FrancophonIA/ELRC3.0 huggingface dataset:
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, ARBs or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Croatian: Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) Postoje dokazi da istodobna primjena ACE inhibitora, ARB-ova ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
English: Following oral administration of Imprida, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Croatian: Nakon peroralne primjene Impride, vršne koncentracije amlodipina i valsartana u plazmi postižu se u 3 odnosno 6-8 sati.
English: Pack sizes: 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets and multipacks containing 280 (4x70 or 20x14) film-coated tablets.
Croatian: Veličina pakovanja: 7, 14, 28, 30, 56, 90, 98 ili 280 filmom obloženih tableta i višestruko pakovanje koje sadrži 280 (4x70 ili 20x14) filmom obloženih tableta.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Imprida or observed with a higher frequency than with Imprida:
Croatian: Prijavljene nuspojave s amlodipinom ili valsartanom primjenjenima samostalno ili uopće nisu opažene s Impridom ili su opažene s većom učestalošću nego s Impridom:
English: Imprida was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Croatian: Imprida je također ispitivana u aktivno kontroliranom kliničkom ispitivanju sa 130 hipertenzivnih bolesnika sa srednjom vrijednošću dijastoličkog krvnog tlaka u sjedećem položaju ≥110 mmHg i <120 mmHg.
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Imprida” and diuretics (a type of medicine also called “water tablets” which increases the amount of urine lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Croatian: ACE inhibitori ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Impridu“ i „Upozorenja i mjere opreza“); diuretici (vrsta lijeka koja se naziva i „tablete za mokrenje“ koje povećavaju količinu mokraće koju proizvodite); litij (lijek koji se koristi za liječenje nekih vrsta depresije); diuretici koji štede kalij, nadomjesci kalija, zamjene za sol koje sadrže kalij i ostale tvari koje mogu povećati razinu kalija; određene vrste lijekova protiv bolova koji se nazivaju nesteoridni protuupalni lijekovi (NSAILi) ili selektivnim inhibitorima ciklooksigenaze-2 (COX-2 inhibitori).
English: Imprida should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Croatian: Bolesnici u kojih se razvije angioedem trebaju odmah prekinuti primjenu Impride i više ga ne smiju ponovo uzimati.
English: Frequency Imprida Amlodipine Valsartan
Croatian: Učestalost Imprida Amlodipin Valsartan
English: In this study (baseline blood pressure 171/113 mmHg), an Imprida regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Croatian: U tom ispitivanju (početni krvni tlak 171/113 mmHg), liječenje Impridom 5 mg/160 mg titriranim do 10 mg/160 mg snizilo je krvni tlak u sjedećem položaju za 36/29 mmHg, u usporedbi s 32/28 mmHg kod liječenja lizinoprilom/hidroklorotiazidom 10 mg/12,5 mg titriranim do 20 mg/12,5 mg.
English: In one rat study, adverse effects were found on male fertility (see section 5.3).
Croatian: U jednom ispitivanju sa štakorima nađeni su štetni učinci na mušku plodnost (vidjeti dio
English: Imprida is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Croatian: Imprida se primjenjuje za liječenje povišenog krvnog tlaka u odraslih osoba čiji krvni tlak nije dovoljno kontroliran bilo samo amlodipinom ili samo valsartanom.
English: Imprida is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Croatian: Imprida je indicirana u odraslih osoba čiji krvni tlak nije odgovarajuće kontroliran monoterapijom amlodipinom ili valsartanom.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Imprida in placebo-controlled studies.
Croatian: U placebo-kontroliranim ispitivanjima, u 0,4% bolesnika s nekompliciranom hipertenzijom liječenih Impridom viđena je izražena hipotenzija.
English: Others
Croatian: Drugi
English: medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Croatian: lijekovi koji se primjenjuju za liječenje HIV infekcije/SIDA (npr. ritonavir, indinavir, nelfinavir); lijekovi za liječenje gljivičnih infekcija (npr. ketokonazol, itrakonazol); lijekovi za liječenje bakterijskih infekcija (npr. rifampicin, eritromicin, klaritromicin, talitromicin); verapamil, diltiazem (lijekovi za srce); simvastatin (lijekovi koji se koriste za kontrolu visokih razina kolesterola); dantrolen (infuzija za teške poremećaje tjelesne temperature); lijekovi koji se koriste kao zaštita od odbacivanja transplantata (ciklosporin).
English: The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
Croatian: Djelatne tvari u Impridi su amlodipin (u obliku amlodipinbesilata) i valsartan.
English: Very rare Very rare Very rare
Croatian: Manje često Često Rijetko Manje često -Vrlo rijetko
English: Hepatic impairment Imprida is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Imprida je kontraindicirana u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the
Croatian: • Preosjetljivost na djelatne tvari, derivate dihidropiridina, ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Fertility There are no clinical studies on fertility with Imprida.
Croatian: Ne postoje klinička ispitivanja djelovanja Impride na plodnost.
English: Pitting oedema
Croatian: Quinckeov edem
English: Caution should be exercised when administering Imprida to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Croatian: Nužan je oprez kod primjene Impride bolesnicima s oštećenjem jetre ili opstruktivnim bolestima žučnog sustava (vidjeti dio 4.4).
English: Particular caution should be exercised when administering Imprida to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Croatian: Nužan je poseban oprez kod primjene Impride bolesnicima s blagim do umjerenim oštećenjem jetre ili opstruktivnim poremećajima žučnog sustava.
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 Imprida.
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: Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from
Croatian: Amlodipin sprečava ulazak kalcija u stijenku krvne žile i tako sprečava sužavanje krvne žile.
English: Cellulose microcrystalline Crospovidone Type A Silica, colloidal anhydrous Magnesium stearate
Croatian: A silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Imprida 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 Imprida 5 mg/160 mg.
Croatian: Imprida 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 Impridom 5 mg/160 mg.
English: Imprida 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: Imprida 5 mg/80 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 80 mg.
English: No dosage adjustment of Imprida 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 Impride nije potrebno prilagođavati.
English: Not known Very rare Not known
Croatian: Nepoznato Vrlo rijetko Nepoznato
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) 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: Imprida 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: Imprida 5 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 160 mg.
English: There are no available clinical data in severely renally impaired patients.
Croatian: Klinički podaci u bolesnika s teškim oštećenjem bubrega nisu dostupnia.
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Croatian: CYP3A4 induktori (antikonvulzivni lijekovi [npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon], rifampicin, Hypericum perforatum)
English: Your doctor may also check your kidney function; anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin and other nitrates, or other substances called “vasodilators”; medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
Croatian: Liječnik će Vam možda provjeriti i bubrežnu funkciju; antikonvulzivni lijekovi (npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon); gospina trava; nitroglicerin i drugi nitrati, ili drugi lijekovi koji se nazivaju „vazodilatatori“;
English: Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
Croatian: Ovojnica: hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172) makrogol 4000 talk
English: Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) Macrogol 4000
Croatian: Ovojnica: hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172) makrogol 4000 talk
English: Imprida 5 mg/80 mg film-coated tablets
Croatian: Imprida 5 mg/80 mg filmom obložene tablete
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Imprida.
Croatian: Bolesnici koji uzimaju Impridu ne smiju konzumirati grejp ili sok od grejpa.
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Imprida, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Croatian: Prilikom prebacivanja starijih hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) na amlodipin ili Impridu, treba se koristiti najniža dostupna doza amlodipina u monoterapiji ili amlodipina kao komponente.
English: The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon tipa A, koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
English: Imprida 10 mg/160 mg film-coated tablets
Croatian: Imprida 10 mg/160 mg filmom obložene tablete
English: The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon tipa A, koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172).
English: Imprida 10 mg/160 mg film-coated tablets amlodipine/valsartan
Croatian: Imprida 10 mg/160 mg filmom obložene tablete amlodipin/valsartan
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Imprida, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Croatian: Prilikom prebacivanja hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) s oštećenjem jetre na amlodipin ili Impridu, treba se koristiti najniža dostupna doza amlodipina u monoterapiji ili amlodipina kao komponente.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Imprida 5 mg/80 mg film-coated tablets amlodipine/valsartan
Croatian: Imprida 5 mg/80 mg filmom obložene tablete amlodipin/valsartan
English: What Imprida looks like and contents of the pack Imprida 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Croatian: Imprida 10 mg/160 mg tablete su ovalne, svijetložute tablete, s oznakom „NVR“ na jednoj strani i „UIC“ na drugoj strani.
English: Imprida 5 mg/160 mg film-coated tablets
Croatian: Imprida 5 mg/160 mg filmom obložene tablete
English: EU/1/06/373/035 280 film-coated tablets (4x70) EU/1/06/373/038 280 film-coated tablets (20x14)
Croatian: EU/1/06/373/035 280 filmom obloženih tableta (4x70) EU/1/06/373/038 280 filmom obloženih tableta (20x14)
English: EU/1/06/373/036 280 film-coated tablets (4x70) EU/1/06/373/039 280 film-coated tablets (20x14)
Croatian: EU/1/06/373/036 280 filmom obloženih tableta (4x70) EU/1/06/373/039 280 filmom obloženih tableta (20x14)
English: EU/1/06/373/034 280 film-coated tablets (4x70) EU/1/06/373/037 280 film-coated tablets (20x14)
Croatian: EU/1/06/373/034 280 filmom obloženih tableta (4x70) EU/1/06/373/037 280 filmom obloženih tableta (20x14)
English: Imprida 5 mg/160 mg film-coated tablets amlodipine/valsartan
Croatian: Imprida 5 mg/160 mg filmom obložene tablete amlodipin/valsartan
English: What Imprida looks like and contents of the pack Imprida 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Croatian: Imprida 5 mg/80 mg tablete su okrugle, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „NV“ na drugoj strani.
English: Facial oedema
Croatian: Posturalna omaglica
English: If you think you may be allergic, talk to your doctor before taking Imprida.
Croatian: Ako mislite da biste mogli biti alergični, porazgovarajte sa svojim liječnikom prije uzimanja Impride. ako imate teške probleme s jetrom ili probleme sa žuči, poput bilijarne ciroze ili kolestaze.
English: What Imprida looks like and contents of the pack Imprida 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Croatian: Imprida 5 mg/160 mg tablete su ovalne, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „ECE“ na drugoj strani.
English: EU/1/06/373/001 7 film-coated tablets EU/1/06/373/002 14 film-coated tablets EU/1/06/373/003 28 film-coated tablets EU/1/06/373/004 30 film-coated tablets EU/1/06/373/005 56 film-coated tablets EU/1/06/373/006 90 film-coated tablets EU/1/06/373/007 98 film-coated tablets EU/1/06/373/008 280 film-coated tablets EU/1/06/373/025 56x1 film-coated tablet (unit dose) EU/1/06/373/026 98x1 film-coated tablet (unit dose) EU/1/06/373/027 280x1 film-coated tablet (unit dose)
Croatian: EU/1/06/373/001 7 filmom obloženih tableta EU/1/06/373/002 14 filmom obloženih tableta EU/1/06/373/003 28 filmom obloženih tableta EU/1/06/373/004 30 filmom obloženih tableta EU/1/06/373/005 56 filmom obloženih tableta EU/1/06/373/006 90 filmom obloženih tableta EU/1/06/373/007 98 filmom obloženih tableta EU/1/06/373/008 280 filmom obloženih tableta EU/1/06/373/025 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/373/026 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/373/027 280x1 filmom obloženih tableta (jedinična doza)
English: EU/1/06/373/017 7 film-coated tablets EU/1/06/373/018 14 film-coated tablets EU/1/06/373/019 28 film-coated tablets EU/1/06/373/020 30 film-coated tablets EU/1/06/373/021 56 film-coated tablets EU/1/06/373/022 90 film-coated tablets EU/1/06/373/023 98 film-coated tablets EU/1/06/373/024 280 film-coated tablets EU/1/06/373/031 56x1 film-coated tablet (unit dose) EU/1/06/373/032 98x1 film-coated tablet (unit dose) EU/1/06/373/033 280x1 film-coated tablet (unit dose)
Croatian: EU/1/06/373/017 7 filmom obloženih tableta EU/1/06/373/018 14 filmom obloženih tableta EU/1/06/373/019 28 filmom obloženih tableta EU/1/06/373/020 30 filmom obloženih tableta EU/1/06/373/021 56 filmom obloženih tableta EU/1/06/373/022 90 filmom obloženih tableta EU/1/06/373/023 98 filmom obloženih tableta EU/1/06/373/024 280 filmom obloženih tableta EU/1/06/373/031 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/373/032 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/373/033 280x1 filmom obloženih tableta (jedinična doza)
English: Imprida.
Croatian: OBLIK
English: EU/1/06/373/009 7 film-coated tablets EU/1/06/373/010 14 film-coated tablets EU/1/06/373/011 28 film-coated tablets EU/1/06/373/012 30 film-coated tablets EU/1/06/373/013 56 film-coated tablets EU/1/06/373/014 90 film-coated tablets EU/1/06/373/015 98 film-coated tablets EU/1/06/373/016 280 film-coated tablets EU/1/06/373/028 56x1 film-coated tablet (unit dose) EU/1/06/373/029 98x1 film-coated tablet (unit dose) EU/1/06/373/030 280x1 film-coated tablet (unit dose)
Croatian: EU/1/06/373/009 7 filmom obloženih tableta EU/1/06/373/010 14 filmom obloženih tableta EU/1/06/373/011 28 filmom obloženih tableta EU/1/06/373/012 30 filmom obloženih tableta EU/1/06/373/013 56 filmom obloženih tableta EU/1/06/373/014 90 filmom obloženih tableta EU/1/06/373/015 98 filmom obloženih tableta EU/1/06/373/016 280 filmom obloženih tableta EU/1/06/373/028 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/373/029 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/373/030 280x1 filmom obloženih tableta (jedinična doza)
English: You should never take Imprida if you are taking any of the following medicines used to treat high blood pressure: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have
Croatian: ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
English: Non cardiac chest pain
Croatian: Bol u prsima koja nije povezana sa srcem
English: Pruritus
Croatian: Gastritis
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Dizziness
Croatian: Egzantem
English: Lithium
Croatian: Tinitus
English: MARKETING AUTHORISATION HOLDER
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Eye disorders
Croatian: Oštećenje vida
English: 20 December 2013 EMA/14811/2014
Croatian: 20. prosinca 2013. EMA/14811/2014
English: • If you have any questions or concerns, speak to your doctor, pharmacist or nurse.
Croatian: • Ako imate bilo kakvih pitanja ili razloga za zabrinutost, obratite se svojem liječniku, ljekarniku ili medicinskoj sestri.
English: The rate can then be increased but should not exceed 15 mg/h.
Croatian: Doza se može povećati, no ne smije premašiti 15 mg/s.
English: These uses are no longer recommended because the available data are insufficient to support use in these conditions.
Croatian: Ove se primjene više ne preporučaju jer dostupni podaci nisu dostatni da podupru primjenu u ovim uvjetima.
English: When the target blood pressure is reached, the dose should be reduced progressively.
Croatian: Kada se dosegne ciljani krvni tlak, doza se mora progresivno smanjiti.
English: The review of intravenous nicardipine was initiated in July 2012 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled intravenoznog nikardipina započet je u srpnju 2012. godine na zahtjev Ujedinjenog Kraljevstva u skladu sa člankom 31. Direktive 2001/83/EK.
English: It works as a ‘calcium-channel blocker': this means that it blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Croatian: Djeluje kao „blokada kalcijevih kanala”: to znači da blokira posebne kanale na površini stanica naziva kalcijevi kanali, kroz koje ioni kalcija normalno ulaze u stanice.
English: − aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective;
Croatian: − aortne disekcije, u slučaju kada terapija kratkodjelujućim beta-blokadama nije pogodna, ili u kombinaciji s beta-blokadama kada samo beta-blokade nisu djelotvorne;
English: Medicines containing nicardipine given into a vein are authorised in the following EU Member States: Belgium, France, Luxemburg, the Netherlands and Spain.
Croatian: Lijekovi koji sadrže nikardipin i primjenjuju se u venu odobreni su u sljedećim državama članicama EUa: Belgija, Francuska, Luksemburg, Nizozemska i Španjolska.
English: The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications.
Croatian: MHRA je bio zabrinut da dostavljeni klinički podaci nisu primjereni za utvrđivanje koristi i rizika generičkih lijekova u predloženim indikacijama.
English: • treatment of post-operative hypertension.
Croatian: • liječenje post-operativne hipertenzije.
English: − malignant arterial hypertension/hypertensive encephalopathy;
Croatian: − maligne arterijske hipertenzije/hipertenzivne encefalopatije;
English: The MHRA therefore decided to request an EU-wide review of these medicines.
Croatian: Stoga je MHRA odlučio zatražiti pregled ovih lijekova na razini EU-a.
English: − severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated;
Croatian: − ozbiljna pred-eklampsija, u slučaju kada druga intravenozna protuhipertenzivna sredstva nisu preporučena ili su kontraindicirana;
English: • treatment of acute life-threatening hypertension, particularly in the event of:
Croatian: • liječenje akutne po život opasne hipertenzije, posebice u slučaju:
English: It should only be administered by specialists in well controlled environments, with continuous monitoring of blood pressure.
Croatian: Treba ga primjenjivati specijalist u dobro kontroliranim okruženjima, s kontinuiranim praćenjem krvnoga tlaka.
English: In adults, treatment should start with a continuous administration of nicardipine at a rate of 3-5 mg/h.
Croatian: U odraslih osoba liječenje se treba započeti s kontinuiranom primjenom nikardipina pri dozi od 3-5 mg/s.