FrancophonIA/ELRC3.0 huggingface dataset:
English: • Inflamed granulated skin at the injection site, fatigue, fever (pyrexia), injection site redness,
Slovenian: • vneta zrnasta koža na mestu injiciranja, utrujenost, povišana telesna temperatura (pireksija),
English: Cycle 1 Cycle 2 Cycle 3 w.1 to w.3 (Days 1-21)
Slovenian: t. 1 do t. 3 (dnevi 1-21)
English: Interleukin-2 (IL-2; aldesleukin)
Slovenian: Interlevkin-2 (IL-2; aldeslevkin)
English: to w.36
Slovenian: do t. 36
English: Periodic Safety Update Reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Metabolism and nutrition disorders decreased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan apetit zelo pogosti dehidracija pogosti
English: How to take Ceplene
Slovenian: Kako uporabljati zdravilo Ceplene
English: For dosing instructions for Ceplene in combination with IL-2, see posology below.
Slovenian: Navodila za odmerjanje zdravila Ceplene v kombinaciji z IL-2 so navedena v nadaljevanju tega poglavja.
English: Table 3: Administration chart for IL-2 (aldesleukin)
Slovenian: Preglednica 3: Tabela odmerjanja za IL-2 (aldeslevkin)
English: One vial contains 0.5 mg histamine dihydrochloride in 0.5 mL solution.
Slovenian: Ena viala vsebuje 0,5 mg histaminijevega diklorida v 0,5 mL raztopine.
English: See Figure 2.
Slovenian: Glejte sliko 2.
English: Patients should remain at rest for 20 minutes after injection of Ceplene.
Slovenian: Po injiciranju zdravila Ceplene naj bolnik počiva 20 minut.
English: Ceplene 0.5 mg/0.5 mL solution for injection histamine dihydrochloride
Slovenian: Ceplene 0,5 mg/0,5 mL raztopina za injiciranje histaminijev diklorid
English: • Wheezing
Slovenian: • zardevanje
English: Ask your doctor if you have any questions about Ceplene or IL-2.
Slovenian: Če imate kakršna koli vprašanja o zdravilu Ceplene ali IL-2, se posvetujete s svojim zdravnikom.
English: -for grade 1 to 3 toxicity, treatment should be discontinued until grade 0 toxicity event has been achieved.
Slovenian: Za bolnike, pri katerih se pojavlja 1.-4. stopnja nevrološke toksičnosti - pri 1. do 3. stopnji toksičnosti je treba zdravljenje prekiniti, dokler ni dosežena stopnja 0 toksičnosti.
English: • bleeding ulcers,
Slovenian: • krvaveče razjede,
English: For instructions on reconstitution and dilution of Interleukin-2 (aldesleukin) before administration, see commercially available IL-2 SmPC.
Slovenian: Za navodila glede rekonstitucije in redčenja interlevkina-2 (aldeslevkina) pred dajanjem glejte komercialno dostopen povzetek glavnih značilnosti zdravila [SmPC] za IL-2.
English: Figure 4
Slovenian: Slika 4
English: • Hot flushes
Slovenian: • vročinski oblivi
English: Psychiatric disorders insomnia
Slovenian: Psihiatrične motnje nespečnost pogosti
English: Figure 7
Slovenian: Slika 7
English: Figure 6
Slovenian: Slika 6
English: • Nausea, indigestion (dyspepsia) and diarrhoea
Slovenian: • slabost, slaba prebava (dispepsija) in driska
English: Figure 3
Slovenian: Slika 3
English: Remain seated or lying down for 20 minutes after injecting Ceplene.
Slovenian: Po injiciranju zdravila Ceplene ostanite v sedečem položaju ali se ulezite za 20 minut.
English: Dose modification
Slovenian: Prilagajanje odmerkov
English: • Inflammation of the lung (pneumonia)
Slovenian: • vnetje pljuč (pljučnica)
English: Adverse reactions were reported to be at least possibly related to IL-2 and Ceplene treatment in almost all patients in studies in AML.
Slovenian: V študijah pri bolnikih z AML so rezultati pokazali, da so neželeni učinki pri skorajda vseh bolnikih najmanj verjetno povezani z uporabo zdravila Ceplene in IL-2.
English: Inject IL-2 as you have been instructed.
Slovenian: V skladu z navodili injicirajte IL-2.
English: Double check the syringe to make sure that you have withdrawn the correct amount.
Slovenian: Ponovno preverite, ali ste v brizgo potegnili ustrezno količino zdravila.
English: Up to two weeks supply of pre-filled capped tuberculin syringes may be provided to patients for home administration, with instructions that the syringes be stored under refrigeration at 2°C - 8°C prior to administration.
Slovenian: Hkrati z brizgami mora bolnik prejeti tudi navodila, da je treba brizge do uporabe hraniti v hladilniku pri temperaturi 2°C - 8°C.
English: Summary of the safety profile
Slovenian: 4.8 Neželeni učinki Povzetek varnostnega profila
English: Vascular disorders flushing, hypotension
Slovenian: Žilne bolezni zardevanje, hipotenzija zelo pogosti
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Ceplene in conjunction with IL-2 must not be used during pregnancy.
Slovenian: Zdravila Ceplene skupaj z IL-2 se v času nosečnosti ne sme uporabljati.
English: See Figure 3.
Slovenian: Glejte sliko 3.
English: One vial of 0.5 mL of solution contains 0.5 mg of histamine dihydrochloride.
Slovenian: Ena viala z 0,5 mL raztopine vsebuje 0,5 mg histaminijevega diklorida.
English: The solution should be visually inspected for particulate matter and discolouration prior to administration.
Slovenian: Pred uporabo je treba raztopino vizualno pregledati glede morebitne prisotnosti delcev in opaznega obarvanja.
English: feeling hot, injection site reaction, itching at the injection site, flu-like symptoms, shivering
Slovenian: rdečina na mestu injiciranja, občutek vročine, reakcija na mestu injiciranja, srbečica na mestu injiciranja, simptomi podobni gripi, tresenje (mrzlica), vnetje in bolečine na mestu injiciranja.
English: • Bloating of the belly (abdominal distension)
Slovenian: • napihnjenost trebuha (trebušna distenzija)
English: Patients should not drive or operate machines for at least 1 hour after receiving Ceplene.
Slovenian: Uporaba zdravila Ceplene lahko povzroči hipotenzijo in posledično omotičnost, lahko glavo in zamegljen vid. Bolniki naj ne vozijo ali upravljajo strojev vsaj eno uro po uporabi zdravila Ceplene.
English: Therefore, the treatment with Ceplene and IL-2 must not be used during pregnancy.
Slovenian: Zdravila Ceplene in IL-2 se zato v času nosečnosti ne sme uporabljati.
English: Ceplene and IL-2 are not to be injected at the same time.
Slovenian: Zdravila Ceplene se ne sme injicirati hkrati z IL-2.
English: Nervous system disorders paraesthesia
Slovenian: Bolezni živčevja parestezija pogosti
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: • Rapid heart beat (tachycardia)
Slovenian: • pospešen krvni utrip (tahikardija)
English: For both men and women using this treatment, an effective method of contraception must be used as it is important not to conceive a child while being treated with Ceplene and IL-2.
Slovenian: Ženske in moški morajo med zdravljenjem z zdravilom Ceplene in IL-2 uporabljati učinkovito kontracepcijo, saj se odsvetuje zanositev v času jemanja tega zdravila.
English: • For the following 63 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a
Slovenian: • Naslednjih 63 tednov: IL-2 in zdravilo Ceplene boste uporabljali vsak dan 3 tedne, obdobju zdravljenja pa bo sledilo 6 tednov premora (brez kakršnega koli zdravljenja).
English: One to 3 minutes after the subcutaneous administration of IL-2 has been completed, Ceplene should be administered by slow subcutaneous injection at a rate not to exceed 0.1 mL (0.1 mg histamine dihydrochloride) per minute.
Slovenian: Hitrost injiciranja ne sme preseči 0,1 mL (0,1 mg histaminijevega diklorida) na minuto.
English: Respiratory, thoracic, and mediastinal disorders wheezing
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sopenje pogosti
English: w.55to w.57
Slovenian: do t. 57
English: Refer to the IL-2 SmPC for information on pregnancy and breast-feeding with IL-2.
Slovenian: Za informacije o uporabi IL-2 med nosečnostjo in dojenjem preberite povzetek glavnih značilnosti zdravila za IL-2.
English: Very common erythema, hyperhidrosis, night sweats, pruritus
Slovenian: Bolezni kože in podkožja izpuščaj zelo pogosti eritem, hiperhidroza, nočno potenje, pruritus pogosti
English: Ceplene and IL-2 doses should be separated by 60 minutes, which should be maintained throughout treatment.
Slovenian: Med dajanjem IL-2 in zdravila Ceplene naj preteče vsaj 60 minut.
English: Ceplene should be administered in the clinic under supervision of the physician on day 1 of the initial treatment cycle.
Slovenian: Prvo injiciranje odmerka zdravila Ceplene, na prvi dan prvega cikla zdravljenja, naj poteka na kliniki pod neposrednim nadzorom zdravnika.
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: Raztopina za injiciranje.
English: Method
Slovenian: Način
English: Always use Ceplene exactly as your doctor has instructed.
Slovenian: Pri uporabi zdravila Ceplene natančno upoštevajte navodila zdravnika.
English: Ceplene should be administered 1 to 3 minutes after IL-2 administration, and not concomitantly.
Slovenian: Zdravilo Ceplene je treba injicirati 1 do 3 minute po injiciranju IL-2 in ne takoj po injiciranju IL-2.
English: Remove the plastic cap from the vial, exposing the stopper with the inner rubber circle.
Slovenian: Z viale odstranite plastični pokrovček.
English: Musculoskeletal and connective tissue disorders arthralgia, myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, mialgija zelo pogosti bolečine v okončinah, bolečine v hrbtu pogosti
English: Treatment should then be resumed at a 20% dose reduction for both Ceplene and IL-2.
Slovenian: Zdravljenje nato nadaljujte z 20-odstotno zmanjšanim odmerkom tako zdravila Ceplene kot IL-2; - pri 4. stopnji toksičnosti je treba premisliti o prekinitvi zdravljenja.
English: • Anxiety
Slovenian: • sopenje
English: Vascular disorders hot flush
Slovenian: Žilne bolezni vročinski oblivi pogosti
English: Respiratory, thoracic, and mediastinal disorders cough, dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašljanje, dispneja zelo pogosti nosna kongestija pogosti
English: Ceplene in conjunction with IL-2 must not be used during breast-feeding.
Slovenian: Zdravila Ceplene skupaj z IL-2 se v obdobju dojenja ne sme uporabljati.
English: IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16,400 IU/kg (1 µg/kg).
Slovenian: Vsak odmerek IL-2 je 16.400 i.e./kg (1 µg/kg).
English: Talk to your doctor or pharmacist before using Ceplene.
Slovenian: Pred začetkom uporabe zdravila Ceplene se posvetujte z zdravnikom ali farmacevtom.
English: • Flushing
Slovenian: • tesnoba
English: Solution for injection 14 vials
Slovenian: 14 vial
English: - H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine which are used to treat stomach ulcers, indigestion (dyspepsia) or heartburn.
Slovenian: Ti se uporabljajo za zaviranje delovanja imunskega sistema (imunosupresivi) in za ublažitev vnetij, - klonidin, zdravilo za zniževanje povišanega krvnega tlaka, - antagoniste H2, kot so cimetidin, ranitidin, famotidin ali nizatidin, ki se uporabljajo za zdravljenje želodčnih razjed, slabe prebave (dispepsije) ali zgage.
English: Sodium chloride
Slovenian: Zdravilo Ceplene
English: Very common injection site fibrosis, pain
Slovenian: Splošne težave in spremembe na mestu aplikacije splošno slabo počutje, periferni edem zelo pogosti fibroza na mestu injiciranja, bolečina pogosti
English: Therefore Ceplene and IL-2 must not be used during breast-feeding.
Slovenian: Zdravila Ceplene in IL-2 se v času dojenja ne sme uporabljati.
English: A timer, clock or watch with a second hand.
Slovenian: Primite vialo z eno in iglo z drugo roko in vialo obrnite na glavo.
English: Gastrointestinal disorders constipation, abdominal distention, stomatitis
Slovenian: Bolezni prebavil zaprtost, trebušna distenzija, stomatitis pogosti
English: -for grade 3 and 4 toxicity, treatment should be discontinued and not resumed until events have been resolved.
Slovenian: Takšen način dajanja vzdržujte celoten čas zdravljenja; - pri 3. in 4. stopnji toksičnosti zdravljenje prekinite, dokler dogodki ne izzvenijo.
English: In addition, a number of typographical and QRD-related changes were made.
Slovenian: Izvedenih je bilo tudi več tipografskih sprememb in sprememb, povezanih s QRD.
English: Corresponding changes were made, where relevant, to the currently approved product information.
Slovenian: Kadar je bilo potrebno, so bile izvedene tudi pripadajoče spremembe trenutno odobrenih informacij o zdravilu.
English: The renin-angiotensin system (RAS) is a hormone system that regulates blood pressure and fluid balance.
Slovenian: Renin-angiotenzinski sistem (RAS) je hormonski sistem, ki uravnava krvni tlak in tekočinsko ravnovesje.
English: This is of particular concern, as
Slovenian: Ob upoštevanju naslednjega:
English: these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
Slovenian: To je zlasti zaskrbljujoče, saj so ti bolniki in bolniki z ledvično okvaro še posebej nagnjeni k razvoju hiperkaliemije.
English: Changes were made to the heart failure indication in section 4.4 for candesartan-containing products and in sections 4.2 and 4.4 for valsartan-containing products, in order to further harmonise the wording for the two substances.
Slovenian: Spremembe so bile izvedene za indikacijo srčnega popuščanja v poglavju 4.4 za zdravila, ki vsebujejo kandesartan, in v poglavjih 4.2 in 4.4 za zdravila, ki vsebujejo valsartan, z namenom nadaljnje uskladitve besedila za obe učinkovini.
English: 1 - Overall summary of the scientific evaluation by PRAC
Slovenian: 1 - Splošni povzetek znanstvenega vrednotenja odbora PRAC
English: However, the CHMP considered that minor additional changes were necessary to the wording proposed for the Summary of Product Characteristics.
Slovenian: Vendar pa je menil, da so potrebne manjše dodatne spremembe besedila, predlaganega za povzetek glavnih značilnosti zdravila.
English: In particular the contraindication statements recommended by the PRAC were deleted from sections 5.1 (where proposed) and from section 4.4 for aliskiren, as these were already proposed in section 4.3 and therefore considered redundant.
Slovenian: Iz poglavja 5.1 (kjer je bilo predlagano) in poglavja 4.4 za aliskiren so bile izbrisane zlasti izjave o kontraindikacijah, ki jih je priporočil odbor PRAC, saj so bile že predlagane v poglavju 4.3 in zato nepotrebne.
English: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC0b01ac058004d5c1
Slovenian: 2 European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC 0b01ac058004d5c1
English: RAS-acting agents include angiotensin-converting enzyme inhibitors (ACEinhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Slovenian: Med snovi, ki delujejo na renin-angiotenzinski sistem, spadajo zaviralci angiotenzin konvertirajočega encima (zaviralci ACE), kot so benazepril, kaptopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moeksipril, perindopril, kvinapril, ramipril, spirapril, trandolapril in zofenopril, zaviralci angiotenzinskih receptorjev (ARB-ji), kot so kandesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan in azilsartan, in neposredni zaviralci renina, kot je aliskiren.
English: Grounds for PRAC recommendation
Slovenian: Razlogi za priporočilo odbora PRAC
English: The PRAC therefore concluded that the product information of all RAS-acting agents should be revised to reflect the identified risks and provide guidance to prescribers and patients.
Slovenian: Zaključil je, da je treba informacije o zdravilu vseh snovi, ki delujejo na reninangiotenzinski sistem, spremeniti tako, da odražajo ugotovljena tveganja in zagotavljajo smernice za zdravnike, ki to zdravilo predpisujejo, in bolnike.
English: RAS-acting agents act by blocking different stages of the renin-angiotensin system, lowering blood pressure and their use in the treatment of hypertension and its complications (including acute myocardial infarction, congestive heart failure and chronic kidney disease) is recommended in many current clinical guidelines.
Slovenian: Snovi, ki delujejo na renin-angiotenzinski sistem, delujejo tako, da zavirajo različne faze renin-angiotenzinskega sistema ter tako znižujejo krvni tlak, njihova uporaba pri zdravljenju hipertenzije in z njo povezanih zapletov (vključno z akutnim miokardnim infarktom, kongestivnim srčnim popuščanjem in kronično boleznijo ledvic) pa je priporočena v mnogih trenutnih kliničnih smernicah.
English: It was noted that the Committee for Medicinal Products for Human Use (CHMP) had already conducted a review2 under Article 20 of Regulation (EC) No 726/2004 for aliskiren-containing products, concluding that these products should be contraindicated in patients with diabetes mellitus or moderate to severe renal impairment who take ACE-inhibitors or ARBs.
Slovenian: Zabeležili so, da je Odbor za zdravila za uporabo v humani medicini (CHMP) že izvedel pregled2 v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravila, ki vsebujejo aliskiren, in zaključil, da so ta zdravila kontraindicirana pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro, ki jemljejo zaviralce ACE ali zaviralce angiotenzinskih receptorjev.
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACEinhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Slovenian: Po preučitvi novih razpoložljivih dokazov iz znanstvene literature in glede na resnost ugotovljenih zadržkov v zvezi z varnostjo je italijanska agencija za zdravila (AIFA) 17. aprila 2013 sprožila pregled v skladu s členom 31 Direktive Sveta 2001/83/ES in zadevo napotila na Odbor za oceno tveganja na področju farmakovigilance (PRAC) ter od njega zahtevala, da izda priporočilo o razmerju med tveganji in koristmi zdravljenja z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena in navede, ali bi bilo treba sprejeti kakršne koli regulativne ukrepe za dovoljenja za promet z zdravili, ki so predmet tega postopka.
English: The PRAC considered that the overall available data strongly suggests that the concerns identified with regard to safety and the lack of efficacy are a class effect and therefore considered that the conclusions of the review apply to all the active substances involved in the procedure.
Slovenian: Odbor PRAC je menil, da skupni razpoložljivi podatki jasno kažejo, da so ugotovljeni zadržki v zvezi z varnostjo in pomanjkanjem učinkovitosti razredni učinek, zato je menil, da zaključki pregleda veljajo za vse zdravilne učinkovine v tem postopku.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC initiated by Italy following the emergence of new evidence on the efficacy and safety of dual RAS blockade therapy through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren, to determine whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure;
Slovenian: • Odbor PRAC je preučil postopek v skladu s členom 31 Direktive 2001/83/ES, ki ga je sprožila Italija po pojavu novih dokazov o učinkovitosti in varnosti zdravljenja z dvojnim zaviranjem reninangiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev II ali aliskirena, da bi določili, ali bi bilo treba sprejeti kakršne koli regulativne ukrepe za dovoljenja za promet z zdravili, ki so predmet tega postopka;
English: In addition, the meta-analysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Slovenian: Poleg tega je metaanaliza pokazala, da uporaba več snovi, ki delujejo na renin-angiotenzinski sistem, morda ni koristnejša od uporabe ene snovi, ki deluje na renin-angiotenzinski sistem, kar zadeva zmanjšanje celokupne smrtnosti.
English: However, new data has emerged in the past years, raising doubts over the efficacy and identifying safety concerns associated with dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren.
Slovenian: Vendar so bili v zadnjih letih objavljeni novi podatki, ki so povečali dvome o učinkovitosti in prepoznavanju zadržkov v zvezi z varnostjo, povezanih z zdravljenjem z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena.
English: 3 ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial 4 Veterans Affairs Nephropathy in Diabetes 5 Aliskiren Trial in Type 2 Diabetes Using Cardiorenal Endpoints
Slovenian: 3 ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial 4 Veterans Affairs Nephropathy in Diabetes 5 Aliskiren Trial in Type 2 Diabetes Using Cardiorenal Endpoints pod nadzorom zdravnika specialista in se pri njih pogosto skrbno spremlja delovanje ledvic, vrednosti elektrolitov in krvni tlak.
English: In particular, a number of trials in heart failure patients have shown that the addition of a second RASacting agent may reduce hospital admissions for heart failure in patients with heart failure, which is considered a meaningful clinical endpoint.
Slovenian: Zlasti številna preskušanja pri bolnikih s srčnim popuščanjem so pokazala, da lahko dodatek druge snovi, ki deluje na renin-angiotenzinski sistem, zmanjša število sprejemov v bolnišnico zaradi srčnega popuščanja pri bolnikih s srčnim popuščanjem, kar velja za pomembno klinično končno točko.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACE-inhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Slovenian: Prav tako je menil, da dodatni pregledani podatki potrjujejo kontraindikacijo na podlagi podatkov iz študije ALTITUDE5 glede sočasne uporabe zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev z zdravili, ki vsebujejo aliskiren, pri bolnikih s sladkorno boleznijo ali ledvično okvaro (stopnja glomerularne filtracije < 60 ml/min/1,73 m2) in da je treba to kontraindikacijo prav tako vključiti v informacije o zdravilu za zaviralce angiotenzinskih receptorjev in zaviralce ACE.
English: The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues (SAG CVS).
Slovenian: Odbor PRAC je pregledal vse razpoložljive podatke, vključno s kliničnimi preskušanji, metaanalizami in publikacijami, odgovori imetnikov dovoljenj za promet z zdravili ter poročilom znanstveno svetovalne skupine za srčno-žilna vprašanja (SAG CVS).