natgillin/translations-raw huggingface dataset:
Depending on how you respond to the treatment, your doctor may suggest a higher or lower strength. 
Ovisno o tome kako reagirate na liječenje, liječnik Vam može predložiti višu ili nižu jačinu.
* Based on patient weight of 50 kg 
* na temelju tjelesne težine bolesnika od 50 kg
10 10.3 NA NA 9.0 9.5 
10,3 ND ND 9,0 9,5
PVC/PCTFE blisters. 
PVC/PCTFE blisteri.
117 Allée des parcs 69800 Saint Priest France 
117 Allée des parcs 69800 Saint Priest Francuska
For Bottle packs: After first opening use within 100 days. 
Za boce: nakon otvaranja iskoristiti u roku od 100 dana.
Additional information on the combination 
Dodatne informacije o kombinaciji
Absolute bioavailability has been calculated as between 64 % and 80 %. 
Apsolutna bioraspoloživost je izračunata između 64% i 80%.
Swelling of the tongue and throat which causes great difficulty breathing. 
- Oticanje jezika i grla koje uzrokuje velike teškoće pri disanju.
A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). 
Nekoliko bolesnika je imalo ove ozbiljne nuspojave (mogu se javiti u do 1 na 1000 osoba).
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. 
Nemojte koristiti ovaj lijek ako primijetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
Rare (may affect up to 1 in 1,000 people): Confusion. 
Rijetko (mogu se javiti u do 1 na 1000 osoba): Smetenost.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal. 
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107c stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
Mylan Hungary Kft. Mylan utca 1, Komárom - 2900 Hungary 
Mylan utca 1, Komárom - 2900 Mađarska
if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). 
ako ste alergični na valsartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Carcinogenesis, mutagenesis 
Kancerogeneza, mutageneza
Valsartan is highly bound to serum proteins (94-97 %), mainly serum albumin. 
Valsartan se u velikoj mjeri veže na serumske proteine (94-97%), uglavnom na serumski albumin.
Mean absolute bioavailability is 23 %. 
Srednja vrijednost apsolutne bioraspoloživosti je 23%.
Clarithromycin is an inhibitor of CYP3A4. 
Klaritromicin je inhibitor CYP3A4.
Swelling of eyelids, face or lips. 
- Oticanje očnih kapaka, lica ili usnica.
Valsartan is primarily eliminated in faeces (about 83 % of dose) and urine (about 13 % of dose), mainly as unchanged drug. 
Valsartan se primarno eliminira stolicom (oko 83% doze) i mokraćom (oko 13% doze), uglavnom kao nepromijenjen lijek.
(It is also better to avoid Amlodipine/Valsartan Mylan in early pregnancy, see Pregnancy section). 
(Također je bolje izbjegavati Amlodipin/Valsartan Mylan u ranoj trudnoći, vidjeti dio Trudnoća).
CARTON FOR BOTTLE AND BLISTER BOTTLE LABEL 
KUTIJA ZA BOCU I BLISTER NALJEPNICA NA BOCI
In vitro studies with amlodipine have shown that approximately 97.5 % of circulating drug is bound to plasma proteins. 
In vitro ispitivanja s amlodipinom pokazala su da se u otprilike 97,5% cirkulirajućeg lijeka veže na proteine plazme.
The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%. 
Procijenjen je udio majčine doze koju primi dojenče, i njegov interkvartilni raspon iznosio je 3 - 7%, uz maksimum od 15%.
Biotransformation: Amlodipine is extensively (approximately 90 %) metabolised in the liver to inactive metabolites. 
Biotransformacija: Amlodipin se u velikoj mjeri (otprilike 90%) metabolizira u jetri do inaktivnih metabolita.
A hydroxy metabolite has been identified in plasma at low concentrations (less than 10 % of the valsartan AUC). 
U plazmi je identificiran hidroksi-metabolit u niskoj koncentraciji (manje od 10% AUC valsartana).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
Mean systemic AUC of valsartan is higher by 70 % in the elderly than in the young, therefore caution is required when increasing the dosage. 
Srednja sistemska vrijednost AUC valsartana viša je za 70% u starijih osoba nego u mladih osoba, te je stoga nužan oprez pri povećavanju doze.
Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to amlodipine/valsartan. 
Dob, spol, rasa ili indeks tjelesne mase (≥30 kg/m 2, <30 kg/m 2) nisu utjecali na odgovor na amlodipin/valsartan.
Amlodipine/Valsartan Mylan is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Amlodipin/Valsartan Mylan se ne preporučuje u ranoj trudnoći (prva 3 mjeseca) te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and angiotensin II receptor blockers (ARBs). 
S obzirom na njihova slična farmakodinamička svojstva, ti su rezultati relevantni i za druge ACE inhibitore i blokatore angiotenzin II receptora (ARB-ove).
In two long-term follow-up studies the effect of amlodipine/valsartan was maintained for over one year. 
U dva dugotrajna ispitivanja praćenja, učinak amlodipina/valsartana bio je održan tijekom više od jedne godine.
Over 1,400 hypertensive patients received amlodipine/valsartan once daily in two placebo-controlled trials. 
Više od 1400 hipertenzivnih bolesnika primalo je amlodipin/valsartan jednom dnevno u dva placebo kontrolirana klinička ispitivanja.
(calculations assume an oral dose of 320 mg/day and a 60 kg patient). 
(u izračunima je korištena pretpostavka da je peroralna doza 320 mg/dan i da je tjelesna težina bolesnika 60 kg).
The safety of amlodipine in human pregnancy has not been established. 
Sigurnost amlodipina u ljudskoj trudnoći nije ustanovljena.
If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with amlodipine/valsartan. 
Ako se diuretik također koristi, rizik od toksičnosti litija vjerojatno se može povećati i više s amlodipinom/valsartanom.
At the time of Commission Decision 
U vrijeme donošenj a Odluke Komisije
In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine. 
U marmoseta su pri usporedivim dozama promjene bile slične iako teže, osobito u bubrezima, gdje su se promjene razvile u nefropatiju uključujući povišenu ureju u krvi i kreatinin.
Amlodipine/Valsartan Mylan and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose. 
Amlodipin/Valsartan Mylan i starije osobe (u dobi od 65 ili više godina) Vaš liječnik treba oprezno postupati kod povećavanja doze.
Biotransformation: Valsartan is not transformed to a high extent as only about 20 % of dose is recovered as metabolites. 
Biotransformacija: Valsartan se ne transformira u većoj mjeri, budući da se svega 20% doze može naći u obliku metabolita.
Correction of this condition prior to administration of amlodipine/valsartan or close medical supervision at the start of treatment is recommended. 
Preporučuje se korigiranje ovog stanja prije primjene amlodipina/valsartana ili pažljiv liječnički nadzor na početku liječenja.
The safety and efficacy of amlodipine in hypertensive crisis have not been established. 
Sigurnost i djelotvornost amlodipina u hipertenzivnoj krizi nisu ustanovljene.
If you forget to take Amlodipine/Valsartan Mylan If you forget to take this medicine, take it as soon as you remember. 
Ako ste zaboravili uzeti Amlodipin/Valsartan Mylan Ako zaboravite uzeti ovaj lijek, uzmite ga čim se sjetite.
To date there is no experience of the safe use of amlodipine/valsartan in patients who have had a recent kidney transplantation. 
Do danas ne postoji iskustvo o sigurnoj primjeni amlodipina/valsartana u bolesnika kojima je nedavno transplantiran bubreg.
Max. daily dose (mg) 
Maksimaln a dnevna doza (mg)
Not all pack sizes may be available in your country. 
Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja.
Pack sizes: 28, 56 or 98 film-coated tablets. 
Veličine pakiranja: 28, 56 ili 98 filmom obloženih tableta.
Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77 % increase in exposure to simvastatin compared to simvastatin alone. 
Istodobna primjena višestrukih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
See also information under the heading “Do not take Amlodipine/Valsartan Mylan”. 
Vidjeti također informacije pod naslovom „Nemojte uzimati Amlodipin/Valsartan Mylan“.
As expected for a compound where renal clearance accounts for only 30 % of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan. 
Kao što se i očekuje za lijek čiji bubrežni klirens iznosi samo 30% ukupnog klirensa iz plazme, nije uočena korelacija između funkcije bubrega i sistemske izloženosti valsartanu.
Your doctor will normally advise you to stop taking Amlodipine/Valsartan Mylan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amlodipine/Valsartan Mylan. 
Liječnik će Vas u pravilu savjetovati da prekinete uzimati Amlodipin/Valsartan Mylan prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto lijeka Amlodipin/Valsartan Mylan.
The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. 
Poluvijek amlodipina je produljen i vrijednosti AUC-a su više u bolesnika s oštećenom jetrenom funkcijom; preporuke za doziranje nisu ustanovljene.
There is an increased risk of hypotension in patients receiving clarithromycin with amlodipine. 
Postoji povećan rizik od hipotenzije u bolesnika koji primaju klaritromicin s amlodipinom.
Patients taking amlodipine/valsartan and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. 
Bolesnici koji uzimaju amlodipin/valsartan i upravljaju vozilima ili rade sa strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC. 
Bolesnici s oštećenjem jetre imaju smanjeni klirens amlodipina s posljedičnim povećanjem AUC-a za otprilike 40-60%.
28 film-coated tablets 56 film-coated tablets 98 film-coated tablets 
28 filmom obloženih tableta 56 filmom obloženih tableta 98 filmom obloženih tableta
Do not take Amlodipine/Valsartan Mylan: if you are allergic to amlodipine or to any other calcium channel blockers. 
Nemojte uzimati Amlodipin/Valsartan Mylan: ako ste alergični na amlodipin ili neki drugi blokator kalcijevih kanala.
Talk to your doctor before taking Amlodipine/Valsartan Mylan: if you have been sick (vomiting or diarrhoea). 
Obratite se svom liječniku prije nego uzmete Amlodipin/Valsartan Mylan: ako ste bili bolesni (povraćanje ili proljev).
Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity. 
Štakori i miševi koji su dvije godine primali amlodipin s hranom u koncentracijama koje su prema izračunu osiguravale razine dnevnog doziranja od 0,5, 1,25 i 2,5 mg/kg/dan nisu pokazali nikakav dokaz kancerogenosti.
Amlodipine can have mild or moderate influence on the ability to drive and use machines. 
Amlodipin može blago ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Pack sizes: 14, 14x1 (unit dose), 28, 28x1 (unit dose), 30x1 (unit dose), 56, 56x1 (unit dose), 90x1 (unit dose), 98 or 98x1 (unit dose) film-coated tablets. 
Veličine pakiranja: 14, 14x1 (jedinična doza), 28, 28x1 (jedinična doza), 30x1 (jedinična doza), 56, 56x1 (jedinična doza), 90x1 (jedinična doza), 98 ili 98x1 (jedinična doza) filmom obloženih tableta.
Food decreases exposure (as measured by AUC) to valsartan by about 40 % and peak plasma concentration (Cmax) by about 50 %, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups. 
Hrana smanjuje izloženost (mjereno pomoću AUC) valsartanu za oko 40% i vršnu koncentraciju u plazmi (Cmax) za oko 50%, premda su koncentracije valsartana u plazmi oko 8 h nakon doziranja slične u skupini koja je uzimala hranu i skupini koja je bila natašte.
Not known (frequency cannot be estimated from the available data): trembling, rigid posture, masklike face, slow movements and a shuffling, unbalanced walk. 
Nepoznato (učestalost se ne može odrediti iz dostupnih podataka): drhtanje, kruto držanje, lice poput maske, spori pokreti i neuravnotežen hod sa sitnim koracima.
The use of Amlodipine/Valsartan Mylan in children and adolescents is not recommended (aged below 18 years old). 
Primjena lijeka Amlodipin/Valsartan Mylan u djece i adolescenata se ne preporučuje (ispod 18 godina starosti).
All packs are available in perforated unit dose blisters; the 14, 28, 56 and 98 tablet packs are also available in standard blisters. 
Sva pakiranja su dostupna s perforiranim blisterima djeljivim na jedinične doze; pakiranja od 14, 28, 56 i 98 tableta dostupna su i sa standardnim blisterima.
Additional information on the individual components Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with amlodipine/valsartan as well, even if not observed in clinical trials or during the post-marketing period. 
Dodatne informacije o pojedinačnim komponentama Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave amlodipina/valsartana, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
The safety and efficacy of amlodipine/valsartan in children aged below 18 years have not been established. 
Sigurnost i djelotvornost amlodipina/valsartana u djece u dobi ispod 18 godina nisu ustanovljene.
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1 % with the amlodipine/valsartan combination. 
Srednja vrijednost incidencije perifernih edema ravnomjerno raspoređena po svim dozama bila je 5,1% kod kombinacije amlodipin/valsartan.
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets 14x1 film-coated tablets (unit dose) 28x1 film-coated tablets (unit dose) 30x1 film-coated tablets (unit dose) 56x1 film-coated tablets (unit dose) 90x1 film-coated tablets (unit dose) 98x1 film-coated tablets (unit dose) 
14 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 98 filmom obloženih tableta 14x1 fimom obložena tableta (jedinična doza) 28x1 fimom obložena tableta (jedinična doza) 30x1 fimom obložena tableta (jedinična doza) 56x1 filmom obložena tableta (jedinična doza) 90x1 fimom obložena tableta (jedinična doza) 98x1 filmom obložena tableta (jedinična doza)
Amlodipine/Valsartan Mylan is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets. 
Amlodipin/Valsartan Mylan je dostupan u blister pakiranjima koja sadrže 14, 28, 30, 56, 90 ili 98 tableta.
The safety of amlodipine/valsartan has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine. 
Sigurnost amlodipina/valsartana je ispitivana u pet kontroliranih kliničkih ispitivanja s 5175 bolesnika, od kojih je 2613 primalo valsartan u kombinaciji s amlodipinom.
For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 
Za N-nitrozodimetilamin (NDMA) i N-nitrozodietilamin (NDEA) nositelj odobrenja za stavljanje lijeka u promet mora uvesti sljedeće specifikacije za djelatnu tvar lijeka: 1)
It is recommended to take Amlodipine/Valsartan Mylan with some water. 
Preporučuje se uzeti Amlodipin/Valsartan Mylan s nešto vode.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2
Clinically significant hypotension due to amlodipine/valsartan overdose 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. 
Klinički značajna hipotenzija zbog predoziranja amlodipinom/valsartanom zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
Do not take Amlodipine/Valsartan Mylan with grapefruit or grapefruit juice. 
Ne uzimajte Amlodipin/Valsartan Mylan s grejpom ili sokom od grejpa.
This may involve itching, reddening of the skin or difficulty in breathing. 
To može uključivati svrbež, crvenilo kože ili otežano disanje.
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 % versus 7.7 %, RR 1.38, 95 % CI [1.25-1.52] p<0.001). 
Među sekundarnim ishodima incidencija zatajivanja srca (komponenta kompozita kombiniranog kardiovaskularnog ishoda) bila je značajno viša u skupini na amlodipinu u usporedbi sa skupinom koja je uzimala klortalidon (10,2% naspram 7,7%, OR 1,38, 95% CI [1,25-1,52] p<0,001).
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan. 
Prijavljena su reverzibilna povećanja koncentracija litija u serumu i toksičnost tijekom istodobne primjene litija s inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, uključujući valsartan.
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure. 
Istodobna primjena amlodipina sa snažnim ili umjerenim inhibitorima CYP3A4 (inhibitori proteaze, azolni antifungalni lijekovi, makrolidi kao eritromicin, verapamil ili diltiazem) mogu izazvati značajno povećanje izloženosti amlodipinu.
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6 % versus 7.9 %, respectively). 
U kliničkim ispitivanjima u kojima se valsartan uspoređivao s ACE inhibitorom, incidencija suhog kašlja bila je značajno (p <0,05) niža u bolesnika liječenih valsartanom, nego u onih liječenih ACE inhibitorom (2,6% naspram 7,9%).
The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5 %), type 2 diabetes (36.1 %), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6 %), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9 %), current cigarette smoking (21.9 %). 
Bolesnici su imali najmanje jedan dodatni faktor rizika za koronarnu bolest srca, uključujući prethodni infarkt miokarda ili moždani udar (>6 mjeseci prije uključivanja u ispitivanje) ili dokumentaciju o drugoj aterosklerotskoj kardiovaskularnoj bolesti (ukupno 51,5%), šećernu bolest tipa 2 (36,1%), lipoprotein visoke gustoćekolesterol <35 mg/dl ili <0,906 mmol/l (11,6%), hipertrofiju lijevog ventrikula dijagnosticiranu elektrokardiogramom ili ehokardiografijom (20,9%), aktivni status pušača (21,9%).
What Amlodipine/Valsartan Mylan is and what it is used for What you need to know before you take Amlodipine/Valsartan Mylan How to take Amlodipine/Valsartan Mylan Possible side effects 
Što je Amlodipin/Valsartan Mylan i za što se koristi Što morate znati prije nego počnete uzimati Amlodipin/Valsartan Mylan Kako uzimati Amlodipin/Valsartan Mylan Moguće nuspojave
In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. 
U bolesnika s aktiviranim reninangiotenzinskim sustavom (poput bolesnika sa smanjenim volumenom tekućine i/ili sniženom razinom soli na visokim dozama diuretika) koji primaju blokatore angiotenzinskih receptora, može doći do simptomatske hipotenzije.
Abrupt withdrawal of amlodipine/valsartan has not been associated with a rapid increase in blood pressure. 
Nagli prekid primjene amlodipina/valsartana nije bio povezan s naglim povišenjem krvnog tlaka.
Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine. 
Mokraćom se izlučuje deset posto originalnog amlodipina i 60% metabolita amlodipina.
Patients with high cardiovascular risks - heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year - were excluded. 
Bolesnici s visokim kardiovaskularnim rizicimazatajivanje srca, tip I i loše kontrolirani tip II šećerne bolesti, kao i s infarktom miokarda ili moždanim udarom unutar godinu dana u anamnezi - bili su isključeni iz ispitivanja.
There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95 % CI (0.90-1.07) p=0.65. 
Nije bilo značajne razlike u primarnom ishodu između terapije temeljene na amlodipinu i terapije temeljene na klortalidonu: omjer rizika (OR) 0,98 95% CI (0,90-1,07) p=0,65.
Amlodipine/Valsartan Mylan combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines. 
Amlodipin/Valsartan Mylan kombinira dva antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, dok valsartan pripada skupini antagonista angiotenzina II.
Amlodipine/Valsartan Mylan is also available in bottles containing 28, 56 or 98 tablets. 
Amlodipin/Valsartan Mylan dostupan je i u bocama koje sadrže 28, 56 ili 98 tableta.