FrancophonIA/ELRC3.0 huggingface dataset:
English: Aerivio Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years.
Slovenian: Uporaba zdravila Aerivio Spiromax ni priporočljiva pri otrocih, starih 12 let in manj, ali mladostnikih, starih, od 13 do 17 let.
English: Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a
Slovenian: Če bolnikova uporaba zdravil za olajšanje (kratkodelujočih bronhodilatatorjev) narašča, to kaže na slabšanje nadzorovanosti bolezni in bolnikovo stanje mora zdravnik znova oceniti.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o
English: Open the mouthpiece cover by folding it down until you hear one loud click.
Slovenian: Pokrovček ustnika preganite navzdol, da zaslišite en glasen klik, in ga tako odprite.
English: The main part of the dose is excreted in faeces as metabolites and unchanged drug.
Slovenian: Glavni del odmerka se izloči v blatu v obliki presnovkov in kot
English: • Write the date you opened the foil pouch on the label on the inhaler.
Slovenian: Datum odprtja ovoja iz folije zabeležite na nalepki na inhalatorju.
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: Aerivio Spiromax has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Aerivio Spiromax nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja
English: [3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily.
Slovenian: Študija je pokazala, da je podvojitev obeh jakosti, salmeterola/flutikazonpropionata za do 14 dni povzročila majhno povečanje neželenih učinkov, povezanih z agonisti β (tremor - 1 bolnik [1 %] v primerjavi z 0, palpitacije - 6 [3 %] v primerjavi z 1 [< 1 %], mišični krči - 6 [3 %] v primerjavi z 1 [< 1 %]) in podobno pojavnost neželenih učinkov, povezanih z inhalacijo kortikosteroidov (npr. kandidazo ustne votline - 6 [6 %] v primerjavi s 16 [8 %], hripavost - 2 [2 %] v primerjavi s 4 [2 %]) v primerjavi z enim inhaliranjem dvakrat na dan.
English: Patients should also be advised to rinse their mouth with water and spit the water out, and/or brush their teeth
Slovenian: Bolnikom je treba svetovati tudi, naj si po inhaliranju usta izplaknejo z vodo, ki naj jo nato izpljunejo, in/ali oščetkajo zobe (glejte poglavje 4.4)
English: Symptomatic mouth and throat candidiasis can be treated with topical antifungal therapy whilst still continuing with Aerivio Spiromax.
Slovenian: Simptomatsko kandidozo ustne votline in žrela je mogoče zdraviti z lokalno antimikotično terapijo ob nadaljevanju uporabe zdravila Aerivio Spiromax.
English: When to start using a new Aerivio Spiromax
Slovenian: Kdaj morate začeti uporabljati novo zdravilo Aerivio Spiromax
English: • Cataract (cloudy lens in the eye).
Slovenian: • katarakta (motnjava očesne leče);
English: COPD One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Slovenian: KOPB Ena inhalacija 50 mikrogramov salmeterola in 500 mikrogramov flutikazonpropionata dvakrat na dan.
English: Do not open and close the mouthpiece cover unless you are about to use your inhaler.
Slovenian: Pokrovčka ustnika ne odpirajte in zapirajte, razen pri uporabi
English: A flow rate of greater than 60L/min is required for optimal delivery of drugs to the lungs through the multidose dry powder Spiromax inhaler.
Slovenian: Za optimalno dostavo zdravila v pljuča skozi večodmerni inhalator Spiromax, ki vsebuje suhi prašek, je potrebna hitrost pretoka nad 60 l/min.
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid undesirable effects.
Slovenian: Kombinaciji se je treba izogniti, razen če koristi odtehtajo večje tveganje za neželene učinke sistemskih glukokortikoidov.
English: All patients should be provided with training by the prescribing Health Care Professional on how to use Aerivio Spiromax.
Slovenian: Vse bolnike mora o uporabi inhalatorja Spiromax za zdravilo Aerivio podučiti zdravstveni delavec.
English: Take care not to block the air vents.
Slovenian: Ne zamašite zračnika.
English: Aerivio Spiromax should only be used to treat severe asthma in adults aged 18 years and older and
Slovenian: Zdravilo Aerivio Spiromax se lahko uporablja le za zdravljenje hude astme pri odraslih, starih 18 let in več, in pri odraslih s KOPB.
English: How to store Aerivio Spiromax
Slovenian: Kako uporabljati zdravilo Aerivio Spiromax
English: The inhaler is white with a semi-transparent yellow mouthpiece cover.
Slovenian: Inhalator je bel pripomoček s polprozornim rumenim pokrovčkom za ustnik.
English: • A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.
Slovenian: • glivična okužba požiralnika, ki lahko povzroči težave pri požiranju.
English: Hypersensitivity reactions with the following
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije, ki se kažejo kot:
English: Patients may notice a taste when using Aerivio Spiromax due to the lactose excipient.
Slovenian: Bolniki bodo med uporabo zdravila Aerivio Spiromax v ustih občutili okus zaradi pomožne snovi
English: Appropriate treatment should be promptly
Slovenian: Če je indicirano, je treba takoj uvesti
English: Aerivio Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Zdravilo Aerivio Spiromax vsebuje salmeterol in flutikazonpropionat, ki imata različna načina
English: Fluticasone propionate:
Slovenian: Flutikazonproprionat
English: Talk to your doctor, pharmacist or nurse before using Aerivio Spiromax if you have:
Slovenian: Pred začetkom uporabe zdravila Aerivio Spiromax se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate
English: It is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-dose combination can be used in patients with severe asthma.
Slovenian: Pri bolnikih s hudo astmo je pred uvedbo katere koli fiksne kombinacije odmerka priporočljivo določiti ustrezni odmerek inhalacijskega kortikosteroida.
English: • Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first.
Slovenian: • Zdravila Aerivio Spiromax ne prenehajte jemati in ne zmanjšujte odmerka zdravila Aerivio
English: Aerivio Spiromax is only appropriate for use in the treatment of patients with severe asthma.
Slovenian: Zdravilo Aerivio Spiromax je primerno le za uporabo pri zdravljenju bolnikov s hudo astmo.
English: The mouthpiece cover is fixed to your inhaler and must not be taken off. Do not use your inhaler if it is damaged or if the mouthpiece has come apart from your inhaler.
Slovenian: Inhalatorja ne uporabljajte, če je poškodovan ali če se je ustnik ločil od inhalatorja.
English: Co-treatment with other potent CYP3A inhibitors, such as itraconazole, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic undesirable effects.
Slovenian: Pričakovati je, da sistemsko izpostavljenost flutikazonpropionatu in tveganje za sistemske neželene učinke poveča tudi sočasno zdravljenje z drugimi močnimi zaviralci CYP3A, npr. z itrakonazolom, in zmernimi zaviralci CYP3A, npr. z eritromicinom.
English: - patients not adequately controlled on a lower strength corticosteroid combination product
Slovenian: - bolniki, pri katerih simptomi niso pod ustreznim nadzorom s kombiniranim zdravilom, ki
English: The recommended dose is:
Slovenian: V celoti so rezultati študije pokazali:
English: The effects include: Slowing of growth in children and adolescents
Slovenian: Ti učinki vključujejo: upočasnitev rasti pri otrocih in mladostnikih okrogel (lunast) obraz (Cushingov sindrom)
English: Rounded (moon shaped) face (Cushing's syndrome) Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma.
Slovenian: Zdravnik vas bo redno pregledoval za te neželene učinke in zagotovil, da uporabljate najmanjši odmerek te kombinacije zdravil za nadzorovanje astme.
English: • Increased number of colds have been reported in patients with chronic obstructive pulmonary disease
Slovenian: • pri bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) so poročali o večjem številu
English: The small increase in β agonist-related adverse events should be taken into account if doubling the dose of salmeterol/fluticasone propionate is considered by the physician in adult patients requiring additional shortterm (up to 14 days) inhaled corticosteroid therapy.
Slovenian: Če zdravnik razmišlja, da bi odmerek salmeterola/flutikazonpropionata pri odraslih bolnikih, ki potrebujejo dodatno kratkoročno (do 14-dnevno) zdravljenje z inhalacijskimi kortikosteroidi, podvojil, mora upoštevati majhno povečanje neželenih učinkov, povezanih z agonisti β.
English: TC
Slovenian: PC:
English: Allergic reactions to Aerivio Spiromax are uncommon (they may affect up to 1 in 100 people).
Slovenian: Alergijske reakcije na zdravilo Aerivio Spiromax so občasne (pojavijo se lahko pri največ
English: • Overactive thyroid gland
Slovenian: Deutschland Teva GmbH
English: When it is appropriate to titrate down to a lower strength not available for Aerivio Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is
Slovenian: Če je treba odmerek zmanjšati na manjšo jakost, ki je z zdravilom Aerivio Spiromax ni mogoče zagotoviti, ga je treba zamenjati za drugo zdravilo s fiksno kombinacijo odmerka salmeterola in flutikazonpropionata, ki vsebuje manjši odmerek inhalacijskega kortikosteroida.
English: Patients using inhaled steroids Patients not using inhaled steroids African-American patients (Risk in bold is statistically significant at the 95% level.)
Slovenian: Bolniki afroameriškega porekla 20/2.366 (Tveganje, navedeno v krepkem tisku, je pri 95 % stopnji zaupanja statistično značilno.)
English: The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
Slovenian: Pri bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) so poročali tudi o naslednjih neželenih
English: Aerivio Spiromax is for the treatment of patients with severe asthma only.
Slovenian: Zdravilo Aerivio Spiromax je le za zdravljenje bolnikov s hudo astmo.
English: Key findings from SMART: primary endpoint Patient group
Slovenian: Ključne ugotovitve študije SMART: primarni opazovani dogodek Število primarnih opazovanih dogodkov
English: This is because using too much Aerivio Spiromax may reduce the amount of steroid hormones produced by your adrenal glands.
Slovenian: Če ste preveč odmerkov zdravila Aerivio Spiromax uporabljali dolgo časa, se morate posvetovati z zdravnikom ali farmacevtom, saj lahko preveč zdravila Aerivio Spiromax zmanjša količino steroidnih hormonov, ki nastajajo v vaši nadledvični žlezi.
English: The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Slovenian: Pri nosečnicah je treba uporabljati najmanjši učinkoviti odmerek flutikazonpropionata, potreben za
English: Aerivio Spiromax is indicated in adults 18 years of age and older only.
Slovenian: Zdravilo Aerivio Spiromax je indicirano samo pri odraslih, starih 18 let in več.
English: White inhaler with a semi-transparent yellow mouthpiece cover.
Slovenian: Bel inhalator s polprozornim rumenim pokrovčkom ustnika.
English: Your inhaler is now ready
Slovenian: Inhalator je
English: Infections and infestations
Slovenian: • bruhanje in drisko
English: Patients should not block the air vents at any time, or breathe out through the Spiromax device when they are preparing the “Breathe” step.
Slovenian: Med pripravo koraka "Vdihnite" naj bolnik ne zamaši zračnikov in naj ne izdihne skozi pripomoček Spiromax.
English: Studies SCO40043 and SCO100250 were randomised, double-blind, parallel-group, replicate studies comparing the effect of salmeterol/fluticasone propionate 50/250 micrograms twice daily (a dose not licensed for COPD treatment in the European Union) with salmeterol 50 micrograms twice daily, on the annual rate of moderate/severe exacerbations in subjects with COPD with FEV1 less than 50% predicted and a history of exacerbations.
Slovenian: Primerjali sta vpliv salmeterola/flutikazonpropionata 50/250 mikrogramov dvakrat na dan (odmerek, ki v Evropski uniji ni odobren za zdravljenje KOPB) z vplivom salmeterola 50 mikrogramov dvakrat na dan na letni delež zmernih/hudih poslabšanj pri bolnikih s KOPB, ki so imeli FEV1 manj kot 50 % predvidenega in anamnezo poslabšanj.
English: If you use more Aerivio Spiromax than you should
Slovenian: Če ste uporabili večji odmerek zdravila Aerivio Spiromax, kot bi smeli Pomembno je, da inhalator uporabljate po navodilih.
English: Your doctor may prescribe an anti-fungal medicine to treat the thrush.
Slovenian: Zdravnik lahko za zdravljenje kandidoza predpiše dodatno terapijo proti glivicam;
English: Pneumonia (in COPD patients)
Slovenian: Pljučnica pri bolnikih s KOPB
English: - If you get any side effects, talk to your doctor pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: There is no incidence of additional adverse events following concurrent administration of the two active substances.
Slovenian: Ni znakov, da bi se po sočasni uporabi teh učinkovin pojavljali dodatni neželeni učinki.
English: It is very important that you take your Aerivio Spiromax every day as directed.
Slovenian: Če ste prenehali uporabljati zdravilo Aerivio Spiromax Zelo pomembno je, da zdravilo Aerivio Spiromax vsak dan uporabljate po navodilih.
English: Ελλάδα
Slovenian: NN:
English: Each delivered dose (the dose from the mouthpiece) contains 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
Slovenian: Vsak dostavljeni odmerek (odmerek iz ustnika) vsebuje 45 mikrogramov salmeterola (v obliki salmeterolijevega ksinafoata) in 465 mikrogramov flutikazonpropionata.
English: <2D barcode carrying the unique identifier included.>]
Slovenian: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Vision, blurred (see also section 4.4)
Slovenian: občasni občasni redki neznana pogostnost zelo pogosti občasni zamegljen vid (glejte tudi poglavje 4.4)
English: Tachycardia
Slovenian: Salmeterol
English: Serious asthma-related adverse events and exacerbations may occur during treatment with Aerivio Spiromax.
Slovenian: V obdobju poslabšanja astme in pri močnem ali akutnem poslabšanju astme se zdravljenja z zdravilom Aerivio Spiromax ne sme uvesti.
English: Each metered dose contains 50 micrograms salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate.
Slovenian: En odmerjen odmerek vsebuje 50 mikrogramov salmeterola (v obliki salmeterolijevega ksinafoata) in 500 mikrogramov flutikazonpropionata.
English: Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely of the oesophagus, can occur in some patients.
Slovenian: Zaradi flutikazonpropionata v zdravilu se nekaterim bolnikom lahko pojavita hripavost in kandidoza (soor) v ustni votlini in žrelu, redkeje pa v požiralniku.
English: Aerivio Spiromax is for use in patients with severe asthma only.
Slovenian: Zdravilo Aerivio Spiromax je namenjeno le za zdravljenje bolnikov s hudo astmo.
English: Do not stop or suddenly reduce your dose of Aerivio Spiromax.
Slovenian: Zdravila Aerivio Spiromax ne nehajte uporabljati in odmerka ne zmanjšajte nenadoma.
English: Angioedema (mainly facial and oropharyngeal
Slovenian: angioedem (predvsem edem obraza in orofaringealni anafilaktične reakcije, vključno z anafilaktičnim občasni redki občasni redki redki
English: Tel: +370 5 266 02 03
Slovenian: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: Tell your doctor if you are taking the following medicines, before starting to use Aerivio Spiromax:
Slovenian: Obvestite svojega zdravnika, če jemljete katero od naslednjih zdravil, preden začnete uporabljati
English: Additional systemic corticosteroid cover should be considered during periods of stress or elective
Slovenian: Med obdobji stresa ali ob načrtovanem kirurškem posegu je treba razmisliti o dodatni zaščiti s sistemskimi kortikosteroidi.
English: Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of
Slovenian: En odmerjen odmerek vsebuje 50 mikrogramov salmeterola (v obliki salmeterolijevega ksinafoata) in
English: Respiratory tract infections
Slovenian: Čiščenje inhalatorja
English: N/A
Slovenian: PRILOGA I
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic
Slovenian: Te kombinacije se je treba izogibati, razen kadar koristi odtehtajo povečano tveganje za sistemske neželene učinke kortikosteroidov.
English: Parodoxical bronchospasm
Slovenian: placebo Z dihali povezani smrtni izidi
English: Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help.
Slovenian: Pomaga lahko, če si po vsakem odmerku zdravila splaknete ustno votlino z vodo, ki jo takoj nato izpljunete, in/ali si oščetkate zobe.
English: Teva Italia S.r.l.
Slovenian: Teva Nederland B.V.
English: Paediatric population
Slovenian: Pomožne snovi
English: The Reference Member State was Germany (BfArM).
Slovenian: Referenčna država članica je bila Nemčija (BfArM).
English: Not known: frequency cannot be estimated from the available data.
Slovenian: Ni znana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
English: Do not exceed the recommended dose.
Slovenian: Ne prekoračite priporočenega odmerka.
English: • Alcohol abuse.
Slovenian: • zloraba alkohola,
English: The harmonisation of the quality aspects was not part of this Article 30 procedure.
Slovenian: Usklajevanje vidikov kakovosti ni bilo del tega postopka po členu 30.
English: In this case take your next dose at the usual time.
Slovenian: V tem primeru vzemite naslednji odmerek ob običajnem času.
English: N % Δ N % Δ N % Δ N % Δ N % Δ
Slovenian: HDL holesterol odmerek n % Δ n % Δ n % Δ n % Δ n % Δ
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
Slovenian: Odvisno od tega, kako se odzivate na zdravljenje, vam bo zdravnik morda predlagal višji ali nižji odmerek.
English: However, enhanced treatment response was observed in women and in elderly people.
Slovenian: Vendar pa so opazili večji odziv na zdravljenje pri ženskah in starejših ljudeh.
English: The absolute bioavailability assessed from systemic blood concentrations is 24%.
Slovenian: Absolutna biološka uporabnost, ocenjena iz koncentracij v sistemski krvi, je 24 %.
English: Results at 24-week from both programs have been presented in a single table with limited repetition in the text, in order to improve clarity of information and ease of use.
Slovenian: Rezultati po 24 tednih iz obeh programov so bili predstavljeni v eni tabeli s čim manjšim ponavljanjem v besedilu, da se izboljša jasnost informacij ter enostavnost uporabe.
English: listed in section 6 of this leaflet.
Slovenian: navedeno v poglavju 6 tega navodila,
English: These beneficial effects were particularly noteworthy in patients with diabetes mellitus and in patients with multivessel disease.
Slovenian: Ti ugodni učinki so bili posebej opazni pri sladkornih bolnikih in pri bolnikih z večžilno boleznijo.
English: The apparent volume of distribution (Vz/f) for the drug is 330 litres.
Slovenian: Navidezni volumen porazdelitve (Vz/f) zdravila je 330 litrov.
English: • Sexual dysfunction
Slovenian: • spolna disfunkcija
English: In both clinical trials no effect was observed on growth and sexual maturation.
Slovenian: V nobeni od obeh kliničnih preskušanj ni bilo opaziti vpliva na rast in spolno dozorevanje.
English: Therapeutic response is well established within two weeks, and a maximum response is achieved within four weeks.
Slovenian: Terapevtski odziv se vzpostavi v dveh tednih, največji odziv pa je dosežen v štirih tednih.
English: The broad recommendation of “supportive measures” would cover gastrointestinal decontamination measures, if appropriate.
Slovenian: Splošno priporočilo „podpornih ukrepov“ bi zajelo ukrepe dekontaminacije prebavil, če bi bilo potrebno.
English: Therefore the CHMP agreed that the available clinical data could not be considered as adequate information to support a paediatric indication statement.
Slovenian: Zato se je CHMP strinjal, da razpoložljivih kliničnih podatkov ni mogoče šteti za zadostne informacije v podporo izjavi o pediatrični indikaciji.
English: All patients
Slovenian: vsi bolniki
English: • Hypothyroidism.
Slovenian: • hipotiroidizem,
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines 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: Other side effects: tell your doctor if they worry you.
Slovenian: Drugi neželeni učinki: zdravniku povejte, če ste zaskrbljeni.
English: Box 241
Slovenian: P.O. Box 241
English: The text proposed regarding recommendations regarding skeletal muscle reflects the wording that is currently implemented in the majority of EU Member States and is in line with various published recommendations on warnings and precautions on skeletal muscle.
Slovenian: Besedilo, predlagano glede priporočil o skeletnih mišicah, odraža besedilo, ki je trenutno veljavno v večini držav članic EU in je skladno z različnimi objavljenimi priporočili o opozorilih in previdnostnih ukrepih glede skeletnih mišic.
English: No direct correlation between the angiographic findings and the risk of cardiovascular events has been demonstrated.
Slovenian: Neposredne korelacije med angiografskimi izvidi in tveganjem za kardiovaskularne dogodke niso dokazali.
English: • Sleep disturbances, including insomnia and nightmares
Slovenian: • motnje spanja, med drugim nespečnost in nočne more
English: Minor modifications from the Worksharing Project wording reflect the paediatric data and were considered to be acceptable.
Slovenian: Manjše spremembe besedila iz projekta „Worksharing Project“ odražajo pediatrične podatke in so se štele za sprejemljive.
English: The secondary prevention indication in patients after PCI is based on the Lescol Intervention Prevention Study (LIPS).
Slovenian: Indikacija sekundarnega preprečevanja pri bolnikih po PCI temelji na študiji „Lescol Intervention Prevention Study“ (LIPS).
English: Also, the relative reduction in LDL-C is similar across different baseline levels of LDL-C.
Slovenian: Poleg tega je bilo relativno znižanje ravni LDL-C podobno pri različnih izhodiščnih ravneh LDL-C.
English: Germany, Luxembourg
Slovenian: Nemčija, Luksemburg
English: Pregnancy There is insufficient data on the use of fluvastatin during pregnancy.
Slovenian: Nosečnost Ni zadostnih podatkov o uporabi fluvastatina pri nosečnicah.
English: À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado
Slovenian: À Av. da Siderurgia Nacional4745-457 S. Mamede do Coronado Portugalska