natgillin/translations-raw huggingface dataset:
The following side effects have been reported with COZAAR:
Poročali so o naslednjih neželenih učinkih zdravila COZAAR:
HOW TO TAKE COZAAR
KAKO JEMATI ZDRAVILO COZAAR
Losartan is not recommended in children with glomerular filtration rate < 30 ml/ min/1.73 m2as no data are available (see section 4.2).
Losartana ne priporočamo za uporabo pri otrocih, ki imajo hitrost glomerulne filtracije < 30 ml/min/1,73 m2, ker ni na voljo nobenih podatkov (glejte poglavje 4.2).
ANNEX II SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
DODATEK IIPOVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
It was found that concomitant treatment of losartan with rifampicine (inducer of metabolism enzymes) gave a 40 % reduction in plasma concentration of the active metabolite.
Ugotovili so, da je pri sočasnem zdravljenju z losartanom in rifampicinom (induktor presnovnih encimov) plazemska koncentracija aktivnega presnovka manjša za 40 %.
Losartan therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3 ).
Znano je, da izpostavljenost losartanu v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnija, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte tudi poglavje 5.3).
WHAT COZAAR IS AND WHAT IT IS USED FOR Losartan (COZAAR) belongs to a group of medicines known as angiotensin-II receptor antagonists.
Losartan (COZAAR) spada v skupino zdravil, imenovanih antagonisti receptorjev angiotenzina II.
As with other medicinal products that block angiotensin II or its effects, concomitant use of other medicinal products which retain potassium (e.g. potassium-sparing diuretics: amiloride, triamterene, spironolactone) or may increase potassium levels (e.g. heparin), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium.
Kot pri drugih zdravilih, ki zavirajo angiotenzin II ali njegove učinke, lahko sočasna uporaba drugih zdravil, ki zadržujejo kalij (npr. diuretikov, ki varčujejo kalij, amilorida, triamterena, spironolaktona) ali lahko povečajo količino kalija (npr. heparin), dodatkov kalija ali nadomestkov soli, ki vsebujejo kalij, povzroči zvišanje vrednosti kalija v serumu.
Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana, Slovenia
Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000
Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
V izjemnih primerih se odmerek lahko prilagodi do največ 100 mg enkrat na dan. Odmerki nad 1,4 mg/kg (ali nad 100 mg) na dan pri pediatričnih bolnikih niso bili preizkušani.
• to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence ofimpaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
• za zaščito ledvic pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2, pri katerih so laboratorijski izvidi pokazali okvaro ledvic in proteinurijo ≥ 0,5 g na dan (stanje s preveliko količino beljakovin v urinu).
Following oral and intravenous administration of 14C-labeled losartan potassium, circulating plasma radioactivity primarily is attributed to losartan and its active metabolite.
Radioaktivnost plazme po peroralni in intravenski aplikaciji s 14C označenega kalijevega losartanata pripisujemo predvsem losartanu in njegovemu aktivnemu presnovku.
• One 240 ml bottle with a child resistant closure for mixing the suspension
• 240 ml plastenko z za otroke varno zaporko za pripravo suspenzije
Investigations: uncommon: increase in blood urea, serum creatinine and serum potassium has been reported.
Občasno: poročali so o zvišanih vrednosti sečnine v krvi ter kreatinina in kalija v serumu.
The plasma concentrations of the active metabolite are not altered in patients with renal impairment or in haemodialysis patients.
Plazemske koncentracije aktivnega presnovka se pri bolnikih z okvaro ledvic ali bolnikih na hemodializi ne razlikujejo.
Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively.
Najvišja srednja koncentracija losartana in njegovega aktivnega presnovka je dosežena po 1 oz. 3-4 urah.
• medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparine),
• zdravila, ki zadržujejo kalij ali lahko povečajo količino kalija (npr. dodatki kalija, nadomestki soli, ki vsebujejo kalij, zdravila, ki varčujejo kalij, kot so določeni diuretiki [amilorid, triamteren, spironolakton], ali heparin).
Reconstitution of COZAAR oral suspension [for 200 ml of a 2.5 mg/ml suspension]:
Priprava COZAAR peroralne suspenzije [za 200 ml suspenzije s koncentracijo 2,5 mg/ml]:
There is no sufficient therapeutic experience with losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV) as well as in patients with heart failure and symptomatic life-threatening cardiac arrhythmias.
Izkušenj z zdravljenjem z losartanom pri bolnikih s srčnim popuščanjem in sočasno hudo okvaro ledvic, pri bolnikih s hudim srčnim popuščanjem (NYHA razred IV) ter bolnikih s srčnim popuščanjem in simptomatsko življenjsko nevarno srčno aritmijo ni dovolj.
Treatment with losartan reduced the risk of stroke by 25 % relative to atenolol (p=0.001 95 % confidence interval 0.63-0.89).
Zdravljenje z losartanom je v primerjavi z atenololom zmanjšalo tveganje za možgansko kap za 25 % (p=0,001;95-odstotni interval zaupanja 0,63-0,89).
• if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
• če močno bruhate ali imate hudo drisko in zato izgubljate veliko tekočine in/ali soli.
Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze tega zdravila ne smejo jemati.
Patients with proteinuria and a serum creatinine of 1.3 - 3.0 mg/dl were randomised to receive Losartan 50 mg once a day, titrated if necessary, to achieve blood pressure response, or to placebo, on a background of conventional antihypertensive therapy excluding ACE-inhibitors and angiotensin II antagonists.
Bolnike s proteinurijo in vrednostjo kreatinina v serumu1,3-3,0 mg/dl so randomizirali tako, da so dobivali losartan 50 mg enkrat na dan (po potrebi so odmerek titrirali, da so dosegli odziv krvnega tlaka) ali placebo; poleg tega so bolniki iz obeh skupin dobivali običajna antihipertenzivna zdravila razen zaviralcev ACE in antagonistov angiotenzina II.
At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dosedependent manner.
Po treh tednih se je pri uporabi losartana enkrat dnevno krvni tlak v času, ko je učinek zdravila najnižji, zmanjšal v skladu z odmerkom.
Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Losartan se lahko jemlje skupaj z drugimi zdravili za zniževanje krvnega tlaka (npr. diuretiki, zaviralci kalcijevih kanalčkov, alfa ali beta zaviralci in zdravili, ki delujejo na centralno živčevje), kot tudi z insulinom in drugimi običajno uprabljenimi zdravili za zmanjševanje količine glukoze v krvi (npr. sulfonilsečnino, glitazoni, zaviralci glukozidaze).
Always take COZAAR exactly as your doctor has instructed you.
Pomembno je, da nadaljujete z jemanjem zdravila COZAAR tako dolgo, kot vam je predpisal zdravnik.
Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored especially patients with heart failure and a creatinine clearance between 30-50 ml/min should be closely monitored.
Še posebej skrbno je treba spremljati bolnike s srčnim popuščanjem in kreatininskim očistkom 30-50 ml/min.
Lindenplatz 1 85540, Haar, Germany
Nemčija VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 85540, Haar, Nemčija
• In a controlled clinical trial in 9193 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy
• V kontroliranem kliničnem preskušanju pri 9193 hipertenzivnih bolnikih, starih 55 do 80 let, s hipertrofijo levega prekata
Use in pediatric patients with renal impairment
Uporaba pri pediatričnih bolnikih z boleznijo ledvic
Renal clearance of losartan and its active metabolite is about 74 ml/min and 26 ml/min, respectively.
Renalni očistek losartana je 74 ml/min, njegovega aktivnega presnovka pa 26 ml/min.
Pull out the plunger to withdraw the medicine into the syringe.
Izvlecite bat, da potegnete zdravilo v brizgo.
Push the plunger of the syringe completely down.
Bat brizge potisnite čisto do konca.
• to treat patients with chronic heart failure when therapy with specific medicines calledangiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower highblood pressure) is not considered suitable by your doctor.
• za zdravljenje bolnikov s kroničnim srčnim popuščanjem, če zdravnik meni, da zdravljenje z zaviralci angiotenzinske konvertaze (zaviralci ACE, zdravila za zniževanje krvnega tlaka) ni primerno.
Hypertensive patients with left-ventricular hypertrophy In a controlled clinical trial in 9193 hypertensive patients 55 to 80 years of age with left-ventricular hypertrophy the following adverse events were reported:
Hipertenzivni bolniki s hipertrofijo levega prekata V kontroliranem kliničnem preskušanju pri 9193 hipertenzivnih bolnikih, starih 55 do 80 let, s hipertrofijo levega prekata so poročali o naslednjih neželenih učinkih:
• In controlled clinical trials in approximately 3300 adult patients 18 years of age and older for essential hypertension
• V kontroliranih kliničnih preskušanjih pri približno 3300 odraslih bolnikih, starih 18 let in več, z esencialno hipertenzijo
Losartan potassium
Kalijev losartanat
Remove the screw cap, place the push-in bottle neck adaptor on the bottle, and re-cap the bottle.
Odstranite zamašek, na plastenko namestite nastavek za vrat plastenke in ponovno zamašite plastenko.
If you accidentally take too much COZAAR oral suspension, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila COZAAR, kot bi smeli Če slučajno vzamete preveč peroralne suspenzije COZAAR, se takoj posvetujte z zdravnikom.
• a 240 ml amber polyethylene terephthalate (PET) bottle with polypropylene child resistant closure for mixing the suspension,
• 240 ml rumeno-rjava PET plastenka (polyethylene terephthalate - polietilenijev tereftalat) s polipropilensko za otroke varno zaporko za pripravo suspenzije
The use of losartan is contraindicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and
Uporaba losartana je kontraindicirana v 2. in 3. trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
Powder microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464) titanium dioxide (E171)
Prašek mikrokristalna celuloza (E460) laktoza monohidrat predgelirani koruzni škrob magnezijev stearat (E572) hidroksipropilceluloza (E463) hipromeloza (E464) titanov dioksid (E171)
Cardiac disorder: Uncommon: palpitations, angina pectoris
Srčne bolezni: občasne: palpitacije, angina pektoris
• In a controlled clinical trial in 1513 type 2 diabetic patients 31 years of age and older with proteinuria
• V kontroliranem kliničnem preskušanju pri 1513 bolnikih, starih 31 let in več, s sladkorno boleznijo tipa 2 in proteinurijo
Very Common:
zelo pogosti:
Neither losartan nor the active metabolite can be removed by haemodialysis.
Niti losartana niti njegovega aktivnega presnovka ni možno odstraniti s hemodializo.
Use in children and adolescents (6 to 16 years):
Pediatrična hipertenzija Uporaba pri otrocih in mladostnikih (6 do 16 let):
As with other medicinal products that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
Tako kot pri drugih zdravilih, ki vplivajo na sistem renin-angiotenzinaldosteron, so o zvišanju sečnine v krvi in zvišanju kreatinina v serumu poročali tudi pri bolnikih z obojestranskim zoženjem ledvične arterije ali zoženjem arterije ene same delujoče ledvice.
• In a controlled clinical trial in approximately 3900 patients 20 years of age and older with chronic heart failure
• V kontroliranem kliničnem preskušanju pri približno 3900 bolnikih, starih 20 let in več, s kroničnim srčnim popuščanjem
Plasma clearance of losartan and its active metabolite is about 600 ml/min and 50 ml/min, respectively.
Plazemski očistek losartana je približno 600 ml/min, njegovega aktivnega presnovka pa 50 ml/min.
Concomitant use of losartan and ACE-inhibitors has shown to impair renal function.
Pokazalo se je, da sočasna uporaba losartana in zaviralcev ACE okvari ledvice.
If your heart failure has beenstabilised with an ACE inhibitor you should not be switched to losartan.
Če je srčno popuščanje stabilno ob zdravljenju z zaviralcem ACE, vam zdravnik zdravila ne sme zamenjati za losartan.
Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Bolnikom s srčnim popuščanjem, katerih stanje je stabilno ob jemanju zaviralca ACE, zdravila ne smemo zamenjati z losartanom.
Powder and solvent for oral suspension.
Prašek in vehikel za peroralno suspenzijo.
After suspension in solvent, COZAAR is an offwhite liquid.
Po suspendiranju v vehiklu je zdravilo COZAAR sivo-bela tekočina.
No difference in exposure was found with concomitant treatment with fluvastatin (weak inhibitor of CYP2C9).
Pri sočasnem zdravljenju s fluvastatinom (šibek zaviralec CYP2C9) niso ugotovili nobenih razlik v izpostavljenosti.
In a controlled clinical trial in approximately 3900 patients 20 years of age and older with cardiac insufficiency the following adverse events were reported:
V kontroliranem kliničnem preskušanju pri približno 3900 bolnikih, starih 20 let in več, s srčno insuficienco so poročali o naslednjih neželenih učinkih:
What COZAAR contains
Kaj vsebuje zdravilo COZAAR
Paediatric Hypertension
Pediatrična hipertenzija
Uncommon: symptomatic hypotension (especially in patients with intravascular volume depletion, e.g. patients with severe heart failure or under treatment with high-dose diuretics), dose-related orthostatic effects, rash.
Žilne bolezni: občasne: simptomatska hipotenzija (posebej pri bolnikih z zmanjšanim intravaskularnim volumnom, npr. bolnikih s hudim srčnim popuščanjem ali bolnikih, ki se zdravijo z velikimi odmerki diuretikov), od odmerka odvisni ortostatski učinki, izpuščaj
-Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
- Losartana ne priporočamo tudi za uporabo pri otrocih z jetrno okvaro (glejte tudi poglavje 4.4).
If goal blood pressure (< 140/90 mmHg) was not reached, hydrochlorothiazide (12.5 mg) was added first and, if needed, the dose of Losartan or atenolol was then increased to 100 mg once daily.
Če ciljnega krvnega tlaka (< 140/90 mmHg) niso dosegli, so najprej dodali hidroklorotiazid (12,5 mg), potem pa so, če je bilo potrebno, povečali odmerek losartana ali atenolola na 100 mg enkrat na dan. Za doseg ciljnega krvnega tlaka so, če je bilo potrebno, dodali še druge antihipertenzive, razen zaviralcev ACE, antagonistov angiotenzina II ali beta zaviralcev.
Cardiac disorders: not known: syncope, palpitations
Srčne bolezni: pogostnost ni znana: sinkopa, palpitacije
Microcrystalline cellulose (E460), carboxymethylcellulose sodium, citric acid anhydrous, purified water, xantham gum (E415), methylhydroxybenzoate (E218), sodium phosphate monobasic monohydrate, potassium sorbate, carrageenan calcium sulfate trisodium phosphate, flavor berry citrus sweet, glycerin, propylhydroxybenzoate (E216), sodium citrate anhydrous, saccharin sodium, sorbitol (E420)antifoam Af emulsion (contains water, polydimethylsiloxane, C-14-18, mono- and diglycerides, polyethylene glucol stearate, and polyethylene glycol).
Vehikel mikrokristalna celuloza (E460), natrijeva karboksimetilceluloza, citronska kislina, brezvodna, prečiščena voda, ksantanski gumi (E415), metilhidroksibenzoat (E218), natrijev dihidrogenfosfat monohidrat, kalijev sorbat, karagenan kalcijev sulfat trinatrijev fosfat, sladilo z okusom jagode in citrusa, glicerin, propilhidroksibenzoat (E216), natrijev citrat, brezvodni, natrijev saharinat, sorbitol (E420), protipenilna Af emulzija (vsebuje vodo, polidimetilsiloksan, C-14-18 mono- in di-gliceride, polietilenglikol stearat in polietilenglikol)
Muscoskeletal and connective tissue disorders: not known: myalgia, arthralgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva: pogostnost ni znana: mialgija, artralgija
The rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan at the lowest dose in each group, again suggesting that the lowest dose in each group did not have significant antihypertensive effect.
Povečanje diastoličnega krvnega tlaka tik pred naslednjim odmerkom je bilo enako pri bolnikih, ki so prejemali placebo, in bolnikih, ki so nadaljevali zdravljenje z losartanom z najmanjšim odmerkom v obeh skupinah.
Microcrystalline cellulose (E460), Lactose monohydrate, Pregelatinized maize starch, Magnesium stearate (E572), Hydroxypropyl cellulose (E463), Hypromellose (E464), and titanium dioxide (E171)
Prašek mikrokristalna celuloza (E460), laktoza monohidrat, predgelirani koruzni škrob, magnezijev stearat (E572), hidroksipropilceluloza (E463), hipromeloza (E464) in titanov dioksid (E171)
• a 10 ml oral dosing polypropylene syringe packed individually with a low density polyethylene push-in bottle neck adapter (PIBA) in a poly bag.
• 10 ml polipropilenska brizga za peroralno odmerjanje, pakirana skupaj z nastavkom za vrat plastenke iz polietilena nizke gostote (PIBA)
• One 473 ml bottle of solvent
• Plastenko s 473 ml vehikla
The following adverse events have been reported in post-marketing experience: Blood and lymphatic system disorders:
O naslednjih neželenih učinkih so poročali v okviru izkušenj z zdravilom v obdobju trženja: Bolezni krvi in limfatičnega sistema: pogostnost ni znana: anemija, trombocitopenija
Discard the excess solvent not used in the preparation of the suspension.
Ostanek vehikla, ki ga niste uporabili za pripravo suspenzije, zavrzite.
Vascular disorders: uncommon: hypotension, including orthostatic hypotension
Žilne bolezni: občasne: hipotenzija, vključno z ortostatsko hipotenzijo
The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg or 10 ml of COZAAR suspension).
Uporaba pri otrocih in mladostnikih (starih 6 do 16 let) Priporočeni začetni odmerek pri bolnikih, ki tehtajo med 20 in 50 kg, je 0,7 mg losartana na kg telesne teže enkrat na dan (do 25 mg ali 10 ml COZAAR suspenzije).
Treatment usually starts with 12.5 mg losartan (5 ml of COZAAR suspension) once a day.
Zdravljenje se običajno začne s 50 mg losartana (20 ml COZAAR suspenzije) enkrat na dan.
Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg losartan (20 ml of COZAAR suspension) once daily according to your condition.
Zdravljenje se običajno začne z 12,5 mg losartana (5 ml COZAAR suspenzije) enkrat na dan. Večinoma je treba odmerek povečati glede na vaše stanje, postopoma, tedensko (tj. 12,5 mg dnevno prvi teden, 25 mg dnevno drugi teden, 50 mg dnevno tretji teden) do običajnega vzdrževalnega odmerka 50 mg losartana (20 ml COZAAR suspenzije) enkrat na dan.
Muscoskeletal and connective tissue disorders: not known: back pain
Bolezni mišično-skeletnega sistema in vezivnega tkiva: pogostnost ni znana: bolečine v hrbtu
In controlled clinical trials of approximately 3300 adult patients 18 years of age and older for essential hypertension with losartan the following adverse events were reported.
V kontroliranih kliničnih preskušanjih z losartanom pri približno 3300 odraslih bolnikih, starih 18 let in več, z esencialno hipertenzijo so poročali o naslednjih neželenih učinkih:
affects 1 to 10 users in 100
se pojavijo pri 1 do 10 od 100 uporabnikov občasni:
If you experience the following, stop taking losartan and tell your doctor immediately or go to the casualty department of your nearest hospital:
Losartan takoj prenehajte jemati in se posvetujte z zdravnikom ali pa takoj pojdite na urgenco, če se pri vas pojavi kaj od sledečega:
Before opening the sachet gently tap on the side of the sachet to facilitate transfer of the material.
Preden odprete vrečko, nežno potrkajte po eni strani vrečke, da umaknete prašek.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 500 mg losartan potassium
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Vsebuje 500 mg kalijevega losartanata.
Solvent microcrystalline cellulose carboxymethylcellulose sodium citric acid anhydrous purified water xantham gum (E415) methylhydroxybenzoate (E218) sodium phosphate monobasic monohydrate potassium sorbate (E202) carrageenan calcium sulfate, trisodium phosphate flavor berry citrus sweet glycerin propylhydroxybenzoate (E216) sodium citrate anhydrous saccharin sodium sorbitol (E420)antifoam AF emulsion (contains water, polydimethylsiloxane, C-14-18, mono- and diglycerides, polyethylene glucol stearate, and polyethylene glycol.)
Vehikel mikrokristalna celuloza natrijeva karboksimetilceluloza citronska kislina, brezvodna prečiščena voda ksantanski gumi (E415) metilhidroksibenzoat (E218) natrijev dihidrogenfosfat monohidrat kalijev sorbat (E202) karagenan kalcijev sulfat, trinatrijev fosfat sladilo z okusom jagode in citrusa glicerin propilhidroksibenzoat (E216) natrijev citrat, brezvodni natrijev saharinat sorbitol (E420) protipenilna AF emulzija (vsebuje vodo, polidimetilsiloksan, C-14-18 mono- in di-gliceride, polietilenglikol stearat in polietilenglikol.)
UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Lithuania
UAB Merck Sharp & Dohme, Geležinio Vilko 18A,
The solvent contains sorbitol.
Intoleranca za sorbitol/fruktozo Vehikel vsebuje sorbitol.
The sachet should NOT be rinsed.
Vrečke ne smete sprati.
The sachet should not be rinsed.
Vrečke NE smete sprati.
Safety data should be presented in the PSUR separated by age group and used formulation (e.g. tablets or oral suspension).
je treba podatke o varnosti predstaviti ločeno po starostni skupini in uporabljenem pripravku
Vascular disorders: not known: orthostatic hypotension
Žilne bolezni: pogostnost ni znana: ortostatska hipotenzija
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Velika Britanija
Treatment with losartan resulted in a 13.0 % risk reduction (p=0.021, 95 % confidence interval 0.77-0.98) compared with atenolol for patients reaching the primary composite endpoint.
Zdravljenje z losartanon je v primerjavi z atenololom tveganje za primarni sestavljeni opazovani dogodek zmanjšalo za 13,0 % (p = 0,021; 95-odstotni interval zaupanja 0,77-0,98).
Place the screw cap on the bottle and shake the contents well to disperse.
Plastenko zaprite z zamaškom in stresajte,da se vsebina lepo porazdeli.