natgillin/translations-raw huggingface dataset:
The potential for hepatic function per se to affect the kinetics of valsartan is therefore limited, except in the case of biliary obstruction or cholestatic liver disease (defined as an alkaline phosphatase concentration > 2 X Upper Limit of Normal).
Iz tega razloga je potencial funkcije jeter kot tak, ki bi lahko vplival na kinetiko valsartana, omejen, razen v primerih biliarne obstrukcije ali holestaze jeter (definirane kot koncentracija alkalne fosfataze > 2- kratnika zgornje meje normalne vrednosti).
Based on a pharmacokinetic study, the dose of valsartan should not exceed 80 mg in these patients and should be used with caution.
Na podlagi farmakokinetične študije je bilo ugotovljeno, da pri teh bolnikih odmerek valsartana ne sme presegati 80 mg, pri uporabi pa je potrebna previdnost.
Valsartan should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction.
CHMP je menil, da je besedilo, ki ga predlaga imetnik dovoljenja za promet z zdravilom v povzetku glavnih značilnosti zdravila, ustrezno, zato je bilo sprejeto naslednje besedilo:
The wording proposed by the MAH in the SPC was acceptable to the CHMP and the following wording was adopted: “ In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4) .”
„ Pri bolnikih z blago do zmerno okvaro jeter brez holestaze odmerek valsartana ne sme presegati 80 mg (glejte poglavje 4. 4). “
4.3 - Contraindications There was disagreement on whether the use of Diovan should be contraindicated in patients with renal failure.
4. 3 - Kontraindikacije Do nesporazuma je prišlo glede tega, ali mora biti uporaba zdravila Diovan kontraindicirana pri bolnikih z odpovedjo ledvic.
Having assessed the data available, the CHMP considered that the use of valsartan 80 mg as the starting dose, with no dosage adjustment, in patients with reduced renal function (creatinine
Varnost in
The safety and tolerability of valsartan in patients with severe renal failure (creatinine clearance of < 10 ml/ min) was not evaluated in any clinical study.
23 toleranca za valsartan pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 10 ml/ min) nista bili ovrednoteni v nobeni klinični študiji.
The CHMP considered it acceptable to remove this contraindication, as the primary route of elimination of valsartan is via biliary route and renal clearance accounts for less than 30% of plasma clearance.
CHMP je menil, da se lahko ta kontraindikacija odstrani, saj je primaren način izločanja valsartana po biliarni poti, ledvični očistek pa predstavlja manj kot 30% očistka plazme.
The CHMP also considered that in view of the fact that Diovan is eliminated via the biliary route, it should be contraindicated in patients with severe liver diseases and “ should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction.
CHMP je poleg tega menil, da mora biti zaradi dejstva, da se zdravilo Diovan izloča po biliarni poti, to zdravilo kontraindicirano pri bolnikih s hudimi boleznimi jeter in „ se ga ne sme dajati bolnikom s hudo okvaro jeter, cirozo ali biliarno obstrukcijo “.
With reference to the contraindication for the use of Diovan during pregnancy or lactation, the CHMP in line with the recommendations of the Pharmacovigilance experts considered that the contraindication shall be removed and the following recommendation included in the specific section relevant to pregnancy and lactation as follows: “ Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
„ Ker ni razpoložljivih informacij glede uporabe valsartana med dojenjem, zdravilo Diovan (valsartan) ni priporočljivo, primernejša pa so druga nadomestna zdravljenja, ki imajo bolje raziskane profile varnosti med dojenjem, zlasti med dojenjem novorojenca in nedonošenega otroka “.
4.5 - Interaction with other medicinal products and other forms of interaction
4. 5 - Medsebojno delovanje z drugimi zdravili in druge vrste interakcij
The CHMP considered the precautions for the concomitant use of other medicinal products containing or raising the level of potassium and adopted the following wording: “ If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”.
„ Če se uporaba zdravila, ki vpliva na raven kalija, šteje za nujno v kombinaciji z valsartanom, se priporoča spremljanje ravni kalija v plazmi “.
The CHMP also considered that special precaution would be needed for patients with hepatic impairment and/ or cholestasis, as the majority of valsartan is eliminated, mainly as unchanged drug in the bile, by hepatic clearance.
CHMP je prav tako menil, da so pri bolnikih z okvaro jeter in/ ali holestazo potrebni posebni previdnostni ukrepi, saj se večina valsartana izloči v obliki nespremenjenega zdravila preko žolča z jetrnim očistkom.
The CHMP agreed about the proposed wording for precautions in dosing Diovan, considering that no dosage adjustment is required for patients with a creatinine clearance > 10ml/ min and that in patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
CHMP se je strinjal glede predlaganega besedila za previdnostne ukrepe pri odmerjanju zdravila Diovan ob upoštevanju, da prilagoditev odmerka ni potrebna pri bolnikih s kreatininskim očistkom > 10 ml/ min ter da pri bolnikih z blago do zmerno okvaro jeter brez holestaze odmerek valsartana ne sme presegati 80 mg (glejte poglavje 4. 4).
Sessions 4.5, 5.1, and 5.2 have been updated in order to guarantee the safety of the medicine.
Poglavja 4. 5, 5. 1 in 5. 2 so bila posodobljena z namenom zagotoviti varnost zdravila.
The following sentence has been added to Section 5.2: “ Diovan has not been studied in patients with severe hepatic dysfunction”.
„ Zdravilo Diovan ni bilo raziskano pri bolnikih s hudo disfunkcijo jeter “.
In patients with a creatinine clearance < 10 ml/ min and patients undergoing dialysis no data are available, therefore valsartan should be used with caution in these patients.
Za bolnike s kreatininskim očistkom < 10 ml/ min in bolnike, ki so na dializi, ni razpoložljivih podatkov, zato se mora valsartan pri takih bolnikih uporabljati s previdnostjo.
4.8 - Undesirable effect
4. 8 - Neželeni učinki
However, the CHMP, requested to summarize all indications in one table, according to the ` Guideline of SPC `.
CHMP pa je zahteval, da se naredi povzetek vseh indikacij v eni tabeli v skladu s „ Smernicami za pripravo povzetka glavnih značilnosti zdravila “.
26 GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
Whereas
24
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- namen napotitvenega postopka je bil uskladitev povzetkov glavnih značilnosti zdravila, označevanja in
labelling and package leaflet.
navodil za uporabo;
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
dovoljenja za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
28 SUMMARY OF PRODUCT CHARACTERISTICS
26 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 40 mg capsules, hard Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg capsules, hard Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg capsules, hard Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I – To be completed nationally]
Diovan in sorodna imena (glejte Dodatek I) 40 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 40 mg trde kapsule Diovan in sorodna imena (glejte Dodatek I) 80 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 80 mg trde kapsule Diovan in sorodna imena (glejte Dodatek I) 160 mg filmsko obložene tablete Diovan in sorodna imena (glejte Dodatek I) 160 mg trde kapsule Diovan in sorodna imena (glejte Dodatek I) 320 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica]
One film-coated tablet contains 40 mg of valsartan One capsule contains 40 mg of valsartan One film-coated tablet contains 80 mg of valsartan One capsule contains 80 mg of valsartan One film-coated tablet contains 160 mg of valsartan One capsule contains 160 mg of valsartan One film-coated tablet contains 320 mg of valsartan
Ena filmsko obložena tableta vsebuje 320 mg valsartana.
Recent myocardial infarction Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Nedavni miokardni infarkt Zdravljenje klinično stabilnih bolnikov s simptomatskim srčnim popuščanjem ali asimptomatsko sistolično disfunkcijo levega prekata po nedavnem miokardnem infarktu (12 ur – 10 dni) (glejte poglavji 4. 4 in 5. 1).
Heart failure Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Srčno popuščanje Zdravljenje simptomatskega srčnega popuščanja v primerih, ko ni mogoče uporabiti zaviralcev angiotenzinske konvertaze (ACE), ali kot dodatno zdravljenje poleg zaviralcev ACE, ko ni mogoče uporabiti antagonistov adrenergičnih receptorjev beta (glejte poglavji 4. 4 in 5. 1).
Heart failure Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Srčno popuščanje Zdravljenje simptomatskega srčnega popuščanja v primerih, ko ni mogoče uporabiti zaviralcev angiotenzinske konvertaze (ACE) ali kot dodatno zdravljenje poleg zaviralcev ACE, ko ni mogoče uporabiti antagonistov adrenergičnih receptorjev beta (glejte poglavji 4. 4 in 5. 1).
30 Hypertension Treatment of essential hypertension.
28 Hipertenzija Zdravljenje esencialne hipertenzije
Recent myocardial infarction In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
Nedavni miokardni infarkt Pri klinično stabilnih bolnikih je mogoče zdravljenje začeti že 12 ur po miokardnem infarktu.
After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Po začetnem odmerku 20 mg dvakrat na dan je treba v naslednjih nekaj tednih odmerek valsartana postopno prilagajati na 40 mg, 80 mg in 160 mg dvakrat na dan.
The starting dose is provided by the 40 mg divisible tablet.
Začetni odmerek vzame bolnik v obliki 40- miligramske deljive tablete.
The target maximum dose is 160 mg twice daily.
Največji ciljni odmerek je 160 mg dvakrat na dan.
In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability.
Na splošno je priporočeno, da bolniki dosežejo raven odmerka 80 mg dvakrat na dan v dveh tednih po začetku zdravljenja in da dosežejo največji ciljni odmerek 160 mg dvakrat na dan v treh mesecih glede na to, kako bolnik odmerjanje prenaša.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e. g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics.
Valsartan lahko uporabljajo bolniki, ki se zdravijo z drugimi zdravili po miokardnem infarktu, npr. s trombolitiki, z acetilsalicilno kislino, z antagonisti adrenergičnih receptorjev beta, s statini in z diuretiki.
The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1).
Kombinacija z zaviralci ACE ni priporočljiva (glejte poglavji 4. 4 in 5. 1).
Heart failure The recommended starting dose of Diovan is 40 mg twice daily.
Srčno popuščanje Priporočen začetni odmerek zdravila Diovan je 40 mg dvakrat na dan.
Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Večanje odmerka na 80 mg in 160 mg dvakrat na dan mora potekati najmanj v dvotedenskih intervalih do največjega odmerka, glede na to, kako bolnik odmerjanje prenaša.
Consideration should be given to reducing the dose of concomitant diuretics.
Razmisliti je treba o zmanjšanju odmerkov sočasno uporabljenih diuretikov.
Valsartan may be administered with other heart failure therapies.
Valsartan je mogoče uporabljati skupaj z drugimi zdravili za srčno popuščanje.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Vendar trojna kombinacija zaviralca ACE, antagonista adrenergičnih receptorjev beta in valsartana ni priporočena (glejte poglavji 4. 4 in 5. 1).
Hypertension The recommended starting dose of Diovan is 80 mg once daily.
Hipertenzija Priporočen začetni odmerek zdravila Diovan je 80 mg enkrat na dan.
The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks.
Do znatnega antihipertenzivnega učinka pride v 2 tednih, do največjega učinka pa v 4 tednih.
In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability.
Večinoma je priporočeno, da bolniki dosežejo raven odmerka 80 mg dvakrat na dan v dveh tednih po začetku zdravljenja in da dosežejo največji ciljni odmerek, 160 mg dvakrat na dan v treh mesecih glede na to, kako bolnik odmerjanje prenaša.
Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the
Večanje odmerka na 80 mg in 160 mg dvakrat na dan mora potekati v vsaj dvotedenskim intervalih do največjega odmerka, glede na to, kako bolnik odmerjanje prenaša.
Consideration should be given to reducing the dose of concomitant diuretics.
Razmisliti je treba o zmanjšanju odmerkov sočasno uporabljanih diuretikov.
Valsartan may be administered with other heart failure therapies.
29 Valsartan je mogoče uporabljati skupaj z drugimi zdravili za srčno popuščanje.
The recommended starting dose of Diovan is 80 mg once daily.
Hipertenzija Priporočen začetni odmerek zdravila Diovan je 80 mg enkrat na dan.
Method of administration Diovan may be taken independently of a meal and should be administered with water.
Zdravilo je treba jemati z vodo.
Renal impairment No dosage adjustment is required for patients with a creatinine clearance > 10 ml/ min (see sections 4.4 and 5.2)
Okvara ledvic Pri bolnikih z očistkom kreatinina > 10 ml/ min (glejte poglavji 4. 4 in 5. 2) ni treba prilagajati odmerka.
Hepatic impairment In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Okvara jeter Pri bolnikih z blago do zmerno okvaro jeter brez holestaze odmerek valsartana ne sme presegati 80 mg.
Diovan is contraindicated in patients with severe hepatic impairment and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Zdravilo Diovan je kontraindicirano pri bolnikih s hudo okvaro jeter in pri bolnikih s holestazo (glejte poglavja 4. 3, 4. 4 in 5. 2).
Paediatric patients Diovan is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Pediatrični bolniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Diovan pri otrocih pod 18 let ni priporočljiva.
-Hypersensitivity to the active substance or to any of the excipients. -Severe hepatic impairment, biliary cirrhosis and cholestasis. -Second and third trimester of pregnancy (see sections 4.4 and 4.6).
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. - Huda okvara jeter, biliarna ciroza in holestaza. - Drugo in tretje trimesečje nosečnosti (glejte poglavji 4. 4 in 4. 6)
Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
Hiperkaliemija Sočasna uporaba kalijevih nadomestkov, diuretikov, ki varčujejo kalij, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki lahko povzročijo zvečanje koncentracije kalija (heparin, itd.), ni priporočena.
Sodium- and/ or volume-depleted patients In severely sodium-depleted and/ or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Bolniki s pomanjkanjem natrija in/ ali hipovolemijo Pri bolnikih s hudim pomanjkanjem natrija in/ ali hipovolemijo, ki prejemajo velike odmerke diuretikov, lahko v redkih primerih po začetku zdravljenja z zdravilom Diovan pride do simptomatske hipotenzije.
Sodium and/ or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Pomanjkanje natrija in hipovolemijo je treba pred začetkom zdravljenja z zdravilom Diovan odpraviti, na primer z zmanjšanjem odmerka diuretika.
32 In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Stenoza ledvične arterije Varnosti uporabe zdravila Diovan pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije solitarne ledvice niso ugotavljali.
Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
Kratkotrajna uporaba zdravila Diovan pri dvanajstih bolnikih z enostransko stenozo ledvične arterije in renovaskularno hipertenzijo ni povzročila pomembnih sprememb ledvične hemodinamike, koncentracije
However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Vendar pa lahko druga zdravila, ki vplivajo na renin- angiotenzinski sistem, povečajo vrednosti dušika sečnine v krvi in kreatinina v serumu pri bolnikih z enostransko stenozo ledvične arterije, zato je med zdravljenjem bolnikov z valsartanom priporočeno spremljanje ledvične funkcije.
Kidney transplantation There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Presaditev ledvic Trenutno ni izkušenj o varni uporabi zdravila Diovan pri bolnikih, ki so jim nedavno presadili ledvico.
Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with Diovan as their renin-angiotensin system is not activated.
Primarni hiperaldosteronizem Bolnikov s primarnim hiperaldosteronizmom se ne sme zdraviti z zdravilom Diovan, saj njihov renin - angiotenzinski sistem ni aktiviran.
Impaired renal function No dosage adjustment is required for patients with a creatinine clearance > 10 ml/ min.
Moteno delovanje ledvic Pri bolnikih z očistkom kreatinina > 10 ml/ min odmerka ni treba prilagajati.
There is currently no experience on the safe use in patients with a creatinine clearance < 10 ml/ min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 5.2).
Trenutno ni izkušenj za varno uporabo pri bolnikih z očistkom kreatinina < 10 ml/ min in pri bolnikih, ki se zdravijo z dializo, zato je treba valsartan pri teh bolnikih uporabljati previdno (glejte poglavji 4. 2 in 5. 2).
Hepatic impairment In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Okvara jeter Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je treba zdravilo Diovan uporabljati previdno (glejte poglavji 4. 2 in 5. 2).
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Recent myocardial infarction The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies (see sections 4.2 and 5.1).
Nedavni miokardni infarkt Uporaba kombinacije kaptoprila in valsartana ni pokazala dodatnih kliničnih koristi, povečalo pa se je tveganje za neželene učinke v primerjavi z uporabo posameznih zdravil (glejte poglavji 4. 2 in 5. 1).
Evaluation of post-myocardial infarction patients should always include assessment of renal function (see section 4.2).
Pregled bolnikov po miokardnem infarktu mora vedno vključevati oceno ledvične funkcije (glejte poglavje 4. 2).
Use of Diovan in post-myocardial infarction patients commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Uporaba zdravila Diovan pri bolnikih po miokardnem infarktu pogosto povzroči določeno znižanje krvnega tlaka, vendar zaradi vztrajne simptomatske hipotenzije običajno ni potrebno prekiniti zdravljenja, če bolnik uporablja zdravilo v skladu z navodili za odmerjanje (glejte poglavje 4. 2).
Heart Failure In patients with heart failure, the triple combination of an ACE inhibitor, a beta blocker and Diovan has not shown any clinical benefit (see section 5.1).
Srčno popuščanje Pri bolnikih s srčnim popuščanjem uporaba trojne kombinacija zaviralca ACE, antagonista adrenergičnih receptorjev beta in zdravila Diovan ni pokazala kliničnih koristi (glejte poglavje 5. 1).
Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Pregled bolnikov s srčnim popuščanjem mora vedno vključevati oceno ledvične funkcije (glejte poglavje 4. 2).
33 Use of Diovan in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Uporaba zdravila Diovan pri bolnikih s srčnim popuščanjem pogosto povzroči določeno znižanje krvnega tlaka, vendar zaradi vztrajne simptomatske hipotenzije običajno ni potrebno prekiniti zdravljenja, če bolnik uporablja zdravilo v skladu z navodili za odmerjanje (glejte poglavje 4. 2).