FrancophonIA/ELRC3.0 huggingface dataset:
English: A booster vaccination with a 7.5 µg heterologous A/Indonesia/05/2005 vaccine strain has been administered in a time window of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older people aged 60 years and above.
Croatian: Booster cijepljenje sa 7,5 µg heterolognog cjepiva soja A/Indonesia/05/2005 primijenjeno je u vremenskom razdoblju od 12 mjeseci do 24 mjeseca nakon primarnog cijepljenja s dvije doze cjepiva soja A/Vietnam/1203/2004 u tri klinička ispitivanja u odraslih u dobi od 18 do 59 godina i u starijih osoba u dobi od 60 godina i više.
English: • The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Croatian: • Kod bolesnika na imunosupresivnoj terapiji moguć je smanjen imunološki odgovor.
English: Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Croatian: Cjepivo protiv pandemijske influence (H5N1) (cijeli virion, inaktivirano, pripremljeno u staničnoj kulturi)
English: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances be administered intravascularly.
Croatian: • CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER ni u kojim se okolnostima ne smije primijeniti intravaskularno.
English: The protective efficacy of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza
Croatian: Zaštitna djelotvornost CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER protiv pobola i smrtnosti izazvanih infekcijom sa smrtonosnim dozama iznimno patogenog virusa ptičje gripe H5N1 procijenjena je neklinički modelom ispitanim na tvorovima.
English: Arthralgia Myalgia
Croatian: Artralgija Mijalgija
English: EAR AND LABYRINTH DISORDERS
Croatian: POREMEĆAJI UHA I LABIRINTA Vrtoglavica
English: Seroprotection rate* Seroconversion rate** Seroconversion factor*** * SRH area ≥ 25 mm² ** either SRH area ≥ 25 mm if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Croatian: Stopa serozaštite* Stopa serokonverzije** Čimbenik serokonverzije*** * SRH površina ≥ 25 mm² ** ili SRH površina ≥ 25 mm ako je polazni uzorak negativan ili 50% povećanje SRH površine ako je polazni uzorak > 4 mm²
English: An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Croatian: Pregled svih spontanih nuspojava po SOC-u, nazivu visoke razine (HLT) i povlaštenom nazivu (PT), raslojenih prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno) i uključujući broj izvješća o smrtnim slučajevima, za razdoblje obuhvaćeno izvješćem i kumulativno.
English: Microneutralisation Assay Immunocompromised subjects
Croatian: Imunokompromitirani ispitanici
English: Dizziness Headache Crying
Croatian: Omaglica Glavobolja
English: NERVOUS SYSTEM DISORDERS
Croatian: POREMEĆAJI ŽIVČANOG
English: Infants, children and adolescents: Adverse Reactions (Infants, Children and Adolescents)
Croatian: Nuspojave (Dojenčad, djeca i adolescenti)
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for
Croatian: Što je CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER i za što se koristi
English: Fatigue Pyrexia Chills
Croatian: Pireksija Zimica Malaksalost
English: Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is stated on the carton.
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: Very common (may affect more than 1 in 10 vaccinees):
Croatian: Vrlo često (može se javiti u više od 1 na 10 cijepljenih):
English: Trometamol Sodium chloride Water for injections Polysorbate 80
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari trometamol natrijev klorid voda za injekcije polisorbat 80
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as immunoglobulins.
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER ne smije se uzimati istovremeno s imunoglobulinima.
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).
Croatian: A/Indonesia/05/2005 primijenjeno je u vremenskom razdoblju od 12 mjeseci nakon primarnog cijepljenja s dvije doze cjepiva soja A/Vietnam/1203/2004 u djece i adolescenata u dobi od 9 do 17 godina (N=196), djece u dobi od 3 do 8 godina (N=79) i u dojenčadi i djece u dobi od 6 do 35 mjeseci (N=25).
English: Seroprotection*/
Croatian: Serozaštita*
English: PT “Bell's palsy”
Croatian: PT “Bellova paraliza”
English: NAME OF THE MEDICINAL PRODUCT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspension for injection
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER Suspenzija za injekciju
English: Seroneutralization rate* Seroconversion rate** Seroconversion factor***
Croatian: Stopa seroneutralizacije* Stopa serokonverzije** Čimbenik serokonverzije*** 1,6
English: per 0.5 ml dose
Croatian: Jednodozna štrcaljka (0,5 ml)
English: • swollen glands
Croatian: • natečene žlijezde
English: • pain in the armpit
Croatian: • bol u udovima
English: Uncommon (affects 1 to 10 in 1,000 vaccinees):
Croatian: Manje često (može se javiti u 1 do 10 na 1000 cijepljenih):
English: After primary vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Croatian: Nakon prvog cijepljenja, stopa ispitanika s titrom neutralizirajućih protutijela ≥ 20, stopa serokonverzije i čimbenik serokonverzije izmjereni mikroneutralizacijskom analizom (MN) u osoba u dobi od 18 do 59 godina i u starijih ispitanika u dobi od 60 godina i više bili su sljedeći:
English: Injection site pruritus Axillary pain
Croatian: Svrbež na mjestu injiciranja Bol u pazuhu
English: Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years and older:
Croatian: djece i adolescenata u dobi od 6 mjeseci do 17 godina bili su sljedeći: SRH analiza
English: MARKETING AUTHORIZATION HOLDER
Croatian: Nositelj odobrenja za stavljanje lijeka u promet
English: EYE DISORDERS
Croatian: POREMEĆAJI UHA
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Croatian: Što je CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER i za što se koristi Što morate znati prije nego što primite CJEPIVO
English: In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the results of these tests may not be correct.
Croatian: INFLUENCE H5N1 BAXTER rezultati testiranja možda neće biti točni.
English: All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Croatian: Sve spontane nuspojave (SOC, HLT, i PT) koje su se javile u trudnica, raslojene prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvješćem i kumulativno.
English: Vomiting Diarrhoea
Croatian: POREMEČAJI METABOLIZMA
English: • vertigo (motion sickness)
Croatian: • vrtoglavica (bolest kretanja)
English: The active substance and other ingredients in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet.
Croatian: PANDEMIJSKE INFLUENCE H5N1 BAXTER navedeni su u dijelu 6 na kraju upute.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Croatian: - Izvjestiteljevo izvješće o procjeni šalje se članovima Povjerenstva za humane lijekove
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Croatian: 35. dana visoka doza iznimno virulentnog soja virusa H5N1 A/Vietnam/1203/2004 aplicirana je intranazalno svim tvorovima te su praćeni 14 dana.
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Croatian: Ozbiljne nenavedene nuspojave (SOC, HLT, PT) raslojene prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvješćem i kumulativno.
English: Marketing Authorisation Holder: Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Ology Bioservices Ireland LTD
English: Malaise
Croatian: POREMEČAJI
English: - Demyelination:
Croatian: - Demijelinizacija:
English: Antibody persistence
Croatian: Perzistencija protutijela
English: Common (may affect up to 1 in 10 vaccinees):
Croatian: Često (može se javiti u do 1 na 10 cijepljenih):
English: After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Croatian: Nakon cijepljenja, stopa ispitanika s titrom neutralizirajućih protutijela ≥ 20, stopa serokonverzije i čimbenik serokonverzije izmjereni mikroneutralizacijskom analizom (MN) u dojenčadi, djece i adolescenata u dobi od 6 mjeseci do 17 godina bili su sljedeći: Mikroneutralizacijska analiza
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza vaccine (whole virion, inactivated) containing antigen* of: A/Vietnam/1203/2004 (H5N1)
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Cjepivo protiv influence (cijeli virion, inaktivirano) koje sadrži antigen*:
English: Uncommon (may affect more than 1 in 100 vaccinees):
Croatian: Manje često (može se javiti u više od 1 na 100 cijepljenih):
English: Class effects:
Croatian: Djelatna tvar:
English: • bruising at the injection site
Croatian: • Krvarenje na mjestu injiciranja
English: Very common (affects more than 1 user in 10): • pain at the injection site
Croatian: Vrlo često (može se javiti u više od 1 na 10 cijepljenih): • pospanost
English: * SRH area ≥ 25 mm² ** either SRH area ≥ 25 mm if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Croatian: * SRH površina ≥ 25 mm² ** ili SRH površina ≥ 25 mm ako je početni uzorak negativan ili 50% povećanje SRH površine ako je početni uzorak > 4 mm² *** geometrijska sredina povećanja
English: • stomach pain
Croatian: • bol u pazuhu
English: • chills
Croatian: • grčevi
English: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Croatian: SUSTAVA, PRSIŠTA I SREDOPRSJA
English: If it is necessary to provide immediate protection, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be given at the same time as normal or specific immunoglobulin.
Croatian: PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER može se dati istovremeno s nespecifičnim ili specifičnim imunoglobulinom.
English: Pyrexia
Croatian: Rinoreja
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines.
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER ne smije se uzimati istovremeno s drugim cjepivima.
English: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines.
Croatian: • CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER ne smije se primijeniti istovremeno s drugim cjepivima.
English: Diarrhea Vomiting Nausea
Croatian: Mučnina Povraćanje
English: Dose nd
Croatian: Ispitan na
English: • malaise
Croatian: • pospanost
English: Summary of adverse reactions
Croatian: OPĆI POREMEĆAJI I REAKCIJE
English: • fatigue (feeling tired)
Croatian: • umor (osjećaj umora)
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Croatian: Sve spontane nuspojave po dobnoj skupini, prema SOC-u, HLT-u i PT-u, raslojene prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvješćem i kumulativno.
English: * SRH area ≥ 25 mm²
Croatian: 12-mjesečni booster * SRH površina ≥ 25 mm²
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Croatian: Stope seroneutralizacije (MN titar ≥ 20) 21 dan nakon 12 do 24-mjesečnog booster cijepljenja dozom od 7,5 µg cjepiva soja A/Indonesia/05/2005, ispitani na homologne i heterologne sojeve bili su sljedeći:
English: - Bell's palsy:
Croatian: - Bellova paraliza:
English: Eye irritation
Croatian: Nadraženost oka
English: Common Very Common
Croatian: Često Vrlo često
English: Insomnia Sleep disorder
Croatian: Poremećaj spavanja
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid.
Croatian: Kako CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER izgleda i sadržaj pakiranja CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER je gotovo bijela, opalescentna,
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: Sadržaj pakiranja i druge informacije Što CJEPIVO
English: Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Croatian: Stope seroneutralizacije (MN titar ≥ 20) 21 dan nakon 12-mjesečnog booster cijepljenja dozom od 7,5 µg cjepiva soja A/Indonesia/05/2005, ispitani na homologne i heterologne sojeve bili su sljedeći:
English: Seroprotection rates (SRH area ≥ 25 mm²) at 21 days after a 12 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Croatian: Stope serozaštite (SRH površina ≥ 25 mm²) 21 dan nakon 12- mjesečnog booster cijepljenja dozom od 7,5 µg cjepiva soja A/Indonesia/05/2005, ispitani i na homologne i heterologne sojeve bili su sljedeći:
English: How to use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Croatian: Kako se CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER primjenjuje
English: • hardness, redness, swelling or bruising at the injection site
Croatian: • otvrdnuće, crvenilo, oticanje ili stvaranje modrica na mjestu injiciranja
English: METHOD OF ADMINISTRATION Shake before use
Croatian: Protresti prije primjene
English: • Injection site hemorrhage
Croatian: ** hemaglutinin
English: Posology
Croatian: izraz
English: Common (affects 1 to 10 in 100 vaccinees):
Croatian: • bol na mjestu injiciranja Često (može se javiti u 1 do 10 na 100 cijepljenih):
English: Seroprotection rate* Seroconversion rate** Seroconversion factor***
Croatian: Stopa serokonverzije** Čimbenik serokonverzije*** 3,3
English: Microneutralisation assay
Croatian: Mikroneutralizacijska analiza
English: • Injection site irritation
Croatian: • Iritacija na mjestu injiciranja
English: Dyspnea
Croatian: TKIVA
English: • There are no data with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER using the subcutaneous route.
Croatian: • Nema podataka o supkutanoj primjeni CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER.
English: • hardness, redness or swelling at the injection site
Croatian: • otvrdnuće, crvenilo ili oticanje na mjestu injiciranja
English: • pain at the injection site
Croatian: • Otvrdnuće na mjestu injiciranja
English: Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Croatian: PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
English: • irritability
Croatian: • slabost
English: • Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Croatian: • Nakon primjene sličnog cjelovirionskog cjepiva protiv influence H1N1 uzgojenog na Vero stanicama, koje je primijenjeno tijekom pandemije, zabilježene su reakcije preosjetljivosti, uključujući anafilaksiju.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose syringe (0.5ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Nasal congestion Rhinorrhea Dry throat
Croatian: • curenje nosa i suho grlo
English: • sleepiness
Croatian: • mučnina
English: • stomach pain, indigestion
Croatian: • bol u trbuhu, probavne smetnje
English: Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vietnam/1203/2004)
Croatian: H5N1 BAXTER (A/Vietnam/1203/2004)
English: • hardness redness, swelling or bruising at the injection site
Croatian: • pojačano znojenje • otvrdnuće, crvenilo, oticanje ili stvaranje modrica na mjestu injiciranja
English: Chest discomfort
Croatian: POREMEĆAJI PROBAVNOG
English: Irritability Malaise Feeling Cold
Croatian: • svrbež na mjestu davanja injekcije • osjećaj hladnoće
English: per 0.5 ml dose * produced in Vero cells ** haemagglutinin
Croatian: po dozi od 0,5 ml * proizveden na Vero stanicama
English: • chest discomfort
Croatian: • zimica • slabost
English: ** either SRH area ≥ 25 mm2 if baseline sample negative or 50% increase in SRH area if baseline sample
Croatian: * SRH površina ≥ 25 mm² ** ili SRH površina ≥ 25 mm ako je početni uzorak negativan ili 50% povećanje SRH površine ako je početni uzorak > 4 mm²
English: Whole virion H5N1 influenza vaccine, inactivated, containing antigen of*: A/Vietnam/1203/2004 (H5N1)
Croatian: Cjepivo protiv influence H5N1(cijeli virion) inaktivirano, koje sadrži antigen*:
English: SRH assay
Croatian: Osip Urtikarija
English: • runny nose and sore throat
Croatian: • osip, urtikarija
English: Nervous system disorders: convulsion
Croatian: POREMEĆAJI DIŠNOG SUSTAVA, PRSIŠTA
English: Seroprotection rate*
Croatian: Stopa serozaštite*
English: Oropharyngeal pain Rhinorrhoea
Croatian: s čepom (bromobutilna guma).
English: Frequency of submission
Croatian: Učestalost predavanja
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of the pack
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER daje se kao injekcija u mišić
English: Min, max
Croatian: Min, maks
English: Elderly population (> 65 years old)
Croatian: Starija populacija (> 65 godina)
English: Your doctor will want to monitor you closely for at least 16 weeks.
Croatian: Liječnik će Vas htjeti pomno pratiti najmanje 16 tjedana.
English: 40 to less than 60 60 to less than 100 above 100
Croatian: od 40 do ispod 60 od 60 do ispod 100 iznad 100
English: The infusion will take approximately 2 hours.
Croatian: Infuzija će trajati otprilike 2 sata.
English: ≥ 40 to < 60 ≥ 60 to < 100
Croatian: ≥ 40 do < 60 ≥ 60 do < 100
English: You should also be aware that vaccination may not always prevent this type of infection.
Croatian: Također morate znati da cijepljenje možda neće uvijek spriječiti ovu vrstu infekcije.
English: Minimum infusion duration minutes (hours)
Croatian: Minimalno trajanje infuzije, minute (sati)
English: A risk to infants cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Croatian: Upamtite da ipak morate otići liječniku čim to bude moguće, čak i ako se osjećate bolje nakon što ste uzeli antibiotike.
English: Other systemic infections
Croatian: Druge sistemske infekcije
English: Sex (n, %)
Croatian: Spol (n, %)
English: It should not be shaken.
Croatian: Ne smije se protresati.
English: The safety and efficacy of ravulizumab in children with PNH aged 0 to < 18 years have not been established.
Croatian: Sigurnost i djelotvornost ravulizumaba u djece s PNH-om u dobi od 0 do < 18 godina nisu ustanovljene.
English: Aseptic technique must be used.
Croatian: Mora se primijeniti aseptička tehnika.
English: Do not give this medicine to children under 18 years of age as no data are available on its safety and effectiveness in this group.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 18 godina jer za tu dobnu skupinu nema dostupnih podataka o sigurnosti i djelotvornosti lijeka.
English: Transfer the recommended dose to an infusion bag.
Croatian: Prenesite preporučenu dozu u infuzijsku vrećicu.
English: Treatment with any therapeutic protein may induce an immune response.
Croatian: Liječenje bilo kojim terapijskim proteinom može izazvati imunosni odgovor.
English: Ravulizumab should be given to a pregnant woman only if clearly needed.
Croatian: Ravulizumab se smije davati trudnicama samo ako je to izrazito potrebno.
English: The patient should be monitored for one hour following infusion.
Croatian: Bolesnika je potrebno nadzirati jedan sat nakon infuzije.
English: No case of overdose has been reported to date.
Croatian: Dosad nije zabilježen nijedan slučaj predoziranja.
English: Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 133% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: The effects of the medicine on an unborn child are not known.
Croatian: Nisu poznati učinci lijeka na nerođeno dijete.
English: In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Croatian: U skladu s nacionalnim preporukama, liječnik može smatrati da je u Vas potrebno spriječiti infekciju dodatnim mjerama.
English: Ultomiris should not be shaken.
Croatian: Ultomiris se ne smije protresati.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2019
Croatian: Datum prvog odobrenja: 02. srpanj 2019
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of ravulizumab.
Croatian: Nisu provedena ispitivanja na životinjama kako bi se procijenio genotoksični i kancerogeni potencijal ravulizumaba.
English: • Physician educational material
Croatian: • edukacijski materijal za liječnike
English: This medicine contains sodium (see section 2 “Ultomiris contains sodium”).
Croatian: Ovaj lijek sadrži natrij (pogledajte dio 2 „Ultomiris sadrži natrij“).
English: Adult patients with PNH
Croatian: Odrasli bolesnici s PNH-om
English: These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis).
Croatian: To su teške infekcije koje zahvate moždane ovojnice i mogu se proširiti u krv i na cijelo tijelo (sepsa).
English: If you have any of these symptoms, contact your doctor.
Croatian: Imate li bilo koji od tih simptoma, obratite se liječniku.
English: Note: LDH = lactate dehydrogenase; CI = Confidence Interval.
Croatian: Napomena: LDH = laktat dehidrogenaza; CI = interval pouzdanosti
English: Your first dose is called the loading dose.
Croatian: Prva doza koju ćete primiti naziva se udarna doza.
English: Prepare Ultomiris as follows:
Croatian: Ultomiris se priprema na sljedeći način: