FrancophonIA/ELRC3.0 huggingface dataset:
English: The placebo-corrected trough-to-peak ratios for SBP and DBP were approximately 80% or higher.
Croatian: Omjeri najniže i najviše vrijednosti sistoličkog i dijastoličkog tlaka korigirani za placebo iznosili su 80% ili više.
English: Serum creatinine
Croatian: Kreatinin u serumu
English: Caution required with concomitant use
Croatian: Lijekovi čija istovremena primjena zahtijeva oprez
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Croatian: Diuretici koji štede kalij, nadomjesci kalija, zamjenske soli koje sadrže kalij i druge tvari koje mogu povisiti razine kalija
English: Common side effects (may affect up to 1 in 10 people): - Dizziness - Diarrhoea - Increased blood creatine phosphokinase (an indicator of muscle damage).
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) omaglica proljev povišena kreatin fosfokinaza u krvi (pokazatelj oštećenja mišića).
English: Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) Study 1
Croatian: Klinički mjereni sistolički krvni tlak: LS prosječna promjena od početne vrijednosti do 6. tjedna (mm Hg) (LOCF)
English: Hypotension in volume- and /or salt-depleted patients In patients with marked volume- and/or salt-depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Edarbi.
Croatian: Hipotenzija u bolesnika sa smanjenim volumenom i/ili nedostatkom elektrolita Bolesnici s izrazito smanjenim volumenom i/ili nedostatkom elektrolita (npr. bolesnika koji povraćaju, imaju proljev ili uzimaju visoke doze diuretika) u početku liječenja Edarbijem mogu razviti simptomatsku hipotenziju.
English: Edarbi is for oral use.
Croatian: Edarbi se uzima kroz usta.
English: Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels.
Croatian: Istovremena primjena diuretika koji štede kalij, nadomjestaka kalija, zamjenskih soli koje sadrže kalij ili drugih lijekova (npr. heparina) može povisiti razine kalija.
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Croatian: Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju zamijeniti terapiju drugim lijekovima za čiji je sigurnosni profil ustanovljeno da se mogu uzimati tijekom trudnoće.
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Croatian: Kad se antagonisti receptora angiotenzina II primjenjuju istovremeno s NSAIL (npr. selektivnim COX-2 inhibitorima, acetilsalicilatnom kiselinom (> 3 g na dan) i neselektivnim NSAIL), može doći do slabljenja antihipertenzivnog učinka.
English: Tlf: + 47 6676 3030 infonorge@takeda.com
Croatian: Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge@takeda.com
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.2 and 5.2).
Croatian: Edarbi nije ispitan u bolesnika s teškim oštećenjem funkcije jetre i stoga se njegova primjena ne preporučuje u ove skupine bolesnika (vidjeti dio 4.2 i 5.2).
English: Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Edarbi in these patients (see sections 4.4 and 5.2).
Croatian: Potreban je oprez u bolesnika s hipertenzijom i teškim oštećenjem funkcije bubrega ili završnim stadijem bubrežne bolesti, jer nema iskustva s primjenom Edarbija u tih bolesnika (vidjeti dio 4.4 i 5.2).
English: There was no evidence of QT/QTc prolongation at a dose of 320 mg of azilsartan medoxomil.
Croatian: Nije bilo dokaza da azilsartanmedoksomil u dozi od 320 mg produljuje QT/QTc interval.
English: Adverse reactions were reported at a similar frequency for the Edarbi 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Croatian: U jednom placebom kontroliranom ispitivanju nuspojave su prijavljene sličnom učestalošću za Edarbi u dozi od 20 mg, kao i za doze od 40 mg i 80 mg.
English: Kidney transplantation
Croatian: Presađivanje bubrega
English: The incidence of adverse reactions with this treatment was not affected by gender, age, or race.
Croatian: Spol, dob i rasa nisu utjecali na incidenciju nuspojava pri tom liječenju.
English: Blood creatinine increased Blood uric acid increased / Hyperuricemia
Croatian: Pretrage često manje često povišena kreatin fosfokinaza u krvi povišen kreatinin u krvi povišena mokraćna kiselina u krvi / hiperuricemija
English: White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other.
Croatian: Bijele do gotovo bijele okrugle tablete promjera 7,6 mm, s utisnutim “ASL” na jednoj strani i “40” na drugoj strani.
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.4 and 5.2).
Croatian: Edarbi nije ispitan u bolesnika s teškim oštećenjem funkcije jetre te se stoga ne preporučuje njegova primjena u te skupine bolesnika (vidjeti dio 4.4 i 5.2).
English: In preclinical safety studies, azilsartan medoxomil and M-II, the major human metabolite, were examined for repeated-dose toxicity, reproduction toxicity, mutagenicity and carcinogenicity.
Croatian: U pretkliničkim ispitivanjima sigurnosti bila je ispitana toksičnost ponovljene doze, reproduktivna toksičnost, mutagenost i kancerogenost azilsartanamedoksomila i M-II, glavnog metabolita u ljudi.
English: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Croatian: - ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: o ACE inhibitor (primjerice enalapril, lizinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću. o aliskiren
English: Takeda UK Ltd Tel: +44 (0) 1628 537 900
Croatian: Takeda UK Limited Tel: +44 (0) 1628 537 900
English: The incidence of elevations in serum creatinine following treatment with Edarbi was similar to placebo in the randomised placebo-controlled monotherapy studies.
Croatian: U randomiziranim, placebom kontroliranim ispitivanjima monoterapije, incidencija povišenja kreatinina u serumu nakon liječenja Edarbijem bila je slična onoj uz placebo.
English: - have heart problems (including heart failure, recent heart attack).
Croatian: - ako ste na dijalizi ili Vam je nedavno presađen bubreg. - ako imate tešku bolest jetre. - ako imate tegobe sa srcem (uključujući zatajenje srca, nedavni srčani udar).
English: Edarbi 40 mg tablets
Croatian: Edarbi 40 mg tablete
English: Edarbi was compared with placebo and active comparators in two 6 week randomised, double blind studies.
Croatian: U dva randomizirana, dvostruko slijepa ispitivanja u trajanju od 6 tjedana, Edarbi je bio uspoređen s placebom i aktivnom kontrolom.
English: Special caution is indicated in patients suffering from aortic or mitral valve stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Croatian: Aortalna i mitralna stenoza, opstruktivna hipertrofična kardiomiopatija Indiciran je poseban oprez u bolesnika koji boluju od aortalne ili mitralne stenoze ili hipertrofične opstruktivne kardiomiopatije.
English: Due to the lack of experience with concomitant use of azilsartan medoxomil and lithium, this combination is not recommended.
Croatian: Ta se kombinacija ne preporučuje zbog toga što nema iskustva s istovremenom primjenom azilsartanmedoksomila i litija.
English: White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other.
Croatian: Bijele do gotovo bijele okrugle tablete promjera 9,6 mm, s utisnutim “ASL” na jednoj strani i “80” na drugoj strani.
English: Edarbi 20 mg tablets
Croatian: Edarbi 20 mg tablete
English: The blood pressure lowering effect of azilsartan medoxomil was also maintained throughout the 24 hour dosing interval.
Croatian: Učinak azilsartanmedoksomila na sniženje krvnog tlaka održao se tijekom cijelog 24-satnog razdoblja između dvije doze.
English: White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other.
Croatian: Bijele do gotovo bijele okrugle tablete promjera 6,0 mm, s utisnutim “ASL” na jednoj strani i “20” na drugoj strani.
English: Edarbi 80 mg tablets
Croatian: Edarbi 80 mg tablete
English: - The active substance is azilsartan medoxomil (as potassium).
Croatian: - Djelatna tvar je azilsartanmedoksomil (u obliku kalijeve soli)
English: Suomi/Finland Takeda Oy
Croatian: Suomi/Finland
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors.
Croatian: Tijekom istovremene primjene litija i inhibitora angiotenzin-konvertirajućeg inhibitora zabilježena su reverzibilna povećanja koncentracije litija.
English: However some people may feel tired or dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines.
Croatian: Međutim, neke osobe mogu osjećati umor ili omaglicu dok uzimaju ovaj lijek.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORANNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Takeda Italia S.p.A. Tel: +39 06 5026 01
Croatian: Tel: +39 06 5026 01
English: 24 Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) Study 1
Croatian: 24-satni prosječni sistolički krvni tlak: LS prosječna promjena od početne vrijednosti do 6. tjedna (mm Hg)
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Croatian: EU/1/11/734/001 14 tableta EU/1/11/734/002 28 tableta EU/1/11/734/012 30 tableta EU/1/11/734/003 56 tableta EU/1/11/734/013 90 tableta EU/1/11/734/004 98 tableta EU/1/11/734/005 14 tableta EU/1/11/734/006 28 tableta EU/1/11/734/014 30 tableta EU/1/11/734/007 56 tableta EU/1/11/734/015 90 tableta EU/1/11/734/008 98 tableta EU/1/11/734/016 14 tableta EU/1/11/734/009 28 tableta EU/1/11/734/017 30 tableta EU/1/11/734/010 56 tableta EU/1/11/734/018 90 tableta EU/1/11/734/011 98 tableta EU/1/11/734/019 14 tableta EU/1/11/734/020 28 tableta EU/1/11/734/021 56 tableta EU/1/11/734/022 98 tableta EU/1/11/734/023 14 tableta EU/1/11/734/024 28 tableta EU/1/11/734/025 56 tableta EU/1/11/734/026 98 tableta EU/1/11/734/027 14 tableta
English: including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers (see sections 4.3, 4.4, 4.5 and 5.1).
Croatian: Ako se krvni tlak ne može na odgovarajući način kontrolirati samo Edarbijem, dodatno sniženje krvnog tlaka može se postići istovremenom primjenom ovog lijeka s drugim antihipertenzivnim lijekovima, uključujući diuretike (kao što su klortalidon i hidroklorotiazid) i blokatore kalcijevih kanala (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
English: Edarbi 20 mg tablets Azilsartan medoxomil
Croatian: Edarbi 20 mg tablete azilsartanmedoksomil
English: Edarbi 40 mg tablets Azilsartan medoxomil
Croatian: Edarbi 40 mg tablete azilsartanmedoksomil
English: Edarbi 80 mg tablets Azilsartan medoxomil
Croatian: Edarbi 80 mg tablete azilsartanmedoksomil
English: Puh/Tel: +358 20 746 5000
Croatian: Oy Leiras Takeda Pharmaceuticals Ab Puh/Tel: +358 20 746 5000
English: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Croatian: Jedna tableta sadrži 80 mg azilsartanmedoksomila (u obliku kalijeve soli)
English: Takeda AS
Croatian: Vianex S.A
English: EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Croatian: EU/1/11/734/016 14 tableta EU/1/11/734/009 28 tableta EU/1/11/734/017 30 tableta EU/1/11/734/010 56 tableta EU/1/11/734/018 90 tableta EU/1/11/734/011 98 tableta EU/1/11/734/027 14 tableta EU/1/11/734/028 28 tableta EU/1/11/734/029 56 tableta EU/1/11/734/030 98 tableta
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često spazam mišića
English: Tel: +48 22 608 13 00
Croatian: Takeda Polska Sp. z o.o. Tel: +48 22 608 13 00
English: Consequently, uptitration of Edarbi and concomitant therapy may be needed more frequently for blood pressure control in black patients.
Croatian: Posljedično tome, za kontrolu krvnog tlaka u bolesnika crne rase može biti potrebno postupno povećavati dozu Edarbija i istovremeno davati dodatnu terapiju.
English: EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets
Croatian: EU/1/11/734/005 14 tableta EU/1/11/734/006 28 tableta EU/1/11/734/014 30 tableta EU/1/11/734/007 56 tableta EU/1/11/734/015 90 tableta EU/1/11/734/008 98 tableta EU/1/11/734/023 14 tableta EU/1/11/734/024 28 tableta EU/1/11/734/025 56 tableta EU/1/11/734/026 98 tableta
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets
Croatian: EU/1/11/734/001 14 tableta EU/1/11/734/002 28 tableta EU/1/11/734/012 30 tableta EU/1/11/734/003 56 tableta EU/1/11/734/013 90 tableta EU/1/11/734/004 98 tableta EU/1/11/734/019 14 tableta EU/1/11/734/020 28 tableta EU/1/11/734/021 56 tableta EU/1/11/734/022 98 tableta
English: Each tablet contains 40 mg azilsartan medoxomil (as potassium)
Croatian: Jedna tableta sadrži 40 mg azilsartanmedoksomila (u obliku kalijeve soli).
English: Each tablet contains 20 mg azilsartan medoxomil (as potassium)
Croatian: Jedna tableta sadrži 20 mg azilsartanmedoksomila (u obliku kalijeve soli).
English: You may feel faint or dizzy if you have taken more than you should.
Croatian: Ako ste uzeli više tableta nego što ste trebali, možete osjetiti nesvjesticu ili omaglicu.
English: - are vomiting, have recently had severe vomiting, or have diarrhoea.
Croatian: - ako povraćate, ako ste nedavno jako povraćali ili imate proljev. - ako imate povišene razine kalija u krvi (što je vidljivo na krvnim pretragama).
English: Tel: +385 1 377 88 96
Croatian: Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 96
English: Elimination Following an oral dose of
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva manje često rijetko osip, svrbež angioedem
English: Further information on Nimenrix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nimenrix.
Croatian: Više informacija o cjepivu Nimenrix dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/nimenrix.
English: This overview was last updated in 08-2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 08. 2019.
English: What measures are being taken to ensure the safe and effective use of Nimenrix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena cjepiva Nimenrix?
English: Nimenrix can only be obtained with a prescription and should be used according to available official recommendations.
Croatian: Nimenrix se izdaje samo na recept i treba se primjenjivati u skladu s dostupnim službenim preporukama.
English: Nimenrix is given as an injection into the thigh or shoulder muscle.
Croatian: Nimenrix se daje injekcijom u mišić bedra ili ramena.
English: Other information about Nimenrix
Croatian: Ostale informacije o cjepivu Nimenrix
English: When the person comes into contact with the bacterium, these antibodies, together with other components of the immune system, will be able to kill the bacteria and help protect against the disease.
Croatian: Kada osoba dođe u kontakt s tom bakterijom, ta će protutijela zajedno s drugim dijelovima imunosnog sustava moći uništiti bakterije i pomoći pri zaštiti od bolesti.
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood poisoning).
Croatian: Invazivna bolest nastupa kad se bakterija proširi tijelom uzrokujući ozbiljne infekcije poput meningitisa (infekcije membrana koje okružuju mozak i kralježnicu) i sepse (trovanja krvi).
English: Side effects reported with Nimenrix are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za cjepivo Nimenrix pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Nimenrix is well tolerated and the Agency considered that it can be safely given together with other routinely used vaccines in the different age groups.
Croatian: Nimenrix se dobro podnosi i Agencija je smatrala da se može sigurno primjenjivati zajedno s drugim uobičajeno korištenim cjepivima u osoba različitih dobnih skupina.
English: Therefore, the Agency decided that the benefits of Nimenrix are greater than its risks and recommended that it be granted marketing authorisation.
Croatian: Agencija je stoga odlučila da koristi cjepiva Nimenrix nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za njegovo stavljanje u promet.
English: What is Nimenrix and what is it used for?
Croatian: Što je Nimenrix i za što se koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nimenrix have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene cjepiva Nimenrix nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: For more information about using Nimenrix, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni cjepiva Nimenrix pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The Agency noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children.
Croatian: Agencija je smatrala da Nimenrix pruža prednosti konjugiranih cjepiva u odnosu na konvencionalna cjepiva, uključujući stvaranje snažnog imunosnog odgovora u male djece.
English: The ability of Nimenrix to trigger the production of antibodies (immunogenicity) was assessed in five main studies involving over 4,000 participants aged 1 year or more.
Croatian: Sposobnost cjepiva Nimenrix da potakne stvaranje protutijela (imunogenost) ocijenjena je u pet glavnih ispitivanja kojima je bilo obuhvaćeno više od 4 000 osoba u dobi od godinu dana i starijih.
English: Based on data from this study and additional data from a supporting study in 187 infants, this dose of Nimenrix was also considered to be effective in children between 12 weeks and less than 6 months of age.
Croatian: Na temelju podataka iz tog ispitivanja i dodatnih podataka iz pomoćnog ispitivanja na 187-ero dojenčadi, ta doza cjepiva Nimenrix smatrala se učinkovitom i u djece u dobi između 12 tjedana i šest mjeseci.
English: An overview of Nimenrix and why it is authorised in the EU
Croatian: Pregled informacija o cjepivu Nimenrix i zašto je odobreno u EU-u
English: The powder is available in a vial, and the solvent is available in a pre-filled syringe or in an ampoule (a sealed container).
Croatian: Prašak je dostupan u bočici, a otapalo je dostupno u napunjenoj štrcaljki ili u ampuli (plombiranom spremniku).
English: The number of people who had an immune response against the polysaccharides with Nimenrix was similar to the other vaccines.
Croatian: Broj osoba koje su imale imunosni odgovor na polisaharide pri primjeni cjepiva Nimenrix bio je sličan broju povezanom s drugim cjepivima.
English: Why is Nimenrix authorised in the EU?
Croatian: Zašto je cjepivo Nimenrix odobreno u EU-u?
English: As for all medicines, data on the use of Nimenrix are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni cjepiva Nimenrix kontinuirano se prate.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium in the vaccine as ‘foreign' and makes antibodies against them.
Croatian: Nakon što osoba primi cjepivo, imunosni sustav prepoznaje dijelove bakterije u cjepivu kao „strano tijelo” i proizvodi protutijela protiv njih.
English: Nimenrix received a marketing authorisation valid throughout the EU on 20 April 2012.
Croatian: Cjepivo Nimenrix dobilo je odobrenje za stavljanje u promet koje je na snazi u EU-u od 20. travnja
English: Nimenrix (meningococcal group A, C, W-135 and Y conjugate vaccine)
Croatian: Nimenrix (cjepivo protiv meningokoka grupe A, C, W-135 i Y, konjugirano)
English: The most common side effects from initial vaccination with Nimenrix (which may affect more than 1 patient in 10) are loss of appetite, irritability, drowsiness, headache, fever, swelling, pain and redness at the site of injection, and tiredness.
Croatian: Najčešće nuspojave nakon prvog cijepljenja cjepivom Nimenrix (koje se mogu javiti u više od 1 na 10 bolesnika) jesu gubitak teka, razdražljivost, pospanost, glavobolja, vrućica, oticanje, bol i crvenilo na mjestu injiciranja te umor.
English: What are the risks associated with Nimenrix?
Croatian: Koji su rizici povezani s cjepivom Nimenrix?
English: The vaccine contains substances from the outer coat of the bacterium N. meningitidis.
Croatian: Cjepivo sadrži tvari iz vanjske ovojnice bakterije N. meningitidis.
English: Nimenrix may also be used as a booster vaccine in people from 1 year of age who have already been vaccinated with another meningococcal vaccine, to reinforce the level of protection.
Croatian: Nimenrix se može koristiti i kao pojačivač cjepiva u osoba starijih od godinu dana koje su već cijepljene nekim drugim meningokoknim cjepivom kako bi se povećala razina zaštite.
English: It is available as a powder and solvent that are mixed together to make a solution for injection.
Croatian: Cjepivo je dostupno u obliku praška i otapala koji se miješaju da bi se dobila otopina za injekciju.
English: The company that markets Nimenrix will carry out a study to assess how long the protective immune response provided by one or two doses of Nimenrix lasts in young children between 1 and 2 years old.
Croatian: Tvrtka koja cjepivo Nimenrix stavlja u promet provest će ispitivanje kako bi se procijenilo koliko dugo zaštitni imunosni odgovor nakon jedne ili dvije doze cjepiva Nimenrix traje u djece stare od jedne do dvije godine.