FrancophonIA/ELRC3.0 huggingface dataset:
English: Dual blockade of the RAAS with aliskiren, ARBs or ACEIs Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Slovenian: Podatki kliničnih preskušanj so pokazali, da je dvojno zaviranje sistema renin-angiotenzin-aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, antagonistov receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, možganske kapi, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in 5.1).
English: Multipacks containing 280 (20x14) tablets.
Slovenian: Skupna pakiranja vsebujejo 280 (20x14) tablet.
English: Multipacks containing 98 (2x49x1) tablets in perforated unit dose blisters.
Slovenian: - Skupna pakiranja vsebujejo 98 (2x49x1) tablet v perforiranih pretisnih omotih za enkratni odmerek.
English: There is a potential for aliskiren overexposure in children with an immature MDR1 (P-gp) system (see section “Transporters” above and sections 4.2, 4.4 and 5.3).
Slovenian: MDR1 (P-gp) lahko pride do prevelike izpostavljenosti aliskirenu (glejte poglavje »Prenašalci« zgoraj in poglavja 4.2, 4.4 in 5.3).
English: In a multicentre, randomised, double-blind, 8-week study with aliskiren monotherapy (3 dose groups by weight category [≥20 kg to <50 kg; ≥50 kg to <80 kg; ≥80 kg to ≤150 kg]: low 6.25/12.5/25 mg [0.13-0.31 mg/kg]; mid 37.5/75/150 mg [0.75-1.88 mg/kg]; and high dose 150/300/600 mg [3.0-7.5 mg/kg], with a wide dose ratio between the low, mid and high dose groups [1:6:24]) in 267 paediatric hypertensive patients aged 6 to 17 years, mostly overweight/obese, aliskiren lowered office and ambulatory blood pressure in a dose-dependent manner during the initial 4 week dose-finding phase of the study (Phase 1).
Slovenian: ≤150 kg]: nizki odmerki 6,25/12,5/25 mg [0,13-0,31 mg/kg]; srednje visoki odmerki 37,5/75/150 mg [0,75-1,88 mg/kg] in visoki odmerki 150/300/600 mg [3,0-7,5 mg/kg] z velikim razmerjem med višino odmerkov v skupinah z nizkimi, srednje visokimi oziroma visokimi odmerki [1:6:24]) pri
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN) and oral mucosal reactions, rash, pruritus, urticaria
Slovenian: (SCAR)), vključno s Stevens-Johnsovim sindromom, s toksično epidermalno nekrolizo (toxic epidermal necrolysis-TEN), z reakcijami ustne sluznice, izpuščajem, srbenjem, urtikarijo redki:
English: The starting doses for enalapril were 2.5/5/10 mg in the low, mid and high weight groups, respectively.
Slovenian: Začetni odmerki enalaprila so bili v skupinah z nizko, srednjo in visoko telesno maso 2,5 mg, 5 mg oziroma
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 doses 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 odmerku.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV) (see section 5.1).
Slovenian: (funkcijskih razredov III-IV po klasifikaciji Newyorškega združenja za srce (New York Heart Association [NYHA])) (glejte poglavje 5.1).
English: - furosemide or torasemide, medicines belonging to the type known as diuretics, or “water”
Slovenian: in dodatki kalija; - furosemid ali torasemid, to sta zdravili, ki sodita v skupino zdravil imenovano diuretiki ali tablete za odvajanje vode, zaradi katerih se poveča količina urina, ki nastaja v telesu;
English: Method of administration Swallow the tablet whole with some water.
Slovenian: Tableto pogoltnite celo z malo vode.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 280 (20 packs of 14) film-coated tablets Multipack: 98 (2 packs of 49 x 1) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje: 280 (20 škatel po 14) filmsko obloženih tablet Skupno pakiranje: 98 (2 škatli po 49 x 1) filmsko obloženih tablet
English: 84 film-coated tablets (3x28)
Slovenian: 84 filmsko obloženih tablet (3x28)
English: Rasilez has minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Rasilez ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Aliskiren was not teratogenic in rats or rabbits (see section 5.3).
Slovenian: Aliskiren ni bil teratogen pri podganah ali kuncih
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 (ACEIs 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 (ACE ali antagonistov angiotenzinskih receptorjev II).
English: Hyperkalaemia
Slovenian: hiperkaliemija občasni:
English: In particular there was an increased incidence of renal dysfunction (14.5% versus 12.4%), hyperkalaemia (39.1% versus 29.0%), hypotension-related events (19.9% versus 16.3%) and adjudicated stroke endpoints (3.4% versus 2.7%).
Slovenian: 12,4 %), hiperkaliemiji (39,1 % v primerjavi z 29,0 %), dogodkih v povezavi s hipotenzijo (19,9 % v primerjavi s 16,3 %) in pri izidih domnevne možganske kapi (3,4 % v primerjavi z 2,7 %).
English: Co-administration of orange or apple juice with aliskiren 150 mg resulted in a 62% decrease in aliskiren AUC or in a 63% decrease in aliskiren AUC, respectively.
Slovenian: Sočasna uporaba pomarančnega soka z aliskirenom v odmerku 150 mg je zmanjšala AUC aliskirena za 62 %, sočasna uporaba jabolčnega soka pa za 63 %.
English: In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.
Slovenian: (100 mg) poveča AUC aliskirena (150 mg) za 6,5-krat in zviša njegovo Cmax za 5,8-krat.
English: When administered with atorvastatin, steady-state Rasilez AUC and Cmax increased by 50%.
Slovenian: Pri sočasni uporabi z atorvastatinom sta se AUC in Cmax zdravila Rasilez v stanju dinamičnega ravnovesja zvišala za 50 %.
English: No overall clinically relevant adverse impact on paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on physical development, assessed in patients with primary or secondary hypertension, and neurocognitive development assessed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril) (see section 4.2, 4.8, 5.1 and 5.2).
Slovenian: ocenjen pri bolnikih s primarno in sekundarno hipertenzijo, in nevrokognitivni razvoj, ki so ga ocenili le pri bolnikih s sekundarno hipertenzijo (19 bolnikov: 9 predhodno zdravljenih z aliskirenom in 10 predhodno zdravljenih z enalaprilom (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
English: 98 film-coated tablets (2x49)
Slovenian: 98 filmsko obloženih tablet (2x49)
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Slovenian: Pri odmerjanju enkratnega peroralnega odmerka 300 mg aliskirena so bile razlike v farmakokinetiki aliskirena zelo majhne (razlika vrednosti Cmax je bila manj kot 1,2-kratna,
English: Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Slovenian: Skupno pakiranje: 84 (3 škatle po 28) filmsko obloženih tablet Skupno pakiranje: 90 (3 škatle po 30) filmsko obloženih tablet Skupno pakiranje: 98 (2 škatli po 49) filmsko obloženih tablet Skupno pakiranje: 280 (20 škatel po 14) filmsko obloženih tablet
English: Compared to a diuretic (hydrochlorothiazide - HCTZ), Rasilez 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 Rasilez po 12 tednih zdravljenja v odmerku 300 mg znižalo sistolični/diastolični krvni tlak za 17,0/12,3 mmHg,
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Slovenian: CYP3A4, ki zavirajo tudi P-gp (glejte druge navedbe v povezavi s P-gp v poglavju 4.5).
English: What Rasilez contains - The active substance is aliskiren (as hemifumarate).
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Rasilez - Učinkovina je aliskiren (v obliki hemifumarata).
English: The incidence of adjudicated stroke was not significantly different between the aliskiren and enalapril groups (4.4% versus 4.0%; HR 1.12, 95% CI 0.848, 1.485) or between the combination and enalapril groups (3.7% versus 4.0%; HR 0.93, 95% CI 0.697, 1.251).
Slovenian: Pogostnosti domnevne možganske kapi se niso statistično značilno razlikovale niti med skupino z aliskirenom in skupino z enalaprilom (4,4 % v primerjavi s 4,0 %; razmerje ogroženosti (HR) 1,12, 95-odstotni IZ 0,848, 1,485) niti med skupino s kombinacijo in skupino z enalaprilom (3,7 % v primerjavi s 4,0%; razmerje ogroženosti (HR) 0,93,
English: No adjustment of the initial dosage of treatment 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 (glejte poglavji 4.2 in 4.4).
English: Digoxin and verapamil bioavailability may be slightly decreased by Rasilez.
Slovenian: Zdravilo Rasilez lahko nekoliko zmanjša biološko uporabnost digoksina in verapamila.
English: Not recommended
Slovenian: Zdravila, ki se jih ne priporoča
English: In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Slovenian: starih 65 let ali več, odmerek 300 mg aliskirena ni pokazal dodatnih koristi pri zmanjševanju krvnega tlaka v primerjavi z odmerkom 150 mg.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 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 56 x 1 filmsko obložena tableta 90 filmsko obloženih tablet 98 filmsko obloženih tablet
English: Haemoglobin decreased, haematocrit decreased, blood creatinine increased
Slovenian: znižana vrednost hemoglobina, znižana vrednost hematokrita, zvišana vrednost kreatinina v krvi pogostnost neznana hiponatriemija
English: In a pharmacokinetic study of aliskiren treatment in 39 paediatric hypertensive patients aged 6 to 17 years given daily doses of 2 mg/kg or 6 mg/kg aliskiren administered as granules (3.125 mg/tablet), pharmacokinetic parameters were similar to those in adults.
Slovenian: Pediatrična populacija V farmakokinetični študiji z aliskirenom pri zdravljenju 39 pediatričnih bolnikov, ki so imeli hipertenzijo in so bili stari od 6 do 17 let, prejemali pa so dnevne odmerke aliskirena 2 mg/kg oziroma
English: Pharmacokinetic interaction with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Slovenian: atenolol, celekoksib, pioglitazon, alopurinol, izosorbid-5-mononitrat in hidroklorotiazid.
English: Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon:
Slovenian: bolezni jeter*, ikterus, hepatitis, odpoved jeter**
English: Titanium dioxide (E 171)
Slovenian: titanov dioksid (E 171) 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
English: - The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Slovenian: - P-glikoproteina (P-gp), in drugih močnih zaviralcev P-gp (na primer kinidina) je kontraindicirana (glejte poglavje 4.5).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje: 84 (3 škatle po 28) filmsko obloženih tablet Skupno pakiranje: 98 (2 škatli po 49) filmsko obloženih tablet Skupno pakiranje: 280 (20 škatel po 14) filmsko obloženih tablet
English: However, the significance of the non-inferiority testing was not maintained when the analysis was performed on the per-protocol set in which the least square mean change in msSBP from baseline was -7.84 mmHg with aliskiren and -9.04 mmHg with enalapril.
Slovenian: (angl. per-protocol set) z metodo najmanjših kvadratov, po kateri je bila povprečna sprememba srednjih vrednosti sistoličnega krvnega tlaka v sedečem položaju od izhodišča -7,84 mmHg pri uporabi aliskirena in -9,04 mmHg pri uporabi enalaprila.
English: What Rasilez looks like and contents of the pack Rasilez 150 mg film-coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Slovenian: Rasilez 150 mg filmsko obložene tablete so bikonveksne okrogle tablete svetlo roza barve, z oznako ‘IL' na eni strani in ‘NVR' na drugi.
English: Dizziness Ear and labyrinth disorders Not known:
Slovenian: omotičnost Ušesne bolezni, vključno z motnjami labirinta pogostnost neznana:
English: It induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Slovenian: Če so aliskiren dodali hidroklorotiazidu, je povzročil aditiven učinek zniževanja krvnega tlaka.
English: No controlled clinical data are available on the use of aliskiren in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Slovenian: Stenoza ledvične arterije Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi aliskirena ni na voljo podatkov iz kontroliranih kliničnih študij.
English: 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: 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, dodatkov kalija,
English: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Slovenian: ali antagonisti angiotenzinskih receptorjev II, na primer valsartan, telmisartan ali irbesartan;
English: - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): angioedema when taking aliskiren.
Slovenian: Če mislite, da bi lahko bili alergični, se posvetujte z zdravnikom; - če ste imeli katero od naslednjih oblik angioedema (težave z dihanjem ali s požiranjem ali otekanje obraza, rok, stopal, oči, ustnic in/ali jezika): angioedem v času jemanja aliskirena;
English: This medicine contains an active substance called aliskiren.
Slovenian: Kaj je zdravilo Rasilez in za kaj ga uporabljamo To zdravilo vsebuje učinkovino z imenom aliskiren.
English: Rasilez 150 mg film-coated tablets Rasilez 300 mg film-coated tablets
Slovenian: Rasilez 150 mg filmsko obložene tablete Rasilez 300 mg filmsko obložene tablete
English: No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
Slovenian: Bolnikom z blago do hudo okvaro jeter začetnega odmerka ni treba prilagajati (glejte poglavje 5.2).
English: In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, extremities, eyes, lips and/or tongue, dizziness) patients should discontinue treatment and contact the physician (see section 4.4).
Slovenian: V primeru znakov, ki bi nakazovali preobčutljivostno reakcijo/angioedem (še posebno, če gre za težave z dihanjem ali pri požiranju, izpuščaj, srbenje, koprivnico ali otekanje obraza, okončin, oči,
English: Aliskiren is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Slovenian: Pri bolnikih s hudo okvaro ledvic (GFR < 30 ml/min/1,73 m2) uporaba aliskirena ni priporočena.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicinal product that can cause angioedema, including
Slovenian: Med temi bolniki so številni v preteklosti že imeli angioedem ali simptome, ki kažejo na angioedem,
English: In a juvenile toxicity study in 8-day-old rats, aliskiren administration at 100 mg/kg/day and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended human dose) was associated with high mortality and severe morbidity.
Slovenian: 300 mg/kg/dan (2,3-kratnik in 6,8-kratnik največjega priporočenega odmerka pri ljudeh) povzročil zvišanje umrljivosti in pojavljanje hudih bolezni.
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9-month 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: An additional 52 to 104 week non-interventional observational extension study in 106 patients (no study treatment administered) was conducted with the objective to evaluate the long-term safety in terms of growth and development of children 6-17 years of age with hypertension (primary or secondary) at baseline in the core study, previously treated with aliskiren.
Slovenian: (ki niso prejemali študijskega zdravila) je bil izvedena s ciljem oceniti dolgoročno varnost v smislu rasti in razvoja otrok, starih od 6 do 17 let, s hipertenzijo (primarno ali sekundarno) ob izhodišču v osnovni študiji, ki so bili predhodno zdravljeni z aliskirenom.
English: Unit packs containing 7, 14, 28, 30, 50 or 56 tablets.
Slovenian: Posamična pakiranja vsebujejo po 7, 14, 28, 30, 50 ali 56 tablet.
English: Hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Slovenian: hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora občasni:
English: In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.
Slovenian: V observacijski študiji po pridobitvi dovoljenja za promet z zdravilom je bilo sočasno odmerjanje aliskirena z zaviralci angiotenzinske konvertaze (zaviralci ACE) ali antagonisti receptorjev angiotenzina II povezano s povečanim tveganjem za angioedem.
English: Angioedema, erythema Musculoskeletal and connective tissue disorders Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
English: Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets.
Slovenian: Skupna pakiranja vsebujejo po 84 (3x28), 90 (3x30), 98 (2x49) ali 280 (20x14) tablet.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Slovenian: zaviralcu kalcijevih kanalčkov amlodipinu in zaviralcu andrenergičnih receptorjev beta atenololu.
English: Anaphylactic reactions have been observed during treatment with aliskiren from post-marketing experience (see section 4.8).
Slovenian: Anafilaktične reakcije in angioedem V obdobju trženja zdravila so opažali anafilaktične reakcije v času zdravljenja z aliskirenom (glejte poglavje 4.8).
English: Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets.
Slovenian: Skupna pakiranja vsebujejo po 84 (3x28), 98 (2x49) ali 280 (20x14) tablet.
English: Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Slovenian: Posamična pakiranja vsebujejo po 14, 28, 30, 50, 56, 90 ali 98 tablet.
English: Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see section “Fruit juice and drinks containing plant extracts” above).
Slovenian: Rezultati predkliničnih študij kažejo, da bi bil aliskiren lahko substrat polipeptidnega prenašalca organskih anionov, zato obstaja pri sočasni uporabi možnost medsebojnega delovanja med zaviralci polipetidnega prenašalca organskih anionov in aliskirenom (glejte zgornje poglavje »Sadni sok in napitki, ki vsebujejo rastlinske izvlečke«).
English: Vascular disorders Uncommon:
Slovenian: driska pogostnost neznana:
English: Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets.
Slovenian: Posamična pakiranja vsebujejo po 7, 14, 28, 30, 50, 56 ali 90 tablet.
English: Rasilez 300 mg film-coated tablets
Slovenian: Rasilez 300 mg filmsko obložene tablete
English: Aliskiren
Slovenian: Varfarin
English: (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
Slovenian: 95-odstotni IZ 0,697, 1,251).
English: aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Slovenian: V 8-tedenski študiji je pri 754 hipertenzivnih starejših (≥ 65 let) in zelo starih (30% ≥ 75 let) bolnikih aliskiren v odmerkih 75 mg, 150 mg in 300 mg znižal krvni tlak (sistolični in diastolični) statistično značilno bolj kot placebo.
English: Following intravenous administration, the mean plasma clearance is approximately
Slovenian: Po intravenski aplikaciji je povprečni plazemski očistek približno 9 l/h.
English: Rasilez 300 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Slovenian: Rasilez 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA, KI VSEBUJE PA/ALU/PVC PRETISNE