natgillin/translations-raw huggingface dataset:
In a double-blind, randomised, active-controlled trial in patients not adequately controlled on hydrochlorothiazide 12.5 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (14.9/11.3 mmHg) compared to hydrochlorothiazide 12.5 mg (5.2/2.9 mmHg) and hydrochlorothiazide 25 mg
V dvojno slepem, randomiziranem, aktivno kontroliranem preskušanju pri bolnikih, pri katerih jemanje hidroklorotiazida 12,5 mg ni dovolj uravnalo visokega krvnega tlaka, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/hidroklorotiazid 80/12,5 mg (14,9/11,3 mmHg) v primerjavi z uporabo samo hidroklorotiazida 12,5 mg (5,2/2,9 mmHg) ali z uporabo hidroklorotiazida 25 mg (6,8/5,7 mmHg).
Diovan Comp 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Diovan Comp 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Nervous system disorders Rare
Bolezni živčevja redki glavobol
• light-headedness
• vrtoglavost
Co-Diovane 80/12,5 mg 160 mg / 12.5 mg film-coated tablets oral
Co-Diovane 80/12,5 mg 160 mg / 12,5 mg filmsko obložene tablete
Metabolism and nutrition disorders Uncommon
Presnovne in prehranske motnje občasni dehidracija
• itchy rash and other types of rash
• srbeč izpuščaj ali druga vrsta izpuščaja
These doses in marmoset, respectively, represent 0.9 and 3.5 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Pri marmozetkah ti odmerki predstavljajo 0,9 oziroma 3,5-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
• skin rash with or without itching together with some of the following signs or symptoms: fever,
• kožni izpuščaj s srbenjem ali brez njega s pridruženimi naslednjimi znaki ali simptomi: zvišana telesna temperatura, bolečine v sklepih, bolečine v mišicah, povečane bezgavke in/ali gripi podobni simptomi
80/12.5 mg film-coated tablets oral
80/12,5 mg filmsko obložene tablete
Co-Diovan (320 + 25 mg) 320 mg / 25 mg film-coated tablets oral
Co-Diovan (320 + 25 mg) 320 mg / 25 mg filmsko obložene tablete
Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Ena tableta vsebuje 80 mg valsartana in 12,5 mg hidroklorotiazida.
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Ena tableta vsebuje 160 mg valsartana in 12,5 mg hidroklorotiazida.
These doses in rat, respectively, represent 0.9 and 3.5-times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Pri podganah ti odmerki predstavljajo 0,9 oziroma 3,5-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
Co-Diovan (160 + 25 mg) 160 mg / 25 mg film-coated tablets oral
Co-Diovan (160 + 25 mg) 160 mg / 25 mg filmsko obložene tablete
Romania Novartis Pharma GmbH Roonstrasse 25
Romunija Novartis Pharma GmbH Roonstrasse 25
The following adverse reactions have been reported in patients treated with monotherapy of thiazide diuretics, including hydrochlorothiazide: Blood and lymphatic system disorders
Pri bolnikih, ki so se zdravili samo s tiazidnimi diuretiki, vključno s hidroklorotiazidom, so poročali o naslednjih neželenih učinkih:
Co-Diovan (160 + 12.5 mg) 160 mg / 12.5 mg film-coated tablets oral
Co-Diovan (160 + 12.5 mg) 160 mg / 12,5 mg filmsko obložene tablete
CORIXIL 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
CORIXIL 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (80 + 12.5 mg) 80 mg / 12.5 mg film-coated tablets oral
Co-Diovan (80 + 12.5 mg) 80 mg / 12,5 mg filmsko obložene tablete
Agranulocytosis, leucopenia, haemolytic anaemia, bone marrow depression
Bolezni kože in podkožja pogostnost neznana angioedem, izpuščaj, srbenje
Co-Diovan (320 + 12.5 mg) 320 mg / 12.5 mg film-coated tablets oral
Co-Diovan (320 + 12.5 mg) 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (160+25) mg 160 mg / 25 mg film-coated tablets oral
Co-Diovan (160+25) mg 160 mg / 25 mg filmsko obložene tablete
Co-Diovan (160+12,5) mg 160 mg / 12,5 mg film-coated tablets oral
Co-Diovan (160+12,5) mg 160 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (80+12,5) mg 80 mg / 12,5 mg film-coated tablets oral
Co-Diovan (80+12,5) mg 80 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (320+25) mg 320 mg / 25 mg film-coated tablets oral
Co-Diovan (320+25) mg 320 mg / 25 mg filmsko obložene tablete
Cardiac arrhythmias
Stenoza ledvične arterije
convulsions)
• vrtoglavica
In addition, a significantly greater percentage of patients responded (BP <140/90 mmHg or SBP reduction ≥20 mmHg or DBP reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/12.5 mg (50%) compared to hydrochlorothiazide 25 mg (25%).
Poleg tega je do odziva na zdravljenje (krvni tlak <140/90 mmHg ali znižanje sistoličnega krvnega tlaka za ≥20 mmHg ali znižanje diastoličnega krvnega tlaka za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 160/12,5 mg (50 %) v primerjavi s tistimi, ki so jemali hidroklorotiazid 25 mg
Co-Diovan (320+12,5) mg 320 mg / 12,5 mg film-coated tablets oral
Co-Diovan (320+12,5) mg 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovan forte 160/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Diovan forte 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Co-Diovan forte 320/25 mg 320 mg / 25 mg film-coated tablets oral
Co-Diovan forte 320/25 mg 320 mg / 25 mg filmsko obložene tablete
Co-Diovane 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Co-Diovane 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Dose-dependent decreases in serum potassium occurred in controlled clinical studies with valsartan + hydrochlorothiazide.
V kontroliranih kliničnih študijah s kombinacijo valsartana in hidroklorotiazida je prišlo do od odmerka odvisnih znižanj koncentracij kalija v serumu.
In patients with severe renal impairment (creatinine clearance <30 ml/min) and patients undergoing dialysis no data are available for Diovan Comp. Valsartan is highly bound to plasma protein and is not to be removed by dialysis, whereas clearance of hydrochlorothiazide will be achieved by dialysis.
O uporabi zdravila Diovan Comp pri bolnikih s hudo ledvično okvaro (z očistkom kreatinina <30 ml/min) in pri bolnikih na dializi ni podatkov.
Co-Diovane 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Co-Diovane 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovan 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Co-Diovan 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
Diovan Comp 160mg/25 160 mg / 25 mg film-coated tablets oral
Diovan Comp 160mg/25 160 mg / 25 mg filmsko obložene tablete
Diovan Comp 80mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Diovan Comp 80mg/12.5 mg80 mg / 12,5 mg filmsko obložene tablete
Co-Diovane 160/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Diovane 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Diovan Comp 320mg/25 mg 320 mg / 25 mg film-coated tablets oral
Diovan Comp 320mg/25 mg 320 mg / 25 mg filmsko obložene tablete
Co-Diovan 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Co-Diovan 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Diovan Comp 320 mg/25 mg320 mg / 25 mg film-coated tablets oral
Diovan Comp 320 mg/25 mg320 mg / 25 mg filmsko obložene tablete
Diovan Comp 160 mg/25 mg160 mg / 25 mg film-coated tablets oral
Diovan Comp 160 mg/25 mg160 mg / 25 mg filmsko obložene tablete
Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Diovan Comp 80 mg/12.5 mg80 mg / 12,5 mg filmsko obložene tablete
Concomitant use requiring caution
Sočasna uporaba, pri kateri je potrebna previdnost Drugi antihipertenzivi
Diovan Comp 160/25 mg 160 mg / 25 mg film-coated tablets oral
Diovan Comp 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Diovan Comp 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Diovan Comp 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
Diovan Comp 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Diovan Comp 160mg/25 mg 160 mg / 25 mg filmsko obložene tablete
Co-Diovan 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Co-Diovan 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovane 320/25 mg 320 mg / 25 mg film-coated tablets oral
Co-Diovane 320/25 mg 320 mg / 25 mg filmsko obložene tablete
[To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
Nervous system disorders Very rare
Bolezni prebavil zelo redki diareja
Diovan Comp 320/25 mg 320 mg / 25 mg film-coated tablets oral
Diovan Comp 320/25 mg 320 mg / 25 mg filmsko obložene tablete
Co-Diovan 160/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Diovan 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Hypotension Respiratory, thoracic and mediastinal disorders
Žilne bolezni pogosti ortostatska hipotenzija
Co-Diovan 320/25 mg 320 mg / 25 mg film-coated tablets oral
Co-Diovan 320/25 mg 320 mg / 25 mg filmsko obložene tablete
Impaired renal function
• odpoved ledvic
Date of first authorisation: 19 January 2007 Date of latest renewal: 19 January 2012
Datum pridobitve dovoljenja za promet: 19. januar 2007 Datum zadnjega podaljšanja: 19. januar 2012
Your doctor may need to change your dose and/or to take other precautions:
Zdravnik vam bo morda moral spremeniti odmerek in/ali uporabiti druge previdnostne ukrepe:
The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established.
Varnost in učinkovitost zdravila Irbesartan Zentiva pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Irbesartan je pomembno znižal tveganje za primarno povezan izid podvojitve serumskega kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
See also information under the heading “Do not take Irbesartan Zentiva”.
Glejte tudi informacije pod naslovom “Ne jemljite zdravila Irbesartan Zentiva”.
You can take Irbesartan Zentiva with or without food.
Zdravilo Irbesartan Zentiva lahko jemljete s hrano ali brez nje.
Please see section 2 “Irbesartan Zentiva contains lactose”.
Prosimo glejte poglavje 2 »Zdravilo Irbesartan Zentiva vsebuje laktozo«.
Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension.
Zdravilo Irbesartan Zentiva je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.
Pomembno je, da zdravilo Irbesartan Zentiva jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
If you get any of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.
Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Irbesartan Zentiva takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Zdravilo Irbesartan Zentiva spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
The study examined the long-term effects (2 years) of Irbesartan Zentiva on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Irbesartan Zentiva na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
What Irbesartan Zentiva is and what it is used for
Kaj je zdravilo Irbesartan Zentiva in za kaj ga uporabljamo
Irbesartan Zentiva at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Na splošno zagotavlja odmerek 150 mg zdravila Irbesartan Zentiva enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
Paediatric population: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Pediatrična populacija: irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4.8, 5.1 in 5.2).
Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Laktoza: Bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE
What Irbesartan Zentiva is and what it is used for What you need to know before you take Irbesartan Zentiva How to take Irbesartan Zentiva Possible side effects
Kaj je zdravilo Irbesartan Zentiva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan Zentiva Kako jemati zdravilo Irbesartan Zentiva
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan Zentiva (see section 4.4).
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Irbesartan Zentiva (glejte poglavje 4.4).
No specific information is available on the treatment of overdose with Irbesartan Zentiva.
Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Irbesartan Zentiva niso na voljo.
Renal impairment and kidney transplantation: when Irbesartan Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Ledvična okvara in presaditev ledvic: pri dajanju zdravila Irbesartan Zentiva bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Čeprav to za zdravilo Irbesartan Zentiva ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin II.
The blood pressure lowering effect of Irbesartan Zentiva is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Učinek zdravila Irbesartan Zentiva na znižanje krvnega tlaka je viden po 1-2 tednih, največji učinek pa nastopi 4-6 tednov po začetku zdravljenja.
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan Zentiva 300 mg group (34%) than in the placebo group (21%).
V skupini s 300 mg zdravila Irbesartan Zentiva je bila pogostejša (34%) regresija na normoalbuminurijo (<30 mg/dan), kot v placebo skupini (21%).
Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan Zentiva, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Bolnikom so postopoma povečevali odmerek zdravila Irbesartan Zentiva od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
Such conditions should be corrected before the administration of Irbesartan Zentiva.
Ta stanja se mora korigirati, preden se uporabi zdravilo Irbesartan Zentiva.
Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Zdravilo Irbesartan Zentiva preprečuje vezavo angiotenzina-II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan Zentiva has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Diuretiki in drugi antihipertenzivi: drugi antihipertenzivi lahko povečajo hipotenzivni učinek irbesartana; vendar pa so zdravilo Irbesartan Zentiva varno uporabljali z drugimi antihipertenzivi, kot so zaviralci adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov z dolgotrajnim delovanjem in tiazidnimi diuretiki.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan Zentiva, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Hiperkaliemija: kot pri drugih zdravilih, ki vplivajo na sistem renin-angiotenzin-aldosteron, se lahko tudi med zdravljenjem z zdravilom Irbesartan Zentiva pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ali odpovedi srca.
For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
N-nitrozodietilamin (NDEA) uvesti naslednje specifikacije za učinkovino:
Therefore, the use of Irbesartan Zentiva is not recommended.
Zato uporaba zdravila Irbesartan Zentiva ni priporočljiva.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Zentiva, amlodipine and placebo.
IDNT je bilo dvojno slepo, kontrolirano preskušanje vpliva zdravila Irbesartan Zentiva na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
If you forget to take Irbesartan Zentiva
Če ste pozabili vzeti zdravilo Irbesartan Zentiva
Other medicines and Irbesartan Zentiva
Druga zdravila in zdravilo Irbesartan Zentiva
Lithium: the combination of lithium and Irbesartan Zentiva is not recommended (see section 4.5).
Litij: sočasna uporaba zdravila Irbesartan Zentiva in litija ni priporočljiva (glejte poglavje 4.5).
Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Neželeni učinki, katerih pogostnost ni znana, so: vrtoglavica, glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, zmanjšano število trombocitov, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic, vnetje malih krvnih žil, predvsem kože (bolezen, znana kot levkocitoklastični vaskulitis) in hude alergijske reakcije
o aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Zdravnik vam bo morda v rednih presledkih kontroliral delovanje ledvic, krvni tlak in količino elektrolitov (npr. kalija) v krvi.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Zentiva (see section 4.5).
In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Irbesartan Zentiva (glejte poglavje 4.5).
arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps Renal and urinary disorders Not known:
artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin kinaze v plazmi), mišični krči
No dosage adjustment is necessary in older people.
običajno pri starejših prilagajanje odmerka ni potrebno.
(It is also better to avoid Irbesartan Zentiva in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
(Jemanju zdravila Irbesartan Zentiva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Zdravila Irbesartan Zentiva ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
The demonstration of renal benefit of Irbesartan Zentiva in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Koristi zdravljenja z zdravilom Irbesartan Zentiva za ledvice pri bolnikih z visokim krvnim tlakom z diabetesom tipa 2 so pokazale študije, kjer so irbesartan uporabljali dodatno z drugimi antihipertenzivi, potrebnimi za doseganje ciljnega krvnega tlaka (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock
preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica, anafilaktična reakcija, anafilaktični šok
Side effects reported in clinical studies for patients treated with Irbesartan Zentiva were:
V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Irbesartan Zentiva, poročali o naslednjih neželenih učinkih:
(It is also better to avoid Irbesartan Zentiva in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren..
(Jemanju zdravila Irbesartan Zentiva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren
Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva.
Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Irbesartan Zentiva prekinete, še preden zanosite ali takoj, ko se izkaže, da ste zanosili, in vam predpisal zdravljenje z drugim zdravilom.
Adverse reactions additionally reported from post-marketing experience are also listed.
Prav tako so navedeni dodatni neželeni učinki, o katerih so poročali po pridobitvi dovoljenja za promet.
There is no experience regarding the administration of Irbesartan Zentiva in patients with a recent kidney transplantation.
Glede uporabe zdravila Irbesartan Zentiva pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Pri bolnikih, ki niso zadostno kontrolirani s samim irbesartanom, se z dodatno uvedbo nizkega odmerka hidroklorotiazida (12,5 mg) enkrat dnevno, poleg enkrat dnevnega odmerka irbesartana, doseže nadaljnje s placebom-uravnano znižanje krvnega tlaka v celoti za 7-10/3-6 mmHg (sistolični/