FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
Croatian: U osoba s umjerenim oštećenjem jetre, AUC se povećava za 568 %, a Cmax za 83 % (vidjeti dio 4.4).
English: Cases of patients, treated with rasagiline and other dopaminergic medicinal products, falling asleep while engaged in activities of daily living have been reported.
Croatian: Zabilježeni su slučajevi bolesnika liječenih razagilinom i drugim dopaminergicima koji su zaspali dok su obavljali svakodnevne aktivnosti.
English: The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
Croatian: Sljedeći su slučajevi prijavljeni tijekom izloženosti nakon stavljanja lijeka u promet s nepoznatom učestalošću: kompulzije, kompulzivno kupovanje, dermatilomanija, sindrom disregulacije dopamina, poremećaj kontrole impulsa, impulzivno ponašanje, kleptomanija, krađa, opsesivne misli, opsesivnokompulzivni poremećaj, stereotipija, kockanje, patološko kockanje, povećani libido, hiperseksualnost, psihoseksualni poremećaj, neprimjereno seksualno ponašanje.
English: If you are starting treatment with Rasagiline ratiopharm, you should wait at least 5 weeks after stopping fluoxetine treatment.
Croatian: Ako započinjete liječenje Razagilin ratiopharmom, morate čekati najmanje 5 tjedana nakon prekida liječenja fluoksetinom.
English: Agents that affect CYP1A2 activity
Croatian: Lijekovi koji utječu na aktivnost CYP1A2
English: Rasagiline ratiopharm contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Croatian: Razagilin ratiopharm sadrži djelatnu tvar razagilin te se primjenjuje za liječenje Parkinsonove bolesti u odraslih.
English: No special precautions are required in patients with renal impairment.
Croatian: Nisu potrebne posebne mjere opreza u bolesnika s oštećenjem bubrega.
English: What you need to know before you take Rasagiline ratiopharm
Croatian: Što morate znati prije nego počnete uzimati Razagilin ratiopharm
English: Aluminium/aluminium perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets.
Croatian: Aluminij/aluminij perforirani blister s jediničnim dozama u pakiranju od 10 x 1, 30 x 1 i 100 x 1 tableta.
English: No human data on the effect of rasagiline on fertility are available.
Croatian: Nema dostupnih podataka o učinku razagilina na plodnost.
English: Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Croatian: Istodobna primjena razagilina i entakapona povećava oralni klirens razagilina za 28 %.
English: Do not take the following medicines while taking Rasagiline ratiopharm: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease, or used for any other indication), including medicinal and natural products without prescription e.g.
Croatian: Nemojte uzimati sljedeće lijekove dok uzimate Razagilin ratiopharm: - inhibitore monoaminooksidaze (MAO) (npr. za liječenje depresije ili Parkinsonove bolesti ili za bilo koju drugu indikaciju), uključujući lijekove i prirodne preparate bez recepta npr. gospinu travu - petidin (snažan lijek protiv boli).
English: The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p<0.0001) to that observed in the rasagiline 1 mg group.
Croatian: Srednje ukupno dnevno smanjenje u OFF vremenu u entakapon skupini (-0,80 h, 95 % CI [-1,20, -0,41], p< 0,0001) bilo je slično onom opaženom u razagilin 1 mg skupini.
English: - The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.
Croatian: - Drugi sastojci su manitol, koloidni, bezvodni silicijev dioksid, kukuruzni škrob, prethodno geliran kukuruzni škrob, stearatna kiselina, talk.
English: Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Primjena razagilina je kontraindicirana u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: What Rasagiline ratiopharm is and what it is used for
Croatian: Što je Razagilin ratiopharm i za što se koristi
English: What Rasagiline ratiopharm looks like and contents of the pack Rasagiline ratiopharm tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Croatian: Kako Razagilin ratiopharm izgleda i sadržaj pakiranja Razagilin ratiopharm tablete su bijele do bjelkaste, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom „GIL” i „1” ispod toga na jednoj strani, i bez oznake na drugoj strani.
English: ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Croatian: Poremećaji kontrole impulsa mogu se pojaviti kod bolesnika liječenih agonistima dopamina i/ili dopaminergičkim lijekovima.
English: CYP1A2 inducers
Croatian: Induktori CYP1A2
English: The recommended dose of Rasagiline ratiopharm is 1 tablet of 1 mg taken by mouth once daily.
Croatian: Preporučena doza Razagilin ratiopharma je 1 tableta od 1 mg uzeta na usta jedanput dnevno.
English: Cerebrovascular accident
Croatian: Cerebrovaskularni inzult
English: If you stop taking Rasagiline ratiopharm Do not stop taking Rasagiline ratiopharm without first talking to your doctor.
Croatian: Nemojte prestati uzimati Razagilin ratiopharm prije razgovora sa svojim liječnikom.
English: Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Croatian: Razagilin može uzrokovati dnevnu omamljenost, somnolenciju te povremeno, posebice ako se primjenjuje s drugim dopaminergičkim lijekovima, padanje u san tijekom dnevnih aktivnosti.
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l. Plasma protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%.
Croatian: Vezanje za proteine plazme nakon pojedinačne oralne doze 14C-obilježenog razagilina je približno 60 do 70 %.
English: Dystonia, Carpal tunnel syndrome, Balance disorder
Croatian: Diskinezija Distonija, Sindrom karpalnog tunela,
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep
Croatian: Serotoninski sindrom*, Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna*
English: In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
Croatian: U ispitivanju III srednja razlika u usporedbi s placebom je iznosila 0,94 h, 95 % CI [-1,36, -0,51], p< 0,0001.
English: Other cytochrome P450 isoenzymes
Croatian: Drugi izoenzimi citokroma P450
English: Bottles
Croatian: Bočice
English: Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se javiti u 1 na 10 osoba)
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain as back and neck pain, and arthralgia in both regimens.
Croatian: U kliničkim ispitivanjima Parkinsonove bolesti nuspojave koje su bolesnici najčešće prijavljivali bile su: glavobolja, depresija, vrtoglavica i gripa (influenca i rinitis) kod monoterapije; diskinezija, ortostatska hipotenzija, pad, bol u abdomenu, mučnina i povraćanje te suha usta kod dodatne terapije uz levodopu; mišićno-koštana bol kao bol u leđima i vratu te artralgija u oba terapijska režima.
English: Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with Rasagiline ratiopharm may influence your ability to do so. Rasagiline ratiopharm can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Croatian: Upitajte svog liječnika za savjet prije upravljanja vozilima i rada sa strojevima jer Parkinsonova bolest sama po sebi, kao i liječenje lijekom Razagilin ratiopharm, može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: In the post-marketing period, cases of potentially life-threating serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants, meperidine, tramadol, methadone, or propoxyphene concomitantly with rasagiline.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su po život opasni slučajevi serotoninskog sindroma povezanog s agitacijom, konfuzijom, rigidnošću, pireksijom i mioklonusom u bolesnika liječenih antidepresivima, meperidinom, tramadolom, metadonom ili propoksifenom istodobno s razagilinom.
English: What Rasagiline ratiopharm contains - The active substance is rasagiline.
Croatian: Što Razagilin ratiopharm sadrži - Djelatna tvar je razagilin.
English: CYP1A2 inhibitors
Croatian: Inhibitori CYP1A2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA ZA BOČICU
English: In blinded placebo-controlled studies (monotherapy and adjunct) severe hypertension was not reported in any subjects in the rasagiline arm.
Croatian: U slijepim placebom kontroliranim ispitivanjima (monoterapija i dodatna terapija) teška hipertenzija nije zabilježena ni u jednog ispitanika u skupini koja je primala razagilin.
English: In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was -0.78h, 95% CI [-1.18, -0.39], p=0.0001.
Croatian: U ispitivanju II, srednja razlika u broju sati provedenih u „OFF“ stanju u usporedbi s placebom je iznosila -0,78 h, 95 % CI [-1,18, -0,39], p=0,0001.
English: Therefore, Rasagiline ratiopharm is not recommended for use under the age of 18.
Croatian: Stoga se ne preporučuje primjena lijeka Razagilin ratiopharm u djece i adolescenata mlađih od 18 godina.
English: In patients taking Rasagiline ratiopharm and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Croatian: Kod bolesnika koji uzimaju Razagilin ratiopharm i/ili druge lijekove koji se koriste za liječenje Parkinsonove bolesti bila su opažena ponašanja kao što su kompulzije, opsesivne misli, ovisnost o kockanju, prekomjerno trošenje, impulzivno ponašanje i nenormalno visok seksualni nagon ili povećanje misli i osjećanja povezanih sa seksualnošću.
English: In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Croatian: U osoba s blagim oštećenjem jetre, AUC se povećava za 80 %, a Cmax za 38 %.
English: - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Croatian: (ortostatska hipotenzija) - smanjen apetit - zatvor - suha usta - mučnina i povraćanje - vjetrovi - abnormalni rezultati krvnih testova (leukopenija) - bol u zglobovima (artralgija) - mišićno-koštana bol - upala zglobova (artritis) - utrnulost i slabost mišića ruke (sindrom karpalnog tunela) - smanjenje tjelesne težine - abnormalni snovi - poteškoće u mišićnoj koordinaciji (poremećaj ravnoteže) - depresija - omaglica (vrtoglavica) - produljene mišićne kontrakcije (distonija) - curenje nosa (rinitis) - nadražaj kože (dermatitis) - osip - crvenilo očiju (konjunktivitis) - hitan nagon za mokrenjem
English: Levodopa and other Parkinson's disease medicinal products In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Croatian: Kod bolesnika s Parkinsonovom bolešću koji primaju kroničnu terapiju levodopom i razagilin kao dodatnu terapiju nije bilo klinički značajnog učinka terapije levodopom na klirens razagilina.
English: You must wait at least 14 days after stopping Rasagiline ratiopharm treatment and starting treatment with MAO inhibitors or pethidine.
Croatian: Morate čekati najmanje 14 dana nakon prestanka liječenja Razagilin ratiopharmom i početka liječenja MAO inhibitorima ili petidinom.
English: Orthostatic hypotension*
Croatian: Ortostatska hipotenzija*
English: Other medicines and Rasagiline ratiopharm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: What Rasagiline ratiopharm is and what it is used for What you need to know before you take Rasagiline ratiopharm How to take Rasagiline ratiopharm Possible side effects
Croatian: Što je Razagilin ratiopharm i za što se koristi Što morate znati prije nego počnete uzimati Razagilin ratiopharm
English: There is no relevant use of Rasagiline ratiopharm in children and adolescents.
Croatian: Nema relevantne primjene lijeka Razagilin ratiopharm u djece i adolescenata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/001-010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/977/001-010
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as mesilate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 1 mg razagilina (u obliku mesilata).
English: You may need urgent medical advice or treatment: - If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
Croatian: Ako razvijete neuobičajena ponašanja poput kompulzija, opsesivnih misli, ovisnosti o kockanju, prekomjerno kupovanje ili trošenje novca, impulzivno ponašanje ili abnormalno jaki seksualni nagon ili učestale misli o seksu (poremećaji kontrole impulsa) (pogledajte dio 2).
English: Half of the reported ICD cases were assessed as serious.
Croatian: Polovica prijavljenih slučajeva poremećaja kontrole impulsa ocijenjena je ozbiljnima.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (mogu se javiti u 1 na 100 osoba)
English: In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 5.2).
Croatian: U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre razagilin je potrebno ukinuti (vidjeti dio 5.2).
English: Each tablet contains 1 mg rasagiline (as mesilate).
Croatian: Svaka tableta sadrži 1 mg razagilina (u obliku mesilata).
English: The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies, in patients receiving 1 mg/day rasagiline.
Croatian: Niže navedeni tablični popis uključuje nuspojave koje su bile prijavljene s većom incidencijom u placebo kontroliranim ispitivanjima, kod bolesnika koji su primali 1 mg/dan razagilina.
English: INFORMATION IN BRAILLE Rasagiline ratiopharm
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Razagilin ratiopharm
English: If you forget to take Rasagiline ratiopharm
Croatian: Ako ste zaboravili uzeti Razagilin ratiopharm
English: A similar pattern of excessive daily sleepiness has been reported post-marketing with rasagiline.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljen je sličan obrazac prekomjerne dnevne pospanosti s razagilinom.
English: Do not store above 30oC.
Croatian: Ne čuvati na temperaturi iznad 30oC.
English: - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Croatian: - moždani udar (cerebrovaskularni događaj) - srčani udar (infarkt miokarda)
English: In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 and 5.2).
Croatian: U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre, razagilin je potrebno ukinuti (vidjeti dio 4.4 i 5.2).
English: Impulse control disorders*
Croatian: Poremećaji kontrole impulsa*
English: Rasagiline ratiopharm 1 mg tablets rasagiline
Croatian: Razagilin ratiopharm 1 mg tablete razagilin
English: Rasagiline ratiopharm
Croatian: Razagilin ratiopharm
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes
Croatian: Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU NALJEPNICA ZA BOČICU
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/977/007
English: One case of hypersexuality was reported in monotherapy placebo-controlled study.
Croatian: U placebom kontroliranom ispitivanju monoterapije zabilježen je jedan slučaj hiperseksualnosti.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
English: Dopaminergic effects
Croatian: Dopaminergični učinci
English: NAME OF THE MEDICINAL PRODUCT Rasagiline ratiopharm 1 mg tablets
Croatian: NAZIV LIJEKA Razagilin ratiopharm 1 mg tablete
English: - Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome) - If you notice any suspicious skin changes because there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section 2).
Croatian: Ako primijetite sumnjive promjene na koži zbog toga jer postoji povećani rizik od raka kože (koji ne mora nužno biti melanom) u bolesnika s Parkinsonovom bolešću (pogledajte dio 2).
English: Simi: +354 550 3300
Croatian: Actavis Pharmaceuticals Iceland ehf. Simi: +354 550 3300
English: The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies in patients receiving 1 mg/day rasagiline.
Croatian: Niže navedeni tablični popis uključuje nuspojave koje su bile prijavljene s većom incidencijom u placebo kontroliranim ispitivanjima u bolesnika koji su primali 1 mg/dan razagilina Klasifikacija organskih sustava
English: NAME OF THE MEDICINAL PRODUCT Rasagiline ratiopharm 1 mg tablets rasagiline
Croatian: NAZIV GOTOVOG LIJEKA Razagilin ratiopharm 1 mg tablete razagilin
English: - Abdominal pain - Fall - Allergy - Fever - Flu (influenza) - General feeling of being unwell (malaise) - Neck pain - Chest pain (angina pectoris) - Low blood pressure when rising to a standing position with symptoms like dizziness/light headedness (orthostatic hypotension) - Decreased appetite - Constipation - Dry mouth - Nausea and vomiting - Flatulence
Croatian: - bol u vratu - bol u prsnom košu (angina pektoris) - nizak krvni tlak pri ustajanju u stojeći položaj sa simptomima kao što su omaglica/ošamućenost
English: Urinary urgency
Croatian: Urgencija
English: In blinded placebo-controlled studies, severe orthostatic hypotension was reported in one subject (0.3%) in the rasagiline arm (adjunct studies), none in the placebo arm. Clinical trial data further suggest that orthostatic hypotension occurs most frequently in the first two months of rasagiline treatment and tends to decrease over time.
Croatian: U slijepim placebom kontroliranim ispitivanjima zabilježena je teška ortostatska hipotenzija u jednog ispitanika (0,3 %) u skupini koja je primala razagilin (dodatna ispitivanja), a nijedan slučaj u skupini koja je primala placebo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rasagiline (as mesilate).
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 1 mg razagilina (u obliku mesilata).
English: Dyskinesia
Croatian: Poremećaji
English: How to store Rasagiline ratiopharm
Croatian: Kako čuvati Razagilin ratiopharm
English: Tablet 30 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu kroz usta.
English: Pregelatinised maize starch Colloidal anhydrous silica Stearic acid
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari manitol kukuruzni škrob kukuruzni škrob, prethodno geliran silicijev dioksid, koloidni, bezvodni stearatna kiselina talk
English: How to take Rasagiline ratiopharm
Croatian: Kako uzimati Razagilin ratiopharm
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Croatian: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel: +372 661 0801
English: - If you get any side effects, talk to your doctor or pharmacist.
Croatian: - Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU
English: Metabolism and nutrition disorders
Croatian: Manje često Nepoznato imunološkog sustava Poremećaji metabolizma i prehrane
English: Musculoskeletal pain,
Croatian: Oštećenje bubrega
English: Talk to your doctor before taking {Drug Name} - if you are due to have a specific blood test (calcium level).
Croatian: Obratite se svom liječniku prije uzimanja {naziv lijeka} - ako morate napraviti određenu krvnu pretragu (utvrđivanje razine kalcija).
English: 2 - What you need to know before you take {Drug Name} Warnings and precautions
Croatian: 2 - Što morate znati prije nego počnete uzimati {naziv lijeka} Upozorenja i mjere opreza
English: Interference with determination of ionised calcium levels
Croatian: Interferencija pri utvrđivanju razina ioniziranog kalcija
English: Adopted at the 3-6 April 2017 PRAC
Croatian: Usvojeno na sjednici PRAC-a 3. - 6. travnja 2017.
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Croatian: Nove ili reaktivirane (ponavljajuće) citomegalovirusne infekcije i reaktivirane infekcije virusom hepatitisa B prijavljene su kao manje česte nuspojave.
English: The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser).
Croatian: Mjerenje razina ioniziranog kalcija može pokazati lažno smanjene vrijednosti kod liječenja leflunomidom i/ili teriflunomidom (aktivnim metabolitom leflunomida) ovisno o vrsti korištenog analizatora ioniziranog kalcija (npr. analizator plina u krvi).
English: Albiglutide - Acute kidney injury (EPITT no 18778)
Croatian: Albiglutid - akutna ozljeda bubrega (EPITT br. 18778)
English: 2 - What you need to know before you use Eperzan Warnings and precautions
Croatian: 2 - Što morate znati prije nego počnete primjenjivati lijek Eperzan Upozorenja i mjere opreza
English: 4.4 - Special warning and precautions for use
Croatian: - Posebna upozorenja i mjere opreza pri uporabi
English: Patients treated with albiglutide should be advised of the potential risk of dehydration, and take precautions to avoid fluid depletion.
Croatian: Bolesnike liječene albiglutidom potrebno je upozoriti na mogući rizik od dehidracije te poduzeti mjere opreza radi sprečavanja gubitka tekućine.
English: Dehydration
Croatian: - Nuspojave
English: Leflunomide; teriflunomide - Falsely decreased ionised calcium levels (EPITT no 18787)
Croatian: Leflunomid; teriflunomid - lažno smanjene razina ioniziranog kalcija (EPITT br. 18787)