FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 44 mg of sodium in 5 ml of solution.
Slovenian: Ena viala vsebuje 44 mg natrija v 5 ml raztopine.
English: The solutions are clear to slightly opalescent, colourless to pale yellow; the Brineura solution may occasionally contain thin translucent fibres or opaque particles.
Slovenian: Raztopini sta bistri do rahlo opalescentni in brezbarvni do bledorumeni; raztopina zdravila Brineura lahko občasno vsebuje tanka prosojna vlakna ali motne delce.
English: Life-threatening allergic reactions are possible with Brineura.
Slovenian: Z zdravilom Brineura se lahko pojavijo življenje ogrožajoče alergijske reakcije.
English: Chemical and physical in-use stability has been demonstrated for up to 12 hours at room temperature (1925°C).
Slovenian: Kemična in fizična stabilnost zdravila med uporabo je bila dokazana za 12 ur pri sobni temperaturi
English: Each vial of Brineura contains 150 mg cerliponase alfa in 5 ml of solution (30 mg/ml)
Slovenian: Ena viala zdravila Brineura vsebuje 150 mg cerliponaze alfa v 5 ml raztopine (30 mg/ml).
English: Label one unused sterile syringe “Brineura” and attach a syringe needle.
Slovenian: Eno neuporabljeno sterilno injekcijsko brizgo označite z napisom "Brineura" in nataknite injekcijsko iglo.
English: The following CE marked disposable infusion components were used in Brineura clinical trials:
Slovenian: V kliničnih preskušanjih z zdravilom Brineura so bile uporabljene naslednje komponente za infundiranje za enkratno uporabo z oznako CE:
English: Label one unused sterile syringe “flushing solution” and attach a syringe needle.
Slovenian: Eno neuporabljeno sterilno injekcijsko brizgo označite z napisom "raztopina za izpiranje" in nataknite injekcijsko iglo.
English: Do not dilute Brineura.
Slovenian: Zdravila Brineura ne redčite.
English: Vital signs should be monitored before infusion starts, periodically during infusion, and post-infusion in a healthcare setting.
Slovenian: Pred začetkom infundiranja, redno med infundiranjem in po infundiranju je treba v bolnišnici preverjati vitalne znake.
English: Clear to slightly opalescent and colourless to pale yellow solution, that may occasionally contain thin translucent fibres or opaque particles.
Slovenian: Bistra do rahlo opalescentna in brezbarvna do bledorumena raztopina, ki lahko občasno vsebuje tanka prosojna vlakna ali motne delce.
English: Do not administer Brineura if there are signs and symptoms of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.3 and 4.4).
Slovenian: Zdravila Brineura ne dajajte, če opazite znake in simptome akutnega puščanja iz pripomočka za intracerebroventrikularni dostop, odpoved pripomočka ali okužbe, povezane s pripomočkom (glejte poglavji 4.3 in 4.4).
English: Open vials or product in syringes should be used immediately.
Slovenian: Odprte viale ali zdravilo v injekcijskih brizgah uporabite takoj.
English: Cerliponase alfa plasma pharmacokinetics were assessed in 13 patients, and a median Tmax of 12.0 hours (since start of infusion), a mean Cmax of 1.39 µg/ml, and mean AUC0-t of 24.1 µg-hour/ml were characterized.
Slovenian: Farmakokinetiko cerliponaze alfa v plazmi so ocenili pri 13 bolnikih in določili mediani tmax 12,0 ur (od začetka infuzije), povprečno Cmax
English: Bradycardia
Slovenian: Anafilaksa
English: Detach and remove the empty syringe from the pump and disconnect from the tubing.
Slovenian: Prazno injekcijsko brizgo odklopite od črpalke in jo odstranite ter ločite od cevja.
English: Table 4: 0 to 6 Point Motor-Language CLN2 Clinical Rating Scale: Rate of Decline over 48 weeks (Intent to Treat (ITT) population)
Slovenian: 6 točk: stopnja upada v 48 tednih (populacija z namenom zdravljenja (ITT - intent to treat))
English: The following components (not supplied) are required for proper administration of Brineura and flushing solution (see Figure 1 in section 4.2).
Slovenian: Za pravilno dajanje zdravila Brineura in raztopine za izpiranje so potrebne naslednje komponente (niso priložene zdravilu) (glejte sliko 1 v poglavju 4.2).
English: What Brineura looks like and contents of the pack
Slovenian: Izgled zdravila Brineura in vsebina pakiranja
English: Insert the port needle into the intracerebroventricular access device.
Slovenian: Iglo za pristopno odprtino vstavite v pripomoček za intracerebroventrikularni dostop.
English: Periodically inspect the infusion components during the infusion for signs of leakage or delivery failure.
Slovenian: Med infundiranjem redno preverjajte, ali kažejo infuzijske komponente znake puščanja ali odpovedi dovajanja.
English: OTHER
Slovenian: Vseh
English: The safety and efficacy of Brineura were assessed in an open label, dose escalation clinical study (190-201) and an ongoing long term extension study (190-202) in patients with CLN2 disease compared to untreated patients with CLN2 disease from a natural history database (natural history control group).
Slovenian: 201) in v potekajočem dolgotrajnem podaljšku študije (190-202) pri nezdravljenih bolnikih s CLN2 v primerjavi z bolniki s CLN2 z naravnim potekom iz baze podatkov (kontrolna skupina z naravnim potekom).
English: A total of 24 patients, aged 3 to 8 years, were treated with Brineura 300 mg every other week.
Slovenian: Skupaj so z zdravilom Brineura 300 mg vsak drugi teden zdravili 24 bolnikov, starih od 3 do 8 let.
English: Place the syringe containing Brineura into the syringe pump and program the pump to deliver at an infusion rate of 2.5 ml per hour.
Slovenian: Injekcijsko brizgo z zdravilom Brineura vstavite v črpalko za injekcijsko brizgo in črpalko programirajte tako, da bo dovajala s hitrostjo infundiranja 2,5 ml na uro.
English: Flushing solution for Brineura Intracerebroventricular use
Slovenian: raztopina za izpiranje za zdravilo Brineura intracerebroventrikularna uporaba
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj urtikarija pogosti pogosti
English: Discard the needle and empty vials per local requirements.
Slovenian: Injekcijsko iglo in prazne viale odstranite v skladu z lokalnimi zahtevami.
English: Periodically inspect the infusion system during the infusion for signs of leakage or delivery failure.
Slovenian: Med infundiranjem redno preverjajte, ali kaže infuzijski sistem znake puščanja ali odpovedi dovajanja.
English: Common side effects: pain rash hives head dropping (so that the chin drops towards the chest) stomach pain leakage of the device mouth or tongue blisters swelling or redness of the eyelid and the white part of the eye feeling nervous disorder of the stomach or intestines
Slovenian: bolečina v trebuhu puščanje pripomočka mehurčki v ustih ali na jeziku oteklina ali rdečina očesne veke in beločnice občutek živčnosti bolezni trebuha ali prebavil
English: Remove the green flip-off caps from both Brineura vials.
Slovenian: Z obeh vial zdravila Brineura odstranite zeleno dvižno zaporko.
English: Intracerebroventricular access device-related infections, including sub-clinical infections and meningitis, have been observed in patients treated with Brineura.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Brineura, so opazili okužbe, povezane s pripomočkom za intracerebroventrikularni dostop, vključno s subkliničnimi okužbami in meningitisom.
English: Solution for infusion.
Slovenian: raztopina za infundiranje
English: Place the syringe containing the flushing solution into the syringe pump and program the pump to deliver an infusion rate of 2.5 ml per hour.
Slovenian: Injekcijsko brizgo z raztopino za izpiranje vstavite v črpalko za injekcijsko brizgo in črpalko programirajte tako, da bo dovajala s hitrostjo infundiranja 2,5 ml na uro.
English: CE marked intracerebroventricular access devices, and disposable components listed below or equivalent should be used to deliver Brineura.
Slovenian: Za dovajanje zdravila Brineura je treba uporabiti pripomočke za intracerebroventrikularni dostop z oznako CE in spodaj naštete komponente za enkratno uporabo ali enakovredne.
English: Healthcare professionals should be aware of the possible symptoms of anaphylaxis such as: generalized hives, pruritus or flushing, swollen lips, tongue, and/or uvula, dyspnoea, bronchospasm, stridor, hypoxemia, hypotonia, syncope, or incontinence.
Slovenian: generalizirana koprivnica, pruritus ali pordevanje, otekle ustnice, jezik in/ali uvula, dispneja, bronhospazem, stridor, hipoksemija, hipotonija, sinkopa ali inkontinenca.
English: There were no patients with advanced disease progression at treatment initiation who were included in clinical trials and no clinical data is available in children < 2 years.
Slovenian: Pediatrična populacija Bolnikov z napredovalo obliko bolezni ob začetku zdravljenja niso vključili v klinična preskušanja,
English: Initiate infusion of Brineura at a rate of 2.5 ml per hour.
Slovenian: Z infundiranjem zdravila Brineura začnite s hitrostjo 2,5 ml na uro.
English: The MAH shall ensure that in each MS where BRINEURA is marketed, all HCPs who are expected to handle / administer the product are provided with an educational programme (i.e. a dosing and administration guide), aiming at preventing and/or minimising the important identified risk of Device issues (infection/blockage/dislocation), containing information about: - How to store BRINEURA; - The device-related complications (i.e. infections, device's leakage and/or failure; the integrity of the device should be confirmed by a neurosurgeon); - How to prepare BRINEURA and the flushing solution; - A detailed step-by step description of BRINEURA intra-cerebro-ventricular infusion and the administration of the flushing solution (provided after BRINEURA infusion is complete) - How to monitor the patients receiving BRINEURA.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo BRINEURA trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo z zdravilom rokovali ali ga dajali, prejeli izobraževalno gradivo (tj. vodnik za odmerjanje in dajanje zdravila), ki je namenjeno preprečevanju in/ali zmanjševanju pomembnega ugotovljenega tveganja glede težav s pripomočkom (okužba/zapora/premik), in vsebuje naslednje informacije:
English: p-valueb
Slovenian: vrednost pb
English: Brineura and flushing solution should be clear to slightly opalescent and colourless to pale yellow.
Slovenian: Zdravilo Brineura in raztopina za izpiranje morata biti bistra do nekoliko opalescentna in brezbarvna do bledorumena.
English: Brineura and flushing solution Sodium phosphate dibasic heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
Slovenian: Zdravilo Brineura in raztopina za izpiranje dvobazni natrijev fosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev klorid kalijev klorid magnezijev klorid heksahidrat kalcijev klorid dihidrat voda za injekcije
English: Your doctor may adjust you or your child's dose or the amount of time the medicine is given if the infusion is not tolerated, there is an allergic reaction or there is a possible increase of pressure in the brain.
Slovenian: Zdravnik lahko ob neprenašanju infuzije, alergijski reakciji ali možnem povečanju tlaka v možganih prilagodi vaš ali otrokov odmerek ali čas dajanja zdravila.
English: It is not known if Brineura impacts human fertility.
Slovenian: Ni znano, ali zdravilo Brineura vpliva na sposobnost razmnoževanja pri ljudeh.
English: Thawed Brineura and flushing solution should be used immediately.
Slovenian: 2 leti Odtaljeno zdravilo Brineura in raztopino za izpiranje je treba uporabiti takoj.
English: Not known (frequency cannot be estimated based on available data) device is displaced and does not function correctly when preparing for infusion inflammation of the brain due to device-related infection
Slovenian: pripomoček se je premaknil in med pripravo na infundiranje ni deloval pravilno vnetje možganov zaradi okužb, povezanih s pripomočkom
English: Device-related complications
Slovenian: Zapleti, povezani s pripomočkom
English: Withdraw flushing solution
Slovenian: Izvlek raztopine za izpiranje
English: Apply gentle pressure and bandage the infusion site per institution standard of care.
Slovenian: Z nežnim pritiskom povijte mesto v skladu s standardom nege, uveljavljenim v ustanovi.
English: Remove the port needle.
Slovenian: Odstranite iglo za pristopno odprtino.
English: Animal reproduction studies have not been conducted using Brineura.
Slovenian: Študij o vplivu zdravila Brineura na sposobnost razmnoževanja pri živalih niso izvedli.
English: Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of solution.
Slovenian: Ena viala zdravila Brineura vsebuje 150 mg cerliponaze alfa* v 5 ml raztopine.
English: Rating
Slovenian: Ocenjevanje
English: Withdraw Brineura
Slovenian: Izvlek zdravila Brineura
English: The most frequent (>20%) adverse reactions observed during Brineura clinical trials include pyrexia, low CSF protein, ECG abnormalities, vomiting, upper respiratory tract infections, and hypersensitivity.
Slovenian: zmanjšano vrednost beljakovin v CSL, nenormalnosti na EKG, bruhanje, okužbe zgornjih dihal in preobčutljivost.
English: Table 5: Pharmacokinetic properties following first Intracerebroventricular infusion (approximately 4 hours in duration) of 300 mg cerliponase alfa in CSF
Slovenian: Preglednica 5: Farmakokinetične lastnosti po prvem intracerebroventrikularnem infundiranju
English: How to store Brineura
Slovenian: Kako se daje zdravilo Brineura
English: Thaw Brineura and flushing solution
Slovenian: Odtajanje zdravila Brineura in raztopine za izpiranje
English: Brineura and the flushing solution are solutions for infusion.
Slovenian: Zdravilo Brineura in raztopina za izpiranje sta raztopini za infundiranje.
English: Verify that the “Brineura” syringe in the syringe pump is empty after the infusion is complete.
Slovenian: Ko je infundiranje zaključeno, se prepričajte, da je injekcijska brizga z zdravilom Brineura v črpalki za injekcijsko brizgo prazna.
English: Very common side effects (may affect more than 1 in 10 people): fever vomiting feeling irritable convulsions (seizures) reactions during or shortly after being given the medicine, such as hives, itching or flushing, swollen lips, tongue and/or throat, shortness of breath, hoarseness, turning blue around finger tips or lips, low muscle tone, fainting or incontinence
Slovenian: reakcije med dajanjem zdravila ali tik po tem, kot so koprivnica, srbenje ali pordevanje, otekle ustnice, jezik in/ali žrelo, zasoplost, hripavost, pomodrenje okoli konic prstov ali ustnic, slab mišični tonus, omedlevanje ali inkontinenca
English: Initiate infusion of the flushing solution at a rate of 2.5 ml per hour.
Slovenian: Z infundiranjem raztopine za izpiranje začnite s hitrostjo 2,5 ml na uro.
English: Talk to your doctor or nurse immediately if you experience any of the following:
Slovenian: Takoj se posvetujte z zdravnikom ali medicinsko sestro, če imate kaj od naslednjega: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Breast-feeding
Slovenian: Lectro-Cath
English: Cardiac disorders
Slovenian: Srčne bolezni bradikardija pogosti
English: Figure 2: CLN2 Score Mean Change from Baseline (Natural History Control Group vs Brineura treated patients, 300 mg every other week)
Slovenian: (kontrolna skupina z naravnim potekom v primerjavi z bolniki, zdravljenimi z zdravilom Brineura, 300 mg vsak drugi teden)
English: Potassium chloride
Slovenian: Vzorce CSL
English: Verify that the “flushing solution” syringe in the syringe pump is empty after the infusion is complete.
Slovenian: Ko je infundiranje zaključeno, se prepričajte, da je injekcijska brizga z raztopino za izpiranje v črpalki za injekcijsko brizgo prazna.
English: Brineura and flushing solution vials should be thawed prior to administration.
Slovenian: Viale z zdravilom Brineura in raztopino za izpiranje je treba pred dajanjem odtajati.
English: 3 Grossly normal gait.
Slovenian: Večinoma normalna hoja.
English: Preparation for administration of Brineura and flushing solution
Slovenian: Priprava na dajanje zdravila Brineura in raztopine za izpiranje
English: Brineura and flushing solution excipients: Sodium phosphate dibasic heptahydrate; Sodium dihydrogen phosphate monohydrate; Sodium chloride;
Slovenian: Pomožne snovi v zdravilu Brineura in raztopini za izpiranje: dvobazni natrijev fosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev klorid kalijev klorid magnezijev klorid heksahidrat kalcijev klorid dihidrat voda za injekcije
English: Median Min, Max 95% CI Limits a Patient rate of decline per 48 weeks: (baseline CLN2 score - last CLN2 score) / (time elapsed in units of 48 weeks) b p-value based on 1-sample T-test comparing rate of decline to the value 2 c Positive estimates indicate clinical decline; negative estimates indicate clinical improvement
Slovenian: a Stopnja upada bolnikov v 48 tednih: (izhodiščni rezultat CLN2 - zadnji rezultat CLN2) / (pretekel čas v enotah 48 tednov)
English: Language
Slovenian: Govor
English: Post-authorisation efficacy study (PAES): Study 190-203.
Slovenian: študija 190-203.
English: Administer the flushing solution provided after the Brineura infusion is complete.
Slovenian: Intracerebroventrikularno infundiranje raztopine za izpiranje Priloženo raztopino za izpiranje uporabite po koncu infundiranja zdravila Brineura.
English: CSF protein increased ECG abnormalities CSF protein decreased
Slovenian: Preiskave zvišana vrednost beljakovin v cerebrospinalnem likvorju nenormalnosti na EKG zmanjšana vrednost beljakovin v cerebrospinalnem likvorju zelo pogosti zelo pogosti zelo pogosti
English: Vomiting
Slovenian: Dojenje
English: Each vial of Brineura contains 150 mg of cerliponase alfa in 5 ml of solution.
Slovenian: Ena viala zdravila Brineura vsebuje 150 mg cerliponaze alfa v
English: Rash Urticaria
Slovenian: OVOJNINAH VIALA
English: Product issues
Slovenian: Težave z zdravilom
English: Device-related infectiona Meningitis
Slovenian: Bolezni imunskega sistema preobčutljivost zelo pogosti
English: Psychiatric disorders
Slovenian: Količina raztopine zdravila
English: Administer flushing solution after Brineura.
Slovenian: Raztopino za izpiranje aplicirajte po zdravilu Brineura.
English: If anaphylaxis occurs, caution should be exercised upon re-administration.
Slovenian: je pri ponovni uporabi zdravila potrebna previdnost.
English: This is further supported by the likely common mechanism of action.
Slovenian: To mnenje je podprto tudi z verjetnim skupnim mehanizmom delovanja.
English: The exposure to these substances is respectively estimated to 565,000 patient-years, 555,470 patient-years and 66,052 patient-years worldwide.
Slovenian: Ocena izpostavljenosti tem zdravilom po svetu je 565 000 bolnik-let, 555 470 bolnik-let in 66 052 bolnik-let.
English: The RMP of all these products should be updated accordingly.
Slovenian: V skladu s tem je treba posodobiti RMP za vsa ta zdravila.
English: Further, in a number of cases, blood glucose values were only moderately increased or normal.
Slovenian: Poleg tega so bile v številnih primerih vrednosti glukoze v krvi le zmerno zvišane ali normalne.
English: A safety warning on DKA was issued by the FDA for this therapeutic class in the same month.
Slovenian: Isti mesec je FDA izdala varnostno opozorilo o DKA za ta terapevtski razred.
English: No definite conclusion could be drawn regarding dose relationship or protective or exacerbating effect of concomitant medicines.
Slovenian: Dokončnih zaključkov o povezavi z odmerkom ali o zaščitnih ali poslabševalnih učinkih sočasnih zdravil ni bilo mogoče podati.
English: The MAHs are required to submit the final study report to the EMA as they become available.
Slovenian: Imetniki dovoljenj za promet z zdravili morajo predložiti končno poročilo o študiji agenciji EMA, takoj ko bo na voljo.
English: Taking into account the severity of these cases and the general pattern seen across these medicinal products, the European Commission requested, on the 10 of June 2015 and pursuant to Article 20 of Regulation No 726/2004, the opinion of the Agency on whether the marketing authorisation of canagliflozin-, dapagliflozin- and empagliflozin-containing medicinal products, should be maintained, varied, suspended or revoked.
Slovenian: Z upoštevanjem resnosti teh primerov in splošnega vzorca, ki je razviden pri vseh teh zdravilih, je Evropska komisija 10. junija 2015 v skladu s členom 20 Uredbe št. 726/2004 zahtevala mnenje agencije o tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo kanagliflozin, dapagliflozin in empagliflozin, ohranijo, spremenijo, začasno umaknejo ali razveljavijo.
English: SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Slovenian: SGLT2 se izraža v proksimalnih ledvičnih tubulih in je odgovoren za večji del ponovne absorpcije filtrirane glukoze iz lumna tubulov.
English: Although the MAHs estimated slightly different incidence rates, these were not all calculated according to the international standards for computation of incidence rate.
Slovenian: Čeprav so bile ocene pojavnosti, ki so jih navedli imetniki dovoljenj za promet z zdravili, nekoliko drugačne, vse niso bile izračunane po mednarodnih standardih za izračun stopnje pojavnosti.
English: Those studies are expected to enable better characterisation of the risk of DKA and its mechanism and should be included in the RMP of those products.
Slovenian: S temi študijami naj bi bolje opredelili tveganje za DKA in njen mehanizem, kar je treba vključiti tudi v RMP za ta zdravila.
English: In addition treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Slovenian: Poleg tega je treba pri bolnikih, ki so hospitalizirani zaradi večjih kirurških posegov ali hude akutne bolezni, zdravljenje prekiniti.
English: In the EU, three SGLT2 inhibitors are currently authorised as monocomponent and as fixed dose combination with metformin: canagliflozin (Invokana and Vokanamet), dapagliflozin (Forxiga and Xigduo) and empagliflozin (Jardiance and Synjardy).
Slovenian: V EU so trenutno odobreni trije zaviralci SGLT2 v monokomponentni obliki in v kombinaciji z metforminom s fiksnim odmerkom: kanagliflozin (zdravili Invokana in Vokanamet), dapagliflozin (zdravili Forxiga in Xigduo) in empagliflozin (zdravili Jardiance in Synjardy).
English: Overall the reported cases were poorly documented and the MAHs are requested to implement targeted follow up questionnaires, in order to document consistent information on the cases.
Slovenian: Na splošno so bili primeri, o katerih so poročali, slabo dokumentirani, zato morajo imetniki dovoljenj za promet z zdravili uvesti ciljno usmerjene vprašalnike za spremljanje, s katerimi bodo dosledno dokumentirali informacije o primerih.
English: Diabetic ketoacidosis (DKA) is a serious, often life-threatening condition, which usually develops in diabetic patients when insulin levels are too low.
Slovenian: Diabetična ketoacidoza (DKA) je resno, pogosto življenjsko nevarno stanje, ki se običajno pojavi pri bolnikih s sladkorno boleznijo, kadar je raven insulina prenizka.
English: A search in Eudravigilance (EV) database was performed by the EMA on 19 May 2015 for the three SGLT2 inhibitors.
Slovenian: Agencija EMA je 19. maja 2015 za omenjene tri zaviralce SGLT2 opravila iskanje v podatkovni bazi Eudravigilance (EV).
English: Ketone bodies have a low pKa and therefore their accumulation in the blood lead to acidosis.
Slovenian: Ketonska telesa imajo nizko vrednost pKa, zato njihovo kopičenje v krvi povzroča acidozo.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for SGLT2 inhibitors-containing medicinal products.
Slovenian: • odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravila, ki vsebujejo zaviralce SGLT2.