FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Rasilamlo - if you are allergic to aliskiren or amlodipine, to any of the other ingredients of this medicine (listed in section 6) or to other dihydropyridine-derived medicines (known as calcium channel blockers) - 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: Ne jemljite zdravila Rasilamlo - če ste alergični na aliskiren ali amlodipin, katero koli sestavino tega zdravila (navedeno v poglavju 6) ali na druge dihidropiridinske derivate (ki so znani kot zaviralci kalcijevih kanalčkov); - če ste imeli katero od naslednjih oblik angioedema (težave z dihanjem ali s požiranjem ali otekanje obraza, rok, stopal, oči, ustnic in/ali jezika):
English: Rasilamlo combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the class of direct renin inhibitors and amlodipine belongs to the calcium antagonist class.
Slovenian: Zdravilo Rasilamlo vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za uravnavanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: aliskiren sodi v skupino neposrednih zaviralcev renina, amlodipin pa sodi v skupino zaviralcev kalcijevih kanalčkov.
English: The safety profile of Rasilamlo presented below is based on clinical studies performed with Rasilamlo and the known safety profile of the individual components aliskiren and amlodipine.
Slovenian: Spodaj opisane varnostne lastnosti zdravila Rasilamlo temeljijo na kliničnih študijah, ki so jih opravili z zdravilom Rasilamlo, in na znanih varnostnih lastnostih posameznih učinkovin zdravilaaliskirena in amlodipina.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Slovenian: V kontroliranih kliničnih preskušanjih je bila uporaba aliskirena občasno povezana s klinično pomembnimi spremembami standardnih laboratorijskih parametrov.
English: Calcium channel blockers act to prevent the influx of calcium into the vascular smooth muscle cells in the vessel wall, thereby preventing smooth muscle cell contraction and vasoconstriction.
Slovenian: Zaviralci kalcijevih kanalčkov delujejo tako, da preprečujejo vstop kalcijevih ionov v gladke mišice žilne stene in s tem preprečuje kontrakcijo gladkih mišičnih celic in vazokonstrikcijo.
English: The pharmacokinetics of aliskiren was evaluated in rats aged from 8 to 28 days after intravenous administration of aliskiren 3 mg/kg.
Slovenian: Farmakokinetiko aliskirena so vrednotili pri podganah, ki so bile stare od 8 do 28 dni in so jim aliskiren dajali intravensko v odmerku 3 mg/kg.
English: Not all pack sizes or strengths may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj oziroma jakosti.
English: In a 8-week study in 754 hypertensive elderly (≥65 years) and very elderly patients (30% ≥75 years) 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: PERFORATED UNIT DOSE BLISTER (PCTFE)
Slovenian: PERFORIRAN PRETISNI OMOT Z RAZDELKI ZA ENKRATNI ODMEREK (PCTFE)
English: If symptomatic hypotension should occur with Rasilamlo, supportive treatment should be initiated.
Slovenian: Če pri prevelikem odmerjanju zdravila Rasilamlo pride do simptomatske hipotenzije, je treba uvesti podporno zdravljenje.
English: Therefore, in view of available data regarding aliskiren/ aliskiren,amlodipine / aliskiren, hydrochlorothiazide, the PRAC considered that changes to the product information were warranted.
Slovenian: Tako je glede na dostopne podatke o aliskirenu / aliskirenu, amlodipinu / aliskirenu, hidroklorotiazidu odbor PRAC mnenja, da so spremembe besedila informacij o zdravilu upravičene.
English: The volume or salt depletion should be corrected prior to administration of Rasilamlo, or the treatment should start under close medical supervision.
Slovenian: Hipovolemijo ali pomanjkanje natrija je treba odpraviti pred dajanjem zdravila Rasilamlo ali pa je treba zdravljenje uvajati pod strogim zdravniškim nadzorom.
English: - clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections - amiodarone, a medicine used to treat abnormal heart rhythms - atorvastatin, a medicine used to treat high cholesterol - furosemide or torasemide, medicines belonging to the type known as diuretics, which are used to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling) - antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone) - rifampicin, a medicine used to prevent or treat infections - St. John's wort (hypericum perforatum), a herbal medicine used to elevate mood - certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs) (used especially in patients over 65 years old) - diltiazem, a medicine used to treat heart problems - ritonavir, a medicine used to treat viral infection
Slovenian: - klaritromicin, telitromicin ali eritromicin, ki so antibiotiki za zdravljenje okužb, - amiodaron, zdravilo za uravnavanje srčnega ritma, - atorvastatin, zdravilo za zniževanje visoke ravni holesterola, - furosemid ali torasemid, zdravili, ki sodita v skupino diuretikov, to je zdravil za odvajanje vode, ki povečujejo količino urina, ki nastaja v telesu, in jih uporabljamo tudi za zdravljenje določenih težav s srcem (srčnega popuščanja) ali edemov (otekanja), - antiepileptiki (na primer karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon), - rifampicin, zdravilo za preprečevanje oziroma zdravljenje okužb, - šentjanževka (Hypericum perforatum), zeliščno zdravilo za izboljšanje razpoloženja, - določene vrste zdravil proti bolečinam z imenom nesteroidna protivnetna zdravila (ki jih uporabljamo zlasti pri bolnikih, starih več kot 65 let), - diltiazem, zdravilo za zdravljenje težav s srcem, - ritonavir, zdravilo za zdravljenje virusnih okužb.
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Slovenian: Zato je potrebna previdnost pri sočasni uporabi aliskirena s ketokonazolom, z verapamilom ali z drugimi zmernimi zaviralci P-gp (klaritromicinom, telitromicinom, eritromicinom,
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) z aliskirenom (300 mg) je povzročila zvečanje AUC aliskirena za 76 % oziroma 97 %.
English: - Warfarin The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Slovenian: Učinkov aliskirena na farmakokinetične lastnosti varfarina niso ocenjevali.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET)
English: Plasma aliskiren exposure in rats aged 14 days was between 85- and 387fold higher than that in adult rats aged 64 days.
Slovenian: Pri 14 dni starih podganah pa je bila izpostavljenost aliskirenu v plazmi od 85 do 387-krat večja kot pri 64 dni starih odraslih podganah.
English: , rhinitis
Slovenian: , rinitis
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: Pri zdravih osebah itrakonazol (100 mg) zviša AUC in Cmax aliskirena (150 mg) za 6,5-krat in zviša njegovo Cmax za 5,8krat.
English: No long-term efficacy data for aliskiren in patients with heart failure are currently available.
Slovenian: Zaenkrat ni na voljo dolgoročnih podatkov o uporabi aliskirena pri bolnikih s srčnim popuščanjem.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »Uporabno do« oziroma EXP. Rok uporabnosti zdravila se izteče na
English: In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Slovenian: V kliničnih študijah, v katerih so pri bolnikih s hipertenzijo ali angino pektoris amlodipin uporabili v kombinaciji z zaviralci adrenergičnih receptorjev beta, niso zabeležili neželenih vplivov na elektrokardiografske parametre.
English: Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% vs 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
Slovenian: Med sekundarnimi cilji opazovanja je bila pogostnost srčnega popuščanja (eden od izidov, ki so bili vključeni v sestavljen kardiovaskularni cilj opazovanja) statistično značilno večja v skupini z amlodipinom v primerjavi s skupino s klortalidonom (10,2 % v primerjavi s 7,7 %, z razmerjem tveganj (RR) 1,38; 95-odstotnim IZ 1,25-1,52 in vrednostjo p<0,001).
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose basis) was close to the maximum tolerated dose for mice but not for rats.
Slovenian: Največji odmerek (pri miših je ta v mg/m izražen odmerek podoben največjemu priporočenemu kliničnemu odmerku 10 mg, pri podganah pa predstavlja dvakratnik* tega odmerka) je bil blizu največjega odmerka, ki ga miši še prenašajo, to pa ni veljalo za podgane.
English: There were no new adverse reactions which occurred specifically with Rasilamlo in addition to those known to be associated with the individual monotherapies.
Slovenian: Niso opažali, da bi pri uporabi zdravila Rasilamlo prišlo do specifičnih novih neželenih učinkov poleg tistih, za katere je znano, da jih povzročata posamezni monoterapiji.
English: However, in patients receiving aliskiren there was a significantly higher rate of hyperkalaemia, hypotension and kidney dysfunction when compared to the placebo group.
Slovenian: Vendar je bil med bolniki, ki so prejemali aliskiren, delež hiperkaliemije, hipotenzije in motenega delovanja ledvic značilno večji kot v skupini, ki je
English: As for other medicinal products acting on the renin-angiotensin-aldosterone system, caution should be exercised when Rasilamlo is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (e.g. due to blood loss, severe or prolonged diarrhoea, prolonged vomiting, etc.), heart disease, liver disease, diabetes mellitus or kidney disease.
Slovenian: Kot pri uporabi drugih zdravil, ki delujejo na sistem renin-angiotenzin-aldosteron, je potreba previdnost pri uporabi zdravila Rasilamlo pri bolnikih z drugimi boleznimi, zaradi katerih so bolj nagnjeni k slabšemu delovanju ledvic, kot so hipovolemija (na primer zaradi izgube krvi, hude ali dolgotrajne diareje, dolgotrajnega bruhanja in podobno), bolezni srca, jeter, sladkorna bolezen ali bolezen ledvic.
English: Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially
Slovenian: Pokazalo se je, da obroki (z veliko ali z majhno vsebnostjo maščob) bistveno zmanjšajo absorpcijo aliskirena (glejte poglavje 4.2).
English: These were statistically significant versus placebo and aliskiren for all doses.
Slovenian: Razlike so bile za vse odmerke statistično značilne v primerjavi s placebom in z aliskirenom.
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (Z “BLUE BOX” PODATKI)
English: In a study in 545 randomised patients not adequately responsive to 5 mg amlodipine, the combination of aliskiren 150 mg/amlodipine 5 mg resulted in greater blood pressure reduction than those patients
Slovenian: V študiji s 545 randomiziranimi bolniki, pri katerih ni prišlo do ustreznega odziva na zdravljenje z amlodipinom v odmerku 5 mg, je kombinacija aliskirena/amlodipina 150 mg/5 mg povzročila večje znižanje krvnega tlaka v primerjavi s tistim pri bolnikih, ki so še naprej prejemali amlodipin v
English: , dry mouth
Slovenian: , suha usta pankreatitis
English: Preclinical safety studies have demonstrated that the combination of aliskiren and amlodipine was well tolerated in rats.
Slovenian: V predkliničnih študijah se je pokazalo, da podgane dobro prenašajo kombinacijo aliskirena in amlodipina.
English: Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.
Slovenian: Če zaradi prevelikega odmerjanja amlodipina pride do klinično pomembne hipotenzije, je treba uvesti kardiovaskularne podporne ukrepe, kar vključuje pogosto pregledovanje delovanja srca in dihanja, namestitev bolnika v položaj z dvignjenimi okončinami in pozorno spremljanje volumna tekočine v krvnem obtoku ter količine izločenega urina.
English: A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild
Slovenian: Randomizirano, dvojno slepo študijo obolevnosti in umrljivosti z nazivom Študija antihipertenzivnega zdravljenja in zniževanja vrednosti lipidov za preprečevanje srčnega infarkta (Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial - ALLHAT) so izvajali zato, da bi ocenili novejše načine zdravljenja: amlodipin 2,5-10 mg/dan (zaviralec kalcijevih kanalčkov) ali lizinopril 10-40 mg/dan (zaviralec ACE) kot zdravili prvega izbora v primerjavi s tiazidnim diuretikom klortalidonom 12,5-25 mg/dan pri blagi do zmerni hipertenziji.
English: Limited safety data are available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children aged 6 to less than 18 years (see sections 4.8 and 5.2).
Slovenian: Omejeni podatki o varnosti so na voljo iz farmakokinetične študije, v kateri so z aliskirenom zdravili 39 otrok s hipertenzijo po dopolnjenem 6. letu in pred dopolnjenim 18. letom starosti (glejte
English: The incidence of adverse events did not show any association with gender, age, body mass index, race or ethnicity.
Slovenian: Ni kazalo, da bi bila pogostnost neželenih učinkov kakorkoli povezana s spolom, starostjo, indeksom telesne mase in z rasno oziroma etnično pripadnostjo bolnikov.
English: , syncope
Slovenian: , sinkopa
English: If co-medication with an agent affecting the level of serum potassium is considered necessary, caution is advisable.
Slovenian: Če je sočasna uporaba zdravila, ki vpliva na koncentracijo kalija v serumu neizogibna, je priporočena
English: 56x1 tablet (PVC/PCTFE single-unit-dose blisters)
Slovenian: 56x1 tableta (PVC/PCTFE pretisni omoti z razdelki za enkratni
English: Rasilamlo is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Zdravljenje z zdravilom Rasilamlo ni priporočljivo za doječe matere, še posebno če je vaš otrok še novorojenček ali je bil
English: Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Slovenian: Zdravilo Rasilamlo je indicirano za zdravljenje esencialne hipertenzije pri odraslih bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren ali samo amlodipin.
English: The results from a food effect study using a standard high fat meal with the 300 mg/10 mg fixed combination tablet showed that food reduced the rate and extent of absorption of aliskiren in the fixed combination tablet with a similar magnitude of effect as for aliskiren monotherapy.
Slovenian: Rezultati študije vpliva sočasnega uživanja hrane, v kateri so bolniki zaužili standarden obrok z veliko vsebnostjo maščob sočasno s tableto s pripravljeno kombinacijo v odmerku 300 mg/10 mg, so pokazali, da je uživanje hrane zmanjšalo tako hitrost kot obseg absorpcije aliskirena iz tablete s pripravljeno kombinacijo, in sicer v približno enakem obsegu kot pri monoterapiji z aliskirenom.
English: Aliskiren was secreted in the milk of lactating rats.
Slovenian: Aliskiren se je izločal v mleko
English: Caution should be exercised when administering Rasilamlo to patients with hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Pri uporabi zdravila Rasilamlo pri bolnikih z okvaro jeter je potrebna previdnost (glejte poglavji 4.2 in 5.2).
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide and the beta blocker atenolol.
Slovenian: Izvajali so študije kombiniranega zdravljenja z dodajanjem aliskirena diuretiku hidroklorotiazidu in zaviralcu adrenergičnih receptorjev beta atenololu.
English: An increased incidence of hyperkalaemia (20.9% versus 17.5%), renal impairment/renal failure (16.6% versus 12.1%) and hypotension (17.1% versus 12.6%) was observed in the aliskiren group compared with placebo and was greater in patients with diabetes.
Slovenian: V skupini z aliskirenom so v primerjavi s tistimi s placebom opažali povečano pogostnost hiperkaliemije (20,9 % v primerjavi s 17,5 %), okvare/odpovedi ledvic (16,6 % v primerjavi z 12,1 %) in hipotenzije (17,1 % v primerjavi z 12,6 %), navedeno povečanje pogostnosti pa je bilo večje pri bolnikih s
English: The clearance of aliskiren increased in an age-dependent manner.
Slovenian: Očistek aliskirena se je s starostjo živali povečeval.
English: All three doses were well tolerated in both elderly and very elderly patients.
Slovenian: Tako starejši kot zelo stari bolniki so vse tri
English: Following oral administration of Rasilamlo, the median peak plasma concentration time is within 3 hours for aliskiren and 8 hours for amlodipine.
Slovenian: Po peroralni uporabi zdravila Rasilamlo doseže aliskiren najvišjo koncentracijo v plazmi v 3 urah, amlodipin pa v 8 urah.
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu calendar blisters: Single pack containing 14, 28, 56, 98 tablets Multi-packs containing 280 tablets (20 packs of 14)
Slovenian: PVC/poliklorotrifluoroetilen (PCTFE) - Alu koledarski pretisni omoti: Posamično pakiranje vsebuje 14, 28, 56 ali 98 tablet.
English: No adjustment of the initial dosage of aliskiren 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 aliskirena (glejte poglavji 4.2 in 4.4).
English: - Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Slovenian: Zdravila brez interakcij z zdravilom Rasilamlo - Med učinkovinami, ki so jih raziskovali v kliničnih farmakokinetičnih študijah aliskirena, so acenokumarol, atenolol, celekoksib, pioglitazon, alopurinol, izosorbid-5-mononitrat in hidroklorotiazid.
English: In controlled clinical trials, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Slovenian: V kontroliranih kliničnih preskušanjih je med zdravljenjem z aliskirenom redko prišlo do angioedema in preobčutljivostnih reakcij in sicer s pogostnostjo, ki je bila primerljiva z zdravljenjem
English: Component of a multipack comprising 2 packs, each containing 49x1 tablet.
Slovenian: Del skupnega pakiranja z 2 pakiranjema, od katerih vsako vsebuje 49x1 tableto.
English: Multipack containing 98 (2 packs of 49) tablets.
Slovenian: Skupno pakiranje, ki vsebuje 98 (2 pakiranji po 49) tablet.
English: A bioequivalence study under light meal conditions has not been conducted for Rasilamlo.
Slovenian: Bioekvivalenčne študije z zaužitjem lahkega obroka za zdravilo Rasilamlo niso opravili.
English: The rate and extent of absorption of Rasilamlo are similar in fasting state to those of aliskiren and amlodipine when administered as individual monotherapies.
Slovenian: Pri odmerjanju zdravila Rasilamlo na tešče sta hitrost in obseg absorpcije aliskirena in amlodipina enaki kot pri odmerjanju posameznih monoterapij.
English: In an 8-week randomised, double-blind, placebo-controlled, parallel group factorial study in 1,688 randomised patients with mild to moderate hypertension, treatment with Rasilamlo at doses from 150 mg/5 mg to 300 mg/10 mg produced dose-dependent clinically meaningful mean blood pressure reductions (systolic/diastolic) ranging between 20.6/14.0 mmHg and 23.9/16.5 mmHg, respectively, compared to 15.4/10.2 mmHg for aliskiren 300 mg, 21.0/13.8 mmHg for amlodipine 10 mg and 6.8/5.4 mmHg with placebo in a population of patients with mean baseline blood pressure of 157.3/99.7 mmHg.
Slovenian: V 8-tedenski randomizirani, dvojno slepi, s placebom kontrolirani, vzporedni študiji s faktorsko analizo pri 1.688 randomiziranih bolnikih z blago do zmerno hipertenzijo je zdravilo Rasilamlo v odmerkih od 150 mg/5 mg do 300 mg/10 mg povzročilo od odmerka odvisno klinično pomembno povprečno znižanje sistoličnega/diastoličnega krvnega tlaka v obsegu 20,6/14,0 mmHg oziroma 23,9/16,5 mmHg v primerjavi z znižanjem za 15,4/10,2 mmHg pri uporabi aliskirena 300 mg, za 21,0/13,8 mmHg pri uporabi amlodipina 10 mg in za 6,8/5,4 mmHg pri uporabi placeba v populaciji bolnikov s povprečno izhodiščno vrednostjo krvnega tlaka 157,3/99,7 mmHg.
English: The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment; therefore, caution should be exercised when administering Rasilamlo to patients with
Slovenian: Pri bolnikih s hudo okvaro jeter niso proučevali farmakokinetike amlodipina, zato je pri uporabi zdravila Rasilamlo pri bolnikih z okvaro jeter potrebna previdnost.
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by components of fruit juice in the gastrointestinal tract.
Slovenian: Do navedenega zmanjšanja AUC verjetno pride zato, ker sestavine sadnega soka v gastrointestinalnem traktu zavirajo privzem aliskirena preko polipeptidnega prenašalca za organske anione.
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 ljudi):
English: The plasma exposure was approximately 100-fold higher in rats aged 14 days and 3-fold higher in rats aged 21 days compared to adult rats.
Slovenian: Izpostavljenost aliskirenu v plazmi je bila pri 14 dni starih podganah približno 100-krat večja kot pri odraslih podganah, pri 21 dni starih podganah pa je bila 3-krat večja.
English: Rasilamlo contains two active substances, called aliskiren and amlodipine.
Slovenian: Zdravilo Rasilamlo vsebuje dve zdravilni učinkovini z imeni aliskiren in amlodipin.
English: It is therefore not recommended for women who are breast-feeding to use Rasilamlo.
Slovenian: Iz tega razloga uporaba zdravila Rasilamlo ni priporočena za ženske, ki dojijo.
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (GFR 89-60 ml/min/1.73 m and 59-30 ml/min/1.73 m 2, respectively, see sections 4.4 and 5.2).
Slovenian: Bolnikom z blago do zmerno okvaro ledvic (z GFR 89-60 ml/min/1,73 m oziroma 2) začetnega odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2).