FrancophonIA/ELRC3.0 huggingface dataset:
English: Common Deep vein thrombosis, haematoma, hot flush Uncommon Embolism, hot flush, thrombophlebitis superficial, flushing
Croatian: Krvožilni poremećaji često duboka venska tromboza, hematomi, navale vrućine (valunzi)
English: CARTON OF 25 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Croatian: KUTIJA S 14, 28, 84 (3 PAKIRANJA od 28) TABLETA
English: Blood tests for platelet count
Croatian: Krvne pretrage za provjeru broja trombocita
English: CARTON OF 12.5 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Croatian: KUTIJA S 14, 28, 84 (3 PAKIRANJA od 28) TABLETA OD 12,5 mg
English: RAISE: 197 ITP patients were randomised 2:1, eltrombopag (n=135) to placebo (n=62), and randomisation was stratified based upon splenectomy status, use of ITP medicinal products at baseline and baseline platelet count.
Croatian: Dvostruko slijepa, placebom kontrolirana ispitivanja RAISE: 197 bolesnika s ITP-om randomizirano je u omjeru 2:1 na eltrombopag (n=135) i placebo (n=62).
English: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag
Croatian: Jedna filmom obložena tableta sadrži eltrombopagolamin u količini koja odgovara 75 mg eltrombopaga.
English: Cough♦ Common Oropharyngeal pain, rhinorrhoea Uncommon Pulmonary embolism, pulmonary infarction, nasal discomfort, oropharyngeal blistering, sinus disorder, sleep apnoea syndrome
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj često orofaringealna bol, rinoreja manje često plućna embolija, plućni infarkt, nelagoda u nosu, mjehurići u orofarinksu, poremećaji sinusa, sindrom apneje u spavanju
English: Headache
Croatian: zubobolja
English: • eye problems including blurred vision, cloudy lens in the eye (cataract), spots or deposits in eye
Croatian: • tegobe s očima uključujući zamagljeni vid, zamućenu leću u oku (katarakta), točkice ili nakupine u oku („leteće mušice” u vidnom polju), suhoću oka, svrbež oka, žutilo bjeloočnica ili kože
English: • Rinse the mixing bottle and lid under running water.
Croatian: • Isperite bočicu za miješanje i poklopac pod tekućom vodom. (Bočica za miješanje može potamniti od lijeka.
English: EU/1/10/612/008 (28 film-coated tablets)
Croatian: EU/1/10/612/008 (28 filmom obloženih tableta)
English: No hepatic effects were observed after chronic dosing in rats (28 weeks) and in dogs (52 weeks) at 4 or 2 times the human clinical exposure in adult ITP patients and 3 or 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times or equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Croatian: Nisu zabilježeni učinci na jetru pri kroničnoj primjeni u štakora (28 tjedana) ili pasa (52 tjedna) pri izloženosti većoj 4, odnosno 2 puta od kliničke izloženosti odraslih bolesnika s ITP-om te 3 ili 2 puta većoj od kliničke izloženosti pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti ili ekvivalentnoj kliničkoj izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjereno AUC-om.
English: • pain in the nose and throat
Croatian: • bolovi u leđima
English: EU/1/10/612/007 (14 film-coated tablets)
Croatian: EU/1/10/612/007 (14 filmom obloženih tableta)
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 12.5 mg film-coated tablets
Croatian: Višestruko pakiranje od 84 (3 pakiranja po 28 filmom obloženih tableta) - bez plavog okvira12,5 mg filmom obložene tablete
English: Common Dry eye, cataract, ocular icterus, vision blurred, visual impairment, vitreous floaters
Croatian: Poremećaji oka često katarakta, retinalni eksudati, suhoća očiju, okularni ikterus, retinalno krvarenje
English: Renal effects were not observed in rats after 28 weeks or in dogs after 52 weeks at exposures 4 and 2 times the human clinical exposure in adult ITP patients and 3 and 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Croatian: Učinci na bubrege nisu primijećeni u štakora nakon 28 tjedana niti u pasa nakon 52 tjedna pri 4, odnosno 2 puta većoj izloženosti od kliničke izloženosti odraslih bolesnika s ITP-om te 3, odnosno 2 puta većoj izloženosti od kliničke izloženosti pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti, odnosno ekvivalentnoj kliničkoj izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjerenoj AUC-om.
English: EU/1/10/612/001 (14 film-coated tablets)
Croatian: EU/1/10/612/001 (14 filmom obloženih tableta)
English: EU/1/10/612/004 (14 film-coated tablets)
Croatian: EU/1/10/612/004 (14 filmom obloženih tableta)
English: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag
Croatian: Jedna filmom obložena tableta sadrži eltrombopagolamin u količini koja odgovara 50 mg eltrombopaga.
English: • bleeding of the gums
Croatian: • krvarenje mrežnice
English: EU/1/10/612/009 84 film-coated tablets (3 packs of 28)
Croatian: EU/1/10/612/009 84 filmom obloženih tableta (3 pakiranja po 28)
English: These may affect up to 1 in 100 people:
Croatian: 1 na 100 osoba)
English: Adults - the usual starting dose for SAA is two 25 mg sachets of Revolade a day.
Croatian: Odrasli - uobičajena početna doza za tešku aplastičnu anemiju su dvije vrećice lijeka Revolade od 25 mg na dan.
English: EU/1/10/612/005 (28 film-coated tablets)
Croatian: EU/1/10/612/005 (28 filmom obloženih tableta)
English: Nervous system disorders
Croatian: Oštećenje bubrega
English: EU/1/10/612/006 84 film-coated tablets (3 packs of 28)
Croatian: EU/1/10/612/006 84 filmom obloženih tableta (3 pakiranja po 28)
English: Increased bone marrow reticulin
Croatian: Povećanje količine retikulina u koštanoj srži
English: EU/1/10/612/002 (28 film-coated tablets)
Croatian: EU/1/10/612/002 (28 filmom obloženih tableta)
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box -75 mg film-coated tablets
Croatian: Višestruko pakiranje od 84 (3 pakiranja po 28 filmom obloženih tableta) - bez plavog okvira75 mg filmom obložene tablete
English: EU/1/10/612/003 84 film-coated tablets (3 packs of 28)
Croatian: EU/1/10/612/003 84 filmom obloženih tableta (3 pakiranja po 28)
English: • decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
Croatian: • povećan broj krvnih pločica smanjena razina kalcija smanjen broj crvenih krvnih stanica (anemija) uzrokovan pretjeranim uništavanjem crvenih krvnih stanica (hemolitička anemija) povećan broj mijelocita povećan opseg neutrofila povišena ureja u krvi povećana razina albumina u krvi povećane razine ukupnih proteina smanjena razina albumina u krvi povišen pH mokraće povećana razina hemoglobina
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki često menoragija
English: • changes in the shape of red blood cells
Croatian: Manje česte nuspojave koje se mogu vidjeti u krvnim pretragama: promjene oblika crvenih krvnih stanica
English: Common Arthralgia, muscle spasms, back pain, pain in extremity, musculoskeletal pain, bone pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često artralgija, bolovi u ekstremitetu, spazmi mišića često bolovi u leđima, mijalgija, bolovi u kostima
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 25 mg film-coated tablets
Croatian: Višestruko pakiranje od 84 (3 pakiranja po 28 filmom obloženih tableta) - bez plavog okvira25 mg filmom obložene tablete
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 50 mg film-coated tablets
Croatian: Višestruko pakiranje od 84 (3 pakiranja po 28 filmom obloženih tableta) - bez plavog okvira50 mg filmom obložene tablete
English: Uncommon Hypersensitivity
Croatian: Poremećaji imunološkog sustava manje često preosjetljivost
English: Posology
Croatian: Poklopac
English: Cough
Croatian: Dob
English: Transaminases increased
Croatian: Vršak štrcaljke
English: Cap
Croatian: Klip
English: bronchitis, nasopharyngitis, influenza, oral herpes Uncommon Gastroenteritis, pharyngitis
Croatian: Infekcije i infestacije često infekcije mokraćnog sustava, infekcije gornjih dišnih puteva, bronhitis, nazofaringitis, influenca, herpes u ustima manje često gastroenteritis, faringitis
English: - If you get any of the side effects talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: Uncommon Rectosigmoid cancer
Croatian: manje često rak rektosigmoidnog dijela debelog crijeva
English: Decreased appetite
Croatian: Manje česte nuspojave
English: Common Oral mucosal blistering, oral pain, vomiting, abdominal discomfort, constipation, abdominal distension, dysphagia, faeces discoloured, swollen tongue, gastrointestinal motility disorder, flatulence
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj, orofaringealna bol, rinoreja često epistaksa Poremećaji probavnog sustava vrlo često proljev, mučnina, krvarenje desni, bol u abdomenu često mjehurići na oralnoj sluznici, bol u ustima, povraćanje, nelagoda u abdomenu, konstipacija, distenzija abdomena, disfagija, promjena boje stolice, oticanje jezika, poremećaj gastrointestinalnog motiliteta, flatulencija
English: This summary was last updated in 05-2017.
Croatian: Sažetak je posljednji put ažuriran: 05.2017.
English: The full EPAR for Eklira Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni lijeka (EPAR) Eklira Genuair nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This helps to keep the airways open and allows the patient to breathe more easily.
Croatian: Tako pomaže da dišni putevi ostanu otvoreni i omogućuje bolesniku lakše disanje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eklira Genuair on 20 July 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Eklira Genuair u promet koje vrijedi na prostoru Europske unije od 20. srpnja 2012.
English: The recommended dose of Eklira Genuair is one inhalation twice a day.
Croatian: Preporučena doza lijeka Eklira Genuair je jedna inhalacija dvaput na dan.
English: This means that it widens the airways by blocking muscarinic receptors.
Croatian: To znači da širi dišne puteve jer blokira muskarinske receptore.
English: This is a summary of the European public assessment report (EPAR) for Eklira Genuair.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni lijeka (EPAR) Eklira Genuair.
English: What is Eklira Genuair and what is it used for?
Croatian: Što je Eklira Genuair i za što se koristi?
English: Eklira Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Eklira Genuair je lijek koji se koristi za ublažavanje simptoma kronične opstruktivne plućne bolesti (KOPB) u odraslih bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eklira Genuair 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 lijeka Eklira Genuair nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Other common side effects (which may affect more than 1 patient in 100) are sinusitis (inflammation of the sinuses), cough, nausea (feeling sick) and diarrhoea.
Croatian: Ostale česte nuspojave (koje se mogu javiti u više od 1 na 100 osoba) su sinusitis (upala sinusa), kašalj, mučnina (osjećaj slabosti) i proljev.
English: Other information about Eklira Genuair
Croatian: Ostale informacije o lijeku Eklira Genuair
English: A main study involving 828 patients with COPD found that Eklira Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work.
Croatian: U glavnom ispitivanju koje je obuhvatilo 828 bolesnika s KOPB-om Eklira Genuair pokazao se učinkovitijim od placeba (prividno liječenje) u poboljšanju plućne funkcije.
English: The most common side effects with Eklira Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće nuspojave lijeka Eklira Genuair (koje se mogu javiti u više od 5 na 100 osoba) su glavobolja i nazofaringitis (upala grla i nosa).
English: On average, after six months of treatment, the FEV1 in patients who used 200 and 400 micrograms Eklira Genuair increased compared with placebo by 99 ml and 128 ml respectively.
Croatian: Nakon šest mjeseci liječenja, povećanje FEV1 u pacijenata koji su uzimali 200 i 400 mikrograma lijeka Eklira Genuair u usporedbi s placebom bilo je u prosjeku 99 ml, odnosno 128 ml.
English: The main measure of effectiveness was how Eklira Genuair improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Croatian: Glavno mjerilo učinkovitosti bilo je poboljšanje forsiranog izdisajnog volumena (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u jednoj sekundi) u bolesnika koji su uzimali lijek Eklira Genuair.
English: It is not intended to provide practical advice on how to use Eklira Genuair.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Eklira Genuair.
English: For more information about treatment with Eklira Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Eklira Genuair pročitajte u uputi o lijeku (također dio EPARa), odnosno obratite se svojem liječniku ili ljekarniku.
English: Each inhalation provides 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium.
Croatian: Svaka inhalacija sadrži 375 mikrograma aklidinijeva bromida, što odgovara dozi od 322 mikrograma aklidinija.
English: The study compared two doses of Eklira Genuair (200 and 400 micrograms) inhaled twice a day with placebo.
Croatian: U ispitivanju je uspoređena inhalacija dviju doza lijeka Eklira Genuair (200 i 400 mikrograma) dvaput na dan s placebom.
English: The CHMP also noted that there were no major safety concerns with Eklira Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) također je zaključio da ne postoje veći sigurnosni rizici primjene lijeka Eklira Genuair te da su nuspojave reverzibilne i slične kao kod ostalih antagonista muskarinskih receptora s bronhodilatacijskim učinkom.
English: Eklira Genuair is available as an inhalation powder in a portable inhaler device.
Croatian: Eklira Genuair dostupan je kao prašak inhalata u prenosivom inhalatoru.
English: Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways.
Croatian: Muskarinski receptori kontroliraju kontrakcije mišića, a inhalirani aklidinijev bromid opušta mišiće dišnih puteva.
English: What are the risks associated with Eklira Genuair?
Croatian: Koji su rizici povezani s lijekom Eklira Genuair?
English: Eklira Genuair is used for maintenance (regular) treatment.
Croatian: Eklira Genuair primjenjuje se kao (redovita) terapija održavanja.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Croatian: KOPB je dugotrajna bolest koju karakterizira oštećenje ili začepljenje dišnih puteva i plućnih mjehurića, što uzrokuje otežano disanje.
English: What measures are being taken to ensure the safe use of Eklira Genuair?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Eklira Genuair?
English: Eklira Genuair aclidinium bromide
Croatian: Eklira Genuair aklidinijev bromid
English: Eklira Genuair can only be obtained with a prescription.
Croatian: Eklira Genuair izdaje se samo na recept.
English: The dose of 400 micrograms Eklira Genuair corresponds to an inhalation providing 322 micrograms of aclidinium.
Croatian: Doza od 400 mikrograma lijeka Eklira Genuair odgovara inhalaciji 322 mikrograma aklidinija.
English: Therefore, the CHMP decided that Eklira Genuair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi lijeka Eklira Genuair nadmašuju s njim povezane rizike te je preporučilo davanje odobrenja za stavljanje lijeka u promet.
English: As antimuscarinic bronchodilator medicines may have an effect on the heart and blood vessels, the company will closely monitor the medicine's cardiovascular effects and will carry out a further study in patients to identify any potential risks.
Croatian: Stoga će tvrtka pomno nadzirati učinke lijeka na srčano-krvožilni sustav te će provesti dodatna ispitivanja na bolesnicima kako bi se utvrdili potencijalni rizici.
English: The CHMP noted that Eklira Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) zaključio je da je lijek Eklira Genuair učinkovit u poboljšanju simptoma KOPB-a te da njegovi povoljni učinci traju i do jedne godine.
English: For practical information about using Eklira Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Eklira Genuair bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Why is Eklira Genuair approved?
Croatian: Zašto je lijek Eklira Genuair odobren?
English: For detailed information on using the inhaler correctly, see the instructions in the package leaflet.
Croatian: Za dodatne informacije o pravilnoj primjeni inhalatora vidjeti uputu o lijeku.
English: What benefits of Eklira Genuair have been shown in studies?
Croatian: Koje su koristi lijeka Eklira Genuair dokazane u ispitivanjima?
English: How is Eklira Genuair used?
Croatian: Kako se Eklira Genuair koristi?
English: Eklira Genuair contains the active substance aclidinium bromide.
Croatian: Eklira Genuair sadrži djelatnu tvar aklidinijev bromid.
English: The active substance in Eklira Genuair, aclidinium bromide, is an antimuscarinic bronchodilator.
Croatian: Djelatna tvar u lijeku Eklira Genuair je aklidinijev bromid, antagonist muskarinskih receptora s bronhodilatacijskim učinkom.
English: For the full list of all side effects and restrictions with Eklira Genuair, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Eklira Genuair potražite u uputi o lijeku.
English: How does Eklira Genuair work?
Croatian: Kako djeluje Eklira Genuair?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: Please open here
Croatian: Molimo ovdje otvorite
English: Unopened bottle: 3 years.
Croatian: Neotvorena boca: 3 godine.
English: • At the request of the European Medicines Agency,
Croatian: • na zahtjev Europske agencije za lijekove;
English: The response rate in these patients was about 52%.
Croatian: Stopa odgovora u ovih bolesnika bila je približno 52%.
English: Not to be sold separately.
Croatian: Ne smije se prodavati odvojeno.
English: Use the entire contents.
Croatian: Upotrijebiti cijeli sadržaj.
English: The potential risk for humans is unknown.
Croatian: Nije poznat mogući rizik u ljudi.
English: The most common ones are usually mild and will probably disappear after a short time.
Croatian: Najčešće nuspojave obično su blage i vjerojatno će nestati nakon kratkog vremena.
English: However, such reports have been infrequent.
Croatian: Međutim, takvi slučajevi nisu bili česti.
English: Adults and older people
Croatian: Odrasli i starije osobe
English: You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Croatian: Stoga morate biti oprezni dok upravljate vozilima, radite na strojevima ili obavljate druge zadatke koji zahtijevaju Vašu punu pozornost.
English: There is no evidence to suggest that any extra precautions are needed.
Croatian: Nema dokaza koji bi ukazivali na potrebu dodatnih mjera opreza.
English: Patients aged 65 years and over
Croatian: Bolesnici u dobi od 65 ili više godina
English: 1 bottle
Croatian: 1 boca
English: The following response rates were observed:
Croatian: Bile su primijećene sljedeće stope odgovora:
English: Risk reduction of suffering from multiple events** (%)
Croatian: Smanjenje rizika od višestrukih događaja**
English: Zometa can be given to people aged 65 years and over.
Croatian: Zometa može se davati osobama u dobi od 65 ili više godina.
English: What Zometa is and what it is used for
Croatian: Što je Zometa i za što se koristi
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Croatian: Konkretno, nije bilo jasnog dokaza djelotvornosti s obzirom na incidenciju prijeloma ili bol.
English: Time on study (weeks)
Croatian: Vrijeme trajanja ispitivanja (tjedni)
English: Follow carefully all instructions given to you by your doctor.
Croatian: Pažljivo slijedite sve upute koje ste dobili od liječnika.
English: Your doctor, pharmacist or nurse knows how to store Zometa properly (see section 6).
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako ispravno čuvati Zometu (vidjeti dio 6).
English: Very common (may affect more than 1 in 10 people): Low level of phosphate in the blood.
Croatian: Vrlo često (može se javiti u više od 1 na 10 osoba): Niska razina fosfata u krvi.
English: If any of these apply to you, tell your doctor straight away.
Croatian: Ako se bilo što od navedenoga odnosi na Vas, odmah obavijestite svog liječnika.
English: Osteonecrosis of other anatomical sites
Croatian: Osteonekroza drugih anatomskih mjesta
English: Median time to normocalcaemia was 4 days.
Croatian: Medijan vremena do normokalcemije iznosio je 4 dana.
English: Increased sweating.
Croatian: Pojačano znojenje
English: Other medicines and Zometa Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Zometa Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: What Zometa contains
Croatian: Što Zometa sadrži
English: The reconstituted solution is stable for 24 hours at 2°C - 8°C.
Croatian: Rekonstituirana otopina je stabilna 24 sata pri 2°C - 8°C.
English: Use immediately after first opening.
Croatian: Primijeniti odmah nakon prvog otvaranja.
English: Acquired Fanconi syndrome
Croatian: Stečeni Fanconijev sindrom
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Croatian: Sigurnost i djelotvornost zoledronatne kiseline u djece u dobi od 1 godine do 17 godina nisu ustanovljene.
English: It is used:
Croatian: Koristi se za:
English: Children and adolescents Zometa is not recommended for use in adolescents and children below the age of 18 years.
Croatian: Ne preporučuje se primjena Zomete u adolescenata i djece mlađe od 18 godina.
English: Hypocalcaemia is an important identified risk with Zometa in the approved indications.
Croatian: Hipokalcemija je važan identificiran rizik kod Zomete u odobrenim indikacijama.
English: Fainting due to low blood pressure.
Croatian: Nesvjestica zbog niskog krvnog tlaka.