FrancophonIA/ELRC3.0 huggingface dataset:
English: Using aseptic technique, withdraw the volume of Brineura solution per required dose (see Table 1 in section 4.2) into the sterile syringe labelled “Brineura”.
Slovenian: Z aseptično tehniko izvlecite količino raztopine zdravila Brineura za potreben odmerek (glejte preglednico 1 v poglavju 4.2) v sterilno injekcijsko brizgo z napisom "Brineura".
English: See Figure 1.
Slovenian: Glejte sliko 1. 3.
English: This should be taken into consideration for patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
English: • Secure the components per institution standard of care.
Slovenian: • Komponente pritrdite v skladu s standardom nege, uveljavljenim v ustanovi.
English: Brineura treatment should be interrupted in cases of device failure and may require replacement of the access device prior to subsequent infusions.
Slovenian: Zdravljenje z zdravilom Brineura je treba v primeru okvare pripomočka prekiniti in morda bo treba pripomoček za dostop pred naslednjim infundiranjem zamenjati.
English: The implanted intracerebroventricular access device should be appropriate for accessing the cerebral ventricles for therapeutic administration.
Slovenian: Vsajeni pripomoček za intracerebroventrikularni dostop mora biti ustrezen za dostopanje do možganskih prekatov za terapevtsko apliciranje.
English: Treatment effect in patients receiving Brineura was assessed using the CLN2 clinical rating scale, and results were compared to the 2 points per 48 weeks predicted decline in the natural history control group.
Slovenian: Učinek zdravljenja pri bolnikih, ki so prejemali zdravilo Brineura, so ocenili z lestvico za klinično oceno CLN2, rezultate pa so primerjali s predvidenim upadom 2 točk na 48 tednov v kontrolni skupini z naravnim potekom.
English: 1 year to < 2 years: 200 mg (first 4 doses), 300 mg (all other doses) ≥ 2 years: 300 mg
Slovenian: od rojstva do < 6 mesecev: 100 mg od 6 mesecev do < 1 leto: 150 mg od 1 leta do < 2 leti: 200 mg (prvi 4 odmerki), 300 mg (vsi naslednji odmerki) ≥ 2 leti: 300 mg
English: After the medicine has been given, a shorter infusion of a solution is given to flush Brineura out of the infusion equipment so that the full dose reaches the brain.
Slovenian: Po dajanju zdravila se s krajšo infuzijo raztopine za izpiranje zdravilo Brineura izpere iz opreme za infundiranje, tako da možgane doseže polni odmerek.
English: For instructions on preparation of Brineura and flushing solution before administration, see section 6.6.
Slovenian: Za navodila glede priprave zdravila Brineura in raztopine za izpiranje pred dajanjem glejte poglavje 6.6.
English: It is used to treat patients with neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase-1 (TPP1) deficiency.
Slovenian: Uporablja se za zdravljenje bolnikov z nevronsko ceroidno lipofuscinozo tipa 2 (CLN2), ki je znana tudi kot pomanjkanje tripeptidil-peptidaze-1 (TPP1).
English: No prominent ataxia, no pathologic falls.
Slovenian: Ni izrazite ataksije, ni patoloških padcev.
English: Pack size: 3 vials (two vials of Brineura and one vial of flushing solution), each containing 5 ml of solution
Slovenian: Velikost pakiranja: 3 viale (dve viali zdravila Brineura in ena viala raztopine za izpiranje), od katerih vsaka vsebuje 5 ml raztopine
English: Attach the infusion set to the port needle (see Figure 1).
Slovenian: Infuzijski set priključite na iglo za pristopno odprtino (glejte sliko 1).
English: Anaphylaxis has not been reported with Brineura use during clinical trials; however, the risk of anaphylaxis cannot be excluded.
Slovenian: Za zdravilo Brineura med kliničnimi preskušanji niso poročali o anafilaksi, vendar pa tveganja anafilakse ni možno izključiti.
English: Discard the empty syringe in accordance with local requirements.
Slovenian: Prazno injekcijsko brizgo odstranite v skladu z lokalnimi zahtevami.
English: See the syringe pump manufacturer's operating manual for details.
Slovenian: Za podrobnosti glejte navodilo za uporabo izdelovalca črpalke.
English: This should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
English: Thaw before use.
Slovenian: Pred uporabo odtajajte.
English: CSF samples should routinely be sent for infection monitoring (see section 4.4).
Slovenian: rutinsko pošiljajte v pregled za spremljanje okužb (glejte poglavje 4.4).
English: Following Brineura infusion, a calculated amount of flushing solution must be used to flush the infusion components including the intracerebroventricular access device in order to fully administer Brineura and to maintain patency of the intracerebroventricular access device (see section 6.6).
Slovenian: Po infundiranju zdravila Brineura je treba uporabiti preračunano količino raztopine in izprati infuzijski pribor, vključno s pripomočkom za intracerebroventrikularni dostop, da se zdravilo Brineura aplicira v celoti in da se ohranja prehodnost pripomočka za intracerebroventrikularni dostop (glejte poglavje 6.6).
English: Drug-specific neutralizing antibodies (NAb) capable of inhibiting receptor-mediated cellular uptake of cerliponase alfa were not detected in the CSF.
Slovenian: Za zdravilo specifičnih nevtralizirajočih protiteles (NAb, neutralizing antibodies), ki lahko zavrejo celični privzem cerliponaze alfa, pri katerem posredujejo receptorji, v CSL niso odkrili.
English: The pump must be programmable to deliver the medicinal product at a constant rate of 2.5 ml/hr.
Slovenian: Programiranje črpalke mora omogočiti dovajanje zdravila s stalno hitrostjo 2,5 ml/uro.
English: Renal elimination of cerliponase alfa is considered a minor pathway for clearance.
Slovenian: Velja, da je izločanje cerliponaze alfa skozi ledvice manj pomembna pot izločanja.
English: Meningitis may present with the following symptoms: fever, headache, neck stiffness, light sensitivity, nausea, vomiting, and change in mental status.
Slovenian: Meningitis je lahko prisoten z naslednjimi simptomi: zvišana telesna temperatura, glavobol, otrdel vrat, občutljivost na svetlobo, slabost, bruhanje in spremembe v mentalnem stanju.
English: Brineura will be given by a doctor with knowledge of giving medicines by intracerebroventricular use (infusion into the fluid of the brain) in a hospital or clinic.
Slovenian: Zdravilo Brineura vam bo dal zdravnik, ki je usposobljen za intracerebroventrikularno dajanje zdravil (infuzija v likvor v možganih) v bolnišnici ali kliniki.
English: Table 2: Frequency of adverse reactions with Brineura
Slovenian: Preglednica 2: Pogostnost neželenih učinkov pri zdravilu Brineura
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Using aseptic technique, withdraw the appropriate amount of flushing solution from the vial into the new sterile syringe labelled “flushing solution”.
Slovenian: Z aseptično tehniko izvlecite potrebno količino raztopine za izpiranje iz viale v novo sterilno injekcijsko brizgo z oznako "raztopina za izpiranje".
English: The inline filter should be placed as close as practically possible to the port needle.
Slovenian: Filter v liniji je treba namestiti čim bliže igli za pristopno odprtino.
English: *Cerliponase alfa is produced in mammalian Chinese Hamster Ovary cells.
Slovenian: *Cerliponaza alfa je pridobljena iz celic sesalcev (celic jajčnika kitajskega hrčka).
English: Other medicines and Brineura
Slovenian: Druga zdravila in zdravilo Brineura
English: Your doctor or pharmacist is responsible for storing Brineura.
Slovenian: Za shranjevanje zdravila Brineura je odgovoren vaš zdravnik ali farmacevt.
English: Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Slovenian: Zdravilo Brineura je indicirano za zdravljenje nevronske ceroidne lipofuscinoze tipa 2 (CLN2), znane tudi kot pomanjkanje tripeptidil-peptidaze 1 (TPP1).
English: It is not known if Brineura will impact the ability to drive or use machines.
Slovenian: Ni znano, ali zdravilo Brineura vpliva na sposobnost vožnje ali upravljanja strojev.
English: Vial (type I glass) with a stopper (butyl rubber), a flip-off cap (polypropylene) and crimp seal (aluminium).
Slovenian: Viala (steklo tipa I) z zamaškom (butilna guma), dvižna zaporka (polipropilen) in zgubana aluminijasta zaporka (aluminij).
English: This medicinal product contains 44 mg sodium per vial of Brineura and flushing solution.
Slovenian: To zdravilo vsebuje 44 mg natrija na vialo zdravila Brineura in raztopine za izpiranje.
English: Volume of Brineura solution (ml)
Slovenian: Brineura (ml)
English: Signs that you or your child may have an infection include fever, headache, neck stiffness, light sensitivity, nausea, vomiting, and change in mental status.
Slovenian: Znaki, da imate morda vi ali vaš otrok okužbo, vključujejo povišano telesno temperaturo, glavobol, otrdel vrat, občutljivost na svetlobo, slabost, bruhanje in spremembe v duševnem stanju.
English: Prepare the scalp for intracerebroventricular infusion using aseptic technique per institution standard of care.
Slovenian: Lasišče pripravite za intracerebroventrikularno infundiranje z uporabo aseptične tehnike in v skladu s standardom nege, uveljavljenim v ustanovi.
English: Pack size of three vials: two 10 ml vials, each containing 150 mg of cerliponase alfa in 5 ml of solution; and one 10 ml vial, containing 5 ml flushing solution.
Slovenian: Velikost pakiranja treh vial: dve 10-ml viali, od katerih vsaka vsebuje 150 mg cerliponaze alfa v 5 ml raztopine, in ena 10-ml viala, ki vsebuje 5 ml raztopine za izpiranje.
English: Each vial contains 44 mg of sodium.
Slovenian: Ena viala vsebuje 44 mg natrija.
English: Do not shake vials.
Slovenian: Vial ne stresajte.
English: Brineura is compatible with disposable infusion components made of PVC, PVC (non-DEHP) polyethylene, polyethersulfone (PES), polypropylene (PP), and PTFE.
Slovenian: PVC, PVC (ne-DEHP) polietilena, polietersulfona (PES), polipropilena (PP) in PTFE.
English: No studies on the effect of Brineura on the ability to drive or use machines have been performed.
Slovenian: Študij o vplivu zdravila Brineura na sposobnost vožnje ali upravljanja strojev niso izvedli.
English: Consultation with a neurosurgeon may be needed to confirm the integrity of the device.
Slovenian: Morda se bo za potrditev nepoškodovanosti pripomočka treba posvetovati z nevrokirurgom.
English: CSF samples should routinely be sent for testing to detect subclinical device infections.
Slovenian: Vzorce CSL je treba rutinsko pošiljati na testiranje za odkrivanje subkliničnih okužb pripomočka.
English: Excretion
Slovenian: Ekskrecija
English: Determine the volume of flushing solution needed to ensure complete delivery of Brineura to the cerebral ventricles.
Slovenian: Določite količino potrebne raztopine za izpiranje, ki jo potrebujete, da zagotovite dovajanje celotne količine zdravila Brineura v možganske prekate.
English: Attach the syringe containing Brineura to the extension line, if used, otherwise connect the syringe to the infusion set.
Slovenian: Injekcijsko brizgo, ki vsebuje zdravilo Brineura, priključite na podaljšek linije, če ga uporabljate, sicer pa injekcijsko brizgo priključite na infuzijski set.
English: Remove the yellow flip-off cap from the flushing solution vial.
Slovenian: Odstranite rumeno dvižno zaporko z viale z raztopino za izpiranje.
English: Rate of Decline (points/48 weeks)a Overall (n = 23)
Slovenian: (točke/48 tednov)a
English: No association was found between serum or CSF ADA titres and incidence or severity of hypersensitivity.
Slovenian: Povezave med titri ADA v serumu ali CSL in incidenco ali resnostjo preobčutljivosti niso ugotovili.
English: Common Common Not known Very common a Propionibacterium acnes, staphylococcus epidermis b Atonic seizures, clonic convulsion, drop attacks, epilepsy, generalised tonic-clonic seizure, myoclonic epilepsy, partial seizures, petit mal epilepsy, seizure, seizure cluster, and status epilepticus c Pyrexia includes combined preferred terms “Pyrexia” and “Increased body temperature” d Catheter flow obstruction e Device dislocation did not occur in clinical trials f Dislodgement of infusion needle
Slovenian: Težave s pripomočkom: puščanje pripomočka zamašitev pripomočkad premik pripomočkae težave z iglof pogosti pogosti neznana pogostnost zelo pogosti a Propionibacterium acnes, staphylococcus epidermis b Atonični epileptični napadi, klonične konvulzije, drop-atake, epilepsija, generalizirani tonično-klonični napadi, mioklonična epilepsija, napadi parcialnega izvora, epilepsija petit mal, epileptični napad, epileptični napadi v rafalih in status epilepticus c Pireksija vključuje kombinirana prednostna izraza "pireksija" in "zvišana telesna temperatura"
English: Brineura is administered to the cerebrospinal fluid (CSF) by infusion via a surgically implanted reservoir and catheter (intracerebroventricular access device).
Slovenian: Zdravilo Brineura se daje v cerebrospinalni likvor (CSL) z infundiranjem skozi kirurško vsajen zbiralnik in kateter (pripomoček za intracerebroventrikularni dostop).
English: Your doctor will monitor you or your child for symptoms of life threatening allergic reactions, 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: Zdravnik bo vas ali vašega otroka spremljal glede pojava simptomov življenje ogrožajočih alergijskih reakcij, 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: Vertical bars represent standard error of the mean Solid line: 190-201 and 190-202 clinical studies Dash line: 190-901 Natural history control group
Slovenian: Navpične črte predstavljajo standardno napako povprečja Neprekinjena črta: klinični študiji 190-201 in 190-202
English: - This includes any possible side effects not listed in this leaflet.
Slovenian: - Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj, je za shranjevanje zdravila med uporabo in za pogoje pred uporabo odgovoren uporabnik.
English: Inspect the scalp for signs of intracerebroventricular access device leakage or failure and for potential infections.
Slovenian: Na lasišču preverite, ali najdete znake puščanja ali okvare pripomočka za intracerebroventrikularni dostop in znake možnih okužb.
English: Detach and remove the empty syringe from the pump and disconnect from the infusion line.
Slovenian: Prazno injekcijsko brizgo odklopite od črpalke in jo odstranite ter ločite od infuzijske linije.
English: of all convulsion events were considered related to cerliponase alfa and ranged from mild to severe, CTCAE grade 1-4.
Slovenian: Na splošno je bilo 6 % vseh dogodkov konvulzije obravnavanih, kot da so povezani s cerliponazo alfa, pri čemer so segali od blagih do resnih, stopnje 1 do 4 po CTCAE.
English: Intracerebroventricular use
Slovenian: intracerebroventrikularna uporaba
English: • A non-coring port needle with a gauge of 22 or smaller and a suggested length of 16 mm.
Slovenian: • Igla za pristopno odprtino, ki ne izrezuje (non-coring port needle), velikosti 22 ali manjša, s priporočeno dolžino 16 mm. Za priporočila glede igle za pristopno odprtino glejte priporočila izdelovalca pripomočka za intracerebroventrikularni dostop.
English: Do not use if the solutions are discoloured or if there is other foreign particulate matter in the solutions.
Slovenian: Raztopine ne uporabljajte, če je neustrezne barve ali so v raztopini drugi tujki.
English: Brineura vials may occasionally contain thin translucent fibres or opaque particles.
Slovenian: Viale zdravila Brineura lahko občasno vsebujejo tanka prosojna vlakna ali motne delce.
English: Common side effects (may affect up to 1 in 10 people): device-related bacterial infections slower heart beat device does not function correctly due to a blockage detected during preparation for infusion
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): bakterijske okužbe zaradi pripomočka upočasnjeno bitje srca nepravilno delovanje pripomočka zaradi zamašitve, odkrite med pripravo na infundiranje
English: - The other ingredients of Brineura and the flushing solution are: sodium phosphate dibasic heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections (see section 2 “Brineura contains sodium”)
Slovenian: - Druge sestavine zdravila Brineura in raztopine za izpiranje so: dvobazni natrijev fosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, kalcijev klorid dihidrat in voda za injekcije (glejte poglavje 2 "Zdravilo Brineura vsebuje natrij").
English: There was no apparent effect of serum or CSF ADA on the plasma or CSF pharmacokinetics, respectively.
Slovenian: Ni bilo opaznega učinka ADA v serumu ali CSL na farmakokinetiko v plazmi ali CSL.
English: Prime the infusion components with Brineura.
Slovenian: Napolnite komponente za infundiranje z zdravilom Brineura.
English: Brineura has a green flip-off cap and flushing solution has a yellow flip-off cap.
Slovenian: Zdravilo Brineura ima zeleno dvižno zaporko, raztopina za izpiranje pa ima rumeno dvižno zaporko.
English: These naturally occurring particles are cerliponase alfa.
Slovenian: Ti delci so v cerliponazi alfa prisotni naravno.
English: Do not mix Brineura with any other medicinal product.
Slovenian: Zdravila Brineura ne mešajte z drugimi zdravili.
English: You or your child will need to have surgery to implant the device for giving Brineura.
Slovenian: Vi ali vaš otrok potrebujete operacijo za vsaditev pripomočka, po katerem se daje zdravilo Brineura.
English: - If you or your child gets any side effects, talk to your doctor.
Slovenian: - Če opazite pri vas ali vašem otroku kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: There is limited experience in a few patients aged 2 years old.
Slovenian: Pri bolnikih, starih 2 leti, je malo izkušenj z le nekaj bolniki.
English: Name and address of the manufacturers of the biological active substance
Slovenian: ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev biološke učinkovine
English: Do not use this medicine after the expiry date, which is stated on the vials and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vialah in ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Brineura 150 mg solution for infusion
Slovenian: Brineura 150 mg raztopina za infundiranje
English: Each ml of solution for infusion contains 30 mg of cerliponase alfa.
Slovenian: En mililiter raztopine za infundiranje vsebuje 30 mg cerliponaze alfa.
English: Solution for infusion Two vials of Brineura One vial of flushing solution
Slovenian: raztopina za infundiranje dve viali zdravila Brineura ena viala raztopine za izpiranje
English: Brineura must only be administered by a trained healthcare professional knowledgeable in intracerebroventricular administration in a healthcare setting.
Slovenian: Zdravilo Brineura sme dajati le usposobljen zdravstveni delavec z ustreznim znanjem za intracerebroventrikularni način uporabe zdravila v bolnišničnih pogojih.
English: Common signs of device leakage and device failure include swelling, erythema of the scalp, extravasation of fluid, or bulging of the scalp around or above the intracerebroventricular access device.
Slovenian: Pogosti znaki puščanja in nedelovanja pripomočka vključujejo oteklino, eritem lasišča, ekstravazacijo tekočine, izbočenost lasišča okoli pripomočka za intracerebroventrikularni dostop ali nad njim.
English: Store upright in a freezer (-25°C to -15°C).
Slovenian: Shranjujte pokonci v zamrzovalniku (-25 °C do -15 °C).
English: Brineura should be given to a pregnant woman only if clearly needed.
Slovenian: Zdravilo Brineura se lahko daje nosečnicam le, kadar je nujno potrebno.
English: If you or your child gets any side effects, talk to your doctor.
Slovenian: Če pri vas ali vašem otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom.
English: Brineura must not be administered as long as there are signs of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.2 and 4.4).
Slovenian: Zdravila Brineura se ne sme dajati, dokler so prisotni znaki akutnega puščanja pripomočka za intracerebroventrikularni dostop, okvare pripomočka ali okužbe, povezane s pripomočkom (glejte poglavji 4.2 in 4.4).
English: Healthcare professionals should inspect the scalp for skin integrity to ensure the intracerebroventricular access device is not compromised prior to each infusion.
Slovenian: Zdravstveni delavci morajo pred vsakim infundiranjem preveriti stanje kože na lasišču, da potrdijo nepoškodovanost pripomočka za intracerebroventrikularni dostop.
English: Each vial of Brineura and flushing solution are intended for single use only.
Slovenian: Vsaka viala zdravila Brineura in raztopine za izpiranje je samo za enkratno uporabo.
English: Convulsions
Slovenian: Konvulzije
English: Package leaflet: Information for the user Brineura 150 mg solution for infusion cerliponase alfa This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Brineura 150 mg raztopina za infundiranje cerliponaza alfa Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Domain Score
Slovenian: Domena Rezultat
English: Do not re-freeze vials or freeze syringes containing Brineura or flushing solution.
Slovenian: Vial ne zamrzujte ponovno in ne zamrzujte injekcijskih brizg, ki vsebujejo zdravilo Brineura in raztopino za izpiranje.
English: Currently no clinical experience of Brineura in children below 2 years of age is available.
Slovenian: Trenutno ni kliničnih izkušenj z zdravilom Brineura pri otrocih, mlajših od 2 let.
English: Inspection of the infusion site and a patency check must be performed to detect intracerebroventricular access device leakage and/or failure prior to initiation of Brineura infusion (see section 4.2 and 4.3).
Slovenian: Opraviti je treba pregled mesta infundiranja in prehodnosti, da se ugotovi puščanje in/ali nedelovanje pripomočka za intracerebroventrikularni dostop, preden se uvede infundiranje zdravila Brineura (glejte poglavji 4.2 in 4.3).
English: • Do not deliver as a bolus or manually.
Slovenian: • Dajanje bolusa ali ročno dovajanje ni dovoljeno.
English: The infusion rate for Brineura and the flushing solution is 2.5 ml/hour.
Slovenian: Hitrost infundiranja zdravila Brineura in raztopine za izpiranje je 2,5 ml/uro.
English: Discard the needle and the vial with the remaining solution per local requirements.
Slovenian: Iglo in vialo s preostalo raztopino zavrzite v skladu z lokalnimi zahtevami.
English: Signs of problems with the device include swelling, redness of the scalp, fluid leaking from device and bulging of the scalp.
Slovenian: Znaki težav s pripomočkom vključujejo oteklino, rdečico na lasišču, iztekanje tekočine iz pripomočka in izbočenost lasišča.
English: Brineura and the flushing solution must only be administered by the intracerebroventricular route.
Slovenian: Zdravilo Brineura in raztopino za izpiranje je dovoljeno dajati le po intracerebroventrikularni poti.
English: Brineura 150 mg solution for infusion cerliponase alfa
Slovenian: Brineura 150 mg raztopina za infundiranje cerliponaza alfa
English: Breastfeeding should be discontinued during treatment with Brineura.
Slovenian: Med zdravljenjem z zdravilom Brineura je treba prenehati z dojenjem.
English: Store upright in a freezer (-20°C ± 5°C).
Slovenian: Shranjujte pokonci v zamrzovalniku (-20 °C ± 5 °C).