natgillin/translations-raw huggingface dataset:
Nepovažuje se za nezbytné č požadovat obecn vyšší pom r mezi zahajovací dávkou a maximální dávkou rosuvastatinu (20 mg u ě ě
It is not considered necessary to request a generally higher ratio between start dose and maximum dose for rosuvastatin (20 mg in the general target population, 40 mg in selected patients) than has been requested for other statins assessed by CHMP (simvastatin, pravastatin).
č ř zahajovací dávky m ly zvážit potenciální otázky bezpe nosti u jednotlivých pacient, nap. na základ
Rather, the choice of start dose should take into account potential safety concerns in the individual patient based e. g. on sensitivity to adverse reactions and pharmacokinetic considerations.
Záv rem lze íci, že pom r rizika/ p ínosu Crestoru 5 mg a 10 mg coby alternativních zahajovacích dávek
In conclusion, the benefit/ risk ratio is favourable for Crestor 5 or Crestor 10 mg as alternative start doses.
P i volb zahajovací dávky u jednotlivých pacient by se m ly zohlednit aspekty ú innosti a
The choice of start dose in the individual patient should take into account aspects of efficacy and safety, as detailed in the SPC.
ZD VODN NÍ POT EBNÝCH ÚPRAV V SOUHRNU ÚDAJ O P ÍPRAVKU
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Vzhledem k tomu, že
Based on the finding that
Denní dávka Crestoru ve výši 10 mg vede v porovnání s 5mg dávkou k v tšímu snížení LDL - C;
⇒ Crestor 10 mg daily dose leads to a higher reduction in LDL-C compared with 5 mg
Ani na základ postmarketingového výzkumu ani klinického hodnocení nejsou z ejmé žádné ě významné rozdíly v bezpe nosti i toleranci mezi rosuvastatinem v 5mg a 10mg dávce, č č
⇒ No important safety or tolerability difference between rosuvastatin 5 mg and 10 mg is evident on the basis of post-marketing or clinical trial data
je pom r rizika/ p ínosu Crestoru 5 mg a a Crestoru 10 mg coby alternativních zahajovacích dávek
The conclusion is that the benefit/ risk ratio is favourable for Crestor 5 mg or Crestor 10 mg as alternative start doses.
P i volb zahajovací dávky u jednotlivých pacient by se m ly zohlednit aspekty ú innosti
The choice of start dose in the individual patient should take into account aspects of efficacy and safety, as detailed in the SPC.
6 P ÍLOHA III Ř SOUHRN ÚDAJ O P ÍPRAVKU
6 ANNEX III
Ů
AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
Pomocné látky viz bod 6. 1.
For excipients see 6.1.
Kulaté tablety žluté barvy s vyrytým ozna ením „ ZD4522 “ a „ 5 “ na jedné stran a bez ozna ení na druhé stran
Round, yellow coloured, intagliated with'ZD4522 'and '5' on one side and plain on the reverse.
č
4.
Primární hypercholesterolémie (typ IIa v etn heterozygotní familiární hypercholesterolémie) nebo
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non- pharmacological treatments (e. g. exercise, weight reduction) is inadequate.
Homozygotní familiární hypercholesterolémie jako dopln k diety nebo v kombinaci s jinou hypolipidemickou lé bou (nap.
Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e. g.
LDL aferézou), nebo samostatn, pokud se tyto nedoporu ují.
LDL apheresis) or if such treatments are not appropriate.
Dávkování p ípravku je individuální
4.2 Posology and method of administration
v závislosti na cíli lé by a odpov di pacienta na lé bu v souladu s platnými sm rnicemi pro lé bu.
Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment.
Doporu ená po áte ní dávka je 5 nebo 10 mg peroráln jednou denn u pacient, kte í ješt statiny
The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines.
Po áte ní dávka se má
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.
V p ípad pot eby je možné dávku po 4 týdnech podávání
The choice of start dose should take into account the individual patient’ s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (see below).
zvýšit na další dávkovací hladinu (viz bod 5. 1 „ Farmakodynamické vlastnosti “).
A dose adjustment to the next dose level can be made after 4 weeks, if necessary (see Section 5.1 Pharmacodynamic properties).
Tito pacienti mají být
In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses (see Section 4.8 Undesirable effects), a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow- up will be performed (see Section 4.4 Special warnings and precautions).
ě ě kontrola specialisty v p ípad, že se p echází na dávku 40 mg. ř ě ř
Specialist supervision is recommended when the 40 mg dose is initiated.
Crestor lze podávat kdykoliv v pr b hu dne, s jídlem nebo bez jídla. ě ů
Crestor may be given at any time of day, with or without food.
u d tí nebyla hodnocena.
Paediatric use Safety and efficacy have not been established in children.
na malý po et d tí (ve v ku nad 8 rok) s homozygotní formou familiární hypercholesterolémie.
Paediatric experience is limited to a small number of children (aged 8 years or above) with homozygous familial hypercholesterolaemia.
Podávání starším pacient m
Therefore, Crestor is not recommended for paediatric use at this time.
Doporu ená po áte ní dávka u pacient > 70 let je 5 mg (viz bod 4. 4 „ Zvláštní upozorn ní a zvláštní
8 Use in the elderly A start dose of 5 mg is recommended in patients > 70 years (see section 4.4 Special warnings and precautions for use).
Další úpravy dávkování p ípravku s ohledem na v k nejsou pot eba.
No other dose adjustment is necessary in relation to age.
Podávání pacient m s renální insuficiencí ů U pacient s mírným a st edn závažným poškozením ledvin není t eba upravovat dávkování.
Dosage in patients with renal insufficiency No dose adjustment is necessary in patients with mild to moderate renal impairment.
Doporu ená po áte ní dávka u pacient se st edn závažným poškozením ledvin je 5 mg (clearance
The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance < 60 ml/ min).
Dávka 40 mg je kontraindikovaná u pacient se st edn závažným poškozením ledvin.
The 40 mg dose is contraindicated in patients with moderate renal impairment.
U pacient s t žkým poškozením ledvin je podávání p ípravku kontraindikované pro všechny
The use of Crestor in patients with severe renal impairment is contraindicated for all doses.
ů ě dávky (viz bod 4. 3 „ Kontraindikace “ a bod 5. 2 „ Farmakokinetické vlastnosti “).
(See Section 4.3 Contraindications and Section 5.2 Pharmacokinetic properties).
Podávání pacient m s hepatální insuficiencí ů U pacient s Child- Pughovým skóre 7 a mén nebylo zaznamenáno žádné zvýšení systémové expozice ů ě
Dosage in patients with hepatic impairment There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below.
Toto zvýšení však bylo pozorováno u pacient s Child- Pughovým skóre 8 a 9 (viz bod 5. 2.
However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9 (see Section 5.2 Pharmacokinetic properties).
U t chto pacient je t eba posoudit funkci ledvin (viz bod 4. 4.
In these patients an assessment of renal function should be considered (see Section 4.4 Special warnings and special precautions for use).
ě „ Zvláštní upozorn ní a zvláštní opat ení pro použití “).
There is no experience in subjects with Child-Pugh scores above 9.
„ Kontraindikace “). ě
Crestor is contraindicated in patients with active liver disease (see Section 4.3 Contraindications).
Doporu ená
Race 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).
po áte ní dávka u pacient japonského a ínského p vodu je 5 mg.
The recommended start dose is 5 mg for patients of Japanese and Chinese ancestry.
Dávka 40 mg je kontraindikována u
The 40 mg dose is contraindicated in Japanese and Chinese patients (see sections 4.3 Contraindications and 5.2 Pharmacokinetic properties).
Doporu ená po áte ní dávka u pacient s predispozicí k myopatii je 5 mg (viz bod 4. 4 „ Zvláštní
Dosage in patients with pre-disposing factors to myopathy The recommended start dose is 5 mg in patients with predisposing factors to myopathy (see Section 4.4 Special warnings and special precautions for use).
„ Kontraindikace “).
The 40 mg dose is contraindicated in some of these patients (see Section 4.3 Contraindications).
Crestor je kontraindikován u pacient:
Crestor is contraindicated:
s p ecitliv lostí na rosuvastatin a kteroukoliv složku p ípravku ř ě s aktivním onemocn ním jater, v etn p etrvávající nevysv tlené zvýšené koncentrace ě č ř ě sérových transamináz a p i zvýšení transamináz nad trojnásobek horní hranice normy (ULN) ř
in patients with hypersensitivity to rosuvastatin or to any of the excipients. in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
se závažným poškozením ledvin (clearance kreatininu < 30 ml/ min) s myopatií kte í užívají cyklosporin ř
in patients with severe renal impairment (creatinine clearance < 30 ml/ min). in patients with myopathy. in patients receiving concomitant cyclosporin. during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.
Dávka 40 mg je kontraindikována u pacient s predispozicí k myopatii/ rhabdomyolýze, jako jsou ů následující faktory:
Such factors include:
-
- - - - - - - -
st edn závažné poškození ledvin (clearance kreatininu < 60 ml/ min) ř ě
moderate renal impairment (creatinine clearence < 60 ml/ min) hypothyroidism personal or family history of hereditary muscular disorders previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate alcohol abuse situations where an increase in plasma levels may occur Japanese and Chinese patients concomitant use of fibrates.
(Viz bod 4. 4 „ Zvláštní upozorn ní a zvláštní opat ení pro použití “, bod 4. 5 „ Interakce s jinými lé ivými
(See sections 4.4 Special warnings and special precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction and 5.2 Pharmacokinetic properties).
4. 4 Zvláštní upozorn ní a zvláštní opat ení pro použití Ú inky na ledviny č
4.4 Special warnings and special precautions for use
U pacient, kterým byl podáván Crestor ve vyšších dávkách, p edevším 40 mg, byla p i vyšet ení mo i
Renal Effects 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.
p echodného charakteru a nevedl k akutnímu i progresivnímu onemocn ní ledvin (viz. bod 4. 8. ř „ Nežádoucí ú inky “).
Proteinuria has not been shown to be predictive of acute or progressive renal disease (see Section 4.8 Undesirable effects).
U pacient lé ených dávkou 40 mg je vhodné zvážit za azení sledování funkce
An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.
Ú inky na kosterní sval č P i podávání p ípravku Crestor ve všech dávkách, zvlášt pak p i dávce > 20 mg byly hlášeny nežádoucí
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.
Pokud jsou hodnoty CK významn zvýšené
Creatine Kinase Measurement 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.
ů (> 5xULN), je t eba test opakovat v pr b hu 5- 7 dní.
If CK levels are significantly elevated at baseline (> 5xULN) a confirmatory test should be carried out within 5 – 7 days.
Jestliže opakovaný test potvrdí CK > 5xULN, lé ba
If the repeat test confirms a baseline CK > 5xULN, treatment should not be started.
P ed lé bou ř č Crestor, podobn jako jiné inhibitory reduktázy HMG- CoA, je t eba p edepisovat s opatrností pacient m
Before Treatment Crestor, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/ rhabdomyolysis.
ě ů č klinické monitorování.
Such factors include:
V pr b hu lé by
- renal impairment
ě ů
- hypothyroidism
č
- personal or family history of hereditary muscular disorders
Pacienty je t eba požádat, aby okamžit hlásili nevysv tlitelné bolesti sval nebo svalovou slabost a
- previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
ř
- alcohol abuse
ě ě
- age > 70 years
U t chto pacient je t eba stanovit č ř
- situations where an increase in plasma levels may occur (see section 5.2 Pharmacokinetic
ě ě
properties)
hladinu kreatinkinázy.
- concomitant use of fibrates.
5xULN), je t eba lé bu p ípravkem Crestor p erušit.
In such patients the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended.
Až se p íznaky a hodnoty CK upraví, je t eba
If CK levels are significantly elevated at baseline (> 5xULN) treatment should not be started.
zvážit op tovné nasazení terapie p ípravkem Crestor, nebo alternativním inhibitorem HMG- CoA
Whilst on Treatment Patients should be asked to report inexplicable muscle pain, weakness or cramps immediately, particularly if associated with malaise or fever.
reduktázy v nejnižší dávce a d kladn pacienta sledovat.
CK levels should be measured in these patients.
Není pot eba pravidelné sledování hodnot CK u asymptomatických pacient.
Therapy should be discontinued if CK levels are markedly elevated (> 5xULN) or if muscular symptoms are severe and cause daily discomfort (even if CK levels are 5x ULN).
V klinickém hodnocení p ípravku na malém po tu pacient nebylo v kombinaci s jinou lé bou
If symptoms resolve and CK levels ≤ return to normal, then consideration should be given to re-introducing Crestor or an alternative HMG- CoA reductase inhibitor at the lowest dose with close monitoring. Routine monitoring of CK levels in asymptomatic patients is not warranted.
U pacient, kte í užívali jiné inhibitory HMG -
In clinical trials there was no evidence of increased skeletal muscle effects in the small number of patients dosed with Crestor and concomitant therapy.
CoA reduktázy spolu s deriváty kyseliny fibrové v etn gemfibrozilu, s cyklosporinem, kyselinou nikotinovou, azolovými antimykotiky, inhibitory proteáz a makrolidovými antibiotiky, byl pozorován zvýšený výskyt myositidy a myopatií.
However, an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics.
Gemfibrozil zvyšuje riziko myopatie, jestliže se podává soub žn s n kterými inhibitory reduktázy HMG- CoA.
Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors.
P ínos další úpravy
Therefore, the combination of Crestor and gemfibrozil is not recommended.
hladin lipid soub žným podáváním p ípravku Crestor a fibrát nebo niacinu by m l p evýšit
The benefit of further alterations in lipid levels by the combined use of
10
10 Crestor with fibrates or niacin should be carefully weighed against the potential risks of such combinations.
Dávka 40 mg je kontraindikovaná p i soub žném užívání fibrát
The 40 mg dose is contraindicated with concomitant use of a fibrate.
ě (viz bod 4. 5 „ Interakce s jinými lé ivými p ípravky a jiné formy interakce “ a bod 4. 8 „ Nežádoucí
(See Section 4.5 Interaction with other medicinal products and other forms of interaction and Section 4.8 Undesirable effects.)
rhabdomyolýzy (nap. sepse, hypotenze, velké chirurgické zákroky, trauma, závažné metabolické, ř endokrinní a elektrolytové poruchy a nekontrolované k e e).
Crestor should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e. g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures).
Ú inky na játra č Podobn jako u jiných inhibitor reduktázy HMG- CoA je t eba v novat zvýšenou pozornost pacient m,
Liver Effects As with other HMG-CoA reductase inhibitors, Crestor should be used with caution in patients who consume excessive quantities of alcohol and/ or have a history of liver disease.
Lé ba se má p erušit ř
It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment.
U pacient se sekundární hypercholesterolémií zp sobenou hypothyreoidismem, pop. nefrotickým
Crestor should be discontinued or the dose reduced if the level of serum transaminases is greater than 3 times the upper limit of normal.
syndromem, je t eba vylé it základní onemocn ní p ed zapo etím lé by p ípravkem Crestor.
In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with Crestor.
Výsledky farmakokinetických studií ukazují zvýšenou systémovou expozici u japonských a ínských subjekt ve srovnání s p íslušníky bílé (caucasian) rasy (viz bod 4. 2 „ Dávkování a zp sob podání “ a bod
Race 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)
ů ř 5. 2 „ Farmakologické vlastnosti “).
4.5 Interaction with other medicinal products and other forms of interaction
Interakce s jinými lé ivými p ípravky a jiné formy interakce č ř Cyklosporin:
Cyclosporin:
Sou asné podávání p ípravku Crestor a cyklosporinu vedlo k sedminásobnému zvýšení č ř plasmatických koncentrací rosuvastatinu ve srovnání se zdravými dobrovolníky (viz bod 4. 3 „ Kontraindikace “).
During concomitant treatment with Crestor and cyclosporin, rosuvastatin AUC values were on average 7 times higher than those observed in healthy volunteers (see Section 4.3 Contraindications).
č ř koncentrace cyklosporinu.
Concomitant administration did not affect plasma concentrations of cyclosporin.
Antagonisté vitamínu K:
Vitamin K antagonists:
p ípravkem i zvýšení dávky p ípravku Crestor u pacient sou asn lé ených antagonisty vitaminu K ř
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. warfarin) may result in an increase in International Normalised Ratio (INR).
P erušení lé by p ípravkem nebo snížení dávky m že vést ke
Discontinuation or down- titration of Crestor may result in a decrease in INR.
Za t chto okolností je vhodná kontrola INR. ě
In such situations, appropriate monitoring of INR is desirable.
Gemfibrozil a další p ípravky na snížení lipid:
Gemfibrozil and other lipid-lowering products:
zdvojnásobení hodnot Cmax a AUC rosuvastatinu (viz bod 4. 4 „ Zvláštní upozorn ní a zvláštní pro použití “). ř
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).
interakce s fenofibrátem, avšak mohou nastat farmakodynamické interakce.
Based on data from specific interaction studies no pharmacokinetic relevant interaction with fenofibrate is expected, however a pharmacodynamic interaction may occur.
Gemfibrozil, fenofibrát, další fibráty a dávky niacinu (kyseliny nikotinové), které snižují hladinu lipid (≥1g/ den), zvyšují riziko myopatie p i podávání sou asn s inhibitorem reduktázy HMG- CoA
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.
Dávka 40 mg je
The 40 mg dose is contraindicated with concomitant use of a fibrate (see Section 4.3 Contraindications and Section 4.4 Special warnings and special precautions for use).
Po áte ní dávka u t chto pacient má být také 5 mg.
These patients should also start with the 5 mg dose.
Tento vliv č ř
The simultaneous dosing of Crestor with an antacid suspension containing aluminium and magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%.
Klinický význam této interakce se nezkoumal.
This effect was mitigated when the antacid was dosed 2 hours after Crestor.
P í inou této interakce m že být zvýšení motility tenkého
The clinical relevance of this interaction has not been studied.
11
11 Erythromycin:
Perorální kontraceptiva/ substitu ní hormonální lé ba (HRT):
Concomitant use of Crestor and erythromycin resulted in a 20% decrease in AUC (0-t) and a 30% decrease in Cmax of rosuvastatin.
Sou asné podávání p ípravku Crestor
This interaction may be caused by the increase in gut motility caused by erythromycin.
č č č
Oral contraceptive/ hormone replacement therapy (HRT):
a perorálních kontraceptiv vedlo ke zv tšení AUC etinylestradiolu o 26% a norgestrelu o 34%.
Concomitant use of Crestor and an oral contraceptive resulted in an increase in ethinyl oestradiol and norgestrel AUC of 26% and 34%, respectively.
U pacientek
These increased plasma levels should be considered when selecting oral contraceptive doses.
užívajících soub žn Crestor a substitu ní hormonální lé bu nejsou dostupné farmakokinetické údaje, a
There are no pharmacokinetic data available in subjects taking concomitant Crestor and HRT and therefore a similar effect cannot be excluded.
Tato kombinace se však podávala velkému
However, the combination has been extensively used in women in clinical trials and was well tolerated.
Jiná lé iva:
Other medicinal products:
Na základ údaj získaných z interak ních studií se neo ekává žádná klinicky významná interakce
Based on data from specific interaction studies no clinically relevant interaction with digoxin is expected.
Enzymy cytochromu P450:
Cytochrome P450 enzymes:
Výsledky studií in vitro a in vivo ukázaly, že rosuvastatin není ani inhibitorem, ani induktorem isoenzym cytochromu P450.
Results from in vitro and in vivo studies show that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes.
Krom toho je rosuvastatin slabým
In addition, rosuvastatin is a poor substrate for these isoenzymes.
Mezi rosuvastatinem a flukonazolem (inhibitor CYP2C9 a CYP3A4) nebo ketokonazolem (inhibitor CYP2A6 a CYP3A4) nebyly pozorovány žádné interakce.
No clinically relevant interactions have been observed between rosuvastatin and either fluconazole (an inhibitor of CYP2C9 and CYP3A4) or ketoconazole (an inhibitor of CYP2A6 and CYP3A4).
Sou asné podávání itrakonazolu (inhibitor CYP3A4) a rosuvastatinu vedlo k 28% zvýšení AUC rosuvastatinu.
Concomitant administration of itraconazole (an inhibitor of CYP3A4) and rosuvastatin resulted in a 28% increase in AUC of rosuvastatin.
Lékové interakce v souvislosti s metabolismem zprost edkovaným cytochromem P450 se proto neo ekávají.
Therefore, drug interactions resulting from cytochrome P450-mediated metabolism are not expected.
č
4.6 Pregnancy and lactation
4. 6 T hotenství a kojení ě Crestor se nesmí používat v pr b hu t hotenství a kojení. ě ů ě Ženy ve fertilním v ku musí používat vhodné antikoncep ní metody.
Crestor is contraindicated in pregnancy and lactation.
ě Vzhledem k tomu, že cholesterol a produkty jeho intermediárního metabolismu jsou pro vývoj plodu
Women of child bearing potential should use appropriate contraceptive measures.