FrancophonIA/ELRC3.0 huggingface dataset:
English: Amlodipine causes blood vessels to dilate and relax, thus blood pressure
Slovenian: Amlodipin omogoči, da se krvne žile razširijo in sprostijo in tako se
English: As with other medicinal products acting on the renin-angiotensinaldosterone 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-aldosteron, 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: A patient who experiences dose limiting adverse reactions on either component alone may be switched to Rasilamlo containing a lower dose of that component to achieve similar blood pressure
Slovenian: Bolniki, pri katerih pri uporabi posameznih učinkovin zdravila pride do neželenih učinkov, zaradi katerih je treba znižati odmerek, lahko preidejo na uporabo zdravila Rasilamlo, ki vsebuje nižji odmerek te učinkovine, pri tem pa dosežejo podobno znižanje krvnega tlaka.
English: It is also available in multi-packs of 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14) in calendar blisters and 98x1 tablet (2 packs of 49x1) as perforated unit dose blisters.
Slovenian: Na voljo je tudi v skupnih pakiranjih, ki vsebujejo 98 tablet (2 pakiranji po 49 tablet ) oziroma 280 tablet (20 pakairanj po 14 tablet) v koledarskih pretisnih omotih oziroma 98x1 tableto (2 pakiranji po 49x1 tableto) v perforiranih pretisnih omotih z razdelki za enkratni odmerek.
English: In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans.
Slovenian: V hemodinamskih študijah amlodipin uporabljen v območju terapevtskih odmerkov pri intaktnih živalih in pri ljudeh, ni bil povezan z negativnim inotropnim učinkom, niti v primeru sočasne uporabe z zaviralci adrenergičnih receptorjev beta pri ljudeh.
English: For adverse reactions observed with more than one component of a fixed-dose combination, the highest frequency is listed in the table below.
Slovenian: Za neželene učinke, ki so jih opažali pri več kot eni zdravilni učinkovini že pripravljene kombinacije zdravila je v spodnji preglednici levkopenija
English: Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Slovenian: Ker se amlodipin v veliki meri veže na proteine v plazmi, ni verjetno, da bi lahko bolniku pomagali z
English: • 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)
Slovenian: • 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,
English: At steady state meals with low fat content reduce Cmax by 76% and AUC 0-tau by 67% in hypertensive patients.
Slovenian: Obroki z majhno vsebnostjo maščob pri hipertenzivnih bolnikih v stanju dinamičnega ravnovesja zmanjšajo Cmax za 76 % in AUC0-tau za 67 %.
English: Another repeat-dose toxicity study was conducted in juvenile rats 14 days post-partum for 8 weeks with aliskiren dosing at 30, 100 or 300 mg/kg/day.
Slovenian: Drugo študijo toksičnosti pri ponavljajočih se odmerkih so izvedli na 14 dni starih podganjih mladičih, ki so jim 8 tednov dajali aliskiren v odmerkih 30, 100 ali 300 mg/kg/dan.
English: • Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever) (uncommon: may affect up to 1 in
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 temperatura) (občasni: lahko se pojavijo pri največ 1 od 100 ljudi),
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, antagonistev 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: However, as with other medicinal products acting on the renin-angiotensin-aldosterone 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-aldosteron, pri uporabi aliskirena pri bolnikih, ki imajo stenozo ledvične arterije, obstaja povečano tveganje za ledvično insuficienco, vključno z akutno ledvično odpovedjo.
English: Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in elderly patients.
Slovenian: Pri starejših bolnikih je očistek amlodipina praviloma zmanjšan, zato je AUC pri njih povečana, razpolovni čas izločanja pa podaljšan.
English: Plasma aliskiren exposure (AUC) in rats aged 8 days was nearly 4-fold higher than that in rats aged 14 days at 100 mg/kg/day.
Slovenian: Izpostavljenost aliskirenu v plazmi (AUC) je bila pri odmerjanju 100 mg/kg/dan pri 8 dni starih podganah skoraj 4-krat večja kot pri 14 dni starih podganah.
English: , dysgeusia
Slovenian: , disgevzija
English: Multipack containing 280 (20 packs of 14) tablets.
Slovenian: Skupno pakiranje, ki vsebuje 280 (20 pakiranj po 14) tablet.
English: Symptomatic hypotension could occur after initiation of treatment with Rasilamlo in the following
Slovenian: Po uvedbi zdravljenja z zdravilom Rasilamlo lahko pride do simptomatske hipotenzije v naslednjih
English: The adverse reactions previously reported with one of the individual components of Rasilamlo (aliskiren and amlodipine) and included in the tabulated list of adverse reactions may occur with Rasilamlo.
Slovenian: Neželeni učinki, o katerih so predhodno poročali pri uporabi ene od posameznih učinkovin zdravila Rasilamlo (aliskiren in amlodipin) in so navedeni v tabelaričnem pregledu neželenih učinkov, se lahko pojavijo
English: , dyspepsia
Slovenian: , dispepsija
English: Component of a multipack comprising 20 packs, each containing 14 tablets.
Slovenian: Del skupnega pakiranja z 20 pakiranji, od katerih vsako vsebuje 14 tablet.
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-angiotenzin-aldosteron, so povezane s hudimi okvarami ploda in smrtjo novorojenčka.
English: With aliskiren, the most likely manifestation of overdose would be hypotension, related to the antihypertensive effect of aliskiren.
Slovenian: Pri aliskirenu bi bila najbolj verjetna posledica prevelikega odmerjanja glede na antihipertenziven
English: Rasilamlo is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled with aliskiren or amlodipine alone.
Slovenian: Zdravilo Rasilamlo uporabljamo za zdravljenje visokega krvnega tlaka pri odraslih bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren ali samo amlodipin.
English: Taking into account the PRAC Assessment Report on the PSUR for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za aliskiren / aliskiren, amlodipin / aliskiren, hidroklorotiazid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Aliskiren monotherapy studies have shown blood-pressure-lowering effects comparable to other classes of antihypertensive medicinal products including selected ACEI and ARB.
Slovenian: Rezultati študij aliskirena v monoterapiji so pokazali učinke zniževanja krvnega tlaka, ki so primerljivi z učinki drugih skupin antihipertenzivnih zdravil, vključno z izbranimi zaviralci angiotenzinske konvertaze in antagonisti angiotenzina II.
English: Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba aliskirena in močnih zaviralcev P-gp kontraindicirana (glejte
English: As for any medicine that acts directly on the RAAS, aliskiren should not be used during the first trimester of pregnancy and is contraindicated during the second and third trimesters (see section 4.3).
Slovenian: Ženske zdravila Rasilamlo ne smejo uporabljati v prvem trimesečju nosečnosti, kontraindicirano pa je tudi v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
English: Dose should be individualised and adjusted according to the patient's clinical response.
Slovenian: Odmerek je treba prilagoditi posameznemu bolniku in
English: Treatment with Rasilamlo at doses up to 300 mg/10 mg had an overall incidence of adverse experiences similar to the component monotherapies.
Slovenian: Pri zdravljenju z zdravilom Rasilamlo v odmerkih do 300 mg/10 mg je do vseh neželenih učinkov skupaj prišlo s približno enako pogostnostjo kot pri uporabi posameznih učinkovin.
English: The PRAC considered the cases of dechallenge and rechallenge to be important causal relationship information that contributes to
Slovenian: Odbor PRAC je mnenja, da so podatki o primerih navedenih odzivov na prekinitev oziroma ponovno uvedbo zdravljenja pomembni za oceno vzročne povezanosti in lahko prispevajo k
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
English: The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Slovenian: Krčenje srčne mišice in žilnih gladkih mišic je odvisno od prehoda zunajceličnih kalcijevih ionov v
English: A repeat-dose toxicity study was conducted in juvenile rats 8 days post-partum for 4 weeks with aliskiren dosing at 30, 100 or 300 mg/kg/day.
Slovenian: Študijo toksičnosti ponovljenih odmerkov so izvedli na 8 dni starih podganjih mladičih, ki so jim 4 tedne dajali aliskiren v odmerkih 30, 100 ali 300 mg/kg/dan.
English: Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.
Slovenian: Amlodipin pri intaktnih živalih in pri ljudeh ne spreminja delovanja sinoatrialnega vozla ali atrioventrikularnega prevajanja.
English: • rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever
Slovenian: • izpuščaj, rdečina kože, mehurčki na ustnicah, očeh ali v ustih, luščenje kože, zvišana telesna temperatura
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: Zato je mogoče pričakovati povečano izpostavljenost aliskirenu v času sočasne uporabe tistih zaviralcev CYP3A4, ki zavirajo tudi P-gp (glejte zgoraj in spodaj Medsebojno delovanje s P-glikoproteinom).
English: Linearity Amlodipine exhibits linear pharmacokinetics between the therapeutic dose range of 5 mg and 10 mg.
Slovenian: Farmakokinetiki amlodipina v okviru odmerjanja med 5 mg in 10 mg je linearna.
English: • skin reaction with skin reddening and peeling, blistering of lips, eyes or mouth
Slovenian: • kožne reakcije z rdečino in luščenjem kože, mehurčki na ustnicah, očeh ali v ustih
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with aliskiren alone.
Slovenian: Pri bolnikih s hipertenzijo brez zapletov, ki so se zdravili samo z aliskirenom, so občasno (pri 0,1 %) opažali pretirano hipotenzijo.
English: Co-administration of aliskiren and amlodipine does not cause meaningful changes in the steady-state pharmacokinetic exposure (AUC) and the maximum concentration (Cmax) of either component in
Slovenian: Pri zdravih prostovoljcih sočasna uporaba aliskirena in amlodipina ne povzroča bistvenih sprememb farmakodinamske izpostavljenosti (AUC) posameznih učinkovin in njunih najvišjih koncentracij
English: Component of a multipack comprising 2 packs, each containing 49 tablets.
Slovenian: Del skupnega pakiranja z 2 pakiranjema, od katerih vsako vsebuje 49 tablet.
English: Individual dose titration with each of the two components may be recommended before changing to the fixed combination.
Slovenian: Pred prehodom na že pripravljeno kombinacijo zdravila je lahko priporočeno ločeno titriranje odmerkov vsake od posameznih učinkovin.
English: There is no experience of overdose with Rasilamlo.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Rasilamlo ni.
English: Amlodipine should be used with caution together with CYP3A4
Slovenian: Pri sočasni uporabi amlodipina in induktorjev CYP3A4 je potrebna previdnost.
English: Dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB is therefore not recommended.
Slovenian: Dvojna blokada sistema RAAS s kombinacijo aliskirena in zaviralcev ACE ali antagonistev receptorjev angiotenzina II zato ni priporočljiva.
English: Liver disorder a,
Slovenian: bolezni jeter a,
English: General disorders and administration site conditions Fatigue
Slovenian: Splošne težave in spremmebe na mestu aplikacije utrujenost bolečina v prsnem košu
English: High acute mortality (within hours) and severe morbidity were observed at 100 and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended basis assuming a 60 kg adult patient) with no cause of death established and occurring without signs or prodromal symptoms.
Slovenian: Pri odmerjanju 100 oziroma 300 mg/kg/dan (kar je 2,3 oziroma 6,8-kratna vrednost največjega priporočenega odmerka pri ljudeh (angl. maximum recommended human dose, MRHD) po prilagoditvi na telesno površino (mg/m2) in ob predpostavki, da ima odrasel bolnik telesno maso 60 kg ) so opažali visoko akutno smrtnost (v nekaj urah) in veliko pojavnost hudih bolezni, pri čemer niso ugotovili, kaj je bil vzrok smrti, in niso opažali prodromskih znakov ali simptomov.
English: - if you have renal artery stenosis (narrowing of the blood vessels to one of both kidneys) - if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body)
Slovenian: Rasilamlo primerno za vas in vas bo mogoče želel pozorno spremljati; - če imate težave z jetri (moteno delovanje jeter); - če imate stenozo ledvične arterije (zoženje krvnih žil, ki dovajajo kri do ene ali obeh ledvic); - če imate hudo kongestivno popuščanje srca (oblika bolezni srca, pri kateri srce ne more načrpati dovolj krvi po telesu).
English: Effects of amlodipine on other medicinal products - The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive medicinal products.
Slovenian: - Zniževanje krvnega tlaka, ki ga povzroča amlodipin, se sešteva z zniževanjem krvnega tlaka, ki ga povzročajo druga antihipertenzivna zdravila.
English: , mood changes (including anxiety)
Slovenian: , spremembe razpoloženja (vključno s tesnobo)
English: - if you are between three and nine months pregnant - if you are taking any of the following medicines ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis) itraconazole (a medicine used to treat fungal infections) quinidine (a medicine used to correct heart rhythm) - if you have diabetes or impaired kidney function and you are treated with 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 the patient is less than 2 years of age - if you have very low blood pressure - if you are suffering from shock, including cardiogenic shock - if you have a narrowing of the aortic heart valve (aortic stenosis) - if you have heart failure after an acute heart attack If any of the above applies to you, do not take Rasilamlo and talk to your doctor.
Slovenian: - če ste v tretjem do devetem mesecu nosečnosti; - če jemljete katero od naslednjih zdravil: ciklosporin (zdravilo, ki se ga uporablja pri presaditvah za preprečevanje zavrnitve organa ali pri drugih boleznih, na primer pri revmatoidnem artritisu ali atopijskem itrakonazol (zdravilo za zdravljenje glivičnih okužb), kinidin (zdravilo za uravnavanje srčnega ritma); - če imate sladkorno bolezen ali okvarjeno delovanje ledvic in jemljete zdravilo iz katere od naslednjih skupin zdravil za zdravljenje visokega krvnega tlaka: zaviralci encima angiotenzinske konvertaze, na primer enalapril, lizinopril ali ramipril,
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of aliskiren.
Slovenian: D rugi induktorji P-gp (šentjanževka) bi lahko zmanjšali biološko uporabnost aliskirena.
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidonebased therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Slovenian: Pri umrljivosti iz kateregakoli vzroka pa ni prišlo do statistično značilne razlike med zdravljenjem, ki je vključevalo amlodipin, in tistim, ki je vključevalo klortalidon (razmerje tveganj (RR) 0,96; 95-odstotni IZ: 0,89-1,02; p=0,20).
English: Medicinal product subject to medical prescription.
Slovenian: Zdravilo je namenjeno peroralni uporabi.
English: , purpura
Slovenian: , alopecjia purpura
English: The increased incidence of stroke was greater in patients with renal
Slovenian: Pojavnost možganske kapi je povečana pri bolnikih z zmanjšanim delovanjem
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 products that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see
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 antagonistev angiotenzinskih receptorjev) (glejte poglavje 4.8).
English: There is limited experience with Rasilamlo, in particular in patients aged 75 years or older.
Slovenian: Izkušenj pri uporabi zdravila Rasilamlo, zlasti pri bolnikih, ki so stari 75 let ali več, je malo, zato je pri teh bolnikih potrebna posebna previdnost.
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: Med izkušnjami v obdobju trženja z aliskirenom 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: There are no clinical data on fertility with the use of Rasilamlo.
Slovenian: Kliničnih podatkov o vplivu zdravila Rasilamlo na plodnost ni.
English: In a study in 847 randomised patients not adequately responsive to amlodipine 10 mg treatment, the combination of aliskiren/amlodipine 150 mg/10 mg and 300 mg/10 mg produced systolic/diastolic mean blood pressure reductions of 11.0/9.0 mmHg and 14.4/11.0 mmHg respectively, which were statistically greater than for amlodipine 10 mg monotherapy.
Slovenian: V študiji z 847 randomiziranimi bolniki, pri katerih ni prišlo do ustreznega odziva na zdravljenje z amlodipinom v odmerku 10 mg, je kombinacija aliskirena/amlodipina jakosti 150 mg/10 mg in 300 mg/10 mg povzročila povprečno znižanje sistoličnega/diastoličnega krvnega tlaka za 11,0/9,0 mmHg oziroma za 14,4/11,0 mmHg, kar je bilo statistično značilno več kot pri monoterapiji z amlodipinom v odmerku 10 mg.
English: • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (may be signs of
Slovenian: • občutek siljenja na bruhanje, izguba apetita, temno obarvan urin ali porumenevanje kože in oči
English: Grounds recommending the variation to the terms of the Marketing Authorisation
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenja za promet z zdravilom
English: Therefore, information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
Slovenian: Študij medsebojnega delovanja zdravila Rasilamlo z drugimi zdravili niso opravili, zato so v tem poglavju navedeni podatki o znanih interakcijah drugih zdravil z vsako od posameznih učinkovin.
English: There were no new toxicities or increased severity of the toxicities which were associated with either
Slovenian: Novih vrst toksičnega delovanja ali povečanega obsega toksičnega delovanja v primerjavi z uporabo posameznih učinkovin niso opažali.
English: , palpitations a,am
Slovenian: , palpitacije a,am
English: , altered bowel habits (including diarrhoea and constipation)
Slovenian: , spremenjeno odvajanje blata (vključno z diarejo in obstipacijo)
English: , gingival hyperplasia
Slovenian: , hipestezija parestezija hipertonija
English: Angioedema a, erythema a
Slovenian: , eksantem angioedem a, eritem a multiformni eritem
English: Delayed mortality was observed at 300 mg/kg/day (8.5-fold the MRHD on mg/m2 basis assuming a 60 kg adult patient) with no cause of death
Slovenian: Pri odmerjanju 300 mg/kg/dan (kar je 8,5-kratnik vrednosti MHRD po prilagoditvi na telesno površino (mg/m2) in ob predpostavki, da ima odrasel bolnik telesno maso 60 kg) so opažali zapoznelo smrtnost, pri čemer niso ugotovili, kaj je bil vzrok smrti.
English: Aliskiren induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Slovenian: Če so aliskiren dodali hidroklorotiazidu je povzročil aditiven učinek zniževanja krvnega
English: The MAH submitted an analysis with 1407 cases of “dyspnoea”, in 13 of them there was positive dechallenge and three cases with positive rechallenge.
Slovenian: Pri 13 primerih so simptomi izzveneli po prekinitvi zdravljenja (positive dechallenge), v 3 primerih pa so se simptomi ponovili po ponovni uvedbi zdravila (positive rechallenge).
English: The results of this study did not suggest that age, body weight or gender have any significant effect on aliskiren
Slovenian: Rezultati te študije so pokazali, da starost, telesna masa in spol nimajo pomembnega vpliva na obseg sistemske izpostavljenosti aliskirenu (glejte poglavje 4.2).
English: 98 tablets (2x49, PA/Alu/PVC blisters) 98 tablets (2x49x1, PVC/PCTFE single-unit-dose blisters) 280 tablets (20x14, PVC/PCTFE blisters) 280 tablets (20x14, PA/Alu/PVC blisters)
Slovenian: 98 tablet (2x49, PA/Alu/PVC pretisni omoti) 98 tablet (2x49x1, PVC/PCTFE pretisni omoti z razdelki za