FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Other special populations
Slovenian: Posebne skupine bolnikov
English: Fluticasone furoate/vilanterol
Slovenian: flutikazonfuro at/vilanterol
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms
Slovenian: ŠKATLA (PAKIRANJE Z ENIM INHALATORJEM) 92/22 mikrogramov
English: 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.
Slovenian: Pripomoček Ellipta je svetlo siv inhalator z rumenim pokrovčkom ustnika in števcem odmerkov.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: It should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Revinty Ellipta se ne sme uporabljati za olajšanje nenadnega napada zasoplosti ali piskajočega dihanja.
English: 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.
Slovenian: 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.
English: How to store Revinty Ellipta
Slovenian: Shranjevanje zdravila Revinty Ellipta
English: 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.
Slovenian: Povečanje sistemske izpostavljenosti flutikazonfuroatu je bilo pri preiskovancih z zmerno okvaro jeter (Child-Pugh B; flutikazonfuroat/vilanterol 184/22
English: • sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
Slovenian: • 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
English: Uncommon side effects This may affect up to 1 in 100 people:
Slovenian: Ti se lahko pojavijo pri največ 1 od 100 bolnikov:
English: Uncommon Rare
Slovenian: Redki neželeni učinki
English: Tlf: + 45 36 35 91 00 dk-info@gsk.com
Slovenian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: 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.
Slovenian: KOPB Priporočeni odmerek za zdravljenje KOPB je ena inhalacija (92 mikrogramov flutikazonfuroata in 22
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revinty Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol za inhaliranje
English: Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Slovenian: 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
English: Your Revinty Ellipta inhaler carton contains
Slovenian: Škatla vašega zdravila Revinty Ellipta vsebuje
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revinty Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol za inhaliranje
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Slovenian: Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Slovenian: Revinty Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
English: Very common Rare
Slovenian: Zelo pogosti neželeni učinki
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Slovenian: Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
English: While you're using Revinty Ellipta
Slovenian: Med uporabo zdravila Revinty Ellipta
English: 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.
Slovenian: (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).
English: - 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).
Slovenian: Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/006
English: Pyrexia
Slovenian: Ellipta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/001
English: • tremor • anxiety
Slovenian: • tresavica, • tesnoba.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/929/003
English: 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].
Slovenian: [n = 197] in 184 mikrogramov FF [n = 194], obeh uporabljenih enkrat na dan, v primerjavi s FP 500 mikrogramov dvakrat na dan [n = 195].
English: - if you are pregnant.
Slovenian: - Če ste noseči.
English: - if you had a heart attack less than a month ago.
Slovenian: - Če imeli srčni napad pred manj kot enim mesecem.
English: Considering the design of the study, no conclusions can be drawn from the results of the separate analysis.
Slovenian: Glede na zasnovo študije ni možno narediti zaključkov iz rezultatov ločene analize.
English: Other types of interactions
Slovenian: Druge vrste interakcij
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 29. november 2004
English: The first two numbers denote the month, the last two numbers denote the year.
Slovenian: Prvi dve številki pomenita mesec, zadnji dve številki pa leto.
English: or as a continuous infusion of 5 mg/min.
Slovenian: ali kot neprekinjeno infuzijo 5 mg/min.
English: This could mainly be attributed to the increased incidence of peripheral oedema.
Slovenian: To je v glavnem možno pripisati povečani pojavnosti perifernega edema.
English: Do not stop the treatment early without consulting your doctor.
Slovenian: Zdravljenja ne smete prekiniti prezgodaj brez posvetovanja s svojim zdravnikom.
English: As a result of this treatment, the serum calcium levels can reach or exceed the upper limit of normal levels.
Slovenian: Kot posledica tega zdravljenja lahko serumske ravni kalcija dosežejo ali presežejo zgornje mejne vrednosti normalnih ravni.
English: It is not known if this can lead to an effect in the infant.
Slovenian: Ni znano, ali lahko to vpliva na dojenčka.
English: If the effects are inadequate, the treatment can be continued, with ECG monitoring.
Slovenian: Če so učinki nezadostni, se lahko zdravljenje nadaljuje s spremljanjem EKG.
English: Quinupristin/Dalfopristin
Slovenian: Kinupristin/dalfopristin
English: BATCH NUMBER Batch:
Slovenian: ŠTEVILKA SERIJE Batch:
English: Therefore, the ability to drive or use machines can be reduced.
Slovenian: Zato lahko zmanjša sposobnost vožnje in upravljanja s stroji.
English: 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.
Slovenian: Dosedanji omejeni podatki pri izpostavljenosti v prvih treh mesecih nosečnosti niso pokazali povečanja pogostosti kongenitalnih anomalij v primerjavi s pogostostjo pri splošni populaciji.
English: International Pharmaceutical Services (IPS), Jozef Nellenslei 10, 2100 Deurne, Belgium
Slovenian: International Pharmaceutical Services (IPS), Jozef Nellenslei 10, 2100 Deurne, Belgija
English: Constipation (obstruction) can occur.
Slovenian: Lahko pride do zaprtja (obstrukcije).
English: - if you use the medicine rifampicin (a medicine used in certain infection disease).
Slovenian: - Če jemljete zdravilo rifampicin (zdravilo, ki se uporablja za določene nalezljive bolezni).
English: 6.6 Instructions for use and handling <and disposal> No special requirements.
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom in odlaganje Ni posebnih zahtev.
English: 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%).
Slovenian: 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 %).
English: You may not use this medicine in such a case.
Slovenian: V tem primeru ne smete uporabiti zdravila.
English: Pregnancy (See section 4.6).
Slovenian: - Nosečnost (glejte poglavje 4.6).
English: - 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
Slovenian: - 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.
English: - if you have a low blood pressure (hypotension).
Slovenian: - Če imate nizek krvni tlak (hipotenzijo).
English: 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.
Slovenian: 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.
English: - if the pumping force of the heart is insufficient (decompensatio cordis).
Slovenian: - Če je črpalna sposobnost srca nezadostna (dekompenzacija srca).
English: The dosage of these medicines should be determined by the patient's response.
Slovenian: Odmerjanje teh zdravil se mora določiti na podlagi odziva bolnika.
English: Adverse reactions are often dose related and occur most frequently in the first couple of weeks after initiation of therapy.
Slovenian: Neželeni učinki so pogosto odvisni od odmerka in se najpogosteje pojavljajo v prvih parih tednih po začetku zdravljenja.
English: An almost constant release rate provides a relatively constant concentration of active substance in plasma, without major differences between maximal and minimal levels.
Slovenian: Skoraj stalna hitrost sproščanja omogoča relativno konstantno koncentracijo zdravilne učinkovine v plazmi brez poglavitnih razlik med maksimalnimi in minimalnimi ravnmi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains lactose.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vsebuje laktozo.
English: The following side effects can occur:
Slovenian: Lahko se pojavijo naslednji neželeni učinki:
English: For hypertension:
Slovenian: Za hipertenzijo:
English: However, plasmaferesis can be recommended (high plasma protein-binding, relatively small volume of distribution).
Slovenian: Priporočljiva pa je lahko plazmafereza (visoka vezavnost plazemskih beljakovin, relativno majhen volumen porazdelitve).
English: Furthermore, a deterioration of heart failure can occur.
Slovenian: Poleg tega lahko pride do poslabšanja srčnega popuščanja.
English: In addition, in some cases, the use of nifedipine in order to treat pregnant hypertensive women is necessary.
Slovenian: Poleg tega je v nekaterih primerih uporaba nifedipina pri zdravljenju nosečih hipertenzivnih ženskah potrebna.
English: In individual cases of concomitant use, neuromuscular block has been observed.
Slovenian: V posameznih primerih sočasne uporabe so opazili nevromuskularni blok.
English: For the treatment of all grades of hypertension.
Slovenian: Za zdravljenje vseh stopenj hipertenzije.
English: - if your blood pressure is continuing to rise despite treatment (malignant hypertension).
Slovenian: - Če se vaš krvni tlak kljub zdravljenju še naprej zvišuje (maligna hipertenzija).
English: This should be considered during treatment of hypertension.
Slovenian: Ta učinek je treba upoštevati pri zdravljenju hipertenzije.
English: Dosage in case of reduced liver function If your liver function is lower than normal, your doctor can prescribe a lower dosage.
Slovenian: Odmerjanje v primeru motenj delovanja jeter Če je delovanje vaših jeter manjše kot normalno, vam bo zdravnik predpisal nižji odmerek.
English: A total of 6321 patients (55-80 years) were treated during 3 to 4.8 years with Nifedipine Retard or a standard combination of diuretics (hydrochlorothiazide 25 mg + amiloride 5 mg).
Slovenian: Skupno 6321 bolnikov (55-80 let) je bilo zdravljenih 3 do 4,8 let z zdravilom Nifedipine Retard ali standardno kombinacijo diuretikov (hidroklorotiazid 25 mg + amilorid 5 mg).
English: The metabolites are pharmacologically inactive and non-toxic.
Slovenian: Presnovki niso farmakološko aktivni in niso toksični.
English: Nifedipine is rapidly and almost completely absorbed (>90%).
Slovenian: Nifedipin se hitro in skoraj povsem absorbira (> 90 %).
English: Safety in malignant hypertension is not established.
Slovenian: Varnost uporabe pri maligni hipertenziji ni ugotovljena.
English: Antihypertensive medicines
Slovenian: Antihipertenzivna zdravila
English: In conclusion, the warning related to women of childbearing potential proposed by the applicant in section 4.6 Pregnancy and lactation is relevant and sufficient.
Slovenian: Zaradi tega je opozorilo, ki ga za ženske v rodni dobi predlaga vlagatelj v poglavju 4.6 Nosečnost in dojenje, smiselno in zadostno.
English: For a full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte 6.1.
English: The following posology is recommended for adults:
Slovenian: Za odrasle so priporočeni naslednji odmerki:
English: - in case of in vitro fertilisation (IVF).
Slovenian: - V primeru oploditve in vitro (IVF - »in vitro fertilisation«).
English: Eventually, unconsciousness can occur.
Slovenian: Pride lahko tudi do nezavesti.
English: - if you use a stoma.
Slovenian: - Če uporabljate stomo.
English: You should not chew or break the tablets.
Slovenian: Tablet ne smete prežvečiti ali zdrobiti.
English: The incidence of heart failure shows a difference between both treatments (0.9% versus 0.3%).
Slovenian: Pri pojavnosti odpovedi srca se je pojavila razlika med zdravljenjema (0,9 % proti 0,3 %).
English: - if you experience severe chest pains, or if the chest pains worsen.
Slovenian: - Če imate hude bolečine v prsih ali če bolečine v prsih postanejo močnejše.
English: Thus, the proposed wording in section 4.6. of the SmPC to avoid breastfeeding during treatment when necessary, is sufficient.
Slovenian: Zatorej zadostuje predlagano besedilo v poglavju 4.6 SmPC, da se je treba med zdravljenjem odpovedati dojenju, kadar je potrebno.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, obvestite svojega zdravnika preden boste vzeli to zdravilo.
English: Special care is needed in case of very low blood pressure (severe hypotension with systolic pressure below 90 mmHg).
Slovenian: Posebno previdno je treba obravnavati primere zelo nizkega krvnega tlaka (huda hipotenzija s sistoličnim tlakom pod 90 mm Hg).
English: For chronic stable angina pectoris (exertion-induced angina):
Slovenian: Za kronično stabilno angino pektoris (angina ob naporu):
English: - if you suffer from unstable angina pectoris.
Slovenian: - Če imate nestabilno angino pektoris.
English: - if you have diabetes.
Slovenian: - Če imate sladkorno bolezen.
English: Intravenous magnesium sulphate
Slovenian: Intravensko dajanje magnezijevega sulfata
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, notably rifampicin, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Nifedipine is contraindicated during pregnancy and not recommended in women who intend to get pregnant in the near future.
Slovenian: Nifedipin je kontraindiciran med nosečnostjo in ni priporočljiv za ženske, ki nameravajo zanositi v bližnji prihodnosti.
English: Carton box with blister strips made of PVC/PVDC and aluminium foil.
Slovenian: Kartonska škatla s pretisnimi omoti iz PVC/PVDC in aluminijaste folije.
English: fever in the first few days after initiating therapy.
Slovenian: povišana telesna temperatura v prvih nekaj dneh po začetku zdravljenja
English: By doing so, the blood flow in the heart and limbs is improved, lowering blood pressure and preventing chest pain (angina pectoris).
Slovenian: S tem izboljša pretok krvi v srce in okončine, zniža krvni tlak in preprečuje bolečine v prsih (angina pektoris).
English: Whenever this is the case, the treating physician should be notified immediately, and treatment with nifedipine should be ceased.
Slovenian: Kadar se to zgodi, je treba nemudoma obvestiti zdravnika, ki vodi zdravljenje, in prekiniti zdravljenje z nifedipinom.
English: Therefore, monitoring of quinidine plasma levels is recommended.
Slovenian: Zato je priporočljivo spremljanje plazemskih koncentracij kinidina.
English: This randomised, double blind, prospective study was carried out on an average population of patients with hypertension that, besides a blood pressure of 150/95 mm Hg or higher or a systolic blood pressure of >160 mm Hg, presented with at least one other cardiovascular risk factor.
Slovenian: V to randomizirano, dvojno slepo, prospektivno študijo so vključili povprečno populacijo bolnikov s hipertenzijo, ki so imeli najmanj en dejavnik tveganja srčno-žilne bolezni in bodisi krvni tlak 150/95 mm Hg ali več bodisi sistolični krvni tlak >160 mmHg.
English: In case of life-threatening bradycardia, a temporary cardiac pacemaker can be used.
Slovenian: V primeru življenjsko ogrožajoče bradikardije lahko uporabimo začasni srčni spodbujevalnik.
English: In addition, β-sympathomimetics may be given, e.g. 0.2 mg isoprenalin slowly i.v.
Slovenian: Poleg naštetega lahko damo β-simpatomimetike, npr. 0,2 mg izoprenalina počasi i.v.
English: Caution should be exercised in patients with hypotension, as there is a risk of further reduction in blood pressure.
Slovenian: Previdnost je potrebna pri bolnikih s hipotenzijo, saj obstaja nevarnost dodatnega znižanja krvnega tlaka.
English: MARKETING AUTHORISATION HOLDER Pharmamatch BV
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Pharmamatch BV
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Nosečnost in dojenje Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
English: Thus, contraindicating the use of nifedipine in women of childbearing potential, which amounts to contraindicating it from the beginning of the first trimester of pregnancy, should result in a loss of chance in this target population since nifedipine cannot be considered as a teratogenic product.
Slovenian: Zaradi tega bi kontraindiciranje zdravila nifedipine pri ženskah v rodni dobi, kar ustreza kontraindiciranju tega zdravila od začetka prvega trimesečja nosečnosti, imelo za posledico zmanjšanje možnosti pri tej ciljni populaciji, saj zdravilo nifedipin ne more biti obravnavano kot teratogeno.
English: nocturnal enuresis, acute, reversible deterioration in renal function in patients with chronic renal insufficiency.
Slovenian: nočna enureza, akutno, reverzibilno poslabšanje ledvične funkcije pri bolnikih s kronično ledvično insuficienco
English: Distribution Both nifedipine and its metabolites are mainly bound to plasma protein (92-98%).
Slovenian: Porazdelitev Nifedipin in njegovi presnovki se v glavnem vežejo na plazemske beljakovine (92-98 %).