FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents Simponi 100 mg is not recommended for children and adolescents (younger than 18 years).
Slovenian: Otroci in mladostniki Zdravilo Simponi 100 mg ni priporočljivo za otroke in mladostnike (mlajše od 18 let).
English: Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).
Slovenian: Zmerno ali hudo srčno popuščanje (razredov III/IV po klasifikaciji NYHA) (glejte poglavje 4.4).
English: Push the pre-filled pen firmly against the skin (see figures 5 and 6) • Hold the pre-filled pen comfortably in your hand.
Slovenian: Napolnjeni injekcijski peresnik močno pritisnite na kožo (glejte sliki 5 in 6) • Napolnjeni injekcijski peresnik udobno držite v roki.
English: • Talk to your doctor if you are going to have any operations or dental procedures.
Slovenian: • Posvetujte se z zdravnikom, če boste imeli kakršno koli operacijo ali zobozdravstven poseg.
English: Do not use Simponi:
Slovenian: Ne uporabljajte zdravila Simponi:
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Slovenian: Ta redka vrsta T-celičnega limfoma poteka zelo agresivno in se po navadi konča s smrtnim izidom.
English: • Front of thighs (recommended)
Slovenian: • sprednjo stran stegen (priporočeno)
English: Common: Depression, insomnia
Slovenian: Pogosti: depresija, nespečnost
English: • 1 Sharps container (See Step 3)
Slovenian: • 1 vsebnik za ostre odpadke (glejte 3. korak)
English: Key results are shown in Table 6 and described below.
Slovenian: Ključni rezultati so prikazani v preglednici 6 in opisani spodaj.
English: The printed expiration date refers to the last day of the month.
Slovenian: Natisnjeni datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Simponi contains latex and sorbitol
Slovenian: Zdravilo Simponi vsebuje lateks in sorbitol
English: The small number of patients positive for antibodies to golimumab limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures.
Slovenian: Majhno število bolnikov s pozitivnimi testi protiteles proti golimumabu omejuje možnost oblikovanja dokončnih zaključkov glede povezave med nastankom protiteles proti golimumabu in klinično učinkovitostjo zdravila ter varnostnimi ukrepi.
English: • If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi.
Slovenian: • Če zdravnik presodi, da obstaja pri vas tveganje za TB, vas bo morda zdravil z zdravili proti TB preden začnete uporabljati zdravilo Simponi.
English: In case you have received Simponi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Slovenian: Če ste med nosečnostjo prejeli zdravilo Simponi, je pomembno, da o tem obvestite zdravnika vašega dojenčka, preden dojenček prejme katero koli cepivo.
English: What Simponi is and what it is used for
Slovenian: Kaj je zdravilo Simponi in za kaj ga uporabljamo
English: Similar rates were shown across rheumatologic indications.
Slovenian: Podobne pogostnosti so dobili za vse revmatološke indikacije.
English: Plan ahead
Slovenian: Načrtujte vnaprej
English: The baseline median number of active joints was 12, and median CRP was 0.17 mg/dL.
Slovenian: Izhodiščno mediano število aktivno prizadetih sklepov je bilo 12, mediana vrednost CRP pa 0,17 mg/dl.
English: The use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed.
Slovenian: Uporaba golimumaba pri nosečih ženskah ni priporočljiva; nosečnici se ga sme predpisati le, če je nujno potrebno.
English: Do not put the cap back on, this may damage the hidden needle.
Slovenian: Pokrovčka ne nameščajte nazaj, saj lahko to poškoduje skrito iglo.
English: • It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had or has TB.
Slovenian: • Zelo pomembno je, da zdravniku poveste, če ste kdaj imeli TB oziroma če ste bili v tesnem stiku z osebo, ki je imela ali ima TB.
English: Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.
Slovenian: Pokazalo se je, da golimumab pri opicah prehaja v materino mleko, in ker se tudi humani imunoglobulini izločajo v materino mleko, ženske med zdravljenjem z golimumabom in še najmanj 6 mesecev po njem ne smejo dojiti.
English: Marketing Authorisation Holder and Manufacturer Janssen Biologics B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Janssen Biologics B.V.
English: For administration instructions, see section 6.6.
Slovenian: Za navodila glede injiciranja glejte poglavje 6.6.
English: Health-related quality of life as measured by the physical component score of the SF-36 was also improved significantly at weeks 14 and 24.
Slovenian: Tudi z zdravjem povezana kakovost življenja, merjena s telesno komponento rezultata SF-36, se je bistveno izboljšala v 14. in 24. tednu.
English: • You should be screened for TB.
Slovenian: • Opraviti morate presejalne preiskave za TB.
English: Eight malignancies in the combined golimumab treatment group (n = 230) and none in the placebo treatment group (n = 79) were reported.
Slovenian: Poročali so o osmih malignomih v skupinah, zdravljenih z golimumabom (n = 230), in nobenem v skupini, ki je prejemala placebo (n = 79).
English: In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account (see section 2).
Slovenian: Pri bolnikih z redko dedno intoleranco za fruktozo je treba upoštevati aditivni učinek sočasno prejetih zdravil, ki vsebujejo sorbitol (ali fruktozo), ter zaužito količino sorbitola (ali fruktoze) (glejte poglavje 2).
English: If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Slovenian: Če imate hudo trdovratno astmo, KOPB ali veliko kadite, se morate posvetovati z zdravnikom, ali je zdravljenje z zaviralcem TNF za vas primerno.
English: • signs of immune system disorders called: lupus (rare).
Slovenian: • znake bolezni imunskega sistema, imenovane: lupus (redko).
English: The orange needle guard will extend and lock.
Slovenian: Oranžen ščitnik igle se bo pomaknil in zaklenil.
English: Operations or dental procedures
Slovenian: Operacije ali zobozdravstveni posegi
English: • Keep this card with you for 6 months after the last Simponi dose, since side effects may occur a long time after your last dose of Simponi.
Slovenian: • To kartico nosite s seboj še 6 mesecev po zadnjem odmerku zdravila Simponi, ker se lahko neželeni učinki zdravila pojavijo še dolgo časa po prejemu zadnjega odmerka.
English: Figure 5a
Slovenian: Slika 5a
English: • Simponi is given by injection under the skin (subcutaneously).
Slovenian: • Zdravilo Simponi je treba injicirati pod kožo (subkutano).
English: • Some patients treated with golimumab have developed certain kinds of skin cancer.
Slovenian: • Pri nekaterih bolnikih, zdravljenih z golimumabom, so se pojavile določene vrste kožnega raka.
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Slovenian: Pojav reakcije na mestu injiciranja običajno ne zahteva ukinitve zdravljenja.
English: Some cases have had fatal outcome.
Slovenian: Nekateri primeri so se končali s smrtnim izidom.
English: In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Slovenian: Pri bolnikih, ki prejemajo anti-TNF terapijo, je na voljo malo podatkov o odzivu na cepljenje z živimi cepivi ali o sekundarnem prenosu okužbe, povzročene z živimi cepivi.
English: Table 6 Key efficacy outcomes from GO-AHEAD at week 16 Improvements in signs and symptoms
Slovenian: Preglednica 6 Ključni izidi učinkovitosti v študiji GO-AHEAD v 16. tednu Izboljšanje znakov in simptomov
English: For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.
Slovenian: Za informacije glede indikacije poliartikularni juvenilni idiopatski artritis, prosimo, glejte SmPC za zdravilo Simponi 50 mg.
English: Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Slovenian: Nekatere od teh resnih okužb so se pojavile pri bolnikih na sočasni imunosupresivni terapiji, ki poleg osnovne bolezni prav tako lahko prispeva k povečani občutljivosti za okužbe.
English: No mutagenicity studies, animal fertility studies nor long-term carcinogenic studies have been conducted with golimumab.
Slovenian: Študije mutagenosti, študije plodnosti pri živalih in dolgoročne študije kancerogenosti z golimumabom niso bile opravljene.
English: Physical function and health-related quality of life Physical function and disability were assessed as a separate endpoint in GO-FORWARD and GO-AFTER using the disability index of the HAQ DI.
Slovenian: Telesna funkcija in z zdravjem povezana kakovost življenja Telesno funkcijo in stopnjo invalidnosti so v študijah GO-FORWARD in GO-AFTER ocenjevali kot ločena končna rezultata s pomočjo indeksa invalidnosti HAQ DI.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated.
Slovenian: Zdravljenje morajo uvesti in nadzorovati usposobljeni zdravniki, ki imajo izkušnje s področja diagnostike in zdravljenja bolezni, za katere je zdravilo Simponi indicirano.
English: Your doctor will record these tests on your Patient Reminder Card.
Slovenian: Zdravnik bo te preiskave zabeležil na vašo opozorilno kartico za bolnika.
English: Lymphoma was reported in 1 patient, non-melanoma skin cancer in 2 patients, and other malignancies in 5 patients.
Slovenian: O limfomu so poročali pri 1 bolniku, o nemelanomskem kožnem raku pri 2 bolnikih in o drugih malignomih pri 5 bolnikih.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Slovenian: Psoriatični artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza, vnetna bolezen kože.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Simponi in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Simponi za eno ali več skupin pediatrične populacije z ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB.
Slovenian: • Pri bolnikih, zdravljenih z zdravilom Simponi, so poročali o primerih TB, v redkih primerih celo pri bolnikih, ki so prejemali zdravila za zdravljenje TB.
English: The prescribed volume of injection should be selected according to patient's height and weight as shown in Table 1.
Slovenian: Predpisano količino za injiciranje je treba izbrati glede na bolnikovo telesno višino in telesno maso, kot je prikazano v preglednici 1.
English: • Melanoma (a type of skin cancer)
Slovenian: • melanom (vrsta kožnega raka),
English: Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Slovenian: Izberite dve različni mesti za injiciranje (npr. ena injekcija v desno stegno in druga injekcija v levo stegno) in si injicirajte injekciji eno za drugo.
English: Mean change in SPARCC
Slovenian: Povprečna sprememba seštevka SPARCC
English: Turn plunger until the dose line for your prescribed dose lines up with the dose selection notch.
Slovenian: Obračajte bat, dokler ni črta odmerka za vaš predpisani odmerek poravnana z zarezo za izbiro odmerka.
English: baseline = week 0 “n” reflects enrolled patients
Slovenian: izhodišče = teden 0 “n”: število vključenih bolnikov
English: It is important that you tell your baby's doctors and other health care professionals about your Simponi use so they can decide when your baby should receive any vaccine.
Slovenian: Pomembno je, da otrokovim zdravnikom in drugim zdravstvenim delavcem poveste za vašo uporabo zdravila Simponi, da bodo lahko presodili, kdaj sme vaš otrok prejeti katero koli cepivo.
English: Physicians global assessment of disease (VAS
Slovenian: Splošna ocena aktivnosti bolezni s strani zdravnika (VAS
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Slovenian: To zdravilo zavrzite, če ga ne uporabite do novega datuma izteka roka uporabnosti ali datuma izteka roka uporabnosti, natisnjenega na škatli, kar nastopi prej.
English: 7% 15% p = 0.021 NA
Slovenian: 7 % 15 % p = 0,021 NA NA
English: Week 24 28% 60%*
Slovenian: 24. teden 28 % 60 %*
English: At week 16, patients entered an open label period in which all patients received Simponi 50 mg administered subcutaneously every 4 weeks through week 48 with efficacy assessments performed through week 52 and safety follow-up through week 60.
Slovenian: V 16. tednu so bolniki vstopili v obdobje odprtega zdravljenja, v katerem so vsi bolniki prejemali 50 mg zdravila Simponi subkutano vsake 4 tedne do 48. tedna z ocenjevanjem učinkovitosti do 52. tedna in spremljanjem varnosti do 60. tedna.
English: The orange needle guard will lock, and you will not receive the full dose.
Slovenian: Oranžen ščitnik igle se bo zaklenil in ne boste prejeli celotnega odmerka.
English: Efficacy evaluation in the study extension was based on changes in corticosteroid use, Physician's Global Assessment (PGA) of disease activity, and improvement in quality of life as measured by Inflammatory Bowel Disease Questionnaire (IBDQ).
Slovenian: Ocena učinkovitosti v podaljšanju študije je temeljila na spremembah glede uporabe kortikosteroidov, zdravnikovi splošni oceni (Physician's Global Assessment - PGA) aktivnosti bolezni ter izboljšanju kakovosti življenja, merjenim z vprašalnikom IBDQ (Inflammatory Bowel Disease Questionnaire).
English: If multiple injections are required, the injections should be administered at different sites on the body.
Slovenian: Če je potrebnih več injekcij, jih je treba dati na različna mesta na telesu.
English: Some of these reactions occurred after the first administration of golimumab.
Slovenian: Nekatere od teh reakcij so nastopile že po prvi uporabi golimumaba.
English: • You may cover the injection site with a small adhesive bandage, if necessary.
Slovenian: • Mesto injiciranja lahko prekrijete z majhnim samolepilnim obližem, če je potrebno.
English: The use of Simponi in pregnant women is not recommended.
Slovenian: Uporaba zdravila Simponi pri nosečnicah ni priporočljiva.
English: GO-FORWARD Active RA despite MTX
Slovenian: GO-FORWARD aktiven RA kljub prejemanju metotreksata
English: * Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Slovenian: * Humano monoklonsko protitelo IgG1κ, ki ga izdelujejo v celični liniji mišjega hibridoma s pomočjo tehnologije rekombinantne DNA.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of golimumab, and in accordance with local recommendations.
Slovenian: V primeru diagnoze neaktivne ("latentne") tuberkuloze je pred uvedbo golimumaba potrebno začeti zdravljenje latentne tuberkuloze s protituberkulozno terapijo, ter v skladu z lokalnimi priporočili.
English: In both the AT and OSI populations, the improvements in signs and symptoms, spinal mobility, physical function, quality of life, and productivity observed at week 16 among patients treated with Simponi 50 mg continued in those remaining in the study at week 52.
Slovenian: Pri obeh populacijah, AT in OSI, so se izboljšanja znakov in simptomov, gibljivosti hrbtenice, telesne funkcije, kakovosti življenja in produktivnosti, ki so jih opazili v 16. tednu pri bolnikih, ki so se zdravili z zdravilom Simponi 50 mg, nadaljevala tudi pri tistih, ki so ostali v študiji v 52. tednu.
English: • When you are ready to inject, hold the body of the pre-filled syringe with one hand.
Slovenian: • Ko ste pripravljeni za injiciranje zdravila, držite trup napolnjene injekcijske brizge z eno roko.
English: At week 48, children entered a long-term extension.
Slovenian: V 48. tednu so otroke vključili v dolgoročno podaljšano študijo.
English: However, population pharmacokinetic analysis indicated that concomitant use of NSAIDs, oral corticosteroids or sulfasalazine did not influence the apparent clearance of golimumab.
Slovenian: Vendar je analiza populacijske farmakokinetike pokazala, da sočasna uporaba nesteroidnih antirevmatikov, peroralnih kortikosteroidov ali sulfasalazina ni vplivala na navidezni očistek golimumaba.
English: In general these elevations were asymptomatic and the abnormalities decreased or resolved with either continuation or discontinuation of golimumab or modification of concomitant medicinal products.
Slovenian: Na splošno so bila ta zvišanja asimptomatična in nenormalne vrednosti so se zmanjšale ali vrnile na normalo bodisi ob nadaljnjem zdravljenju, po ukinitvi golimumaba ali po spremembi sočasno predpisanih zdravil.
English: • Treatment with TNF blockers such as Simponi may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases.
Slovenian: • Zdravljenje z zaviralci TNF, kot je zdravilo Simponi, lahko pri bolnikih, ki so nosilci tega virusa, povzroči reaktivacijo HBV, kar je lahko v nekaterih primerih življenjsko nevarno.
English: Latex sensitivity
Slovenian: Občutljivost za lateks
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Slovenian: V primeru suma na latentno tuberkulozo se je treba posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
English: Storage information Store in refrigerator at 2° to 8°C.
Slovenian: Informacije o shranjevanju Shranjujte v hladilniku pri temperaturi od 2 do 8 °C.
English: Where golimumab use is described by dose, the median duration of follow-up varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may have switched between doses.
Slovenian: Kjer je uporaba golimumaba opredeljena z odmerkom, je mediano trajanje spremljanja bolnikov spremenljivo (približno 2 leti za odmerek 50 mg in približno 3 leta za odmerek 100 mg), saj so bolniki morda prehajali med odmerki.
English: Simponi belongs to a group of medicines called ‘TNF blockers'.
Slovenian: Zdravilo Simponi spada v skupino zdravil, imenovanih "zaviralci TNF".
English: 70 to < 75 0.15 0.15 0.2 75 to < 85 0.15 0.15 0.2 85 to < 95 0.15 0.2
Slovenian: 70 do < 75 0,15 0,15 0,2 75 do < 85 0,15 0,15 0,2 85 do < 95 0,15 0,2
English: In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following golimumab administration.
Slovenian: V okviru izkušenj v obdobju trženja so poročali o resnih sistemskih preobčutljivostnih reakcijah (vključno z anafilaktično reakcijo) po uporabi golimumaba.
English: Do not administer a second dose without speaking to your doctor.
Slovenian: Ne smete si dati drugega odmerka, ne da bi se posvetovali z zdravnikom.
English: If you received Simponi while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy.
Slovenian: Če ste zdravilo Simponi prejemali v času nosečnosti, lahko pri vašem dojenčku obstaja večje tveganje, da dobi takšno okužbo še približno šest mesecev po tem, ko ste v nosečnosti prejeli zadnji odmerek tega zdravila.
English: Previous treatment with an anti-TNF agent was not allowed.
Slovenian: Prejšnje zdravljenje z zaviralci TNF pa ni bilo več dovoljeno.
English: • Store in a refrigerator (2°C-8°C).
Slovenian: • Shranjujte v hladilniku (2 °C - 8 °C).
English: Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati ustrezno kontracepcijo za preprečevanje nosečnosti, in sicer še vsaj 6 mesecev po zadnjem zdravljenju z golimumabom.
English: Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage.
Slovenian: Ko se zdravilo Simponi enkrat shranjuje na sobni temperaturi, se ga ne sme vrniti nazaj v hladilnik.
English: • Pain and discolouration in the fingers or toes
Slovenian: • bolečine in obarvanje prstov na rokah ali nogah,
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Slovenian: Pri tistih bolnikih, ki imajo pozitiven izvid na okužbo z virusom HBV, je priporočljiv posvet z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
English: • Depression
Slovenian: • depresija,
English: The primary endpoint, the proportion of children who were ACR Ped 30 responders at week 16 and who did not experience a flare between week 16 and week 48, was not achieved.
Slovenian: Primarni opazovani dogodek, opredeljen kot delež otrok z odzivom ACR Ped 30 v 16. tednu ter brez ponovnega zagona bolezni med 16. in 48. tednom, ni bil dosežen.
English: The presence of antibodies to golimumab may increase the risk of injection site reactions.
Slovenian: Prisotnost protiteles proti golimumabu lahko poveča tveganje za reakcije na mestu injiciranja.
English: ACR 50 Week 14 10% 35%*
Slovenian: ACR 50 14. teden 10 % 35 %*
English: Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn.
Slovenian: Ker je golimumab zaviralec TNF, bi lahko njegova uporaba v času nosečnosti vplivala na normalen imunski odziv pri novorojenčku.
English: NL-2333 CB Leiden The Netherlands
Slovenian: NL-2333 CB Leiden Nizozemska
English: *: Observed with other TNF-blocking agents.
Slovenian: *: Opaženo pri drugih zaviralcih TNF.
English: Responders, % of patients ASAS 20
Slovenian: Odzivni, % bolnikov ASAS 20
English: 1.1 Prior to Simponi treatment:
Slovenian: 1.1 Pred zdravljenjem z zdravilom Simponi:
English: Do not warm the pre-filled syringe in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Napolnjene injekcijske brizge ne smete segrevati na noben drug način (na primer v mikrovalovni pečici ali v vroči vodi).
English: Height (cm)
Slovenian: Telesna višina (cm)
English: The next dose should be administered based on the following guidance:
Slovenian: Pri naslednjem odmerku je treba upoštevati naslednja navodila:
English: Neoplasms, benign, malignant and unspecified
Slovenian: Benigne, maligne in neopredeljene novotvorbe
English: What you need to know before you use Simponi
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Simponi
English: If this happens, do not ride bicycles, drive or use any tools or machines.
Slovenian: Če se vam to zgodi, ne vozite kolesa, ne upravljajte vozil in orodij ali strojev.
English: Keep pushing the pre-filled pen against the skin for approximately 5 seconds.
Slovenian: Napolnjen injekcijski peresnik še naprej pritiskajte na kožo približno 5 sekund.
English: • If you have mild heart failure and you are being treated with Simponi, you must be closely monitored by your doctor.
Slovenian: • Če imate blago srčno popuščanje in se zdravite z zdravilom Simponi, vas mora zdravnik skrbno spremljati.