natgillin/translations-raw huggingface dataset:
Despite agreeing to the Applicant's request not to exclude females and non-diabetics from the indication, the CHMP regards the claimed indication, which mirrors the ASCOT-LLA and CARDS patient populations, to be too broad.
Kljub temu, da se CHMP strinja z vlagateljevo zahtevo, da se iz indikacije ne izključi žensk in bolnikov brez sladkorne bolezni, CHMP meni, da je prijavljena indikacija, ki odraža populacije bolnikov v raziskavah ASCOT-LLA in CARDS, preširoka.
It is obvious that the age-adjusted absolute benefit of primary CVD prevention is much lower in women than in men, as women have a lower CVD risk at the same age.
Očitno je, da je absolutni koristni učinek primarnega preprečevanja srčno-žilnih bolezni, ki je prilagojen glede na starost, veliko manjši pri ženskah kakor pri moških, saj imajo ženske pri enaki starosti manjše tveganje za srčno-žilne bolezni.
If you are at an increased risk of heart disease, {PRODUCT NAME}can also be used to reduce such risk even if your cholesterol levels are normal.
Če imate povišano tveganje za srčne bolezni, se lahko {(Lastniško) ime} uporablja tudi za zmanjševanje takšnega tveganja, čeprav je raven holesterola v vaši krvi normalna.
<[To be completed nationally]> {Name and Address} <{tel}> <{fax}> <{e-mail}>
[Izpolni država članica] {Ime in naslov} <{tel.}> <{fax}> <{e-mail}>
This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with evidence of myocardial ischaemia (p=0.018).
Razlog za to je bilo predvsem 26-odstotno zmanjšanje števila ponovnih hospitalizacij zaradi angine pektoris z znaki ishemije miokarda (p=0,018).
In order to put the results from ASCOT-LLA into a wider perspective and to further support the safety and benefit of atorvastatin in the primary prevention of CV events, regardless of gender, the Applicant has provided i) a brief review of data with respect to gender from other statin clinical trials, ii) the current position of scientific societies on the recommended management of CVD in women, iii) key results by gender for ASCOT-LLA and CARDS, highlighting similarities between the studies, and iv) reference to current regulatory guidance and scientific limitations in interpreting results from subgroup analyses.
Z namenom oceniti rezultate raziskave ASCOT-LLA s širšega vidika in ponuditi dodatne dokaze za varnost in koristne učinke atorvastatina v primarnem preprečevanju srčno-žilnih dogodkov ne glede na spol je vlagatelj predložil i) kratek pregled podatkov po spolu iz drugih kliničnih preskušanj statinov, ii) trenutno stališče strokovne skupnosti o priporočeni obravnavi srčno-žilnih bolezni pri ženskah, iii) ključne rezultate raziskav ASCOT-LLA in CARDS po spolu, pri čemer so bile izpostavljene podobnosti med obema raziskavama ter iv) sklic na trenutne regulatorne smernice in znanstvene omejitve pri interpretaciji rezultatov analize podskupin.
− If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint.
− Če pride do težav z nepričakovanim ali nenavadnim krvavenjem ali podplutbami, lahko to kaže na težave z jetri.
After oral administration, atorvastatin film-coated tablets are 95% to 99% bioavailable compared to the oral solution.
Po peroralni uporabi filmsko obloženih tablet atorvastatina je njegova biološka uporabnost v primerjavi z raztopino od 95 do 99%.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATORVASTATIN (Sortis and associated names - see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ATORVASTATINA (zdravilo Sortis in povezana imena - glejte Dodatek I)
If you have muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature, stop taking {PRODUCT NAME} and tell your doctor immediately.
Če čutite šibkost v mišicah, občutljivost na dotik ali bolečino, in še posebej, če to spremljata slabo počutje in vročina, prenehajte jemati {(Lastniško) ime} in takoj obvestite svojega zdravnika.
Atorvastatin increased mean HDL-C by 2.9% (pravastatin: +5.6%, p=NS).
Atorvastatin je zvišal povprečni holesterol HDL za 2,9% (pravastatin: +5,6%, p=NZ).
Concomitant administration of atorvastatin 40 mg and itraconazole 200 mg daily resulted in a 3-fold increase in atorvastatin AUC.
Sočasna uporaba 40 mg atorvastatina in 200 mg itrakonazola na dan je povzročila 3-kratno zvečanje AUC atorvastatina.
Intake of one 240 ml glass of grapefruit juice resulted in an increase in atorvastatin AUC of 37% and a decreased AUC of 20.4% for the active orthohydroxy metabolite.
Zaužitje 240-ml kozarca grenivkinega soka je AUC atorvastatina zvečalo za 37%, AUC aktivnega ortohidroksi presnovka pa zmanjšalo za 20,4%.
− Angioneurotic oedema (swelling of the face, tongue and windpipe which can cause great difficulty in breathing).
− Angionevrotični edem (oteklina obraza, jezika in sapnika, ki lahko povzroči velike težave pri dihanju).
− If you have an under-active thyroid gland (hypothyroidism)
− če imate premalo aktivno žlezo ščitnico (hipotiroidizem)
Estimated frequencies of events are ranked according to the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (≤ 1/10,000).
Ocenjene pogostnosti neželenih učinkov so po dogovoru razvrščene, kot sledi: pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1000, < 1/100); redki (≥ 1/10000, < 1/1000); zelo redki (≤ 1/10000).
4 tablets 7 tablets 10 tablets 14 tablets 20 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 98 tablets 100 tablets 200 tablets 500 tablets
4 tablete 7 tablet 10 tablet 14 tablet 20 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 tablet 98 tablet 100 tablet 200 tablet 500 tablet
− if you have had any unexplained abnormal blood tests for liver function
− če ste kdaj dobili nenormalne in nepojasnjene izvide krvnih preiskav za delovanje jeter
Uncommon: tinnitus
Občasno: tinitus
− If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
− če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte,
The appropriate place for dose recommendations is section 4.2 of the SPC, not section 4.1, and adequate dosing recommendations have been added.
Ustrezno mesto za priporočila glede odmerjanja je poglavje 4.2 v Povzetku glavnih značilnosti zdravila in ne poglavje 4.1.
Uncommon: amnesia.
Občasno: amnezija.
Creatine phosphokinase measurement
Merjenje kreatin fosfokinaze
Relative Risk Reduction
Relativno zmanjšanje tveganja
Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
Zvišanje nad 10-kratno ZNM se je pojavilo pri 0,4% bolnikov, zdravljenih s {(Lastniško) ime} (glejte poglavje 4.4).
In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk.
Pri podganah je bila koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi podobna kot v mleku.
Prevention of cardiovascular disease
Preprečevanje kardiovaskularnih bolezni
CHD = coronary heart disease; MI = myocardial infarction.
CHD = koronarna srčna bolezen; MI = miokardni infarkt.
From these 46 patients, the mean percent reduction in LDL-C was approximately 21%.
Povprečno znižanje holesterola LDL pri teh 46 bolnikih je bilo približno 21%.
Should an increase in transaminases of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of {PRODUCT NAME} is recommended (see section 4.8).
Če zvišanje transaminaz, ki presega 3-kratno ZNM, traja, je odmerek {(Lastniško) ime} priporočljivo zmanjšati ali zdravilo ukiniti (glejte poglavje 4.8).
Therefore, the CHMP agrees that excluding females from the indication would deprive an important sub-group of the population of atorvastatin treatment if their CV risk warrants this treatment, and believes the above findings in the female subgroup of ASCOTLLA should be reflected in section 5.1 of the SPC.
Zato se CHMP strinja, da bi izključitev žensk iz indikacije, pomembno podskupino populacije prikrajšala za zdravljenje z atorvastatinom, če je njihovo tveganje za srčno-žilno bolezen utemeljena podlaga za takšno zdravljenje, ter je mnenja, da naj se zgoraj omenjeni rezultati za ženske v raziskavi ASCOT-LLA prikažejo v poglavju 5.1 Povzetka glavnih značilnosti zdravila.
Nevertheless, patients receiving warfarin should be closely monitored when {PRODUCT NAME} is added to their therapy.
Kljub temu je treba bolnike, ki dobivajo varfarin, po dodatku {(Lastniško) ime} v terapijo natančno nadzorovati.
To what extent the claimed therapeutic indication could be applied to atorvastatin doses other than the one tested in the CARDS and ASCOT-LLA trials.
Do kakšne mere se lahko prijavljena terapevtska indikacija uporabi za tiste odmerke atorvastatina, ki niso bili raziskani v preskušanjih CARDS in ASCOT-LLA?
In animal studies atorvastatin had no effect on male or female fertility at doses up to 175 and 225 mg/kg/day, respectively, and was not teratogenic.
V raziskavah na živalih atorvastatin v odmerkih do 175 mg/kg/dan pri samcih in do 225 mg/kg/dan pri samicah ni vplival na plodnost in ni bil teratogen.
However, large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites) HMG-CoA reductase inhibitors 1.3 fold.
Vendar pa so velike količine zaužitega grenivkinega soka (več kot 1,2 litra na dan pet dni) AUC atorvastatina zvečale za 2,5-krat in AUC aktivnih zaviralcev HMG CoA reduktaze (atorvastatina in metabolitov) za 1,3-krat.
Very rare: angioneurotic oedema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).
Zelo redko: angionevrotski edem, bulozni izpuščaji (vključno z multiformnim eritemom, StevensJohnsonovim sindromom in toksično epidermalno nekrolizo).
Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention” in Atherosclerosis 140 (1998) 199-270.
Prirejeno po ״Prevention of coronary heart disease in clinical practice: Recomendations of the Second Joint Task Force of European and Other Societes on Coronary Prevention״ ; Atherosclerosis 140 (1998)
Therefore, special caution should be exercised when atorvastatin is used in combination with such medicinal agents (see section 4.4).
Zato je med sočasno uporabo atorvastatina v kombinaciji s takšnimi zdravili potrebna posebna previdnost (glejte tudi poglavje 4.4).
Coadministration of {PRODUCT NAME} and warfarin caused a small decrease in prothrombin time during the first days of dosing which returned to normal within 15 days of {PRODUCT NAME} treatment.
Sočasna uporaba {(Lastniško) ime} in varfarina je v prvih dneh uporabe povzročila majhno skrajšanje protrombinskega časa; protrombinski čas se je normaliziral v 15 dneh uporabe {(Lastniško) ime}.
<[See Annex I - To be completed nationally]> [For referral procedures, as appropriate]
<[Glejte Dodatek I - Izpolni država članica]> [For referral procedures]
− If you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin' or ‘-fibrate' medicines)
− če ste v preteklosti imeli težave z mišicami pri zdravljenju z drugimi zdravili za zniževanje ravni maščob v krvi (npr. zdravili iz skupine 'statinov' ali 'fibratov')
In the light of the above the CHMP concludes that the indication for atorvastatin “Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.” adequately reflects the available data.
Glede na zgoraj zapisano CHMP zaključuje, da indikacija „Preprečevanje srčno-žilnih dogodkov pri bolnikih, ki imajo veliko ocenjeno tveganje za prvi srčno-žilni dogodek, kot dopolnilo h korekciji drugih dejavnikov tveganja.“ zadostno odraža dostopne podatke.
Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Sočasna uporaba večkratnih odmerkov {(Lastniško) ime} in fenazona je na očistek fenazona vplivala malo ali nič.
− if you have a muscle disorder called myopathy (repeated or unexplained muscle aches or pains)
− če imate bolezen skeletnih mišic, imenovano miopatija (ponavljajoče se bolečine in krči v mišicah nepojasnjenega izvora)
If you experience side effects, please inform your doctor.
Če izkusite neželene učinke, o tem obvestite svojega zdravnika.
Whether to exclude the target population of the ASCOT-LLA study from the proposed indication, thus precluding the treatment of non-diabetic patients at high cardiovascular risk.
Ali naj se iz predlagane indikacije izključi ciljna populacija preskušanja ASCOT-LLA in s tem onemogoči zdravljenje bolnikov brez sladkorne bolezni, ki imajo veliko tveganje za srčno-žilno bolezen?
However, the medicinal product does not appear to undergo significant enterohepatic recirculation.
Kot kaže, zdravilo nima pomembne enterohepatične recirkulacije.
- It is proposed to add the following indication in section 4.1: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
- Predlaga se dodatek naslednje indikacije v poglavje 4.1: Preprečevanje srčno-žilnih dogodkov pri bolnikih, ki imajo veliko ocenjeno tveganje za prvi srčno-žilni dogodek (glejte poglavje 5.1), kot dopolnilo h korekciji drugih dejavnikov tveganja.
Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
Klinično pomembno zvišanje (> 3-kratna ZNM) serumskih transaminaz se je pojavilo pri 0,8% bolnikov, ki so jemali {(Lastniško) ime}.
Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Zvišanje kreatin fosfokinaze (CPK), ki je presegalo 3-kratno ZNM, se je pojavilo pri 2,5% bolnikov, ki so jemali {(Lastniško) ime}, kar je podobno kot v kliničnih raziskavah z drugimi zaviralci HMG CoA reduktaze.
The main concern relates to the “risk of CVD”.
Glavni zadržek se nanaša na „tveganje za srčno-žilne bolezni“.
Whether the cardioprotective effect of atorvastatin is higher when used in combination with particular antihipertensive therapy(ies) and whether this should be reflected in the SPC.
Ali je kardioprotektivni učinek atorvastatina večji, če se uporablja v kombinaciji s specifičnim(i) antihipertenzivnim(i) zdravljenjem(nji) in ali naj to odraža Povzetek glavnih značilnosti zdravila?
Overall and cardiovascular mortality were numerically higher in the female patients (38 vs. 30 and 17 vs. 12), but this was not statistically significant.
Celotna umrljivost in kardiovaskularna umrljivost sta bili številčno večji pri ženskah (38 v primerjavi s 30 in 17 v primerjavi z 12), vendar to ni bilo statistično pomembno.
The effect of inducers of cytochrome P450 3A4 (e.g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
Vpliv induktorjev citokroma P450 3A4 (npr. rifampicina ali fenitoina) na {(Lastniško) ime} ni znan.
− Geriatric: Plasma concentrations of atorvastatin and its active metabolites are higher in healthy elderly subjects than in young adults while the lipid effects were comparable to those seen in younger patient populations.
Posebne populacije - Starejši: Koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi je pri zdravih starejših osebah večja kot pri mladih odraslih, učinki na lipide pa so primerljivi tistim pri mlajših bolnikih.
In a 2-year study in mice, incidences of hepatocellular adenoma in males and hepatocellular carcinomas in females were increased at the maximum dose used, and the maximum dose used was 250-fold higher than the highest human dose on a mg/kg body-weight basis.
Med dveletno raziskavo na miših je ob največjem uporabljenem odmerku pri samcih porasla incidenca hepatocelularnega adenoma, pri samicah pa hepatocelularnega karcinoma; največji uporabljeni odmerek (v mg/kg telesne mase) je bil 250-krat večji od največjega odmerka pri človeku.
These include:
Ti učinki so:
Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
Odmerjanje je treba določiti posamezno glede na izhodiščno koncentracijo holesterola LDL, cilj zdravljenja in bolnikov odziv.
Do not take {PRODUCT NAME} if you are pregnant, if you think you may be pregnant, or if you are trying to become pregnant.
Če ste noseči, če mislite, da bi lahko bili noseči, ali če skušate zanositi, ne smete jemati zdravila {(Lastniško) ime}.
The absolute and relative risk reduction effect of atorvastatin was as follows:
Absolutni in relativni učinek zmanjšanja tveganja z atorvastatinom je bil naslednji:
Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Jetra trigliceride in holesterol vgradijo v lipoproteine zelo majhne gostote (VLDL) in jih sprostijo v plazmo, s katero pridejo v periferna tkiva.
The CARDS study was conducted in 2,838 patients (40-75 years of age) with normal to mildly elevated cholesterol levels, with type 2 diabetes and 1 additional CV risk factor, and without clinically evident CHD.
Raziskava CARDS je bila opravljena na 2838 bolnikih (starih od 40 do 75 let) z normalnimi ali rahlo zvišanimi ravnmi holesterola, sladkorno boleznijo tipa 2 in 1 dodatnim srčno-žilnim dejavnikom tveganja in brez klinično izražene koronarne srčne bolezni.
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Tveganje za rabdomiolizo se zveča, če je atorvastatin uporabljen sočasno z določenimi zdravili, kakršna so npr.: ciklosporin, eritromicin, klaritromicin, itrakonazol, ketokonazol, nefazodon, niacin, gemfibrozil, drugi fibrati ali zaviralci HIV-proteaze (glejte poglavji 4.5 in 4.8).
Atorvastatin significantly reduced the frequency of coronary and CV events, strokes and revascularisation procedures in the entire study cohort, but a beneficial effect in the female subgroup could not be established, and overall mortality and CV mortality were numerically higher (not significant) in female patients.
Atorvastatin je statistično značilno znižal pogostnost koronarnih in srčno-žilnih dogodkov, infarktov in revaskularizacijskih posegov v celotni preiskani kohorti, vendar koristnega učinka pri ženskah niso mogli dokazati, razen tega je bila skupna smrtnost ter smrtnost zaradi srčnožilnih bolezni pri bolnicah številčno višja (statistično neznačilno).
Do not use any tools or machines if your ability to use them is affected by this medicine.
Ne upravljajte z orodji ali s stroji, če to zdravilo vpliva na vaše sposobnosti za upravljanje le-teh.
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Preprečevanje kardiovaskularnih dogodkov pri bolnikih, za katere so ocenili, da pri njih obstaja visoko tveganje za prvi kardiovaskularni dogodek (glejte poglavje 5.1), kot dodatek k obvladovanju ostalih dejavnikov tveganja.
Women of child-bearing age must take appropriate contraceptive measures.
Ženske v rodni dobi morajo uporabljati primerno kontracepcijsko zaščito.
In the primary prevention trials the dose was 10 mg/day.
V preskušanjih primarnega preprečevanja je bil odmerek 10 mg/dan.
All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Vsi bolniki so imeli najmanj enega od naslednjih dejavnikov tveganja: hipertenzija, trenutno kadilstvo, retinopatija, mikroalbuminurija ali makroalbuminurija.
The trial results show that for some low risk subgroups included in the studies, corresponding to large populations, treatment is probably not justified with current knowledge, and approving such an indication would result in the treatment of many patients that have no benefit from lipid lowering therapy.
Rezultati preskušanja kažejo, da za nekatere podskupine z majhnim tveganjem, ki ustrezajo velikim populacijam, zdravljenje na osnovi trenutnega znanja verjetno ni upravičeno.
Other possible side effects with {PRODUCT NAME}:
Ostali možni neželeni učinki pri jemanju {(Lastniško) ime}:
Treatment with atorvastatin 80 mg/day increased the time to occurrence of the combined primary endpoint, defined as death from any cause, nonfatal MI, resuscitated cardiac arrest, or angina pectoris with evidence of myocardial ischaemia requiring hospitalization, indicating a risk reduction by 16% (p=0.048).
Zdravljenje z atorvastatinom 80 mg dnevno je podaljšalo čas do nastopa sestavljenega primarnega opazovanega dogodka, ki je bil definiran kot smrt zaradi kateregakoli razloga, miokardni infarkt brez smrtnega izida, uspešno oživljanje po zastoju srca ali angina pektoris z znaki ishemije miokarda, zaradi katere je potrebna hospitalizacija, kar kaže na 16odstotno zmanjšanje tveganja (p=0,048).
If CPK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.
Če je vrednost CPK izhodiščno zelo velika (> 5-kratna ZNM), je treba CPK za potrditev izvida ponovno izmeriti čez 5 do 7 dni.
For oral use only.
Za peroralno uporabo.
Rare: myositis, rhabdomyolysis.
Redko: miozitis, rabdomioliza.
− If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
- Če se takšni simptomi pojavijo med zdravljenjem z atorvastatinom, je treba določiti CPK.
A standard cholesterol lowering diet should be continued during treatment.
Med zdravljenjem je treba nadaljevati s standardno prehrano za zmanjševanje ravni holesterola.
− Renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of atorvastatin and its active metabolites.
- Ledvična insuficienca: Bolezen ledvic ne vpliva niti na koncentracijo atorvastatina in njegovih aktivnih presnovkov v plazmi niti na njihov učinek na lipide.
Less than 2% of patients were discontinued from clinical trials due to side effects attributed to {PRODUCT NAME}.
V kliničnih raziskavah so zaradi neželenih učinkov, ki so jih pripisali {(Lastniško) ime}, zdravljenje prekinili pri manj kot 2% bolnikov.
− If muscular symptoms are severe and cause daily discomfort, even if the CPK levels are elevated to ≤ 5 x ULN, treatment discontinuation should be considered.
- Če so mišični simptomi hudi in povzročajo težave v vsakodnevnem življenju, je treba razmisliti o prekinitvi zdravljenja tudi, če je vrednost CPK ≤ 5-kratna ZNM.
− Angioneurotic oedema (swelling of the face, tongue and windpipe which can cause great difficulty in breathing), Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals), erythema multiforme (patchy red rash).
− Angionevrotični edem (oteklina obraza, jezika in sapnika, ki lahko povzroči velike težave pri dihanju), Stevens-Johnsonov sindrom (hujši mehurjasti izpuščaji po koži, ustih, očeh in genitalijah), multiformni eritem (makulopapulozen rdeč izpuščaj).
Nonetheless, the CHMP thought it relevant to reflect this finding and include following factual statement in the pragraph summarising the results of ASCOT-LLA under section 5.1 of the SPC.
Kljub temu je CHMP mnenja, da je pomembno prikazati ta rezultat in ga vključiti za navedbami dejstev v odstavku, ki povzema rezultate raziskave ASCOT-LLA v poglavju 5.1 Povzetka glavnih značilnosti zdravila.
If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your {PRODUCT NAME} treatment to predict your risk of muscle related side effects.
Če karkoli od zgoraj naštetega velja za vas, bo vaš zdravnik za oceno tveganja za pojav neželenih učinkov, povezanih z mišicami, izvedel preiskave krvi pred zdravljenjem s {(Lastniško) ime} in verjetno tudi med njim.