FrancophonIA/ELRC3.0 huggingface dataset:
English: Compared to a diuretic (hydrochlorothiazide, HCTZ), aliskiren 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 aliskiren po 12 tednih zdravljenja v odmerku 300 mg znižal sistolični/diastolični krvni tlak za 17,0/12,3 mmHg, hidroklorotiazid v odmerku 25 mg pa za
English: Therefore the combination of aliskiren with an NSAID requires caution, especially in
Slovenian: Zato je pri uporabi aliskirena z nesteroidnimi protivnetnimi zdravili, posebno pri starejših bolnikih, potrebna previdnost.
English: • skin rash with flaking or peeling
Slovenian: • kožni izpuščaj z grobim ali drobnim luščenjem kože
English: The findings from the 2- and 13-week oral toxicity studies in rats were consistent with those of aliskiren and amlodipine when both active substances are administered alone.
Slovenian: Ugotovitve iz 2-tedenske in 13-tedenske študije peroralnega toksičnega delovanja so se ujemale s tistimi pri uporabi posameznih učinkovin.
English: As a result no dose adjustment for aliskiren or these co-administered
Slovenian: Iz tega razloga pri sočasni uporabi ni treba prilagajati odmerkov aliskirena oziroma navedenih zdravil.
English: micturition disorder
Slovenian: • motnje okušanja
English: - Fruit juice and drinks containing plant extracts Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Slovenian: Zdravila, ki se jih ne priporoča (glejte poglavje 4.2) - Sadni sok in napitki, ki vsebujejo rastlinske izvlečke Uživanje sadnega soka z aliskirenom je zmanjšalo AUC in znižalo Cmax aliskirena.
English: Your doctor may need to change your dose and/or take other precautions if you are taking one of
Slovenian: Če jemljete katero od naslednjih zdravil, vam bo moral zdravnik morda spremeniti odmerjanje ali
English: The effects of Rasilamlo on all cause and cardiovascular mortality and on cardiovascular morbidity and target organ damage are currently unknown.
Slovenian: Zaenkrat ni znano, kako zdravilo Rasilamlo vpliva na umrljivost iz kateregakoli vzroka, na kardiovaskularno umrljivost, na kardiovaskularno obolevnost in morebitno škodljivo delovanje na
English: Arthralgia has been reported in post-marketing experience.
Slovenian: O njih so poročali tudi med izkušnjami v obdobju trženja z aliskirenom.
English: , hypotension c,a,am
Slovenian: , hipotenzija c,a,am vaskulitis
English: Keep your appointments with the doctor even if
Slovenian: Redno obiskujte zdravnika, tudi če se počutite dobro.
English: Unit dose pack (perforated unit dose blister) containing 56x1 tablet Multi-packs of unit dose (perforated unit dose blister) containing 98x1 tablet (2 packs of 49x1)
Slovenian: Skupna pakiranja z razdelki za enkratni odmerek (perforiran pretisni omot z razdelki za enkratni odmerek) vsebuje 98x1 tableto (2 pakiranji po 49x1 tableto).
English: No controlled clinical data are available on the use of Rasilamlo 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 Rasilamlo ni na voljo podatkov iz kontroliranih kliničnih študij.
English: In a study in 820 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/amlodipine 300 mg/10 mg produced systolic/diastolic mean blood pressure reductions of 18.0/13.1 mmHg, which were statistically significantly greater than aliskiren 300 mg monotherapy.
Slovenian: V študiji z 820 randomiziranimi bolniki, pri katerih ni prišlo do ustreznega odziva na zdravljenje z aliskirenom v odmerku 300 mg, je kombinacija aliskirena/amlodipina 300 mg/10 mg povzročila povprečno znižanje sistoličnega/diastoličnega krvnega tlaka za 18,0/13,1 mmHg, kar je bilo statistično značilno več kot pri monoterapiji z aliskirenom v odmerku 300 mg. Tudi kombinacija v odmerku 300 mg/5 mg je statistično značilno bolj znižala krvni tlak kot monoterapija z aliskirenom v odmerku 300 mg.
English: , Quincke oedema photosensitivity
Slovenian: , Quinckejev edem
English: In a subset of 584 patients, the combination of aliskiren/amlodipine produced additional systolic/diastolic mean blood pressure reductions of 7.9/4.8 mmHg and 11.7/7.7 mmHg for the 300/5 mg and 300/10 mg strengths respectively compared to aliskiren 300 mg (the subset constitutes patients without aberrant readings, defined as difference in systolic blood pressure (SBP) ≥10 mmHg at baseline or endpoint).
Slovenian: Pri podskupini 584 bolnikov je kombinacija aliskirena/amlodipina jakosti 300/5 mg in 300/10 mg povzročila dodatno povprečno znižanje sistoličnega/diastoličnega krvnega tlaka za 7,9/4,8 mmHg oziroma za 11,7/7,7 mmHg v primerjavi z aliskirenom 300 mg (podskupina je obsegala bolnike brez nepravilno odčitane meritve krvnega tlaka, kar je bilo opredeljeno s spremembo sistoličnega krvnega tlaka ≥10 mmHg tako ob izhodišču kot pri meritvah za vrednotenje
English: The most frequently reported adverse reaction for Rasilamlo in clinical trials was peripheral oedema, which occurred at a frequency lower than or equal to that of the corresponding amlodipine doses, but higher than with aliskiren; ** Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked
Slovenian: Neželeni učinek zdravila Rasilamlo, o katerem so v kliničnih študijah najbolj pogosto poročali, so periferni edemi, do katerih je prihajalo z enako ali manjšo pogostnostjo kot pri uporabi ustreznih odmerkov amlodipina, a bolj pogosto, kot pri uporabi
English: - if you are taking either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan - if you have diabetes (high blood sugar)
Slovenian: antagonisti angiotenzinskih receptorjev II, na primer valsartan, telmisartan ali irbesartan; - če imate sladkorno bolezen (visoko raven sladkorja v krvi);
English: Additional information on individual components Adverse reactions previously reported with one of the individual components may occur with Rasilamlo even if not observed in clinical trials.
Slovenian: Pri uporabi zdravila Rasilamlo lahko pride do neželenih učinkov, o katerih so poročali pri ločeni uporabi posameznih učinkovin zdravila, čeprav teh neželenih učinkov niso opažali v kliničnih
English: , thrombocytopenia
Slovenian: , ginekomastija
English: 98 tablets (2x49x1, PVC/PCTFE single-unit-dose blisters) 280 tablets (20x14, PVC/PCTFE blisters)
Slovenian: 280 tablet (20x14, PVC/PCTFE pretisni omoti) 280 tablet (20x14, PA/Alu/PVC pretisni omoti)
English: , nocturia
Slovenian: , nikturija
English: In hypertensive patients not controlled by the component monotherapies, once-daily administration of Rasilamlo provided dose-dependent clinically meaningful reductions in both systolic and diastolic
Slovenian: Pri hipertenzivnih bolnikih, katerih krvni tlak ni bil ustrezno urejen z monoterapijo s posameznima učinkovinama, je enkrat dnevno odmerjanje zdravila Rasilamlo povzročilo od odmerka odvisno klinično pomembno znižanje tako sistoličnega kot diastoličnega krvnega tlaka.
English: Single pack containing 14, 28, 56 tablets Multi-packs containing 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14)
Slovenian: Skupna pakiranja vsebujejo 98 tablet (2 pakiranji po 49 tablet) ali 280 tablet (20 pakiranj po
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome, have been reported with amlodipine.
Slovenian: Pri prevelikem odmerjanju amlodipina so poročali o izraziti in verjetno dolgotrajni sistemski hipotenziji, ki se je stopnjevala do šoka tudi do šoka s smrtnim izidom.
English: Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilatation resulting in a reduction of supine and standing blood pressures.
Slovenian: Po uporabi terapevtskih odmerkov amlodipina pri bolnikih s hipertenzijo to zdravilo povzroči vazodilatacijo.
English: Rasilamlo is not recommended in patients with severe renal impairment (GFR <30 ml/min/1.73 m
Slovenian: Pri bolnikih s hudo okvaro ledvic (GFR <30 ml/min/1,73 m 2) uporaba zdravila Rasilamlo ni priporočena.
English: - if you have impaired kidney function, your doctor will carefully consider whether Rasilamlo is suitable for you and may wish to monitor you carefully - if you suffer from liver problems (impaired liver function)
Slovenian: - če imate okvarjeno delovanje ledvic bo vaš zdravnik pozorno premislil, ali je zdravilo
English: - In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin,
Slovenian: Brez interakcij - V kliničnih študijah medsebojnega delovanja amlodipin ni vplival na farmakokinetiko atorvastatina, digoksina, varfarina in ciklosporina.
English: In a subset of 1,069 patients, Rasilamlo produced mean blood pressure reductions (systolic/diastolic) ranging between 20.6/13.6 mmHg and 24.2/17.3 mmHg (the subset of patients without aberrant readings, defined as difference in SBP ≥10 mmHg at baseline or endpoint).
Slovenian: Pri podskupini 1,069 bolnikov je zdravilo Rasilamlo povzročilo povprečno znižanje sistoličnega/diastoličnega krvnega tlaka od 20,6/13,6 mmHg do 24,2/17,3 mmHg (podskupina je obsegala bolnike brez nepravilno odčitane meritve krvnega tlaka, kar je bilo opredeljeno z vrednostjo sistoličnega krvnega tlaka ≥10 mmHg tako ob izhodišču kot pri meritvah za vrednotenje krvnega tlaka v študiji).
English: In a subset of 549 patients, the combination of aliskiren/amlodipine produced additional systolic/diastolic mean blood pressure reductions of 4.0/2.2 mmHg and 7.6/4.7 mmHg for the 150/10 mg and 300/10 mg strengths respectively compared to amlodipine 10 mg (the subset constitutes patients without aberrant readings, defined as difference in SBP ≥10 mmHg at baseline or endpoint).
Slovenian: Pri podskupini 549 bolnikov je kombinacija aliskirena/amlodipina jakosti 300/5 mg in 300/10 mg povzročila dodatno povprečno znižanje sistoličnega/diastoličnega krvnega tlaka za 4,0/2,2 mmHg oziroma za 7,6/4,7 mmHg v primerjavi z amlodipinom 10 mg (podskupina je obsegala bolnike brez nepravilno odčitane meritve krvnega tlaka, kar je bilo opredeljeno s spremembo sistoličnega krvnega tlaka ≥10 mmHg tako ob izhodišču kot pri meritvah za vrednotenje krvnega tlaka v študiji).
English: Reproductive system and breast disorders
Slovenian: Toksičen vpliv na sposobnost razmnoževanja
English: - Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Slovenian: - Zaviralci polipeptidnega prenašalca organskih anionov Rezultati predkliničnih raziskav kažejo, da bi bil aliskiren lahko substrat polipeptidnega prenašalca organskih anionov, zato obstaja pri sočasni uporabi možnost medsebojnega delovanja med zaviralci polipeptidnega prenašalca organskih anionov in aliskirenom (glejte medsebojno delovanje s sadnim
English: The concomitant use of Rasilamlo with an ACEI or an ARB is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Slovenian: Zdravilo Rasilamlo je mogoče jemati v kombinaciji z drugimi antihipertenzivnimi zdravili, razen v kombinaciji z zaviralci encima angiotenzinske konvertaze (zaviralci ACE) ali antagonisti 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: • inflammation of the liver
Slovenian: • vnetje krvnih žil
English: If pregnancy is detected during therapy, Rasilamlo should be discontinued accordingly as soon as
Slovenian: Če ženska med zdravljenjem z zdravilom Rasilamlo ugotovi, da je noseča, mora zdravljenje v skladu
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).
Slovenian: Druge sestavine zdravila so: mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, titanov dioksid (E171), makrogol, smukec, rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: Hyperkalaemia a
Slovenian: , hiperplazija dlesni hepatitis a,am
English: Rare
Slovenian: Splošno
English: 280 tablets (20x14, PA/Alu/PVC blisters)
Slovenian: 28 tablet (PA/Alu/PVC pretisni omoti)
English: Description of selected adverse reactions: Hypersensitivity reactions including anaphylactic reactions and angioedema have occurred during
Slovenian: , trombocitopenija anafilaktične reakcije a, preobčutljivostne reakcije a alergijske reakcije hiperglikemija nespečnost
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja a,am
English: Dizziness a,am
Slovenian: izpuščaj a,am
English: Talk to your doctor before taking Rasilamlo: - if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to increase the amount of urine you produce) - if you have already experienced angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Slovenian: - če bruhate ali imate drisko ali če jemljete diuretike (zdravila za odvajanje vode, ki povečujejo - če ste že kdaj imeli angioedem (težave z dihanjem ali s požiranjem ali otekanjem obraza, rok,
English: Hepatic impairment
Slovenian: , mišični krči
English: Amlodipine, one of the active substances in Rasilamlo, may make you feel dizzy and drowsy.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Amlodipin, ki je ena od zdravilnih učinkovin v zdravilu Rasilamlo, lahko povzroča omotičnost in zaspanost.
English: Consistent with the monotherapy formulation, food had no effect on the pharmacokinetics of amlodipine in the
Slovenian: Uživanje hrane sočasno s tableto z že pripravljeno kombinacijo pa ni vplivalo na farmakokinetiko amlodipina, kar se ujema z odmerjanjem amlodipina v samostojni formulaciji.
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 medicinal products known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
Slovenian: Med temi bolniki jih je veliko imelo v anamnezi angioedem oziroma simptome, ki nakazujejo angioedem, do česar je v nekaterih primerih prišlo po uporabi drugih zdravil, ki lahko povzročajo angioedem, med drugim tudi po uporabi zaviralcev sistema renin-angiotenzin-aldosteron (zaviralcev angiotenzinske konvertaze ali antagonistev angiotenzinskih receptorjev).
English: Smaller changes in furosemide pharmacokinetics and efficacy were
Slovenian: Pri uporabi aliskirena v odmerku 150 mg/dan so opažali manjše spremembe farmakokinetike in učinkovitosti furosemida.
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, macrogol, talc and yellow iron oxide (E172).
Slovenian: Druge sestavine zdravila so: mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, makrogol, smukec in rumeni železov oksid (E172).
English: Light yellow, convex, ovaloid tablet with a bevelled edge, with “T2” debossed on one side and
Slovenian: Svetlo rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T2” vtisnjeno na eni strani
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
Slovenian: Druge sestavine zdravila so: mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, titanov dioksid (E171), makrogol, smukec in rumeni železov oksid (E172).
English: Rasilamlo 150 mg/10 mg film-coated tablets are yellow, convex, oval film-coated tablets, with “T7” debossed on one side and “NVR” on the other.
Slovenian: Rasilamlo 150 mg/10 mg filmsko obložene tablete so rumene konveksne ovalne filmsko obložene tablete z oznako “T7” vtisnjeno na eni strani in oznako “NVR” na drugi.
English: , exanthema
Slovenian: , astenija
English: Rasilamlo 300 mg/10 mg film-coated tablets
Slovenian: Rasilamlo 300 mg/10 mg filmsko obložene tablete
English: • severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
Slovenian: • 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
English: The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is
Slovenian: Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6) Kontraindicirana je sočasna uporaba aliskirena s ciklosporinom oziroma z itrakonazolom, ki sta zelo močna zaviralca P-glikoproteina (P-gp), in z drugimi močnimi zaviralci P-gp (na primer s
English: Dark yellow, convex, ovaloid tablet with a bevelled edge, with “T11” debossed on one side and
Slovenian: Temno rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T11” vtisnjeno na eni strani
English: Rasilamlo 300 mg/5 mg film-coated tablets are dark yellow, convex, oval film-coated tablets, with “T11” debossed on one side and “NVR” on the other.
Slovenian: Rasilamlo 300 mg/5 mg filmsko obložene tablete so temno rumene konveksne ovalne filmsko obložene tablete z oznako “T11” vtisnjeno na eni strani in oznako “NVR” na drugi.
English: , cough a,am
Slovenian: , srbenje a,am
English: Rasilamlo 150 mg/10 mg film-coated tablets
Slovenian: Rasilamlo 150 mg/10 mg filmsko obložene tablete
English: Rasilamlo 300 mg/10 mg film-coated tablets are brown-yellow, convex, oval film-coated tablets, with “T12” debossed on one side and “NVR” on the other.
Slovenian: Rasilamlo 300 mg/10 mg filmsko obložene tablete so rjavo rumene konveksne ovalne filmsko obložene tablete z oznako “T12” vtisnjeno na eni strani in oznako “NVR” na drugi.
English: Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than
Slovenian: Pri odmerjanju enkrat dnevno nastopi stanje dinamičnega ravnovesja koncentracij v plazmi v 5 do 7 dneh.
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or amlodipine 10 mg alone or Rasilamlo 150 mg/10 mg or
Slovenian: Zdravilo Rasilamlo 300 mg/10 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen samo z uporabo aliskirena v odmerku 300 mg oziroma amlodipina v odmerku 10 mg ali z zdravilom Rasilamlo 150 mg/10 mg ali z zdravilom Rasilamlo 300 mg/5 mg.
English: - Each Rasilamlo 150 mg/5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Slovenian: - Vsaka filmsko obložena tableta zdravila Rasilamlo 150 mg/5 mg vsebuje 150 mg aliskirena (v obliki hemifumarata) in 5 mg amlodipina (v obliki besilata).
English: • vomiting
Slovenian: • nespečnost
English: As for other RAAS blockers, headache is a common adverse event in children treated with aliskiren.
Slovenian: Tako kot pri uporabi drugih učinkovin, ki zavirajo sistem renin-angiotenzinaldosteron, je pri zdravljenju otrok z aliskirenom glavobol pogost neželeni dogodek.
English: Rasilamlo 150 mg/5 mg film-coated tablets
Slovenian: Rasilamlo 150 mg/5 mg filmsko obložene tablete
English: Magnesium stearate
Slovenian: - Furosemid in torasemid
English: Vasculitis
Slovenian: Aliskiren
English: Visual disturbance (including diplopia)
Slovenian: , periferna nevropatija občasni motnje vida (vključno z dvojnim vidom)
English: Symptoms
Slovenian: Zdravljenje
English: - Each Rasilamlo 300 mg/10 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Slovenian: - Vsaka filmsko obložena tableta zdravila Rasilamlo 300 mg/10 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 10 mg amlodipina (v obliki besilata).
English: Chest pain
Slovenian: • vnetje jeter
English: Rasilamlo 300 mg/5 mg film-coated tablets
Slovenian: Rasilamlo 300 mg/5 mg filmsko obložene tablete
English: , nausea a,am
Slovenian: , navzea a,am bruhanje a,am
English: Brown-yellow, convex, ovaloid tablet with a bevelled edge, with “T12” debossed on one side and
Slovenian: Rjavo rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T12” vtisnjeno na eni strani
English: Aliskiren should be used with caution in patients with heart failure treated with furosemide or
Slovenian: Previdnost je potrebna pri uporabi aliskirena pri bolnikih, ki imajo srčno popuščanje in se zdravijo s furosemidom ali torasemidom (glejte poglavje 4.5).
English: , pruritus a,am
Slovenian: , urtikarija a,am
English: - Each Rasilamlo 300 mg/5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Slovenian: - Vsaka filmsko obložena tableta zdravila Rasilamlo 300 mg/5 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 5 mg amlodipina (v obliki besilata).
English: - Each Rasilamlo 150 mg/10 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Slovenian: - Vsaka filmsko obložena tableta zdravila Rasilamlo 150 mg/10 mg vsebuje 150 mg aliskirena (v obliki hemifumarata) in 10 mg amlodipina (v obliki besilata).
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg alone or with Rasilamlo 150 mg/5 mg.
Slovenian: Zdravilo Rasilamlo 300 mg/5 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen samo z uporabo aliskirena v odmerku 300 mg ali z zdravilom Rasilamlo 150 mg/5 mg.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the
Slovenian: Zato lahko induktorji P-gp (šentjanževka, rifampicin) zmanjšajo biološko uporabnost aliskirena.
English: If renal failure occurs, treatment
Slovenian: V primeru ledvične odpovedi je treba z zdravljenjem prekiniti.
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 150 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone or with Rasilamlo 150 mg/5 mg.
Slovenian: Zdravilo Rasilamlo 150 mg/10 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen samo z uporabo amlodipina v odmerku 10 mg ali z zdravilom Rasilamlo 150 mg/5 mg.
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 150 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or amlodipine 5 mg alone.
Slovenian: Zdravilo Rasilamlo 150 mg/5 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen z uporabo samo aliskirena 150 mg ali samo amlodipina v odmerku 5 mg.
English: Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in postmarketing experience.
Slovenian: Med izkušnjami v obdobju trženja zdravila so pri bolnikih s povečanim tveganjem, ki so jemali aliskiren, opisovali akutno ledvično odpoved, ki je bila reverzibilna po prekinitvi zdravljenja.
English: Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate) and 5 mg amlodipine (as
Slovenian: Ena tableta vsebuje 300 mg aliskirena (v obliki aliskirenijevega hemifumarata) in 5 mg amlodipina