natgillin/translations-raw huggingface dataset:
If the patient requires additional or continuation of pain relief, a new system may be applied to a new skin site on the upper outer arm or chest.
Če bolnik potrebuje dodatno lajšanje bolečin ali nadaljnje lajšanje bolečin, lahko na novo mesto na koži zunanjega dela nadlahti ali na prsih namestite nov sistem.
A maximum of 3 days’ treatment can be given, using three separate systems.
Zdravljenje lahko traja največ 3 dni in pri tem uporabite tri ločene sisteme.
Dose delivery
Sproščanje odmerkov
A dosing button and a red light are located on top of the IONSYS system.
Na vrhu sistema IONSYS se nahajata odmerni gumb in rdeča lučka.
To initiate a fentanyl dose, the patient presses the button twice within 3 seconds.
Če želi sprožiti sproščanje odmerka fentanila, naj bolnik pritisne na gumb dvakrat v 3 sekundah.
A beep indicates the start of delivery of the dose; the red light comes on and remains on throughout the 10-minute delivery cycle.
Pisk bo označil začetek sproščanja odmerka - prižgala se bo rdeča lučka in bo ostala prižgana ves čas 10- minutnega ciklusa odmerjanja.
The next dose cannot be started until the cycle is complete: pressing the button during delivery will not initiate another dose.
Naslednjega odmerka ne bo mogel sprožiti, dokler ne bo zaključen tekoči ciklus, kar pomeni, da s pritiskom na gumb med dajanjem odmerka ne bo sprožil naslednjega odmerka.
The red light starts to blink after the 10-minute dose has been delivered.
Rdeča lučka bo začela utripati, ko bo zaključeno 10- minutno sproščanje odmerka.
Approximate number of doses delivered.
Približno število sproščenih odmerkov.
Between doses, the red light flashes in one-second pulses, which indicate the approximate number of doses administered.
Med posameznimi odmerki bo rdeča lučka utripala v enosekundnih pulzih in s tem kazala približno število že sproščenih odmerkov.
Each one-second pulse/ flash of light indicates administration of up to five doses.
Vsak utrip pomeni sproščanje do petih odmerkov.
So:
Torej pomeni:
- a single flash represents 1 to 5 doses
- en utrip 1 do 5 odmerkov,
- flashing twice represents 6-10 doses
- dva utripa 6- 10 odmerkov,
- flashing three times represents 11-15 doses
- trije utripi 11- 15 odmerkov.
This continues to a maximum of 16 pulses which represent 76-80 doses.
Utripov je lahko največ 16, kar pomeni 76 do 80 sproščenih odmerkov.
The system may also be queried during delivery of a dose by pressing the button once.
Število že sproščenih odmerkov lahko tudi preverite med sproščanjem odmerka, in sicer tako, da enkrat pritisnete na gumb.
The red light will pulse as above to indicate the approximate number of doses delivered up to the query.
Rdeča lučka bo utripala, kakor je opisano zgoraj, in tako kazala približno število odmerkov, ki jih je bolnik že prejel do trenutka preverjanja.
This query will not influence dose delivery.
Preverjanje števila odmerkov ne bo vplivalo na odmerjanje zdravila.
Each IONSYS system is designed to deliver one on-demand dose of fentanyl over approximately 10 minutes.
Vsak sistem IONSYS je konstruiran tako, da dovaja posamezen odmerek fentanila na zahtevo v času približno 10 minut.
If a technical failure with a system is suspected, the staff member or patient should monitor both the illumination of the red light and any audible signals (beeps) over the next dose.
Če sumite na tehnično napako v sistemu, bo moralo osebje ali sam bolnik v času sproščanja naslednjega odmerka spremljati tako vklop rdeče lučke kot vse morebitne zvočne signale (piske).
Error Description 2 beeps repeated 8 times (approximately 15 seconds) and red light turns off before 10 minutes 4 continuous beeps and red light turns off before 10 minutes
Opis napake 2 piska, ponovljena 8- krat (približno 15 sekund) in rdeča lučka ugasne prej kot v 10 minutah
If all attempts fail, the system should be removed and a new system applied to a new skin site.
Če bodo vsi poskusi neuspešni, sistem snemite in namestite nov sistem na novo mesto na koži.
The system cannot be restarted.
4 neprekinjeni piski in rdeča lučka ugasne prej kot v 10 minutah
It should be removed and a new system applied to a new skin site.
Morate ga sneti in nov sistem namestiti na novo mesto na koži.
Red light fails to illuminate
Rdeča lučka se ne prižge
The system should be removed and a new system applied to a new skin site.
Sistem snemite in novega namestite na novo mesto na koži.
Safe disposal of IONSYS
Varno odlaganje sistema IONSYS
The used system should be disposed of by medical staff only.
Uporabljene sisteme sme odlagati le medicinsko osebje.
Contact with the fentanyl hydrogel can be harmful to humans.
Stik s fentanilovim hidrogelom je lahko škodljiv za ljudi.
Handle the used system carefully and only by the sides and top housing.
Z uporabljenim sistemom ravnajte previdno in ga smete prijemati le ob strani in za zgornji del ohišja.
The used patch should be disposed of as medical waste in accordance with local regulations.
Uporabljeni obliž odlagajte kot medicinski odpadek, v skladu z lokalnimi predpisi.
If required by local regulations, the design of the system allows separate disposal of the red fentanyl- containing bottom housing and the white electronic/ battery containing top housing.
Če je to potrebno zaradi lokalnih predpisov, konstrukcija sistema omogoča ločeno odlaganje rdečega spodnjega dela ohišja, ki vsebuje fentanil, in belega zgornjega dela ohišja, ki vsebuje elektronske elemente in baterijo.
To segregate a used IONSYS system:
Za ločeno odlaganje uporabljenega sistema IONSYS ravnajte, kot sledi:
Dispose of bottom housing in accordance with local legislation.
Spodnji del ohišja odlagajte v skladu z lokalno zakonodajo.
Dispose of top housing, containing electronics, according to local procedures for electronic / battery waste.
Zgornji del ohišja, ki vsebuje elektronske elemente, odlagajte v skladu z lokalnimi postopki za elektronske/ baterijske odpadke.
Ref.
London, 26. aprila 2007 Sklic dok.
EMEA/ 111199/ 2007
EMEA/ 231332/ 2007
IPLEX is a solution for injection containing 60 mg/ ml mecasermin rinfabate as the active substance.
Zdravilo IPLEX je raztopina za injiciranje, ki kot zdravilno učinkovino vsebuje 60 mg/ ml mekasermin rinfabata.
IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because: • they have primary insensitivity to the hormone, so that injected growth hormone has no effect. ‘ Primary’ means that there is no known reason for the insensitivity. • they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
„ Primarno “ pomeni, da za neobčutljivost ni znanih razlogov; • niso sposobni proizvajati rastnega hormona in so v preteklosti prejemali rastni hormon, a so proti njemu razvili protitelesa, posebne beljakovine, ki vbrizganemu hormonu preprečujejo, da bi imel kakršne koli učinke.
Because the number of patients with these diseases is low, they are considered ‘ rare’, and mecasermin rinfabate was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 20 June 2006.
Ker je število bolnikov s temi boleznimi majhno, bolezen velja za redko, zato je bil mekasermin rinfabat 20. junija 2006 opredeljen kot zdravilo sirota (zdravilo za redke bolezni).
The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Mekasermin rinfabat, ki je zdravilna učinkovina zdravila IPLEX, je dvojna beljakovina, sestavljena iz dveh beljakovin, ki ju telo proizvaja v normalnih pogojih: insulinu podobnega rastnega faktorja (IGF - I) in insulinu podobnega veznega proteina 3 (IGFBP- 3).
Mecasermin rinfabate is produced by a method known as ‘ recombinant DNA technology’: it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Mekasermin rinfabat se izdeluje z metodo, ki se imenuje „ tehnologija rekombinantne DNA “: tvori ga celica, ki je prejela gen (DNA), zaradi katerega lahko tvori mekasermin rinfabat.
IGF-I then stimulates the bones to grow.
Naravni rastni hormon pospešuje telesno rast otrok, tako da telo spodbuja k tvorjenju IGF- I, ta pa nadalje spodbuja rast kosti.
IPLEX provides IGF-I directly, as part of the binary protein, and this allows bone growth while bypassing the need for growth hormone itself.
Zdravilo IPLEX telo oskrbuje neposredno z IGF- I, ki je del dvojne beljakovine, in s tem omogoča rast kosti brez potrebe po samem rastnem hormonu.
In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
IGF- I v zdravilu IPLEX je vezano na IGFBP- 3, ker se s tem posnema način, po katerem se IGF- 1 prenaša po telesu.
This may allow IGF-I to circulate in the body at higher levels and for longer periods than unbound IGF-I.
Zaradi tega lahko IGF- I po telesu kroži pri večji koncentraciji in dlje časa kakor nevezani IGF- I.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Kako daleč je bil postopek ocenjevanja vloge ob umiku vloge?
The application was at day 120 when the company withdrew.
Podjetje je umaknilo vlogo na 120. dan.
Following the CHMP’ s opinion, it usually takes around 2 months for the European Commission to grant a licence.
Ko CHMP izda mnenje, potrebuje Evropska komisija še približno dva meseca, da izda dovoljenje.
They also had major concerns regarding the way in which the medicine’ s effectiveness had been assessed, especially regarding the type of patients that have been included in the clinical trial.
Glavni zadržki CHMP so se nanašali tudi na način ocenjevanja učinkovitosti zdravila, zlasti glede tipov bolnikov, ki so jih vključili v klinično preizkušanje.
Patients had also not been treated for long enough to show that the medicine’ s effect continues when used for longer than one year.
Zdravljenje bolnikov poleg tega ni trajalo dovolj dolgo, da bi lahko dokazalo učinkovanje zdravila tudi pri uporabi, daljši od enega leta.
Therefore, at the time of the withdrawal, the CHMP’ s view was that the benefit of IPLEX had not been sufficiently demonstrated and did not outweigh the identified risks.
Zato je bil v času umika CHMP mnenja, da koristi zdravila IPLEX niso bile zadostno dokazane in niso večje od znanih tveganj.
This medicine is the same as Karvea, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Karvea, ki je že odobreno v Evropski uniji (EU).
The company that makes Karvea has agreed that its scientific data can be used for Irbesartan BMS.
Družba, ki proizvaja zdravilo Karvea, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Irbesartan BMS.
Irbesartan BMS is used in patients who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
„ Esencialna “ pomeni, da visok krvni tlak ni posledica nobenega drugega bolezenskega stanja.
Irbesartan BMS is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Zdravilo Irbesartan BMS se uporablja tudi za zdravljenje renalne (ledvične) bolezni pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki je neodvisna od insulina).
Irbesartan BMS is not recommended for use in patients below 18 years of age.
Uporaba zdravila Irbesartan BMS pri bolnikih, mlajših od 18 let, ni priporočena.
In patients with hypertension and type 2 diabetes, Irbesartan BMS is added to other treatments for hypertension.
Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Irbesartan BMS uvede poleg drugih načinov zdravljenja hipertenzije.
The active substance in Irbesartan BMS, irbesartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Irbesartan BMS, irbesartan, je „ antagonist receptorjev angiotenzina II “, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
This allows the blood pressure to drop, reducing the risk of damage caused by high blood pressure, such as having a stroke.
Posledica tega je znižanje krvnega tlaka, kar posledično zmanjša tveganje za poškodbe, ki jih povzroča visok krvni tlak, kot je denimo kap.
Irbesartan BMS was originally studied in 11 trials for its effects on blood pressure.
Učinke zdravila Irbesartan BMS na krvni tlak so prvotno preučevali v 11 preskušanjih.
Irbesartan BMS was compared with placebo (a dummy treatment) in 712 patients, and compared with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Zdravilo Irbesartan BMS so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 712 bolnikih in drugimi zdravili za zdravljenje visokega krvnega tlaka (atenolol, enalapril ali amlodipin) pri 823 bolnikih.
Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Preučevali so tudi njegovo uporabo v kombinaciji s hidroklorotiazidom pri 1736 bolnikih.
For the treatment of kidney disease, Irbesartan BMS was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Zdravilo Irbesartan BMS so glede zdravljenja ledvične bolezni preučevali v okviru dveh velikih študij, ki sta vključevali skupno 2326 bolnikov s sladkorno boleznijo tipa 2.
One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Prva študija je preučevala označevalce poškodb ledvic, in sicer na podlagi merjenja, ali ledvice izločajo v urin beljakovino albumin.
The second study looked at whether Irbesartan BMS increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Druga študija je preučevala, ali Irbesartan BMS podaljša čas, v katerem se raven kreatinina v krvi (označevalca ledvične bolezni) pri bolnikih podvoji, ali čas do pojava potrebe po presaditvi ali dializi oziroma do nastopa smrti.
In the second kidney disease study, Irbesartan BMS reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
V drugi študiji ledvične bolezni je zdravilo Irbesartan BMS v primerjavi s placebom za 20% zmanjšalo relativno tveganje za podvojitev ravni kreatinina v krvi, za pojav potrebe po presaditvi ledvic ali dializi ali za nastop smrti med študijo.
In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease have the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), orthostatic hypotension (low blood pressure when standing up) and musculoskeletal (joint) pain.
Poleg tega je pri več kot 1 bolniku od 100, ki so imeli sladkorno bolezen tipa 2 in ledvično bolezen, prišlo do naslednjih neželenih učinkov: hiperkaliemije (visokih ravni kalija v krvi), ortostatske omotice (omotice v stoječem položaju), ortostatske hipotenzije (nizkega krvnega tlaka v stoječem položaju) in mišičnoskeletnih bolečin (bolečin v sklepih).
For the full list of all side effects reported with Irbesartan BMS, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan BMS, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan BMS’ s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Irbesartan BMS pri zdravljenju esencialne hipertenzije in ledvične bolezni pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 večje od z njim povezanih tveganj.
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan BMS, veljavno po vsej Evropski uniji, odobrila družbi Bristol- Myers Squibb Pharma EEIG dne 19. januarja 2007.
Each tablet contains 75 mg irbesartan.
Vsaka tableta vsebuje 75 mg irbesartana.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan BMS can be increased to 300 mg, or other anti-hypertensive agents can be added.
Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Irbesartan BMS ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan BMS (see section 4.5).
In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid pokazal sinergistični učinek z zdravilom Irbesartan BMS (glejte poglavje 4. 5).
The demonstration of renal benefit of Irbesartan BMS 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 section 5.1).
Koristi zdravljenja z zdravilom Irbesartan BMS 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 poglavje 5. 1).
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.
Pri bolnikih na hemodializi se mora pretehtati možnost uporabe nižjega začetnega odmerka (75 mg).
Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan BMS.
Zmanjšan intravaskularni volumen: pred uporabo zdravila Irbesartan BMS je treba korigirati zmanjšani volumen krvi in/ ali pomanjkanje natrija.
2 Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
2 Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
Hypersensitivity to the active substances or to any of the excipients (see section 6.1).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov zdravila (glejte poglavje 6. 1).
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan BMS, 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 BMS pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ ali odpovedi srca.
Lithium: the combination of lithium and Irbesartan BMS is not recommended (see section 4.5).
Litij: sočasna uporaba zdravila Irbesartan BMS in litija ni priporočljiva (glejte poglavje 4. 5).
As with any anti- hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Kot pri vseh antihipertenzivih, ima lahko izrazito zmanjšanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično srčnožilno boleznijo za posledico infarkt miokarda ali kap.
3 As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
3 Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno zaradi večje prevalence stanj z nizko vrednostjo renina pri temnopoltih bolnikih z visokim krvnim tlakom (glejte poglavje 5. 1).
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan BMS (see section 4.4).
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Irbesartan BMS (glejte poglavje 4. 4).
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) in neselektivne NSAID) lahko oslabi antihipertenzivni učinek.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Kot z zaviralci ACE, sočasna uporaba antagonistov angiotenzina II in NSAID lahko poveča tveganje za poslabšanje delovanja ledvic, vključno z možno akutno ledvično odpovedjo, in zvišanje kalija v plazmi, predvsem pri starejših bolnikih.
4 4.6 Pregnancy and lactation
Uporaba antagonistov angiotenzina II v prvem trimesečju nosečnosti ni priporočljiva (glejte poglavje 4. 4).
Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4. 3 in 4. 4).
Irbesartan BMS is contraindicated (see section 4.3) during lactation.
Dojenje: med dojenjem je zdravilo Irbesartan BMS kontraindicirano (glejte poglavje 4. 3).
Hypertension: in placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Hipertenzija: v s placebom kontroliranih preskušanjih z bolniki s hipertenzijo, se celotna pogostost neželenih učinkov med skupinama z irbesartanom (56, 2%) in placebom (56, 5%) ni razlikovala.
In placebo-controlled trials in which 1,965 patients received irbesartan, the following adverse drug reactions were reported:
V s placebom kontroliranih preskušanjih, v katerih je sodelovalo 1. 965 bolnikov, ki so prejemali irbesartan, so poročali o naslednjih neželenih učinkih:
dizziness
omotica.
tachycardia
tahikardija.
flushing
rdečica.
5 Respiratory, thoracic and mediastinal disorders:
5 Bolezni dihal, prsnega koša in mediastinalnega prostora:
cough
kašelj.
nausea/ vomiting diarrhea, dyspepsia/ heartburn
slabost/ bruhanje. driska, dispepsija / zgaga.
sexual dysfunction
motnje na področju spolnosti.
Common:
Splošne težave in Pogosti:
fatigue chest pain
spremembe na mestu aplikacije: utrujenost. bolečina v prsih.
Hypertension and type 2 diabetes with renal disease: in addition to the adverse drug reactions mentioned under hypertension, in diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i. e., uncommon) but in excess of placebo.
Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo: poleg neželenih učinkov navedenih pri hipertenziji, so pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalnim delovanjem ledvic poročali o ortostatski omotici in ortostatski hipotenziji pri 0, 5% bolnikov (to je občasno), a več kot pri placebu.