FrancophonIA/ELRC3.0 huggingface dataset:
English: • moderately to severely active Crohn's disease (a disease causing inflammation of the gut) in adults whose condition has not responded well enough to other treatments for Crohn's disease or who cannot receive such treatments.
Slovenian: • zmerne do hude aktivne Crohnove bolezni (bolezni, ki povzroča vnetje črevesa) pri odraslih, katerih bolezen se ni zadosti odzvala na druga zdravila za zdravljenje Crohnove bolezni ali ki tovrstnih zdravil ne morejo prejemati.
English: For practical information about using Stelara, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Stelara naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Therefore, the CHMP decided to restrict the use of the medicine in moderate to severe plaque psoriasis to patients aged 12 years and above in whom other treatments had failed or who could not receive them.
Slovenian: Odbor CHMP je zato odločil, da se pri zmerni do hudi psoriazi s plaki uporaba zdravila omeji na bolnike, starejše od 12 let, pri katerih drugi načini zdravljenja niso bili uspešni ali niso mogoči.
English: In Crohn's disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had failed or who could not receive them were considered important, also given the unmet medical need of these patients.
Slovenian: Pri Crohnovi bolezni so bili učinki zdravila Stelara pri zmanjševanju simptomov bolezni pri bolnikih, pri katerih druga zdravljenja niso bila uspešna ali teh niso mogli prejemati, pomembni glede na to, da ni drugih zdravil, primernih za te bolnike.
English: • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not responded well enough to other treatments called disease-modifying antirheumatic drugs' (DMARDs).
Slovenian: • aktivnega psoriatičnega artritisa (vnetja sklepov zaradi psoriaze) pri odraslih, katerih bolezen se ni zadostno odzvala na zdravljenje z drugimi vrstami zdravil, imenovanimi protirevmatična zdravila za spreminjanje poteka bolezni (DMARD).
English: The patient material will also include details of how Stelara should be injected under the skin.
Slovenian: Gradivo za bolnike bo vključevalo tudi podrobne napotke o injiciranju zdravila Stelara v podkožje.
English: Patients then continue with Stelara given under the skin every 8 or 12 weeks depending on response to treatment.
Slovenian: Dajanje injekcij zdravila Stelara v podkožje se nato ponovi vsakih 8 ali 12 tednov, odvisno od odziva na zdravljenje.
English: The active substance in Stelara, ustekinumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila Stelara, ustekinumab, je monoklonsko protitelo.
English: In plaque psoriasis and psoriatic arthritis, Stelara is given as an injection under the skin.
Slovenian: Pri psoriazi s plaki in psoriatičnem artritisu se zdravilo Stelara daje z injiciranjem v podkožje.
English: The CHMP considered that studies had shown that Stelara was effective in the treatment of adults and children over 12 years of age with moderate to severe plaque psoriasis.
Slovenian: Menil je, da se je zdravilo Stelara v študijah izkazalo za učinkovito pri zdravljenju odraslih in otrok, starejših od 12 let, z zmerno do hudo psoriazo s plaki.
English: The comparative study showed that Stelara is more effective than etanercept after 12 weeks of treatment.
Slovenian: V primerjalni študiji so ugotovili, da je zdravilo po 12 tednih zdravljenja učinkovitejše od etanercepta.
English: For adults with psoriatic arthritis who have not responded well to DMARDs the CHMP noted the limited treatments available and considered that Stelara would be of benefit in these patients.
Slovenian: Glede odraslih bolnikov s psoriatičnim artritisom, ki se niso dobro odzvali na zdravljenje z zdravili DMARD, je odbor menil, da so zanje na voljo le omejene možnosti zdravljenja in da bi jim zdravilo Stelara lahko koristilo.
English: In the treatment of Crohn's disease, Stelara (concentrate for infusion) was compared with placebo in two main studies involving 1,369 patients with moderately to severely active disease.
Slovenian: Pri zdravljenju Crohnove bolezni so zdravilo Stelara (koncentrat za infundiranje) primerjali s placebom v dveh glavnih študijah, v kateri je bilo vključenih 1 369 bolnikov z zmerno do hudo aktivno boleznijo.
English: After 44 weeks of starting treatment by injection under the skin, 53% of patients on Stelara every 8 weeks and 49% of patients on Stelara every 12 weeks had a significant reduction in symptoms of Crohn's disease, compared with 36% of patients on placebo.
Slovenian: Po 44 tednih prejemanja injekcij v podkožje so se simptomi Crohnove bolezni bistveno zmanjšali pri 53 % bolnikov, ki so prejemali zdravilo Stelara vsakih 8 tednov, in pri 49 % bolnikov, ki so zdravilo Stelara prejemali vsakih 12 tednov, v primerjavi s 36 % bolnikov, ki so prejemali placebo.
English: In the treatment of active psoriatic arthritis, Stelara was compared with placebo in two main studies involving a total of 927 adults with the condition who did not have an adequate response with previous treatments.
Slovenian: Zdravilo Stelara so pri zdravljenju aktivnega psoriatičnega artritisa primerjali s placebom v dveh glavnih študijah, ki sta vključevali skupno 927 odraslih, ki se niso ustrezno odzvali na predhodna zdravljenja.
English: For the full list of all side effects reported with Stelara, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stelara, glejte navodilo za uporabo.
English: Plaque psoriasis
Slovenian: Psoriaza s plaki
English: These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Slovenian: Družba, ki izdeluje zdravilo Stelara, bo zdravstvenemu osebju in bolnikom priskrbela izobraževalno gradivo, ki bo obravnavalo predvsem varnost zdravila, zlasti tveganje za razvoj tuberkuloze, drugih okužb in raka.
English: How is Stelara used?
Slovenian: Kako se zdravilo Stelara uporablja?
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se po 12 tednih odzvali na zdravljenje, kar pomeni, da so se ocene njihovih simptomov izboljšale za najmanj 75 %.
English: Looking at the results of the two main studies in adults taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo.
Slovenian: Skupni rezultati obeh glavnih študij pri odraslih kažejo, da se je po 12 tednih na zdravljenje odzvalo približno 69 % bolnikov, ki so prejemali zdravilo Stelara, v primerjavi s 3 % bolnikov, ki so prejemali placebo.
English: The children received placebo or Stelara and the main measure of effectiveness was the number of patients who responded to treatment after 12 weeks as shown by an improvement in symptom scores.
Slovenian: Otroci so prejemali bodisi placebo bodisi zdravilo Stelara, v obeh študijah pa je bilo glavno merilo učinkovitosti število bolnikov, ki so se po 12 tednih odzvali na zdravljenje, kar so ugotavljali na podlagi izboljšanja ocene simptomov.
English: In the first study, around 34% patients who received Stelara (at a dose calculated based on bodyweight) responded to treatment compared with 21% of patients who were given placebo.
Slovenian: V prvi študiji se je na zdravljenje odzvalo okoli 34 % bolnikov, ki so prejemali zdravilo Stelara (v odmerku, izračunanem na podlagi njihove telesne mase), v primerjavi z 21 % bolnikov, ki so prejemali placebo.
English: In around 69% of children (25 out of 36) who received Stelara responded, compared with 5% of patients receiving placebo (2 out of 37).
Slovenian: Študija pri otrocih je pokazala, da se je približno 69 %(25 od 36) otrok, ki so prejeli zdravilo Stelara, odzvalo nanj, v primerjavi s 5 % bolnikov (2 od 37), ki so prejemali placebo.
English: In the first study, around 42% of those given Stelara 45 mg and 50% of those given 90 mg responded, compared with around 23% of those given placebo.
Slovenian: V prvi študiji se je na zdravljenje odzvalo okoli 42 % bolnikov, ki so prejemali 45-miligramski odmerek zdravila, in 50 % tistih, ki so prejemali 90-miligramski odmerek, v primerjavi s 23 % bolnikov, ki so prejemali placebo.
English: The longer-term results showed that with continuous treatment, the response to Stelara is maintained over 5 years.
Slovenian: Dolgoročni rezultati so pokazali, da se je ob neprekinjenem zdravljenju odziv na zdravilo
English: How does Stelara work?
Slovenian: Kako zdravilo Stelara deluje?
English: In both studies the main measure of effectiveness was the number of patients who responded to treatment after 24 weeks as shown by an improvement in symptom scores.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se po 24 tednih odzvali na zdravljenje, kar so ugotavljali na podlagi izboljšanja ocene simptomov.
English: In the treatment of moderate to severe plaque psoriasis, Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with the condition.
Slovenian: Zdravilo Stelara so pri zdravljenju zmerne do hude psoriaze s plaki primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v kateri je bilo vključenih skupno 1 996 odraslih bolnikov s to boleznijo.
English: In both studies the main measure of effectiveness was the number of patients who responded to treatment 6 weeks after the injection as shown by an improvement in symptom scores.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se po šestih tednih po infundiranju odzvali na zdravljenje, kar so ugotavljali na podlagi izboljšanja ocene simptomov.
English: In the second study, around 44% of those given either dose of Stelara responded, compared with around 20% of those given placebo.
Slovenian: V drugi študiji se je odzvalo okoli 44 % bolnikov, ki so prejemali enega od obeh odmerkov zdravila Stelara, v primerjavi z okoli 20 % bolnikov, ki so prejemali placebo.
English: Patients or their caregivers may inject Stelara under the skin once they have been trained, if their doctor thinks that this is appropriate.
Slovenian: Če zdravnik presodi, da je primerno, si lahko bolniki po opravljenem ustreznem usposabljanju zdravilo Stelara v podkožje injicirajo sami ali to naredijo njihovi negovalci.
English: Stelara contains the active substance ustekinumab.
Slovenian: Zdravilo Stelara vsebuje zdravilno učinkovino ustekinumab.
English: Date of first authorisation: 15 October 1998 Date of latest renewal: 15 October 2008
Slovenian: Datum pridobitve dovoljenja za promet: 15 oktober 1998 Datum zadnjega podaljšanja: 15 oktober 2008
English: Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: CoAprovel should be taken at least one hour before or four hours after these medications;
Slovenian: CoAprovel je treba jemati vsaj eno uro pred ali štiri ure po jemanju teh zdravil.
English: Do not store above 30°C.
Slovenian: Shranjujte pri temperaturi do 30°C.
English: What CoAprovel is and what it is used for
Slovenian: Kaj je zdravilo CoAprovel in za kaj ga uporabljamo
English: * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Slovenian: * Te meje ne veljajo za serije, v katerih so hkrati ugotovili več kot enega od zgornjih N-nitrozaminov; take serije je treba zavrniti.
English: Investigations:
Slovenian: Preiskave:
English: 63.09 17404 Riells i Viabrea (Girona) - Spain
Slovenian: 63.09 17404 Riells i Viabrea (Girona) Španija
English: See also information under the heading “Do not take CoAprovel”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila CoAprovel”.
English: Please see section 2 “CoAprovel contains lactose”.
Slovenian: Prosimo glejte poglavje 2 »Zdravilo CoAprovel vsebuje laktozo«.
English: 2) After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Slovenian: 2) Po dveletnem prehodnem obdobju je treba za NDMA in NDEA uvesti mejo največ 0,03 ppm.
English: It is important that you continue to take CoAprovel until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo CoAprovel jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
English: Children and adolescents CoAprovel should not be given to children and adolescents (under 18 years).
Slovenian: Otroci in mladostniki Zdravila CoAprovel otroci in mladostniki (mlajši od 18 let) ne smejo jemati.
English: if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Slovenian: če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
English: Other medicines and CoAprovel
Slovenian: Druga zdravila in zdravilo CoAprovel
English: At the time of Commission Decision.
Slovenian: Ob sprejetju sklepa Komisije
English: Such conditions should be corrected before initiating therapy with CoAprovel.
Slovenian: Ta stanja je treba popraviti pred začetkom zdravljenja z zdravilom CoAprovel.
English: sexual dysfunction, libido changes
Slovenian: motnje pri spolnosti, spremembe libida
English: If you forget to take CoAprovel
Slovenian: Če ste pozabili vzeti zdravilo CoAprovel
English: Children should not take CoAprovel
Slovenian: Otroci ne smejo jemati zdravila CoAprovel
English: Excipient with known effect:
Slovenian: Pomožne snovi z znanim učinkom:
English: 2112 Veresegyház - Hungary
Slovenian: 2112 Veresegyház - Madžarska
English: 2112 Veresegyhaz Hungary
Slovenian: 2112 Veresegyhaz Madžarska
English: If CoAprovel is used during breast feeding, doses should be kept as low as possible.
Slovenian: Če se zdravilo CoAprovel uporablja med dojenjem, je treba uporabiti najmanjši možni odmerek.
English: You should discontinue CoAprovel treatment and seek medical attention.
Slovenian: Prenehajte z jemanjem zdravila CoAprovel in poiščite zdravniško pomoč.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v prilogi V.
English: 56 x 1 tablets
Slovenian: 56 x 1 tableta
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev (npr. laktoze), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PRILOGA POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Slovenian: Srednja starost bolnikov je bila 52,5 let, 13% bolnikov je bilo starih 65 let ali starejših.
English: The recommended dose of CoAprovel is one or two tablets a day.
Slovenian: Priporočeni odmerek zdravila CoAprovel je ena ali dve tableti na dan.
English: Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Slovenian: Vrednosti AUC in Cmax za irbesartan sta pri starejših osebah (≥ 65 let) nekoliko večji kot pri mlajših (18 do 40 let).
English: See leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: The study recruited 58% males.
Slovenian: V študijo je bilo vključenih 58% bolnikov moškega spola.
English: If you take more CoAprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila CoAprovel, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: What you need to know before you take CoAprovel
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo CoAprovel
English: What CoAprovel is and what it is used for What you need to know before you take CoAprovel How to take CoAprovel
Slovenian: Kaj je zdravilo CoAprovel in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CoAprovel Kako jemati zdravilo CoAprovel Možni neželeni učinki
English: Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Slovenian: Na plazemske beljakovine se veže približno 96% irbesartana, na celične sestavine krvi pa zanemarljivo malo.
English: Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
Slovenian: Ambarès & Lagrave F-33565 Carbon Blanc Cedex - Francija
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET
English: Alcohol: potentiation of orthostatic hypotension may occur;
Slovenian: Alkohol: pojavi se lahko ortostatska hipotenzija.
English: When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Slovenian: Kadar je nujno, smejo bolniki poleg zdravila CoAprovel jemati tudi drug antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pregledati postopke proizvodnje učinkovin, uporabljenih za svoja zdravila, glede morebitnega tveganja za nastajanje N-nitrozaminov in jih po potrebi spremeniti tako, da se onesnaženje z nitrozamini čim bolj zmanjša.
English: Not known (frequency cannot be estimated from the available data): skin and lip cancer (nonmelanoma skin cancer).
Slovenian: Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): kožni rak in rak ustnice (nemelanomski kožni rak).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: The recommended dose of CoAprovel is one tablet a day.
Slovenian: Priporočeni odmerek zdravila CoAprovel je ena tableta na dan.
English: The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Slovenian: Glavni presnovek v obtoku je irbesartanov glukuronid (približno 6%).
English: As with any antihypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke.
Slovenian: Kot pri vseh antihipertenzivih lahko preveliko znižanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično kardiovaskularno boleznijo povzroči miokardni infarkt ali kap.
English: increases in blood urea nitrogen (BUN), creatinine and creatine kinase
Slovenian: zvišanje vrednosti dušika sečnine v krvi (BUN), kreatinina in kreatin-kinaze
English: Based on its pharmacodynamic properties, CoAprovel is unlikely to affect the ability to drive and use machines.
Slovenian: Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo CoAprovel vplivalo na sposobnost vožnje in upravljanja s stroji.
English: Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Slovenian: 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.
English: The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili omotica (5,6 %), utrujenost (4,9 %), navzea/bruhanje (1,8 %) in motnje uriniranja (1,4 %).
English: Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09DA04.
Slovenian: Farmakoterapevtska skupina: antagonisti angiotenzina II, kombinacije oznaka ATC: C09DA04
English: In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Slovenian: Poleg tega so v študijah pogosto opazili tudi zvišanje vrednosti dušika sečnine v krvi (BUN) (2,3 %), kreatin-kinaze (1,7 %) in kreatinina (1,1 %).
English: Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Laktoza: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Slovenian: Pomembno je, da zdravnika obvestite tudi, če jemljete druga zdravila za zniževanje krvnega tlaka, kortikosteroide, zdravila za zdravljenje raka, lajšanje bolečin, zdravila proti artritisu ali zdravili holestiramin in holestipol za zniževanje holesterola v krvi.
English: Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Slovenian: Na plazemske beljakovine se veže približno 68% hidroklorotiazida; njegov porazdelitveni volumen je 0,83 do 1,14 l/kg.
English: There is no difference in response to CoAprovel, regardless of age or gender.
Slovenian: Odziv na zdravljenje z zdravilom CoAprovel ni odvisen od starosti ali spola.
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Slovenian: Omejeno kopičenje irbesartana v plazmi (< 20%) se pojavi po več dneh jemanja irbesartana enkrat na dan.
English: Table 2: Adverse reactions reported with the use of irbesartan alone
Slovenian: Tabela 2: Neželeni učinki, o katerih so poročali pri uporabi irbesartana samega
English: Since CoAprovel contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Slovenian: Zdravilo CoAprovel vsebuje hidroklorotiazid, zato njegova uporaba v prvem trimesečju nosečnosti ni priporočena.
English: 30 - 56 x 1 - 90 tablets
Slovenian: 30 - 56 x 1 - 90 tablet
English: respiratory distress (including pneumonitis and pulmonary oedema)
Slovenian: respiratorni distres (vključno s pljučnico in pljučnim edemom)
English: Excipients: also contains lactose monohydrate.
Slovenian: Pomožne snovi: vsebuje tudi laktozo monohidrat.
English: Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Slovenian: Nosečnost: zdravljenja z antagonisti angiotenzina II se ne sme začeti med nosečnostjo.
English: CoAprovel can be taken once daily, with or without food.
Slovenian: Bolniki lahko zdravilo CoAprovel jemljejo enkrat na dan skupaj s hrano ali brez nje.
English: Do not throw away any medicines via wastewater or household waste.
Slovenian: Tega zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.