natgillin/translations-raw huggingface dataset:
It is not known whether aliskiren is excreted in human milk.
Nije poznato izlučuje li se aliskiren u majčino mlijeko.
In this study, aliskiren at a target dose of 300 mg was compared to enalapril at a target dose of 20 mg when added to standard of care which included a beta blocker (and a mineralocorticoid receptor antagonist in 37% of patients) and a diuretic as needed.
U ovom ispitivanju aliskiren u ciljnoj dozi od 300 mg uspoređen je s enalaprilom u ciljnoj dozi od 20 mg kada se dodaju standardu skrbi koji uključuje beta-blokator (i antagonist mineralokortikoidnih receptora u 37% bolesnika) i diuretik po potrebi.
Pancreatitish
Pankreatitish
- if the level of potassium in your blood is too low despite treatment.
- ako je razina kalija u Vašoj krvi preniska unatoč liječenju.
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Značajna hiperkalcijemija može biti dokaz prikrivenog hiperparatireoidizma.
Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndromea, toxic epidermal necrolysis (TEN)a, oral mucosal reactionsa, pruritusa
Teške kožne nuspojave (SCAR) uključujući Stevens Johnsonov sindroma, toksičnu epidermalnu nekrolizu (TEN)a, reakcije oralne sluznicea, pruritusa
Posology The recommended dose of Rasilez HCT is one tablet per day.
Doziranje Preporučena doza Rasilez HCT-a je jedna tableta na dan.
The adverse reactions observed with Rasilez HCT or with monotherapy with one or both of the two components are included in the table below.
Nuspojave opažene s Rasilez HCT-om ili u monoterapiji s jednom ili svakom od dvije komponente uključene su u tablici u nastavku.
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Može biti potrebna prilagodba doze urikozuričnih lijekova budući da hidroklorotiazid može povisiti razinu mokraćne kiseline u serumu.
Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Opažena su mala sniženja hemoglobina i hematokrita (srednja vrijednost sniženja od približno 0,05 mmol/l, odnosno 0,16 volumnog postotka.
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
Predoziranje hidroklorotiazidom je povezano sa smanjenjem razina elektrolita (hipokalijemija, hipokloremija, hiponatrijemija) i dehidracijom koja rezultira prekomjernom diurezom.
There were no statistically significant differences in the mean changes in weight, height, or BMI between the treatment groups from Baseline to LT Visit 18 (Week 104) (primary analysis).
Nije bilo statistički značajnih razlika u promjenama srednjih vrijednosti težine, visine ili BMI-a između liječenih skupina od početnih vrijednosti do onih u 18. posjetu provedenom u sklopu procjene dugoročne sigurnosti (104. tjedan) (primarna analiza).
Aliskiren 150 mg or 300 mg per day or ramipril 5 mg or 10 mg per day were administered for 36 weeks with optional add-on therapy of hydrochlorothiazide (12.5 mg or 25 mg) at week 12, and amlodipine (5 mg or 10 mg) at week 22.
Aliskiren 150 mg ili 300 mg na dan ili ramipril 5 mg ili 10 mg na dan primjenjivani su 36 tjedana s mogućom dodatnom terapijom hidroklortiazidom (12,5 mg ili 25 mg) u 12. tjednu i amlodipinom (5 mg ili 10 mg) u 22. tjednu.
Aliskiren 150 mg (increased to 300 mg if tolerated) added to conventional therapy was evaluated in a double-blind placebo-controlled randomised trial in 1,639 patients with reduced ejection fraction hospitalised for an episode of acute heart failure (NYHA Class III-IV) who were haemodynamically stable at baseline.
Aliskiren 150 mg (povećan na 300 mg ako se podnosi) dodan konvencionalnoj terapiji, bio je ocijenjen u dvostruko slijepom, placebo kontroliranom randomiziranom ispitivanju provedenom na 1639 bolesnika sa smanjenom ejekcijskom frakcijom koji su bili hospitalizirani zbog epizode akutnog zatajenja srca (NYHA klasa III-IV), a koji su na početku bili hemodinamički stabilni.
In the event of severe and perisistent diarrhoea, Rasilez HCT therapy should be stopped (see section 4.8).
Općenito U slučaju teškog i ustrajnog proljeva, potrebno je prekinuti terapiju Rasilez HCT-om (vidjeti dio 4.8).
Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italy
Novartis Farma S.p.A. Via Provinciale Schito 131 I-80058 Torre Annunziata/NA
Aliskiren/hydrochlorothiazide
Aliskiren/hidroklorotiazid
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.
Povećana incidencija hiperkalijemije (20,9% naspram 17,5%), oštećenje bubrežne funkcije/zatajenje bubrega (16,6% naspram 12,1%) i hipotenzija (17,1% naspram 12,6%) uočeni su u skupini koja je primala aliskiren u odnosu na onu koja je primala placebo i bili su veći u bolesnika sa šećernom bolesti.
Aliskiren should be used with caution in patients with heart failure treated with furosemide or torasemide (see section 4.5).
Aliskiren treba oprezno primjenjivati u bolesnika sa zatajenjem srca koji se liječe furosemidom ili torasemidom (vidjeti dio 4.5).
The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.
Uobičajena preporučena početna doza aliskirena u starijih bolesnika u dobi od 65 godina ili više iznosi 150 mg.
Statistically significantly higher incidences in the occurrence of cardiac failure and ischaemic stroke were also found for aliskiren compared to enalapril in patients with NYHA I/II with hypertension, and in the occurrence of chronic cardiac failure and ventricular extrasystole in patients with NYHA III/IV with hypertension.
Također, statistički značajno veća incidencija nastanka srčanog zatajivanja i ishemijskog moždanog udara utvđena je za aliskiren u usporedbi s enalaprilom u bolesnika s NYHA I/II s hipertenzijom, te nastanka kroničnog zatajivanja srca i ventrikularnih ekstrasistola u bolesnika s NYHA III/IV s hipertenzijom.
Haemoglobin decreaseda, haematocrit decreaseda, blood creatinine increaseda, glycosuriah c Adverse reaction observed with Rasilez HCT a Adverse reaction observed with monotherapy with aliskiren h Adverse reaction observed with monotherapy with hydrochlorothiazide * Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Sniženi hemoglobina, sniženi hematokrita, povišeni kreatinin u krvia, glikozurijah c Nuspojave opažene s Rasilez HCT-om a Nuspojave opažene u monoterapiji s aliskirenom h Nuspojave opažene u monoterapiji s hidroklortiazidom *Izolirani slučajevi poremećaja jetre s kliničkim simptomima i laboratorijskim dokazom izraženije jetrene disfunkcije.
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.
Aliskiren je ocjenjivan s obzirom na kardiovaskularnui/ili bubrežnu korist u dvostruko slijepom placebom kontroliranom randomiziranom ispitivanju u kojem je sudjelovalo 8606 bolesnika sa šećernom bolešću tip 2 i kroničnom bolešću bubrega (koja se dokazuje proteinurijom i/ili GFR-om <60 ml/min/1,73 m2) sa ili bez kardiovaskularne bolesti.
In another clinical studies, the efficacy and safety of Rasilez HCT were also assessed in 489 obese hypertensive patients who did not respond to hydrochlorothiazide 25 mg (baseline systolic/diastolic blood pressure 149.4/96.8 mmHg).
U drugim kliničkim ispitivanjima također se procjenjivala djelotvornost i sigurnost Rasilez HCT-a u 489 pretilih hipertenzivnih bolesnika koji nisu odgovarali na hidroklorotiazid u dozi od 25 mg (početni sistolički/dijastolički krvni tlak od 149,4/96,8 mmHg).
• Sleep disturbances
• poremećaji sna
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.
U većine bolesnika od 65 godina ili starijih, doza od 300 mg aliskirena ne pokazuje dodatnu korist u smanjenju krvnog tlaka u usporedbi s dozom od 150 mg.
If any of these affect you severely, tell your doctor.
Ako je kod Vas bilo koja od ovih nuspojava jako izražena, obavijestite svojeg liječnika.
Angioedemaa, erythemaa, photosensitivity reactionsh
Angioedema, eritema, fotosenzitivne reakcijeh
If anaphylactic reactions or angioedema occur, Rasilez HCT should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Ako se pojavi anafilaktička reakcija ili angioedem, primjenu Rasilez HCT-a treba odmah prekinuti i omogućiti odgovarajuću terapiju i praćenje dok ne dođe do potpunog i trajnog nestanka znakova i simptoma.
In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (< 2% of oral clearance).
U ispitivanju provedenom na bolesnicima u završnom stadiju bubrežne bolesti (ESRD) na hemodijalizi klirens aliskirena dijalizom bio je nizak (<2% zabilježenog klirensa nakon peroralne primjene).
High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Velika primjena hidroklorotiazida (≥50,000 mg kumulativno) bila je povezana s prilagođenim OR od 1,29 (95% CI: 1,23-1,35) za BCC i 3,98 (95% CI: 3,68-4,31) za SCC.
Dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB is therefore not recommended.
Stoga se ne preporučuje dvostruka blokada RAAS-a kombiniranjem aliskirena s ACEI-om ili ARB-om.
Dizzinessa,h
Omaglicaa,h
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).
U multicentričnom, randomiziranom, dvostruko slijepom, 8-tjednom ispitivanju s aliskirenom u monoterapiji (3 dozne skupine prema kategoriji težine [≥20 kg do <50 kg; ≥50 kg do <80 kg; ≥80 kg do ≤150 kg]: niska doza 6,25/12,5/25 mg [0,13-0,31 mg/kg]; srednja doza 37,5/75/150 mg [0,75-1,88 mg/kg]; i visoka doza 150/300/600 mg [3,0-7.5 mg/kg], uz širok raspon doze između skupina s niskom, srednjom i visokom dozom [1:6:24]) u 267 pedijatrijskih hipertenzivnih bolesnika u dobi od 6 do 17 godina, većinom s prekomjernom težinom/pretilih, aliskiren je doveo do sniženja krvnog tlaka kod ambulantnog mjerenja i kod 24-satnog kontinuiranog mjerenja tlaka, pri čemu je sniženje bilo ovisno o dozi tijekom početne 4-tjedne faze utvrđivanja doze u ispitivanju (1. faza).
Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium is recommended when Rasilez HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Lijekovi na koje utječu poremećaji kalija u serumu Preporučuje se periodičko praćenje kalija u serumu kada se Rasilez HCT primjenjuje s lijekovima na koje utječu poremećaji kalija u serumu (npr. glikozidi digitalisa, antiaritmici).
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.
Istodobna primjena ketokonazola (200 mg) ili verapamila (240 mg) s aliskirenom (300 mg) rezultirala je 76%-im odnosno 97%-im povećanjem AUC-a aliskirena.
• High level of sugar in the blood
• visoka razina šećera u krvi
In the event that any signs or clinical suspicion of systematic lupus erythematosus (SLE), Rasilez HCT should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
U slučaju pojave bilo kojih znakova ili kliničke sumnje na sistemski eritematozni lupus, lijek Rasilez HCT treba odmah prekinuti i primijeniti odgovarajuću terapiju i nadzor do potpunog i trajnog povlačenja znakova i simptoma.
90 film-coated tablets (3 packs of 30)
90 filmom obloženih tableta (3 pakiranja od 30)
You should take this medicine either with a light meal or without a meal, once a day, preferably at the same time each day.
Ovaj lijek trebate uzimati ili s laganim obrokom ili bez obroka jednom na dan, po mogućnosti svaki dan u isto vrijeme.
There is therefore a potential for aliskiren overexposure in paediatric patients with immature MDR1 efflux system (see sections 4.2, 4.3 and 5.2).
Stoga, postoji potencijal za prekomjernu izloženost aliskirenu u pedijatrijskih bolesnika s nezrelim MDR1 efluksnim sustavom (vidjeti dio 4.2, 4.3 i 5.2).
Following intravenous administration, the mean plasma clearance is approximately 9 l/h.
Nakon intravenske primjene srednja vrijednost klirensa iz plazme je približno 9 l/h.
Moderate P-gp inhibitors
Umjereni P-gp inhibitori
- if you are on a low-salt diet. - if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide.
- ako imate znakove i simptome kao što su prekomjerna žeđ, suha usta, opća slabost, omamljenost, bolovi ili grčevi u mišićima, mučnina, povraćanje te nenormalno brzo lupanje srca što može ukazivati na prekomjerni učinak hidroklorotiazida.
If pregnancy is detected during therapy, Rasilez HCT should be discontinued as soon as possible.
Ako se tijekom terapije utvrdi trudnoća, primjena lijeka Rasilez HCT se sukladno tome mora prekinuti čim je prije moguće.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets
7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta
Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated for use in patients with anuria and in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Zbog hidroklorotiazidne komponente, Rasilez HCT je kontraindiciran za primjenu u bolesnika s anurijom i u bolesnika s teškim oštećenjem bubrežne funkcije (brzina glomerularne filtracije (GFR) <30 ml/min/1,73 m2).
Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure.
Smanjujući količinu angiotenzina II omogućava relaksaciju krvnih žila što dovodi do sniženja krvnog tlaka.
Intrahepatic cholestasish, jaundicea,h
Intrahepatična kolestazah, žuticaa,h
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).
Postoji potencijal za prekomjernu izloženost aliskirenu u djece s nezrelim MDR1 (P-gp) sustavom (vidjeti dio “Prijenosnici” iznad u tekstu i dijelove 4.2, 4.4 i 5.3).
280 film-coated tablets.
280 filmom obloženih tableta.
Preclinical evaluations to support the administration of hydrochlorothiazide in humans included in vitro genotoxicity assays and reproductive toxicity and carcinogenicity studies in rodents.
Pretklinička istraživanja koja govore u prilog primjene hidroklorotiazida u ljudi uključivala su in vitro određivanje testova genotoksičnosti te ispitivanja reproduktivne toksičnosti i kancerogenosti u glodavaca.
• Severely decreased urine output (possible signs of renal disorder or renal failure), weakness
• jako smanjeno mokrenje (mogući znakovi poremećaja bubrega ili zatajenja bubrega), slabost
Rasilez HCT should be used with caution in patients who have recently undergone kidney transplantation due to limited clinical efficacy and safety data.
Rasilez HCT treba primjenjivati uz oprez u bolesnika koji su se nedavno podvrgli transplantaciji bubrega zbog ograničenih podataka o kliničkoj djelotvornosti i sigurnosti.
No data are available on patients with severe hepatic impairment treated by Rasilez HCT.
Nisu dostupni podaci o bolesnicima s teškim oštećenjem jetrene funkcije liječenim Rasilez HCT-om.
98 (2 x 49 x 1) film-coated tablets
98 (2 x 49 x 1) filmom obloženih tableta
Pharmacokinetic interactions with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Lijekovi koji su istraživani u ispitivanjima kliničke farmakokinetike uključuju acenokumarol, atenolol, celekoksib, pioglitazon, alopurinol, izosorbid-5-mononitrat i hidroklorotiazid.
Concomitant administration of aliskiren with fruit juice or drinks containing plant extracts, including herbal teas, should be avoided.
Treba izbjegavati istodobno uzimanje aliskirena s voćnim sokom ili napitcima koji sadrže biljne ekstrakte, uključujući biljne čajeve.
Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height).
Opcionalna titracija odgovarajućih doza ispitivanog lijeka do sljedeće najviše doze na osnovu težine bila je moguća udvostručavanjem doze pomoću dvije dozvoljene titracije doza, do 600 mg (najviša ispitivana doza u odraslih) za aliskiren i 40 mg za enalapril u težinskoj skupini od ≥80 do ≤150 kg, ako je to bilo medicinski neophodno radi kontroliranja srednje vrijednosti sistoličkog krvnog tlaka u sjedećem položaju (tj. srednja vrijednost sistoličkog krvnog tlaka u sjedećem položaju treba biti ispod 90. percentile za dob, spol i visinu).
Therefore, if administration of aliskiren in ESRD patients receiving haemodialysis is considered necessary, no dose adjustment is warranted in these patients.
Ako se primjena aliskirena u bolesnika s ESRD-om na hemodijalizi smatra nužno potrebnom, u takvih bolesnika prilagodba doze stoga nije opravdana.
A single dose interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Ispitivanje interakcija lijekova uz primjenu jednokratne doze lijeka u zdravih ispitanika pokazalo je da ciklosporin (200 i 600 mg) povećava Cmax aliskirena u dozi od 75 mg otprilike 2,5 puta, a AUC otprilike 5 puta.
Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Pretklinička ispitivanja pokazuju da istodobna primjena aliskirena i ketokonazola pojačava gastrointestinalnu apsorpciju aliskirena i smanjuje njegovo izlučivanje putem žuči.
Aliskiren is a P-glycoprotein (P-gp) substrate, and there is a potential for aliskiren overexposure in children with an immature P-gp drug transporter system.
Aliskiren je supstrat P-glikoproteina (P-gp) pa u djece s nezrelim sustavom prijenosa lijekova P-gp-om postoji potencijal za prekomjernu izloženost aliskirenu.
You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas), as it could cause a decrease in the effectiveness of this medicine
Izbjegavajte uzimanje ovog lijeka zajedno s voćnim sokomi/ili napitcima koji sadrže biljne ekstrakte (uključujući biljne čajeve), jer mogu dovesti do smanjenja djelotvornosti ovog lijeka.
Patients should be rehydrated before administration.
Bolesnike je prije primjene potrebno rehidrirati.
Tolerability was comparable in both treatment arms, however cough was more often reported with the ramipril regimen than the aliskiren regimen (14.2% vs. 4.4%), whilst diarrhoea was more common with the aliskiren regimen than for the ramipril regimen (6.6% vs. 5.0%).
Podnošljivost je bila usporediva u obje liječene skupine, no kašalj je bio češće prijavljivan kod liječenja ramiprilom u odnosu na liječenje aliskirenom (14,2% naspram 4,4%), dok je proljev bio češći tijekom liječenja aliskirenom nego tijekom liječenja ramiprilom (6,6% naspram
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Tiazidi, uključujući hidroklorotiazid, mogu smanjiti izlučivanje citostatika (npr. ciklofosfamid, metotreksat) bubrezima i potencirati njihove mijelosupresivne učinke.
• Irregular heart beat
• nepravilni otkucaji srca
The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Pokazalo se da incidencija nuspojava nije povezana sa spolom, dobi, indeksom tjelesne mase, rasom ili etničkom pripadnošću.
The starting doses for aliskiren were 37.5/75/150 mg in the low, mid and high weight groups, respectively.
Početne doze za aliskiren iznosile su 37,5/75/150 mg u skupini s niskom težinom odnosno skupini sa srednjom težinom odnosno u skupini s visokom težinom.
You should take this medicine once a day, always with or always without food, preferably at the same time each day.
Ovaj lijek trebate uzimati jednom na dan, uvijek sa hranom ili uvijek bez hrane, po mogućnosti svaki dan u isto vrijeme.
Timing of haemodialysis did not significantly alter the pharmacokinetics of aliskiren in ESRD patients.
Vrijeme hemodijalize nije značajno izmijenilo farmakokinetiku aliskirena u bolesnika s ESRD-om.
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.
To je smanjenje vjerojatno zbog inhibicijskog djelovanja sastojaka voćnog soka na unos aliskirena posredovan polipeptidnim prijenosnikom organskih aniona u gastrointestinalnom traktu.
Rasilez HCT should be used with caution in patients with heart failure due to limited clinical efficacy and safety data.
Rasilez HCT treba primjenjivati s oprezom u bolesnika sa zatajenjem srca zbog ograničenih podataka o kliničkoj djelotvornosti i podataka o sigurnosti.
The finding was observed in animals treated with hydrochlorothiazide but not in those animals receiving aliskiren alone or vehicle.
Nalaz je opažen u životinja liječenih hidroklorotiazidom, ali ne i u životinja koje su primale samo aliskiren ili placebo.
Medicinal products that could induce torsades de pointes Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Zbog rizika od hipokalijemije potreban je oprez s primjenom hidroklorotiazida kad je povezan s lijekovima koji mogu izazvati torsades de pointes, osobito antiaritmicima klase Ia i klase III te nekim antipsihoticima.
Results from an in vitro MDR1 human tissue study suggested an age and tissue dependent pattern of MDR1 (P-gp) transporter maturation.
Rezultati iz in vitro ispitivanja MDR1 u ljudskom tkivu ukazali su na obrazac sazrijevanja MDR1 (Pgp) prijenosnika ovisan o dobi i tkivu.
Hypersensitivity reactions including anaphylactic reactions have also been reported in post-marketing experience (see section 4.4).
Reakcije preosjetljivosti uključujući anafilaktične reakcije također su bile prijavljene nakon stavljanja lijeka u promet (vidjeti dio 4.4).
In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.
U zdravih ispitanika itrakonazol (100 mg) povećava AUC aliskirena (150 mg) za 6,5 puta, a Cmax za 5,8 puta.
Hypochloraemic alkalosish
Hipokloremijska alkalozah