FrancophonIA/ELRC3.0 huggingface dataset:
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6fold increase in AUC and Cmax, respectively.
Slovenian: Pri aplikaciji enkratnih odmerkov v obsegu od 75 do 600 mg dvakratno zvišanje odmerka povzroči 2,3-kratno povečanje AUC in 2,6-kratno zvišanje Cmax.
English: Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Slovenian: Zdravila, ki vplivajo na koncentracijo kalija v serumu Sočasna uporaba drugih zdravil, ki vplivajo na RAAS, nesteroidnih protivnetnih zdravil ali zdravil, ki zvišujejo koncentracijo kalija v serumu (na primer diuretikov, ki varčujejo s kalijem, nadomestkov kalija, nadomestkov soli s kalijem, heparina) lahko povzroča zvišanje koncentracije kalija v serumu.
English: Exposure to aliskiren increased more than in proportion to the increase in dose.
Slovenian: Izpostavljenost aliskirenu ni naraščala sorazmerno z višanjem odmerka, ampak hitreje.
English: Other substances that act directly on the RAAS have been associated with serious foetal malformations and neonatal death.
Slovenian: Druge snovi, ki delujejo neposredno na sistem renin-angiotenzinaldosteron, so povezane s hudimi okvarami ploda in smrtjo novorojenčka.
English: Packs containing 56 and 98 (2x49) tablets are perforated unit-dose blisters.
Slovenian: Pakiranja, ki vsebujejo po 56 in 98 (2x49) tablet, so perforirani pretisni omoti z razdelki za enkratni odmerek.
English: Aliskiren was evaluated for cardiovascular and/or renal benefit in a double-blind placebo controlled randomised trial in 8,606 patients with type 2 diabetes and chronic kidney disease (evidenced by proteinuria and/or GFR < 60 ml/min/1.73 m2) with or without cardiovascular disease.
Slovenian: Koristne učinke aliskirena za srčnožilni sistem in/ali ledvice so ocenjevali v dvojno slepem, s placebom kontroliranem, randomiziranem preskušanju, ki je vključevalo 8.606 bolnikov s sladkorno boleznijo tipa 2 in s kronično boleznijo ledvic (dokazano s proteinurijo in/ali s GFR < 60 ml/min/1,73 m2) ter s sočasno srčnožilno boleznijo ali brez nje.
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by grapefruit juice in the gastrointestinal tract.
Slovenian: Do navedenega zmanjšanja AUC verjetno pride zato, ker grenivkin sok v gastrointestinalnem traktu zavira privzem aliskirena preko transportnega polipeptida za organske anione.
English: At steady state the non-linearity may be more pronounced.
Slovenian: V stanju dinamičnega ravnovesja je nelinearnost lahko bolj izrazita.
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Slovenian: V randomizirani, dvojno slepi, s placebom in aktivno kontrolirani študiji, v kateri so uporabljali standardno in Holter elektrokardiografijo, niso opažali učinka na QT interval.
English: Rare (affecting less than 1 in 1,000 patients): Allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness), increased level of creatinine in the blood.
Slovenian: Redki (pojavijo se pri manj kot 1 od 1.000 bolnikov): alergijske reakcije (preobčutljivost) in angioedem (med njegovimi simptomi so lahko oteženo dihanje ali požiranje, izpuščaj, srbenje, koprivnica ali otekanje v obraz, roke in stopala, oči, ustnice in/ali jezik, omotica), zvišana raven kreatinina v krvi.
English: The enzyme responsible for this metabolism is CYP3A4.
Slovenian: Za presnovo je odgovoren encim CYP3A4.
English: Co-administration of Sprimeo had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Slovenian: Sočasna uporaba zdravila Sprimeo ni pomembno vplivala na farmakokinetične lastnosti atorvastatina, metformina in amlodipina.
English: • When new information is received that may impact on the current Safety Specification,
Slovenian: • po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja
English: Moderate P-gp inhibitors
Slovenian: Zmerni zaviralci P-gp
English: In some patients with compromised renal function (dehydrated patients or elderly patients) aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Slovenian: Sočasna uporaba aliskirena z nesteroidnimi protivnetnimi zdravili lahko pri nekaterih bolnikih z oslabljenim delovanjem ledvic (pri dehidriranih ali starejših bolnikih) povzroči nadaljnje poslabšanje delovanja ledvic, vključno z možnostjo akutne ledvične odpovedi, ki je običajno reverzibilna.
English: As with other agents acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Slovenian: Kot pri drugih zdravilih, ki delujejo na sistem renin-angiotenzin, so tudi pri bolnikih, zdravljenih z aliskirenom, opisovali angioedem oziroma simptome, ki kažejo na angioedem (otekanje obraza, ustnic, grla oziroma žrela in/ali jezika).
English: Sprimeo monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Slovenian: Rezultati študij zdravila Sprimeo v monoterapiji so pokazali učinke zniževanja krvnega tlaka, ki so primerljivi z učinki drugih skupin antihipertenzivnih zdravil, vključno z zaviralci ACE in antagonisti angiotenzina II.
English: You should not take Sprimeo together with grapefruit juice.
Slovenian: Zdravila Sprimeo ne jemljite skupaj z grenivkinim sokom.
English: Angioedema
Slovenian: Angioedem
English: When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49% respectively.
Slovenian: Pri sočasni uporabi aliskirena s furosemidom se je AUC furosemida znižala za 28 %, Cmax furosemida pa za 49 %.
English: Do not take Sprimeo if you are pregnant.
Slovenian: Če ste noseči, ne jemljite zdravila Sprimeo.
English: Limited data are available related to overdose in humans.
Slovenian: O prevelikem odmerjanju pri ljudeh je na voljo le malo podatkov.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicines that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see section 4.8).
Slovenian: Med temi bolniki so številni v preteklosti že imeli angioedem ali simptome, ki kažejo na angioedem, do katerih je v nekaterih primerih prišlo zaradi uporabe drugih zdravil, ki lahko povzročajo angioedem, med drugim zaradi zaviralcev sistema renin-angiotenzin-aldosteron (zaviralcev angiotenzinske konvertaze ali zaviralcev angiotenzinskih receptorjev) (glejte poglavje 4.8).
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Sprimeo alone.
Slovenian: Pri bolnikih s hipertenzijo brez zapletov, ki so se zdravili samo z zdravilom Sprimeo, so občasno (pri 0,1 %) opažali pretirano hipotenzijo.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Sprimeo.
Slovenian: Zato lahko induktorji P-gp (šentjanževka, rifampicin) zmanjšajo biološko uporabnost zdravila Sprimeo.
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of Sprimeo.
Slovenian: Drugi induktorji P-gp (šentjanževka) bi lahko zmanjšali biološko uporabnost zdravila Sprimeo.
English: The clinical implications of the differences in effect on PRA are not known at the present time.
Slovenian: Klinični pomen drugačnega učinka na delovanje renina v plazmi zaenkrat ni znan.
English: Grapefruit juice should not be taken together with Sprimeo.
Slovenian: Zdravila Sprimeo se ne sme jemati skupaj z grenivkinim sokom.
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Sprimeo 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Slovenian: V primerjavi z diuretikom hidroklorotiazidom je zdravilo Sprimeo po 12 tednih zdravljenja v odmerku 300 mg znižalo sistolični/diastolični krvni tlak za 17,0/12,3 mmHg, hidroklorotiazid v odmerku 25 mg pa za 14,4/10,5 mmHg.
English: Haemoglobin and haematocrit: Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Slovenian: Hemoglobin in hematokrit: Opažali so majhno znižanje vrednosti hemoglobina in hematokrita (povprečno znižanje koncentracije hemoglobina za približno 0,05 mmol/l in hematokrita za 0,16 volumskega odstotka).
English: Nervous system disorders Common: Vascular disorders Uncommon: Gastrointestinal disorders Common: Immune system disorders Rare: Skin and subcutaneous tissue disorders Uncommon:
Slovenian: Bolezni ţivčevja pogosti: Ţilne bolezni občasni: Bolezni prebavil pogosti: Bolezni imunskega sistema redki: Bolezni koţe in podkoţja občasni:
English: Take special care with Sprimeo - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Slovenian: Bodite posebno pozorni pri uporabi zdravila Sprimeo - kadar jemljete diuretike (vrsta zdravil za odvajanje vode, ki povečuje količino urina, ki nastaja v telesu); - če jemljete zdravilo iz katere od naslednjih skupin zdravil za zdravljenje visokega krvnega tlaka:
English: Metabolism and elimination
Slovenian: Presnova in izločanje
English: 56 film-coated tablets (perforated unit-dose blister)
Slovenian: 56 filmsko obloženih tablet (perforirani pretisni omoti z razdelki za
English: Uncommon (affecting less than 1 in 100 patients): Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever) , low blood pressure.
Slovenian: Občasni (pojavijo se pri manj kot 1 od 100 bolnikov): kožni izpuščaj (to je lahko tudi znak alergijskih reakcij ali angioedema - glejte "Redki" neželeni učinki, spodaj), težave z ledvicami, vključno z akutno ledvično odpovedjo (zelo zmanjšanim nastajanjem urina), otekanje rok, gležnjev ali stopal (periferni edemi), hude kožne reakcije (toksična epidermalna nekroliza in/ali reakcije ustne sluznice - rdeča koža, nastajanje mehurjev na ustnicah, očeh ali v ustih, luščenje kože, zvišana telesna temperatura), nizek krvni tlak.
English: Sprimeo induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Slovenian: Če so zdravilo Sprimeo dodali hidroklorotiazidu, je povzročilo aditiven učinek zniževanja krvnega tlaka.
English: The increased incidence of non-fatal stroke was greater in patients with renal insufficiency.
Slovenian: Pojavnost možganske kapi (brez smrtnega izida) je povečana pri bolnikih z zmanjšanim delovanjem ledvic.
English: Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary.
Slovenian: Kadar je navedena sočasna uporaba neizogibna, je v skladu z običajno klinično prakso priporočeno občasno določanje delovanja ledvic, vključno s koncentracijo elektrolitov v serumu.
English: It is important to talk to your doctor immediately if you think you may be pregnant or are planning to become pregnant.
Slovenian: Če mislite, da bi lahko bili noseči, ali če želite zanositi, je zelo pomembno, da se takoj pogovorite z zdravnikom.
English: Rash, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions
Slovenian: izpuščaj, hude kožne neželene reakcije (angl. severe cutaneous adverse reactions (SCAR)), vključno s toksično epidermalno nekrolizo (TEN)
English: Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Slovenian: Sočasna uporaba ketokonazola (200 mg) ali verapamila (240 mg) in aliskirena (300 mg) je povzročila zvečanje AUC aliskirena za 76 % oziroma 97 %.
English: However, when driving vehicles or operating machinery it must be borne in mind that dizziness or weariness may occasionally occur when taking any antihypertensive therapy.
Slovenian: Vendar pa je treba upoštevati, da lahko med jemanjem antihipertenzivnih zdravil občasno pride do omotičnosti in preutrujenosti.
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the dosages chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Slovenian: V 12-tedenskem obdobju monoterapije z aliskirenom je prišlo do znižanja sistoličnega/diastoličnega krvnega tlaka za 14,0/5,1 mmHg v primerjavi z znižanjem za 11,6/3,6 mmHg pri uporabi ramiprila, skladno s tem, da aliskiren ni slabši v primerjavi z ramiprilom pri izbranem odmerjanju.
English: Where there is involvement of the tongue, glottis or larynx adrenaline should be administered.
Slovenian: Kadar so zajeti jezik, glotis ali grlo, mora bolnik dobiti adrenalin.
English: Co-administration of aliskiren 300 mg with ketoconazole 200 mg or verapamil 240 mg resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Slovenian: Sočasna uporaba 300 mg aliskirena in 200 mg ketokonazola ali 240 mg verapamila je povzročila 76 % oziroma 97 % zvečanje AUC aliskirena v plazmi.
English: If renal failure occurs, treatment should be discontinued.
Slovenian: V primeru ledvične odpovedi je treba z zdravljenjem prekiniti.
English: However, as with other agents acting on the renin-angiotensin system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Slovenian: Vendar pa tako kot pri uporabi drugih zdravil, ki delujejo na sistem renin-angiotenzin, pri uporabi aliskirena pri bolnikih, ki imajo stenozo ledvične arterije, obstaja povečano tveganje za ledvično insuficienco, vključno z akutno ledvično odpovedjo.
English: Characteristics in patients
Slovenian: Posebne skupine bolnikov
English: P-gp potent inhibitors
Slovenian: Močni zaviralci P-gp
English: No additional blood pressure lowering effect was detected with 300 mg aliskiren compared to 150 mg aliskiren.
Slovenian: Z odmerkom 300 mg aliskirena v primerjavi s 150 mg aliskirena niso ugotovili dodatnega učinka na znižanje krvnega tlaka.
English: Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Slovenian: Pakiranja, ki vsebujejo po 84 (3x28), 90 (3x30), 98 (2x49) ali 280 (20x14) tablet, so skupna pakiranja.
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/kg/day were not statistically significant.
Slovenian: Pri podganah je pri odmerku 1.500 mg/kg/dan prišlo do enega adenoma debelega črevesa in enega adenokarcinoma slepega črevesa, kar pa ni bilo statistično značilno.
English: Hyperkalaemia
Slovenian: hiperkaliemija redki:
English: The pharmacokinetics of aliskiren were evaluated in patients with end stage renal disease receiving haemodialysis.
Slovenian: Farmakokinetiko aliskirena so ocenjevali pri bolnikih, ki so imeli končno ledvično odpoved in so se zdravili s hemodializo.
English: Non-steroidal anti-inflammatory drugs (NSAIDs)
Slovenian: Nesteroidna protivnetna zdravila
English: Digoxin and verapamil bioavailability may be slightly decreased by Sprimeo.
Slovenian: Zdravilo Sprimeo lahko nekoliko zmanjša biološko uporabnost digoksina in verapamila.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicines known to cause angioedema, including RAAS blockers (ACE inhibitors or ARBs).
Slovenian: Med temi bolniki so številni v preteklosti že imeli angioedem ali simptome, ki kažejo na angioedem, do katerih je v nekaterih primerih prišlo zaradi uporabe drugih zdravil, ki lahko povzročajo angioedem, med drugim zaradi zaviralcev sistema renin-angiotenzin-aldosteron (zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev).
English: Packs containing 98 (2x49) or 280 (20x14) tablets are multi-packs.
Slovenian: Pakiranja, ki vsebujejo po 98 (2x49) ali 280 (20x14) tablet, so skupna pakiranja.
English: Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Slovenian: Zato pri bolnikih z blago do hudo okvaro jeter začetnega odmerka aliskirena ni treba prilagajati.
English: Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Slovenian: Pakiranja, ki vsebujejo po 84 (3x28), 98 (2x49) ali 280 (20x14) tablet, so skupna pakiranja.
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9month non-inferiority study in 901 elderly patients (≥ 65 years) with essential systolic hypertension.
Slovenian: V 9-mesečni študiji, s katero so želeli dokazati, da aliskiren ni slabši kot ramipril, so pri 901 starejšem bolniku (≥ 65 let) z esencialno sistolično hipertenzijo primerjali učinkovitost in varnost zdravljenja na osnovi aliskirena in zdravljenja na osnovi ramiprila.
English: The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
Slovenian: Pri večini starejših bolnikov po povečanju odmerka na 300 mg ni opaznega klinično pomembnega dodatnega znižanja krvnega tlaka.
English: Angioedema and hypersensitivity reactions have occurred during treatment with aliskiren.
Slovenian: Med zdravljenjem z aliskirenom je prišlo do angioedema in preobčutljivostnih reakcij.
English: Sprimeo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Slovenian: Zdravilo Sprimeo je na voljo v pakiranjih, ki vsebujejo po 7, 14, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
English: Increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: V okviru izkušenj z aliskirenom po prihodu zdravila na trg so opažali zvišanje koncentracije kalija v serumu, ki jo je morda sprožila sočasna uporaba drugih zdravil, ki delujejo na RAAS, ali nesteroidnih protivnetnih zdravil.
English: No adjustment of the initial dosage of Sprimeo is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic ni treba prilagajati začetnega odmerjanja zdravila Sprimeo (glejte poglavji 4.2 in 4.4).
English: When administered with atorvastatin, steady-state Sprimeo AUC and Cmax increased by 50%.
Slovenian: Zaradi sočasne uporabe z atorvastatinom sta se AUC in Cmax zdravila Sprimeo v stanju dinamičnega ravnovesja zvišala za 50 %.
English: Iron oxide, black (E 172) Iron oxide, red (E 172) Titanium dioxide (E 171)
Slovenian: 6.1 Seznam pomoţnih snovi krospovidon magnezijev stearat mikrokristalna celuloza povidon brezvodni koloidni silicijev dioksid hipromeloza makrogol smukec črni železov oksid (E 172) rdeči železov oksid (E 172) titanov dioksid (E 171)
English: There has been no evidence of first-dose hypotension and no effect on pulse rate in patients treated in controlled clinical studies.
Slovenian: Pri bolnikih v kontroliranih kliničnih študijah ni prišlo do hipotenzije po prvem odmerjanju, prav tako ni bilo vpliva na srčno frekvenco.
English: Serum potassium: Increases in serum potassium have been observed with aliskiren and these may be exacerbated by concomitant use of other agents acting on the RAAS or by NSAIDs.
Slovenian: Kalij v serumu: Pri uporabi aliskirena so opažali zvišanje vrednosti kalija v serumu, ki ga lahko sproži sočasna uporaba drugih zdravil, ki delujejo na RAAS ali uporaba nesteroidnih protivnetnih zdravil.
English: No controlled clinical data are available on the use of Sprimeo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Slovenian: Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi zdravila Sprimeo ni na voljo podatkov iz kontroliranih kliničnih študij.
English: This effect is also seen with other agents acting on the reninangiotensin system, such as ACEI and ARBs.
Slovenian: Ta učinek so opažali tudi pri drugih učinkovinah, ki delujejo na sistem renin-angiotenzin, kot so zaviralci angiotenzinske konvertaze (zaviralci ACE) in zaviralci angiotenzinskih receptorjev.
English: Packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Slovenian: Pakiranja vsebujejo po 7, 14, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
English: The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Slovenian: Pričakovani obseg sprememb v koncentracijah aliskirena v prisotnosti ketokonazola ali verapamila se giblje v okviru, ki bi ga dosegli s podvojenim odmerjanjem aliskirena.
English: Packs containing 14, 28, 30, 50, 56, 90, 98 or 280 tablets.
Slovenian: Pakiranja vsebujejo po 14, 28, 30, 50, 56, 90, 98 ali 280 tablet.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
English: Sprimeo may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m
Slovenian: Zdravilo Sprimeo se lahko jemlje samostojno ali v kombinaciji z drugimi učinkovinami za zniževanje krvnega tlaka, razen v kombinaciji z zaviralci encima angiotenzinske konvertaze (zaviralci ACE) ali zaviralci angiotenzinskih receptorjev II pri bolnikih s sladkorno boleznijo ali okvaro ledvic (s hitrostjo glomerulne filtracije (GFR) < 60 ml/min/1,73 m2) (glejte poglavja 4.3, 4.4 in 5.1).
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets
Slovenian: 7 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet