natgillin/translations-raw huggingface dataset:
During repeated dosing, the antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks and persist during long-term therapy.
Po večkratnem odmerjanju pride do znatnega znižanja krvnega tlaka v 2 tednih, v 4 tednih pa do največjega učinka, ki se med dolgotrajnim zdravljenjem ohranja.
Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2-4 hours with tablets and 1-2 hours with solution formulation.
Po peroralni uporabi samo valsartana doseže ta najvišjo koncentracijo v plazmi v 2-4 urah po zaužitju tablet in v 1-2 urah po zaužitju raztopine.
• decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
• zmanjšana koncentracija hemoglobina in zmanjšan odstotek rdečih krvnih celic v krvi (ki lahko v hudih primerih povzroči anemijo)
In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
V kontroliranih kliničnih študijah pri odraslih bolnikih s hipertenzijo je bila pogostnost vseh neželenih učinkov primerljiva s tisto pri placebu in v skladu s farmakologijo valsartana.
For children who are unable to swallow tablets, the use of the Diovan oral solution up to 80 mg valsartan (corresponding to 27 ml) is recommended.
Za otroke, ki ne morejo pogoltniti tablet, je priporočena uporaba Diovan peroralne raztopine v odmerkih do 80 mg valsartana (kar ustreza 27 ml raztopine).
Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.
Pri ocenjevanju nevrokognitivnih sposobnosti in razvoja pri pediatričnih bolnikih, starih od 6 do 16 let, po zdravljenju z zdravilom Diovan v obdobju do 1 leta niso opažali nobenega neugodnega vpliva, ki bi bil v celoti klinično pomemben.
Find the marker on the oral syringe that corresponds to the required amount of medicine.
Na brizgi za peroralno dajanje poiščite ustrezno oznako za količino zdravila, ki jo potrebujete.
Method of administration Diovan may be taken independently of a meal.
Način uporabe Zdravilo Diovan je mogoče jemati neodvisno od obrokov.
• The solution is supplied in a pack containing one 180 ml amber glass bottle with a childresistant screw cap and a yellow tamper evident ring.
• Raztopina je na voljo v pakiranju, ki vsebuje eno 180-mililitrsko steklenico iz rjavega stekla z navojno za otroke varno zaporko in rumenim varovalnim obročem.
Paediatric heart failure and recent myocardial infarction Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Srčno popuščanje in nedavni miokardni infarkt pri pediatričnih bolnikih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Diovan ni priporočljiva za zdravljenje srčnega popuščanja ali nedavnega miokardnega infarkta pri otrocih in mladostnikih, ki so mlajši od 18 let.
Valsartan is highly bound to plasma protein and is unlikely to be removed by dialysis.
Ker pa je valsartan v veliki meri vezan na beljakovine v plazmi, ni verjetno, da bi se izločal med dializo.
- Severe hepatic impairment, biliary cirrhosis and cholestasis.
- Huda okvara jeter, biliarna ciroza in holestaza.
Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Po odprtju lahko steklenico do 3 mesece shranjujete pri temperaturi do 30°C.
Instructions for using the oral syringe and the dosing cup
Navodila za uporabo brizge za peroralno dajanje in merice
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in karcinogenega potenciala ne kažejo posebnega tveganja za človeka.
In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Bolniki s pomanjkanjem natrija in/ali hipovolemijo Pri bolnikih s hudim pomanjkanjem natrija in/ali hipovolemijo, ki prejemajo velike odmerke diuretikov, lahko v redkih primerih po začetku zdravljenja z zdravilom Diovan pride do simptomatske hipotenzije.
The bottle contains 160 ml of solution.
Steklenica vsebuje 160 ml raztopine.
Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
S tem so se ujemali tudi rezultati meritev diastoličnega tlaka, ki ga je valsartan znižal za 9,1 mmHg, enalapril pa za 8,5 mmHg.
It is not recommended to switch between Diovan tablets and Diovan oral solution unless clinically required as there is insufficient information to guide an appropriate dose on switching between the two formulations.
Prehajanje z uporabe Diovan tablet na uporabo Diovan peroralne raztopine in obratno ni priporočeno, razen če je to potrebno iz kliničnih razlogov, saj ni dovolj podatkov, na podlagi katerih bi lahko svetovali uporabo ustreznih odmerkov pri prehajanju z ene oblike zdravila na drugo.
Daily oral dosing of neonatal/juvenile rats (from a postnatal day 7 to postnatal day 70) with valsartan at doses as low as 1 mg/kg/day (about 10-35% of the maximum recommended paediatric dose of 4 mg/kg/day on systemic exposure basis)produced persistent, irreversible kidney damage.
Vsakodnevno peroralno odmerjanje valsartana novorojenim/mladim podganam (od 7. do 70. dne po porodu) v višini samo 1 mg/kg/dan (kar je približno 10-35 % najvišjega priporočenega pediatričnega odmerka 4 mg/kg/dan glede na sistemsko izpostavljenost zdravilu) je povzročilo persistentno neozdravljivo okvaro ledvic.
The antihypertensive effect of valsartan have been evaluated in four randomized, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age and 165 paediatric patients 1 to 6 years of age.
Antihipertenzivno delovanje valsartana so ocenjevali v štirih randomiziranih, dvojno slepih kliničnih študijah s 561 pediatričnimi bolniki v starosti od 6 do 18 let in s 165 pediatričnimi bolniki v starosti od 1 leta do 6 let.
As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2).
Kot pri odraslih, je zdravilo Diovan kontraindicirano pri pediatričnih bolnikih s hudo okvaro jeter, z biliarno cirozo in pri bolnikih s holestazo (glejte poglavji 4.3 in 5.2).
In patients who continued to receive the medium and high doses of valsartan, systolic blood pressure at trough was -4 and -7 mm Hg lower than patients who received the placebo treatment.
Pri bolnikih, ki so nadaljevali zdravljenje s srednje visokimi in z visokimi odmerki valsartana, je bila najnižja vrednost sistoličnega krvnega tlaka nižja za 4 oziroma 7 mmHg od vrednosti pri bolnikih, ki so prejemali placebo.
Diovan oral solution contains poloxamer (188) which may cause softened stools.
Diovan peroralna raztopina vsebuje poloksamer (188), ki lahko povzroča odvajanje mehkejšega blata.
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
Sočasna uporaba kalijevih nadomestkov, diuretikov, ki varčujejo kalij, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki lahko povzročijo zvečanje koncentracije kalija (heparin, itd.), ni priporočena.
Slowly push the plunger in and swallow the medicine directly from the oral syringe.
Počasi potiskajte bat in zaužijte zdravilo neposredno iz brizge za peroralno dajanje.
Check that the plunger is pushed fully into the oral syringe.
Poglejte, ali je bat v brizgi za peroralno dajanje pritisnjen do konca.
• if you have severe kidney disease or if you are undergoing dialysis.
• če imate hude težave z ledvicami ali če se zdravite z dializo,
In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (p<0.05).
V kliničnem preskušanju pri bolnikih, ki so imeli v anamnezi suh kašelj v času zdravljenja z zaviralcem ACE, je do kašlja prišlo pri 19,5 % preiskovancev, ki so dobivali valsartan, pri 19,0 % tistih, ki so prejemali tiazidni diuretik, in pri 68,5 % preiskovancev, ki so dobivali zaviralec ACE (p < 0,05).
Note: You may not be able to push the bottle adapter down fully but this does not matter as it will be forced into the bottle when you screw the cap back on.
Opozorilo: Nastavka za steklenico morda ne boste mogli potisniti do konca, vendar naj vas to ne skrbi.
Remove the oral syringe from the bottle adapter by gently twisting it out.
Brizgo za peroralno dajanje odstranite iz steklenice tako, da jo izvlečete z rahlim vrtenjem.
• diarrhoea
• diareja
Holding the open bottle upright on a table, push the bottle adapter firmly into the neck of the bottle as far as it will go.
Steklenico postavite pokonci na mizo in nastavek močno pritisnite v vrat steklenice, dokler se ne ustavi.
At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Po 30 tednih je bila z valsartanom 160 mg sprememba izločanja albumina z urinom v odstotkih značilno manjša za 36 % od izhodiščne vrednosti (95 % IZ: 22 do 47 %), z valsartanom 320 mg pa za 44 % (95 % IZ: 31 do 54 %).
In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
V študiji s 26 pediatričnimi hipertenzivnimi bolniki (v starosti od 1 leta do 16 let), ki so prejeli en sam odmerek valsartana v obliki suspenzije (povprečno 0,9 do 2 mg/kg, pri čemer je bil najvišji odmerek 80 mg), je bilo izločanje valsartana (l/h/kg) primerljivo pri vseh starostih od 1 leta do 16 let, in podobno izločanju pri odraslih, ki uporabljajo isto obliko zdravila.
With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Razen posameznih prebavnih motenj (kot so bolečine v trebuhu, navzea, bruhanje) in omotičnosti, med varnostnimi lastnostmi zdravila pri pediatričnih bolnikih, starih 6 do 18 let, in že opisanimi varnostnimi lastnostmi pri odraslih, niso ugotovili bistvenih razlik glede vrste, pogostnosti ali izraženosti neželenih učinkov.
These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
To vključuje kalijeve nadomestke ali nadomestke soli, ki vsebujejo kalij, zdravila, ki varčujejo s kalijem in heparin.
Use in paediatric patients aged 6 to 18 years with hepatic impairment As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Uporaba pri pediatričnih bolnikih, ki so stari od 6 do 18 let in imajo okvaro jeter Kot pri odraslih je zdravilo Diovan kontraindicirano pri pediatričnih bolnikih s hudo okvaro jeter, z biliarno cirozo in pri bolnikih s holestazo (glejte poglavja 4.3, 4.4 in 5.2).
ANNEX II AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
• severely decreased kidney function (signs of acute renal failure)
• zelo zmanjšano delovanje ledvic (znak akutne ledvične odpovedi)
Valsartan is unlikely to be removed by haemodialysis.
Ni verjetno, da bi se valsartan lahko izločil s hemodializo.
ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure are listed below.
Neželeni učinki, ki so se pojavljali pri odraslih bolnikih po miokardnem infarktu in/ali odraslih bolnikih s srčnim popuščanjem, so navedeni spodaj:
• allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
• lahko pride do alergijskih reakcij z izpuščajem, s srbenjem in s koprivnico; simptomov zvišane telesne temperature, otekanja sklepov in bolečin v sklepih, bolečin v mišicah, otekanja bezgavk in/ali simptomov, podobni gripi (znaki serumske bolezni)
Subsequently, frequent blood pressure monitoring should be performed taking into account potential under-dosing and dose should be titrated further based on blood pressure response and tolerability.
Nato je treba bolniku pogosto meriti krvni tlak, upoštevati možnost, da prejema prenizek odmerek in odmerek titrirati glede na odziv krvnega tlaka in glede na to, kako bolnik prenaša odmerek.
Contains sucrose, methyl parahydroxybenzoate (E218) and poloxamer (188) (see leaflet for further information).
Vsebuje saharozo, metilparahidroksibenzoat (E218) in poloksamer (188) (za več podatkov glejte priloženo navodilo).
A bottle containing the medicine:
Steklenica z zdravilom:
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 (see sections 4.2 and 4.4).
Trenutno ni izkušenj o varni uporabi pri bolnikih z očistkom kreatinina < 10 ml/min in pri bolnikih, ki se zdravijo z dializo, zato je treba pri teh bolnikih valsartan uporabljati previdno (glejte poglavji 4.2 in 4.4).
• 1 ml oral solution contains 3 mg of valsartan.
• 1 ml peroralne raztopine vsebuje 3 mg valsartana.
A doubling of exposure (AUC) was observed in patients with mild to moderate hepatic impairment compared to healthy subjects.
Pri bolnikih z blago do zmerno jetrno okvaro so v primerjavi z zdravimi osebami opazili podvojitev izpostavljenosti (AUC).
The signs may include rash, itching, hives.
Znaki reakcije lahko vključujejo izpuščaj, srbenje ali koprivnico.
POSSIBLE SIDE EFFECTS Like all medicines, Diovan can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Diovan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have accidentally taken more Diovan solution than you should, contact your doctor, pharmacist, or hospital.
Če nehote vzamete preveč Diovan raztopine, pokličite svojega zdravnika, farmacevta ali v bolnišnico.
In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je treba zdravilo Diovan uporabljati previdno (glejte poglavji 4.2 in 5.2).
• Do not store above 30°C.
• Shranjujte pri temperaturi do 30 °C.
Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Zato pri bolnikih z okvarjenim delovanjem ledvic odmerka ni treba prilagajati (očistek kreatinina > 10 ml/min).
• breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
• zadihanost, težave z dihanjem v ležečem položaju, oteklina stopal in nog (znaki srčnega popuščanja)
• if you have liver disease.
• če imate bolezen jeter,
180 ml amber type III glass bottle with a white child resistant polypropylene cap, including a polyethylene sealing disk and a yellow tamper evident ring, in addition the pack includes one dispensing kit containing one 5 ml oral dosing polypropylene syringe, one press in bottle adapter and one 30 ml polypropylene dosing cup.
180-mililitrska steklenica iz rjavega stekla (tipa III) z belo polipropilensko za otroke varno zaporko, ki jo dopolnjujeta še polietilenska zaporna ploščica in rumeni varovalni obroč; pakiranju je priložen tudi komplet za odmerjanje, ki vsebuje eno 5-mililitrsko polipropilensko brizgo za peroralno dajanje, en pritisni nastavek za steklenico in eno 30-mililitrsko polipropilensko merico.
The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
• if you have severe liver disease.
• če imate hudo bolezen jeter,
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.
Nesteroidna protivnetna zdravila (NSAIDs), vključno s selektivnimi zaviralci COX-2, z acetilsalicilno kislino >3 g/dan) in z neselektivnimi nesteroidnimi protivnetnimi zdravili(NSAIDs)
The effect of the treatment can be influenced if Diovan is taken together with certain other medicines.
Sočasno jemanje nekaterih drugih zdravil lahko vpliva na učinek zdravljenja z zdravilom Diovan.
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.
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.
Valsartan does not undergo any noteworthy biotransformation.
Valsartan se biološko ne transformira v veliki meri.
INSTRUCTIONS FOR USING THE ORAL SYRINGE AND THE DOSING CUP Please read these instructions carefully before taking the medicine.
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.
• you must tell your doctor if you think you are (or might become) pregnant.
• Svojemu zdravniku morate povedati, če mislite da ste noseči ali če načrtujete nosečnost.
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).
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).
- Hypertension
- Hipertenzija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 3 mg of valsartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter raztopine vsebuje 3 mg valsartana.
• increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
• zvišana koncentracija kalija v krvi (ki lahko v hudih primerih sproži mišične krče in nenormalen srčni ritem)
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Če se izkaže, da je sočasna uporaba obeh zdravil nujna, je priporočeno skrbno spremljanje koncentracije litija v serumu.
These cases occurred in a population who had significant comorbidities.
Do tega je prišlo v populaciji otrok, ki so imeli sočasno še druge pomembne bolezni.
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.
CHMP ob vključitvi odbora PDCO za pomoč pri protokolu, katerega cilj je pridobiti nadaljnji vpogled v klinično preskušanje hipertenzije pri majhnih otrocih,
Pack size: 1 bottle containing 160 ml oral solution
Velikost pakiranja: 1 steklenica vsebuje 160 ml peroralne raztopine
Use a new bottle adapter and oral dosing syringe each time you start a new bottle of medicine.
Vsakokrat, ko odprete novo steklenico z zdravilom, uporabite tudi nov nastavek za steklenico in novo brizgo za peroralno dajanje.
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.
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.
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.
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.
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).
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).
What you will be using
Uporabljali boste:
Functional renal maturation is an ongoing process within the first year of life in humans.
Pri ljudeh poteka fukcionalno dozorevanje ledvic še celo prvo leto življenja.
• 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.
• 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,
Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Valsartan v peroralnih odmerkih do 200 mg/kg/dan ni neugodno vplival na razmnoževanje podganjih samic in samcev.
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
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.
• decreased kidney function (signs of renal impairment)
• zmanjšano delovanje ledvic (znak ledvične okvare)