicati in kaj storiti v primeru resne preobčutljivostne reakcije.
English: These medicines may include antihistamines, antipyretics, and corticosteroids.
Slovenian: Med temi zdravili so lahko antihistaminiki, antipiretiki in kortikosteroidi.
English: • About the disease, treatment and home infusion;
Slovenian: • o bolezni, zdravljenju in infuzijah na domu;
English: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 USA
Slovenian: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 Združene države Amerike
English: The safety profile in these patients was similar to that observed in other clinical trials.
Slovenian: Varnostni profil pri teh bolnikih je bil podoben kot v drugih kliničnih preskušanjih.
English: Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth.
Slovenian: Gaucherjeva bolezen se lahko pri ženskah poslabša med nosečnostjo in v prvih nekaj tednih po porodu.
English: The infusion should be initiated within 24 hours from the time of reconstitution.
Slovenian: Infundiranje je treba začeti v 24 urah po rekonstituciji.
English: - if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste hudo alergični na velaglucerazo alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: These are called infusion-related reactions and may affect more than 1 in 10 people (very common).
Slovenian: Ti učinki se imenujejo reakcije, povezane z infundiranjem, in se lahko pojavijo pri več kot 1 od 10 bolnikov (zelo pogosto).
English: It is given by a doctor or nurse by intravenous infusion.
Slovenian: Daje ga zdravnik ali medicinska sestra z intravenskim infundiranjem.
English: The steady state volume of distribution was approximately 10% of the body weight.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je bil približno 10 % telesne mase.
English: *An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37ºC.
Slovenian: * Encimska enota je opredeljena kot količina encima, potrebna za pretvorbo enega mikromola p-nitrofenil ß-D-glukopiranozida v p-nitrofenol na minuto pri 37 ºC.
English: The MAH shall ensure that in each Member State where VPRIV is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use VPRIV have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer se trži zdravilo VPRIV, vsi zdravstveni delavci in bolniki/skrbniki za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo VPRIV, imeli dostop ali prejeli naslednji paket izobraževalnih gradiv:
English: Water for Injections
Slovenian: Sterilna voda za injekcije
English: Use in the age group 4 to 17 is supported by evidence from controlled studies in adults and paediatric [20 of 94 (21%)] patients.
Slovenian: Uporabo v starostni skupini od 4 do 17 let podpirajo dokazi iz nadzorovanih študij pri odraslih in pediatričnih [20 od 94 (21 %)] bolnikih.
English: Patients were required to have a stable dose of imiglucerase for at least 6 months prior to study enrolment.
Slovenian: Bolniki so morali prejemati stabilen odmerek imigluceraze vsaj 6 mesecev pred začetkom študije.
English: The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg.
Slovenian: Največji odmerek velagluceraze alfa v kliničnih študijah je bil 60 enot/kg.
English: The safety and efficacy profiles were similar between paediatric and adult patients.
Slovenian: Profili varnosti in učinkovitosti pri pediatričnih in odraslih bolnikih so bili podobni.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij inkompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: VIAL - 400 UNITS
Slovenian: VIALA - 400 ENOT
English: Most side effects occurred during the infusion or shortly after.
Slovenian: Večina neželenih učinkov se je pojavila med infundiranjem ali takoj po njem.
English: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 USA
Slovenian: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 Združene države Amerike
English: Cartons with 1, 5 or 25 vials.
Slovenian: Škatle z 1, 5 ali 25 vialami.
English: Patients were between 4 and 71 years old at the time of first treatment with VPRIV, and included 46 male and 48 female patients.
Slovenian: Pri prvem zdravljenju z zdravilom VPRIV so bili bolniki stari od 4 do 71 let, med njimi pa je bilo 46 moških in 48 žensk.
English: In Studies 025EXT and 034, patients were offered home therapy.
Slovenian: V študijah 025EXT in 034 so bolnikom ponudili zdravljenje na domu.
English: Excipient with known effect: One vial contains 12.15 mg sodium.
Slovenian: Pomožna snov z znanim učinkom: Ena viala vsebuje 12,15 mg natrija.
English: Do not use this medicine after the expiry date which is stated on the carton and label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepkipoleg oznake »Uporabno do«.
English: If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.
Slovenian: Če dobro prenašate infundiranje na kliniki, lahko zdravnik ali medicinska sestra izvaja infundiranje tudi pri vas doma.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB10.
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove - encimi, oznaka ATC: A16AB10.
English: • Organisation of home infusion/preparation of infusion;
Slovenian: • organiziranje infuzij na domu/priprava infuzij;
English: Therefore, it was not possible to evaluate the effect of antibody response on the pharmacokinetic profile of velaglucerase alfa.
Slovenian: Zaradi tega ni bilo mogoče oceniti učinka odziva protiteles na farmakokinetični profil velagluceraze alfa.
English: Elderly population (≥65 years)
Slovenian: Starejši bolniki (≥ 65 let)
English: Fertility Animal studies show no evidence of impaired fertility.
Slovenian: Plodnost Študije na živalih ne kažejo dokazov za zmanjšano plodnost.
English: 57 patients were treatment-naïve.
Slovenian: 57 bolnikov je bilo še nezdravljenih.
English: Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
Slovenian: Vsako vialo s 400 enotami rekonstituirajte s 4,3 ml sterilne vode za injekcije.
English: The only adverse reaction leading to discontinuation of treatment was an infusion-related reaction.
Slovenian: Edini neželeni učinek, zaradi katerega je bilo treba prekiniti zdravljenje, je bil reakcija, povezana z infundiranjem.
English: Uncommon side effects are: - blurry vision (may be associated with an infusion-related reaction) - vomiting
Slovenian: Občasni neželeni učinki so: - zamegljen vid (lahko je povezan z infundiranjem povezano reakcijo), - bruhanje.
English: A severe allergic reaction, with difficulty breathing, swelling of the face, lips, tongue or throat occured.
Slovenian: Pojavile so se hude alergijske reakcije s težavami pri dihanju, otekanjem obraza, ustnic, jezika ali grla.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C under protection from light.
Slovenian: Raztopina ostane kemično in fizično stabilna 24 ur pri temperaturi od 2 °C do 8 °C, zaščitena pred svetlobo.
English: An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion.
Slovenian: Reakcija, povezana z infundiranjem, je opredeljena kot vsaka neželena reakcija na zdravilo, ki nastopi v 24 urah po začetku infundiranja velagluceraze alfa.
English: Immune system disorders hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions)
Slovenian: Bolezni imunskega sistema preobčutljivostna reakcija (vključuje alergijski dermatitis in anafilaktične/anafilaktoidne reakcije)
English: The required vials are removed from the refrigerator.
Slovenian: Vzemite viale iz hladilnika.
English: - If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
Slovenian: - Če je reakcija resna, bo vaš zdravnik takoj prekinil intravensko infundiranje in vam začel nuditi ustrezno zdravljenje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with VPRIV in all subsets of the paediatric population with type 2 Gaucher disease.
Slovenian: Evropska agencija za zdravila odstopa od obveznosti predložitve rezultatov študij z zdravilom VPRIV pri vseh podskupinah pediatričnih bolnikov z Gaucherjevo boleznijo tipa 2.
English: ** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
Slovenian: ** Izdelano s tehnologijo rekombinantne DNA v humani fibroblastni celični liniji HT-1080.
English: However a few patients experienced an allergic skin reaction which may affect up to 1 in 10 people (common) such as severe rash or itching.
Slovenian: Nekaj bolnikov je imelo alergijsko kožno reakcijo, ki se lahko pojavi pri največ 1 od 10 bolnikov (pogosto), kot je hud izpuščaj ali srbenje.
English: Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies.
Slovenian: Reakcije, povezane z infundiranjem (IRR), so bile najpogosteje opažene neželene reakcije pri bolnikih, ki so bili zdravljeni v kliničnih študijah.
English: The build-up of this material causes the signs and symptoms found in Gaucher disease.
Slovenian: Kopičenje te snovi povzroča znake in simptome, ki se pojavljajo pri Gaucherjevi bolezni.
English: Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.
Slovenian: Ženske z Gaucherjevo boleznijo, ki so noseče ali nameravajo zanositi, se morajo pred uporabo tega zdravila posvetovati z zdravnikom.
English: Reconstituted and diluted solution for infusion:
Slovenian: Rekonstituirana in razredčena raztopina za infundiranje:
English: Table 2: Results at 24 months - Change from Baseline - Study 044 ITT Population Clinical Parameters
Slovenian: Preglednica 2: Rezultati po 24 mesecih - sprememba od izhodišča - populacija ITT v študiji 044
English: Elderly patients may be treated within the same dose range (15 to 60 units/kg) as other adult patients.
Slovenian: Starejši bolniki se lahko zdravijo z enakim razponom odmerkov (od 15 do 60 enot/kg) kot drugi odrasli bolniki.
English: The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
Slovenian: Najresnejši neželeni učinki pri bolnikih v kliničnih preskušanjih so bile preobčutljivostne reakcije.
English: The high clearance of velaglucerase alfa from serum (mean 6.7 to 7.6 ml/min/kg) is consistent with the rapid uptake of velaglucerase alfa into macrophages via mannose receptors.
Slovenian: Visok očistek velagluceraze alfa iz seruma (povprečna vrednost 6,7 do 7,6 ml/min/kg) je skladen s hitrim privzemom velagluceraze alfa v makrofage prek receptorjev za manozo.