FrancophonIA/ELRC3.0 huggingface dataset:
English: Active-controlled trials in patients who were non-responders to monotherapy A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/valsartan 10 mg/160 mg and 62% of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Croatian: Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani valsartanom 160 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju <90 mmHg na kraju ispitivanja) u 75% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg i 62% bolesnika liječenih amlodipinom/valsartanom 5 mg/160 mg, u usporedbi s 53% bolesnika koji su ostali na valsartanu 160 mg.
English: A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Croatian: Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju <90 mmHg na kraju ispitivanja) u 78% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg, u usporedbi s 67% bolesnika koji su ostali na amlodipinu 10 mg.
English: In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Croatian: U ispitivanju embriofetalnog razvoja štakora, zamjećene su povećane incidencije dilatacije uretera, malformiranih sternebra, te neosificiranih falangi prednjih šapa pri izloženosti oko 12 (valsartan) i 10 (amlodipin) puta višoj od izloženosti kliničkim dozama od 160 mg valsartana i 10 mg amlodipina.
English: Particular caution should be exercised when administering Dafiro to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Croatian: Nužan je poseban oprez kod primjene Dafira bolesnicima s blagim do umjerenim oštećenjem jetre ili opstruktivnim poremećajima žučnog sustava.
English: The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush.
Croatian: Sljedeće su nuspojave nađene kao najučestalije ili kao najznačajnije ili teške: nazofaringitis, influenca, preosjetljivost, glavobolja, sinkopa, ortostatska hipotenzija, edem, tjestasti edem, facijalni edem, periferni edem, umor, crvenilo uz osjećaj vrućine, astenija i navala vrućine.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Dafiro.
Croatian: Grejp i sok od grejpa u nekih bolesnika može dovesti do povećanja razina djelatne tvari amlodipina u krvi, što može uzrokovati neočekivano pojačani učinak na snižavanje krvnog tlaka.
English: Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination.
Croatian: Prije prelaska na fiksnu kombinaciju doza preporučuje se individualno titriranje doze sa sastojcima (tj. amlodipinom i valsartanom).
English: Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders.
Croatian: Vrlo rijetko (mogu se javiti kod 1 na 10 000 osoba): Smanjen broj bijelih krvnih stanica, smanjen broj krvnih pločica što može rezultirati stvaranjem neuobičajenih modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica); povišen šećer u krvi (hiperglikemija), oticanje desni, nadutost u trbuhu (gastritis), nepravilna jetrena funkcija, upala jetre (hepatitis), žutilo kože (žutica), povišeni jetreni enzimi što može imati učinak na neke medicinske testove, povećana napetost mišića, upala krvnih žila često s kožnim osipom, osjetljivost na svjetlost, poremećaji koji kombiniraju krutost, nevoljno drhtanje i/ili poremećaje kretanja.
English: Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment.
Croatian: Preporučeno doziranje amlodipina nije utvrđeno u bolesnika s blagim do umjerenim oštećenjem jetre.
English: Common (may affect up to 1 in 10 people): Influenza (flu); blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; asthenia (weakness); redness and warm feeling of the face and/or neck.
Croatian: Česte (mogu se javiti kod 1 na 10 osoba): Influenca (gripa); začepljen nos, grlobolja i osjećaj nelagode pri gutanju; glavobolja; oticanje ruku, šaka, nogu, gležnjeva ili stopala; umor; astenija (slabost); crvenilo i osjećaj topline u licu i/ili vratu.
English: If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Croatian: Ako je lijek uzet nedavno, u obzir dolazi izazivanje povraćanja ili ispiranje želuca.
English: Not known (frequency cannot be estimated from the available data): Decrease in red blood cells, fever, sore throat or mouth sores due to infections; spontaneous bleeding or bruising; high level of potassium in the blood; abnormal liver test results; decreased renal functions and severely decreased renal functions; swelling mainly of the face and the throat; muscle pain; rash, purplish-red spots; fever; itching; allergic reaction; blistering skin (sign of a condition called dermatitis bullous).
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): smanjenje broja crvenih krvnih stanica, vrućica, grlobolja ili ranice u ustima zbog infekcija, spontano krvarenje ili stvaranje modrica, visoka razina kalija u krvi, poremećeni nalazi testova jetrene funkcije, smanjene funkcije bubrega i jako smanjene funkcije bubrega, oticanje uglavnom lica i grla, bol u mišićima, osip, ljubičasto-crvene pjege, vrućica, svrbež, alergijska reakcija; stvaranje mjehura na koži (znak stanja koje se zove bulozni dermatitis).
English: There are no available clinical data in severely renally impaired patients.
Croatian: Klinički podaci u bolesnika s teškim oštećenjem bubrega nisu dostupni.
English: Very rare Not known
Croatian: Vrlo rijetko Nepoznato
English: Dafiro 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Croatian: Dafiro 5 mg/80 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 80 mg.
English: Dafiro 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Dafiro 5 mg/160 mg.
Croatian: Dafiro 10 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 10 mg ili valsartanom 160 mg ili s Dafirom 5 mg/160 mg.
English: Uncommon Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Croatian: Manje često Nesanica, promjene raspoloženja (uključujući anksioznost), depresija, tremor, disgeuzija, sinkopa, hipoestezija, poremećaj vida (uključujući diplopiju), tinitus, hipotenziju, dispneju, rinitis, povraćanje, dispepsija, alopecija, purpura, promjena boje kože, hiperhidroza, svrbež, egzantem, mijalgija, grčevi u mišićima, bol, poremećaj mikturicije, povećana učestalost mokrenja, impotencija, ginekomastija, bol u prsima, malaksalost, povećanje tjelesne težine, smanjenje tjelesne težine.
English: Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
Croatian: Rijetke (mogu se javiti kod 1 na 1000 osoba): Osjećaj tjeskobe; zvonjava u ušima (tinitus); nesvjestica; pojačano mokrenje ili pojačan nagon na mokrenje; nemogućnost postizanja ili održavanja erekcije; osjećaj težine; niski krvni tlak sa simptomima poput omaglice, omamljenosti; pojačanog znojenja; kožni osip po čitavom tijelu; svrbež; grč mišića.
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Croatian: Takve doze u štakora (200 i 600 mg/kg/dan) otprilike su 6 i 18 puta veće od najviše preporučene doze za ljude izražene u mg/m
English: Extrapyramidal syndrome
Croatian: Ekstrapiramidni sindrom -
English: Nasopharyngitis
Croatian: Nazofaringitis
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.
Croatian: CYP3A4 induktori (antikonvulzivni lijekovi [npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon], rifampicin, Hypericum perforatum)
English: Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Croatian: Manje često (mogu se javiti kod 1 na 100 osoba): Promjene raspoloženja, tjeskoba, depresija, pospanost, drhtanje, poremećaji okusa, nesvjestica, gubitak osjećaja boli; poremećaji vida, oštećenje vida, zvonjava u ušima; niski krvni tlak; kihanje/curenje iz nosa uzrokovano upalom sluznice nosa (rinitis); loša probava, povraćanje; ispadanje kose, pojačano znojenje, svrbljiva koža, promjena boje kože; poremećaj mokrenja, pojačana potreba za mokrenjem noću, povećan broj mokrenja, nemogućnost postizanja erekcije, nelagoda ili povećanje dojki u muškaraca, bol, loše osjećanje, bol u mišićima, grčevi u mišićima; povećanje ili smanjenje tjelesne težine.
English: Amlodipine bioavailability is unaffected by food ingestion.
Croatian: Unos hrane ne utječe na bioraspoloživost amlodipina.
English: Dafiro 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Croatian: Dafiro 10 mg/160 mg tablete su ovalne, svijetložute tablete, s oznakom „NVR“ na jednoj strani i „UIC“ na drugoj strani.
English: No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m2) doziranje Dafira nije potrebno prilagođavati.
English: Micturition disorder
Croatian: Poremećaj mikturicije
English: Dafiro 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Croatian: Dafiro 5 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 160 mg.
English: Aortic and mitral valve stenosis
Croatian: Stenoza aortalnog i mitralnog zaliska
English: Gingival hyperplasia
Croatian: Hiperplazija gingive
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Croatian: Oštećenje bubrega ne utječe u značajnoj mjeri na farmakokinetiku amlodipina.
English: Sodium- and/or volume-depleted patients
Croatian: Bolesnici sa sniženom razinom natrija i/ili smanjenim volumenom tekućine
English: Dermatitis bullous
Croatian: Bulozni dermatitis
English: Polyuria
Croatian: Polakiurija
English: - Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.
Croatian: - Teške kožne reakcije, uključujući intenzivan kožni osip, koprivnjaču, crvenilo kože po čitavom tijelu, jaki svrbež, stvaranje mjehurića, ljuštenje i oticanje kože, upalu sluznica (Stevens
English: Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Croatian: Manje česte (mogu se javiti kod 1 na 100 osoba): Omaglica; mučnina i bol u trbuhu; suha usta; omamljenost, trnci ili obamrlost šaka ili stopala; vrtoglavica; ubrzani otkucaji srca, uključujući osjećaj lupanja srca; omaglica kod ustajanja; kašalj; proljev; zatvor; kožni osip, crvenilo kože; oticanje zglobova, bol u leđima; bol u zglobovima.
English: * Mostly consistent with cholestasis
Croatian: * Uglavnom upućuje na kolestazu Dodatne informacije o kombinaciji
English: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue, has been reported in patients treated with valsartan.
Croatian: U bolesnika koji su liječeni valsartanom prijavljena je pojava angioedema, uključujući oticanje grkljana i glotisa, koji uzrokuje opstrukciju dišnih puteva i/ili oticanje lica, usnica, ždrijela i/ili jezika.
English: Change of bowel habit
Croatian: Promijenjene navike pražnjenja crijeva
English: Myalgia
Croatian: Mijalgija
English: Dafiro 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Croatian: Dafiro 5 mg/160 mg tablete su ovalne, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „ECE“ na drugoj strani.
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172).
English: Dyspnoea
Croatian: Dispepsija
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
Croatian: Ovojnica hipromeloza zamjenski tip 2910 (3 mPas) titanijev dioksid (E171) željezov oksid, žuti (E172) makrogol 4000 talk
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
English: Facial oedema
Croatian: Facijalni edem
English: Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets
Croatian: Dafiro 5 mg/80 mg filmom obložene tablete Dafiro 5 mg/160 mg filmom obložene tablete
English: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Croatian: U podložnih pojedinaca mogu se očekivati promjene bubrežne funkcije kao posljedica inhibicije reninangiotenzin-aldosteronskog sustava.
English: Visual impairment
Croatian: Oštećenje vida
English: Dafiro 5 mg/80 mg film-coated tablets
Croatian: Dafiro 5 mg/80 mg filmom obložene tablete
English: Dafiro 10 mg/160 mg film-coated tablets
Croatian: Dafiro 10 mg/160 mg filmom obložene tablete
English: EU/1/06/371/035 280 film-coated tablets (4x70) EU/1/06/371/038 280 film-coated tablets (20x14)
Croatian: EU/1/06/371/035 280 filmom obloženih tableta (4x70) EU/1/06/371/038 280 filmom obloženih tableta (20x14)
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Dafiro.
Croatian: Bolesnici koji uzimaju Dafiro ne smiju konzumirati grejp ili sok od grejpa.
English: Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of your heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).
Croatian: Često (mogu se javiti kod 1 na 10 osoba): Omaglica, pospanost; palpitacije (svijest o radu Vašeg srca); crvenilo uz osjećaj vrućine, oticanje gležnjeva (edem); bol u trbuhu, mučnina.
English: EU/1/06/371/036 280 film-coated tablets (4x70) EU/1/06/371/039 280 film-coated tablets (20x14)
Croatian: EU/1/06/371/036 280 filmom obloženih tableta (4x70) EU/1/06/371/039 280 filmom obloženih tableta (20x14)
English: Each tablet contains 5 mg amlodipine and 80 mg valsartan.
Croatian: Jedna tableta sadrži 5 mg amlodipina i 80 mg valsartana.
English: EU/1/06/371/034 280 film-coated tablets (4x70) EU/1/06/371/037 280 film-coated tablets (20x14)
Croatian: EU/1/06/371/034 280 filmom obloženih tableta (4x70) EU/1/06/371/037 280 filmom obloženih tableta (20x14)
English: Visual disturbance
Croatian: Poremećaji oka Poremećaj vida
English: Arthralgia
Croatian: Artralgija
English: Paraesthesia
Croatian: Parestezija
English: Dafiro 5 mg/160 mg film-coated tablets
Croatian: Dafiro 5 mg/160 mg filmom obložene tablete
English: Flushing, hot flush
Croatian: Crvenilo uz osjećaj vrućine, navale vrućine
English: Mood swings
Croatian: Promjene raspoloženja
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Croatian: Ovojnica hipromeloza zamjenski tip 2910 (3 mPas) titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172) makrogol 4000 talk
English: Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side.
Croatian: Tamnožuta, okrugla filmom obložena tableta s kosim rubovima i oznakom „NVR“ na jednoj strani te „NV“ na drugoj strani.
English: Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Croatian: Jedna tableta sadrži 10 mg amlodipina i 160 mg valsartana.
English: Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Croatian: Dafiro 10 mg/160 mg filmom obložene tablete amlodipin/valsartan
English: Each tablet contains 5 mg amlodipine and 160 mg valsartan.
Croatian: Jedna tableta sadrži 5 mg amlodipina i 160 mg valsartana.
English: Dafiro 5 mg/80 mg film-coated tablets amlodipine/valsartan
Croatian: Dafiro 5 mg/80 mg filmom obložene tablete amlodipin/valsartan
English: Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side.
Croatian: Tamnožuta, ovalna filmom obložena tableta s oznakom „NVR“ na jednoj strani te „ECE“ na drugoj strani.
English: Apontis Pharma GmbH & Co. KG Tel: +49 2173 48 4949
Croatian: KG Tel: +49 2173 48 4949
English: Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side.
Croatian: Svijetložuta, ovalna filmom obložena tableta s oznakom „NVR“ na jednoj strani te „UIC“ na drugoj strani.
English: Dafiro 5 mg/160 mg film-coated tablets amlodipine/valsartan
Croatian: Dafiro 5 mg/160 mg filmom obložene tablete amlodipin/valsartan
English: EU/1/06/371/001 7 film-coated tablets EU/1/06/371/002 14 film-coated tablets EU/1/06/371/003 28 film-coated tablets EU/1/06/371/004 30 film-coated tablets EU/1/06/371/005 56 film-coated tablets EU/1/06/371/006 90 film-coated tablets EU/1/06/371/007 98 film-coated tablets EU/1/06/371/008 280 film-coated tablets EU/1/06/371/025 56x1 film-coated tablet (unit dose) EU/1/06/371/026 98x1 film-coated tablet (unit dose) EU/1/06/371/027 280x1 film-coated tablet (unit dose)
Croatian: EU/1/06/371/001 7 filmom obloženih tableta EU/1/06/371/002 14 filmom obloženih tableta EU/1/06/371/003 28 filmom obloženih tableta EU/1/06/371/004 30 filmom obloženih tableta EU/1/06/371/005 56 filmom obloženih tableta EU/1/06/371/006 90 filmom obloženih tableta EU/1/06/371/007 98 filmom obloženih tableta EU/1/06/371/008 280 filmom obloženih tableta EU/1/06/371/025 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/026 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/027 280x1 filmom obloženih tableta (jedinična doza)
English: Vomiting
Croatian: Povraćanje
English: EU/1/06/371/017 7 film-coated tablets EU/1/06/371/018 14 film-coated tablets EU/1/06/371/019 28 film-coated tablets EU/1/06/371/020 30 film-coated tablets EU/1/06/371/021 56 film-coated tablets EU/1/06/371/022 90 film-coated tablets EU/1/06/371/023 98 film-coated tablets EU/1/06/371/024 280 film-coated tablets EU/1/06/371/031 56x1 film-coated tablet (unit dose) EU/1/06/371/032 98x1 film-coated tablet (unit dose) EU/1/06/371/033 280x1 film-coated tablet (unit dose)
Croatian: EU/1/06/371/017 7 filmom obloženih tableta EU/1/06/371/018 14 filmom obloženih tableta EU/1/06/371/019 28 filmom obloženih tableta EU/1/06/371/020 30 filmom obloženih tableta EU/1/06/371/021 56 filmom obloženih tableta EU/1/06/371/022 90 filmom obloženih tableta EU/1/06/371/023 98 filmom obloženih tableta EU/1/06/371/024 280 filmom obloženih tableta EU/1/06/371/031 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/032 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/033 280x1 filmom obloženih tableta (jedinična doza)
English: Dizziness
Croatian: Dispneja
English: Hyperlipidaemia
Croatian: Hiperlipidemija
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega nije potrebno prilagođavati doziranje.
English: Impairment of fertility
Croatian: Poremećaj plodnosti