natgillin/translations-raw huggingface dataset:
Reproductive system and breast Uncommon: disorders:
Občasni:
* Frequency for adverse reactions detected by spontaneous reports is described as “ not known”
* Pogostnost neželenih učinkov, o katerih so bila prejeta spontana poročila, je označena kot “ Neznana ”.
Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Neželeni učinki, o katerih so poročali pri uporabi irbesartana samega Splošne težave in spremembe na Občasni: mestu aplikacije:
chest pain
bolečina v prsnem košu
Adverse reactions (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone Investigations:
Neželeni učinki (neodvisno od zdravila), o katerih so poročali pri uporabi hidroklorotiazida samega Preiskave:
electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
neravnovesje elektrolitov (vključno s hipokaliemijo in hiponatriemijo, glejte poglavje 4. 4), hiperurikemija, glikozurija, hiperglikemija in zvišanje vrednosti holesterola ter trigliceridov
cardiac arrhythmias aplastic anaemia, bone marrow depression, neutropenia/ agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
aplastična anemija, zavora delovanja kostnega mozga, nevtropenija/ agranulocitoza, hemolitična anemija, levkopenija, trombocitopenija
transient blurred vision, xanthopsia respiratory distress (including pneumonitis and pulmonary oedema)
respiratorni distres (vključno s pljučnico in pljučnim edemom)
interstitial nephritis, renal dysfunction anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
anafilaktične reakcije, toksična epidermalna nekroliza, nekrotizirajoči angiitis (vaskulitis, vnetje kožnih žil ali mezgovnic), reakcije, podobne kožnemu eritematoznemu lupusu, fotosenzitivne reakcije, izpuščaj, urtikarija
postural hypotension fever
zvišana telesna temperatura
8 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Neželeni učinki hidroklorotiazida, ki so odvisni od odmerka (zlasti elektrolitske motnje), se lahko med titriranjem hidroklorotiazida povečajo.
4.9 Overdose
8 4. 9 Preveliko odmerjanje
Suggested measures include induction of emesis and/ or gastric lavage.
Pri bolniku je priporočeno izzvati bruhanje in/ ali mu izprati želodec.
Hypokalaemia may result in muscle spasms and/ or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Posledica hipokaliemije so mišični krči in/ ali povdarjene srčne aritmije, povezane s sočasno uporabo digitalisovih glikozidov in nekaterih antiaritmikov.
Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code:
Farmakoterapevtska skupina: antagonisti angiotenzina II, kombinacije, oznaka ATC:
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5).
Priporočeni odmerki irbesartana na serumsko koncentracijo kalija bistveno ne vplivajo pri bolnikih, pri katerih ni nevarnosti za pojav motenj ravnovesja elektrolitov (glejte poglavji 4. 4 in 4. 5).
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Irbesartan ne zavira ACE (kininaza- II), encima, ki tvori angiotenzin II in razgrajuje bradikinin v neaktivne presnovke.
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
Med hkratnim zdravljenjem z irbesartanom se verjetno, zaradi blokade sistema renin- angiotenzin- aldosteron, zmanjša izplavljanje kalija, ki ga povzročajo ti diuretiki.
With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Diureza se zveča 2 uri po zaužitju hidroklorotiazida, njegov učinek je največji čez približno 4 ure, traja pa približno 6- 12 ur.
9 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Kombinacija hidroklorotiazida in irbesartana povzroči od odmerka odvisno aditivno znižanje krvnega tlaka znotraj terapevtskega intervala.
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Diastolični krvni tlak se je pri bolnikih, pri katerih zdravljenje s 300 mg irbesartana ni bilo dovolj učinkovito in so začeli jemati tudi po 12, 5 mg hidroklorotiazida enkrat na dan, 24 ur po zaužitju odmerka znižal za povprečno 6, 1 mmHg bolj kot po uporabi placeba.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/ diastolic reductions of up to 13.6/ 11.5 mm Hg.
9 Med kombiniranim zdravljenjem s 300 mg irbesartana in 12, 5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13, 6 mmHg, diastolični pa do 11, 5 mmHg bolj kot po uporabi placeba.
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/ 12.5 mg combination may respond when uptitrated to 300 mg/ 25 mg.
Omejeni klinični podatki (7 od 22 bolnikov) kažejo, da se lahko bolniki, ki niso urejeni s kombinacijo 300 mg/ 12, 5 mg, odzovejo na povečanje na 300 mg/ 25 mg.
In these patients, an incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (13.3 and 8.3 mm Hg, respectively).
Pri teh bolnikih so opazili stopnjevanje učinka na znižanje sistoličnega in diastoličnega krvnega tlaka (sistoličnega za 13, 3 mmHg, diastoličnega za 8, 3 mmHg).
Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/ diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/ 6.9 mm Hg in patients with mild-to-moderate hypertension.
Pri bolnikih z blago do zmerno hipertenzijo, ki so enkrat na dan dobili po 150 mg irbesartana in 12, 5 mg hidroklorotizida, se je 24 ur po zaužitju odmerka sistolični krvni tlak znižal za 12, 9 mmHg bolj kot po uporabi placeba, diastolični pa za 6, 9 mmHg.
Peak effects occurred at 3-6 hours.
Največji učinek je bil dosežen po 3- 6 urah.
When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebo-subtracted systolic/ diastolic reductions of 15.8/ 10.0 mm Hg.
Ocenjevanje krvnega tlaka pri bolnikih, ki so jim ga merili 24 ur in so dobivali enkrat na dan po 150 mg irbesartana in 12, 5 mg hidroklorotiazida je pokazal, da se je krvni tlak v obdobju 24 ur konstantno zmanjševal in da je srednje 24 urno znižanje sistoličnega krvnega tlaka 15, 8 mmHg večje kot pri uporabi placeba, diastoličnega pa za 10, 0 mmHg.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of CoAprovel 150 mg/ 12.5 mg were 100%.
Med 24- urnim merjenjem krvnega tlaka pri bolnikih, ki so prejemali zdravilo CoAprovel 150 mg/ 12, 5 mg, je bilo razmerje med najmanjšim in največjim učinkom 100%.
The trough to peak effects measured by cuff during office visits were 68% and 76% for CoAprovel 150 mg/ 12.5 mg and CoAprovel 300 mg/ 12.5 mg, respectively.
Pri merjenju z manšeto v ambulanti je bilo pri bolnikih, ki so jemali zdravilo CoAprovel 150 mg/ 12, 5 mg, to razmerje 68%, pri tistih, ki so dobivali zdravilo CoAprovel 300 mg/ 12, 5 mg, pa 76%.
In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/ diastolic mean reduction of 11.1/ 7.2 mm Hg.
Pri bolnikih, pri katerih se krvni tlak med zdravljenjem s 25 mg hidroklorotiazida ni dovolj znižal, se je po dodatku irbesartana sistolični krvni tlak dodatno znižal za povprečno 11, 1 mmHg glede na placebo, diastolični pa za 7, 2 mmHg.
The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 6-8 weeks.
Krvni tlak se zniža že po prvem odmerku irbesartana in hidroklorotiazida, izrazito v 1- 2 tednih, najbolj pa v 6- 8 tednih.
In long-term follow-up studies, the effect of irbesartan/ hydrochlorothiazide was maintained for over one year.
V študijah, ki so trajale dolgo časa, so ugotovili, da je učinek irbesartana/ hidroklorotiazida trajal še več kot eno leto.
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Pri temnopoltih bolnikih s hipertenzijo je odziv na samostojno zdravljenje z irbesartanom pomembno manjši, podobno kot pri drugih zdravilih, ki vplivajo na renin- angiotenzinski sistem.
12.5 mg daily), the antihypertensive response in black patients approaches that of non-black patients.
Če se irbesartanu doda majhen odmerek hidroklorotiazida (na primer 12, 5 mg na dan), se antihipertenzivni učinek pri temnopoltih bolnikih približa tistemu pri netemnopoltih bolnikih.
Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Učinkovitost in varnost zdravila CoAprovel kot začetnega zdravila za zdravljenje hude hipertenzije (definirana kot diastolični tlak v sedečem položaju (SeDBP) ≥ 110 mmHg) sta bili ovrednoteni z multicentrično, randomizirano, dvojno slepo, z učinkovino nadzorovano, 8- tedensko študijo paralelnih skupin.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
Po enem tednu zdravljenja so odmerek sistematično povečali (pred ovrednotenjem odziva na nižji odmerek) na irbesartan/ hidroklorotiazid 300 mg/ 25 mg oziroma irbesartan 300 mg.
The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Srednja starost bolnikov je bila 52, 5 let, 13% bolnikov je bilo starih 65 let ali starejših.
Twelve percent (12%) of patients were diabetic, 34% were hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of the participants.
Najpogostejša bolezen srca je bila stabilna angina pektoris, ki jo je imelo 3, 5% vključenih bolnikov.
Forty-seven percent (47.2%) of patients on
Vrednost SeDBP < 90 mmHg je bila dosežena pri sedeminštiridesetih odstotkih (47, 2%) bolnikov, ki so se zdravili s kombinacijo in 33, 2%
10 the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Ob vključitvi v študijo je bila srednja vrednost krvnega tlaka v obeh skupinah približno 172/ 113 mmHg.
The mean baseline blood pressure was approximately 172/ 113 mmHg in each treatment group and decreases of SeSBP/ SeDBP at five weeks were 30.8/ 24.0 mmHg and 21.1/ 19.3 mmHg for irbesartan/ hydrochlorothiazide and irbesartan, respectively (p < 0.0001).
Po 5- ih tednih zdravljenja se je v skupini, ki je prejemala irbesartan/ hidroklorotiazid, zmanjšala za 30, 8/ 24, 0 mmHg (sistolični/ diastolični krvni tlak v sedečem položaju), v skupini, ki je prejemala irbesartan pa za 21, 1/ 19, 3 mmHg (p < 0, 0001).
During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
V skupini, ki je prejemala kombinacijo učinkovin so pri 0, 6% bolnikov poročali o pojavu hipotenzije in pri 2, 8% bolnikov o pojavu omotice.
There were 0.6% and 0% of patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
V skupini, ki je prejemala samo eno učinkovino, o pojavu hipotenzije niso poročali, o pojavu omotice pa so poročali pri 3, 1% bolnikov.
Following oral administration of CoAprovel, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Po peroralnem jemanju zdravila CoAprovel je biološka uporabnost irbesartana približno 60- 80%, hidroklorotiazida pa 50- 80%.
Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Najvišja plazemska koncentracija irbesartana se doseže 1, 5- 2 ure po peroralnem jemanju, najvišja plazemska koncentracija hidroklorotiazida pa čez 1- 2, 5 ure.
The volume of distribution for irbesartan is 53-93 litres.
Porazdelitveni volumen irbesartana je 53- 93 litrov.
Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/ kg.
Na plazemske beljakovine se veže približno 68% hidroklorotiazida; njegov porazdelitveni volumen je 0, 83 do 1, 14 l/ kg.
The total body and renal clearance are 157-176 and 3.0-3.5 ml/ min, respectively.
Celoten telesni očistek je 157 do 176 ml/ min, ledvični pa 3 do 3, 5 ml/ min.
In patients with creatinine clearance < 20 ml/ min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Pri bolnikih z ledvičnim očistkom < 20 ml/ min se razpolovni čas izločanja hidroklorotiazida podaljša na 21 ur.
11 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Jetrna okvara: pri bolnikih z blago do zmerno cirozo farmakokinetični parametri irbesartana niso bistveno spremenjeni.
Irbesartan/ hydrochlorothiazide: the potential toxicity of the irbesartan/ hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Irbesartan/ hidroklorotiazid: potencialno toksičnost kombinacije irbesartan/ hidroklorotiazid so po peroralnem dajanju ocenjevali pri podganah in opicah, v raziskavah ki so trajale do 6 mesecev.
These lesions were not observed in macaques; decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Pri podganah in opicah, ki so prejemale kombinacijo 10 mg irbesartana in 10 mg hidroklorotiazida na kg/ dan ter 90 mg irbesartana in 90 mg hidroklorotiazida na kg/ dan, so se po znižanju krvnega tlaka (pri čemer niso opazili pomembnih toksikoloških interakcij) zaradi uporabe ene učinkovine ali kombiniranega dajanja pojavile naslednje spremembe: ledvične spremembe so se kazale kot blago zvečanje sečnine in kreatinina v serumu ter hiperplazija/ hipertrofija jukstaglomerulnega aparata, kar je neposredna posledica interakcije med irbesartanom in sistemom renin- angiotenzin blago zmanjšanje eritrocitnih parametrov (eritrocitov, hemoglobina in hematokrita) pri nekaj podganah, ki so v študiji toksičnosti 6 mesecev dobivale po 90 mg irbesartana na kg/ dan in 90 mg hidroklorotiazida na kg/ dan ter kombinacijo irbesartana in hidroklorotiazida (10 mg/ 10 mg/ kg/ dan), so opazili spremembo barve želodca, razjede in fokalno nekrozo želodčne sluznice; teh lezij pri opicah ni bilo znižanje kalija v serumu med uporabo hidroklorotiazida, ki je bilo med kombiniranim dajanjem z irbesartanom manj izrazito.
These findings appear to have no relevance to the use of therapeutic doses of irbesartan/ hydrochlorothiazide in humans.
Ugotovitve pa ne veljajo za terapevtske odmerke irbesartana/ hidroklorotiazida pri ljudeh.
The effects of the irbesartan/ hydrochlorothiazide combination on fertility have not been evaluated in animal studies, as there is no evidence of adverse effect on fertility in animals or humans with either irbesartan or hydrochlorothiazide when administered alone.
Vpliva kombinirane uporabe irbesartana in hidroklorotiazida na plodnost v študijah na živalih niso ugotavljali, kajti neželenih učinkov na plodnost bodisi irbesartana bodisi hidroklorotiazida pri živalih in ljudeh niso dokazali.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
Dokazov o mutagenem in klastogenem delovanju kombinacije irbesartana in hidroklorotiazida ni.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
V predkliničnih varnostnih študijah so veliki odmerki irbesartana (≥ 250 mg/ kg/ dan pri podganah in ≥ 100 mg/ kg/ dan pri opicah) povzročili zmanjšanje parametrov rdečih krvnih celic (eritrociti, hemoglobin, hematokrit).
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidneys (such as interstitial nephritis, tubular distention, 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.
Zelo veliki odmerki irbesartana (≥ 500 mg/ kg/ dan) so povzročili degeneracijske spremembe ledvic (kot na primer intersticijski nefritis, razširjanje tubulov, bazofilne tubule, zvečano plazemsko koncentracijo sečnine in kreatinina) pri podganah in opicah, kar je bila verjetno posledica hipotenzivnega učinka zdravila, zaradi katerega se je zmanjšala renalna perfuzija.
Furthermore, irbesartan induced hyperplasia/ hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/ kg/ day, in macaques at ≥ 10 mg/ kg/ day).
Irbesartan je povzročil hiperplazijo/ hipertrofijo jukstaglomerulnih celic (pri podganah po odmerku ≥ 90 mg/ kg/ dan in pri opicah po odmerku ≥ 10 mg/ kg/ dan).
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Pri terapevtskih odmerkih irbesartana pri ljudeh ne kaže, da bi bila hiperplazija/ hipertrofija jukstaglomerulnih celic kakorkoli pomembna.
12 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hkrati pa tudi izkušnje z uporabo hidroklorotiazida pri ljudeh niso potrdile povezanosti med tem zdravilom in pogostejšim pojavom neoplazem.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides (E172)
mikrokristalna celuloza premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat hidratirani koloidni silicijev dioksid predgelirani koruzni škrob rdeči in rumeni železov oksid (E172)
Cartons of 14 tablets; 1 blister card of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 14 tabletami; 1 pretisni omot iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 28 tablets; 2 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Škatle z 28 tabletami; 2 pretisna omota iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 56 tablets; 4 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 56 tabletami; 4 pretisni omoti iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Škatle z 98 tabletami; 7 pretisnih omotov iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 56 x 1 tablets; 7 blister cards of 8 x 1 tablets each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
Škatle s 56 x 1 tableto; 7 pretisnih omotov z 8 x 1 tableto, vsaka v perforiranem enoodmernem pretisnem omotu iz PVC/ PVDC/ aluminija.
MARKETING AUTHORISATION NUMBERS
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
15 October 1998 Date of last renewal:
15 oktober 1998 Datum zadnjega podaljšanja:
1 October 2008
1 oktober 2008
CoAprovel 300 mg/ 12.5 mg tablets.
CoAprovel 300 mg/ 12, 5 mg tablete
Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena tableta vsebuje 300 mg irbesartana in 12, 5 mg hidroklorotiazida.
Each tablet contains 65.8 mg of lactose (as lactose monohydrate).
Ena tableta vsebuje 65, 8 mg laktoze (v obliki laktoze monohidrata).
15 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
15 Starostniki: pri starostnikih odmerka zdravila CoAprovel ni treba prilagajati.
16 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
16 Med zdravljenjem s tiazidnimi diuretiki se lahko zvečajo vrednosti holesterola in trigliceridov.
17 Lactose: this medicinal product contains lactose.
17 Laktoza: zdravilo vsebuje laktozo.
18 Alcohol: potentiation of orthostatic hypotension may occur;
Alkohol: pojavi se lahko ortostatska hipotenzija.
Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins;
18 Holestiramin in holestipol: absorpcija hidroklorotiazida je zaradi anionskih izmenjevalnih smol motena.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
19 Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4. 3 in 4. 4).
21 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Neželeni učinki hidroklorotiazida, ki so odvisni od odmerka (zlasti elektrolitske motnje), se lahko med titriranjem hidroklorotiazida povečajo.
4.9 Overdose
21 4. 9 Preveliko odmerjanje
22 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Kombinacija hidroklorotiazida in irbesartana povzroči od odmerka odvisno aditivno znižanje krvnega tlaka znotraj terapevtskega intervala.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/ diastolic reductions of up to 13.6/ 11.5 mm Hg.
22 Med kombiniranim zdravljenjem s 300 mg irbesartana in 12, 5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13, 6 mmHg, diastolični pa do 11, 5 mmHg bolj kot po uporabi placeba.
23 the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Ob vključitvi v študijo je bila srednja vrednost krvnega tlaka v obeh skupinah približno 172/ 113 mmHg.
24 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Jetrna okvara: pri bolnikih z blago do zmerno cirozo farmakokinetični parametri irbesartana niso bistveno spremenjeni.
5.3 Preclinical safety data
24 5. 3 Predklinični podatki o varnosti
25 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hkrati pa tudi izkušnje z uporabo hidroklorotiazida pri ljudeh niso potrdile povezanosti med tem zdravilom in pogostejšim pojavom neoplazem.
CoAprovel 150 mg/ 12.5 mg film-coated tablets.
CoAprovel 150 mg/ 12, 5 mg filmsko obložene tablete
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 150 mg irbesartana in 12, 5 mg hidroklorotiazida.
Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 38, 5 mg laktoze (v obliki laktoze monohidrata).