natgillin/translations-raw huggingface dataset:
In the Reversing Atherosclerosis with Aggressive Lipid- Lowering Study (REVERSAL), the effect of intensive lipid lowering with atorvastatin 80 mg and standard degree of lipid lowering with pravastatin 40 mg on coronary atherosclerosis was assessed by intravascular ultrasound (IVUS), during angiography, in patients with coronary heart disease.
Morebitne interakcije z drugimi substrati tega izoencima niso znane, vendar jih je treba upoštevati pri drugih zdravilih z nizkim terapevtskim indeksom, npr. pri antiaritmikih iz skupine III, vključno z amiodaronom.
In this randomized, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients.
Rezultati raziskav in vitro kažejo, da gemfibrozil zavira presnovo atorvastatina z glukuronidacijo.
In the atorvastatin group (n=253), there was no progression of atherosclerosis.
To bi lahko povzročilo zvišano koncentracijo atorvastatina v plazmi (glejte tudi poglavje 4. 4).
The median percent change, from baseline, in total atheroma volume (the primary study criteria) was - 0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
Pri določitvi odmerka peroralnih kontraceptivov je treba zvečanje upoštevati.
When compared to pravastatin the effects of atorvastatin were statistically significant (p=0.02).
Holestipol Če je bil holestipol uporabljen sočasno s {(Lastniško) ime}, so bile koncentracije atorvastatina in njegovih aktivnih presnovkov nižje za približno 25%.
The effect of intensive lipid lowering on cardiovascular endpoints (e. g. need for revascularisation, non fatal myocardial infarction, coronary death) was not investigated in this study.
Vendar pa je bil učinek na lipide večji, če sta bila {(Lastniško) ime} in holestipol uporabljena skupaj, kot če je bilo vsako zdravilo uporabljeno posebej.
In the atorvastatin group, LDL-C was reduced to a mean of 2.04 mmol/ l ± 0.8 (78.9 mg/ dl ± 30) from baseline 3.89 mmol/ l ± 0.7 (150 mg/ dl ± 28) and in the pravastatin group, LDL-C was reduced to a mean of 2.85 mmol/ l ± 0.7 (110 mg/ dl ± 26) from baseline 3.89 mmol/ l ± 0.7 (150 mg/ dl ± 26) (p < 0.0001).
Antacidi Sočasna uporaba {(Lastniško) ime} s peroralno antacidno suspenzijo, ki je vsebovala magnezijev in aluminijev hidroksid, je zmanjšala plazemsko koncentracijo atorvastatina in njegovih aktivnih presnovkov v plazmi za približno 35%, vendar na znižanje holesterola LDL ni vplivala.
Atorvastatin also significantly reduced mean TC by 34.1% (pravastatin: -18.4%, p < 0.0001), mean TG levels by 20% (pravastatin: -6.8%, p < 0.0009), and mean apolipoprotein B by 39.1% (pravastatin: -22.0%, p < 0.0001).
Varfarin 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}.
Atorvastatin increased mean HDL-C by 2.9% (pravastatin: +5.6%, p=NS).
Kljub temu je treba bolnike, ki dobivajo varfarin, po dodatku {(Lastniško) ime} v terapijo natančno nadzorovati.
There was a 36.4% mean reduction in CRP in the atorvastatin group compared to a 5.2% reduction in the pravastatin group (p < 0.0001).
Fenazon Sočasna uporaba večkratnih odmerkov {(Lastniško) ime} in fenazona je na očistek fenazona vplivala malo ali nič.
Study results were obtained with the 80 mg dose strength.
43 Cimetidin Raziskava interakcij cimetidina in {(Lastniško) ime} ni pokazala nobenega medsebojnega delovanja.
Therefore, they cannot be extrapolated to the lower dose strengths.
Amlodipin Sočasna uporaba 80 mg atorvastatina in 10 mg amlodipina v stanju dinamičnega ravnovesja ni spremenila farmakokinetike atorvastatina.
The safety and tolerability profiles of the two treatment groups were comparable.
Drugo V kliničnih raziskavah, v katerih so {(Lastniško) ime} uporabljali hkrati z antihipertenzivi ali antidiabetiki, niso ugotovili klinično pomembnih interakcij.
Acute coronary syndrome
4. 6 Nosečnost in dojenje
In the MIRACL study, atorvastatin 80 mg has been evaluated in 3,086 patients (atorvastatin n=1,538; placebo n=1,548) with an acute coronary syndrome (non Q-wave MI or unstable angina).
{(Lastniško) ime} je med nosečnostjo in dojenjem kontraindiciran.
Treatment was initiated during the acute phase after hospital admission and lasted for a period of 16 weeks.
Varnost atorvastatina med nosečnostjo in dojenjem ni dokazana.
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).
Če so breje samice dobivale atorvastatin v odmerkih nad 20 mg/ kg/ dan (klinična sistemska izpostavljenost), je bil razvoj mladičev upočasnjen, preživetje neposredno po rojstvu pa manjše.
This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with
Ni znano, ali se to zdravilo ali njegovi presnovki pri ljudeh človeku izločajo v materinem mleku.
49 evidence of myocardial ischaemia (p=0.018).
{(Lastniško) ime} ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The other secondary endpoints did not reach statistical significance on their own (overall:
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).
Placebo:
Bolezni prebavil
22.2%, Atorvastatin:
Občasno: anoreksija, bruhanje.
22.4%).
Občasno: trombocitopenija.
The safety profile of atorvastatin in the MIRACL study was consistent with what is described in Section 4.8.
Zelo redko: anafilaksija.
Prevention of cardiovascular disease
44 Bolezni endokrinega sistema
Patients were hypertensive, 40-79 years of age, with no previous myocardial infarction or treatment for angina, and with TC levels ≤ 6.5 mmol/ l (251 mg/ dl).
Občasno: alopecija, hiperglikemija, hipoglikemija, pankreatitis.
All patients had at least 3 of the pre-defined cardiovascular risk factors: male gender, age ≥ 55 years, smoking, diabetes, history of CHD in a first-degree relative, TC: HDL-C > 6, peripheral vascular disease, left ventricular hypertrophy, prior cerebrovascular event, specific ECG abnormality, proteinuria/ albuminuria.
Psihiatrične motnje
Not all included patients were estimated to have a high risk for a first cardiovascular event.
Občasno: amnezija.
Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5,168) or placebo (n=5,137).
Pogosto: glavobol, omotica, parestezije, hipestezija Nepogoste: periferna nevropatija.
The absolute and relative risk reduction effect of atorvastatin was as follows:
Redko: hepatitis, holestatski ikterus.
Relative Risk
Bolezni kože in podkožja
No. of Events (Atorvastatin
Občasno: urtikarija.
Absolute Risk
Ušesne bolezni, vključno z motnjami labirinta
Reduction
Občasno: tinitus
vs Placebo)
Občasno: miopatija.
Reduction1
Motnje reprodukcije in dojk
Event
Občasno: impotenca.
(%)
Splošne težave
(%)
Občasno: slabo počutje, zvečanje telesne mase.
p-value
Preiskave
Fatal CHD plus non-fatal MI Total cardiovascular events and revascularization procedures Total coronary events
Klinično pomembno zvišanje (> 3- kratna ZNM) serumskih transaminaz se je pojavilo pri 0, 8% bolnikov, ki so jemali {(Lastniško) ime}.
36% 20%
Zvišanje nad 10- kratno ZNM se je pojavilo pri 0, 4% bolnikov, zdravljenih s {(Lastniško) ime} (glejte poglavje 4. 4).
483
45 4. 9 Preveliko odmerjanje
1.1% 1.9%
Ker se atorvastatin v veliki meri veže na beljakovine v plazmi, ni pričakovati, da bi hemodializa pomembno zvečala njegov očistek.
0.0005 0.0008
5 FARMAKOLOŠKE LASTNOSTI
1
5. 1 Farmakodinamične lastnosti
178 vs 247
To velja tako za bolnike s heterozigotno familiarno hiperholesterolemijo, kot za tiste z nefamiliarno hiperholesterolemijo in mešano hiperlipidemijo, vključno z diabetiki tipa 2.
1.4%
Raziskave obolevnosti in umrljivosti z atorvastatinom še niso končane.
0.0006
Ateroskleroza
Based on difference in crude events rates occurring over a median follow-up of 3.3 years.
Preiskavo z IVUZ so v tej randomiziranem, dvojno slepem, multicentričnem kontroliranem kliničnem preskušanju opravili pri 502 bolnikih, in sicer na začetku in po 18 mesecih.
CHD = coronary heart disease; MI = myocardial infarction.
V skupini z atorvastatinom (n=253) ateroskleroza ni napredovala.
Total mortality and cardiovascular mortality were not significantly reduced (185 vs.
Učinki atorvastatina so bili v primerjavi z učinki pravastatina statistično pomembni (p=0, 02).
212 events, p=0.17 and 74 vs.
Atorvastatin je tudi pomembno znižal povprečni celotni holesterol za 34, 1% (pravastatin: – 18, 4%, p < 0, 0001), povprečno koncentracijo trigliceridov za 20% (pravastatin: – 6, 8%, p < 0, 0009) in povprečni apolipoprotein B za 39, 1% (pravastatin: – 22, 0%, p < 0, 0001).
82 events, p=0.51).
Atorvastatin je zvišal povprečni holesterol HDL za 2, 9% (pravastatin: +5, 6%, p=NZ).
In the subgroup analyses by gender (81% males, 19% females), a beneficial effect of atorvastatin was seen in males but could not be established in females possibly due to the low event rate in the female subgroup.
V skupini z atorvastatinom se je CRP v povprečju znižal za 36, 4%, vskupini s pravastatinom pa za 5, 2% (p < 0, 0001).
Overall and cardiovascular mortality were numerically higher in the female patients (38 vs.
Kar zadeva varnost in prenašanje obeh zdravil, sta bili skupini primerljivi.
30 and 17 vs.
Akutni koronarni sindrom
12), but this was not statistically significant.
Z zdravljenjem so pričeli med akutno fazo po sprejemu v bolnišnico in je trajalo 16 tednov.
There was significant treatment interaction by antihypertensive baseline therapy.
Razlog za to je bilo predvsem 26- odstotno zmanjšanje števila ponovnih hospitalizacij zaradi angine pektoris z znaki ishemije miokarda (p=0, 018).
The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with Amlodipine (HR 0.47 (0.32-0.69), p=0.00008), but not in those treated with Atenolol (HR 0.83 (0.59-1.17), p=0.287).
Ostali sekundarni opazovani dogodki sami niso bili statistično pomembni (skupno: placebo 22, 2%, atorvastatin 22, 4%).
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤ 4.14 mmol/ l (160 mg/ dl) and TG ≤ 6.78 mmol/ l (600 mg/ dl).
Bolniki so bili hipertenzivni, stari od 40 do 79 let, pred tem niso imeli miokardnega infarkta, se niso zdravili zaradi angine pektoris in so imeli koncentracijo trigliceridov ≤ 6, 5 mmol/ l (251 mg/ dl).
All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Vsi bolniki so imeli vsaj 3 od naslednjih, vnaprej določenih dejavnikov kardiovaskularnega tveganja: moški spol, starost ≥ 55 let, kajenje, diabetes, anamnezo koronarne bolezni pri sorodniku v prvem kolenu, razmerje trigliceridi: HDL > 6, periferno žilno bolezen, hipertrofijo levega prekata, predhoden cerebrovaskularni dogodek, specifične nenormalnosti EKG ali proteinurijo/ albuminurijo.
Patients were treated with either atorvastatin 10 mg daily (n=1428) or placebo (n=1410) for a median follow-up of 3.9 years
Bolnike so zdravili z antihipertenzivno terapijo (program na podlagi amlodipina ali atenolola) ter bodisi z 10 mg atorvastatina na dan (n=5168), bodisi s placebom (n=5137).
Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA, revascularization, stroke)
CHD s smrtnim izidom in MI brez smrtnega izida
127
100 v primerjavi s 154
MI (fatal and non-fatal AMI, silent MI)
Skupno število ardiovaskularnih dogodkov in revaskularizacij
38 vs 64
389 v primerjavi s 483
Strokes (Fatal and non-fatal) 1
Skupno število koronarnih dogodkov 1
39
178 v primerjavi s 247
AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CHD = coronary heart disease; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3, 3 leta; CHD = koronarna bolezen; MI = miokardni infarkt.
There was no evidence of a difference in the treatment effect by patient’ s gender, age, or baseline LDL-C level.
Celotna umrljivost in kardiovaskularna umrljivost se nista pomembno zmanjšali (185 dogodkov v primerjavi z 212, p=0, 17, in 74 dogodkov v primerjavi z 82, p=0, 51).
A favourable trend was observed regarding the mortality rate (82 deaths in the placebo group vs.
V analizi podskupin po spolu (81% moških, 19% žensk) so ugoden učinek atorvastatina na glavni opazovani dogodek potrdili pri moških, ne pa tudi pri ženskah, verjetno zato, ker je bila pogostost dogodkov v ženski podskupini manjša.
61 deaths in the atorvastatin group, p=0.0592).
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.
5.2 Pharmacokinetic properties
Opazili so pomembno interakcijo z zdravljenjem glede na izhodiščno antihipertenzivno terapijo.
Extent of absorption increases in proportion to atorvastatin dose.
Učinek atorvastatina na kardiovaskularne bolezni s smrtnim izidom in brez njega so ocenili tudi v randomiziranem, dvojno slepem, multicentričnem, s placebom kontroliranem preskušanju CARDS (Collaborative Atorvastatin Diabetes Study), ki je vključevalo bolnike z diabetesom tipa 2, stare od 40 do 75 let, brez anamneze predhodne kardiovaskularne bolezni ter s koncentracijo holesterola LDL 4, 14 mmol/ l (160 mg/ dl) in trigliceridov ≤ 6, 78 mmol/ l (600 mg/ dl).
After oral administration, atorvastatin film-coated tablets are 95% to 99% bioavailable compared to the oral solution.
Vsi bolniki so imeli vsaj enega od naslednjih dejavnikov tveganja: hipertenzija, kajenje v času preskušanja, retinopatija, mikroalbuminurija ali makroalbuminurija.
The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.
Bolnike so zdravili bodisi z atorvastatinom 10 mg na dan (n=1428), bodisi s placebom (n=1410); povprečno spremljanje je trajalo 3, 9 leta.
The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/ or hepatic first-pass metabolism
Učinek atorvastatina na absolutno in relativno zmanjšanje tveganja je bil naslednji:
Distribution
relativno
Atorvastatin is ≥ 98% bound to plasma proteins.
št. dogodkov
Metabolism
absolutno
Atorvastatin is metabolized by cytochrome P450 3A4 to ortho- and parahydroxylated derivatives and various beta-oxidation products.
zmanjšanje
Excretion
(atorvastatin v
Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours.
zmanjšanje tveganja1
Special populations
tveganja (%)
51 − Geriatric:
primerjavi s
20% higher for Cmax and approx.
dogodek
10% lower for AUC).
placebom)
16-fold in Cmax and approx.
(%) vrednost p
11-fold in AUC) in patients with chronic alcoholic liver disease (Childs-Pugh B).
Pomembni kardiovaskularni dogodki (AMI s smrtnim izidom in brez njega, nemi MI, akutna smrt zaradi koronarne bolezni, nestabilna angina pektoris, CABG, PTCA, revaskularizacija, možganska kap)
5.3 Preclinical safety data
83 v primerjavi 127
Atorvastatin was not carcinogenic in rats.
MI (AMI s smrtnim izidom in brez njega, nemi MI)
The maximum dose used was 63-fold higher than the highest human dose (80 mg/ day) on a mg/ kg body-weight basis and 8- to 16-fold higher based on AUC(0-24) values as determined by total inhibitory activity.
42%
52 6.
38 v
6.1 List of excipients
primerjavi s 64
Calcium carbonate Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Polysorbate 80 Hyprolose Magnesium stearate
1, 9%
Hypromellose Polyethylene glycol Titanium dioxide (E171) Talc Simethicone Stearate emulsifiers Sorbic acid Candelilla wax
Možganske kapi (s smrtnim izidom in brez njega) 1
6.2 Incompatibilities
48%
Not applicable
21 v
6.3 Shelf life
primerjavi s 39
6.4 Special precautions for storage
Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3, 9 leta.
This medicinal product does not require any special storage conditions.
Opažen je bil ugoden trend glede na stopnjo smrtnosti (82 smrti v skupini s placebom, 61 smrti v skupini z zdravljenjem, p=0, 0592).
6.5 Nature and contents of container
5. 2 Farmakokinetične lastnosti
Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 and 100 film-coated tablets.
Atorvastatin se po peroralni uporabi hitro absorbira; največjo koncentracijo v plazmi (Cmax) doseže v 1 do 2 urah.
Hospital packs containing 200 (10 x 20) or 500 film-coated tablets.
Delež absorpcije se povečuje sorazmerno z odmerkom atorvastatina.
The blisters consist of a forming film made of polyamide/ aluminum foil/ polyvinyl chloride and a backing made of either paper/ polyester/ aluminum foil/ vinyl heat-seal coating or aluminum foil/ vinyl heat-seal coating.
Atorvastatin je ≥ 98% vezan na beljakovine v plazmi.
Not all pack sizes may be marketed.
Poleg drugih poti poteka nadaljnja presnova teh produktov tudi z glukuronidacijo.
6.6 Special precautions for disposal
Izločanje
No special requirements
Kot kaže, zdravilo nima pomembne enterohepatične recirkulacije.
MARKETING AUTHORISATION HOLDER
Posebne populacije – Starejši:
< [To be completed nationally] >
49 5. 3 Predklinični podatki o varnosti
< [See Annex I - To be completed nationally] > [For referral procedures]
Glede na AUC( 0- 24) je bila sistemska izpostavljenost od 6 - do 11- krat večja.
{Name and address }< {tel }> < {fax }> < {e-mail }>
6 FARMACEVTSKI PODATKI
MARKETING AUTHORISATION NUMBER(S)
6. 1 Seznam pomožnih snovi
< [To be completed nationally] >
Filmska obloga
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
hipromeloza polietilenglikol titanov dioksid (E171) smukec simetikon stearatni emulgatorji sorbinska kislina kandelila vosek
< {DD/MM/YYYY} > < {DD month YYYY} >
6. 2 Inkompatibilnosti
< [To be completed nationally] >
Navedba smiselno ni potrebna.
DATE OF REVISION OF THE TEXT
6. 3 Rok uporabnosti
54 1.
3 leta
NAME OF THE MEDICINAL PRODUCT
6. 4 Posebna navodila za shranjevanje
< [See Annex I - To be completed nationally] > [For referral procedures] {PRODUCT NAME} 80mg film-coated tablet
Za shranjevanje zdravila niso potrebna posebna navodila.
QUALITATIVE AND QUANTITATIVE COMPOSITION
6. 5 Vrsta ovojnine in vsebina
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Bolnišnična pakiranja z 200 (10 x 20) ali 500 filmsko obloženimi tabletami.
Excipients:
50 Na trgu ni vseh navedenih pakiranj.
Each {PRODUCT NAME} 80 mg film-coated tablet contains 262.44 mg lactose monohydrate.
6. 6 Navodila za uporabo in ravnanje z zdravilom
For a full list of excipients, see section 6.1.
Ni posebnih zahtev.
PHARMACEUTICAL FORM
[Izpolni država članica]
Film-coated tablet White elliptical, film-coated tablets debossed "80" on one side and "PD 158" on the other.
< [Glejte Dodatek I - Izpolni država članica] > [For referral procedures]
CLINICAL PARTICULARS
8 ŠTEVILKA DOVOLJENJA ZA PROMET
4.1 Therapeutic indications
[Izpolni država članica]
Hypercholesterolaemia
21. 11. 1996 / 31. 10. 2001
{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
51 1 IME ZDRAVILA
{PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e. g.
< [Glejte Dodatek I - Izpolni država članica] > [For referral procedures] {(Lastniško) ime} 80 mg filmsko obložene tablete
Prevention of cardiovascular disease
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA
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.
1 filmsko obložena tableta vsebuje 80 mg atorvastatina (v obliki kalcijeve soli trihidrata).
4.2 Posology and method of administration
Pomožne snovi:
The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Vsaka {(Lastniško) ime} 80 mg filmsko obložena tableta vsebuje 262. 44 mg laktoze monohidrata.
Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
The usual starting dose is 10 mg once a day.
3 FARMACEVTSKA OBLIKA
Adjustment of dosage should be made at intervals of 4 weeks or more.
4 KLINIČNI PODATKI
The maximum dose is 80 mg once a day.
4. 1 Terapevtske indikacije
Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Preprečevanje kardiovaskularnih bolezni
55 For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/ l (or < 115 mg/ dl) and total cholesterol < 5 mmol/ l (or < 190 mg/ dl).
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.
Adapted from “ Prevention of coronary heart disease in clinical practice:
4. 2 Odmerjanje in način uporabe
Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention” in Atherosclerosis 140 (1998) 199-270.
Pred začetkom zdravljenja s {(Lastniško) ime} je treba bolniku predpisati standardno dieto za znižanje holesterola, ki jo mora nadaljevati tudi med zdravljenjem s {(Lastniško) ime}.
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
Odmerjanje je treba določiti posamezno glede na izhodiščno koncentracijo holesterola LDL, cilj zdravljenja in bolnikov odziv.
The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Običajni začetni odmerek je 10 mg enkrat na dan.
A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks.
Odmerjanje je treba prilagajati v presledku 4 tednov ali več.
The response is maintained during chronic therapy.
Največji odmerek je 80 mg enkrat na dan.
Heterozygous familial hypercholesterolaemia
Primarna hiperholesterolemija in kombinirana (mešana) hiperlipidemija
Patients should be started with {PRODUCT NAME} 10 mg daily.
Pri večini bolnikov se stanje uredi z 10 mg {(Lastniško) ime} enkrat na dan.
Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
Terapevtski odziv je opazen že v 2 tednih, največji odziv pa se ponavadi pokaže v 4 tednih.
Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Odziv se med kroničnim zdravljenjem ohrani.
Homozygous familial hypercholesterolaemia
Heterozigotna familiarna hiperholesterolemija
In a compassionate-use study of 64 patients there were 46 patients for whom confirmed LDL receptor information was available.
Zdravljenje je treba začeti z 10 mg {(Lastniško) ime} na dan.
From these 46 patients, the mean percent reduction in LDL-C was approximately 21%.
Odmerke je treba določiti posamezno in jih prilagajati vsake 4 tedne, do odmerka 40 mg na dan.
Atorvastatin was administered at doses up to 80 mg/ day.
Potem je mogoče bodisi zvečati odmerek do največ 80 mg na dan bodisi atorvastatin v odmerku 40 mg uporabiti v kombinaciji z adsorbentom žolčnih kislin.