natgillin/translations-raw huggingface dataset:
The most serious adverse reactions experienced by 3% of patients in clinical studies were signs and symptoms consistent with anaphylaxis.
Najresnejši neželeni učinki, ki so jih doživeli 3% bolnikov v kliničnih študijah, so bili znaki in simptomi, skladni z anafilakso.
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.
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.
The total volume of the infusion should be administered over approximately 2 hours.
Skupno količino infuzije je treba dati v približno 2-urnem obdobju.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala z 10 ml
For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.
Pri bolnikih, ki so med infundiranjem imeli alergijske reakcije, je potrebna previdnost pri ponovnem dajanju.
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.
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.
In addition to liver disease, patients with LAL deficiency experience increased risk for cardiovascular disease and accelerated atherosclerosis.
Poleg bolezni jeter se pri bolnikih s pomanjkanjem LAL pojavi večje tveganje za srčno-žilna obolenja in pospešeno aterosklerozo.
Side effects were seen while patients were being given the medicine or shortly after (infusion reactions).
Neželeni učinki so se pojavili pri bolnikih med prejemanjem zdravila ali tik po tem (reakcija na infuzijo).
This medicinal product may contain traces of egg proteins.
To zdravilo lahko vsebuje sledove jajčnih beljakovin.
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.
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.
• Warning and precautions on the the risk of hypersensitivity including anaphylaxis or ADA development, with particular reference to symptoms, time to onset and severity.
• opozorilo in previdnostne ukrepe glede tveganja preobčutljivosti, vključno z anafilaksijo, ali za razvoj ADA, s posebnim poudarkom na simptomih, času do pojava in resnosti.
One infant was treated with 5 mg/kg once weekly in LAL-CL03; no new adverse reactions were reported at this dose.
En dojenček je bil zdravljen s 5 mg/kg enkrat na teden pri LAL-CL3; o novih neželenih učinkih pri tem odmerku niso poročali.
Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francija
LAL-CL02 was a multicentre, double-blind, placebo-controlled study in 66 children and adults with LAL deficiency.
LAL-CL02 je bila multicentrična, dvojno slepa, s placebom nadzorovana študija pri 66 otrocih in odraslih s pomanjkanjem LAL.
Pharmacokinetic Parameter
Farmakokinetični parametri
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.
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.
Tell your doctor if you or your child is on a controlled sodium diet.
Povejte svojemu zdravniku, če sta vi oziroma vaš otrokna dieti z nadzorovanim vnosom natrija.
Pack sizes: 1 vial containing 10 ml of concentrate.
Velikosti pakiranja: 1 viala, ki vsebuje 10 ml koncentrata.
Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom
Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA Velika Britanija
• Information on the ongoing LAL Deficiency Registry, including the importance of enrolling patients, also those not treated with Kanuma, and the modalities for participation.
Informacije o aktualnem Registru o pomanjkanju LAL, vključno s pomenom vpisovanja bolnikov, tudi tistih, ki niso zdravljeni z zdravilom Kanuma, in o načinih udeležbe.
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.
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.
• Information on how to manage patients experiencing severe hypersensitivity reactions including anaphylaxis.
• Informacije o tem, kako ravnati z bolniki, ki doživijo hude preobčutljivostne reakcije, vključno z anafilaksijo.
Preparation of the sebelipase alfa infusion KANUMA should be prepared and used according to the following steps.
Priprava infuzije sebelipaze alfa Zdravilo KANUMA je treba pripraviti in uporabiti v skladu z naslednjimi koraki.
Table 4: Mean Population Pharmacokinetic Parameters
Preglednica 4: Povprečni parametri populacijske farmakokinetike
Medical or healthcare professionals are encouraged to participate and enrol all patients diagnosed with LAL deficiency in the LAL deficiency registry.
Medicinske oziroma zdravstvene delavce spodbujamo k sodelovanju in vpisu vseh bolnikov z diagnozo pomanjkanja LAL v register o pomanjkanju LAL.
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.
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.
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.
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.
Following the occurrence of a hypersensitivity reaction, appropriate pre-treatment should be considered according to the standard of care (see section 4.4).
Po pojavu preobčutljivostne reakcije je treba razmisliti o ustrezni premedikaciji v skladu s standardno nego (glejte poglavje 4.4).
Sebelipase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Sebelipaza alfa je beljakovina in pričakuje se, da se bo s presnovo razgradila s pomočjo peptidne hidrolize.
The management of hypersensitivity reactions may include temporarily interrupting the infusion, lowering the infusion rate, and/or treatment with antihistamines, antipyretics, and/or corticosteroids.
Obvladovanje preobčutljivostne reakcije lahko vključuje začasno prekinitev infundiranja, zmanjšanje infuzijske hitrosti in/ali zdravljenje z antihistaminiki, antipiretiki in/ali kortikosteroidi.
It is not known whether sebelipase alfa is excreted in human milk.
Ni znano, ali se sebelipaza alfa izloča v materino mleko.
Most patients who developed ADA did so within the first 2 months of exposure.
Pri večini bolnikov se je ADA razvila v prvih 2 mesecih izpostavljenosti.
All patients were receiving 1 mg/kg once every other week.
Vsi bolniki so dobivali 1 mg/kg enkrat vsak drugi teden.
LAL deficiency is a rare disease associated with significant morbidity and mortality, which affects individuals from infancy through adulthood.
Pomanjkanje LAL je redka bolezen, povezana z znatno obolevnostjo in smrtnostjo, ki prizadene posameznike od dojenčkov do odraslih.
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.
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.
In the historical cohort, 0 of 21 patients survived beyond 8 months of age (0% 12-month survival, 95% CI: 0% to
V zgodovinski kohorti ni nobeden od 21 bolnikov preživel več kot 8 mesecev (0% 12-mesečno preživetje, 95% IZ: 0% do 16%).
This medicine works by lowering the build-up of fat that causes medical complications, including impaired growth, liver damage and heart complications.
To zdravilo deluje tako, da zmanjšuje kopičenje maščobe, ki povzroča zdravstvene zaplete, vključno z moteno rastjo, poškodbo jeter in zapleti na srcu.
Frequency a
Pogostnost a
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.
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.
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.
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.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na sposobnost razmnoževanja (glejte poglavje 5.3).
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.
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.
The vials should not be frozen, heated or microwaved and should be protected from light.
Vial ni dovoljeno zamrzovati, segrevati ali dajati v mikrovalovno pečico; zaščititi jih je treba pred svetlobo.
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).
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).
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.
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.
Body temperature increased b,c
Preiskave pogosti zvišana telesna temperatura b,c
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.
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.
• 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.
• 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.
Anaphylaxis occurred during the infusion as late as 1 year after treatment initiation.
Anafilaksa se je med infundiranjem pojavila tudi še 1 leto po uvedbi zdravljenja.
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).
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).
*Sebelipase alfa is produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology.
*Sebelipaza alfa se pridobiva iz jajčnega beljaka transgene kokoši vrste Gallus s pomočjo rekombinantne DNA (rDNA) tehnologije.
It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.
Izboljša tudi ravni maščobe v krvi, vključno s povečanim LDL (slabim holesterolom) in trigliceridi (maščobami).
In LAL-CL03, 6 of 9 KANUMA-treated infants survived beyond 12 months (67% 12-month survival, 95% CI: 30% to 93%).
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%).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
This medicine is an enzyme replacement therapy.
To zdravilo je namenjeno terapiji z nadomestnimi encimi.
No accumulation was seen at 1 mg/kg (once weekly or once every other week) or 3 mg/kg once weekly.
Kopičenja pri 1 mg/kg niso opazili (enkrat na teden ali enkrat vsak drugi teden) ali 3 mg/kg enkrat na teden.
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.
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.
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.
Brezbarvna steklena viala (tip I) s silikoniziranim zamaškom iz butilne gume in aluminijasto zaporo s plastično dvižno zaporko, ki vsebuje 10 ml koncentrata.
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).
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).
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).
< 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Interim reports expected yearly
Vmesna poročila se pričakujejo enkrat letno
The MAH shall ensure that in each Member State where Kanuma is marketed, all healthcare professionals who are expected to use Kanuma have access to the educational material.
Imetnik dovoljenja za promet mora zagotoviti, da bodo imeli vsi zdravstveni delavci v vsaki državi članici, kjer je zdravilo Kanuma v prometu in za katere se pričakuje, da bodo uporabljali zdravilo Kanuma, dostop do izobraževalnega gradiva.
The diluted solution should be administered to patients using a low-protein binding infusion set equipped with an in-line, low-protein binding 0.2 μm filter, with a surface area of greater than 4.5 cm2
Razredčeno raztopino je treba bolniku dati z infuzijskim kompletom z majhno vezavo beljakovin, opremljenim z vgrajenim filtrom velikosti 0,2 μm z majhno vezavo beljakovin, s površino večjo kot 4,5 cm2, ki je na voljo, da se prepreči zamašitev filtra.
If you or your child experiences symptoms like these, seek immediate medical attention.
Če vi ali vaš otrok doživita tovrstne simptome, poiščite takojšnjo zdravniško pomoč.
Patients have developed anti-drug antibodies (ADA) to sebelipase alfa.
Pri bolnikih so se razvila protitelesa proti zdravilu (ADA-anti-drug antibodies) na sebelipazo alfa.
After dilution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C, or up to 12 hours below 25°C.
Po redčenju: Kemična in fizikalna stabilnost med uporabo je bila dokazana za do 24 ur pri 2 °C do 8 °C ali za do 12 ur pod 25 °C.
Renal elimination of sebelipase alfa is considered a minor pathway for clearance.
Izločanje sebelipaze alfa skozi ledvice je manj pomembna pot očistka.
If you or your child has an egg allergy or a history of allergies to eggs, tell your doctor or nurse (see You must not be given KANUMA).
Če sta vi oziroma vaš otrok alergična na jajca ali ste imeli alergije na jajca v preteklosti, je treba to povedati zdravniku ali medicinski sestri (glejte poglavje Zdravila KANUMA ne smete prejeti).
What KANUMA looks like and contents of the pack KANUMA is supplied as a concentrate for solution for infusion.
Izgled zdravila KANUMA in vsebina pakiranja Zdravilo KANUMA je na voljo kot koncentrat za raztopino za infundiranje.
P-value d
Vrednost d
Dose escalation to 3 mg/kg once weekly was associated with additional improvements in weight gain, lymphadenopathy and serum albumin.
Večanje odmerka na 3 mg/kg enkrat na teden je bilo povezano z dodatnim izboljšanjem v pridobivanju telesne mase, limfadenopatiji in serumskem albuminu.
There are no clinical data on the effects of sebelipase alfa on fertility.
Ni kliničnih podatkov o vplivu sebelipaze alfa na plodnost.
As a precautionary measure, it is preferable to avoid use of sebelipase alfa during pregnancy.
Kot previdnostni ukrep se uporaba sebelipaze alfa med nosečnostjo ne priporoča.
Study LAL-CL08: an open-label, Phase 2 study in infants with rapidly progressive LAL Deficiency to explore long-term safety and efficacy data.
Študija LAL-CL08: odprta študija faze II pri dojenčkih s hitro napredujočim pomanjkanjem LAL za raziskovanje podatkov o dolgoročni varnosti in
Sebelipase alfa binds to cell surface receptors via glycans expressed on the protein and is subsequently internalized into lysosomes.
Sebelipaza alfa se veže na receptorje na površini celice s pomočjo glianov, izraženih na beljakovini, in se nato internalizira v lizosome.
Consequently, impaired liver function is not expected to affect the pharmacokinetics of sebelipase alfa.
Posledično se ne pričakuje, da bi okvarjeno delovanje jeter vplivalo na farmakokinetiko sebelipaze alfa.
In a separate open-label study (LAL-CL01/LAL-CL04) in adult patients with LAL deficiency, improvements in serum transaminase and lipid levels were sustained through the 104-week treatment period.
V ločeni odprti študiji (LAL-CL01/LAL-CL04) pri odraslih bolnikih s pomanjkanjem LAL so se izboljšanja serumskih transaminaz in ravni maščob ohranile do konca 104-tedenskega obdobja zdravljenja.
You must not be given KANUMA: - if you or your child has experienced life-threatening allergic reactions to sebelipase alfa that cannot be managed when you or your child receives the medicine again, or to egg or any of the other ingredients of this medicine (listed in section 6).
Zdravila KANUMA vam ne smejo dati: če ste vi sami ali je vaš otrok doživel življenjsko nevarne alergijske reakcije na sebelipazo alfa, ki jih ob ponovnem jemanju zdravila ne bo mogoče nadzirati, ali na jajca ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The pharmacokinetics of sebelipase alfa in children and adults were determined using a population pharmacokinetic analysis of 65 patients with LAL deficiency who received intravenous infusions of KANUMA at 1 mg/kg once every other week in LAL-CL02.
Farmakokinetiko sebelipaze alfa pri otrocih in odraslih so določili s pomočjo analize populacijske farmakokinetike pri 65 bolnikih s pomanjkanjem LAL, ki so prejemali intravenske infuzije zdravila KANUMA v odmerku 1 mg/kg enkrat na vsak drugi teden v študiji LAL-CL02.
Efficacy was assessed by comparing the survival experience of KANUMA-treated patients who survived past 12 months of age in LAL-CL03 with a historical cohort of untreated infants presenting with LAL deficiency with similar clinical characteristics.
Učinkovitost so ocenili s primerjavo izkušnje preživetja pri bolnikih, zdravljenih z zdravilom KANUMA, ki so preživeli več kot 12 mesecev starosti v LAL-CL03 z zgodovinsko kohorto nezdravljenih dojenčkov, ki so imeli pomanjkanje LAL s podobnimi kliničnimi značilnostmi.
Evaluated in patients with abnormal baseline values (n = 36 for KANUMA; n = 29 for placebo).
Ocenjeno pri bolnikih z abnormalnimi izhodiščnimi vrednostmi (n=36 za zdravilo KANUMA; n=29 za placebo).
What KANUMA is and what it is used for What you need to know before you are given KANUMA How KANUMA is given
Kaj je zdravilo KANUMA in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo KANUMA Kako se daje zdravilo KANUMA Možni neželeni učinki
If you or your child experiences a severe infusion reaction like this, seek immediate medical attention.
Če vi ali vaš otrok doživite tovrstno hudo reakcijo na infuzijo, poiščite takojšnjo zdravniško pomoč.
If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions.
Če imata vi oziroma ima vaš otrok reakcijo na infuzijo, bosta vi oziroma vaš otrok morda prejela dodatna zdravila za zdravljenje ali preprečevanje reakcij v prihodnje.
Paired liver biopsies at baseline and week 20 were available in a subset of patients (n = 26).
Parne jetrne biopsije ob izhodišču in v 20. tednu so bile na voljo za podskupino bolnikov (n=26).