natgillin/translations-raw huggingface dataset:
Fluticasone furoate/vilanterol 92/22 micrograms provided significantly greater protection against allergen-induced bronchial hyper-reactivity compared with monotherapies FF and vilanterol as assessed on Day 22 by methacholine challenge.
Flutikazonfuroat/vilanterol 92/22 mikrogramov je prinesel bistveno večjo zaščito pred bronhialno hiperreaktivnostjo, povzročeno z alergeni, kot monoterapiji s FF oziroma vilanterolom, ocenjeno
• infection of the nose sinuses or throat
• okužba obnosnih votlin (sinusov) ali žrela,
The safety and efficacy of fluticasone furoate/vilanterol in children under the age of 12 years has not yet been established.
Varnost in učinkovitost zdravila Revinty Ellipta pri otrocih, mlajših od 12 let, še nista ugotovljeni.
• awareness of heart beat (palpitations)
• neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije)
Both fluticasone furoate/vilanterol 92/22 micrograms and FF 92 micrograms virtually abolished the late asthmatic response compared with vilanterol alone.
Tako flutikazonfuroat/vilanterol 92/22 mikrogramov kot 92 mikrogramov FF sta v primerjavi s samim vilanterolom praktično odpravila pozni astmatični odziv.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Revinty Ellipta.
Bolnikom je treba naročiti, naj v primeru, da simptomi astme po uvedbi zdravila Revinty Ellipta niso obvladani ali se poslabšajo, zdravljenje nadaljujejo, a naj se hkrati posvetujejo z zdravnikom.
You do not need to prepare Revinty Ellipta in any special way, not even the first time you use it.
Inhalatorja ni potrebno posebej pripraviti za uporabo, niti ko zdravilo Revinty Ellipta uporabite prvič.
If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Revinty Ellipta (92/22 micrograms once daily).
če imate bolezen jeter, ker lahko obstaja večja verjetnost, da boste imeli neželene učinke; Če imate zmerno ali hudo bolezen jeter, vam bo vaš zdravnik omejil odmerek na nižjo jakost zdravila Revinty Ellipta (92/22 mikrogramov enkrat na dan).
In patients with a cardiovascular history/risk factors, fluticasone furoate/vilanterol 92/22 micrograms resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (adjusted mean annual rates of 0.83 and 1.18 respectively, 30% reduction (95% CI 16, 42%, p<0.001)).
Pri bolnikih s kardiovaskularno anamnezo/dejavniki tveganja je flutikazonfuroat/vilanterol 92/22 mikrogramov dosegel značilno manjši letni delež zmernih/hudih poslabšanj KOPB kot vilanterol (korigirana povprečna letna deleža 0,83 in 1,18, 30 % zmanjšanje, 95 % IZ: 16, 42 %, p < 0,001).
How to store Revinty Ellipta 6.
Shranjevanje zdravila Revinty Ellipta 6.
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI
V integrirani analizi dveh repliciranih enoletnih študij pri zmerni do hudi KOPB (povprečni predvideni FEV1 po bronhodilatatorju ob presejanju 45 %, standardni odklon 13 %) s poslabšanjem v predhodnem letu (n =
Driving and using machines This medicine is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Revinty Ellipta vplivalo na sposobnost upravljanja vozil in strojev.
For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22, 42.9 with FF/VI 92/22, 12.1 with VI 22.
Za hudo pljučnico je bilo ustrezno število pljučnic na 1000 bolnik-let 33,6, 35,5 in 7,6, za resno pljučnico pa je bilo ustrezno število pljučnic na 1000 bolnik-let 35,1 s FF/VI 184/22, 42,9 s
The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied.
Farmakokinetika zdravila Revinty Ellipta pri bolnikih, mlajših od 12 let, ni raziskana.
If you forget to use Revinty Ellipta Do not take a double dose to make up for a forgotten dose.
Ne uporabite dvojnega odmerka, da bi nadomestili pozabljenega.
Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Revinty Ellipta.
Med uporabo simpatikomimetičnih zdravil, vključno z zdravilom Revinty Ellipta, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kakršne so supraventrikularna tahikardija in ekstrasistole.
Revinty Ellipta has been shown to reduce flare-ups of COPD symptoms.
Dokazano je, da zdravilo Revinty Ellipta zmanjša pogostnost poslabšanj simptomov KOPB.
Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA).
Vilanterolijev trifenatat je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (LABA - longacting, beta2-adrenergic agonist).
Two different strengths of Revinty Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Na voljo sta dve različni jakosti zdravila Revinty Ellipta: flutikazonfuroat 92 mikrogramov/vilanterol 22 mikrogramov in flutikazonfuroat 184 mikrogramov/vilanterol 22 mikrogramov.
The European Medicines Agency has waived the obligation to submit the results of studies with Revinty Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Ellipta za vse skupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017).
Flutikazonfuroat/vilanterol 92/22 mikrogramov je povečal najnižji FEV1 v primerjavi z vilanterolom za 46 ml (95 % IZ: 8, 83 ml, p = 0,017).
Forty four percent of patients in the fluticasone furoate/vilanterol 92/22 micrograms group were well controlled (ACQ7 ≤0.75) at end of treatment compared to 36% of subjects in the FF 92 micrograms group (p<0.001 95% CI 1.23, 1.82).
44 % bolnikov v skupini s flutikazonfuroatom/vilanterolom 92/22 mikrogramov je imelo na koncu zdravljenja dobro urejeno bolezen (ACQ7 ≤ 0,75); v skupini z 92 mikrogrami FF je bilo takšnih 36 % (p < 0,001, 95 % IZ od 1,23 do
This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
To ustreza odmerjenemu odmerku 200 mikrogramov flutikazonfuorata in 25 mikrogramov vilanterola (v obliki trifenatata).
Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Če ste noseči, tega zdravila ne uporabljajte, razen, če vam je tako svetoval zdravnik.
United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com to navodilo za uporabo škatla pokrov embalaže inhalator vrečka s sušilom embalaža vrečka s sušilom
Do not stop using Revinty Ellipta without advice
Ne prenehajte uporabljati zdravila Revinty Ellipta, ne da bi vam to naročil zdravnik.
You can also report side effects directly via the national reporting system listed in Appendix V .
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S poročanjem o neželenih učinkih lahko prispevate k boljši obveščenosti glede varnosti tega zdravila.
Use this medicine for as long as your doctor recommends.
Zdravilo Revinty Ellipta uporabljajte toliko časa, kot vam svetuje vaš zdravnik.
0.19 in the FF 92 micrograms group (approximately 1 in every 5 years) and 0.14 in the fluticasone furoate/vilanterol 92/22 micrograms group (approximately 1 in every 7 years).
Delež hudih poslabšanj astme na bolnika na leto je bil v skupini z 92 mikrogrami FF 0,19 (približno 1 na 5 let) in v skupini z flutikazonfuroatom/vilanterolom 92/22 mikrogramov 0,14 (približno 1 na 7 let).
How to use Revinty Ellipta
Kako uporabljati zdravilo Revinty Ellipta
Asthma Revinty Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
Zdravilo Revinty Ellipta je indicirano za redno zdravljenje astme pri odraslih in mladostnikih, starih 12 let ali več, za katere je primerna uporaba kombiniranega zdravila (dolgodelujočega agonista adrenergičnih receptorjev beta2 in inhalacijskega kortikosteroida): • bolniki, ki bolezni nimajo ustrezno urejene ob uporabi inhalacijskih kortikosteroidov in inhalacijskih kratkodelujočih agonistov adrenergičnih receptorjev beta2 ''po potrebi'';
Revinty Ellipta contains lactose
Zdravilo Revinty Ellipta vsebuje laktozo.
Multipacks contain 3 x 30 dose inhalers.
Revinty Ellipta z več inhalatorji vsebuje 3 inhalatorje s 30 odmerki.
Prepare a dose Wait to open the cover until you are ready to take your dose.
Pokrovček odprite šele, kot ste pripravljeni, da vzamete odmerek.
Based on in vitro data, the major routes of metabolism of both fluticasone furoate and vilanterol in human are mediated primarily by CYP3A4.
Na podlagi podatkov in vitro poteka pri človeku glavna pot presnove obeh, flutikazonfuroata in vilanterola,
At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
Na 168. dan je flutikazonfuroat/vilanterol 92/22 mikrogramov povečal korigirani povprečni uteženi povprečni FEV1 v obdobju 0-4 ure za 193 ml (95 % IZ:156, 230 ml, p < 0,001) in vilanterol za 145 ml (95 %
NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
IME ZDRAVILA Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
These include: beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition.
Med takšnimi so: antagonisti adrenergičnih receptorjev beta, npr. metoprolol, ki se uporablja za zdravljenje visokega krvnega tlaka ali bolezni srca, ketokonazol za zdravljenje glivičnih okužb, ritonavir ali kobicistat za zdravljenje okužb z virusom HIV,
Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Flutikazonfuroat/vilanterol 92/22 mikrogramov je v primerjavi z 92 mikrogrami FF dosledno dosegal izboljšanje najnižjega FEV1 za 83 do 95 ml 12., 36. in 52. teden ter na končni točki študije (p < 0,001 95 % IZ od 52 do 126 ml na končni točki).
184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
3255) je bilo število pljučnic na 1000 bolnik-let v skupini s FF/VI 184/22 97,9, v skupini s FF/VI 92/22 85,7 in v skupini z VI 22 42,3.
HZA106827 was 12 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=201] and FF 92 micrograms [n=205]) compared with placebo [n=203], all administered once daily.
12 tednov in je ocenila učinkovitost flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 201] in 92 mikrogramov FF [n = 205] v primerjavi s placebom [n = 203], vseh uporabljenih enkrat na dan.
Other special populations
Posebne skupine bolnikov
Fluticasone furoate/vilanterol
flutikazonfuro at/vilanterol
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms
ŠKATLA (PAKIRANJE Z ENIM INHALATORJEM) 92/22 mikrogramov
What Revinty Ellipta looks like and contents of the pack The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter.
Pripomoček Ellipta je svetlo siv inhalator z rumenim pokrovčkom ustnika in števcem odmerkov.
Revinty Ellipta 184/22 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
Za odrasle bolnike in mladostnike, stare 12 let ali več, ki potrebujejo višji odmerek inhaliranega kortikosteroida v kombinaciji z dolgodelujočim agonistom adrenergičnih receptorjev beta2, pride v poštev zdravilo Revinty Ellipta 184/22 mikrogramov.
In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
V 24-tedenski študiji (HZA113091) pri odraslih in mladostnikih z neurejeno astmo so izboljšanje pljučne funkcije glede na izhodišče dosegli tako s flutikazonfuroatom/vilanterolom 92/22 mikrogramov enkrat na dan zvečer kot s kombinacijo salmeterola/FP 50/250 mikrogramov dvakrat na dan. Korigirano povprečno terapevtsko povečanje uteženega povprečja FEV1 glede na izhodišče za 341 ml (flutikazonfuroat/vilanterol) in 377 ml (salmeterol/FP) kaže celotno izboljšanje pljučne funkcije v 24 urah z obema načinoma zdravljenja.
It should not be used to relieve a sudden attack of breathlessness or wheezing.
Zdravila Revinty Ellipta se ne sme uporabljati za olajšanje nenadnega napada zasoplosti ali piskajočega dihanja.
A starting dose of one inhalation of Revinty Ellipta 92/22 micrograms once daily should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
Za odrasle in mladostnike v starosti 12 let ali več, ki potrebujejo nizek do srednji odmerek inhaliranega kortikosteroida v kombinaciji z dolgodelujočim agonistom adrenergičnih receptorjev beta2, pride v poštev začetni odmerek ene inhalacije zdravila Revinty Ellipta 92/22 mikrogramov enkrat dnevno.
How to store Revinty Ellipta
Shranjevanje zdravila Revinty Ellipta
The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (Child-Pugh B; fluticasone furoate/vilanterol 184/22 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Povečanje sistemske izpostavljenosti flutikazonfuroatu je bilo pri preiskovancih z zmerno okvaro jeter (Child-Pugh B; flutikazonfuroat/vilanterol 184/22
• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
• boleče, dvignjene lehe v ustih ali žrelu, ki jih povzroča glivična okužba (kandidoza), Nastanek tega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Revinty
Uncommon side effects This may affect up to 1 in 100 people:
Ti se lahko pojavijo pri največ 1 od 100 bolnikov:
Uncommon Rare
Redki neželeni učinki
The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.
KOPB Priporočeni odmerek za zdravljenje KOPB je ena inhalacija (92 mikrogramov flutikazonfuroata in 22
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revinty Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
IME ZDRAVILA IN POT(I) UPORABE Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol za inhaliranje
Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Navodilo za uporabo Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
Your Revinty Ellipta inhaler carton contains
Škatla vašega zdravila Revinty Ellipta vsebuje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revinty Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
IME ZDRAVILA IN POT(I) UPORABE Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol za inhaliranje
NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
Very common Rare
Zelo pogosti neželeni učinki
NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
While you're using Revinty Ellipta
Med uporabo zdravila Revinty Ellipta
There were no clinically relevant effects of the fluticasone furoate/vilanterol combination on beta-adrenergic systemic effects (heart rate or serum potassium) in subjects with mild or moderate hepatic impairment (vilanterol, 22 micrograms) or with severe hepatic impairment (vilanterol, 12.5 micrograms) compared with healthy subjects.
(12,5 mikrogramov vilanterola) v primerjavi z zdravimi preiskovanci ni bilo klinično pomembnih učinkov kombinacije flutikazonfuroata/vilanterola na sistemske beta-adrenergične učinke (srčna frekvenca ali kalij v serumu).
- For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/006
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/006
Pyrexia
Ellipta.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/001
• tremor • anxiety
• tresavica, • tesnoba.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/004
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/004
MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/003
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/003
HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
[n = 197] in 184 mikrogramov FF [n = 194], obeh uporabljenih enkrat na dan, v primerjavi s FP 500 mikrogramov dvakrat na dan [n = 195].
- if you are pregnant.
- Če ste noseči.
- if you had a heart attack less than a month ago.
- Če imeli srčni napad pred manj kot enim mesecem.
Considering the design of the study, no conclusions can be drawn from the results of the separate analysis.
Glede na zasnovo študije ni možno narediti zaključkov iz rezultatov ločene analize.
Other types of interactions
Druge vrste interakcij
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2004
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 29. november 2004
The first two numbers denote the month, the last two numbers denote the year.
Prvi dve številki pomenita mesec, zadnji dve številki pa leto.
or as a continuous infusion of 5 mg/min.
ali kot neprekinjeno infuzijo 5 mg/min.
This could mainly be attributed to the increased incidence of peripheral oedema.
To je v glavnem možno pripisati povečani pojavnosti perifernega edema.
Do not stop the treatment early without consulting your doctor.
Zdravljenja ne smete prekiniti prezgodaj brez posvetovanja s svojim zdravnikom.
As a result of this treatment, the serum calcium levels can reach or exceed the upper limit of normal levels.
Kot posledica tega zdravljenja lahko serumske ravni kalcija dosežejo ali presežejo zgornje mejne vrednosti normalnih ravni.
It is not known if this can lead to an effect in the infant.
Ni znano, ali lahko to vpliva na dojenčka.
If the effects are inadequate, the treatment can be continued, with ECG monitoring.
Če so učinki nezadostni, se lahko zdravljenje nadaljuje s spremljanjem EKG.
Quinupristin/Dalfopristin
Kinupristin/dalfopristin
BATCH NUMBER Batch:
ŠTEVILKA SERIJE Batch:
Therefore, the ability to drive or use machines can be reduced.
Zato lahko zmanjša sposobnost vožnje in upravljanja s stroji.
To date, limited data on exposed first trimester pregnancies have not shown an increase in the frequency of congenital anomalies compared to the frequency in the general population.
Dosedanji omejeni podatki pri izpostavljenosti v prvih treh mesecih nosečnosti niso pokazali povečanja pogostosti kongenitalnih anomalij v primerjavi s pogostostjo pri splošni populaciji.
International Pharmaceutical Services (IPS), Jozef Nellenslei 10, 2100 Deurne, Belgium
International Pharmaceutical Services (IPS), Jozef Nellenslei 10, 2100 Deurne, Belgija
Constipation (obstruction) can occur.
Lahko pride do zaprtja (obstrukcije).
- if you use the medicine rifampicin (a medicine used in certain infection disease).
- Če jemljete zdravilo rifampicin (zdravilo, ki se uporablja za določene nalezljive bolezni).
6.6 Instructions for use and handling <and disposal> No special requirements.
6.6 Navodila za pripravo in ravnanje z zdravilom in odlaganje Ni posebnih zahtev.
Frequency of undesirable effects is classified as very common (>10%); common (1-10%); uncommon (0.1-1%); rare (0.01-0.1%) or very rare including isolated reports (<0.01%).
Neželeni učinki se po pogostnosti razvrščajo kot zelo pogosti (> 10 %); pogosti (1-10 %); občasni (0,1-1 %); redki (0,01-0,1 %) ali zelo redki, vključno s posameznimi primeri (< 0,01 %).
You may not use this medicine in such a case.
V tem primeru ne smete uporabiti zdravila.
Pregnancy (See section 4.6).
- Nosečnost (glejte poglavje 4.6).
- The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD templates version 7
- Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki jih je predlagal vlagatelj, so bili ovrednoteni na podlagi predložene dokumentacije, znanstvene razprave znotraj Odbora in novega besedila, predlaganega v posodobljenih smernicah o SPC iz oktobra 2005 ter zadnje različice 7 predloge QRD.
- if you have a low blood pressure (hypotension).
- Če imate nizek krvni tlak (hipotenzijo).
However, if it is already almost time to take the next dose (i.e. you skipped one day), skip the missed dose and continue to take the medicine according to the normal dosage scheme.
Če pa je skoraj čas za naslednji odmerek (npr. če ste izpustili en dan), preskočite pozabljeni odmerek in nadaljujte z jemanjem zdravila po običajnem urniku.
- if the pumping force of the heart is insufficient (decompensatio cordis).
- Če je črpalna sposobnost srca nezadostna (dekompenzacija srca).
The dosage of these medicines should be determined by the patient's response.
Odmerjanje teh zdravil se mora določiti na podlagi odziva bolnika.
Adverse reactions are often dose related and occur most frequently in the first couple of weeks after initiation of therapy.
Neželeni učinki so pogosto odvisni od odmerka in se najpogosteje pojavljajo v prvih parih tednih po začetku zdravljenja.
An almost constant release rate provides a relatively constant concentration of active substance in plasma, without major differences between maximal and minimal levels.
Skoraj stalna hitrost sproščanja omogoča relativno konstantno koncentracijo zdravilne učinkovine v plazmi brez poglavitnih razlik med maksimalnimi in minimalnimi ravnmi.
OTHER SPECIAL WARNING(S), IF NECESSARY Contains lactose.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vsebuje laktozo.
The following side effects can occur:
Lahko se pojavijo naslednji neželeni učinki:
For hypertension:
Za hipertenzijo: