FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical experience in children less than 6 years of age Two clinical studies were conducted in patients aged 1 to 6 years with 90 and 75 patients, respectively.
Slovenian: Pri bolnikih v starosti od 1 leta do 6 let so izvedli dve klinični študiji: v eno je bilo vključenih 90 bolnikov, v drugo pa 75.
English: Novartis Healthcare A/S
Slovenian: Novartis Healthcare A/S Lyngbyvej 172
English: Valsartan does not undergo any noteworthy biotransformation.
Slovenian: Valsartan se biološko ne transformira v veliki meri.
English: INSTRUCTIONS FOR USING THE ORAL SYRINGE AND THE DOSING CUP Please read these instructions carefully before taking the medicine.
Slovenian: NAVODILA ZA UPORABO BRIZGE ZA PERORALNO DAJANJE IN MERICE Preden začnete jemati zdravilo, skrbno preberite ta navodila, saj boste le z njihovo pomočjo pravilno uporabljali brizgo za peroralno dajanje in merico.
English: • you must tell your doctor if you think you are (or might become) pregnant.
Slovenian: • Svojemu zdravniku morate povedati, če mislite da ste noseči ali če načrtujete nosečnost.
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p<0.05) less 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 pogostnost suhega kašlja pri bolnikih, ki so prejemali valsartan, statistično značilno manjša kot pri tistih, ki so prejemali zaviralec ACE (2,6 % v primerjavi s 7,9 %, p < 0,05).
English: - Hypertension
Slovenian: - Hipertenzija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 3 mg of valsartan.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter raztopine vsebuje 3 mg valsartana.
English: • increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
Slovenian: • zvišana koncentracija kalija v krvi (ki lahko v hudih primerih sproži mišične krče in nenormalen srčni ritem)
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Slovenian: Če se izkaže, da je sočasna uporaba obeh zdravil nujna, je priporočeno skrbno spremljanje koncentracije litija v serumu.
English: These cases occurred in a population who had significant comorbidities.
Slovenian: Do tega je prišlo v populaciji otrok, ki so imeli sočasno še druge pomembne bolezni.
English: The applicant will initiate a scientific dialogue via the CHMP's Scientific Advice with the involvement of the PDCO for protocol assistance with the aim of gaining further insight on a hypertensive clinical trial in younger children with valsartan and to define objectives and design parameters in investigating the efficacy in this population.
Slovenian: CHMP ob vključitvi odbora PDCO za pomoč pri protokolu, katerega cilj je pridobiti nadaljnji vpogled v klinično preskušanje hipertenzije pri majhnih otrocih,
English: Pack size: 1 bottle containing 160 ml oral solution
Slovenian: Velikost pakiranja: 1 steklenica vsebuje 160 ml peroralne raztopine
English: Use a new bottle adapter and oral dosing syringe each time you start a new bottle of medicine.
Slovenian: Vsakokrat, ko odprete novo steklenico z zdravilom, uporabite tudi nov nastavek za steklenico in novo brizgo za peroralno dajanje.
English: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Slovenian: Ker antagonisti angiotenzina II ne delujejo na ACE in ker ne stopnjujejo delovanja bradikinina ali snovi P, ni verjetno, da bi bili povezani s kašljanjem.
English: Children weighing between 18 kg and <35 kg received valsartan 80 mg or enalapril 10 mg; those between 35 kg and <80 kg received valsartan 160 mg or enalapril 20 mg; those 80 kg received valsartan 320 mg or enalapril 40 mg.
Slovenian: Otroci s telesno maso med ≥ 18 in < 35 kg so prejemali valsartan v odmerku 80 mg ali enalapril v odmerku 10 mg; tisti s telesno maso med ≥ 35 kg in < 80 kg so prejemali valsartan v odmerku 160 mg ali enalapril v odmerku 20 mg; tisti s telesno maso ≥ 80 kg pa so prejemali valsartan v odmerku 320 mg ali enalapril v odmerku 40 mg.
English: Diovan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Uporaba zdravila Diovan ni priporočljiva v zgodnjem obdobju nosečnosti, po tretjem mesecu nosečnosti pa lahko povzroči resno škodo vašemu otroku (glejte poglavje Nosečnost in dojenje).
English: What you will be using
Slovenian: Uporabljali boste:
English: Functional renal maturation is an ongoing process within the first year of life in humans.
Slovenian: Pri ljudeh poteka fukcionalno dozorevanje ledvic še celo prvo leto življenja.
English: • Restart the cycle of PSUR submission for Diovan as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Slovenian: • ponovno začel cikel rednega predlaganja posodobljenih poročil o varnosti zdravila Diovan, kot sledi: o enkrat na 6 mesecev je treba predložiti posodobljena poročila o varnosti zdravila, dokler ne bodo na voljo izkušnje s pediatrično indikacijo v EU za obdobje dveh celih let,
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Slovenian: Valsartan v peroralnih odmerkih do 200 mg/kg/dan ni neugodno vplival na razmnoževanje podganjih samic in samcev.
English: If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
Slovenian: Če ste vzeli večji odmerek zdravila Diovan, kot bi smeli Če občutite hudo omotičnost in/ali omedlevico, se takoj povežite s svojim zdravnikom in se ulezite.
English: • decreased kidney function (signs of renal impairment)
Slovenian: • zmanjšano delovanje ledvic (znak ledvične okvare)
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Slovenian: V študiji MARVAL (Zmanjšanje mikroalbuminurije z valsartanom - Micro Albuminuria Reduction with Valsartan) so ocenili zmanjšanje izločanja albumina z urinom (urinary albumin excretion - UAE) z valsartanom (v odmerku 80-160 mg/enkrat na dan) v primerjavi z amlodipinom ( v odmerku 5-10 mg/enkrat na dan), pri 332 bolnikih s sladkorno boleznijo tipa 2 (povprečna starost: 58 let; 265 moških) z mikroalbuminurijo (v skupini z valsartanom: 58 µg/min; v skupini z amlodipinom: 55,4 µg/min), z normalnim ali zvišanim krvnim tlakom in z ohranjenim delovanjem ledvic (koncentracija kreatinina v krvi < 120 µmol/l).
English: NO-0510 Oslo (Tel: +47-2305 20 00 )
Slovenian: Postboks 237 Økern NO-0510 Oslo (Tel: +47-2305 20 00 )
English: The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/min; 20-700 µg/min) and preserved renal function (mean serum creatinine = 80 µmol/l).
Slovenian: V študiji zmanjševanja proteinurije z zdravilom Diovan (Diovan Reduction of Proteinuria - DROP) so naprej preučevali učinkovitost valsartana pri zmanjšanju izločanja albumina z urinom pri 391 hipertenzivnih bolnikih (s krvnim tlakom 150/88 mmHg), s sladkorno boleznijo tipa 2, z albuminurijo (v povprečju 102 µg/min; v obsegu 20-700 µg/min) in z ohranjenim delovanjem ledvic (s povprečno koncentracijo kreatinina v serumu 80 µmol/l).
English: AIIRAs 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, hyperkalemia); see also section 5.3 “Preclinical safety data”.
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte tudi poglavje 5.3).
English: This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
Slovenian: To je zlasti pomembno, če ima bolnik, ki prejema valsartan, še druge težave, ki lahko ovirajo delovanje ledvic (če ima zvišano telesno temperaturo ali je dehidriran).
English: Need for dose adaptation when switching between oral solution and tablets.
Slovenian: potrebo po prilagoditvi odmerka ob prehodu s peroralne raztopine na tablete in obratno,
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: V primeru izpostavljenosti antagonistom angiotenzina II od drugega trimesečja nosečnosti dalje je priporočen ultrazvočni pregled delovanja ledvic in lobanje.
English: Use in paediatric patients aged 6 to 18 years with renal impairment Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Slovenian: Uporaba pri pediatričnih bolnikih, ki so stari od 6 do 18 let in imajo okvaro ledvic Pri pediatričnih bolnikih z očistkom kreatinina < 30 ml/min in pri pediatričnih bolnikih, ki se zdravijo z dializo, uporabe valsartana niso proučevali, zato pri teh bolnikih ni priporočena.
English: Screw the cap back on the bottle.
Slovenian: Na steklenico privijte zaporko.
English: Diovan has not been studied in patients with severe hepatic dysfunction (see sections 4.2, 4.3 and 4.4).
Slovenian: Študij z zdravilom Diovan pri bolnikih z hudo okvaro jeter (glejte poglavja 4.2, 4.4 in 4.4) niso izvedli.
English: The dose should be titrated based on blood pressure response and tolerability.
Slovenian: Odmerek je treba titrirati glede na odziv krvnega tlaka in glede na to, kako bolnik prenaša odmerek.
English: Note: The total amount of solution that can be measured into the oral syringe is 5 ml.
Slovenian: Opozorilo: Z brizgo za peroralno dajanje lahko odmerite največ 5 ml raztopine.
English: In some cases your doctor may ask you to take up to 80 mg of valsartan (corresponding to 27 ml of the solution).
Slovenian: V nekaterih primerih vam bo zdravnik svetoval jemanje višjega odmerka, največ do 80 mg valsartana (kar ustreza 27 ml raztopine).
English: Clinical experience in children at or above 6 years of age In a clinical study involving 261 hypertensive paediatric patients 6 to 16 years of age, patients who weighed <35 kg received 10, 40 or 80 mg of valsartan tablets daily (low, medium and high doses), and patients who weighed 35 kg received 20, 80, and 160 mg of valsartan tablets daily (low, medium and high doses).
Slovenian: V klinični študiji, v katero je bilo vključenih 261 hipertenzivnih pediatričnih bolnikov v starosti od 6 do 16 let, so bolniki s telesno maso < 35 kg v obliki tablet prejemali 10, 40 ali 80 mg valsartana na dan (nizke, srednje ali visoke odmerke), bolniki s telesno maso ≥ 35 kg pa so v obliki tablet prejemali 20, 80 ali 160 mg valsartana na dan (nizke, srednje ali visoke odmerke).
English: Potential risks: renal impairment, elevation of liver function values, hypersensitivity including angioedema and serum sickness, hemoglobin/hematocrit decreased and medication error including overdose.
Slovenian: preobčutljivost, vključno z angioedemi in serumsko boleznijo, znižane vrednosti hemoglobina/hematokrita in napačna uporaba zdravila, vključno s prevelikim odmerjanjem,
English: Missing information: clinical management and use of pharmacotherapy in paediatric heart failure, paediatric recent myocardial infarction, paediatric hypertension with renal impairment (GFR < 30 mL/min) and paediatric hypertension with mild to moderate hepatic impairment.
Slovenian: manjkajoče informacije: klinična obravnava in uporaba zdravil pri srčnem popuščanju pri pediatričnih bolnikih, pri nedavnem miokardnem infarktu pri pediatričnih bolnikih, pri hipertenziji z okvaro ledvic pri pediatričnih bolnikih
English: • increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
Slovenian: • zvišana koncentracija dušika sečnine v krvi in zvišana koncentracija kreatinina v serumu (kar lahko kaže na nenormalno delovanje ledvic)
English: • if you are suffering from a narrowing of the kidney artery.
Slovenian: • če imate zožanje ledvične arterije,
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients.
Slovenian: Trenutno ni izkušenj z varno uporabo pri bolnikih z očistkom kreatinina < 10 ml/min in pri bolnikih, ki se zdravijo z dializo, zato je treba valsartan pri teh bolnikih uporabljati previdno.
English: Stella-Klein-Löw-Weg 17 A-1020 Wien (Tel: + 43-1-8665 70)
Slovenian: Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A-1020 Wien (Tel: + 43-1-8665 70)
English: To clean the oral syringe:
Slovenian: Čiščenje brizge za peroralno dajanje:
English: o In the pharmacovigilance plan: Targeted checklists for follow up of adverse events listed above as potential risks in the paediatric population A study primarily aimed at establishing the long-term safety in CKD and non-CKD paediatric patients.
Slovenian: ciljno usmerjene sezname za preverjanje pri nadaljnjem spremljanju neželenih dogodkov, ki so navedeni zgoraj kot potencialna tveganja v pediatrični populaciji,
English: Nausea, Diarrhoea
Slovenian: Bolezni prebavil občasni navzea, diareja
English: Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Slovenian: Natančno je treba spremljati delovanje ledvic in vrednosti kalija v serumu (glejte poglavji 4.4 in 5.2).
English: Bartók Béla út 43-47 H-1114 Budapest
Slovenian: Novartis Hungaria Kft. Bartók Béla út 43-47
English: These effects above mentioned represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Slovenian: Navedeni učinki so pričakovani prekomerno izraženi farmakološki učinki zaviralcev angiotenzinske konvertaze in antagonistov receptorjev tipa 1 angiotenzina II.
English: Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Diovan oral solution as it contains sucrose.
Slovenian: Bolniki z redkimi prirojenimi motnjami, kot so intoleranca za fruktozo, malabsorpcija glukoze/galaktoze ali zmanjšana aktivnost saharaze-izomaltaze, ne smejo jemati Diovan peroralne raztopine, ker vsebuje saharozo.
English: Blood and lymphatic system disorders Not known
Slovenian: Bolezni krvi in limfatičnega sistema neznana trombocitopenija
English: An oral dosing syringe:
Slovenian: Brizga za peroralno dajanje:
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Slovenian: Diuretiki, ki varčujejo s kalijem, kalijevi nadomestki, nadomestki soli, ki vsebujejo kalij, in druge snovi, ki lahko zvišajo koncentracijo kalija
English: The systemic exposure and peak plasma concentration of valsartan is higher with the solution compared to the tablets.
Slovenian: Pri uporabi raztopine je sistemska izpostavljenost valsartanu večja, njegova najvišja koncentracija v plazmi pa višja kot pri uporabi tablet.
English: Diovan and associated names 3 mg/ml oral solution Valsartan
Slovenian: Diovan in sorodna imena 3 mg/ml peroralna raztopina Valsartan
English: Novartis Norge AS
Slovenian: Novartis Norge AS Brynsalléen 4
English: Renal function and serum potassium should be closely monitored (see sections 4.2 and 4.4).
Slovenian: Natančno je treba spremljati delovanje ledvic in vrednosti kalija v serumu (glejte poglavji 4.2 in 4.4).
English: Measuring a dose of medicine
Slovenian: Odmerjanje prave količine zdravila
English: Metsänneidonkuja 10
Slovenian: Novartis Finland Oy Metsänneidonkuja 10
English: • Always put the dosing cup back onto the cap after use and cleaning.
Slovenian: • Po uporabi in čiščenju merico vedno namestite spet na zaporko.
English: Carefully turn the bottle and oral syringe back upright.
Slovenian: Previdno obrnite steklenico z vstavljeno brizgo spet v pokončen položaj.
English: No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Slovenian: Pri odraslih bolnikih z očistkom kreatinina > 10 ml/min odmerka ni treba prilagajati (glejte poglavji 4.2 in 5.2).
English: MARKETING AUTHORISATION NUMBER [To be completed nationally]
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment.
Slovenian: Obseg kliničnih izkušenj z uporabo zdravila Diovan pri pediatričnih bolnikih z blago do zmerno okvaro jeter je omejen.
English: Vascular disorders Not known
Slovenian: Žilne bolezni neznana vaskulitis
English: Hypersensitivity including serum sickness
Slovenian: Bolezni imunskega sistema neznana preobčutljivost vključno s serumsko boleznijo
English: Hyperkalaemia was more frequently observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease.
Slovenian: Pri otrocih in mladostnikih, ki so bili stari od 6 do 18 let in so že imeli kronično bolezen ledvic, so pogosteje opažali hiperkaliemijo.
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Slovenian: Pri pediatričnih bolnikih z očistkom kreatinina > 30 ml/min odmerkov ni treba prilagajati (glejte poglavji 4.2 in 5.2).
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/m2 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: If switching from Diovan oral solution to Diovan tablets is considered clinically essential, initially the same dose in milligrams should be given.
Slovenian: Če kaže, da je iz kliničnih razlogov nujno potreben prehod z uporabe Diovan peroralne raztopine na uporabo Diovan tablet, je treba začeti z odmerki valsartana, ki so po miligramih enakovredni prejšnjim.
English: It comes with a dispensing kit containing one press in bottle adapter, one 5 ml oral polypropylene dosing syringe and one 30 ml polypropylene dosing cup.
Slovenian: Pakiranju je priložen tudi komplet za odmerjanje, ki vsebuje en pritisni nastavek za steklenico, eno 5-mililitrsko polipropilensko brizgo za peroralno dajanje in eno 30-mililitrsko polipropilensko merico.
English: 1 bottle containing 160 ml oral solution.
Slovenian: 1 steklenica vsebuje 160 ml peroralne raztopine.
English: I-21040 Origgio (Tel: + 39-02-96542214)
Slovenian: Largo Umberto Boccioni 1 I-21040 Origgio (Tel: + 39-02-96542214)
English: What Diovan contains
Slovenian: Kaj vsebuje zdravilo Diovan
English: HOW TO TAKE DIOVAN
Slovenian: KAKO JEMATI ZDRAVILO DIOVAN
English: • The other ingredients are sucrose, methyl parahydroxybenzoate (E218), potassium sorbate,
Slovenian: • Pomožne snovi so saharoza, metilparahidroksibenzoat (E218), kalijev sorbat, poloksamer (188),
English: In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Slovenian: Varnosti uporabe zdravila Diovan pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije solitarne ledvice niso ugotavljali.
English: HOW TO STORE DIOVAN
Slovenian: SHRANJEVANJE ZDRAVILA DIOVAN
English: Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Slovenian: Pri pediatričnih bolnikih z očistkom kreatinina < 30 ml/min in pri pediatričnih bolnikih, ki se zdravijo z dializo, uporabe valsartana niso proučevali, zato pri teh bolnikih ni priporočena.
English: 1 dispenser kit containing one press in bottle adapter, one 5 ml oral syringe and one 30 ml dosing cup.
Slovenian: 1 komplet za odmerjanje vsebuje en pritisni nastavek za steklenico, eno 5-mililitrsko brizgo za peroralno dajanje in eno 30-mililitrsko merico.
English: Keeping the bottle upright, insert the oral syringe firmly into the bottle adapter.
Slovenian: Steklenico postavite pokonci in brizgo za peroralno dajanje trdno vstavite v nastavek za steklenico.
English: The Risk Management Plan should include the following: o In the safety specification: results of juvenile safety studies regarding the risk of nephrotoxicity and its relevance for the use in the different paediatric groups paediatric exposure in clinical trials and in post marketing use by age group, indication (including off label use), dose, duration of use, gender and ethnicity o As safety concerns: Identified risks: hyperkalemia and hypotension.
Slovenian: izpostavljenost pediatričnih bolnikov zdravilu v kliničnih preskušanjih in pri uporabi v času trženja zdravila glede na starostno skupino, indikacijo (vključno z uporabo izven obsega indikacij), odmerek, trajanje uporabe, spol in etnično pripadnost,
English: poloxamer (188), citric acid anhydrous, sodium citrate, artificial blueberry flavour, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water.
Slovenian: brezvodna citronska kislina, natrijev citrat, umetna aroma borovnice, propilenglikol (E1520),
English: These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of
Slovenian: Ti odmerki pri podganah (600 mg/kg/dan) so približno 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: NAME OF THE MEDICINAL PRODUCT Diovan and associated names 3 mg/ml oral solution
Slovenian: IME ZDRAVILA Diovan in sorodna imena 3 mg/ml peroralna raztopina
English: • Diovan solution contains 0.3 g sucrose per millilitre.
Slovenian: • Diovan raztopina vsebuje 0,3 g saharoze na mililiter, kar morate upoštevati, če imate sladkorno bolezen.
English: The protocol of the study will be submitted by the applicant in the second quarter of 2010 for agreement with the CHMP with input from the PDCO.
Slovenian: 2010 za pridobitev soglasja odbora CHMP ob upoštevanju mnenja Odbora za pediatrijo (PDCO).
English: o the usual dose is 40 mg of valsartan (corresponding to 13 ml of the solution).
Slovenian: • Če tehtate 35 kg ali več: o je običajni odmerek 40 mg valsartana (kar ustreza 13 ml raztopine).
English: Diovan oral solution contains 0,3 g sucrose per mililiter.
Slovenian: Diovan peroralna raztopina vsebuje 0,3 g saharoze na mililiter, kar je treba upoštevati pri bolnikih s sladkorno boleznijo.
English: Renal function and serum potassium should be closely monitored during treatment with valsartan.
Slovenian: Med zdravljenjem z valsartanom je treba natančno spremljati delovanje ledvic in vrednosti kalija v serumu.