FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no reproductive and developmental toxicology studies with Flucelvax Tetra.
Croatian: Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti cjepiva Flucelvax Tetra.
English: Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season
Croatian: Flucelvax Tetra suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano sezona 2019/2020
English: In children who received a second dose of Flucelvax Tetra or cell-based trivalent influenza vaccine, the incidence of adverse reactions following the second dose of vaccine was similar to that observed with the first dose in this clinical trial.
Croatian: U ovom kliničkom ispitivanju u djece koja su primila drugu dozu cjepiva Flucelvax Tetra ili trovalentno cjepivo protiv influence dobiveno iz kulture stanica incidencija nuspojava nakon druge doze cjepiva bila je slična onoj primijećenoj nakon prve doze.
English: Use of Flucelvax Tetra during breast-feeding has not been studied.
Croatian: Primjena cjepiva Flucelvax Tetra za vrijeme dojenja nije ispitana.
English: GMT (95% CI) Seroconversion Ratea 56% (48%-65%)
Croatian: GMT (95% CI) Stopa serokonverzijea 56% (48%-65%)
English: Carton box for syringe(s) with needle: - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle Carton box for syringe(s) without needle: - 10 pre-filled syringes (0.5 ml) without needle
Croatian: Kartonska kutija za štrcaljku(e) bez igle: - 10 napunjenih štrcaljki (0,5 ml) bez igle Kartonska kutija za štrcaljku(e) s iglom: - 1 napunjena štrcaljka (0,5 ml) s iglom - 10 napunjenih štrcaljki (0,5 ml) s iglom
English: Seroconversion Rateb a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.
Croatian: GMT (95% CI) Stopa serokonverzijeb a Za sojeve virusa influence H1N1, H3N2 i B1 prikazani su podaci za TIV1c, a za soj B2 prikazani su podaci za TIV2c.
English: Flucelvax Tetra is a clear to slightly opalescent suspension.
Croatian: Flucelvax Tetra je bistra do blago opalescentna suspenzija.
English: Uncommon (≥1/1,000 to
Croatian: (≥ 1/1000 do
English: Immunogenicity of Flucelvax Tetra in Children and Adolescents 9 to less than 18 Years of Age
Croatian: Imunogenost cjepiva Flucelvax Tetra u djece i adolescenata u dobi od 9 do manje od 18 godina
English: Seqirus S.r.l.
Croatian: Seqirus Inc.
English: Flucelvax Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Croatian: Flucelvax Tetra omogućuje aktivnu imunizaciju protiv 4 soja virusa influence (dva podtipa
English: GMT (95% CI) Seroconversion Rateb
Croatian: GMT (95% CI) Stopa serokonverzijeb
English: Bold- CHMP immunogenicity criteria met.
Croatian: Masno tiskano = CHMP (Committee for Medicinal Products for Human Use) kriteriji imunogenosti su zadovoljeni.
English: Flucelvax Tetra is manufactured using Madin Darby Canine Kidney (MDCK) cells.
Croatian: Flucelvax Tetra proizvodi se pomoću psećih bubrežnih stanica Madin Darby (engl.
English: Flucelvax Tetra may be given at the same time as other vaccines.
Croatian: Flucelvax Tetra se smije davati istodobno s drugim cjepivima
English: Non-inferiority was established for all 4 influenza strains included in Flucelvax Tetra, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination.
Croatian: Takva neinferiornost utvrđena je za sva 4 soja influence sadržana u cjepivu Flucelvax Tetra, kako je utvrđeno omjerom GMT-ova i razlika u postotku ispitanika kod kojih je nastupila serokonverzija 3 tjedna nakon cijepljenja.
English: Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
Croatian: Tablica 2: Neinferiornost cjepiva Flucelvax Tetra u odnosu na cjepivo TIVc u odraslih u dobi od 18 i više godina - analiza podataka osoba koje su završile ispitivanje prema planu ispitivanja (V130_01)
English: The percentage of subjects with seroconversion or significant increase in HI antibody titre is >40%, the percentage of subjects achieving an HI titre ≥1:40 is >70%.
Croatian: postotak ispitanika koji su postigli titar HI ≥ 1:40 je > 70%.
English: The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Croatian: Djelatne tvari su površinski antigeni virusa influence (hemaglutinin i neuraminidaza), inaktivirani,
English: Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.
Croatian: U slučaju akutne febrilne bolesti cijepljenje se mora odgoditi dok vrućica ne prođe.
English: There are no data available on coadministration of Flucelvax Tetra with other vaccines.
Croatian: Nema dostupnih podataka o istodobnoj primjeni cjepiva Flucelvax Tetra s drugim cjepivima.
English: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Croatian: Flucelvax Tetra - suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano
English: Arthralgia
Croatian: artralgija
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid kalijev klorid magnezijev klorid heksahidrat natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: GMT (95% CI) Seroconversion Rateb (95% CI)
Croatian: GMT (95% CI) Stopa serokonverzijeb (95% CI)
English: Common (≥1/100 to <1/10)
Croatian: (≥ 1/100 do
English: Flucelvax Tetra was noninferior to TIVc in children 4 to less than 18 years of age.
Croatian: Cjepivo Flucelvax Tetra nije bilo inferiorno cjepivu TIVc u djece u dobi od 4 do < 18 godina.
English: No interaction studies have been performed with Flucelvax Tetra.
Croatian: Nisu provedena ispitivanja interakcija s cjepivom Flucelvax Tetra.
English: There are no data for overdose with Flucelvax Tetra.
Croatian: Nema podataka o predoziranju cjepivom Flucelvax Tetra .
English: Flucelvax Tetra may be used during lactation.
Croatian: Flucelvax Tetra smije se primjenjivati tijekom laktacije.
English: Allergic or immediate hypersensitivity reactions, including anaphylactic shock
Croatian: Poremećaji imunološkog sustava alergijske ili neposredne reakcije preosjetljivosti,
English: Similar rates of solicited local and systemic adverse reactions were reported in subjects who received Flucelvax Tetra and cell-based trivalent influenza vaccine comparator in this clinical trial.
Croatian: U ovom kliničkom ispitivanju zabilježena je slična stopa izazvanih lokalnih i sistemskih nuspojava u ispitanika koji su primili Flucelvax Tetra i usporedno trovalentno cjepivo protiv influence dobiveno iz kulture stanica.
English: Immunogenicity of Flucelvax Tetra was evaluated in children 9 to less than 18 years of age as part of a randomised, double-blind, controlled study (V130_03) that was performed in the paediatric population 4 to less than 18 years of age.
Croatian: Imunogenost cjepiva Flucelvax Tetra ispitana je u djece u dobi od 4 do < 18 godina kao dio randomiziranog, dvostruko slijepog, kontroliranog ispitivanja (V130_03) koje je provedeno na pedijatrijskoj populaciji u dobi od 4 do < 18 godina.
English: The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03).
Croatian: Sigurnost cjepiva Flucelvax Tetra u djece u dobi od 4 do < 18 godina procijenjena je u randomiziranom kontroliranom ispitivanju (V130_03).
English: Paraesthesia
Croatian: parestezija
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Croatian: Prije primjene cjepivo se mora vizualno pregledati kako bi se isključila prisutnost čestica i promjene boje.
English: Immune responses following vaccination with TIVc in the paediatric population (9 to < 18 years) were similar to those observed in the adult population in study V58P13 (see Table 5) in whom efficacy was demonstrated (results on vaccine efficacy are presented in Table 3).
Croatian: Imunosni odgovor nakon cijepljenja s cjepivom TIVc u pedijatrijskoj populaciji (9 do < 18 godina) bio je sličan onome zabilježenom u odrasloj populaciji u ispitivanju
English: The safety of Flucelvax Tetra in adults 18 years and older was evaluated in a randomised, controlled study (V130_01), in which 1334 subjects received Flucelvax Tetra.
Croatian: Sigurnost primjene cjepiva Flucelvax Tetra u odraslih u dobi od 18 godina i starijih procijenjena je u randomiziranom kontroliranom ispitivanju (V130_01) u kojemu je 1334 ispitanika primilo cjepivo
English: Erythema, Induration1
Croatian: Nepoznato3
English: The immunogenicity data with TIVc are relevant to the use of Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Croatian: Usporedba imunogenosti TIVc u pedijatrijskoj populaciji i populaciji odraslih Podaci o imunogenosti koji se odnose na cjepivo TIVc relevantni su i za cjepivo Flucelvax Tetra jer se oba cjepiva proizvode korištenjem istog postupka i imaju komponente koji se podudaraju.
English: Immunogenicity of Flucelvax Tetra in children 4 to less than 9 years of age
Croatian: Imunogenost cjepiva Flucelvax Tetra u djece u dobi od 4 do < 9 godina
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mialgija1
English: or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)].
Croatian: U tom ispitivanju ispitanici su primili cjepivo Flucelvax Tetra (N=1334) ili jedan od dvije formulacije usporednog trovalentnog cjepiva protiv influence dobivenog iz kulture stanica (TIVc) [TIV1c (N=677) ili TIV2c (N= 669)].
English: The following side effects have been reported during clinical trials and during general use:
Croatian: Tijekom kliničkih ispitivanja i opće uporabe nakon što je lijek odobren primijećene su sljedeće nuspojave:
English: Flucelvax Tetra may be used during breast-feeding.
Croatian: Flucelvax Tetra smije se primijeniti tijekom razdoblja dojenja.
English: Holly Springs
Croatian: Madin Darby
English: No human fertility data are available.
Croatian: Plodnost Nisu dostupni podaci o utjecaju na plodnost u ljudi.
English: Seqirus Netherlands B.V. Paasheuvelweg 28
Croatian: България Seqirus Netherlands B.V.
English: Immunogenicity of Flucelvax Tetra was evaluated in adults 18 years of age and older in a randomised, double-blind, controlled study (V130_01).
Croatian: Imunogenost cjepiva Flucelvax Tetra u odraslih u dobi od 18 i više godina Imunogenost cjepiva Flucelvax Tetra procjenjivana je u odraslih u dobi od 18 i više godina u randomiziranom, dvostruko slijepom, kontroliranom ispitivanju (V130_01).
English: The immunogenicity endpoints were GMTs of HI antibodies response and percentage of subjects who achieved seroconversions (seroconversion rate), defined as a pre-vaccination HI titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI titre ≥ 1:10 and a minimum 4-fold increase in serum HI antibody titre.
Croatian: Mjere ishoda imunogenosti bile su GMT odgovora HI protutijela i postotak ispitanika u kojih je došlo do serokonverzije (stopa serokonverzije), definirane kao HI titar prije cijepljenja < 1:10 s titrom HI nakon cijepljenja ≥ 1:40, ili s HI titrom prije cijepljenja ≥ 1:10 i minimalno četverostrukim porastom titra serumskih HI protutijela.
English: Flucelvax Tetra is not indicated for use in children less than 9 years of age, see section 4.2.
Croatian: Cjepivo Flucelvax Tetra nije indicirano za primjenu u djece mlađe od 9 godina, vidjeti dio 4.2. Dostupni podaci o sigurnosti primjene u pedijatrijskoj populaciji prikazani su u nastavku.
English: Vaccine Group Difference (95% CI)
Croatian: Razlika između cijepljenih skupina (95% CI)
English: TIVc = cell-based trivalent influenza vaccine; TIVeA = egg-based trivalent influenza vaccine (Agrippal); TIVeF = egg-based trivalent influenza vaccine (Fluvirin) a Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
Croatian: TIVeF = trovalentno cjepivo protiv virusa influence dobiveno iz jaja (Fluvirin) a Stopa serokonverzije = postotak ispitanika s prevakcinacijskim titrom HI < 1:10 i postvakcinacijskim titrom HI ≥ 1:40 ili s prevakcinacijskim titrom HI ≥ 1:10 i minimalno četverostrukim porastom titra HI protutijela nakon cijepljenja.
English: The immunogenicity endpoints were geometric mean antibody titres (GMTs) of haemagglutination inhibition (HI) antibodies response and percentage of subjects who achieved seroconversions, defined as a pre-vaccination HI titre of <1:10 with a post vaccination titre ≥1:40 or with a prevaccination HI titre of ≥10 and a minimum 4-fold increase in serum HI antibody titre.
Croatian: Mjere ishoda za imunogenost bile su geometrijska srednja vrijednost titra (GMTs) protutijela inhibicije hemaglutinacije (HI) i postotak ispitanika kod kojih je došlo do serokonverzije, definirane kao titar HI prije cijepljenja < 1:10 s titrom nakon cijepljenja ≥ 1:40 ili s titrom HI prije cijepljenja od
English: b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
Croatian: b Stopa serokonverzije = postotak ispitanika s prevakcinacijskim titrom HI < 1:10 i postvakcinacijskim titrom HI ≥ 1:40 ili s prevakcinacijskim titrom HI ≥ 1:10 i minimalno četverostrukim porastom titra HI protutijela nakon cijepljenja.
English: Injection site pain, Fatigue1,
Croatian: Opći poremećaji i reakcije na mjestu primjene bol na mjestu injekcije, umor1, eritem, induracija1
English: Generalised skin reactions including pruritus, urticaria or non-specific rash
Croatian: Poremećaji kože i potkožnog tkiva generalizirane kožne reakcije uključujući svrbež, urtikariju i nespecifični osip
English: How Flucelvax Tetra is given
Croatian: Kako se primjenjuje Flucelvax Tetra
English: TIV2c.
Croatian: RMP-a.
English: • Muscle pain
Croatian: ** hemaglutinin
English: How to store Flucelvax Tetra
Croatian: Kako čuvati Flucelvax Tetra
English: Name and address of the manufacturer(s) of the biological active substance(s) Seqirus Inc.
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Flucelvax Tetra - suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano Ovaj je lijek pod dodatnim praćenjem.
English: Seqirus Netherlands B.V. Netherlands Tél: +31 (0) 20 204 6900
Croatian: Netherlands Tél: +31 (0) 20 204 6900
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA**
Croatian: soju A/Brisbane/02/2018 (H1N1)pdm09 sličan soj (A/Idaho/07/2018) 15 mikrograma HA** soju A/Kansas/14/2017 (H3N2) sličan soj (A/Indiana/08/2018) 15 mikrograma HA** soju B/Colorado/06/2017 sličan soj (B/Iowa/06/2017) 15 mikrograma HA** soju B/Phuket/3073/2013 sličan soj (B/Singapore/INFTT-16-0610/2016) 15 mikrograma HA** po dozi od 0,5 ml
English: Seqirus Netherlands B.V. Alankomaat Puh/Tel: +31 (0) 20 204 6900
Croatian: Alankomaat Puh/Tel: +31 (0) 20 204 6900
English: The available immunogenicity data in the paediatric population 4 to less than 9 years of age were obtained in trial V130_03.
Croatian: Cjepivo Flucelvax Tetra nije indicirano za primjenu u djece mlađe od 9 godina, vidjeti dio 4.2. Dostupni podaci o imunogenosti u pedijatrijskoj populaciji u dobi od 4 do < 9 godina dobiveni su tijekom ispitivanja V130_03.
English: Antigenically Matched Strains Overall
Croatian: Antigenski podudarni sojevi
English: Vaccine Group Ratio (95% CI)
Croatian: Omjer cijepljenih skupina (95% CI)
English: Seqirus Netherlands B.V. Netherlands Tél/Tel: +31 (0) 20 204 6900
Croatian: Netherlands Tél/Tel: +31 (0) 20 204 6900
English: Extensive swelling of injected limb
Croatian: • opsežno oticanje uda u koji je dana injekcija cjepiva
English: Seqirus Netherlands B.V. Nederland Tlf: +31 (0) 20 204 6900
Croatian: Nederland Tlf: +31 (0) 20 204 6900
English: Headache1
Croatian: povraćanje2
English: Seqirus Netherlands B.V. Holland Tlf: +31 (0) 20 204 6900
Croatian: Holland Tlf: +31 (0) 20 204 6900
English: Immune system disorders
Croatian: Poremećaji probavnog sustava mučnina,
English: Seqirus Netherlands B.V. Nederländerna Tel: +31 (0) 20 204 6900
Croatian: Nederland/Netherlands Tel: +31 (0) 20 204 6900
English: Attack Rate
Croatian: Stopa rizika
English: antibody titre.
Croatian: PRILOG III.
English: Seqirus Netherlands B.V. Holland Sími: +31 (0) 20 204 6900
Croatian: Holland Sími: +31 (0) 20 204 6900
English: Seqirus Netherlands B.V. Nīderlande Tel: +31 (0) 20 204 6900
Croatian: In-Netherlands Tel: +31 (0) 20 204 6900
English: Studies 301 and 202
Croatian: Ispitivanja 301 i 202
English: What is MPS VII
Croatian: Što je MPS VII
English: Compatibility with other medicinal products has not been evaluated.
Croatian: Kompatibilnost s drugim lijekovima nije procijenjena.
English: Currently available data are described in section 4.8 and section 5.1.
Croatian: Trenutno dostupni podaci opisani su u dijelu 4.8 i 5.1.
English: He or she will check that the correct dose has been given and take action as needed.
Croatian: On ili ona će provjeriti je li doza točna i poduzeti mjere, ako je to potrebno.
English: Other symptoms to look out for
Croatian: Drugi simptomi na koje trebate paziti
English: Starting treatment early in children may stop the illness getting worse and reduce permanent damage.
Croatian: Rano uvođenje liječenja u djece može zaustaviti pogoršanje bolesti i smanjiti trajno oštećenje.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava - možda trebate hitnu medicinsku pomoć:
English: Appropriate clinical treatment should be immediately sought.
Croatian: Potrebno je odmah potražiti prikladno bolničko liječenje.
English: - These sugars are re-cycled all the time - new ones are made and old ones are broken down.
Croatian: - Ti se šećeri cijelo vrijeme zamjenjuju - novi nastaju, stari se razgrađuju.
English: You will not be given Mepsevii if you are pregnant unless treatment is clearly necessary.
Croatian: Nećete dobiti Mepsevii ako ste trudni, osim ako liječenje nije nužno.
English: These problems can be signs of the illness and may be caused by pressure on your spinal cord.
Croatian: Ti problemi mogu biti znakovi bolesti i mogu biti uzrokovani pritiskom na kralježničnu moždinu.
English: Based on mechanism of action, rhGUS is not expected to be tumorigenic.
Croatian: Na temelju mehanizma djelovanja, ne očekuje se da će rhGUS biti tumorogen.
English: - Treatment may improve various signs and symptoms of illness, like walking difficulties and tiredness.
Croatian: - Liječenje može poboljšati razne znakove i simptome bolesti, poput poteškoća s hodanjem i umora.
English: The dose you will receive is based on how much you weigh.
Croatian: Doza koju ćete primiti temelji se na Vašoj tjelesnoj težini.
English: The posology in the paediatric population is the same as in adults.
Croatian: Doziranje u pedijatrijske populacije jednako je doziranju u odraslih.
English: Reports to be submitted as part of the annual reassessment
Croatian: Izvješća se podnose kao dio redovne godišnje procjene
English: Infusion should be avoided if the patient has an acute febrile or respiratory illness at the time.
Croatian: Infuzije je potrebno izbjegavati ako bolesnik u to vrijeme ima akutnu febrilnu ili respiratornu bolest.
English: Nine patients were younger than 18 years of age.
Croatian: Devet je bolesnika bilo mlađe od 18 godina.
English: - The medicine has to be diluted before being given.
Croatian: - Lijek je potrebno razrijediti prije primjene.
English: Patients should be observed for a minimum of 60 minutes after completing the infusion of vestronidase alfa.
Croatian: Bolesnike je potrebno nadzirati najmanje 60 minuta nakon dovršetka infuzije vestronidaze alfa.
English: Contents of the pack and other information What Mepsevii contains
Croatian: Sadržaj pakiranja i druge informacije Što Mepsevii sadrži
English: This belongs to a group of medicines called enzyme replacement therapies.
Croatian: Pripada skupini lijekova koji se nazivaju nadomjesna enzimska terapija.
English: Treatment with Mepsevii should be started and monitored by your doctor.
Croatian: Liječenje lijekom Mepsevii treba započeti i nadzirati Vaš liječnik.
English: No alternative dose regimen is recommended in these patients (see section 5.1).
Croatian: Ne preporučuje se drugačiji dozni režim u tih bolesnika (vidjeti dio 5.1).
English: Nineteen patients were younger than 18 years of age.
Croatian: Devetnaest bolesnika bilo je mlađe od 18 godina.
English: Block-7, City North Business Campus Stamullen, Co. Meath, Ireland
Croatian: Block-7, City North Business Campus Stamullen, Co.
English: - If you have ever had a severe allergic reaction to vestronidase alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste ikad imali tešku alergijsku reakciju na vestronidazu alfa ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Patients should be informed of the signs and symptoms of hypersensitivity reactions and instructed to seek immediate medical care should such signs and symptoms occur.
Croatian: Bolesnike treba obavijestiti o znakovima i simptomima reakcija preosjetljivosti te ih uputiti da odmah potraže medicinsku pomoć ako se takvi znakovi i simptomi jave.
English: These side effects are called infusion reactions because they are caused by the infusion (drip) of the medicine.
Croatian: Ove nuspojave nazivaju se reakcije na infuziju, jer ih uzrokuje infuzija (drip) lijeka.
English: As end organ damage progresses over time, it is more difficult for the treatment to reverse the damage or to show improvements.
Croatian: Kako krajnje oštećenje organa napreduje tijekom vremena, sve je teže liječenjem poništiti oštećenja ili postići poboljšanja.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Croatian: Učestalosti se definiraju kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: - If you have an allergic reaction during your infusion your doctor may slow down, or stop your infusion.
Croatian: Ako imate alergijsku reakciju tijekom infuzije, Vaš liječnik može usporiti ili prekinuti infuziju.
English: No alternative dose regimen is recommended in these patients.
Croatian: Ne preporučuje se drugačiji dozni režim u tih bolesnika.
English: Talk to your doctor before you are given Mepsevii.
Croatian: Obratite se svom liječniku prije nego što počnete primati Mepsevii.
English: Ultragenyx Netherlands B. V. Evert van de Beekstraat 1, Unit 104 1118 CL Schiphol The Netherlands
Croatian: Ultragenyx Netherlands B. V. Evert van de Beekstraat 1, Unit 104 1118 CL Schiphol Nizozemska
English: If you are given more Mepsevii than you should
Croatian: Ako primite više lijeka Mepsevii nego što ste trebali
English: There is no definitive correlation between the antibody titre and neutralizing antibody development.
Croatian: Nema definitivne povezanosti između titra protutijela i razvoja neutralizirajućih protutijela.