natgillin/translations-raw huggingface dataset:
The inhaler is white with a semi-transparent yellow mouthpiece cover.
Inhalator je bel pripomoček s polprozornim rumenim pokrovčkom za ustnik.
• A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.
• glivična okužba požiralnika, ki lahko povzroči težave pri požiranju.
Hypersensitivity reactions with the following
Bolezni imunskega sistema preobčutljivostne reakcije, ki se kažejo kot:
Patients may notice a taste when using Aerivio Spiromax due to the lactose excipient.
Bolniki bodo med uporabo zdravila Aerivio Spiromax v ustih občutili okus zaradi pomožne snovi
Appropriate treatment should be promptly
Če je indicirano, je treba takoj uvesti
Aerivio Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Mehanizem delovanja in farmakodinamični učinki Zdravilo Aerivio Spiromax vsebuje salmeterol in flutikazonpropionat, ki imata različna načina
Fluticasone propionate:
Flutikazonproprionat
Talk to your doctor, pharmacist or nurse before using Aerivio Spiromax if you have:
Pred začetkom uporabe zdravila Aerivio Spiromax se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate
It is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-dose combination can be used in patients with severe asthma.
Pri bolnikih s hudo astmo je pred uvedbo katere koli fiksne kombinacije odmerka priporočljivo določiti ustrezni odmerek inhalacijskega kortikosteroida.
• Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first.
• Zdravila Aerivio Spiromax ne prenehajte jemati in ne zmanjšujte odmerka zdravila Aerivio
Aerivio Spiromax is only appropriate for use in the treatment of patients with severe asthma.
Zdravilo Aerivio Spiromax je primerno le za uporabo pri zdravljenju bolnikov s hudo astmo.
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.
Inhalatorja ne uporabljajte, če je poškodovan ali če se je ustnik ločil od inhalatorja.
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.
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.
- patients not adequately controlled on a lower strength corticosteroid combination product
- bolniki, pri katerih simptomi niso pod ustreznim nadzorom s kombiniranim zdravilom, ki
The recommended dose is:
V celoti so rezultati študije pokazali:
The effects include: Slowing of growth in children and adolescents
Ti učinki vključujejo: upočasnitev rasti pri otrocih in mladostnikih okrogel (lunast) obraz (Cushingov sindrom)
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.
Zdravnik vas bo redno pregledoval za te neželene učinke in zagotovil, da uporabljate najmanjši odmerek te kombinacije zdravil za nadzorovanje astme.
• Increased number of colds have been reported in patients with chronic obstructive pulmonary disease
• pri bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) so poročali o večjem številu
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.
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.
TC
PC:
Allergic reactions to Aerivio Spiromax are uncommon (they may affect up to 1 in 100 people).
Alergijske reakcije na zdravilo Aerivio Spiromax so občasne (pojavijo se lahko pri največ
• Overactive thyroid gland
Deutschland Teva GmbH
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
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.
Patients using inhaled steroids Patients not using inhaled steroids African-American patients (Risk in bold is statistically significant at the 95% level.)
Bolniki afroameriškega porekla 20/2.366 (Tveganje, navedeno v krepkem tisku, je pri 95 % stopnji zaupanja statistično značilno.)
The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
Pri bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) so poročali tudi o naslednjih neželenih
Aerivio Spiromax is for the treatment of patients with severe asthma only.
Zdravilo Aerivio Spiromax je le za zdravljenje bolnikov s hudo astmo.
Key findings from SMART: primary endpoint Patient group
Ključne ugotovitve študije SMART: primarni opazovani dogodek Število primarnih opazovanih dogodkov
This is because using too much Aerivio Spiromax may reduce the amount of steroid hormones produced by your adrenal glands.
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.
The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Pri nosečnicah je treba uporabljati najmanjši učinkoviti odmerek flutikazonpropionata, potreben za
Aerivio Spiromax is indicated in adults 18 years of age and older only.
Zdravilo Aerivio Spiromax je indicirano samo pri odraslih, starih 18 let in več.
White inhaler with a semi-transparent yellow mouthpiece cover.
Bel inhalator s polprozornim rumenim pokrovčkom ustnika.
Your inhaler is now ready
Inhalator je
Infections and infestations
• bruhanje in drisko
Patients should not block the air vents at any time, or breathe out through the Spiromax device when they are preparing the “Breathe” step.
Med pripravo koraka "Vdihnite" naj bolnik ne zamaši zračnikov in naj ne izdihne skozi pripomoček Spiromax.
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.
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.
If you use more Aerivio Spiromax than you should
Če ste uporabili večji odmerek zdravila Aerivio Spiromax, kot bi smeli Pomembno je, da inhalator uporabljate po navodilih.
Your doctor may prescribe an anti-fungal medicine to treat the thrush.
Zdravnik lahko za zdravljenje kandidoza predpiše dodatno terapijo proti glivicam;
Pneumonia (in COPD patients)
Pljučnica pri bolnikih s KOPB
- If you get any side effects, talk to your doctor pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
There is no incidence of additional adverse events following concurrent administration of the two active substances.
Ni znakov, da bi se po sočasni uporabi teh učinkovin pojavljali dodatni neželeni učinki.
It is very important that you take your Aerivio Spiromax every day as directed.
Če ste prenehali uporabljati zdravilo Aerivio Spiromax Zelo pomembno je, da zdravilo Aerivio Spiromax vsak dan uporabljate po navodilih.
Ελλάδα
NN:
Each delivered dose (the dose from the mouthpiece) contains 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
Vsak dostavljeni odmerek (odmerek iz ustnika) vsebuje 45 mikrogramov salmeterola (v obliki salmeterolijevega ksinafoata) in 465 mikrogramov flutikazonpropionata.
<2D barcode carrying the unique identifier included.>]
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Vision, blurred (see also section 4.4)
občasni občasni redki neznana pogostnost zelo pogosti občasni zamegljen vid (glejte tudi poglavje 4.4)
Serious asthma-related adverse events and exacerbations may occur during treatment with Aerivio Spiromax.
V obdobju poslabšanja astme in pri močnem ali akutnem poslabšanju astme se zdravljenja z zdravilom Aerivio Spiromax ne sme uvesti.
Each metered dose contains 50 micrograms salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate.
En odmerjen odmerek vsebuje 50 mikrogramov salmeterola (v obliki salmeterolijevega ksinafoata) in 500 mikrogramov flutikazonpropionata.
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.
Zaradi flutikazonpropionata v zdravilu se nekaterim bolnikom lahko pojavita hripavost in kandidoza (soor) v ustni votlini in žrelu, redkeje pa v požiralniku.
Aerivio Spiromax is for use in patients with severe asthma only.
Zdravilo Aerivio Spiromax je namenjeno le za zdravljenje bolnikov s hudo astmo.
Do not stop or suddenly reduce your dose of Aerivio Spiromax.
Zdravila Aerivio Spiromax ne nehajte uporabljati in odmerka ne zmanjšajte nenadoma.
Angioedema (mainly facial and oropharyngeal
angioedem (predvsem edem obraza in orofaringealni anafilaktične reakcije, vključno z anafilaktičnim občasni redki občasni redki redki
Tell your doctor if you are taking the following medicines, before starting to use Aerivio Spiromax:
Obvestite svojega zdravnika, če jemljete katero od naslednjih zdravil, preden začnete uporabljati
Additional systemic corticosteroid cover should be considered during periods of stress or elective
Med obdobji stresa ali ob načrtovanem kirurškem posegu je treba razmisliti o dodatni zaščiti s sistemskimi kortikosteroidi.
Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of
En odmerjen odmerek vsebuje 50 mikrogramov salmeterola (v obliki salmeterolijevega ksinafoata) in
Respiratory tract infections
Čiščenje inhalatorja
N/A
PRILOGA I
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
Te kombinacije se je treba izogibati, razen kadar koristi odtehtajo povečano tveganje za sistemske neželene učinke kortikosteroidov.
Parodoxical bronchospasm
placebo Z dihali povezani smrtni izidi
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.
Pomaga lahko, če si po vsakem odmerku zdravila splaknete ustno votlino z vodo, ki jo takoj nato izpljunete, in/ali si oščetkate zobe.
Paediatric population
Pomožne snovi
The Reference Member State was Germany (BfArM).
Referenčna država članica je bila Nemčija (BfArM).
Not known: frequency cannot be estimated from the available data.
Ni znana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
Do not exceed the recommended dose.
Ne prekoračite priporočenega odmerka.
• Alcohol abuse.
• zloraba alkohola,
The harmonisation of the quality aspects was not part of this Article 30 procedure.
Usklajevanje vidikov kakovosti ni bilo del tega postopka po členu 30.
In this case take your next dose at the usual time.
V tem primeru vzemite naslednji odmerek ob običajnem času.
N % Δ N % Δ N % Δ N % Δ N % Δ
HDL holesterol odmerek n % Δ n % Δ n % Δ n % Δ n % Δ
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
Odvisno od tega, kako se odzivate na zdravljenje, vam bo zdravnik morda predlagal višji ali nižji odmerek.
However, enhanced treatment response was observed in women and in elderly people.
Vendar pa so opazili večji odziv na zdravljenje pri ženskah in starejših ljudeh.
The absolute bioavailability assessed from systemic blood concentrations is 24%.
Absolutna biološka uporabnost, ocenjena iz koncentracij v sistemski krvi, je 24 %.
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.
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.
listed in section 6 of this leaflet.
navedeno v poglavju 6 tega navodila,
These beneficial effects were particularly noteworthy in patients with diabetes mellitus and in patients with multivessel disease.
Ti ugodni učinki so bili posebej opazni pri sladkornih bolnikih in pri bolnikih z večžilno boleznijo.
The apparent volume of distribution (Vz/f) for the drug is 330 litres.
Navidezni volumen porazdelitve (Vz/f) zdravila je 330 litrov.
• Sexual dysfunction
• spolna disfunkcija
In both clinical trials no effect was observed on growth and sexual maturation.
V nobeni od obeh kliničnih preskušanj ni bilo opaziti vpliva na rast in spolno dozorevanje.
Therapeutic response is well established within two weeks, and a maximum response is achieved within four weeks.
Terapevtski odziv se vzpostavi v dveh tednih, največji odziv pa je dosežen v štirih tednih.
The broad recommendation of “supportive measures” would cover gastrointestinal decontamination measures, if appropriate.
Splošno priporočilo „podpornih ukrepov“ bi zajelo ukrepe dekontaminacije prebavil, če bi bilo potrebno.
Therefore the CHMP agreed that the available clinical data could not be considered as adequate information to support a paediatric indication statement.
Zato se je CHMP strinjal, da razpoložljivih kliničnih podatkov ni mogoče šteti za zadostne informacije v podporo izjavi o pediatrični indikaciji.
All patients
vsi bolniki
• Hypothyroidism.
• hipotiroidizem,
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Other side effects: tell your doctor if they worry you.
Drugi neželeni učinki: zdravniku povejte, če ste zaskrbljeni.
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.
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.
No direct correlation between the angiographic findings and the risk of cardiovascular events has been demonstrated.
Neposredne korelacije med angiografskimi izvidi in tveganjem za kardiovaskularne dogodke niso dokazali.
• Sleep disturbances, including insomnia and nightmares
• motnje spanja, med drugim nespečnost in nočne more
Minor modifications from the Worksharing Project wording reflect the paediatric data and were considered to be acceptable.
Manjše spremembe besedila iz projekta „Worksharing Project“ odražajo pediatrične podatke in so se štele za sprejemljive.
The secondary prevention indication in patients after PCI is based on the Lescol Intervention Prevention Study (LIPS).
Indikacija sekundarnega preprečevanja pri bolnikih po PCI temelji na študiji „Lescol Intervention Prevention Study“ (LIPS).
Also, the relative reduction in LDL-C is similar across different baseline levels of LDL-C.
Poleg tega je bilo relativno znižanje ravni LDL-C podobno pri različnih izhodiščnih ravneh LDL-C.
Germany, Luxembourg
Nemčija, Luksemburg
Pregnancy There is insufficient data on the use of fluvastatin during pregnancy.
Nosečnost Ni zadostnih podatkov o uporabi fluvastatina pri nosečnicah.
À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado
À Av. da Siderurgia Nacional4745-457 S. Mamede do Coronado Portugalska
• during pregnancy and lactation (see section 4.6).
• med nosečnostjo in dojenjem (glejte poglavje 4.6).
Section 4.5 - Interaction with other medicinal products and other forms of interaction Food interactions were restricted to grapefruit juice only.
Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije z živili so bile omejene le na grenivkin sok.
- the Summary of Products Characteristics, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
• Personal or familial history of hereditary muscular disorders.
• osebna ali družinska anamneza dednih mišičnih bolezni,
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LESCOL AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LESCOL IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Section 4.4 - Special warnings and precautions for use The CHMP considered it reasonable to maintain the recommendations on liver function testing which have been implemented in clinical practice over the last decade(s), although routine monitoring of transaminases has been discouraged more recently by various experts.
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi CHMP je menil, da je utemeljeno ohraniti priporočila glede preiskav jetrne funkcije, ki so bile uvedene v klinično prakso v zadnjem(-ih) desetletju(-ih), čeprav so različni strokovnjaki nedavno odsvetovali rutinsko spremljanje ravni transaminaz.
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Neželeni učinki (preglednica 1) so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, pri čemer je uporabljen naslednji dogovor: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (< 1/10.000), vključno s posameznimi primeri.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Če pride do prevelikega odmerjanja, je treba bolnika zdraviti simptomatsko in po potrebi uvesti podporne ukrepe.
Fibrates and niacin
Fibrati in niacin
The ultimate result of these mechanisms is a reduction in the plasma cholesterol concentration.
Končni rezultat teh mehanizmov je znižanje plazemske koncentracije holesterola.
The information that the study was conducted in patients after PCI was added.
Dodana je bila informacija, da je bila študija opravljena pri bolnikih po PCI.
The CHMP agreed with the wording proposed for the paediatric population in line with the wording agreed during the EU Worksharing Project.
CHMP se je strinjal s predlaganim besedilom za pediatrično populacijo, ki je v skladu z besedilom, dogovorjenim med projektom „EU Worksharing Project“.
2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
2 & 4, rue Lionel Terray 92500 Rueil Malmaison Cédex Francija
• Memory loss
• izguba spomina
A creatine kinase level should be measured before starting fluvastatin treatment in the following situations:
Vrednosti kreatinkinaze je treba določiti pred začetkom zdravljenja s fluvastatinom v naslednjih primerih:
The majority of patients with these abnormal biochemical findings were asymptomatic.
Večina bolnikov, pri katerih je prišlo do teh nenormalnih biokemičnih izvidov, je bila brez simptomov.
Your cholesterol levels need to be checked regularly to monitor your progress.
Zdravnik bo moral redno določati raven vašega holesterola, da bo lahko spremljal potek vaše bolezni.
The hydroxylated metabolites have pharmacological activity but do not circulate systemically.
Hidroksilirani presnovki so farmakološko aktivni, a ne krožijo sistemsko.
The CHMP agreed with the following wording for a flexible initial dosing of 40-80mg: ‘The recommended dosing range is 20 to 80 mg/day.
CHMP se je strinjal z naslednjim besedilom za fleksibilno začetno odmerjanje 40-80 mg: „Priporočeni razpon odmerkov je od 20 do 80 mg/dan.
Fluvastatin inhibited only the metabolism of compounds that are metabolised by CYP2C9.
Fluvastatin je zaviral samo metabolizem spojin, ki jih presnavlja CYP2C9.
Austria, Germany
Avstrija, Nemčija
This medicinal product is authorised in the Member States of the EEA under the following names:
Zdravilo je v državah članicah Evropskega gospodarskega prostora pridobilo dovoljenje za promet z naslednjimi imeni:
In very rare cases, possibly drug-related hepatitis was observed that resolved upon discontinuation of treatment.
V zelo redkih primerih so opažali hepatitis, ki bi lahko bil povezan z zdravilom in je po prekinitvi zdravljenja izzvenel.
Lescol is efficacious in monotherapy.
Zdravilo Lescol je učinkovito v monoterapiji.
Based on preclinical data, it is expected that fluvastatin is excreted into human milk.
Na osnovi predkliničnih podatkov je mogoče pričakovati, da se fluvastatin pri ljudeh izloča v materino mleko.
UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy
UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italija
However appropriate wording for the paediatric population were included in the sections agreed during the EU Worksharing procedure; sections 4.2, 4.4, 4.8, 5.1 and 5.2.
Vendar je bilo ustrezno besedilo za pediatrično populacijo vključeno v poglavja 4.2, 4.4, 4.8, 5.1 in 5.2, kakor je bilo dogovorjeno med projektom „EU Worksharing“.
In the case of pre-pubertal children, as experience is very limited in this group, the potential risks and benefits should be carefully evaluated before the initiation of treatment.
Glede na zelo omejen obseg izkušenj pri otrocih v predpubertetnem obdobju je treba pri njih pred začetkom zdravljenja skrbno pretehtati možna tveganja in koristi.
The risk ratios of cardiac death (RR 0.53) and cardiac death or nonfatal MI (RR 0.69) were also less than 1 but the study was not powered for these endpoints.
Razmerji tveganja za srčno smrt (RR 0,53) in srčno smrt ali MI brez smrtnega izida (RR 0,69) sta bili tudi pod 1, vendar študija ni bila dovolj močna za vrednotenje teh končnih točk.
Should an increase in aspartate aminotransferase or alanine aminotransferase exceed 3 times the upper limit of normal and persist, therapy should be discontinued.
Če se koncentracija aspartat-aminotransferaze (AST) ali alanin-aminotransferaze (ALT) zviša za več kot trikrat nad zgornjo mejo normalnih vrednosti in ostane zvišana, je treba zdravljenje prekiniti.
An overall recommendation to monitor liver function and CK levels seemed a reasonable approach considering that effects on liver and muscle may be generally expected in statin overdosage.
Skupno priporočilo za spremljanje jetrne funkcije in ravni kreatin kinaze se je zdelo kot razumen pristop glede na splošno pričakovane učinke na jetra in mišičje pri prevelikem odmerjanju statinov.