natgillin/translations-raw huggingface dataset:
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic, lahko krvne preiskave pokažejo zvišanje vrednosti kalija v krvi.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Zentiva can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Irbesartan Zentiva ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): hitro utripanje srca, rdečica, kašelj, driska, motnje prebave/zgaga, motnje pri spolnih aktivnostih, bolečina v prsnem košu.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Nesteroidna protivnetna zdravila: kadar sočasno jemljemo antagoniste angiotenzina II in nesteroidna protivnetna zdravila (NSAID) (npr. selektivne COX-2 zaviralce, acetilsalicilno kislino (> 3 g dnevno)
How to take Irbesartan Zentiva
Kako jemati zdravilo Irbesartan Zentiva
Irbesartan Zentiva should not be given to children under 18 years of age.
Otroci in mladostniki, mlajši od 18 let, zdravila Irbesartan Zentiva ne smejo jemati.
Olmesartan 40 Irbesartan 300 Candesartan 32
v ppm v učinkovini valsartan 320 losartan olmesartan 40 irbesartan 300 kandesartan 32
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
dodatke kalija nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki) zdravila, ki vsebujejo litij
How to store Irbesartan Zentiva Contents of the pack and other information
Shranjevanje zdravila Irbesartan Zentiva Vsebina pakiranja in dodatne informacije
Exposure to AIIRA therapy 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).
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,
Hypertension and type 2 diabetes with renal disease
Študija ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease
Do not take Irbesartan Zentiva  if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant.
Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan Zentiva Ne jemljite zdravila Irbesartan Zentiva če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) če ste noseči dlje kot tri mesece.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Izločanje Irbesartan in njegovi metaboliti se izločajo tako z žolčem kot preko ledvic.
Iif you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).
Zdravnik vam bo morda moral spremeniti odmerek in/ali uporabiti druge previdnostne ukrepe: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Irbesartan Zentiva" in "Opozorila in previdnostni ukrepi").
Each tablet contains: irbesartan 150 mg
Ena tableta vsebuje: irbesartan 150 mg
Each tablet of Irbesartan Zentiva 75 mg contains 75 mg irbesartan.
Ena tableta zdravila Irbesartan Zentiva 75 mg vsebuje 75 mg irbesartana.
Each tablet of Irbesartan Zentiva 300 mg contains 300 mg irbesartan.
Ena tableta zdravila Irbesartan Zentiva 300 mg vsebuje 300 mg irbesartana.
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines.
Verjetnost, da bi zdravilo Irbesartan Zentiva vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
Warning and precautions Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan Zentiva for diabetic kidney disease.
Pred začetkom jemanja zdravila Irbesartan Zentiva se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenega:: če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Irbesartan Zentiva jemljete zaradi diabetične bolezni ledvic.
Each tablet of Irbesartan Zentiva 150 mg contains 150 mg irbesartan.
Ena tableta zdravila Irbesartan Zentiva 150 mg vsebuje 150 mg irbesartana.
The concomitant use of Irbesartan Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1).
Sočasna uporaba zdravila Irbesartan Zentiva in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavji 4.5 in 5.1).
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Irbesartan Zentiva on the progression of renal disease and all-cause mortality were examined.
Pri 1.715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥900 mg/dan in serumskim kreatininom 1,0-3,0 mg/dl, so raziskovali dolgotrajne učinke zdravila Irbesartan Zentiva (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
If you take more Irbesartan Zentiva than you should If you accidentally take too many tablets, contact your doctor immediately.
Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
Irbesartan Zentiva 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).
Zdravila Irbesartan Zentiva ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
V podskupinah z ženskami in temnopoltimi, ki so predstavljale 32% oziroma 26% celotne preiskovane populacije, ni bila dokazana koristnost irbesartana za ledvice, čeprav je meje zaupanja ne izključujejo.
Metabolism and nutrition disorders
Bolezni krvi in limfatičnega sistema
Irbesartan Zentiva 75 mg film-coated tablets irbesartan
Irbesartan Zentiva 75 mg filmsko obložene tablete irbesartan
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
(npr. z enim kozarcem vode).
The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo Preskušanje irbesartana pri diabetični nefropatiji “Irbesartan Diabetic Nephropathy Trial" (IDNT) kaže, da irbesartan pri bolnikih s kronično ledvično insuficienco in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
Conditions to the MA
Meja za NDMA
At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
(kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so sekundarne hipotenzivnim učinkom zdravila, ki vodi do zmanjšanega pretoka v ledvicah.
leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common:
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
Irbesartan Zentiva contains lactose.
Zdravilo Irbesartan Zentiva vsebuje laktozo.
Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Irbesartan Zentiva 300 mg filmsko obložene tablete irbesartan
Because no information is available regarding the use of Irbesartan Zentiva during breast-feeding, Irbesartan Zentiva is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Podatkov o uporabi zdravila Irbesartan Zentiva med dojenjem ni na voljo, zato uporaba zdravila Irbesartan Zentiva med dojenjem ni priporočljiva.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva ” and “Warnings and precautions”).
Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi mikrokristalna celuloza premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat koloidni hidratirani silicijev dioksid predgelirani koruzni škrob poloksamer 188
The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
300 mg (štiri tablete) enkrat na dan, odvisno od odziva krvnega tlaka.
How to store Irbesartan Zentiva
Shranjevanje zdravila Irbesartan Zentiva
Irbesartan Zentiva is for oral use.
Irbesartan Zentiva ni priporočljivo.
In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara Farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Irbesartan Zentiva 150 mg filmsko obložene tablete irbesartan
Lévai u.5.
Po peroralnem ali i.v.
Rebound hypertension has not been observed.
Ponovnega padca zvečanega krvnega tlaka niso opazili.
Irbesartan Zentiva is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Zdravilo Irbesartan Zentiva uporabljamo pri odraslih bolnikih: za zdravljenje visokega krvnega tlaka (primarne hipertenzije).
Investigations:
Preiskave Zelo pogosti:
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (dve tableti) enkrat na dan.
Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Zentiva 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
 If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, , se posvetujte z zdravnikom ali s farmacevtom.
The efficacy of Irbesartan Zentiva is not influenced by age or gender.
Spol in starost ne vplivata na učinkovitost zdravila Irbesartan Zentiva.
Irbesartan Zentiva 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Zentiva 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Irbesartan Zentiva 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Zentiva 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets irbesartan
Navodilo za uporabo Irbesartan Zentiva 150 mg tablete irbesartan
Some undesirable effects have been reported since marketing of Irbesartan Zentiva.
Po prihodu zdravila Irbesartan Zentiva na tržišče so poročali še o nekaterih drugih neželenih učinkih.
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
(30-300 mg/dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤1,5 mg/dl, pri ženskah <1,1 mg/dl).
Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Irbesartan Zentiva 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Irbesartan Zentiva 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Aliskiren-containing products or ACE-inhibitors: clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in
Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Irbesartan Zentiva 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Package leaflet: Information for the user Irbesartan Zentiva 75 mg tablets irbesartan
Navodilo za uporabo Irbesartan Zentiva 75 mg tablete irbesartan
Do not pass it on to others.
ne sme uporabljati sočasno.
This results in an increase in blood pressure.
za zdravljenje povečanega krvnega tlaka (primarne hipertenzije).
Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food.
Zdravilo Irbesartan Zentiva skupaj s hrano in pijačo
EU/1/06/376/011 - 14 tablets EU/1/06/376/012 - 28 tablets EU/1/06/376/013 - 56 tablets EU/1/06/376/014 - 56 x 1 tablets EU/1/06/376/015 - 98 tablets
EU/1/06/376/014 - 56 x 1 tableta EU/1/06/376/015 - 98 tablet
PHARMACEUTICAL FORM AND CONTENTS 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
14 tablet 28 tablet 56 tablet 56 x 1 tableta 98 tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan.
Ena filmsko obložena tableta vsebuje 75 mg irbesartana.
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Irbesartan Zentiva 75 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
Package leaflet: Information for the user Irbesartan Zentiva 75 mg film-coated tablets irbesartan
Navodilo za uporabo Irbesartan Zentiva 75 mg filmsko obložene tablete irbesartan
EU/1/06/376/006 - 14 tablets EU/1/06/376/007 - 28 tablets EU/1/06/376/008 - 56 tablets EU/1/06/376/009 - 56 x 1 tablets EU/1/06/376/010 - 98 tablets
EU/1/06/376/009 - 56 x 1 tableta EU/1/06/376/010 - 98 tablet
EU/1/06/376/001 - 14 tablets EU/1/06/376/002 - 28 tablets EU/1/06/376/003 - 56 tablets EU/1/06/376/004 - 56 x 1 tablets EU/1/06/376/005 - 98 tablets
EU/1/06/376/004 - 56 x 1 tableta EU/1/06/376/005 - 98 tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
Ena filmsko obložena tableta vsebuje 150 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg film-coated tablets.
Irbesartan Zentiva 75 mg filmsko obložene tablete.
Package leaflet: Information for the user Irbesartan Zentiva 300 mg tablets irbesartan
Navodilo za uporabo Irbesartan Zentiva 300 mg tablete irbesartan
Package leaflet: Information for the user Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Navodilo za uporabo Irbesartan Zentiva 300 mg filmsko obložene tablete irbesartan
Film-coating:
Ledvična okvara:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana.
Package leaflet: Information for the user Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Navodilo za uporabo Irbesartan Zentiva 150 mg filmsko obložene tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg film-coated tablets.
Irbesartan Zentiva 300 mg filmsko obložene tablete.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg film-coated tablets.
Irbesartan Zentiva 150 mg filmsko obložene tablete.
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Irbesartan Zentiva 75 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Irbesartan Zentiva 150 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders Uncommon: sexual dysfunction
(glejte poglavje 4.4) Motnje reprodukcije in dojk
hyperkalaemia Nervous system disorders Common:
hiperkaliemijo in spremembe delovanja ledvic.
Annex III Conditions for lifting the suspension
Dodatek III Pogoji za preklic začasnega umika
New clinical and bioanalytical studies are performed and submitted to the relevant national competent authorities.
Nove kritične in bioanalitične študije se izvedejo in predložijo zadevnim pristojnim nacionalnim organom.
The marketing authorisation holder should demonstrate therapeutic equivalence based on a clinical and bioanalytical study performed in compliance with GCP requirements.
Imetnik dovoljenja za promet z zdravilom mora dokazati terapevtsko enakovrednost na podlagi klinične in bioanalitične študije, izvedene v skladu z zahtevami dobre klinične prakse.
Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pred preklicem začasnega umika dovoljenj za promet z zdravilom morajo pristojni nacionalni organi, ki jih koordinira referenčna država članica, zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
If your symptoms do not improve
Če se vaši simptomi ne izboljšajo
contact your doctor as soon as possible.
Čimprej se posvetujte z zdravnikom.
No risk factors were identified.
Dejavnikov tveganja niso ugotovili.
It is not known whether the ingredients of this medicine can pass into breast milk.
Ni znano, ali lahko sestavine tega zdravila prehajajo v materino mleko.
These differences are unlikely to be of clinical relevance.
Ni verjetno, da bi bile te razlike klinično pomembne.
Just take your next dose at the usual time.
Preprosto vzemite naslednji odmerek ob običajnem času.
Results for the primary and key secondary endpoints in these studies are described in Table 1.
Rezultati primarnega in ključnih sekundarnih opazovanih dogodkov v teh študijah so prikazani v preglednici 1.
Date of latest renewal: 26 July 2018
Datum zadnjega podaljšanja: 26. julij 2018
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Nadaljnje ukrepanje mora potekati, kot je klinično indicirano ali kot priporoča nacionalni Center za zastrupitve, kjer je ta na voljo.
The final decision on evening or morning dosing should be left to the discretion of the physician.
Dokončna odločitev o uporabi zvečer ali zjutraj mora biti prepuščena presoji zdravnika.
if you have low potassium in your blood.
če imate nizek kalij v krvi;
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 13. november 2013
• suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
• nenadno slabo počutje ali omotičnost (ki lahko vodi v kolaps ali izgubo zavesti).
Other side effects include:
Ostali neželeni učinki vključujejo:
No dose adjustment is required in this population (see section 5.2).
Prilagoditev odmerka v tej populaciji ni potrebna (glejte poglavje 5.2).
This dose is also used once daily at the same time each day.
Tudi ta odmerek se uporablja enkrat na dan, vsak dan ob istem času.
See section 4 for information on symptoms to look out for while you are using this medicine.
Glejte poglavje 4 za informacije o simptomih, na katere morate biti pozorni, medtem ko uporabljate to zdravilo.
Table 2: Analysis of Exacerbation Rates following 12 months of treatment
Preglednica 2: Analiza deležev poslabšanj po 12 mesecih zdravljenja
Immediate breathing difficulties
Takojšnje težave z dihanjem
*, ** See below ‘Description of selected adverse reactions'
*, ** Glejte spodaj "Opis izbranih neželenih učinkov" Opis izbranih neželenih učinkov
How to prepare a dose
Kako pripraviti odmerek
Children aged under 12 years
Otroci, mlajši od 12 let:
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Odmerek je treba titrirati do najnižjega odmerka, ki učinkovito obvladuje simptome.
Hold this breath for as long as possible (at least 3-4 seconds).
Dih zadržite, kolikor je mogoče dolgo (vsaj 3 do 4 sekunde).
if you have ever been told you have diabetes or high blood sugar.
če so vam kdaj povedali, da imate sladkorno bolezen ali povišan sladkor v krvi;
• weakening of the bones, leading to fractures
• oslabitev kosti, ki je vzrok zlomov,