FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (these may affect up to 1 in 100 people) - high fever (≥40°C) - seizures (including febrile seizures) - dry skin - paleness (rare after booster)
Croatian: - visoka vrućica (≥40°C) - napadaji (uključujući febrilne napadaje) - suhoća kože
English: Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Croatian: Dojenčad u dobi od 6 do 11 mjeseci treba primiti dvije injekcije cjepiva, a nakon toga još jednu dodatnu injekciju (docjepljivanje).
English: General disorders and administration site conditions Very common: injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site erythema, malaise
Croatian: Vrlo često: bol na mjestu injiciranja (uključujući tešku bol na mjestu injiciranja definirano kao nemogućnost izvršavanja normalnih svakodnevnih aktivnosti), oticanje mjesta injiciranja, otvrdnuće na mjestu injiciranja, eritem na mjestu injiciranja, malaksalost
English: Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Croatian: Bexsero suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv meningokoka grupe B (rDNK, komponentno, adsorbirano)
English: The response to a booster dose administered 7.5 years after the primary series was indicative of immunological memory as the percentages of subjects reaching an hSBA ≥ 1:4 across strains ranged from 93% to 100%.
Croatian: Odgovor na booster dozu primijenjenu 7,5 godina nakon primarne serije ukazivao je na imunološko pamćenje jer su postoci ispitanika koji su postigli hSBA ≥ 1:4 kod svih sojeva iznosili od 93% do 100%.
English: Not known: injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site and injection site nodule which may persist for more than one month)
Croatian: Nepoznato: reakcije na mjestu injiciranja (uključuju opsežno oticanje cijepljenih ekstremiteta, mjehuriće na mjestu injiciranja ili oko njega i kvržicu na mjestu uboda koja može trajati dulje od mjesec dana)
English: % seropositive (95% CI)
Croatian: % seropozitivnih (95% CI)
English: Bexsero contains four different components from the surface of the bacteria Neisseria meningitidis group B.
Croatian: Bexsero sadrži četiri različita sastojka iz površine bakterije
English: * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4.
Croatian: * % seropozitivnih = postotak ispitanika koji su postigli hSBA ≥ 1:4.
English: Very common (these may affect more than 1 in 10 people) - fever (≥38ºC) - loss of appetite - tenderness at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved) - painful joints - skin rash (children aged 12 to 23 months) (uncommon after booster) - sleepiness - feeling irritable - unusual crying - vomiting (uncommon after booster) - diarrhoea - headache
Croatian: - osjetljivost na mjestu injiciranja (uključujući jaku osjetljivost na mjestu injiciranja koja rezultira plakanjem uslijed pomicanja injicirane ruke ili noge) - bol u zglobovima - osip na koži (djeca u dobi od 12 do 23 mjeseca) (manje često nakon docjepljivanja) - pospanost - razdražljivost
English: Very common (these may affect more than 1 in 10 people) - pain at the injection site resulting in inability to perform normal daily activity - painful muscles and joints - nausea - generally feeling unwell - headache
Croatian: - bol na mjestu injiciranja što rezultira nemogućnošću izvršavanja normalnih dnevnih aktivnosti - bolni mišići i zglobovi - mučnina - opće loše osjećanje
English: Serum bactericidal antibody responses in adults after two doses of Bexsero administered according to different two-dose schedules
Croatian: Tablica 9. Odgovori serumskih baktericidnih protutijela u odraslih nakon dvije doze Bexsera primijenjene prema različitim shemama s dvije doze
English: % seropositive* (95% CI)
Croatian: % seropozitivnih* (95% CI)
English: Data are not available from all vaccine schedules using the reference strain for NHBA.
Croatian: Podaci referentnog soja za NHBA nisu dostupni za sve sheme cijepljenja.
English: Via Fiorentina 1 53100 Siena Italy.
Croatian: GSK Vaccines S.r.l. Via Fiorentina 1 53100 Siena Italija.
English: The response to a booster dose administered 4 years after the primary series was indicative of immunological memory as the percentages of subjects with hSBA ≥ 1:5 ranged across strains from 92% to 100%.
Croatian: Odgovor na booster dozu primijenjenu 4 godine nakon primarne serije ukazivao je na imunološko pamćenje jer su postoci ispitanika koji su postigli hSBA ≥ 1:5 kod svih sojeva iznosili od 92% do
English: Bexsero can be given at the same time as any of the following vaccine components: diphtheria, tetanus, whooping cough (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumococcus, measles, mumps, rubella, chickenpox, and meningococcus A, C, W, Y. Talk to your doctor or nurse for further information.
Croatian: Bexsero se smije dati istodobno s bilo kojim sastojkom slijedećih cjepiva: difterija, tetanus, hripavac (pertusis), Haemophilus influenzae tip b, polio, hepatitis B, pneumokok, ospice, zaušnjaci, rubeola,
English: Infants up to 5 months of age at the time of first dose
Croatian: Dojenčad koja prvu dozu primi u dobi do 5 mjeseci
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Gastrointestinal disorders Very common: nausea
Croatian: Poremećaji probavnog sustava Vrlo često: mučnina
English: Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3
Croatian: Rekombinantni protein NadA iz Neisseria meningitidis grupe B 1, 2, 3
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
Croatian: NZ98/254 izmjereno kao količina ukupnih proteina koji sadrže PorA P1.4 2
English: ** % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:5.
Croatian: ** % seropozitivnih = postotak ispitanika koji su postigli hSBA ≥ 1:5.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bexsero suspension for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bexsero suspenzija za injekciju cjepivo protiv meningokoka B i.m. primjena
English: The seroresponse rates and hSBA GMTs were high after the two-dose schedule in children against each of the vaccine antigens (Table 5).
Croatian: Nakon cijepljenja prema shemi s dvije doze u djece su zabilježene visoke stope serološkog odgovora i hSBA GMT za svaki od antigena sadržanih u cjepivu (Tablica 5).
English: Via Fiorentina, 1 IT-53100 Siena Italy
Croatian: GSK Vaccines S.r.l. Via Fiorentina, 1 IT-53100 Siena Italija
English: Recombinant Neisseria meningitidis group B NHBA fusion/NadA/fHbp fusion proteins
Croatian: Doza od 0,5 ml sadrži: rekombinantne proteine NHBA (fuzijski)/NadA/fHbp (fuzijski) iz Neisseria meningitidis grupe B
English: Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating.
Croatian: Prilikom cijepljenja potrebno je uzeti u obzir učinak invazivne bolesti u različitim dobnim skupinama kao i varijabilnost epidemiologije antigena za sojeve grupe B u različitim geografskim područjima.
English: - if you or your child have an allergy to the antibiotic kanamycin.
Croatian: - ako Vi ili Vaše dijete imate tešku infekciju uz visoku temperaturu.
English: General disorders and administration site conditions Very common: fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema, injection site swelling, injection site induration, irritability
Croatian: Vrlo često: vrućica (≥38°C), osjetljivost na mjestu injiciranja (uključujući jaku osjetljivost na mjestu injiciranja što rezultira plakanjem uslijed pomicanja injiciranog ekstremiteta), eritem na mjestu injiciranja, oticanje mjesta injiciranja, otvrdnuće na mjestu injiciranja, iritabilnost Manje često: vrućica (≥40°C)
English: % seropositive* (95% CI) hSBA GMT** (95% CI)
Croatian: % seropozitivnih* (95% CI) hSBA GMT** (95% CI)
English: As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Kao i kod drugih cjepiva, primjenu Bexsera treba odgoditi u osoba s akutnom teškom febrilnom bolešću.
English: Adolescents (from 11 years of age) and adults
Croatian: Adolescenti (u dobi od 11 i više godina) i odrasli
English: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3
Croatian: Rekombinantni fuzijski protein NHBA iz Neisseria meningitidis grupe B 1, 2, 3
English: at.info@gsk.com
Croatian: 441customercontactuk@gsk.com
English: * There are no data in adults above 50 years of age.
Croatian: Vidjeti dio 5.1. * Ne postoje podaci u odraslih starijih od 50 godina.
English: Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3
Croatian: Rekombinantni fuzijski protein fHbp iz Neisseria meningitidis grupe B 1, 2, 3
English: How to use BEXSERO
Croatian: Kako primjenjivati BEXSERO
English: Age at first dose Primary Immunisation
Croatian: Dob pri prvoj dozi
English: Musculoskeletal and connective tissue disorders Very common: myalgia, arthralgia
Croatian: Vrlo često: mialgija, artralgija
English: Children 2 years to 10 years of age at the time of first dose
Croatian: Djeca koja prvu dozu prime u dobi od 2 do 10 godina
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Croatian: Prije primjene cjepivo treba vizualno pregledati na moguću prisutnost čestica i promjenu boje.
English: How to store BEXSERO
Croatian: Kako primjenjivati Bexsero
English: Adolescents received two doses of Bexsero with one, two or six month intervals between doses; these data are summarised in Tables 7 and 8.
Croatian: Adolescenti su primili dvije doze Bexsera u intervalima od jednog, dva ili šest mjeseci između doza.
English: Bexsero is a Meningococcal group B Vaccine.
Croatian: Što je BEXSERO i za što se koristi Bexsero je cjepivo protiv meningokoka grupe B.
English: NAME OF THE MEDICINAL PRODUCT Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Croatian: Uputa o lijeku: Informacije za korisnika Bexsero suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv meningokoka grupe B (rDNK, komponentno, adsorbirano)
English: % seropositive (95% CI) hSBA GMT (95% CI) 18-23 months after 2nd dose
Croatian: % seropozitivnih (95% CI) hSBA GMT (95% CI) 18-23 mjeseca nakon 2. doze
English: % seropositive* (95% CI) hSBA GMT** (95% CI) 18-23 months after 2nd dose
Croatian: % seropozitivnih* (95% CI) hSBA GMT** (95% CI) 18-23 mjeseca nakon 2. doze
English: % seropositive (95% CI) hSBA GMT (95% CI)
Croatian: % seropozitivnih (95% CI) hSBA GMT (95% CI)
English: Bexsero is a suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Croatian: Kako Bexsero izgleda i sadržaj pakiranja Bexsero je suspenzija za injekciju u napunjenoj štrcaljki (staklo tipa I) s čepom klipa (bromobutilna guma tip I) i zaštitnim zatvaračem vrha (guma tipa
English: Serum bactericidal antibody responses at 1 month following the second dose of Bexsero given to children 2-10 years of age following a 0, 1-month schedule
Croatian: Tablica 6. Odgovori serumskih baktericidnih protutijela mjesec dana nakon primjene druge doze Bexsera u djece u dobi od 2 do 10 godina kod cijepljenja prema shemi primjene 0, 1 mjesec
English: The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) ranged from 44% to 100% one month after the second dose and from 55% to 100% one month after the third dose.
Croatian: Postotak seropozitivnih ispitanika (tj. onih koji su postigli hSBA od najmanje 1:4) kretao su se u rasponu od 44% do 100%
English: Very common: rash (children aged 12 to 23 months) (uncommon after booster) Common: rash (infants and children 2 to 10 years of age) Uncommon: eczema
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često: osip (djeca u dobi od 12 do 23 mjeseca) (manje često nakon boostera)
English: % seropositive* (95% CI) hSBA GMT** (95% CI) 12 months after 2nd dose
Croatian: % seropozitivnih* (95% CI) hSBA GMT** (95% CI) 12 mjeseci nakon 2. doze
English: % seropositive (95% CI) hSBA GMT (95% CI) 12 months after 2nd dose
Croatian: % seropozitivnih (95% CI) hSBA GMT (95% CI) 12 mjeseci nakon 2. doze
English: Children 12 months to 23 months of age at the time of first dose
Croatian: Djeca koja prvu dozu prime u dobi od 12 do 23 mjeseca
English: 12 months after booster % seropositive (95% CI) hSBA GMT (95% CI)
Croatian: 12 mjeseci nakon boostera % seropozitivnih (95% CI) hSBA GMT (95% CI)
English: - if you or your child have haemophilia or any other problem that may stop your blood from clotting properly, such as treatment with blood thinners (anticoagulants).
Croatian: Prisutnost manje infekcije, primjerice prehlade, ne mora zahtijevati odgađanje cijepljenja, no prvo razgovarajte sa svojim liječnikom ili medicinskom sestrom. - ako Vi ili Vaše dijete imate hemofiliju ili neki drugi problem koji može spriječiti pravilno zgrušavanje Vaše krvi, primjerice liječenje lijekovima za razrjeđivanje krvi (antikoagulansima).
English: Serum bactericidal antibody responses at 1 month following the second dose of Bexsero given to children 2-10 years of age following a 0, 2-month schedule
Croatian: Tablica 5. Odgovori serumskih baktericidnih protutijela mjesec dana nakon primjene druge doze Bexsera u djece u dobi od 2 do 10 godina kod cijepljenja prema shemi primjene 0, 2 mjeseca
English: Infants 6 months to 11 months of age at the time of first dose
Croatian: Dojenčad koja prvu dozu primi u dobi od 6 do 11 mjeseci
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use only.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: 1 month after booster % seropositive (95% CI) hSBA GMT (95% CI)
Croatian: 1 mjesec nakon boostera % seropozitivnih (95% CI) hSBA GMT (95% CI)
English: Separate injection sites must be used if more than one vaccine is administered at the same time.
Croatian: Ako se istodobno primjenjuje više od jednog cjepiva, potrebno ih je injicirati na zasebna mjesta.
English: Immunogenicity
Croatian: Primarna imunizacija
English: The immunogenicity after two primary doses (at 3 and a half and 5 months of age) or three primary doses (at 2 and a half, 3 and a half and 5 months of age) of Bexsero followed by a booster dose in infants starting vaccination between 2 and 5 months of age has been evaluated in an additional phase 3 clinical study.
Croatian: Primarna serija od dvije doze nakon kojih slijedi booster doza Imunogenost nakon dvije doze primarne imunizacije (primijenjene u dobi od 3,5 mjeseci i 5 mjeseci) ili tri doze primarne imunizacije (primijenjene u dobi od 2,5 mjeseci, 3,5 mjeseci i 5 mjeseci)
English: If you or your child may have allergy to kanamycin, talk to your doctor or nurse first.
Croatian: Obratite se najprije svom liječniku ili medicinskoj sestri ako ste Vi ili Vaše dijete alergični na kanamicin.
English: Serum bactericidal antibody responses to each of the vaccine antigens NadA, fHbp, NHBA and PorA P1.4 was evaluated using a set of four meningococcal group B reference strains.
Croatian: Imunogenost Odgovori serumskih baktericidnih protutijela na svaki od antigena cjepiva NadA, fHbp, NHBA i PorA
English: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441 customercontactuk@gsk.com
Croatian: United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221
English: Even if you or your child have been vaccinated with Bexsero you or your child remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria.
Croatian: Bexserom, i dalje postoji povećani rizik od bolesti uzrokovane bakterijom Neisseria meningitidis grupe B.
English: Not known: allergic reactions (including anaphylactic reactions)
Croatian: Nepoznato: vrućica, reakcije na mjestu injiciranja (uključuju opsežno oticanje cijepljenih ekstremiteta,
English: - If you get any side effects talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: The following information is intended for healthcare professionals only: Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.
Croatian: Pri čuvanju lijeka, u napunjenoj štrcaljki koja sadrži suspenziju može se primijetiti tanak bjelkasti sloj.
English: Meningococcal B vaccine
Croatian: Neisseria meningitidis grupe B.
English: IM use
Croatian: Dojenje
English: pre-booster % seropositive (95% CI) hSBA GMT (95% CI)
Croatian: prije boostera % seropozitivnih (95% CI) hSBA GMT (95% CI)
English: % seropositive* after 2nd dose
Croatian: % seropozitivnih nakon 2. doze (95% CI)
English: Česká republika GlaxoSmithKline s.r.o.
Croatian: Magyarország GlaxoSmithKline Kft.
English: This could be dangerous to yourself and others.
Croatian: To može biti opasno po Vas i druge.
English: This is normal, they will not harm you.
Croatian: To je uobičajeno, oni Vam neće naškoditi.
English: You may need to talk about:
Croatian: Možda ćete morati razgovarati o:
English: Be familiar with your warning signs.
Croatian: [15,0 do 26,7]
English: • You drink alcohol - especially when you have not eaten much.
Croatian: • Pijete alkohol - osobito kada niste mnogo pojeli.
English: Ask your doctor whether you can drive if:
Croatian: Pitajte svog liječnika možete li voziti ako:
English: Talk to your doctor before travelling.
Croatian: Obratite se svom liječniku prije putovanja.
English: Extra items you will need:
Croatian: Dodatni pribor koji ćete trebati:
English: This must always be treated by a doctor, normally in a hospital.
Croatian: Njih uvijek mora liječiti liječnik i to obično u bolnici.
English: • If you have poor eyesight, please see section 3.
Croatian: • ako imate slab vid, molimo pogledajte dio 3.
English: This may damage it.
Croatian: To je može oštetiti.
English: • Any health risks in the countries you will visit.
Croatian: • mogućim rizicima po zdravlje u zemljama koje ćete posjetiti
English: Your concentration may be affected.
Croatian: Vaša koncentracija može biti oslabljena.
English: Your healthcare professional will give you this information.
Croatian: Zdravstveni radnik će Vam dati taj podatak.
English: Elderly (≥65 years old)
Croatian: Starije osobe (≥65 godina)
English: Be especially aware of the following:
Croatian: Obratite posebnu pozornost na sljedeće:
English: ATC Code: A10AE54.
Croatian: ATK oznaka: A10AE54.
English: If you use insulin, you should always carry the following things with you:
Croatian: Ako uzimate inzulin, uvijek nosite sa sobom sljedeće:
English: • Information so that others know you have diabetes.
Croatian: • informaciju tako da ostali znaju da imate šećernu bolest..
English: You also need to be careful when you stop taking a medicine.
Croatian: Morate biti oprezni i kada prestajete uzimati neki lijek.
English: • Never share your pen - it is only for you
Croatian: • Nikada nemojte dijeliti svoju brizgalicu - namijenjena je samo Vama.
English: Do not leave the pen in a car on an exceptionally warm or cold day.
Croatian: Nemojte ostavljati brizaglicu u automobilu na osobito topao ili hladan dan.
English: • How much Suliqua you need each day and at what time.
Croatian: • odrediti koliko lijeka Suliqua Vam je potrebno svaki dan i u koje vrijeme
English: Age, Race, Gender and Body weight
Croatian: Dob, rasa, spol i tjelesna težina
English: This difference is not considered clinically relevant.
Croatian: Ova razlika se ne smatra klinički značajnom.
English: These signs often develop before the signs of a low sugar level in the brain.
Croatian: Ovi znakovi obično se razvijaju prije znakova niske razine šećera u mozgu.
English: • You are elderly.
Croatian: • ste starije dobi,
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin obično nestane nakon nekoliko dana ili nekoliko tjedana.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama gdje su takve sposobnosti posebno važne (npr. vožnja automobila ili rad sa strojevima).
English: • The possible effects of changing to different time zones.
Croatian: • mogućim utjecajima promjene vremenskih zona
English: • You are doing more exercise than usual or a different type of physical activity.
Croatian: • Vježbate više nego obično ili se bavite drugačijim tipom tjelesne aktivnosti.
English: Injecting cold medication is more painful.
Croatian: Injiciranje hladnog lijeka je bolnije.
English: • You may need to repeat this step up to 3 times before seeing medicine.
Croatian: Možda ćete morati ponoviti ovaj korak do 3 puta da biste vidjeli lijek.
English: • What you should do in an emergency if you feel unwell or become ill.
Croatian: • tome što učiniti u hitnim slučajevima ako se ne osjećate dobro ili obolite
English: If no liquid appears:
Croatian: Ako se tekućina ne pojavi:
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Croatian: Treba razmotriti je li u takvim okolnostima preporučljivo voziti ili raditi sa strojevima.
English: Other important information about using the pre-filled pens
Croatian: Druge važne informacije o uporabi napunjenih brizgalica
English: Take a new pen out of the refrigerator at least 1 hour before you inject.
Croatian: Izvadite novu brizgalicu iz hladnjaka barem 1 sat prije injiciranja.
English: Close glucose monitoring is recommended during the transfer and in the following weeks.
Croatian: Preporučuje se pažljivo praćenje glukoze tijekom prijelaza i u narednim tjednima.
English: If you do, you may not get the correct amount of medicine.
Croatian: Ako to učinite, možda nećete dobiti odgovarajuću dozu lijeka.
English: The first signs may be in your body generally.
Croatian: Prvi znakovi se mogu javiti u cijelom tijelu.
English: • A safety test must be performed before each injection.
Croatian: • Test sigurnosti se mora izvesti prije svakog injiciranja.
English: Suliqua with alcohol
Croatian: Suliqua s alkoholom
English: • Do not take two injections per day
Croatian: • Nemojte primijeniti dvije injekcije dnevno.
English: A. Choose a place to inject as shown in the picture above.
Croatian: Izaberite mjesto za injiciranje kako je prikazano na gornjoj slici.
English: The information given below is based on studies with the monocomponents.
Croatian: Dolje navedeni podaci temeljeni su na ispitivanjima za pojedinačne komponente.
English: • You are doing less exercise than usual.
Croatian: • ako vježbate manje nego obično
English: STEP 3: Do a safety test
Croatian: KORAK 3: Napravite test sigurnosti
English: • You have recently had too low blood sugar (for example the day before).
Croatian: • ste nedavno imali prenisku razinu šećera (primjerice dan ranije)
English: Populations not studied
Croatian: Populacije koje nisu ispitivane
English: • Never use your pen if it is damaged or if you are not sure that it is working properly.
Croatian: • Nikada nemojte koristiti svoju brizgalicu ako je oštećena ili niste sigurni da radi ispravno.
English: Of the 1479 patients who started the run-in phase, 1170 were randomised.
Croatian: Od 1479 bolesnika koji su započeli uvodno razdoblje, randomizirano je 1170.
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Croatian: Da bi se spriječio mogući prijenos bolesti, svaku brizgalicu smije koristiti samo jedan bolesnik.