natgillin/translations-raw huggingface dataset:
Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg- Filmtabletten Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30, 60, 90, 120 mg 41
This leaflet was last approved in (MM/ YYYY).
Dánia Arcoxia Észtország Finnország Franciaország Németország Görögország Magyarország Izland Írország Olaszország Lettország Litvánia Luxemburg Málta Hollandia Norvégia Lengyelország Portugália Románia Szlovákia Szlovénia Spanyolország Svédország
40 ANNEX IV
Arcoxia Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Arcoxia 30 mg, comprimé pelliculé ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten ARCOXIA 30mg, 60mg, 90mg, 120mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta Arcoxia Arcoxia 30, 60, 90 or 120 mg film- coated tablets Arcoxia 30, 60, 90, 120 mg compresse rivestite con film Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA 30, 60, 90 or 120 mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg Arcoxia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko obložene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter
CONDITIONS OF THE MARKETING AUTHORISATION
Egyesült Királyság:
41 CONDITIONS OF THE MARKETING AUTHORISATION
ARCOXIA 30, 60, 90 or 120 mg film- coated tablets
- A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals
A betegtájékoztató engedélyezésének dátuma (HH/ ÉÉÉÉ):
42
42 IV.
London, 23 October 2008 EMEA/ 438258/ 2008
EMEA/ CHMP/ 619558/ 2008
International non-proprietary name (INN): etoricoxib
Nemzetközi szabadnév (INN): etoricoxib
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Az etorikoxib a COX- 2 (cyklooxigenáz- 2) szelektív inhibitora, amely az osteoarthritis (OA, naponta egyszer 30- 60 mg), a reumás arthritis (RA, naponta egyszer 90 mg), valamint az akut arthritis uricához társuló fájdalom és gyulladás (naponta egyszer 120 mg) tüneti enyhítésére javallt.
This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Ez a beterjesztési eljárás a II. típusú változatra vonatkozó döntőbírósági eljárás iránti kérelemmel kapcsolatos, melynek tárgya a javallatnak a spondylarthritis ankylopoetica (AS) 90 mg- os napi ajánlott adag melletti kezelésére való kiterjesztése.
At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication.
A kölcsönös elismerési eljárást követően az Európai Unió (EU) tagállamai között nézeteltérés mutatkozott az új javallatban szereplő etorikoxib 90 mg- os adagjának biztonságosságát illetően.
As these concerns were not resolved during the course of the procedure, a notification of an official referral for arbitration under Article 6(12) of Commission Regulation EC No 1084/ 2003 to the CHMP was made by France on 19 September 2007.
Mivel ezeket az aggályokat az eljárás során nem tisztázták, Franciaország 2007. szeptember 19- én a 1084/ 2003/ EK bizottsági rendelet 6. cikk (12) bekezdése értelmében hivatalos döntőbírósági beterjesztésről szóló értesítést készített.
The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the ankylosing spondylitis (AS) indication.
A Franciaország által azonosított, főbb aggodalomra okot adó és nem tisztázott kérdések az etorikoxib 90- mg- os napi adagjának hosszú távú biztonságosságára vonatkoztak a spondylarthritis ankylopoetica (AS) javallatában szereplő 90 mg- os napi adag használatához társuló lehetséges, illetve fokozott szív - és érrendszeri kockázat figyelembevételével.
France considered that a review of the benefit/ risk profile of Arcoxia was needed.
Franciaország úgy ítélte meg, hogy szükség van az Arcoxia haszon/ kockázat profiljának felülvizsgálatára.
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr.
A döntőbírósági eljárást a CHMP 2007. szeptemberi plenáris ülésén megvitatták, és egy előadót (dr.
Karl Broich) and Co-Rapporteur (Dr.
Karl Broich), valamint társelőadót (dr.
Matthew Thatcher) were appointed.
Matthew Thatcher) jelöltek ki.
The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
A beterjesztési eljárás 2007. szeptember 20- án kezdődött a forgalomba hozatali engedély jogosultjaihoz szóló kérdések listájának a CHMP általi elfogadásával.
During the February 2008 plenary meeting Dr.
A 2008. februári plenáris ülésen dr.
Rafe Survana was appointed Co-Rapporteur, replacing Dr.
Rafe Survanát nevezték ki társelőadónak, aki dr.
Matthew Thatcher.
Matthew Thatchert váltotta fel.
Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
A forgalomba hozatali engedélyek jogosultjai 2007. december 14- én, 2008. május 5- én, 2008. június 12- én és 2008. június 20- án nyújtottak be írásbeli magyarázatokat.
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Az adatok megerősítették továbbá, hogy a szív - és érrendszeri trombózissal kapcsolatos kockázatok a diklofenákhoz hasonlóak, és a gyomor- bélrendszer felső szakaszát érintő biztonság a naproxenhez és a diklofenákhoz képest valamivel előnyösebb (bár a gyomor- bélrendszer alsó szakaszát illetően nem áll fenn kifejezett biztonsági előny).
Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
A diklofenákon és a naproxenen kívül más különálló nem szteroid gyulladáscsökkentő szerrel (NSAID) kapcsolatban kevés közvetlen összehasonlító biztonsági adat állt rendelkezésre.
The CHMP therefore recommended the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially
Ezért az etorikoxib kockázatait nehéz volt az ibuprofenhez, ketoprofenhez vagy más, kevésbé elterjedt NSAID- hez viszonyítva meghatározni.
Reproduction is authorised provided the source is acknowledged. within 2 weeks of treatment initiation.
Reproduction is authorised provided the source is acknowledged.
The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
A CHMP ezért javasolta, hogy dózis- meghatározó vizsgálatokban tárják fel, hogy bizonyos betegeknél a naponta egyszer 60 mg adaggal végzett kezelés szintén megfelelő lenne- e.
On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
A CHMP a forgalomba hozatali engedélyek jogosultjai által benyújtott adatok mérlegelése után 2008. június 26- án a forgalomba hozatali engedélyek módosítását javasolta.
The list of product names concerned is given in Annex I.
Az érintett termékek neveinek felsorolása az I. mellékletben található.
The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
A tudományos következtetések a II. mellékletben, a módosított terméktájékoztató a III. mellékletben, a forgalomba hozatali engedély feltételei pedig a IV. mellékletben találhatók.
The final opinion was converted into a decision by the European Commission on 9 September 2008.
A végleges véleményt az Európai Bizottság 2008. szeptember 9- i határozata tartalmazza.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
A jelen dokumentumban és mellékleteiben szereplő információk a CHMP 2008. június 26- i véleményét tükrözik.
The Member States’ competent authorities will continue to keep the product under regular review.
A tagállamok illetékes hatóságai folytatják a készítmény rendszeres felülvizsgálatát.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
NÉV, GYÓGYSZERFORMA, GYÓGYSZERKÉSZÍTMÉNY- DÓZISOK, ALKALMAZÁSI MÓD, KÉRELMEZŐK, FORGALOMBA HOZATALI ENGEDÉLY JOGOSULTJAI A TAGÁLLAMOKBAN
1 Member State Austria Austria Austria Austria Belgium Belgium Belgium Belgium Denmark Denmark Denmark Denmark Finland Finland Finland Finland Germany Germany Germany Germany Greece Greece
1 Tagállam Ausztria
Marketing Authorisation Holder Pfizer Corporation Austria Ges. m. b. H.
Forgalomba hozatali engedély jogosultja Pfizer Corporation Austria Ges. m. b. H.
Pfizer S. A.
Filmtabletta
Pfizer S. A.
Belgium
Invented name Sortis Sortis Sortis Sortis Lipitor Lipitor Lipitor Lipitor Zarator Zarator Zarator Zarator Lipitor Lipitor Lipitor Lipitor Sortis Sortis Sortis Sortis Lipitor Lipitor
Lipitor
Strength 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg
10mg
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmtabletta
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Oralis alkalmazás
2 Member State Greece Greece Italy Italy Italy Italy Luxembourg Luxembourg Luxembourg Luxembourg Netherlands Netherlands Netherlands Netherlands Portugal Portugal Portugal Portugal Spain Spain Spain Spain
Belgium
Pfizer S. A.
Lipitor
PARKE-DAVIS, S. L.
Oralis alkalmazás
PARKE-DAVIS, S. L.
Belgium
PARKE-DAVIS, S. L.
Pfizer S. A.
Invented name Lipitor Lipitor Xarator Xarator Xarator Xarator Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Zarator Zarator Zarator Zarator Zarator Zarator Zarator Zarator
Lipitor
Strength 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg
40mg
3 Member State Sweden Sweden Sweden Sweden
Belgium
Marketing Authorisation Holder Pfizer AB Pfizer AB Pfizer AB Pfizer AB
Pfizer S. A.
Invented name Lipitor Lipitor Lipitor Lipitor
Lipitor
Strength 10mg 20mg 40mg 80mg
80mg
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmtabletta
Route of administration Oral use Oral use Oral use Oral use
Oralis alkalmazás
4 ANNEX II
Dánia
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Pfizer ApS
5 SCIENTIFIC CONCLUSIONS
Zarator
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATORVASTATIN (Sortis and associated names - see Annex I)
10mg
The currently approved indications for atorvastatin are:
Filmtabletta
- as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein
Oralis alkalmazás
B, and tryglicerides in patients with primary hypercholesterolemia including familial hypercholesterolemia (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.
Dánia
- to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia an
Pfizer ApS
adjunct to other lipid-lowering treatments (e. g.
Zarator
Background information on the type II variation through the MRP In the initial type II variation dossier submitted by MRP, the Applicant claimed the following indication: “ Prevention of cardiovascular events in patients with multiple risk factors (e. g. type 2 diabetics with one risk factor and hypertensive patients with 3 risk factors) with normal or elevated cholesterol levels but without clinically evident coronary heart disease (CHD )”.
20mg
This wording was based on the results of 2 randomised controlled trials performed with atorvastatin 10 mg for the primary prevention of cardiovascular disease (CVD).
Filmtabletta
In the Final Assessment report (1 November 2005) the Reference Member State proposed, and the MAH agreed to, the following indication: “ Prevention of cardiovascular events in patients with type 2 diabetes and one additional risk factor with normal to mildly elevated cholesterol level without clinically evident coronary heart disease”.
Oralis alkalmazás
thus restricting the indication to the population included in the CARDs trial and relegating the results of the ASCOT-LLA trial to a description in section 5.1. of the SPC, based on the lack of demonstrated efficacy in the female subgroup.
Dánia
At the end of the MRP procedure there was a discrepancy between Member States regarding the wording of the proposed indication that adequately reflects the data of the ASCOT-LLA and CARDS studies, effectively excluding treatment in non-diabetics, and an official referral for arbitration was notified by Spain to the CHMP on 1 December 2005.
Pfizer ApS
1.
Zarator
2.
40mg
3.
Filmtabletta
4.
Oralis alkalmazás
5.
Dánia
Evaluation of Clinical Efficacy
Pfizer ApS
The main issue discussed by the CHMP has been the results of the ASCOT-LLA trial, most importantly the lack of established benefit and adverse mortality trends in the female subgroup and, secondly, the impact of the observed interaction between the antihypertensive amlodipine and atorvastatin on the main trial outcomes for certain subgroups.
80mg
The Applicant has presented arguments for the view that the results for women in ASCOT-LLA based on subgroup analyses are most likely chance findings and are not considered scientifically robust enough to form the basis for regulatory actions.
Filmtabletta
The main concern relates to the “ risk of CVD”.
Oralis alkalmazás
Regarding the interaction observed between atorvastatin and amlodipine, the body of data assessed indicates that this interaction is of questionable clinical relevance, if it exists at all, and does not warrant regulatory action dictating the prescription of the product.
Finnország
The appropriate place for dose
Pfizer Oy
7 recommendations is section 4.2 of the SPC, not section 4.1, and adequate dosing recommendations have been added.
Lipitor
Finally, there has been much discussion regarding the wording of the indication that best reflects the results of the of the assessed trials.
10mg
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.
Filmtabletta
Overall conclusion on benefit/ risk
Oralis alkalmazás
At its meeting of 20-23 March 2006, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that atorvastatin, as an adjunct to correction of other risk factors, was effective in the prevention of CV events in patients estimated to have a high risk for a first CV event.
Finnország
The CHMP recommended the granting of the type II variation to extend the indication.
Pfizer Oy
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Lipitor
Whereas, • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/ 2003, for atorvastatin (Sortis and associated names - see Annex I), • The MAH has implemented the text proposed by the CHMP in the SPC:
20mg
- It is proposed to add the following indication in section 4.1:
Filmtabletta
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.
Oralis alkalmazás
-
Finnország
The posology in Section 4.2 has been revised as follows:
Pfizer Oy
-
Lipitor
Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
40mg
8 Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5168) or placebo (n=5137).
Filmtabletta
The absolute and relative risk reduction effect of atorvastatin was as follows:
Oralis alkalmazás
Relative
Finnország
No. of
Pfizer Oy
Absolute
Lipitor
Risk
80mg
Events
Filmtabletta
Risk
Németország
Reduction1
Filmtabletta
Event
Németország
(%)
PARKE- DAVIS GmbH
Placebo)
Sortis
(%)
20mg
p-value
Filmtabletta
Fatal CHD plus non-fatal MI Total cardiovascular events
Oralis alkalmazás
36%
Németország
100 vs.
PARKE- DAVIS GmbH
154
Sortis
1.1%
40mg
0.0005
Filmtabletta
and revascularization procedures Total coronary events 1
Oralis alkalmazás
20% 29%
Németország
389 vs.
PARKE- DAVIS GmbH
483 178 vs 247
Sortis
1.9% 1.4%
80mg
0.0008 0.0006
Filmtabletta
CHD = coronary heart disease; MI = myocardial infarction.
Oralis alkalmazás
212 events, p=0.17 and 74 vs.
Görögország
82 events, p=0.51).
Pfizer Hellas AE
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.
10mg
30 and 17 vs.
Filmtabletta
12), but this was not statistically significant.
Oralis alkalmazás
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomised, double-blind, multicentre, 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).
Tagállam Görögország
The absolute and relative risk reduction effect of atorvastatin were as follows:
Forgalomba hozatali engedély jogosultja Pfizer Hellas AE
Relative
Név Lipitor
No. of
Dózis 20mg
Absolute
Görögország
Risk
Pfizer Hellas AE
Events
Lipitor
Risk
40mg
Reduction
Filmtabletta
(Sortis vs
Oralis alkalmazás
Reduction1
Görögország
Event Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA,
Pfizer Hellas AE
Placebo)
80mg
(%)
Filmtabletta
p-value
Oralis alkalmazás
revascularisation, stroke) MI (fatal and non-fatal AMI, silent MI) Strokes (Fatal and non-fatal) 1
Olaszország
37% 42% 48%
PARKE- DAVIS SpA
83 vs.
Xarator
39
10mg
3.2% 1.9% 1.3%
Filmtabletta
0.0010 0.0070 0.0163
Oralis alkalmazás
Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Olaszország
61 deaths in the atorvastatin group, p=0.0592).
PARKE- DAVIS SpA
• no untoward safety findings related to the extension of the indication have been identified.
Xarator
• the CHMP, as a consequence, considered the benefit/ risk balance for the above-mentioned extension of indication to be favourable,
20mg
The CHMP has recommended the granting of the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and Package Leaflet are set out in Annex III for atorvastatin (Sortis and related names - see Annex I).
Filmtabletta
10 ANNEX III
Oralis alkalmazás
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Olaszország
11 SUMMARY OF PRODUCT CHARACTERISTICS
PARKE- DAVIS SpA
12 1.
Xarator
< [See Annex I - To be completed nationally] > [For referral procedures] {PRODUCT NAME} 10 mg film-coated tablet
40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Filmtabletta
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Oralis alkalmazás
Excipients:
Olaszország
Each {PRODUCT NAME} 10 mg film-coated tablet contains 32.80 mg lactose monohydrate.
PARKE- DAVIS SpA
For a full list of excipients, see section 6.1.
Xarator
3.
80mg
PHARMACEUTICAL FORM
Filmtabletta
Film-coated tablet White elliptical, film-coated tablets debossed "10" on one side and "PD 155" on the other.
Oralis alkalmazás
CLINICAL PARTICULARS
Luxembourg
4.1 Therapeutic indications
Pfizer S. A.
Hypercholesterolaemia
Lipitor
{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.
10mg
LDL apheresis) or if such treatments are unavailable.
Filmtabletta
Prevention of cardiovascular disease
Oralis alkalmazás
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.
Luxembourg
4.2 Posology and method of administration
Pfizer S. A.
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}.
Lipitor
Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
20mg
The maximum dose is 80 mg once a day.
Filmtabletta
Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Oralis alkalmazás
13 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).
Luxembourg
The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
40mg
Heterozygous familial hypercholesterolaemia
Filmtabletta
Patients should be started with {PRODUCT NAME} 10 mg daily.
Oralis alkalmazás
Homozygous familial hypercholesterolaemia
Luxembourg
Atorvastatin was administered at doses up to 80 mg/ day.
Pfizer S. A.
The dosage of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily.
Lipitor
Prevention of cardiovascular disease
80mg
In the primary prevention trials the dose was 10 mg/ day.
Filmtabletta
Dosage in patients with renal insufficiency
Oralis alkalmazás
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Hollandia
Geriatric use
Pfizer bv
Efficacy and safety in patients older than 70 using recommended doses is similar to that seen in the general population.
Lipitor
Pediatric use
10mg
Pediatric use should only be carried out by specialists.
Filmtabletta
4.3 Contraindications
Oralis alkalmazás
14 {PRODUCT NAME} is contraindicated in patients: − with hypersensitivity to the active substance or to any of the excipients of this medication − with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal − with myopathy − during pregnancy − while breast-feeding − in women of child-bearing potential not using appropriate contraceptive measures.
Hollandia
4.4 Special warnings and precautions for use
Pfizer bv
Liver effects
Lipitor