FrancophonIA/ELRC3.0 huggingface dataset:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Myclausen 250 mg hard capsules Mycophenolate mofetil
Croatian: Myclausen 250 mg tvrde kapsule mofetilmikofenolat
English: NAME OF THE MEDICINAL PRODUCT Myclausen 250 mg hard capsules Mycophenolate mofetil
Croatian: NAZIV LIJEKA Myclausen 250 mg tvrde kapsule mofetilmikofenolat
English: PVC-aluminium blisters containing 10 hard capsules.
Croatian: PVC-aluminij blisteri koji sadrže 10 tvrdih kapsula Jedna kutija sadrži 100 ili 300 tvrdih kapsula.
English: • The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
Croatian: • Dnevna doza je 8 kapsula (2 g lijeka) koje se uzimaju u 2 odvojene doze.
English: Take care not to let any powder from inside a broken capsule get into your eyes or mouth • If this happens, rinse with plenty of water.
Croatian: Pazite da prašak koji se rasipa iz oštećenih kapsula ne dospije u Vaše oči ili usta.
English: The following undesirable effects cover adverse reactions from post-marketing experience The types of adverse reactions reported during post-marketing with mycophenolate mofetil are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
Croatian: Sljedeće nuspojave obuhvaćaju nuspojave prijavljene nakon stavljanja lijeka u promet Nuspojave prijavljene u sklopu stalnog praćenja sigurnosti primjene mofetilmikofenolata slične su onima opaženima u kontroliranim ispitivanjima bolesnika s bubrežnim, srčanim i jetrenim presatkom.
English: Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy (see section 4.3).
Croatian: Liječenje ne smije započeti prije nego što se predoči negativan nalaz testa na trudnoću kako bi se isključila mogućnost nehotične primjene u trudnoći
English: Full patient information about the teratogenic risk and the pregnancy prevention measures should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
Croatian: Liječnici moraju ženama reproduktivne dobi, a po potrebi i bolesnicima muškoga spola, pružiti cjelovite informacije o teratogenom riziku i mjerama za sprječavanje trudnoće.
English: Common Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Croatian: Poremećaji probavnog sustava vrlo često povraćanje, bolovi u abdomenu, proljev, mučnina često gastrointestinalno krvarenje, peritonitis, ileus, kolitis, želučani ulkus, ulkus dvanaesnika, gastritis, ezofagitis, stomatitis, konstipacija, dispepsija, flatulencija, eruktacija
English: Capsule content: pre-gelatinised starch (maize), croscarmellose sodium, povidone (K-30), magnesium stearate
Croatian: Prethodno gelirani škrob (kukuruzni), umrežena karmelozanatrij, povidon (K-30), magnezijev stearat
English: · The Package Leaflet · Guide for patients
Croatian: Paket s informacijama za bolesnike mora sadržavati: · Uputu o lijeku · Vodič za bolesnike
English: Adverse drug reactions Common Skin hypertrophy, rash, acne, alopecia
Croatian: Poremećaji kože i potkožnog tkiva vrlo čestočesto hipertrofija kože, osip, akne, alopecija
English: The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Croatian: Preporučena doza za bolesnike s presađenim srcem iznosi 1,5 g dvaput dnevno (dnevna doza 3 g).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil.
Croatian: TVARI Jedna kapsula sadrži 250 mg mofetilmikofenolata.
English: The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients.
Croatian: Sistemska izloženost pri ovoj dozi iznosila je otprilike 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan za bolesnike s presađenim bubregom i otprilike 0,3 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 3 g/dan kod bolesnika s presađenim srcem.
English: Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Croatian: Muškarci ne smiju donirati spermu tijekom liječenja ili 90 dana nakon prekida primjene mikofenolata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/647/001-002
English: • The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
Croatian: • Dnevna doza je 4 tablete (2 g lijeka) koje se uzimaju u 2 odvojene doze.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressants.
Croatian: Prijavljeni su slučajevi izolirane aplazije eritrocita (engl.Pure Red Cell Aplasia, PRCA) kod bolesnika liječenih mofetilmikofenolatom u kombinaciji s drugim imunosupresivima.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Croatian: Preporučena doza za bolesnike s presađenim bubregom iznosi 1 g dvaput dnevno (dnevna doza 2 g).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg mycophenolate mofetil. For the full list of excipients, see section 6.1.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 500 mg mofetilmikofenolata.
English: Posology
Croatian: Novotvorine
English: Tablet core: Microcrystalline cellulose, povidone (K-30), croscarmellose sodium, magnesium stearate
Croatian: Mikrokristalična celuloza, povidon (K-30), umrežena karmelozanatrij, magnezijev stearat Ovojnica tablete:
English: • The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
Croatian: • Dnevna doza je 12 kapsula (3 g lijeka) koje se uzimaju u 2 odvojene doze.
English: Conversely, changes of MPA exposure should be expected when switching patients from CsA to one of the immunosuppressants which does not interfere with MPA´s enterohepatic cycle.
Croatian: A na neki od imunosupresiva koji ne interferiraju s enterohepatičnom cirkulacijom MPA, treba očekivati promjene u izloženosti MPA-u.
English: The systemic exposure at this dose represents 2-3 times the clinical exposure at the recommended clinical dose of 2 g/day in renal transplant patients and 1.3-2 times the clinical exposure at the recommended clinical dose of 3 g/day in cardiac transplant patients.
Croatian: Sistemska izloženost pri tim dozama je 2-3 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan kod bolesnika s presađenim bubregom i 1,3-2 puta veće od kliničke izloženosti pri preporučenoj kliničkoj dozi od 3 g/dan kod bolesnika s presađenim srcem.
English: • The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
Croatian: • Dnevna doza je 6 tableta (3 g lijeka) koje se uzimaju u 2 odvojene doze.
English: Common Hypotension, hypertension, vasodilatation
Croatian: Krvožilni poremećaji vrlo čestočesto hipotenzija, hipertenzija, vazodilatacija
English: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Croatian: •1,73 m2) izvan neposrednog postoperativnog razdoblja, treba izbjegavati doze veće od 1 g primijenjene dvaput dnevno.
English: The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Croatian: Preporučena peroralna doza za bolesnike s presađenom jetrom iznosi 1,5 g dvaput dnevno (dnevna doza od 3 g).
English: No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Croatian: Za bolesnike s presađenim srcem ili jetrom i teškim kroničnim oštećenjem bubrega podaci nisu dostupni.
English: • Myclausen should not be given to women who are breastfeeding (see section 4.6).
Croatian: Myclausen se ne smije davati dojiljama (vidjeti dio 4.6).
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leucoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including mycophenolate mofetil. Agranulocytosis (≥ 1/1000 to < 1/100) and neutropenia have been reported; therefore, regular monitoring of patients taking Myclausen is advised (see section 4.4).
Croatian: Prijavljene su agranulocitoza (≥ 1/1000 do < 1/100) i neutropenija, stoga se preporučuje redovito praćenje bolesnika koji uzimaju Myclausen (vidjeti dio 4.4).
English: As can happen in patients taking this type of medicine (immune-suppressants), a very small number of Myclausen patients have developed cancer of the lymphoid tissues and skin.
Croatian: Kod vrlo malog broja bolesnika koji uzimaju Myclausen razvio se rak limfoidnog tkiva i kože, što se može dogoditi kod bolesnika koji uzimaju ovu vrstu lijeka (imunosupresivi).
English: Lymphoproliferative disease or lymphoma developed in 0.6 % of patients receiving mycophenolate mofetil (2 g or 3 g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year.
Croatian: U kontroliranim kliničkim ispitivanjima bolesnika s presađenim bubregom (podaci o dozi od 2 g), srcem ili jetrom praćenima barem jednu godinu, kod 0,6 % bolesnika koji su primali mofetilmikofenolat (2 g ili 3 g dnevno) u kombinaciji s drugim imunosupresivima, došlo je do razvoja limfoproliferativne bolesti ili limfoma.
English: cysts and polyps)
Croatian: (TBC))
English: Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Myclausen should be administered with caution in patients with active serious digestive system disease.
Croatian: Primjena mofetilmikofenolata povezuje se s povećanom incidencijom štetnih događaja vezanih uz probavni sustav, uključujući manje česte pojave ulkusa gastrointestinalnog trakta, krvarenja i perforacije.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo čestočesto artralgija
English: The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Croatian: U toksikološkim ispitivanjima provedenima s mofetilmikofenolatom na štakorima, miševima, psima i majmunima prvi organi na kojima je primijećen učinak bili su hematopoetski i limfoidni sustav.
English: PRCA may resolve with dose reduction or cessation of Myclausen therapy.
Croatian: MPA pa nije potrebno smanjiti dozu ni prekinuti primjenu Myclausena.
English: Neoplasms
Croatian: Doziranje
English: Delayed renal graft function
Croatian: Odgođena funkcija presađenog bubrega
English: Live vaccines
Croatian: Živa cjepiva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/647/001
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 500 mg mycophenolate mofetil.
Croatian: TVARI Jedna tableta sadrži 500 mg mofetilmikofenolata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg mycophenolate mofetil. For the full list of excipients, see section 6.1.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 250 mg mofetilmikofenolata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/647/002
English: No data are available for paediatric cardiac transplant patients.
Croatian: Pedijatrijska populacija Nisu dostupni podaci za pedijatrijske bolesnike s presađenim srcem.
English: In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Croatian: Najčešće su prijavljene sljedeće malformacije: abnormalnosti uha (npr. abnormalan oblik ili izostanak vanjskog uha), atrezija vanjskog zvukovoda (srednje uho); malformacije lica, poput rascjepa usne, rascjepa nepca, mikrognatije i orbitalnog hipertelorizma; abnormalnosti oka (npr. kolobom); prirođena srčana bolest, poput atrijskih i ventrikularnih septalnih defekata; malformacije prstiju (npr. polidaktilija, sindaktilija); malformacije dušnika i jednjaka (npr. atrezija jednjaka); malformacije živčanog sustava, kao što je spina bifida; abnormalnosti bubrega.
English: The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Croatian: Za starije se osobe preporučuje doza od 1 g dvaput dnevno ako im je presađen bubreg te 1,5 g dvaput dnevno ako im je presađeno srce ili jetra.
English: Malignancies
Croatian: Takrolimus
English: Myclausen contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: However, in renal transplant patients, tacrolimus concentration did not appear to be altered by mycophenolate mofetil (see also section 4.4).
Croatian: Čini se da mofetilmikofenolat nije promijenio koncentraciju takrolimusa kod bolesnika s presađenim bubregom (vidjeti i dio 4.4).
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen film-coated tablets should not be broken or crushed.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja lijekom ili njegove primjene Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, Myclausen tablete ne smiju se drobiti.
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94 % relative to IV mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
Croatian: Srednja bioraspoloživost oralnog mofetilmikofenolata utemeljena na AUC-u MPA iznosi 94 % u odnosu na intravenski mofetilmikofenolat.
English: Capsule content Pregelatinised starch (maize) Croscarmellose sodium Povidone (K-30) Magnesium stearate
Croatian: Prethodno gelirani škrob (kukuruzni) Umrežena karmelozanatrij Povidon (K-30)
English: The full name of your medicine is Myclausen 500 mg film-coated tablets.
Croatian: Puno ime Vašeg lijeka je Myclausen 500 mg filmom obložene tablete. • U ovoj uputi koristi se skraćeno ime Myclausen.
English: Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Croatian: , mofetilmikofenolat nije utjecao na plodnost muških štakora.
English: You must not donate blood during treatment with Myclausen and for at least 6 weeks after stopping treatment.
Croatian: Tijekom liječenja lijekom Myclausen i najmanje 6 tjedana nakon prestanka liječenja ne smijete darivati.
English: There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate mofetil, some of which have been fatal.
Croatian: Kod bolesnika liječenih mofetilmikofenolatom zabilježeni su i slučajevi aplastične anemije i depresije koštane srži, od kojih su neki imali smrtan ishod.
English: As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of mycophenolate mofetil is correlated with MPA concentration.
Croatian: Imunosupresivna aktivnost mofetilmikofenolata povezana je s koncentracijom MPA što je dokazano supresijom akutnog odbacivanja nakon transplantacije bubrega.
English: Contraception in men taking Myclausen
Croatian: • razdoblje prije početka uzimanja lijeka Myclausen
English: (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with Myclausen.
Croatian: Žene reproduktivne dobi mora se upoznati s rizicima i upozoriti da se pridržavaju preporuka navedenih u dijelu 4.6 (npr. korištenja kontracepcijskih metoda, provođenja testova na trudnoću) prije, tijekom i nakon liječenja lijekom Myclausen.
English: Myclausen capsules should only be prescribed to patients with a body surface area of at least 1.25 m 2.
Croatian: Myclausen kapsule bi trebalo propisivati bolesnicima tjelesne površine od 2. Bolesnicima tjelesne površine od 1,25 do 1,5 m najmanje 1,25 m mogu se propisivati Myclausen kapsule u dozi od 750 mg dvaput dnevno (dnevna doza od 1,5 g).
English: Kidney transplant
Croatian: Presađivanje bubrega
English: Use in hepatic transplant
Croatian: Primjena kod presađivanja jetre
English: Leucopenia, thrombocytopenia, anaemia Common Pancytopenia, leukocytosis
Croatian: Poremećaji krvi i limfnog sustava vrlo često leukopenija, trombocitopenija, anemija često pancitopenija, leukocitoza
English: myasthenic syndrome, dizziness, headache,
Croatian: • osjećaj omaglice, omamljenosti ili utrnulosti
English: Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Croatian: Ciklosporin A interferira s enterohepatičnom recirkulacijom MPA, što u bolesnika s presađenim bubregom koji se liječe mofetilmikofenolatom i ciklosporinom
English: The active substance is mycophenolate mofetil. Each tablet contains 500 mg mycophenolate mofetil
Croatian: Jedna tableta sadrži 500 mg mofetilmikofenolata
English: The overall safety profile is considered acceptable.
Croatian: Ukupni sigurnosni profil smatra se prihvatljivim.
English: The full EPAR for Lokelma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Lokelma nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended starting dose of Lokelma is 10 g three times a day.
Croatian: Preporučena početna doza lijeka Lokelma iznosi 10 g triput dnevno.
English: What is Lokelma and what is it used for?
Croatian: Što je Lokelma i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Lokelma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lokelma?
English: This is a summary of the European public assessment report (EPAR) for Lokelma.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Lokelma.
English: Other information about Lokelma
Croatian: Ostale informacije o lijeku Lokelma
English: The powder is stirred into water to make a mixture to be drunk straight away.
Croatian: Prašak se istrese u vodu i promiješa, a dobivenu mješavinu treba popiti odmah.
English: Once the blood levels of potassium return within the normal range (usually within 1-2 days), patients should take the lowest effective dose of Lokelma to prevent the return of hyperkalaemia, starting with 5 g once a day and not exceeding 10 g once a day.
Croatian: Kada se razine kalija u krvi vrate na normalne vrijednosti (obično unutar 1 do 2 dana), bolesnici trebaju uzimati najnižu učinkovitu dozu lijeka Lokelma kako bi se spriječilo vraćanje hiperkalijemije, na početku 5 g jednom dnevno s tim da to ne bude više od 10 g jednom dnevno.
English: The European Medicines Agency decided that Lokelma's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Lokelma nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za njegovu primjenu u Europskoj uniji.
English: Lokelma is available as powder sachets (5 g and 10 g).
Croatian: Lijek Lokelma dostupan je kao prašak u vrećicama (od 5 g i 10 g).
English: The Agency considered that Lokelma is effective at controlling blood potassium levels, especially during initial (acute) treatment.
Croatian: Agencija smatra da je lijek Lokelma učinkovit za kontrolu razina kalija u krvi, osobito tijekom početnog (akutnog) liječenja.
English: What are the risks associated with Lokelma?
Croatian: Koji su rizici povezani s lijekom Lokelma?
English: It is not intended to provide practical advice on how to use Lokelma.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Lokelma.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lokelma have 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 Lokelma nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: In a main study of 754 patients with hyperkalaemia, 86% of patients taking Lokelma 10 g had normal potassium levels after 2 days compared with 48% of those taking placebo (a dummy treatment).
Croatian: U glavnom ispitivanju koje je uključilo 754 bolesnika s hiperkalijemijom, 86 % bolesnika koji su uzimali lijek Lokelma u dozi od 10 g imalo je normalne razine kalija nakon 2 dana u usporedbi s 48 % onih koji su uzimali placebo (prividno liječenje).
English: When taken by mouth, Lokelma attaches to potassium from food and body fluids in the gut, forming a compound that
Croatian: Kada se uzme na usta, Lokelma se veže na kalij iz hrane i tjelesnih tekućina u crijevima te stvara spoj koji se zatim izluči
English: For more information about treatment with Lokelma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Lokelma pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: This action removes potassium from the body overall, thus helping to lower the potassium levels in the blood.
Croatian: Takvim djelovanjem uklanja se kalij iz cijeloga tijela što pomaže sniziti razine kalija u krvi.
English: Lokelma is a medicine used to treat hyperkalaemia (high levels of potassium in the blood) in adults.
Croatian: Lokelma se koristi za liječenje hiperkalijemije (visoke razine kalija u krvi) u odraslih osoba.
English: Lokelma sodium zirconium cyclosilicate
Croatian: Lokelma natrijev cirkonijev ciklosilikat
English: The most common side effects with Lokelma (which may affect up to 1 in 10 people) are oedema (fluid build-up with swelling in the ankles and feet) and hypokalaemia (low levels of potassium in the blood).
Croatian: Najčešće nuspojave lijeka Lokelma (koje se mogu pojaviti u do 1 na 10 osoba) jesu edem (nakupljanje tekućine uz oticanje gležnjeva i stopala) te hipokalijemija (niske razine kalija u krvi).
English: In addition, when patients who had normal potassium levels after Lokelma treatment were given further treatment with either Lokelma or placebo, potassium levels stayed normal for longer with Lokelma than with placebo.
Croatian: Osim toga, kada su bolesnici nakon terapije lijekom Lokelma nastavili uzimati ili lijek Lokelma ili placebo, normalne razine kalija zadržale su se dulje uz lijek Lokelma nego uz placebo.
English: Lokelma is effective at lowering blood potassium levels and keeping levels of potassium within the normal range.
Croatian: Lokelma djelotvorno snižava razine kalija u krvi i održava razine kalija unutar normalnog raspona.