natgillin/translations-raw huggingface dataset:
Packaging Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC)
ovojnina pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC)
Package size 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
velikost pakiranja 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 280 tablet (4 x 70) 280 tablet (4 x 70) 280 tablet (4 x 70)
Copalia 5 mg/ 80 mg film-coated tablets
Copalia 5 mg/ 80 mg filmsko obložene tablete
Dark yellow, round film-coated tablet with bevelled edges, imprinted with “ NVR” on one side and “ NV” on the other side.
Temnorumene, okrogle filmsko obložene tablete s poševnimi robovi, ki imajo na eni strani oznako “ NVR ” in na drugi “ NV ”.
Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Zdravilo Copalia je indicirano pri bolnikih, pri katerih krvni tlak ni ustrezno urejen ob monoterapiji z amlodipinom ali valsartanom.
Copalia 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Copalijo 5 mg/ 80 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali z 80 mg valsartana.
Copalia can be used with or without food.
Bolnik lahko Copalijo vzame s hrano ali brez nje.
It is recommended to take Copalia with some water.
Copalijo je priporočljivo vzeti z nekaj vode.
Individual dose titration with the components (i. e. amlodipine and valsartan) is recommended before changing to the fixed dose combination.
Pred prehodom na kombinacijo s fiksnim odmerkom je priporočljivo individualno titriranje odmerka sestavin (tj. amlodipina in valsartana).
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Copalia containing the same component doses.
Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/ kapsulah, prevesti na Copalijo, ki vsebuje enaka odmerka sestavin.
Renal impairment No dosage adjustment is required for patients with mild to moderate renal impairment.
Okvara ledvic Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
Hepatic impairment Caution should be exercised when administering Copalia to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Okvara jeter Previdnost je potrebna pri uporabi zdravila Copalia pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4. 4).
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
Starejši (starost 65 let in več) Pri starejših bolnikih je treba odmerjanje povečevati previdno.
2 Children and adolescents Copalia is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
2 Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti zdravila Copalia ni priporočljivo uporabljati pri bolnikih, mlajših od 18 let.
Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients.
Preobčutljivost za zdravilni učinkovini, dihidropiridinske derivate ali katerokoli pomožno snov.
Severe renal impairment (GFR < 30 ml/ min/ 1.73 m2) and patients undergoing dialysis.
Huda okvara ledvic (hitrost glomerulne filtracije < 30 ml/ min/ 1, 73 m2) in bolniki na dializi.
Second and third trimesters of pregnancy (see section 4.4 and 4.6).
Drugo in tretje trimesečje nosečnosti (glejte poglavji 4. 4 in 4. 6).
Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Nosečnost Zdravljenja z antagonisti angiotenzina II se ne sme začeti med nosečnostjo.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6).
Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4. 3 in 4. 6).
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Copalia in placebo-controlled studies.
Bolniki s pomanjkanjem natrija in/ ali volumna V študijah, kontroliranih s placebom, so čezmerno hipotenzijo opažali pri 0, 4% bolnikov z nezapleteno hipertenzijo, ki so dobivali Copalijo.
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.
Pri bolnikih z aktiviranim sistemom renin - angiotenzin (npr. pri bolnikih s pomanjkanjem volumna in/ ali soli, ki dobivajo velike odmerke diuretikov), ki dobivajo blokatorje receptorjev angiotenzina, se lahko pojavi simptomatska hipotenzija.
Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be undertaken with caution and with frequent monitoring of potassium levels.
Hiperkaliemija Med sočasno uporabo dodatkov kalija, diuretikov, ki varčujejo s kalijem, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki lahko povečajo koncentracijo kalija (npr. heparin), je potrebna previdnost; v takšnih primerih je potrebno pogosto nadziranje koncentracije kalija.
Renal artery stenosis No data are available on the use of Copalia in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenoza ledvične arterije Ni podatkov o uporabi zdravila Copalia pri bolnikih z obojestransko stenozo ledvične arterije oz. s stenozo v primeru solitarne ledvice.
Kidney transplantation To date there is no experience of the safe use of Copalia in patients who have had a recent kidney transplantation.
Presaditev ledvice Doslej ni izkušenj glede varnosti uporabe zdravila Copalia pri bolnikih, ki jim je bila nedavno presajena ledvica.
Hepatic impairment Valsartan is mostly eliminated unchanged via the bile, whereas amlodipine is extensively metabolised by the liver.
Okvara jeter Valsartan se večinoma izloči nespremenjen v žolču, amlodipin pa se izdatno presnovi v jetrih.
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
3 Okvara ledvic Pri bolnikih z blago do zmerno okvaro ledvic (hitrost glomerulne filtracije > 30 ml/ min/ 1, 73 m2) odmerka zdravila Copalia ni treba prilagajati.
3 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Primarni hiperaldosteronizem Bolnikov s primarnim hiperaldosteronizmom ne smete zdraviti z antagonistom angiotenzina II, valsartanom, ker tem bolnikom osnovna bolezen prizadene sistem renin- angiotenzin.
Heart failure As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Srčno popuščanje Zaradi zavrtja sistema renin- angiotenzin- aldosteron je pri dovzetnih posameznikih mogoče pričakovati spremenjeno delovanje ledvic.
In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/ or progressive azotaemia and (rarely) with acute renal failure and/ or death.
Pri bolnikih s hudim srčnim popuščanjem, pri katerih je delovanje ledvic lahko odvisno od aktivnosti sistema renin- angiotenzin- aldosteron, so se med zdravljenjem z zaviralci angiotenzinske konvertaze (ACE) in antagonisti receptorjev angiotenzina pojavile oligurija in/ ali napredujoča azotemija ter (redko) akutna odpoved ledvic in/ ali smrt.
In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
V dolgoročni, s placebom kontrolirani študiji (PRAISE- 2) amlodipina pri bolnikih s srčnim popuščanjem neishemične etiologije, ki so bili v razredih III in IV po NYHA (razvrstitev po New York Heart Association) je bil amlodipin povezan s številnejšimi opisanimi primeri pljučnega edema, čeprav se pojavnost poslabšanja srčnega popuščanja ni značilno razlikovala od tiste pri placebu.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija Tako kot pri vseh vazodilatatorjih, je posebna previdnost potrebna pri bolnikih z aortno ali mitralno stenozo ali obstruktivno hipertrofično kardiomiopatijo.
Copalia has not been studied in any patient population other than hypertension.
Copalia ni raziskana pri nobeni drugi populaciji, razen pri hipertenzivnih bolnikih.
Interactions linked to amlodipine Caution required with concomitant use CYP3A4 inhibitors A study in elderly patients has shown that diltiazem inhibits the metabolism of amlodipine, probably via CYP3A4 (plasma concentration increases by approximately 50% and the effect of amlodipine is increased).
Interakcije, povezane z amlodipinom Med sočasno uporabo je potrebna previdnost Zaviralci CYP3A Študija pri starejših bolnikih je pokazala, da diltiazem zavre presnovo amlodipina, verjetno prek CYP3A4 (plazemska koncentracija se zviša za približno 50% in učinek amlodipina se poveča).
The possibility that more potent inhibitors of CYP3A4 (i. e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine to a greater extent than diltiazem cannot be excluded.
Ni možno izključiti možnosti, da močnejši zaviralci CYP3A4 (npr. ketokonazol, itrakonazol, ritonavir) plazemsko koncentracijo amlodipina povečajo bolj kot diltiazem.
CYP3A4 inducers (anticonvulsant agents [e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Co-administration may lead to reduced plasma concentrations of amlodipine.
Induktorji CYP3A4 (antiepileptiki [kot so npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon], rifampicin, Hypericum perforatum) Sočasna uporaba lahko zniža plazemsko koncentracijo amlodipina.
Clinical monitoring is indicated, with possible dosage adjustment of amlodipine during the treatment with the inducer and after its withdrawal.
Med zdravljenjem z induktorjem in po prenehanju njegove uporabe je potrebno klinično nadziranje ter morebitna prilagoditev odmerka amlodipina.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
Med sočasno uporabo je treba paziti Drugo V monoterapiji so amlodipin varno uporabljali s tiazidnimi diuretiki, zaviralci beta, zaviralci ACE, dolgodelujočimi nitrati, sublingvalnim nitroglicerinom, digoksinom, varfarinom, atorvastatinom, sildenafilom, antacidi (gel aluminijevega hidroksida, magnezijev hidroksid, simetikon), cimetidinom, nesteroidnimi protivnetnimi zdravili, antibiotiki in peroralnimi antidiabetiki.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Interakcije, povezane z valsartanom Sočasna uporaba ni priporočljiva Litij Med sočasno uporabo zaviralcev ACE so poročali o reverzibilnem povečanju koncentracije litija v serumu in povečanju njegovih toksičnih učinkov.
Despite the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Kljub pomanjkanju izkušenj s sočasno uporabo
If the combination proves necessary, careful monitoring of serum lithium levels is recommended (see section 4.4).
Če se ta kombinacija izkaže za potrebno, je priporočljivo natančno kontrolirati koncentracijo litija v serumu (glejte poglavje 4. 4).
4 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Diuretiki, ki varčujejo s kalijem, kalijevi dodatki, nadomestki soli, ki vsebujejo kalij in druge učinkovine, ki lahko zvišajo koncentracijo kalija Če je treba v kombinaciji z valsartanom predpisati zdravilo, ki vpliva na koncentracijo kalija, je priporočljivo kontrolirati koncentracijo kalija v plazmi.
Caution required with concomitant use Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur.
Med sočasno uporabo je potrebna previdnost Nesteroidna protivnetna zdravila (NSAIDs), vključno s selektivnimi zaviralci COX- 2, acetilsalicilno kislino (> 3 g/ dan) in neselektivnimi NSAIDs Če so antagonisti angiotenzina II uporabljeni sočasno z NSAIDs, se lahko njihov antihipertenzivni učinek zmanjša.
Others In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Drugo Med monoterapijo z valsartanom niso ugotovili klinično pomembnih interakcij z naslednjimi učinkovinami: cimetidinom, varfarinom, furosemidom, digoksinom, atenololom, indometacinom, hidroklorotiazidom, amlodipinom, glibenklamidom.
Interactions common to the combination No drug interaction studies were performed with Copalia and other medicinal products.
Interakcije, pogoste ob kombinaciji Študij medsebojnega delovanja z zdravilom Copalia in drugimi zdravili ni bilo.
To be taken into account with concomitant use Other antihypertensive agents Commonly used antihypertensive agents (e. g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e. g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Med sočasno uporabo je treba paziti Drugi antihipertenzivi Pogosto uporabljana antihipertenzivna zdravila (npr. zaviralci alfa, diuretiki) in druga zdravila, ki imajo lahko neželene hipotenzivne učinke (npr. triciklični antidepresivi, zaviralci alfa za zdravljenje benigne hiperplazije prostate), lahko povečajo hipotenzivni učinek kombinacije.
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Uporaba antagonistov angiotenzina II v prvem trimesečju nosečnosti ni priporočljiva (glejte poglavje 4. 4).
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see section 4.3 and 4.4).
Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4. 3. in 4. 4).
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, an, if appropriate, alternative therapy should be started.
Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
AIIRAs therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3).
(glejte tudi poglavje 5. 3).
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see section 4.3 and 4.4).
Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti hipotenzije (glejte tudi poglavji 4. 3 in 4. 4).
There is no experience on the use of Copalia in pregnant women.
5 Z uporabo zdravila Copalia pri nosečnicah ni izkušenj.
Data on a limited number of exposed pregnancies
Študije na živalih kažejo, da ima kombinacija valsartan/ amlodipin reproduktivne toksične učinke, ki se skladajo z učinki, opisanimi za valsartan in druge antagoniste angiotenzina II (glejte poglavje 5. 3).
5 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Podatki o majhnem številu nosečnosti, izpostavljenih amlodipinu in drugim zaviralcem kalcijevih kanalčkov, ne kažejo neželenih učinkov teh učinkovin.
However, there may be a risk of prolonged delivery.
Kljub temu pa lahko obstaja tveganje za dolgotrajnejši porod.
It is not known whether valsartan and/ or amlodipine are excreted in human milk.
Ni znano, ali se valsartan in/ ali amlodipin pri človeku izločata v materino mleko.
Valsartan was excreted in the milk of lactating rats.
Valsartan se je izločal v mleko doječih podgan.
Because of the potential adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy, taking into account the importance of this therapy for the mother.
Ker ima zdravilo lahko neželene učinke na dojene otroke, se je treba odločiti, ali naj ženska prekine dojenje ali pa terapijo; pri tem je treba upoštevati pomen te terapije za mater.
The safety of Copalia has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Varnost zdravila Copalia so ocenili v petih kontroliranih kliničnih študijah s 5. 175 bolniki, od katerih jih je 2. 613 dobivalo valsartan v kombinaciji z amlodipinom.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Neželeni učinki so razvrščeni po oznakah pogostnosti upoštevaje naslednji dogovor: zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥1/ 1. 000, < 1/ 100), redki (≥1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
Tachycardia, palpitations Syncope
tahikardija, palpitacije sinkopa
Headache Dizziness, somnolence, dizziness postural, paraesthesia
glavobol omotica, zaspanost, posturalna omotica, parestezije
Cough, pharyngolaryngeal pain
kašelj, faringo- laringealne bolečine
Gastrointestinal disorders Renal
Bolezni prebavil
Uncommon: and urinary disorders Rare:
Občasni:
Diarrhoea, nausea, abdominal pain, constipation, dry mouth Pollakisuria, polyuria
driska, navzeja, bolečine v trebuhu, zaprtje, suhost ust
Rash, erythema Hyperhidrosis, exanthema, pruritus
polakisurija, poliurija
Joint swelling, back pain, arthralgia Muscle spasm, sensation of heaviness
osip, eritem hiperhidroza, izpuščaj, srbenje
Infections and infestations
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Orthostatic hypotension Hypotension
oteklost sklepov, bolečine v hrbtu, artralgija mišični spazmi, občutek teže
General disorders and administration site conditions
Infekcijske in parazitske bolezni Žilne
Common:
Pogosti: bolezni Občasni:
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia, hot flush
nazofaringitis, gripa ortostatska hipotenzija hipotenzija
6
6 Splošne težave in spremembe na mestu aplikacije
Additional information on the combination Peripheral oedema, a recognised side effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/ valsartan combination than in those who received amlodipine alone.
Dodatne informacije o kombinaciji Periferne edeme, ki so znan neželeni učinek amlodipina, so na splošno opažali manj pogosto pri bolnikih, ki so prejemali kombinacijo amlodipin/ valsartan, v primerjavi z bolniki, ki so prejemali samo amlodipin.
% of patients who experienced peripheral oedema
% bolnikov s perifernimi edemi
Valsartan (mg)
valsartan
0 2.5 Amlodipine 5 (mg) 10
0 2, 5 amlodipin 5 (mg) 10
3.0 5.5 8.0 2.3 3.1 4.8 10.3 NA
5, 5 2, 3 4, 8 ni podatka
2.4 5.4 2.3 NA
2, 4 5, 4 2, 3 ni podatka
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/ valsartan combination.
Povprečna incidenca perifernih edemov, enakovredno uravnotežena za vse odmerke kombinacije amlodipin/ valsartan, je bila 5, 1%.