FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions following booster vaccination in 268 subjects aged 15 to 23 years were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.
Croatian: U 268 ispitanika u dobi od 15 do 23 godine nuspojave nakon docjepljivanja bile su nalik nuspojavama nakon primarne serije cijepljenja Trumenbom prije otprilike 4 godine.
English: Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidis serogroup B, for use in people 10 years and older.
Croatian: Trumenba je cjepivo za sprječavanje invazivne meningokokne bolesti, uzrokovane bakterijom Neisseria meningitidis serogrupe B, koje se primjenjuje u osoba u dobi od 10 godina i starijih.
English: Study B1971016 (18-25 years of age)
Croatian: Ispitivanje B1971016 (18 do 25 godina starosti)
English: 1 dose (0.5 ml) contains:
Croatian: 1 doza (0,5 ml) sadrži:
English: Trumenba is a vaccine composed of 2 recombinant lipidated factor H binding protein (fHbp) variants.
Croatian: Trumenba je cjepivo koje se sastoji od 2 varijante rekombinantnog lipidiranog proteina koji veže faktor H (engl. factor H binding protein, fHbp).
English: How to store Trumenba
Croatian: Kako čuvati Trumenbu
English: As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba.
Croatian: Kao i kod drugih cjepiva koja se ubrizgavaju, povezano s primjenom Trumenbe može se pojaviti sinkopa (nesvjestica).
English: Pre-filled syringe label
Croatian: Naljepnica napunjene štrcaljke
English: Study B1971016 was a Phase 3, randomised, placebo-controlled, observer-blinded, multicentre trial in which subjects 18 to 25 years of age were assigned to 2 groups in a 3:1 ratio (Group 1:Group 2).
Croatian: Ispitivanje B1971016 je bilo randomizirano, placebom kontrolirano, slijepo za promatrača, multicentrično ispitivanje faze 3 u kojem su ispitanici u dobi od 18 do 25 godina bili podijeljeni u 2 skupine u omjeru 3:1 (1. skupina : 2. skupina).
English: When given concomitantly with other vaccines Trumenba must be administered at a separate injection site.
Croatian: Kad se primjenjuje istodobno s drugim cjepivima, Trumenbu se mora injicirati na zasebno mjesto.
English: Outer Carton Pack of 1, 5 or 10 pre-filled syringes; with or without needles
Croatian: Vanjsko kartonsko pakiranje od 1, 5 ili 10 napunjenih štrcaljki; sa ili bez igala
English: What you need to know before you or your child receives Trumenba
Croatian: Vi ili Vaše dijete primite Trumenbu
English: It is unknown whether Trumenba is excreted in human milk.
Croatian: Nije poznato izlučuje li se Trumenba u majčino mlijeko.
English: The Meningococcal Antigen Surface Expression (MEASURE) assay was developed to relate the level of fHbp surface expression to killing of meningococcal serogroup B strains in serum bactericidal assays with human complement (hSBAs).
Croatian: Meningococcal Antigen Surface Expression, MEASURE) razvijena je kako bi se uspostavio odnos između razine izraženosti fHbp-a na površini bakterije s uništenjem sojeva meningokoka serogrupe B u analizi baktericidnosti seruma s humanim komplementom (engl. serum bactericidal assays with human complement, hBSA).
English: (0 and 6 Months)
Croatian: (0 i 6 mjeseci)
English: A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1).
Croatian: U osoba s kontinuiranim rizikom od invazivne meningokokne bolesti potrebno je razmotriti dozu docjepljivanja nakon bilo kojeg režima doziranja (vidjeti dio 5.1).
English: Study B1971009 was a Phase 3, randomised, active-controlled, observer-blinded, multicentre trial in which subjects aged 10 to 18 years received 1 of 3 lots (Groups 1, 2, and 3) of Trumenba or the active control hepatitis A virus (HAV) vaccine/saline.
Croatian: Ispitivanje B1971009 je bilo randomizirano, aktivno kontrolirano, slijepo za promatrača, multicentrično ispitivanje faze 3 u kojem su ispitanici u dobi od 10 do 18 godina primili 1 od 3 serije (1., 2. i 3. skupina) Trumenbe ili aktivnu kontrolu u obliku cjepiva protiv hepatitisa A (HAV)/fiziološku otopinu.
English: Trumenba must not be mixed with any other vaccines in the same syringe.
Croatian: Trumenba se ne smije miješati s bilo kojim drugim cjepivima u istoj štrcaljki.
English: (Cyprus Branch) Tηλ: +357 22 817690
Croatian: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690
English: Bactericidal antibodies act in concert with human complement to kill meningococci.
Croatian: Baktericidna protutijela djeluju u suglasju s humanim komplementom kako bi uništili meningokoke.
English: General disorders and administration site conditions Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site Common:
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često: Zimica; umor; crvenilo (eritem), oticanje (induracija) i bol na mjestu injekcije Često:
English: 12 Months after last primary Dose
Croatian: 12 mjeseci nakon posljednje primarne doze
English: hSBA GMT 1 Month after last primary Dose 12 Months after last primary Dose 48 Months after last primary Dose 1 Month after booster Dose
Croatian: hSBA GMT Mjesec dana nakon posljednje primarne doze 12 mjeseci nakon posljednje primarne doze 48 mjeseci nakon posljednje primarne doze Mjesec dana nakon doze docjepljivanja
English: Trumenba suspension for injection in pre-filled syringe
Croatian: Trumenba suspenzija za injekciju u napunjenoj štrcaljki
English: Trumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed)
Croatian: Trumenba suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv meningokoka grupe B (rekombinantno, adsorbirano)
English: For intramuscular injection only.
Croatian: Samo za primjenu intramuskularnom injekcijom.
English: How Trumenba is given
Croatian: Kako se Trumenba daje
English: 1 Month after last primary Dose
Croatian: Mjesec dana nakon posljednje primarne doze
English: The hSBA responses for subjects enrolled from primary Study B1971012 Group 1 (0-, 1-, 6-Month Schedule), Group 2 (0-, 2-, 6-Month) and Group 3 (0-, 6-Month) are presented in Tables 6 and 7.
Croatian: Odgovori hSBA u ispitanika uključenih u primarno ispitivanje B1971012 u 1. skupinu (raspored 0, 1 i 6 mjeseci), 2. skupinu (0, 2 i 6 mjeseci) i 3. skupinu (u 0, 6 mjeseci) prikazani su u Tablicama 6 i 7.
English: hSBA Strain (fHbp Variant)
Croatian: hSBA soj (fHBP varijanta)
English: Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to 4 meningococcal serogroup B test strains (see the Immunogenicity section).
Croatian: Zaključak o djelotvornosti cjepiva izveden je temeljem prikazanog potaknutog odgovora serumskih baktericidnih protutijela na 4 testna soja meningokoka serogrupe B (vidjeti dio Imunogenost).
English: Trumenba contains sodium This medicinal product contains less than 23 mg sodium per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Pfizer s.r.1
Croatian: Pfizer s.r.l
English: It will be injected into the upper arm muscle.
Croatian: Cjepivo se injicira u mišić nadlaktice.
English: Gastrointestinal disorders Very Common: Diarrhoea; nausea Common:
Croatian: Poremećaji probavnog sustava Vrlo često: Proljev; mučnina Često:
English: Pack sizes of 1, 5, and 10 pre-filled syringes, with or without needle.
Croatian: Veličine pakiranja od 1, 5 i 10 napunjenih štrcaljki, sa ili bez igle.
English: Group 2 received saline at months 0, 2, and 6.
Croatian: 2. skupina je primala fiziološku otopinu u rasporedu 0, 2, i 6 mjeseci.
English: The immunogenicity of Trumenba following 2 or 3 vaccinations was evaluated in individuals 11 to 18 years of age in Europe (Study B1971012) and following 3 vaccinations in individuals 10 to 25 years of age globally (Studies B1971009 and B1971016).
Croatian: Imunogenost Trumenbe nakon dva ili tri cijepljenja procijenjena je u osoba u dobi od 11 do 18 godina u Europi (ispitivanje B1971012) i nakon tri cijepljenja u osoba u dobi od 10 do 25 godina u svijetu (ispitivanja B1971009 i B1971016).
English: The presence of a minor infection, such as a cold, should not require postponement of the vaccination,
Croatian: Prisutnost manje infekcije poput prehlade ne zahtijeva odgodu cijepljenja, no prvo razgovarajte s liječnikom.
English: (0, 1, and 6 Months)
Croatian: (0, 1 i 6 mjeseci)
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: 1 Month after booster Dose
Croatian: Mjesec dana nakon doze docjepljivanja
English: (0, 2, and 6 Months)
Croatian: (0, 2 i 6 mjeseci)
English: See section 5.1 for information on the immune response against specific serogroup B strains.
Croatian: Za informacije o imunološkom odgovoru na specifične sojeve serogrupe B vidjeti dio 5.1.
English: Composite response (A response for all 4 hSBA strains combined) Before
Croatian: Kompozitni odgovor (odgovor za sva 4 hSBA soja zajedno) Prije 1. doze
English: Group 1
Croatian: 1. skupina
English: Immune system disorder Not known:
Croatian: Poremećaji imunološkog sustava Nepoznato: Alergijske reakcije*
English: Composite response (A response for all 4 hSBA strains combined) 1 Month after last primary Dose
Croatian: Doza Kompozitni odgovor (odgovor za sva 4 hSBA soja zajedno) Prije 1. doze
English: Dose 3 362
Croatian: 3 doze 362
English: Neisseria meningitidis serogroup B fHbp subfamily B
Croatian: iz Neisseria meningitidis serogrupe B 60 mikrograma fHbp, potporodica B
English: Trumenba suspension for injection Meningococcal B vaccine IM
Croatian: Trumenba suspenzija za injekciju cjepivo protiv meningokoka grupe B i.m.
English: Dose 3 360
Croatian: 3 doze 360
English: Trumenba has not been evaluated for impairment of fertility in males.
Croatian: Nije ocijenjen učinak Trumenbe na smanjenje plodnosti u muškaraca.
English: Dose 3 351
Croatian: 3 doze 351
English: The hSBA responses observed after the third dose in Group 1 are presented in Tables 3 and 4.
Croatian: Odgovori hSBA uočeni nakon treće doze u 1. skupini prikazani su u Tablicama 3 i 4.
English: Pack sizes of 1, 5, and 10 pre-filled syringes with or without needles.
Croatian: Veličina pakiranja od 1, 5 ili 10 napunjenih štrcaljki sa ili bez igala.
English: Group 2
Croatian: 2. skupina
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Croatian: Prije primjene cjepivo treba vizualno pregledati zbog moguće prisutnosti čestica i promjene boje.
English: Dose 3 356
Croatian: 3 doze 356
English: Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 666 7500
Croatian: Pfizer Luxembourg SARL Eesti filial Tel.: +372 6 405 328
English: Dose 3 354
Croatian: 3 doze 354
English: The hSBA responses observed after the second or third dose for Groups 1, 2, and 3 are presented in Tables 1 and 2.
Croatian: Odgovori hSBA uočeni nakon druge ili treće doze u 1., 2. i 3. skupini prikazani su Tablicama 1 i 2.
English: Dose 3 337
Croatian: 3 doze 337
English: Table 1: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Croatian: Tablica 1: Imunološki odgovori među osobama u dobi od 11 do 18 godina kojima je Trumenba primijenjena u različitim režimima doziranja s 2 ili 3 doze (ispitivanje B1971012) 1. skupina
English: Table 2: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Croatian: Tablica 2: Imunološki odgovori među osobama u dobi od 11 do 18 godina kojima je Trumenba primijenjena u različitim režimima doziranja s 2 ili 3 doze (ispitivanje B1971012) 1. skupina
English: Table 7: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033) Primary Study B1971012 Vaccine Group (as Randomised) Group 1
Croatian: Tablica 7: Trajnost imunološkog odgovora i odgovora na docjepljivanje među osobama u dobi od 11 do 18 godina u kojih je primijenjena primarna serija cijepljenja Trumenbom po rasporedu 0, 1 i 6 mjeseci, 0, 2 i 6 mjeseci te 0 i 6 mjeseci te docjepljivanje 4 godine nakon serije primarnog cijepljenja (ispitivanje B1971033) Skupina koja je primila cjepivo u primarnom ispitivanju B1971012 (prema randomizaciji)
English: The hSBA responses observed after the third dose in Groups 1 and 2 are presented in Tables 3 and 4.
Croatian: Odgovori hSBA uočeni nakon treće doze u 1. i 2. skupini prikazani su u Tablicama 3 i 4.
English: Table 6: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033) Primary Study B1971012 Vaccine Group (as Randomised) Group 1
Croatian: Tablica 6: Trajnost imunološkog odgovora i odgovora na docjepljivanje među osobama u dobi od 11 do 18 godina u kojih je primijenjena primarna serija cijepljenja Trumenbom po rasporedu 0, 1 i 6 mjeseci, 0, 2 i 6 mjeseci te 0 i 6 mjeseci te docjepljivanje 4 godine nakon serije primarnog cijepljenja (ispitivanje B1971033) Skupina koja je primila cjepivo u primarnom ispitivanju B1971012 (prema randomizaciji)
English: Group 3
Croatian: 3. skupina
English: Group 4
Croatian: 4. skupina
English: Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein.
Croatian: Skraćenice: GMT= geometrijski srednji titar; hSBA=analiza baktericidnosti seruma s humanim komplementom; fHBP= faktor H vezujući protein.
English: Dose 3 347
Croatian: 3 doze 347
English: During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe containing the suspension.
Croatian: Tijekom čuvanja se u napunjenoj štrcaljki koja sadrži suspenziju mogu uočiti bijeli talog i bistri supernatant.
English: % hSBA ≥ 1:16 1 Month after last primary Dose 12 Months after last primary Dose 48 Months after last primary Dose 1 Month after booster Dose
Croatian: % hSBA ≥ 1:16 Mjesec dana nakon posljednje primarne doze
English: Saline hSBA Strain (fHbp Variant)
Croatian: Fiziološka otopina hSBA soj (fHBP varijanta)
English: Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHBP=factor H binding protein.
Croatian: Skraćenice: GMT= geometrijski srednji titar; hSBA=analiza baktericidnosti seruma s humanim komplementom; fHBP= protein koji veže faktor H.
English: Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein.
Croatian: Skraćenice: hSBA=analiza baktericidnosti seruma s humanim komplementom; fHBP = protein koji veže faktor H.
English: Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and B1971016)
Croatian: Tablica 4. Imunološki odgovori među osobama u dobi od 10 do 25 godina mjesec dana nakon treće doze Trumenbe ili kontrole, primijenjene po rasporedu 0, 2 i 6 mjeseci (ispitivanje B1971009 i
English: Dose 1
Croatian: doze doze
English: Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and Study B1971016)
Croatian: Tablica 3. Imunološki odgovori među osobama u dobi od 10 do 25 godina mjesec dana nakon treće doze Trumenbe ili kontrole, primijenjene po rasporedu 0, 2 i 6 mjeseci (ispitivanje B1971009 i ispitivanje B1971016) Ispitivanje B1971009 (10 do 18 godina starosti)
English: hSBA GMT Dose 2 344
Croatian: hSBA GMT
English: This process is measured in vitro with serum bactericidal assay using human complement (hSBA) for meningococcal serogroup B. An hSBA titre of greater than or equal 1:4 is assumed to be protective against meningococcal disease.
Croatian: Titar hSBA veći ili jednak 1:4 smatra se zaštitnim protiv meningokokne bolesti.
English: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Croatian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
English: HAV/saline
Croatian: HAV/fiziološka otopina
English: Vivian Corporation Ltd. Tel: + 35621 344610
Croatian: Tel: + 35621 344610
English: PMB824 (A12) PMB1989 (A19)
Croatian: PMB824 (A12)
English: Neisseria meningitidis serogroup B fHbp subfamily A and B
Croatian: fHbp, potporodice A i B iz Neisseria meningitidis serogrupe B 60 mikrograma od svakog
English: th
Croatian: OBLIK
English: This generally occurs within the first year of treatment.
Croatian: To se obično događa u prvoj godini liječenja.
English: • Changes in behaviour, especially in children.
Croatian: • Promjene ponašanja, posebice u djece.
English: • Taste changes, such as an unpleasant taste in the mouth.
Croatian: • Promjene u osjetu okusa, poput neugodnog okusa u ustima.
English: If you are to take a second inhalation, repeat steps 1 to 7.
Croatian: Ako ćete uzimati drugu inhalaciju, ponovite korake od 1 do 7.
English: Special populations:
Croatian: Posebne populacije:
English: The difference is considered not to have an impact on clinical safety.
Croatian: Smatra se da razlika nema utjecaja na kliničku sigurnost.
English: • Depression.
Croatian: • Depresija.
English: If you forget to take a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite.
English: Headache, tremor
Croatian: Glavobolja, tremor
English: Specific treatment should be initiated for these conditions.
Croatian: Za ta stanja mora se započeti specifično liječenje.
English: The duration of effect is at least 12 hours after a single dose.
Croatian: Trajanje učinka je najmanje 12 sati nakon jednokratne doze.
English: If it is nearly time for your next dose just take your next dose at the usual time.
Croatian: Ako je uskoro vrijeme za Vašu sljedeću dozu, jednostavno primijenite sljedeću dozu u uobičajeno vrijeme.
English: Breathe out gently (as far as is comfortable).
Croatian: Lagano izdahnite (dokle god vam je ugodno).
English: Depression, behavioural changes (predominantly in children)
Croatian: Depresija, promjene ponašanja (uglavnom u djece)
English: Breathe in through your mouth as deeply and as hard as you can.
Croatian: Udahnite kroz usta što dublje i što jače možete.
English: Angina pectoris.
Croatian: Angina pektoris.
English: These tend to be mild and usually disappear within a few days of treatment.
Croatian: Te pojave uglavnom su blage i obično nestaju unutar nekoliko dana liječenja.
English: These are used to treat high blood pressure.
Croatian: Koriste se za liječenje visokog krvnog tlaka.
English: Your medicine is actively metered.
Croatian: Vaš lijek je aktivno baždaren.
English: Supportive and symptomatic treatment may be indicated.
Croatian: Može biti indicirano potporno i simptomatsko liječenje.
English: Systemic effects
Croatian: Sistemski učinci
English: Take care not to block the air vents.
Croatian: Pazite da ne blokirate dišne puteve.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Posebice recite svojem liječniku ili ljekarniku ako uzimate bilo koji od sljedećih lijekova:
English: ATC code: R03AK07
Croatian: ATK oznaka: R03AK07
English: Your inhaler is now ready for use.
Croatian: Vaš inhalator sada je spreman za primjenu.
English: However, an initial small but transient reduction in growth (approximately 1 cm) has been observed.
Croatian: Međutim, bilo je opaženo početno malo, ali prolazno usporavanje rasta (približno 1 cm).
English: Elderly patients (≥65 years old)
Croatian: Stariji bolesnici (≥65 godina)
English: However, do not take a double dose to make up for a forgotten dose.
Croatian: Međutim, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: There are no special dosing requirements for elderly patients.
Croatian: Za starije bolesnike nema posebnih zahtjeva za doziranje.
English: Contact your doctor immediately as you may need to have your treatment changed.
Croatian: Odmah se javite svojem liječniku jer će Vam može biti potrebna promjena liječenja.
English: Each pack contains 1 inhaler.
Croatian: Svako pakiranje sadrži 1 inhalator.
English: • Disturbed sleep.
Croatian: • Poremećaj spavanja.
English: NL-2031 GA Haarlem The Netherlands
Croatian: NL-2031 GA Haarlem Nizozemska
English: Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana 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), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: There was no sign of attenuation of the anti-asthmatic effect over time.
Croatian: Nije bilo znakova smanjenja antiastmatičnog učinka tijekom vremena.
English: Keep your Spiromax dry and clean.
Croatian: Spiromax održavajte suhim i čistim.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Front panel: Not for use in children and adolescents.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Prednja strana: Nije za primjenu kod djece i adolescenata.
English: However, at therapeutic doses no effects on the suckling child are anticipated.
Croatian: Međutim, u terapijskim dozama ne očekuju se učinci na dojenče.
English: After opening the foil wrap: 6 months.
Croatian: Nakon otvaranja folije: 6 mjeseci
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.
Croatian: Kad se brojevi u prozorčiću zacrvene, morate se javiti svojem liječniku i nabaviti novi inhalator.
English: Caution with special diseases
Croatian: Oprez kod posebnih bolesti
English: The bronchodilating effect is dose-dependant, with an onset of effect within 1-3 minutes.
Croatian: Bronhodilatatorni učinak ovisi o dozi, s nastupom učinka unutar 1 do 3 minute.
English: High dose corticosteroids
Croatian: Visoke doze kortikosteroida
English: These are often used to treat asthma.
Croatian: Oni se često koriste u liječenju astme.
English: Other possible side effects:
Croatian: Ostale moguće nuspojave:
English: However, these animal experimental results do not seem to be relevant in humans.
Croatian: Međutim, čini se kako ti eksperimentalni rezultati na životinjama nisu relevantni za ljude.
English: Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).
Croatian: Vaš liječnik može razmotriti dodavanje tableta steroida vašem redovitom liječenju tijekom stresnih razdoblja (primjerice, ako imate infekciju u prsnom košu ili prije operacije).
English: This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose is adjusted.
Croatian: To se mora uzeti u obzir ne samo pri započinjanju liječenja kombiniranim lijekovima nego i kod prilagodbe doze održavanja.
English: Very few patients had PIFRs below 40L/min; when PIFRs were less than 40L/min there appeared to be no clustering by age or disease severity.
Croatian: Jako maleni broj bolesnika imao je PIFR ispod 40 l/min; u slučaju kada su PIFR bili manji od 40 l/min čini se kako nije bilo grupiranja po dobi ili težini bolesti.
English: Remove your inhaler from your mouth.
Croatian: Izvadite inhalator iz usta.