FrancophonIA/ELRC3.0 huggingface dataset:
English: Over 1,400 hypertensive patients received amlodipine/valsartan once daily in two placebo-controlled trials.
Slovenian: V dveh s placebom kontroliranih preskušanjih je amlodipin/valsartan enkrat na dan dobivalo več kot 1.400 bolnikov s hipertenzijo.
English: The mean incidence of peripheral oedema evenly weighted across all doses was 5.1 % with the amlodipine/valsartan combination.
Slovenian: Povprečna incidenca perifernih edemov, enakovredno uravnotežena za vse odmerke kombinacije amlodipin/valsartan, je bila 5,1 %.
English: White high density polyethylene (HDPE) bottle with white opaque polypropylene cap with aluminium induction sealing liner wad.
Slovenian: Bela polietilenska plastenka visoke gostote (HDPE) z belo neprozorno polipropilensko zaporko z vatirano oblogo in indukcijsko zavarjeno pečatno plastjo aluminija.
English: Following oral administration of amlodipine/valsartan, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Slovenian: Po peroralni uporabi amlodipina/valsartana doseže valsartan največjo koncentracijo v plazmi v 3 urah, amlodipin pa v 6 do 8 urah.
English: Caution should be exercised when administering amlodipine/valsartan to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Slovenian: Previdnost je potrebna pri uporabi amlodipina/valsartana pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4.4).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila se posvetujte z zdravnikom ali farmacevtom.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Slovenian: Dvojno zaviranje sistema renin-angiotenzin-aldosteron (RAAS) Obstajajo dokazi, da sočasna uporaba zaviralcev ACE, antagonistov angiotenzinskih receptorjev II (ARB) ali aliskirena poveča tveganje za hipotenzijo, hiperkaliemijo in zmanjšano delovanje ledvic (vključno z akutno odpovedjo ledvic).
English: Your doctor may also check your kidney function; anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin and other nitrates, or other substances called “vasodilators”;
Slovenian: Zdravnik bo morda pregledal tudi delovanje vaših ledvic; antiepileptična zdravila (npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon); šentjanževko; nitroglicerin in druge nitrate ter učinkovine, ki jih imenujemo “vazodilatatorji”;
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with amlodipine/valsartan.
Slovenian: Če je uporabljen tudi diuretik, uporaba amlodipina/valsartana predvidoma poveča toksične učinke litija.
English: medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, talithromycin); clarithromycin (for infections caused by bacteria); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); tacrolimus (used to control your body's immune response, enabling your body to accept the transplanted organ); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Slovenian: zdravila za zdravljenje okužb z virusom HIV ali AIDS (npr. ritonavir, indinavir, nelfinavir); zdravila za zdravljenje glivičnih okužb (npr. ketokonazol, itrakonazol); zdravila za zdravljenje bakterijskih okužb (kot so rifampicin, eritromicin, talitromicin); klaritromicin (za bakterijske okužbe); verapamil, diltiazem (zdravili za srce); simvastatin (zdravilo za uravnavanje previsoke ravni holesterola); takrolimus (za nadzorovanje imunskega odziva vašega telesa, kar omogoča, da vaše telo sprejme presajeni organ); dantrolen (zdravilo v infuziji pri hudih odstopanjih telesne temperature); zdravila za preprečevanje zavrnitve presadka (ciklosporin).
English: The rate and extent of absorption of amlodipine/valsartan are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Slovenian: Hitrost in obseg absorpcije amlodipina/valsartana sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenih v ločenih tabletah.
English: In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Slovenian: V kliničnih študijah, v katerih so pri bolnikih s hipertenzijo ali angino pektoris amlodipin uporabili v kombinaciji z zaviralci receptorjev beta, niso zabeležili neželenih vplivov na elektrokardiografske parametre.
English: Particular caution should be exercised when administering amlodipine/valsartan to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Slovenian: Posebna previdnost je potrebna v primeru uporabe amlodipina/valsartana pri bolnikih z blago do zmerno okvaro jeter ali z obstruktivnimi biliarnimi boleznimi.
English: For bottle packs: After first opening use within 100 days.
Slovenian: EXP Za pakiranja s plastenkami: Po prvem odprtju porabite v 100 dneh.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Amlodipine/Valsartan Mylan or observed with a higher frequency than with Amlodipine/Valsartan Mylan:
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi amlodipina ali valsartana samega, ki jih bodisi niso opažali pri uporabi zdravila Amlodipin/valsartan Mylan ali pa so jih opažali z večjo pogostnostjo kot pri uporabi zdravila Amlodipin/valsartan Mylan:
English: 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.
Slovenian: To je tudi pričakovano pri spojini, pri kateri ledvični očistek predstavlja le 30 % celotnega očistka iz plazme.
English: Coating:
Slovenian: Pretisni omot:
English: Other possible side effects of Amlodipine/Valsartan Mylan:
Slovenian: Drugi možni neželeni učinki zdravila Amlodipin/valsartan Mylan:
English: Amlodipine/Valsartan Mylan with food and drink Grapefruit and grapefruit juice should not be consumed by people who are taking Amlodipine/Valsartan Mylan.
Slovenian: Zdravilo Amlodipin/valsartan Mylan skupaj s hrano in pijačo Ljudje, ki jemljejo zdravilo Amlodipin/valsartan Mylan, ne smejo uživati grenivk in grenivkinega soka.
English: Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Slovenian: Valsartan spada med zdravila, ki jih imenujemo ''antagonisti angiotenzina II''.
English: If you stop taking Amlodipine/Valsartan Mylan Stopping your treatment with Amlodipine/Valsartan Mylan may cause your disease to get worse.
Slovenian: Če ste prenehali jemati zdravilo Amlodipin/valsartan Mylan Če prenehate jemati zdravilo Amlodipin/valsartan Mylan, se lahko vaša bolezen poslabša.
English: Dilated ureters were also found in the valsartan alone group (exposure 12 times the clinical dose of 160 mg valsartan).
Slovenian: Razširjene ureterje so ugotovili tudi v skupini, ki je dobivala samo valsartan (12krat večja izpostavljenost kot ob kliničnem odmerku 160 mg valsartana).
English: Read the package leaflet before use.
Slovenian: POSTOPEK IN POT UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Mylan” and “Warnings and precautions”); diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce); lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Slovenian: To še posebej velja za naslednja zdravila: zaviralci ACE ali aliskiren (glejte tudi informacije pod naslovoma “Ne jemljite zdravila Amlodipin/valsartan Mylan” in “Opozorila in previdnostni ukrepi”); diuretike (vrsto zdravil, ki jim pravimo tudi "tablete za odvajanje vode" in povečajo nastajanje urina v telesu); litij (zdravilo, ki se uporablja za zdravljenje nekaterih vrst depresij); diuretike, ki varčujejo s kalijem, kalijeve dodatke, nadomestke soli, ki vsebujejo kalij, in druge učinkovine, ki lahko zvišajo koncentracijo kalija; določena zdravila proti bolečinam, ki jih imenujemo nesteroidna protivnetna zdravila (NSAID) ali selektivni zaviralci ciklooksigenaze-2 (zaviralci COX-2).
English: 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.
Slovenian: Pri primarnem cilju opazovanja ni bilo statistično značilne razlike med zdravljenjem, ki je vključevalo amlodipin, in tistim, ki je vključevalo klortalidon: razmerje tveganj (risk ratio - RR) je bilo 0,98; 95-odstotni IZ: 0,90-1,07 in vrednost p=0,65.
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or amlodipine/valsartan, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Slovenian: Pri prehodu hipertenzivnih bolnikov (glejte poglavje 4.1) z okvaro jeter na amlodipin ali amlodipin/valsartan je potrebno uporabiti najmanjši razpoložljivi odmerek amlodipina kot monoterapije ali komponente v kombiniranem zdravilu.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: It is recommended to take Amlodipine/Valsartan Mylan with some water.
Slovenian: Zdravilo Amlodipin/valsartsan Mylan je priporočljivo vzeti z malo vode.
English: (It is also better to avoid Amlodipine/Valsartan Mylan in early pregnancy, see Pregnancy section).
Slovenian: ste noseči več kot 3 mesece (zdravilu Amlodipin/valsartan Mylan se je bolje izogibati tudi v zgodnji nosečnosti, glejte poglavje Nosečnost).
English: In this study (baseline blood pressure 171/113 mmHg), an amlodipine/valsartan regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Slovenian: V tej študiji (izhodiščni krvni tlak 171/113 mm Hg) je shema odmerjanja amlodipina/valsartana 5 mg/160 mg, titrirana do 10 mg/160 mg, znižala krvni tlak sede za 36/29 mm Hg; v primerjavi s tem je shema odmerjanja lizinoprila/hidroklorotiazida 10 mg/12,5 mg, titrirana do 20 mg/12,5 mg, znižala krvni tlak za 32/28 mm Hg.
English: Fertility There are no clinical studies on fertility with amlodipine/valsartan.
Slovenian: Plodnost Kliničnih študij glede plodnosti pri uporabi amlodipina/valsartana ni.
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an angiotensin II receptor blocker (ARB).
Slovenian: Drugo: Dvojno zaviranje sistema renin-angiotenzin-aldosteron (RAAS) Uporabo zaviralca ACE v kombinaciji z antagonistom angiotenzinskih receptorjev II (ARB) so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] in VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes].
English: Excessive hypotension was seen in 0.4 % of patients with uncomplicated hypertension treated with amlodipine/valsartan in placebo-controlled studies.
Slovenian: V študijah, kontroliranih s placebom, so čezmerno hipotenzijo opažali pri 0,4 % bolnikov z nezapleteno hipertenzijo, ki so dobivali amlodipin/valsartan.
English: There is no experience of overdose with amlodipine/valsartan.
Slovenian: Izkušenj s prevelikim odmerjanjem amlodipina/valsartana ni.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m basis) was close to the maximum tolerated dose for mice but not for rats.
Slovenian: Največji odmerek (pri miših je ta v mg/m2 izražen odmerek podoben največjemu priporočenemu kliničnemu odmerku 10 mg, pri podganah pa predstavlja dvakratnik* tega odmerka) je bil blizu največjega odmerka, ki ga miši še prenašajo, to pa ni veljalo za podgane.
English: 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).
Slovenian: V kliničnih preskušanjih, v katerih so valsartan primerjali z zaviralcem ACE, je bila pojavnost suhega kašlja med prejemniki valsartana značilno manjša kot pri prejemnikih zaviralca ACE (2,6 % med prvimi, 7,9 % med drugimi, p < 0,05).
English: Renal impairment There are no available clinical data in severely renally impaired patients.
Slovenian: Okvara ledvic Pri bolnikih s hudo okvaro ledvic kliničnih podatkov ni na voljo.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: What Amlodipine/Valsartan Mylan is and what it is used for
Slovenian: Kaj je zdravilo Amlodipin/valsartan Mylan in za kaj ga uporabljamo
English: The effect of amlodipine/valsartan on infants is unknown.
Slovenian: Učinek amlodipina na dojene otroke ni znan.
English: What you need to know before you take Amlodipine/Valsartan Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Amlodipin/valsartan Mylan
English: Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Slovenian: Če se pojavi karkoli od naslednjega, morate o tem namudoma obvestiti zdravnika: alergijska reakcija s simptomi, kot so osip, srbenje, otekanje obraza, ustnic ali jezika, težko dihanje, nizek krvni tlak (občutek omedlevice, vrtoglavica).
English: If any of these apply to you, tell your doctor before taking Amlodipine/Valsartan Mylan.
Slovenian: Če kaj od naštetega velja za vas, morate to povedati zdravniku, preden vzamete zdravilo Amlodipin/valsartan Mylan.
English: Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data have shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren is associated with a higher frequency of adverse events such as hypotension, 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 dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, antagonistov angiotenzinskih receptorjev II (ARB) ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, 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: Marketing Authorisation Holder Mylan S.A.S.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Mylan S.A.S.
English: Talk to your doctor before taking Amlodipine/Valsartan Mylan: if you have been sick (vomiting or diarrhoea).
Slovenian: Pred začetkom jemanja zdravila Amlodipin/valsartan Mylan se posvetujte z zdravnikom: če vam je bilo slabo (bruhanje ali driska).
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based 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: Amlodipine/valsartan should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Slovenian: Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oz. s stenozo v primeru solitarne ledvice je pri zdravljenju hipertenzije z amlodipinom/valsartanom potrebna previdnost, saj pri takih bolnikih lahko pride do zvišanja koncentracij sečnine v krvi in kreatinina v serumu.
English: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Slovenian: Srčno popuščanje/obdobje po miokardnem infarktu Zaradi zavrtja sistema renin-angiotenzin-aldosteron je pri dovzetnih posameznikih mogoče pričakovati spremenjeno delovanje ledvic.
English: Amlodipine/Valsartan Mylan is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Slovenian: Zdravilo Amlodipin/valsartan Mylan uporabljamo za zdravljenje visokega krvnega tlaka pri odraslih, pri katerih krvni tlak ni dovolj dobro urejen samo z amlodipinom ali samo z valsartanom.
English: No drug-drug interaction studies have been performed with amlodipine/valsartan and other medicinal products.
Slovenian: Interakcije pogoste ob kombinaciji Študij medsebojnega delovanja z amlodipinom/valsartanom in drugimi zdravili niso izvedli.
English: If any of the above applies to you, do not take Amlodipine/Valsartan Mylan and talk to your doctor.
Slovenian: Če kaj od naštetega velja za vas, ne vzemite zdravila Amlodipin/valsartan Mylan, temveč se posvetujte z zdravnikom.
English: Hepatic impairment Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment.
Slovenian: Klinični podatki o uporabi amlodipina pri bolnikih z okvaro jeter so zelo omejeni.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pregledati postopke proizvodnje učinkovin, uporabljenih za svoja zdravila, glede morebitnega tveganja za nastajanje N-nitrozaminov in jih po potrebi spremeniti tako, da se onesnaženje z nitrozamini čim bolj zmanjša.
English: If you get these symptoms, stop taking Amlodipine/Valsartan Mylan and contact your doctor straight away.
Slovenian: Če opazite navedene simptome, takoj prenehajte jemati zdravilo Amlodipin/valsartan Mylan in obvestite zdravnika.
English: Similar changes were also seen in the valsartan alone group (exposure 8.5-11.0 times the clinical dose of 160 mg valsartan).
Slovenian: Podobne spremembe so ugotovili tudi v skupini, ki je dobivala samo valsartan (od 8,5- do 11-krat večja izpostavljenost kot ob kliničnem odmerku 160 mg valsartana).
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Slovenian: Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Slovenian: Zdravilo Amlodipin/valsartan Mylan je indicirano pri odraslih, pri katerih krvni tlak ni ustrezno urejen ob monoterapiji z amlodipinom in valsartanom.
English: You can take Amlodipine/Valsartan Mylan with or without food.
Slovenian: Zdravilo Amlodipin/valsartan Mylan lahko vzamete s hrano ali brez nje.
English: You should never take Amlodipine/Valsartan Mylan again.
Slovenian: V tem primeru zdravila Amlodipin/valsartan Mylan nikoli več ne smete jemati.
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: 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 receptorjev beta pri ljudeh.
English: Frequency Amlodipine/Valsartan Amlodipine Valsartan
Slovenian: Pogostnost Amlodipin/valsartan Amlodipin Valsartan
English: Amlodipine/Valsartan Mylan tablets contain two active substances called amlodipine and valsartan.
Slovenian: Tablete zdravila Amlodipin/valsartan Mylan vsebujejo dve učinkovini: amlodipin in valsartan.
English: Майлан ЕООД Тел: +359 2 44 55 400
Slovenian: Тел: +359 2 44 55 400
English: In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Slovenian: Obstaja tveganje povečanih vrednosti takrolimusa v krvi, kadar se zdravilo daje sočasno z amlodipinom, V izogib toksičnosti takrolimusa je pri dajanju amlodipina bolnikom, zdravljenih s takrolimusim, potrebno spremljanje vrednosti takrolimusa v krvi in prilagoditev odmerka takrolimusa, kadar je to potrebno.
English: PVC/PCTFE blisters.
Slovenian: PVC/PCFTE pretisni omoti
English: SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DODATEK I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: There is an increased risk of hypotension in patients receiving clarithromycin with amlodipine.
Slovenian: Pri bolnikih, ki prejemajo klaritromicin v kombinaciji z amlodipinom, obstaja povečano tveganje za hipotenzijo.
English: Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
Slovenian: Redki (pojavijo se pri njaveč 1 od 1.000 bolnikov): občutek tesnobe; zvenjenje v ušesih (tinitus); omedlevica; izločanje več urina kot ponavadi ali pogostejše siljenje na vodo; nezmožnost doseganja ali ohranitvev erekcije; občutek teže; nizek krvni tlak s simptomi, kot sta omotica in vrtoglavica; čezmerno znojenje; osip po koži po vsem telesu; srbenje; mišični krči.
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of
Slovenian: Ti odmerki pri podganah (200 do 600 mg/kg/dan) so približno 6-krat in 18-krat večji od največjega priporočenega odmerka za ljudi na osnovi mg/m2 (izračun predvideva peroralni odmerek 320 mg/dan in 60-kg bolnika).
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Amlodipine/Valsartan Mylan is also available in bottles containing 28, 56 or 98 tablets.
Slovenian: Zdravilo Amlodipin/valsartan Mylan je na voljo tudi v plastenkah s po 28, 56, ali 98 filmsko obloženih tablet.