FrancophonIA/ELRC3.0 huggingface dataset:
English: The risks and benefits of re-administering sebelipase alfa following a severe reaction should be considered.
Slovenian: Upoštevati je treba koristi in tveganja ponovnega zdravljenja s sebelipazo alfa po hudi reakciji.
English: • Information to healthcare professionals that it is the responsibility of the MAH to provide the test for the monitoring of ADA positive patients including the modalities for requesting the test.
Slovenian: • Informacije za zdravstvene delavce o tem, da je odgovornost imetnika dovoljenja za promet z zdravilom zagotoviti preskus za spremljanje ADA-pozitivnih bolnikov, vključno z načini, kako tak preskus zahtevati.
English: Children and adults with LAL deficiency
Slovenian: Otroci in odrasli s pomanjkanjem LAL
English: 12-17 years old N=23
Slovenian: 12 do 17 let starosti n=23
English: This medicine may contain egg proteins.
Slovenian: Zdravilo lahko vsebuje jajčne beljakovine.
English: Of the 32 patients who had a liver biopsy at study entry, 100% had fibrosis and 31% had cirrhosis.
Slovenian: Od 32 bolnikov, pri katerih so ob vstopu v študijo opravili biopsijo jeter, jih je imelo 100% fibrozo in 31% cirozo.
English: What you need to know before KANUMA is given
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo KANUMA
English: This means that it replaces the missing or defective LAL enzyme in patients with LAL deficiency.
Slovenian: To pomeni, da nadomesti manjkajoči ali okvarjeni encim LAL pri bolnikih s pomanjkanjem LAL.
English: The age range of patients with biopsy evidence of cirrhosis was 4-21 years old.
Slovenian: Starostni razpon bolnikov s cirozo, dokazano z biopsijo, je bil od 4 do 21 let.
English: Open-label period
Slovenian: Odprto obdobje
English: Table 3: Primary and secondary efficacy endpoints in LAL-CL02 Endpoint
Slovenian: Preglednica 3: Primarni in sekundarni opazovani dogodki učinkovitosti v študiji LAL-CL02
English: There are no data from studies in breast-feeding women.
Slovenian: Ni podatkov iz študij z ženskami, ki dojijo.
English: The safety objectives should focus on hypersensitivity reactions, particularly anti-drug antibodies development impacting response to drug.
Slovenian: Cilji za varnostni bi se morali osredotočiti na preobčutljivostne reakcije, zlasti razvoj protiteles proti zdravilu, ki vplivajo na odziv na zdravilo.
English: You should not be given KANUMA if you are pregnant unless clearly necessary.
Slovenian: Če ste noseči, zdravila KANUMA ne smete dobiti, razen če je nujno potrebno.
English: Following the first sebelipase alfa infusion, including the first infusion after a dose escalation, patients should be observed for 1 hour in order to monitor for any signs or symptoms of anaphylaxis or a severe hypersensitivity reaction.
Slovenian: Po prvem infundiranju sebelipaze alfa, vključno s prvo infuzijo po povečanjku odmerka, je treba bolnike opazovati 1 uro in spremljati morebitne znake ali simptome anafilaksije ali hudih preobčutljivostnih reakcij.
English: Twenty-four patients were aged 411 years, 23 were aged 12-17 years, and 18 were aged ≥ 18 years (Table 4).
Slovenian: Štiriindvajset bolnikov je bilo starih od 4 do 11 let, 23 jih je bilo starih od 12 do 17 let in 18 jih je bilo starih ≥ 18 let
English: The European Medicines Agency has deferred the obligation to submit the results of studies with KANUMA in one or more subsets of the paediatric population in LAL deficiency (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom KANUMA za eno ali več podskupin pediatrične populacije s pomanjkanjem LAL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The absolute reduction in mean ALT level was -57.9 U/l (-53%) in the sebelipase alfa-treated group and -6.7 U/l (-6%) in the placebo group.
Slovenian: Absolutno zmanjšanje povprečne ravni ALT je bilo -57,9 e./l (-53%) v skupini, zdravljeni s sebelipazo alfa, in -6,7 e./l (-6%) v skupini s placebom.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Slovenian: Za obvladovanje neželenih učinkov glejte poglavji 4.4 in 4.8.
English: KANUMA (n = 36)
Slovenian: Zdravilo KANUMA (n=36)
English: It is not known whether sebelipase alfa passes into breast milk; therefore it is recommended that you stop breast-feeding or using KANUMA treatment while breast-feeding.
Slovenian: Ni znano, ali sebelipaza alfa prehaja v materino mleko, zato priporočamo, da med dojenjem prenehate dojiti ali uporabljati zdravilo KANUMA.
English: These medicines may include antihistamines, fever-reducing medicines and/or corticosteroids (a type of antiinflammatory medicines).
Slovenian: Ta zdravila lahko vključujejo antihistaminike, zdravila za zbijanje zvišane telesne temperature in/ali kortikosteroide (vrsta protivnetnih zdravil).
English: c. The vials should not be shaken.
Slovenian: c. Vial ni dovoljeno stresati.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes; ATC code: not yet assigned
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi; oznaka ATC: še ni dodeljena
English: KANUMA should be administered by a trained healthcare professional who can manage medical emergencies.
Slovenian: Zdravilo KANUMA mora dajati usposobljen zdravstveni delavec, ki obvlada obravnavo nujnih zdravstvenih primerov.
English: Of patients with paired liver biopsies, 63% (10/16) of KANUMA-treated patients had improvement in hepatic steatosis (at least ≥ 5% reduction) as measured by morphometry compared to 40% (4/10) of placebo patients.
Slovenian: Pri bolnikih s parnimi jetrnimi biopsijami se je pri 63% (10/16) bolnikov, zdravljenih z zdravilom KANUMA, jetrna steatoza izboljšala (vsaj ≥ 5-% zmanjšanje), izmerjeno z morfometrijo, v primerjavi s 40% (4/10) bolnikov s placebom.
English: KANUMA should be administered through a 0.2 μm filter (see section 6.6).
Slovenian: Zdravilo KANUMA je treba dati skozi filter velikosti 0,2 μm (glejte poglavje 6.6).
English: Adverse reactions are listed by System Organ Class and frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
English: The most serious adverse reactions experienced by 3% of patients in clinical studies were signs and symptoms consistent with anaphylaxis.
Slovenian: Najresnejši neželeni učinki, ki so jih doživeli 3% bolnikov v kliničnih študijah, so bili znaki in simptomi, skladni z anafilakso.
English: From baseline to week 48, mean weight-for-age percentile improved from 12.74% to 29.83% and mean serum albumin levels increased from 26.7 g/l to 38.7 g/l.
Slovenian: Od izhodišča do 48. tedna se je povprečni percentil telesne mase glede na starost izboljšal z 12,74% na 29,83%, povprečne ravni serumskega albumina pa so se povečale s 26,7 g/l na 38,7 g/l.
English: The total volume of the infusion should be administered over approximately 2 hours.
Slovenian: Skupno količino infuzije je treba dati v približno 2-urnem obdobju.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala z 10 ml
English: For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.
Slovenian: Pri bolnikih, ki so med infundiranjem imeli alergijske reakcije, je potrebna previdnost pri ponovnem dajanju.
English: The safety and efficacy of KANUMA in overweight patients have not been thoroughly evaluated and therefore no alternative dose regimens can be recommended for these patients at this time.
Slovenian: Varnost in učinkovitost zdravila Kanuma pri bolnikih s prekomerno telesno maso ni bila celovito ocenjena, zato za to skupino bolnikov trenutno ni mogoče priporočiti alternativnih režimov odmerjanja.
English: In addition to liver disease, patients with LAL deficiency experience increased risk for cardiovascular disease and accelerated atherosclerosis.
Slovenian: Poleg bolezni jeter se pri bolnikih s pomanjkanjem LAL pojavi večje tveganje za srčno-žilna obolenja in pospešeno aterosklerozo.
English: Side effects were seen while patients were being given the medicine or shortly after (infusion reactions).
Slovenian: Neželeni učinki so se pojavili pri bolnikih med prejemanjem zdravila ali tik po tem (reakcija na infuzijo).
English: This medicinal product may contain traces of egg proteins.
Slovenian: To zdravilo lahko vsebuje sledove jajčnih beljakovin.
English: The difference in exposures to sebelipase alfa between the once weekly 0.35 mg/kg and 3 mg/kg groups was more than dose proportional, with a 8.6-fold increase in dose resulting in a 9.6-fold increase in exposure for AUC and a 10.0-fold increase for Cmax.
Slovenian: Razlika v izpostavljenostih sebelipazi alfa v skupini 0,35 mg/kg enkrat na teden in 3 mg/kg je bila več kot sorazmerna z odmerkom, z 8,6kratnim povečanjem odmerka, kar je povzročilo 9,6-kratno povečanje izpostavljenosti za AUC in 10,0-kratno povečanje za Cmax.
English: • Warning and precautions on the the risk of hypersensitivity including anaphylaxis or ADA development, with particular reference to symptoms, time to onset and severity.
Slovenian: • opozorilo in previdnostne ukrepe glede tveganja preobčutljivosti, vključno z anafilaksijo, ali za razvoj ADA, s posebnim poudarkom na simptomih, času do pojava in resnosti.
English: One infant was treated with 5 mg/kg once weekly in LAL-CL03; no new adverse reactions were reported at this dose.
Slovenian: En dojenček je bil zdravljen s 5 mg/kg enkrat na teden pri LAL-CL3; o novih neželenih učinkih pri tem odmerku niso poročali.
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Slovenian: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francija
English: LAL-CL02 was a multicentre, double-blind, placebo-controlled study in 66 children and adults with LAL deficiency.
Slovenian: LAL-CL02 je bila multicentrična, dvojno slepa, s placebom nadzorovana študija pri 66 otrocih in odraslih s pomanjkanjem LAL.
English: Pharmacokinetic Parameter
Slovenian: Farmakokinetični parametri
English: LAL deficiency presenting in infants is a medical emergency with rapid disease progression over a period of weeks that is typically fatal within the first 6 months of life.
Slovenian: Pomanjkanje LAL pri dojenčkih je nujno zdravstveno stanje s hitrim napredovanjem bolezni v obdobju nekaj tednov, ki se običajno konča s smrtjo v prvih 6 mesecih življenja.
English: Tell your doctor if you or your child is on a controlled sodium diet.
Slovenian: Povejte svojemu zdravniku, če sta vi oziroma vaš otrokna dieti z nadzorovanim vnosom natrija.
English: Pack sizes: 1 vial containing 10 ml of concentrate.
Slovenian: Velikosti pakiranja: 1 viala, ki vsebuje 10 ml koncentrata.
English: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom
Slovenian: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA Velika Britanija
English: • Information on the ongoing LAL Deficiency Registry, including the importance of enrolling patients, also those not treated with Kanuma, and the modalities for participation.
Slovenian: Informacije o aktualnem Registru o pomanjkanju LAL, vključno s pomenom vpisovanja bolnikov, tudi tistih, ki niso zdravljeni z zdravilom Kanuma, in o načinih udeležbe.
English: The majority of patients (58%) had LDLcholesterol > 190 mg/dl at study entry, and 24% of patients with LDL-cholesterol > 190 mg/dl were on lipid lowering medicinal products.
Slovenian: Večina bolnikov (58%) je imela ob vstopu v študijo holesterol LDL > 190 mg/dl in 24% bolnikov, ki je imelo holesterol LDL > 190 ml/dl je jemalo zdravila za zmanjševanje maščob.
English: • Information on how to manage patients experiencing severe hypersensitivity reactions including anaphylaxis.
Slovenian: • Informacije o tem, kako ravnati z bolniki, ki doživijo hude preobčutljivostne reakcije, vključno z anafilaksijo.
English: Preparation of the sebelipase alfa infusion KANUMA should be prepared and used according to the following steps.
Slovenian: Priprava infuzije sebelipaze alfa Zdravilo KANUMA je treba pripraviti in uporabiti v skladu z naslednjimi koraki.
English: Table 4: Mean Population Pharmacokinetic Parameters
Slovenian: Preglednica 4: Povprečni parametri populacijske farmakokinetike
English: Medical or healthcare professionals are encouraged to participate and enrol all patients diagnosed with LAL deficiency in the LAL deficiency registry.
Slovenian: Medicinske oziroma zdravstvene delavce spodbujamo k sodelovanju in vpisu vseh bolnikov z diagnozo pomanjkanja LAL v register o pomanjkanju LAL.
English: The safety and efficacy of KANUMA in patients older than 65 years have not been evaluated and no alternative dose regimens can be recommended for these patients.
Slovenian: Varnost in učinkovitost zdravila KANUMA pri bolnikih, starejših od 65 let, nista bili ovrednoteni, zato priporočil o drugačnem režimu odmerjanja pri teh bolnikih ni mogoče dati.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sebelipase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s sebelipazo alfa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Following the occurrence of a hypersensitivity reaction, appropriate pre-treatment should be considered according to the standard of care (see section 4.4).
Slovenian: Po pojavu preobčutljivostne reakcije je treba razmisliti o ustrezni premedikaciji v skladu s standardno nego (glejte poglavje 4.4).
English: Sebelipase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Slovenian: Sebelipaza alfa je beljakovina in pričakuje se, da se bo s presnovo razgradila s pomočjo peptidne hidrolize.
English: The management of hypersensitivity reactions may include temporarily interrupting the infusion, lowering the infusion rate, and/or treatment with antihistamines, antipyretics, and/or corticosteroids.
Slovenian: Obvladovanje preobčutljivostne reakcije lahko vključuje začasno prekinitev infundiranja, zmanjšanje infuzijske hitrosti in/ali zdravljenje z antihistaminiki, antipiretiki in/ali kortikosteroidi.
English: It is not known whether sebelipase alfa is excreted in human milk.
Slovenian: Ni znano, ali se sebelipaza alfa izloča v materino mleko.
English: Most patients who developed ADA did so within the first 2 months of exposure.
Slovenian: Pri večini bolnikov se je ADA razvila v prvih 2 mesecih izpostavljenosti.
English: All patients were receiving 1 mg/kg once every other week.
Slovenian: Vsi bolniki so dobivali 1 mg/kg enkrat vsak drugi teden.
English: LAL deficiency is a rare disease associated with significant morbidity and mortality, which affects individuals from infancy through adulthood.
Slovenian: Pomanjkanje LAL je redka bolezen, povezana z znatno obolevnostjo in smrtnostjo, ki prizadene posameznike od dojenčkov do odraslih.
English: Chronic toxicity studies in juvenile cynomolgous monkeys showed no toxicity at doses up to 3 times the recommended dose in infants and 10 times the recommended dose in adults/children.
Slovenian: Študije kronične toksičnosti pri juvenilnih opicah cynomolgous niso pokazale toksičnosti pri odmerkih, ki so bili do 3-krat večji od priporočenega odmerka pri dojenčkih in 10-krat večji od priporočenega odmerka pri odraslih/otrocih.
English: In the historical cohort, 0 of 21 patients survived beyond 8 months of age (0% 12-month survival, 95% CI: 0% to
Slovenian: V zgodovinski kohorti ni nobeden od 21 bolnikov preživel več kot 8 mesecev (0% 12-mesečno preživetje, 95% IZ: 0% do 16%).
English: This medicine works by lowering the build-up of fat that causes medical complications, including impaired growth, liver damage and heart complications.
Slovenian: To zdravilo deluje tako, da zmanjšuje kopičenje maščobe, ki povzroča zdravstvene zaplete, vključno z moteno rastjo, poškodbo jeter in zapleti na srcu.
English: Frequency a
Slovenian: Pogostnost a
English: In clinical studies, doses of sebelipase alfa were explored up to 5 mg/kg once weekly and no specific signs or symptoms were identified following the higher doses.
Slovenian: V kliničnih preskušanjih so preučili odmerke sebelipaze alfa do 5 mg/kg enkrat na teden, pri višjih odmerkih pa niso opazili specifičnih znakov ali simptomov.
English: The most serious side effects may include an allergic reaction (seen very commonly [may affect more than 1 in 10 people] in infants younger than 6 months old, or commonly [may affect up to 1 in 10 people] in children and adults) with symptoms including difficulty breathing, swelling of the throat, rapid breathing, fast heartbeat, chest discomfort, mild swelling of eyelids, red eyes, runny nose, flushing, and hives.
Slovenian: Najresnejši neželeni učinki lahko vključujejo alergijsko reakcijo (zelo pogosto se je pojavila [pojavi se lahko pri več kot 1 od 10 bolnikov] pri dojenčkih, mlajših od 6 mesecev, ali pogosto [pojavi se lahko pri več kot 1 od 10 bolnikov] pri otrocih in odraslih - pojavi se lahko pri do 1 od 10 bolnikov) s simptomi, ki vključujejo težave z dihanjem, oteklost žrela, hitro dihanje, hiter srčni utrip, nelagodje v prsnem košu, blago oteklost vek, rdeče oči, izcedek iz nosu, oblivanje in koprivnico.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Patients were randomised to receive KANUMA at a dose of 1 mg/kg (n = 36) or placebo (n = 30) once every other week for 20 weeks in the double-blind period.
Slovenian: Bolniki so bili randomizirani za dobivanje zdravila KANUMA v odmerku 1 mg/kg (n=36) ali placeba (n=30) enkrat na teden na vsaka dva tedna v 20-tedenskem dvojno slepem obdobju.
English: The vials should not be frozen, heated or microwaved and should be protected from light.
Slovenian: Vial ni dovoljeno zamrzovati, segrevati ali dajati v mikrovalovno pečico; zaščititi jih je treba pred svetlobo.
English: Fifty-six of 84 patients (67%) who received sebelipase alfa during clinical studies (LAL-CL01/LALCL04, LAL-CL02 and LAL-CL03) were in the paediatric and adolescent age range (1 month up to 18 years).
Slovenian: Šestinpetdeset od 84 bolnikov (67 %), ki so v kliničnih študijah prejemali sebelipazo alfa (LALCL01/LAL-CL04, LAL-CL02 in LAL-CL03), je bilo pediatričnih bolnikov in mladostnikov (starih v razponu od 1 meseca do 18 let).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, or up to 12 hours below 25°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravilo ni porabljeno takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; čas običajno ne sme biti daljši kot 24 ur pri 2 °C do 8 °C ali do 12 ur pod 25 °C, razen če je redčenje potekalo v nadzorovanih in preverjenih aseptičnih pogojih.
English: Body temperature increased b,c
Slovenian: Preiskave pogosti zvišana telesna temperatura b,c
English: The following endpoints were assessed: normalisation of ALT, decrease in LDL-cholesterol, decrease in non-HDL-cholesterol, normalisation of AST, decrease in triglycerides, increase in HDLcholesterol, decrease in liver fat content assessed by multi-echo gradient echo magnetic resonance imaging (MEGE-MRI), and improvement in hepatic steatosis measured by morphometry.
Slovenian: Ocenjeni so bili naslednji opazovani dogodki: normalizacija ALT, zmanjšanje LDL-holesterola, zmanjšanje ne-HDL-holesterola, normalizacija AST, zmanjšanje trigliceridov, zvišanje HDLholesterola, zmanjšanje vsebnosti jetrnih maščob, ocenjeno s slikanjem z magnetno resonanco z multiodmevom in gradientnim odmevom (MEGE-MR-multi-echo gradient echo magnetic resonance imaging), in izboljšanje jetrne steatoze, izmerjeno z morfometrijo.
English: • Details on how to monitor for potential ADA formation following initiation of treatment with Kanuma, particularly in patients on Kanuma who experience clinically important hypersensitivity reactions or potential loss of clinical response.
Slovenian: • Podrobnosti o tem, kako spremljati potencialno nastajanje ADA po uvedbi zdravljenja z zdravilom Kanuma, zlasti pri bolnikih, ki jemljejo to zdravilo in ki doživijo klinično pomembne preobčutljivostne reakcije ali morebitno izgubo kliničnega odziva.
English: Anaphylaxis occurred during the infusion as late as 1 year after treatment initiation.
Slovenian: Anafilaksa se je med infundiranjem pojavila tudi še 1 leto po uvedbi zdravljenja.
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance when attempts to rechallenge are unsuccessful, or to egg or any of the excipients listed in section 6.1, (see section 4.4).
Slovenian: Življenjsko nevarna preobčutljivost (anafilaktična reakcija) na zdravilno učinkovino, če so poskusi ponovnega zdravljenja neuspešni, ali na jajca ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
English: *Sebelipase alfa is produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology.
Slovenian: *Sebelipaza alfa se pridobiva iz jajčnega beljaka transgene kokoši vrste Gallus s pomočjo rekombinantne DNA (rDNA) tehnologije.
English: It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.
Slovenian: Izboljša tudi ravni maščobe v krvi, vključno s povečanim LDL (slabim holesterolom) in trigliceridi (maščobami).
English: In LAL-CL03, 6 of 9 KANUMA-treated infants survived beyond 12 months (67% 12-month survival, 95% CI: 30% to 93%).
Slovenian: V LAL-CL03 je 6 od 9 dojenčkov, zdravljenih z zdravilom KANUMA, živelo več kot 12 mesecev (67% 12-mesečno preživetje, 95% IZ: 30% do 93%).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
English: This medicine is an enzyme replacement therapy.
Slovenian: To zdravilo je namenjeno terapiji z nadomestnimi encimi.
English: No accumulation was seen at 1 mg/kg (once weekly or once every other week) or 3 mg/kg once weekly.
Slovenian: Kopičenja pri 1 mg/kg niso opazili (enkrat na teden ali enkrat vsak drugi teden) ali 3 mg/kg enkrat na teden.
English: b. It is recommended to allow KANUMA vials to reach a temperature between 15°C and 25°C prior to reconstitution to minimize the potential for the formation of sebelipase alfa protein particles in solution.
Slovenian: b. Priporočljivo je, da viale z zdravilom KANUMA pred rekonstitucijo dosežejo sobno temperaturo med 15 in 25 ºC, da se zmanjša možnost nastajanja beljakovinskih delcev sebelipaze alfa v raztopini.
English: Clear glass vial (Type I) with a siliconised butyl rubber stopper, and an aluminium seal with a plastic flip-off cap, containing 10 ml of concentrate.
Slovenian: Brezbarvna steklena viala (tip I) s silikoniziranim zamaškom iz butilne gume in aluminijasto zaporo s plastično dvižno zaporko, ki vsebuje 10 ml koncentrata.
English: In LAL-CL03, sebelipase alfa was eliminated from the systemic circulation with a median T1/2 of 0.1 hr (range: 0.1-0.2) at the 3 mg/kg once weekly dose (n = 4).
Slovenian: V študiji LAL-CL03 je bila sebelipaza alfa izločena iz sistemske cirkulacije z mediano T1/2 0,1 ure (razpon: 0,1 do 0,2) pri odmerku 3 mg/kg enkrat na teden (n=4).
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Interim reports expected yearly
Slovenian: Vmesna poročila se pričakujejo enkrat letno