FrancophonIA/ELRC3.0 huggingface dataset:
English: In a force-titration, open label trial, 42 patients with homozygous familial hypercholesterolaemia were evaluated for their response to Crestor 20 - 40 mg.
Slovenian: V odprti raziskavi z določanjem odmerka na podlagi forsiranega titriranja so pri 42 bolnikih s homozigotno družinsko hiperholesterolemijo ocenjevali njihov odziv na zdravljenje z 20- do 40miligramskimi odmerki Crestorja.
English: Creatine Kinase (CK) should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may confound interpretation of the result.
Slovenian: Kreatin-kinaze (CK) se ne sme meriti po napornem razgibavanju ali če obstaja drug možen vzrok zvečanja vrednosti CK, ki lahko vpliva na izvid.
English: Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
Slovenian: Rosuvastatin zvečuje število jetrnih receptorjev za LDL na površini celice in zveča prevzem in katabolizem LDL ter zavira nastajanje VLDL v jetrih in tako zmanjša skupno število delcev VLDL in
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>
English: It also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG and increases ApoA-I (see Table 1).
Slovenian: Znižuje tudi raven ApoB, neHDL holesterola, holesterola VLDL, VLDL-TG in zvišuje raven ApoA-I (glejte preglednico 1).
English: The 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis.
Slovenian: Uporaba 40 mg odmerkov je kontraindicirana pri bolnikih, pri katerih je prisoten kateri od predispozicijskih dejavnikov za miopatijo/rabdomiolizo.
English: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with higher doses of Crestor, in particular 40 mg, where it was transient or intermittent in most cases.
Slovenian: Proteinurija, ki so jo odkrili s testiranjem s testnimi lističi in je bila v glavnem tubulna, se je pojavila pri bolnikih, ki so dobivali velike odmerke Crestorja, zlasti 40-miligramske; pri večini bolnikov je bila prehodna ali intermitentna.
English: In conclusion, the benefit/risk ratio is favourable for Crestor 5 or Crestor 10 mg as alternative start doses.
Slovenian: Zaključimo lahko, da je razmerje med koristmi in tveganji za zdravili Crestor 5 ali Crestor 10 mg kot alternativnima začetnima odmerkoma ugodno.
English: Oral contraceptive/hormone replacement therapy (HRT): Concomitant use of Crestor and an oral contraceptive resulted in an increase in ethinyl oestradiol and norgestrel AUC of 26% and 34%, respectively.
Slovenian: Peroralni kontraceptivi/nadomestno hormonsko zdravljenje (NHZ): Med hkratno uporabo Crestorja in peroralnih kontraceptivov se AUC etinilestradiola zveča za 26 %, norgestrela pa za 34 %.
English: This transporter is important in the hepatic elimination of rosuvastatin.
Slovenian: Ta prenosnik je pomemben pri izločanju rosuvastatina prek jeter.
English: Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol.
Slovenian: Rosuvastatin je selektiven in kompetitiven zaviralec reduktaze HMG-CoA, encima, ki določa hitrost pretvorbe 3-hidroksi-3-metilglutaril koencima A v mevalonat, ki je prekurzor holesterola.
English: However, two subjects with Child-Pugh scores of 8 and 9 showed an increase in systemic exposure of at least 2-fold compared to subjects with lower Child-Pugh scores.
Slovenian: Pri dveh preiskovancih, ocenjenih z 8 in 9 točkami po Child-Pughovi lestvici, je bila sistemska izpostavljenost najmanj dvakrat večja kot pri tistih z nižjo oceno po tej lestvici.
English: Crestor reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDLcholesterol.
Slovenian: Crestor zmanjšuje zvečano koncentracijo holesterola LDL, skupnega holesterola in trigliceridov ter zvečuje vrednost holesterola HDL.
English: Cytochrome P450 enzymes: Results from in vitro and in vivo studies show that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes.
Slovenian: Encimi citokroma P450: V raziskavah in vitro in in vivo so ugotovili, da rosuvastatin ni niti zaviralec niti induktor izoencimov citokroma P450.
English: DK-2620 Albertslund Denmark
Slovenian: Roskildevej 22 DK-2620 Albertslund
English: Crestor is contraindicated in pregnancy and lactation.
Slovenian: Uporaba Crestorja med nosečnostjo in dojenjem je kontraindicirana.
English: The choice of start dose in the individual patient should take into account aspects of efficacy and safety, as detailed in the SPC.
Slovenian: Pri izbiri začetnega odmerka pri posameznem bolniku je treba upoštevati vidike učinkovitosti in varnosti, kakor je opisano v Povzetku glavnih značilnosti zdravila.
English: CYP2C9 was the principal isoenzyme involved, with 2C19, 3A4 and 2D6 involved to a lesser extent.
Slovenian: Glavni izoencim, ki sodeluje, je CYP2C9, drugi, manj pomembni, pa so 2C19, 3A4 in
English: There are no data to support a steeper dose relationship for adverse reactions (myopathy, hepatotoxicity) for rosuvastatin, compared with other statins.
Slovenian: V primerjavi z drugimi statini ni podatkov, ki bi podpirali močnejšo povezavo neželenih reakcij (miopatija, hepatotoksičnost) z odmerkom rosuvastatina.
English: 4.4 Special warnings and special precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Vpliv na ledvice
English: From pooled phase III data, Crestor has been shown to be effective at treating the majority of patients with type IIa and IIb hypercholesterolaemia (mean baseline LDL-C about 4.8 mmol/l) to recognised European Atherosclerosis Society (EAS; 1998) guideline targets; about 80% of patients treated with 10 mg reached the EAS targets for LDL-C levels (<3 mmol/l).
Slovenian: Atherosclerosis Society (EAS; 1998) učinkovito pri večini bolnikov s hiperholesterolemijo tipa IIa in IIb (srednja izhodiščna vrednost holesterola LDL približno 4,8 mmol/l); okoli 80 % bolnikov, ki so jemali po 10 mg zdravila, je po EAS doseglo ciljno vrednost za holesterol LDL (< 3 mmol/l).
English: Steady-state plasma concentrations of rosuvastatin in subjects undergoing haemodialysis were approximately 50% greater compared to healthy volunteers.
Slovenian: Koncentracija rosuvastatina v stanju dinamičnega ravnovesja je bila pri ljudeh na hemodializi približno za 50 % večja kot pri zdravih prostovoljcih.
English: Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Slovenian: Homozigotna družinska hiperholesterolemija - kot dodatek dieti in drugim ukrepom za zmanjšanje vrednosti lipidov (npr. afereza LDL) ali kadar ti ukrepi niso primerni.
English: This effect was mitigated when the antacid was dosed 2 hours after Crestor.
Slovenian: kadar so bolniki antacid vzeli dve uri po zaužitju Crestorja.
English: Absorption: Maximum rosuvastatin plasma concentrations are achieved approximately 5 hours after oral administration.
Slovenian: 5.2 Farmakokinetične lastnosti Absorpcija: Plazemska koncentracija rosuvastatina je največja čez približno pet ur po peroralnem zaužitju zdravila.
English: The 40 mg dose is contraindicated in some of these patients (see Section 4.3 Contraindications).
Slovenian: Odmerek 40 mg je kontraindiciran pri nekaterih od teh bolnikov (glejte poglavje 4.3 Kontraindikacije).
English: UK
Slovenian: Združeno kraljestvo
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Distribution: Rosuvastatin is taken up extensively by the liver which is the primary site of cholesterol synthesis and LDL-C clearance.
Slovenian: Porazdelitev: Rosuvastatin se obsežno privzame v jetra, v katerih tudi nastaja največ holesterola in očistka holesterola LDL.
English: Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other nonpharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Slovenian: Primarna hiperholesterolemija (tip IIa, tudi heterozigotna družinska hiperholesterolemija) ali mešana dislipidemija (tip IIb) - kot dodatek dieti, kadar odziv nanjo ali druge nefarmakološke ukrepe (npr. telesna vadba, zmanjšanje telesne mase) ni bil zadovoljiv.
English: Increased systemic exposure has been seen in Japanese and Chinese subjects (see section 4.4 Special warnings and special precautions for use and section 5.2 Pharmacokinetic properties).
Slovenian: Sistemska izpostavljenost je bila povečana pri osebah japonskega in kitajskega porekla (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi in poglavje 5.2 Farmakokinetične lastnosti).
English: If CK levels are elevated (>5xULN), treatment should be discontinued (see Section 4.4 Special warnings and special precautions for use).
Slovenian: Če je vrednost CK zvečana (> 5x ULN), je treba zdravljenje ustaviti (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Renal insufficiency: In a study in subjects with varying degrees of renal impairment, mild to moderate renal disease had no influence on plasma concentration of rosuvastatin or the N-desmethyl metabolite.
Slovenian: Ledvična odpoved: V raziskavi, v kateri so sodelovali preiskovanci z različnimi stopnjami ledvične okvare, blaga do zmerna huda ledvična bolezen ni vplivala na plazemske koncentracije rosuvastatina ali njegovega N-demetilnega presnovka.
English: If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started.
Slovenian: Če so izhodiščne vrednosti CK bistveno zvečane (> 5x ULN), se zdravljenja ne sme začeti.
English: Excretion: Approximately 90% of the rosuvastatin dose is excreted unchanged in the faeces (consisting of absorbed and non-absorbed active substance) and the remaining part is excreted in urine.
Slovenian: Izločanje: Z blatom (bodisi absorbirana bodisi neabsorbirana učinkovina) se v nespremenjeni obliki izloči okoli 90 % odmerka rosuvastatina, preostanek pa se izloči s sečem.
English: Gemfibrozil and other lipid-lowering products: Concomitant use of Crestor and gemfibrozil resulted in a 2-fold increase in rosuvastatin C max and AUC (see Section 4.4 Special warnings and special precautions for use).
Slovenian: Gemfibrozil in druga zdravila, ki znižujejo koncentracijo lipidov: Med sočasno uporabo Crestorja in gemfibrozila sta Cmax in AUC rosuvastatina dvakrat večja (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Hepatic insufficiency: In a study with subjects with varying degrees of hepatic impairment there was no evidence of increased exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below.
Slovenian: Jetrna insuficienca: V raziskavi, v kateri so sodelovali preiskovanci z različnimi stopnjami jetrne okvare, niso dokazali zvečanja izpostavljenosti rosuvastatinu pri bolnikih, ocenjenih s 7 ali manj točkami po Child-Pughovi lestvici.
English: A start dose of 5 mg is recommended in patients > 70 years (see section 4.4 Special warnings and precautions for use).
Slovenian: Uporaba pri starejših Začetni odmerek 5 mg je priporočen pri bolnikih > 70 let (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: In controlled clinical trials, less than 4% of Crestor-treated patients were withdrawn due to adverse events.
Slovenian: kontroliranih kliničnih preskušanjih je zaradi njihovega pojavljanja prenehalo sodelovati manj kot 4 %
English: (See Section 4.5 Interaction with other medicinal products and other forms of interaction and Section 4.8
Slovenian: (Glejte poglavje 4.5 Medsebojno delovanje zdravil in druge oblike interakcij in poglavje 4.8 Neželeni učinki).
English: Preclinical safety data).
Slovenian: 5.3 Predklinični podatki o varnosti).
English: Apo B
Slovenian: V
English: The difference in lipid-lowering efficacy between rosuvastatin 5 mg and 10 mg is that anticipated with a statin, i.e. a doubling of the dose from 5 mg to 10 mg (either through start dose or through up-titration)
Slovenian: Razlika v učinkovitosti znižanja ravni lipidov med rosuvastatinom 5 mg in 10 mg ustreza pričakovanjem za statin, tj. podvojitev odmerka s 5 mg na 10 mg (bodisi preko začetnega odmerka bodisi s povečano titracijo) povzroči povprečno povečanje učinka znižanja ravni LDL-C za 6 %, iz povprečno 41 % na 47 %.
English: HDPE bottles: Do not store above 30°C.
Slovenian: Plastenke DHPE: Zdravilo shranjujte pri temperaturi do 30 ºC.
English: - in patients with severe renal impairment (creatinine clearance <30 ml/min).
Slovenian: - pri bolnikih s hudo ledvično odpovedjo (očistek kreatinina < 30 ml/min) - pri bolnikih z miopatijo
English: P O Box 599 NL-2700 An Zoetermeer
Slovenian: NL-2700 An Zoetermeer Nizozemska
English: Crestor is contraindicated in patients with active liver disease (see Section 4.3 Contraindications).
Slovenian: Uporaba Crestorja je kontraindicirana pri bolnikih z aktivno jetrno boleznijo (glejte poglavje 4.3
English: Concomitant administration of itraconazole (an inhibitor of CYP3A4) and rosuvastatin resulted in a 28% increase in AUC of rosuvastatin.
Slovenian: CYP3A4) in rosuvastatina se AUC rosuvastatina zveča za 28 %.
English: Nervous system disorders Common: headache, dizziness
Slovenian: Bolezni živčevja pogosti: glavobol, vrtoglavica
English: B-1180 Brussels, Belgium
Slovenian: Egide Van Ophemstraat 110 B-1180 Brussels, Belgija
English: The recommended start dose is 5 or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor.
Slovenian: Priporočen začetni peroralni odmerek je 5 ali 10 mg enkrat na dan, tako pri bolnikih, ki se še niso zdravili s statini kot tudi pri tistih bolnikih, ki so se pred tem zdravili z drugim zaviralcem HMG-CoA
English: In vitro metabolism studies using human hepatocytes indicate that rosuvastatin is a poor substrate for cytochrome P450
Slovenian: V raziskavah o presnovi in vitro so na človeških jetrnih parenhimskih celicah ugotovili, da je rosuvastatin slab substrat za presnovo s pomočjo citokroma P450.
English: A dose-related increase in CK levels has been observed in patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient.
Slovenian: Vrednost CK se je v skladu z velikostjo odmerka zvečala pri bolnikih, ki so jemali rosuvastatin; v večini primerov je bilo zvečanje blago, asimptomatsko in prehodno.
English: In clinical studies with a limited number of patients, Crestor has been shown to have additive efficacy in lowering triglycerides when used in combination with fenofibrate and in increasing HDL-C levels when used in combination with niacin (see Section 4.4 Special warnings and special precautions for use).
Slovenian: V kliničnih raziskavah z omejenim številom bolnikov je Crestor med kombiniranim zdravljenjem s fenofibratom dodatno prispeval k učinkovitemu zmanjšanju vrednosti trigliceridov, v kombinaciji z niacinom pa k zvišanju ravni holesterola HDL (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Gemfibrozil, fenofibrate, other fibrates and lipid lowering doses (> or equal to 1g/day) of niacin (nicotinic acid) increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors, probably because they can produce myopathy when given alone.
Slovenian: (nikotinske kisline) v odmerkih, ki znižujejo koncentracijo lipidov (> ali enaka 1 g/dan), se poveča tveganje za pojav miopatije najverjetneje zato, ker lahko tudi sami povzročajo miopatijo.
English: If CK levels are significantly elevated at baseline (>5xULN) a confirmatory test should be carried out within 5 - 7 days.
Slovenian: (> 5x ULN), je treba test za potrditev izvida ponoviti čez pet do sedem dni.
English: The potential relevance of need of >45% reduction of LDL-C, and that this could be taken into account in an individualised choice of start dose, has already been acknowledged by CHMP for other products of this class.
Slovenian: za >45 % morebiti pomembna, in da se le-ta lahko upošteva z izbiro začetnega odmerka, prilagojenega posamezniku.
English: Metabolism: Rosuvastatin undergoes limited metabolism (approximately 10%).
Slovenian: Presnova: Presnova rosuvastatina je majhna (približno 10 %).
English: There is no experience in subjects with Child-Pugh scores above 9.
Slovenian: Ni izkušenj s preiskovanci, ocenjenimi z več kot 9 točkami po Child-Pughovi lestvici.
English: (adjusted mean percent change from baseline)
Slovenian: IIb) (prilagojen povprečni odstotek spremembe glede na izhodiščno vrednost) odmerek N holesterol LDL
English: The primary site of action of rosuvastatin is the liver, the target organ for cholesterol lowering.
Slovenian: Rosuvastatin deluje predvsem v jetrih, tarčnem organu zmanjševanja vrednosti holesterola.
English: Liver Effects
Slovenian: Vpliv na jetra
English: Skeletal muscle effects: Effects on skeletal muscle e.g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported in Crestor-treated patients with all doses and in particular with doses > 20 mg.
Slovenian: Vpliv na skeletno mišičje: Pri jemanju zdravila Crestor so pri bolnikih opazili učinke na skeletne mišice, npr. mialgijo, miopatijo in v redkih primerih tudi rabdomiolizo, pri vseh odmerkih, predvsem pa pri odmerkih > 20 mg.
English: However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9 (see Section 5.2 Pharmacokinetic properties).
Slovenian: Zvečala se je pri bolnikih, ki so bili po Child-Pughovi lestvici ocenjeni z 8 in 9 točkami (glejte poglavje 5.2 Farmakokinetične lastnosti).
English: - during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.
Slovenian: - pri bolnikih, ki sočasno dobivajo ciklosporin - med nosečnostjo in obdobjem dojenja ter pri ženskah v rodnem obdobju, ki ne uporabljajo zanesljive kontracepcijske metode.
English: As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Slovenian: Tako kot velja za druge zaviralce reduktaze HMG-CoA, je tudi pri uporabi Crestorja incidenca neželenih učinkov odvisna od velikosti odmerka.
English: Haemodialysis is unlikely to be of benefit.
Slovenian: pri asimptomatskih bolnikih ni smiselno.
English: Rosuvastatin accounts for greater than 90% of the circulating HMG-CoA reductase inhibitor activity.
Slovenian: 90 % aktivnosti v krvi krožečega zaviralca reduktaze HMG-CoA.
English: If the repeat test confirms a baseline CK >5xULN, treatment should not be started.
Slovenian: Če je tudi tedaj izhodiščna vrednost CK > 5x ULN, se zdravljenja ne sme začeti.
English: Pharmacotherapeutic group: HMG-CoA reductase inhibitors ATC code: C10A A07
Slovenian: Oznaka ATC: C10A A07
English: The 40 mg dose is contraindicated in Japanese and Chinese patients (see sections 4.3 Contraindications and 5.2 Pharmacokinetic properties).
Slovenian: Uporaba 40 mg odmerkov je kontraindicirana pri japonskih in kitajskih bolnikih (glejte poglavji 4.3 Kontraindikacije in 5.2
English: The use of Crestor in patients with severe renal impairment is contraindicated for all doses.
Slovenian: Crestorja pri bolnikih s hudo ledvično odpovedjo je kontraindicirana pri vseh odmerkih (glejte poglavje
English: Marketing Authorisation Holders/Applicants
Slovenian: Imetniki/Vlagatelji dovoljenja za promet z zdravilom
English: Vitamin K antagonists: As with other HMG-CoA reductase inhibitors, the initiation of treatment or dosage up-titration of Crestor in patients treated concomitantly with vitamin K antagonists (e.g.
Slovenian: Antagonisti vitamina K: Pri bolnikih, ki dobivajo antagoniste vitamina K (npr. varfarin), se lahko na začetku zdravljenja s Crestorjem ali pri zvečevanju njegovega odmerka s titriranjem - enako kot pri uporabi drugih zaviralcev reduktaze HMG-CoA - zveča INR (International Normalised Ratio).
English: In these patients an assessment of renal function should be considered (see Section 4.4 Special warnings and special precautions for use).
Slovenian: Pri teh bolnikih je smiselno oceniti delovanje ledvic (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below.
Slovenian: Sistemska izpostavljenost rosuvastatinu se pri bolnikih, ocenjenih s 7 ali manj točkami po Child
English: Dosage in patients with hepatic impairment
Slovenian: Odmerjanje pri bolnikih s poslabšanjem jetrnega delovanja
English: In such patients the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended.
Slovenian: Pri teh bolnikih je treba pretehtati, kako nevarno bi bilo zdravljenje in kolikšna njegova koristnost,
English: ApoA-I
Slovenian: apoB apoA-I
English: Pharmacokinetic studies show an increase in exposure in Japanese and Chinese subjects compared with Caucasians (see section 4.2 Posology and Method of administration and section 5.2 Pharmacokinetic properties)
Slovenian: V farmakokinetičnih raziskavah so ugotovili, da je izpostavljenost Japoncev in Kitajcev večja od izpostavljenosti belcev (glejte poglavje 4.2 Odmerjanje in način uporabe in poglavje 5.2
English: Dosage in patients with renal insufficiency
Slovenian: Odmerjanje pri bolnikih z ledvično odpovedjo
English: 4, Theotokopoulou
Slovenian: AstraZeneca S A 4, Theotokopoulou
English: Race: Pharmacokinetic studies show an approximate 2-fold elevation in median AUC compared with western Caucasians in both Japanese subjects residing in Japan, and Chinese subjects living in
Slovenian: Rasa: V farmakokinetičnih raziskavah so ugotovili, da je srednja vrednost AUC in Cmax pri Japoncih,
English: ANNEX III AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: Patients should be asked to report inexplicable muscle pain, weakness or cramps immediately,
Slovenian: Bolnikom je treba naročiti, naj v primeru pojava nepojasnjenih bolečin, oslabelosti ali krčev v mišicah, še posebej če je to povezano tudi z občutkom slabosti ali zvišano telesno temperaturo, nemudoma obvestijo svojega zdravnika.
English: Crestor with fibrates or niacin should be carefully weighed against the potential risks of such combinations.
Slovenian: Skrbno je treba pretehtati, kolikšna je koristnost kombinirane uporabe Crestorja in fibratov ali niacina in kolikšna morebitna nevarnost.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment.
Slovenian: Bolnikom z blagim do zmerno hudim poslabšanjem ledvičnega delovanja odmerka ni treba prilagajati.
English: If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing Crestor or an alternative HMG
Slovenian: Če simptomi izginejo in se vrednost CK normalizira, je treba pretehtati, ali bolnik spet lahko začne dobivati najmanjši odmerek Crestorja ali drugega zaviralca reduktaze HMG-CoA; v tem primeru ga je treba skrbno spremljati.
English: <1% of patients at some time during treatment with 10 and 20 mg, and in approximately 3% of patients treated with 40 mg. A minor increase in shift from none or trace to + was observed with the 20 mg dose.
Slovenian: Sprememba beljakovin v seču z 0 ali v sledeh na stopnjo ++ ali več se je pojavila pri < 1 % bolnikov med zdravljenjem z 10- in 20-miligramskimi odmerki, ki je trajalo že nekaj časa, in pri približno 3 % bolnikov, ki so jemali po 40 mg.