natgillin/translations-raw huggingface dataset:
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Det fanns få direkt jämförbara säkerhetsuppgifter för enskilda icke- steroida antiinflammatoriska läkemedel (NSAID) förutom diklofenak och naproxen.
Reproduction is authorised provided the source is acknowledged. within 2 weeks of treatment initiation.
Uppgifter om läkemedelsanvändning visade att behandling med etoricoxib inleds för vissa patienter med högt blodtryck.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Vårdpersonal bör påminnas om dessa åtgärder genom ett informationsbrev (” Dear Healthcare Professional Letter ”).
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect.
Vissa uppgifter tyder dock på att lägre doser också kan visa sig effektiva.
The list of product names concerned is given in Annex I.
Förteckningen över produktnamnen i fråga finns i bilaga I.
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.
De vetenskapliga slutsatserna finns i bilaga II, den ändrade produktinformationen i bilaga III och villkoren för godkännande för försäljning i bilaga IV.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Uppgifterna i detta dokument och bilagorna speglar enbart CHMP: s yttrande av den 26 juni 2008.
The Member States’ competent authorities will continue to keep the product under regular review.
Medlemsstaternas behöriga myndigheter kommer att granska produkten regelbundet.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
FÖRTECKNING ÖVER LÄKEMEDLETS NAMN, LÄKEMEDELSFORM, STYRKOR, ADMINISTRERINGSSÄTT AV LÄKEMEDLET SAMT INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING I MEDLEMSSTATERNA
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 Medlemsstat
Pfizer S. A.
Oral användning
Pfizer S. A.
Belgien
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
Filmdragerad tablett
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
Oral användning
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
Belgien
PARKE-DAVIS, S. L.
Filmdragerad tablett
PARKE-DAVIS, S. L.
Oral användning
3 Member State Sweden Sweden Sweden Sweden
Belgien
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmdragerad tablett
Route of administration Oral use Oral use Oral use Oral use
Oral användning
4 ANNEX II
Danmark
The currently approved indications for atorvastatin are:
Filmdragerad tablett
- as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein
Oral användning
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.
Danmark
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).
Filmdragerad tablett
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”.
Oral användning
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.
Danmark
3.
Filmdragerad tablett
4.
Oral användning
The main concern relates to the “ risk of CVD”.
Filmdragerad tablett
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.
Oral användning
The appropriate place for dose
Finland
7 recommendations is section 4.2 of the SPC, not section 4.1, and adequate dosing recommendations have been added.
Pfizer Oy
Finally, there has been much discussion regarding the wording of the indication that best reflects the results of the of the assessed trials.
Lipitor
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.
10mg
Overall conclusion on benefit/ risk
Filmdragerad tablett
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.
Finland
- It is proposed to add the following indication in section 4.1:
Filmdragerad tablett
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.
Oral användning
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).
Filmdragerad tablett
The absolute and relative risk reduction effect of atorvastatin was as follows:
Oral användning
Relative
Finland
Events
Oral användning
Risk
Tyskland
Reduction1
Filmdragerad tablett
Event
Oral användning
(%)
Tyskland
Fatal CHD plus non-fatal MI Total cardiovascular events
Filmdragerad tablett
36%
Tyskland
and revascularization procedures Total coronary events 1
Filmdragerad tablett
20% 29%
Oral användning
389 vs.
Tyskland
CHD = coronary heart disease; MI = myocardial infarction.
Filmdragerad tablett
82 events, p=0.51).
Oral användning
30 and 17 vs.
Medlemsstat
12), but this was not statistically significant.
Innehavare av godkännande för försäljning
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).
Läkemedlets namn
The absolute and relative risk reduction effect of atorvastatin were as follows:
Styrka
Relative
Läkemedelsform
No. of
Administreringssätt
Absolute
Grekland
Risk
10mg
Reduction
Oral användning
(Sortis vs
Grekland
Reduction1
Pfizer Hellas AE
Event Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA,
Lipitor
Placebo)
Filmdragerad tablett
(%)
Oral användning
p-value
Grekland
revascularisation, stroke) MI (fatal and non-fatal AMI, silent MI) Strokes (Fatal and non-fatal) 1
Pfizer Hellas AE
37% 42% 48%
Lipitor
83 vs.
40mg
3.2% 1.9% 1.3%
Filmdragerad tablett
0.0010 0.0070 0.0163
Oral användning
Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Grekland
61 deaths in the atorvastatin group, p=0.0592).
Pfizer Hellas AE
• no untoward safety findings related to the extension of the indication have been identified.
Lipitor
• the CHMP, as a consequence, considered the benefit/ risk balance for the above-mentioned extension of indication to be favourable,
80mg
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).
Filmdragerad tablett
10 ANNEX III
Oral användning
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Italien
< [See Annex I - To be completed nationally] > [For referral procedures] {PRODUCT NAME} 10 mg film-coated tablet
10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Filmdragerad tablett
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Oral användning
Excipients:
Italien
3.
20mg
PHARMACEUTICAL FORM
Filmdragerad tablett
Film-coated tablet White elliptical, film-coated tablets debossed "10" on one side and "PD 155" on the other.
Oral användning
CLINICAL PARTICULARS
Italien
4.1 Therapeutic indications
PARKE- DAVIS SpA
Hypercholesterolaemia
Xarator
{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.
40mg
LDL apheresis) or if such treatments are unavailable.
Filmdragerad tablett
Prevention of cardiovascular disease
Oral användning
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.
Italien
4.2 Posology and method of administration
PARKE- DAVIS SpA
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}.
Xarator
Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
80mg
The maximum dose is 80 mg once a day.
Filmdragerad tablett
Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Oral användning
The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
10mg
Heterozygous familial hypercholesterolaemia
Filmdragerad tablett
Patients should be started with {PRODUCT NAME} 10 mg daily.
Oral användning
Homozygous familial hypercholesterolaemia
Luxemburg
Prevention of cardiovascular disease
20mg
In the primary prevention trials the dose was 10 mg/ day.
Filmdragerad tablett
Dosage in patients with renal insufficiency
Oral användning
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Luxemburg
Pediatric use
40mg
Pediatric use should only be carried out by specialists.
Filmdragerad tablett
4.3 Contraindications
Oral användning
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.
Luxemburg
4.4 Special warnings and precautions for use
Pfizer S. A.
Liver function tests should be performed before the initiation of treatment and periodically thereafter.
80mg
{PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/ or have a history of liver disease.
Filmdragerad tablett
Skeletal muscle effects
Oral användning
Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated CPK levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Nederländerna Pfizer bv Nederländerna Pfizer bv Nederländerna Pfizer bv Nederländerna Pfizer bv Laboratórios Pfizer, Lda Portugal
Before the treatment Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
Lipitor Lipitor Lipitor Lipitor Zarator
In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
10mg 20mg 40mg 80mg 10mg
If CPK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.
Filmdragerad tablett Filmdragerad tablett Filmdragerad tablett Filmdragerad tablett Filmdragerad tablett
Whilst on treatment − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
Oral användning Oral användning Oral användning Oral användning Oral användning
15 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Laboratórios Pfizer, Lda Portugal
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Zarator
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine.
20mg
4.5 Interaction with other medicinal products and other forms of interaction
Filmdragerad tablett
Therefore, the benefit and the risk of concurrent treatment should be carefully weighed (see section 4.4).
Laboratórios Pfizer, Lda Portugal
Inhibitors of cytochrome P450 3A4
Zarator
Atorvastatin is metabolized by cytochrome P450 3A4.
40mg
Inhibitors of P-glycoprotein
Filmdragerad tablett
Atorvastatin and atorvastatin-metabolites are substrates of P-glycoprotein.
Oral användning
Erythromycin, clarithromycin
Laboratórios Pfizer, Lda Portugal
Itraconazole
80mg
Concomitant administration of atorvastatin 40 mg and itraconazole 200 mg daily resulted in a 3-fold increase in atorvastatin AUC.
Filmdragerad tablett
Protease inhibitors
Oral användning
Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Spanien
Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
10mg
Inducers of cytochrome P450 3A4
Filmdragerad tablett
The effect of inducers of cytochrome P450 3A4 (e. g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
Oral användning
Other concomitant therapy
3 Medlemsstat
This may possibly lead to increased plasma levels of atorvastatin (see section 4.4).
Innehavare av godkännande för försäljning
Patients taking digoxin should be monitored appropriately.
Läkemedlets namn
Oral contraceptives Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Styrka
25%) when colestipol was coadministered with {PRODUCT NAME}.
Läkemedelsform
35%; however, LDL-C reduction was not altered.
Administreringssätt
Warfarin Coadministration of {PRODUCT NAME} and warfarin caused a small decrease in prothrombin time during the first days of dosing which returned to normal within 15 days of {PRODUCT NAME} treatment.
Spanien
Amlodipine Atorvastatin pharmacokinetics were not altered by the coadministration of atorvastatin 80 mg and amlodipine 10 mg at steady state.
20mg
Other In clinical studies in which {PRODUCT NAME} was administered with antihypertensives or hypoglycaemic agents no clinically significant interactions were seen.
Filmdragerad tablett
4.6 Pregnancy and lactation
Oral användning
{PRODUCT NAME} is contraindicated in pregnancy and while breast feeding.
Spanien
There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
PARKE- DAVIS, S. L.
In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk.
Zarator
4.7 Effects on ability to drive and use machines
40mg
{PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Filmdragerad tablett
18 4.8 Undesirable effects
Oral användning
The most commonly expected adverse events are mainly gastrointestinal, including constipation, flatulence, dyspepsia, abdominal pain and usually ameliorate on continued treatment.
Spanien
Estimated frequencies of events are ranked according to the following convention: common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (≤ 1/ 10,000).
80mg
Gastrointestinal disorders
Filmdragerad tablett
Uncommon: anorexia, vomiting.
Oral användning
Blood and lymphatic system disorders
Sverige
Uncommon: thrombocytopenia.
Pfizer AB
Immune system disorders
Lipitor
Very rare: anaphylaxis.
Filmdragerad tablett
Endocrine disorders
Oral användning
Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis.
Sverige
Psychiatric
Pfizer AB
Common: insomnia.
Lipitor
Uncommon: amnesia.
20mg
Nervous system disorders
Filmdragerad tablett
Uncommon: peripheral neuropathy.
Oral användning
Hepato-biliary disorders
Sverige
Rare: hepatitis, cholestatic jaundice.
Pfizer AB
Skin/ Appendages
Lipitor
Common:
40mg
Uncommon: urticaria.
Filmdragerad tablett
Ear and Labyrinth Disorders
Oral användning
Uncommon: tinnitus
Sverige
Rare: myositis, rhabdomyolysis.
80mg
Reproductive system disorders
Filmdragerad tablett
Uncommon: impotence.
Oral användning
General disorders
4 BILAGA II
Common: asthenia, chest pain, back pain, peripheral oedema.
EMEA: S VETENSKAPLIGA SLUTSATSER OCH SKÄLEN TILL ÄNDRING AV PRODUKTRESUMÉN
Uncommon: malaise, weight gain.
5 VETENSKAPLIGA SLUTSATSER
Investigations
ÖVERGRIPANDE SAMMANFATTNING AV DEN VETENSKAPLIGA UTVÄRDERINGEN AV ATORVASTATIN (Sortis och synonymer - se bilaga I)
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}.
Sortis och synonymer innehåller atorvastatin, en välkänd substans som hämmar enzymet HMG- CoA - reduktas (statin), registrerad i EU sedan 1996 genom förfarandet för ömsesidigt erkännande och nationella förfaranden.
These changes were usually mild, transient, and did not require interruption of treatment.
- Som kosttillskott för att sänka höga värden av kolesterol, LDL- kolesterol, apolipoprotein B och
Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
triglycerider hos patienter med primär hyperkolesterolemi, inklusive familjär hyperkolesterolemi (heterozygot variant) eller kombinerad (blandad) hyperlipidemi (motsvarande typ IIa och IIb i Fredricksons klassificeringssystem) när reaktionen på dietariska och andra icke- farmakologiska åtgärder är otillräckliga.
These elevations were dose related and were reversible in all patients.
- För att sänka höga värden av total- C och LDL- C hos patienter med homozygot familjär
Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
hyperkolesterolemi, som ett komplement till andra blodfettsänkande behandlingar (t. ex.
Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
LDL- aferesi) eller om sådana behandlingar inte finns tillgängliga.
4.9 Overdose
Bakgrundsinformation om typ- II- ändringen genom förfarandet för ömsesidigt erkännande I den ursprungliga dokumentationen för typ II- ändring som lämnades in inför förfarandet för ömsesidigt erkännande hävdade den sökande följande indikation: “ Förebyggande av hjärt- kärlsjukdom hos patienter med flera riskfaktorer (t. ex. typ 2- diabetes med en riskfaktor och patienter med högt blodtryck och tre riskfaktorer) med normala eller förhöjda kolesterolvärden men utan kliniskt konstaterad kranskärlssjukdom ”.
Specific treatment is not available for {PRODUCT NAME} overdosage.
Formuleringen bygger på resultaten från två randomiserade, kontrollerade studier av atorvastatin 10 mg för primär prevention av hjärt- kärlsjukdom.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
ASCOT- LLA- studien genomfördes på 10 000 patienter (40- 79 år) med normala till lätt förhöjda kolesterolvärden, ingen tidigare hjärtinfarkt (MI) eller behandling för kärlkramp men med förhöjt blodtryck och minst tre andra riskfaktorer för hjärt- kärlsjukdom.
Liver function tests should be performed and serum CPK levels should be monitored.
Syftet med studien var att utvärdera effekterna av atorvastatin på dödlig och icke- dödlig kranskärlssjukdom.
Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Atorvastatin sänkte antalet fall av kranskärlssjukdom och hjärt- kärlsjukdom, stroke och revaskulariseringsförfaranden i hela försökspopulationen.
PHARMACOLOGICAL PROPERTIES
för att därigenom begränsa indikationen till den population som ingick i CARD- studien och förpassa resultaten från ASCOT- LLA- studien till en beskrivning i avdelning 5. 1. i produktresumén, på grund av bristen på påvisbar effekt i den kvinnliga delgruppen.
5.1 Pharmacodynamic properties
I slutfasen av förfarandet för ömsesidigt erkännande förelåg det en skillnad mellan medlemsstaterna vad gällde formuleringen av den föreslagna indikationen, som på ett korrekt sätt återspeglade data från ASCOT- LLA - och CARDS- studien och som i realiteten undantog behandling av icke- diabetiker, och
C10AA05
I sitt plenarsammanträde i december antog CHMP en frågelista (LoQ) som fokuserade på följande punkter:
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Hur man på ett korrekt sätt i produktresumén skulle kunna återge bristen på märkbar effekt för atorvastatin för det gemensamma primära utvärderingskriteriet och flera sekundära utvärderingskriterier för den kvinnliga delgruppen.
Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Om man skulle utesluta ASCOT- LLA- studiens målpopulation från den föreslagna indikationen, för att därigenom utesluta behandling av icke- diabetiska patienter med hög risk för hjärt- kärlsjukdomar.
Low- density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Om atorvastatinets skyddande effekt vad gäller hjärt- kärlsjukdom är högre när det används i kombination med speciella blodtryckssänkande behandlingar och om detta bör framgå av produktresumén.