natgillin/translations-raw huggingface dataset:
Among 9 boys with left ventricular mass (LVMI) indexed to height2.7 within the normal range for children (<39 g/m2.7 in boys) at baseline, LVMI remained stable at levels below the left ventricular hypertrophy
Pri 9 dečkih, ki so ob izhodišču imeli maso levega prekata (LVMI), indeksirano na telesno višino2.7, v normalnem razponu za otroke (< 39 g/m2.7 pri dečkih), je LVMI
Replagal was also associated with improved myocardial contractility, a decrease in mean QRS duration and a concomitant decrease in septal thickness on echocardiography.
Uporaba zdravila Replagal je bila povezana tudi z izboljšanjem krčljivosti srčne mišice, zmanjšanjem srednje dolžine QRS kompleksa in s hkratnim zmanjšanjem debeline septuma, kar je bilo vidno pri ehokardiografiji.
Patients with hepatic impairment No studies have been performed in patients with hepatic impairment.
Bolniki z jetrno okvaro Pri bolnikih z jetrno okvaro študije niso bile opravljene.
After one year of treatment with agalsidase alfa 0.2 mg/kg every other week, the abnormally high eGFR decreased from 143.4 ± 6.8 to 121.3 ± 5.6 mL/min/1.73 m2 in this subgroup and these eGFRs stabilized in the normal range during 4 years of
0,2 mg/kg vsak drugi teden se je abnormalno visoka raven receptorjev EGF v tej podskupini zmanjšala s 143,4 ± 6,8 na 121,3 ± 5,6 ml/min/1,73 m2.
Patients with renal disease
Bolniki z boleznijo ledvic
13.7% of adult patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Idiosinkratične reakcije, povezane z infundiranjem 13,7 % odraslih bolnikov, zdravljenih z zdravilom Replagal v kliničnih preskušanjih, je izkusilo idiosinkratične reakcije, povezane z infundiranjem.
Mean clearance of Replagal in children aged (7-11 years), in adolescents (aged 12-18 years), and adults was 4.2 ml/min/kg, 3.1 ml/min/kg, and 2.3 ml/min/kg, respectively.
Srednja vrednost očistka zdravila Replagal pri otrocih, starih od 7 do 11 let, je bila 4,2 ml/min/kg, pri mladostnikih, starih od 12 do 18 let, 3,1 ml/min/kg, pri odraslih pa
Clearance normalised for body weight was 2.66 and 2.10 ml/min/kg for males and females, respectively.
Očistek, normaliziran na telesno maso, je bil približno 2,66 za bolnice in 2,10 ml/min/kg za bolnike.
Four of 17 (23.5%) paediatric patients ≥7 years of age enrolled in clinical trials experienced at least one infusion reaction over a period of 4.5 years of treatment (mean duration of approx. 4 years).
7 let ali več in vključenih v klinična preskušanja, so imeli vsaj eno reakcijo na infundiranje v 4,5 letih zdravljenja (srednje trajanje približno 4 leta).
Replagal has to be diluted in 9 mg/ml (0.9%) sodium chloride solution before use.
Pred uporabo je treba zdravilo Replagal razredčiti z 9 mg/ml (0,9 %) raztopino natrijevega klorida.
In each treatment group, LVMI remained stable over the treatment period of the study.
V obeh zdravljenih skupinah je ostal indeks mase levega prekata stalen skozi obdobje zdravljenja v okviru študije.
Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injections
natrijev dihidrogenfosfat monohidrat polisorbat 20 natrijev klorid natrijev hidroksid voda za injekcije
Fabry Disease is a glycosphingolipid storage disorder that is caused by deficient activity of the lysosomal enzyme α-galactosidase A, resulting in accumulation of globotriaosylceramide (Gb3 or GL-3, also known as ceramidetrihexoside (CTH)), the glycosphingolipid substrate for this enzyme.
Fabryjeva bolezen je motnja skladiščenja glikosfingolipidov, ki jo povzroča premajhna aktivnost lizosomskega encima α-galaktozidaze A, kar povzroči kopičenje globotriaozilceramida (Gb3 ali GL-3,
Borderline IgE antibody positivity not associated with anaphylaxis has been reported in clinical trials in a very limited number of patients.
V kliničnih preskušanjih so poročali o mejni pozitivnosti za protitelesa IgE, nepovezani z anafilaksijo, pri zelo omejenem številu bolnikov.
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity.
Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
After 6 months of therapy Replagal stabilised renal function compared with a decline in placebo treated patients.
Po 6 mesecih zdravljenja je zdravilo Replagal stabiliziralo delovanje ledvic v nasprotju z upadom ledvične funkcije pri bolnikih, ki so prejemali placebo.
Contents of the pack and other information
Shranjevanje zdravila Replagal Vsebina pakiranja in dodatne informacije
Patients with renal impairment No dose adjustment is necessary in patients with renal impairment.
Bolniki z ledvično okvaro Pri bolnikih z ledvično okvaro prilagajanje odmerkov ni potrebno.
After 12 to 18 months treatment a reduction of 5080% was observed in plasma and urine sediment.
Po 12 do 18 mesecih zdravljenja so opazili za 50 do 80% zmanjšanje kopičenja Gb3 v plazmi in sedimentu seča.
If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor.
Če boste imeli hudo alergijsko (anafilaktično) reakcijo, bo infundiranje zdravila Replagal takoj prekinjeno, zdravnik pa bo začel ustrezno zdravljenje.
Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein.
Vsakič, ko prejmete zdravilo, bo intravenska infuzija zdravila Replagal trajala 40 minut.
However, infusion related reactions (fever, difficulty breathing, chest pain) and pain aggravated occurred more frequently.
Vendar so se pogosteje pojavile reakcije, povezane z infuzijo (povišana telesna temperatura, težave pri dihanju, bolečine v prsih), in močnejše bolečine.
What Replagal contains
Kaj vsebuje navodilo
Based on the analysis of pre- and post-dose liver biopsies in males with Fabry Disease, the tissue halflife has been estimated to be in excess of 24 hours and hepatic uptake of the enzyme estimated to be 10% of administered dose.
Pri moških bolnikih s Fabryjevo boleznijo so na osnovi analize vzorcev jetrne biopsije pred in po odmerku ocenili, da razpolovni čas zdravila v tkivih presega 24 ur, privzem zdravila v jetra pa so ocenili na 10% prejetega odmerka.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON / 3.5 ML VIAL
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA / 3,5-MILILITRSKA VIALA
You may drive and use machines whilst on Replagal.
Vpliv na sposobnost upravljanja vozil in strojev V obdobju uporabe zdravila Replagal lahko vozite in uporabljate stroje.
Each ml of Replagal contains 1 mg of agalsidase alfa.
En ml zdravila Replagal vsebuje 1 mg agalzidaze alfa.
Your doctor may stop the infusion temporarily (5 - 10 min) until the symptoms go away and then begin the infusion again.
Zdravnik lahko začasno prekine infundiranje (5 - 10 min), dokler simptomi ne izginejo, nato pa infundiranje nadaljuje.
Ear and labyrinth disorders tinnitus, tinnitus aggravated
vključno z motnjami labirinta tinitus, poslabšanje tinitusa
In an open‐label randomised study, there were no statistically significant differences between adult patients treated for 52 weeks with 0.2 mg/kg intravenously every other week (n=20) and those treated with 0.2 mg/kg weekly (n=19) in mean change from baseline LVMI or other endpoints (cardiac functional status, renal function, and pharmacodynamic activity).
zdravljenimi 52 tednov z intravenskim odmerkom 0,2 mg/kg vsak drugi teden (n = 20), in tistimi, ki so dobivali po 0,2 mg/kg tedensko (n = 19), kar zadeva srednjo spremembo od izhodišča v indeksu mase levega prekata (LVMI) ali drugih opazovanih dogodkih (delovanje srca, delovanje ledvic in farmakodinamično delovanje).
Cardiac disorders tachycardia, palpitations cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischaemia, heart failure
(atrijska fibrilacija, ventrikularne ekstrasistole, tahiaritmija), miokardna ishemija, srčna odpoved
The infusion can be temporarily interrupted (5 to 10 minutes) until symptoms subside and the infusion may then be restarted.
Infuzijo lahko začasno prekinete (za 5 do 10 minut), dokler simptomi ne izzvenijo, potem pa lahko nadaljujete z njo.
The reductions in LV mass observed by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment were associated with meaningful symptom improvement as measured using the NYHA and CCS in Fabry patients with severe heart failure or anginal symptoms at baseline.
Zaporedne odprte študije so pokazale, da je bilo pomembno zmanjšanje mase levega prekata, izmerjeno z ehokardiografijo, pri moških in ženskah s Fabryjevo boleznijo po 24 do 36 mesecih zdravljenja z zdravilom Replagal povezano s pomembnim izboljšanjem simptomov; zmanjšanje mase je bilo pri začetni vrednosti izmerjeno glede na klasifikaciji NYHA in CCS bolnikov s Fabryjevo boleznijo in hudo srčno odpovedjo ali simptomi angine.
Replagal reduced left ventricle mass in treated patients compared to placebo treated patients.
Zdravilo Replagal je pri zdravljenih bolnikih zmanjšalo maso levega prekata v primerjavi s tistimi, ki so dobivali placebo.
The occurrence of an event in a single patient is defined as uncommon in view of the number of patients treated.
Glede na število zdravljenih bolnikov je pojav določenega neželenega pojava že pri enem samem bolniku opredeljen kot občasen.
NAME OF THE MEDICINAL PRODUCT Replagal 1 mg/ml concentrate for solution for infusion.
IME ZDRAVILA Replagal 1 mg/ml koncentrat za raztopino za infundiranje
Caution should be exercised when prescribing to breast-feeding women.
Pri predpisovanju zdravila doječim ženskam je potrebna previdnost.
Dilute the total volume of Replagal concentrate required in 100 ml 9 mg/ml sodium chloride solution for infusion (0.9%w/v).
Vso potrebno količino koncentrata zdravila Replagal razredčite s 100 ml raztopine natrijevega klorida za intravensko infundiranje 9 mg/ml (0,9-% m/v).
Your medicine is available in vials containing 3.5 mg/ 3.5 ml of agalsidase alfa.
Zdravilo je na voljo v vialah po 3,5 mg/3,5 ml agalzidaze alfa.
Pack sizes of 1, 4 or 10 vials.
4 ali 10 vial.
The pharmacokinetic properties were essentially unaffected by the dose of the enzyme.
Odmerek encima ni bistveno vplival na farmakokinetične lastnosti.
The most common infusion related reactions were mild and include rigors, pyrexia, flushing, headache, nausea, dyspnea, tremor and pruritus.
Najpogostejše so bile blage reakcije, povezane z infundiranjem, ki so vključevale mrzlico, pireksijo, pordevanje, glavobol, navzeo, dispnejo, tremor in pruritus.
How to store Replagal
Kako se daje zdravilo Replagal
Infusion related reactions reported in the postmarketing setting (also see section 4.4) may include cardiac events such as cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischemia, and heart failure in patients with Fabry disease involving the heart structures.
Reakcije, povezane z infundiranjem, o katerih so poročali v obdobju trženja (glejte tudi poglavje 4.4), lahko vključujejo srčne dogodke, kot so srčne aritmije (atrijska fibrilacija, prekatne ekstrasistole,
Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
Ena viala s 3,5 ml koncentrata vsebuje 3,5 mg agalzidaze alfa.
(LVH) threshold throughout the 6.5 years of treatment.
ostala stabilna na ravni pod pragom hipertrofije levega prekata v celotnem 6,5-letnem obdobju zdravljenja.
Talk to your doctor or pharmacist before Replagal is used.
Pred začetkom uporabe zdravila Replagal se posvetujte z zdravnikom ali farmacevtom.
Fertility No effects on male fertility were seen in reproductive studies in male rats.
V študijah o vplivu na sposobnost razmnoževanja, opravljenih na podganjih samcih, niso opazili vpliva na plodnost samcev.
• Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
• Vso potrebno količino koncentrata zdravila Replagal razredčite s 100 ml raztopine natrijevega klorida za intravensko infundiranje 9 mg/ml (0,9-% m/v).
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
(UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Replagal 1 mg/ml sterile concentrate agalsidase alfa
IME ZDRAVILA IN POT(I) UPORABE Replagal 1 mg/ml sterilni koncentrat agalzidaza alfa intravenska uporaba
Infusion of Replagal at home may be considered for patients who are tolerating their infusions well.
Pri bolnikih, ki dobro prenašajo infundiranje, se lahko pretehta možnost infundiranja zdravila Replagal doma.
If severe hypersensitivity or anaphylactic reactions occur, the administration of Replagal should be discontinued immediately and appropriate treatment initiated.
Če se pojavijo hude preobčutljivostne ali anafilaktične reakcije, takoj prekinite dajanje zdravila Replagal in uvedite ustrezno zdravljenje.
The presence of extensive renal damage may limit the renal response to enzyme replacement therapy, possibly due to underlying irreversible pathological changes.
Obstoječa obsežna poškodba ledvic lahko zmanjša odziv ledvic na encimsko nadomestno zdravljenje,
After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients.
Zdravilo Replagal je po 6 mesecih zdravljenja pomembno zmanjšalo bolečino pri bolnikih v primerjavi s tistimi, ki so dobivali placebo (zdravilo brez zdravilne učinkovine).
Very common: may affect more than 1 in 10 people - general pain or discomfort.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
In this study, only one patient had LVH at baseline and remained stable over time.
Ob izhodišču te študije je samo en bolnik imel hipertrofijo levega prekata, ki se s časom ni spremenila.
Do not infuse Replagal concomitantly in the same intravenous line with other agents.
Skozi isti intravenski kanal ne smete infundirati hkrati zdravila Replagal in drugih zdravil.
These effects include chills, headache, nausea, fever, facial flushing (redness), tiredness, low blood pressure, unsteadiness, sweating, difficulty breathing, itching, shaking, cough and vomiting.
utrujenost, nizek krvni tlak, nestabilnost, znojenje, težave pri dihanju, srbenje, tresenje, kašelj in bruhanje.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*.
1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg agalzidaze alfa*.
Replagal 1 mg/ml concentrate for solution for infusion Agalsidase alfa
Replagal 1 mg/ml koncentrat za raztopino za infundiranje agalzidaza alfa
After 6 months of therapy there was a significant reduction in pain in the Replagal treated patients compared with placebo (p=0.021), as measured by the Brief Pain Inventory (a validated pain measurement scale).
Kot so izmerili s kratko lestvico za oceno bolečine (Brief Pain Inventory, validirana lestvica za merjenje bolečine), se je po 6 mesecih zdravljenja pri bolnikih, zdravljenih z zdravilom Replagal, pomembno zmanjšala bolečina v primerjavi s tistimi, ki so prejemali placebo (p = 0,021).
Replagal is a concentrate for solution for infusion.
Zdravilo Replagal je koncentrat za raztopino za infundiranje.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM
- The active substance is agalsidase alfa.
- Zdravilna učinkovina je agalzidaza alfa.
In male paediatric patients ≥ 7 years of age, heart rate variability was abnormal at baseline and improved after 6 months of Replagal therapy in 15 boys and the improvement was sustained through 6.5 years of Replagal 0.2 mg/kg therapy in an open-label long-term extension study in 9 boys.
Pri moških pediatričnih bolnikih, starih ≥ 7 let, je bila variabilnost srčnega utripa na izhodišču abnormalna in se je pri 15 dečkih izboljšala po 6 mesecih zdravljenja z zdravilom Replagal.
• The solution should be inspected visually for particulate matter and discolouration prior to administration.
• Raztopino pred uporabo preglejte, da ugotovite prisotnost delcev ali obarvanje.
PHARMACEUTICAL FORM Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje Bistra in brezbarvna raztopina.
Gastrointestinal disorders nausea diarrhoea , vomiting, abdominal pain/discomfort
Bolezni prebavil navzea driska, bruhanje, trebušne bolečine/nelagodje
Three of 8 (37.5%) paediatric patients <7 years of age experienced at least one infusion related reaction over a mean observation time of 4.2 years.
Trije od 8 (37,5 %) pediatričnih bolnikov, mlajših od 7
What Replagal is and what it is used for The active substance in Replagal is agalsidase alfa (1mg/ml).
Zdravilna učinkovina v zdravilu Replagal je agalzidaza alfa (1 mg/ml).
Pharmacotherapeutic group: Other alimentary tract and metabolism products - Enzymes.ATC code: A16AB03.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove - encimi.
Respiratory, thoracic and mediastinal disorders cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, throat secretion increased, rhinorrhoea oxygen saturation decreased
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, hripavost, stiskanje v žrelu, dispneja, nazofaringitis,
Skin and subcutaneous tissue disorders acne, erythema, pruritus, rash, livedo reticularis angioneurotic oedema,
livedo reticularis angionevrotičn i edem, urtikarija hiperhidroza
In paediatric patients <7 yrs of age, 0/7 male patients tested positive for IgG anti-agalsidase alfa antibodies.
moških bolnikov pozitivnih za protitelesa IgG proti agalzidazi alfa.
The most common symptoms have been rigors, headache, nausea, pyrexia, flushing and fatigue.
Najpogostejši simptomi so okorelost, glavobol, navzeja, zvišana telesna temperatura, pordelost obraza in utrujenost.
This will usually be in your arm.
Po redčenju boste prejeli zdravilo Replagal v veno, običajno na roki.
Tell your doctor if you experience any side effects whilst having the infusion.
Če imate med infuzijo kakršne koli neželene učinke, o tem obvestite zdravnika.
- The other ingredients are: Sodium phosphate monobasic, monohydrate Polysorbate 20
- Druge sestavine zdravila so: natrijev dihidrogenfosfat monohidrat, polisorbat 20, natrijev klorid, natrijev hidroksid, voda za injekcije.
(p=0.030).
Oznaka ATC: A16AB03.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium phosphate monobasic, monohydrate Polysorbate 20
6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat monohidrat, polisorbat 20, natrijev klorid, natrijev hidroksid, voda za injekcije.
Nervous system disorders headache dizziness, dysgeusia, neuropathic pain, tremor, hypersomnia, hypoesthesia, paraesthesia parosmia
Bolezni živčevja glavobol omotica, disgevzija,
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 3.5 mg of agalsidase alfa
Ena viala vsebuje 3,5 mg agalzidaze alfa.
Agalsidase alfa is unlikely to be a candidate for drug-drug interactions.
Verjetnost, da bi agalzidaza alfa medsebojno delovala z drugimi zdravili, je majhna.
Reduction in their hypernormal eGFRs was observed within 6 months of initiating Replagal therapy.
6 mesecih po začetku zdravljenja z zdravilom Replagal.
The following adverse reactions have been identified for agalsidase alfa:
Pri agalzidazi alfa so ugotovili naslednje neželene reakcije: Preglednica 1
Anaphylactic reaction, hypersensitivity
hipersomnija, hipestezija, parestezije parozmija
Idiosyncratic infusion related reactions
Bolezni imunskega sistema anafilaktična reakcija,
Musculoskeletal, connective tissue and bone disorders musculoskeletal discomfort, myalgia, back pain, limb pain, peripheral swelling, arthralgia, joint swelling sensation of heaviness
Bolezni mišično skeletnega sistema in vezivnega tkiva nelagodje v mišicah in sklepih, mialgija,
The solution should be inspected visually for particulate matter and discolouration prior to administration.
Raztopino pred uporabo preglejte, da ugotovite prisotnost delcev ali obarvanje.
Sodium hydroxide
rinoreja zmanjšana nasičenost s kisikom
The safety and efficacy of Entresto in children and adolescents aged below 18 years have not been established.
Varnost in učinkovitost zdravila Entresto pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
Entresto may be administered with or without food (see section 5.2).
Entresto je mogoče jemati skupaj s hrano ali brez nje (glejte poglavje 5.2).
What Entresto is and what it is used for
Kaj je zdravilo Entresto in za kaj ga uporabljamo
Do not take Entresto:
Ne jemljite zdravila Entresto:
• Stop taking Entresto and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing.
• Prenehajte jemati zdravilo Entresto in takoj poiščite zdravniško pomoč, če opazite otekanje obraza, ustnic, jezika in/ali grla oziroma žrela, kar lahko oteži dihanje ali požiranje.
• if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”).
• če ste že kadarkoli imeli angioedem (glejte pod naslovom "Ne jemljite zdravila Entresto" in poglavje 4 "Možni neželeni učinki").
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Entresto affects you.
Vpliv na sposobnost upravljanja vozil in strojev Preden začnete voziti, uporabljati orodje, upravljati stroje ali izvajati druge dejavnosti, ki zahtevajo zbranost, morate zagotovo vedeti, kako zdravilo Entresto deluje na vas.
Other medicines and Entresto Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Entresto Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Patients randomised to the Entresto group received treatment for a median duration of exposure of 24 months; 3,271 patients were treated for more than one year.
Bolniki, ki so jih randomizirali v skupino z zdravilom Entresto, so zdravilo prejemali z medianim trajanjem izpostavljenosti zdravilu 24 mesecev, pri tem pa je 3.271 bolnikov prejemalo zdravilo več kot eno leto.
If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce your Entresto dose, or stop your Entresto treatment completely.
Če pride do navedenega, vam zdravnik lahko zniža odmerek katerega od drugih zdravil, ki jih jemljete, začasno zniža odmerek zdravila Entresto ali pa vam dokončno ukine zdravljenje z zdravilom Entresto.
The European Medicines Agency has deferred the obligation to submit the results of studies with Entresto in one or more subsets of the paediatric population in the treatment of heart failure (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Entresto za eno ali več podskupin pediatrične populacije za zdravljenje srčnega popuščanja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Use of Entresto may be associated with decreased renal function.
Uporaba zdravila Entresto je lahko povezana z zmanjšanim delovanjem ledvic.
The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, except in the situations described below.
Priporočeni začetni odmerek zdravila Entresto je ena tableta 49 mg/51 mg dvakrat na dan, razen v spodaj opisanih primerih.
Entresto does not induce or inhibit CYP450 enzymes.
Zdravilo Entresto niti ne inducira niti ne zavira encimov CYP450.
When initiating therapy or during dose titration with Entresto, blood pressure should be monitored routinely.
Ob začetku zdravljenja oziroma med titriranjem odmerka zdravila Entresto je treba rutinsko spremljati krvni tlak.