natgillin/translations-raw huggingface dataset:
This information should inform healthcare professionals on the cardiorenal risks associated with Arcoxia and should be in line with the DHPC endorsed by the CHMP.
Tento list má lekárov informovať o kardiorenálnych rizikách spojených s liekom Arcoxia a má byť v súlade s PLZ schváleným výborom CHMP.
London, 23 October 2008 EMEA/ 438258/ 2008
Londýn 23. októbra 2008 EMEA/ CHMP/ 619545/ 2008
International non-proprietary name (INN): etoricoxib
Medzinárodný nechránený názov (INN): etorikoxib
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).
Etorikoxib je selektívnym inhibítorom COX- 2 (cyklooxygenázy 2) indikovaným pri zmierňovaní symptómov osteoartritídy (OA, 30- 60mg raz denne (od)), reumatoidnej artritídy (RA, 90mg raz denne) a bolesti a príznakov zápalu spojených s akútnou dnavou artritídou (120mg raz denne).
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.
Postup vo veci predloženého podnetu sa vzťahuje na žiadosť o arbitrážne konanie v súvislosti so zmenou typu II v novej indikácii, kde sa má zahrnúť aj liečba ankylozujúcej spondylitídy (AS), v odporúčanej dennej dávke 90mg.
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.
V závere postupu vzájomného uznávania sa objavil rozpor medzi rôznymi členskými štátmi Európskej únie (EÚ) vzhľadom na bezpečnosť etorikoxibu v dávke 90mg v novej navrhnutej indikácii.
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.
1084/ 2003.
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.
Hlavné nevyriešené oblasti výhrad, ktoré určilo Francúzsko, sa týkali dlhodobej bezpečnosti etorikoxibu v dennej dávke 90mg vzhľadom na možné zvýšené kardiovaskulárne (KV) riziko spojené s užívaním dávky 90mg v indikácii ankylozujúcej spondylitídy.
France considered that a review of the benefit/ risk profile of Arcoxia was needed.
Francúzsko sa domnievalo, že je potrebné prehodnotiť pomer prínosu a rizík profilu lieku Arcoxia.
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr.
Výbor CHMP rokoval na svojom plenárnom zasadnutí v septembri 2007 o arbitrážnom konaní a boli vymenovaní spravodajca (Dr.
Karl Broich) and Co-Rapporteur (Dr.
Karl Broich) a spolupracujúci spravodajca (Dr.
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).
Postup vo veci predloženého podnetu sa začal 20 septembra 2007 schválením zoznamu otázok CHMP, ku ktorým sa majú vyjadriť držitelia povolenia na uvedenia na trh.
During the February 2008 plenary meeting Dr.
Počas plenárneho zasadnutia vo februári 2008 bol Dr.
Rafe Survana was appointed Co-Rapporteur, replacing Dr.
Rafe Survana vymenovaný za spolupracujúceho spravodajcu a nahradil tak Dr.
Matthew Thatcher.
Matthew Thatchera.
Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
Držitelia povolenia na uvedenie na trh poskytli písomné vyjadrenia 14. decembra 2007, 5. mája 2008, 12. júna 08 a 20. júna 2008.
The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Výbor CHMP usúdil, že údaje potvrdzovali známy renovaskulárny bezpečnostný profil etorikoxibu (hypertenzia, edém a kongestívne srdcové zlyhanie).
The data further confirmed a similar CV thrombotic risk like diclofenac and some degree of upper gastrointestinal (GI) safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Údaje ďalej potvrdili podobné KV trombotické riziko, ako má diklofenak a určitý stupeň bezpečnostnej výhody pré hornú časť gastrointestinálneho (GI) traktu v porovnaní s naproxenom a diklofenakom (avšak bez bezpečnostnej výhody pre dolný gastrointestinálny trakt).
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Okrem diklofenaku a naproxenu bolo k dispozícii málo priamych porovnávacích bezpečnostných údajov pre jednotlivé nesteroidné protizápalové lieky (NSAIDs).
Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Z tohto dôvodu bolo ťažké stanoviť riziká pre etorikoxib pri porovnávaní s ibuprofenom, ketoprofenom alebo inými menej často používanými nesteroidnými protizápalovými liekmi.
Reproduction is authorised provided the source is acknowledged. within 2 weeks of treatment initiation.
Údaje o používaní liekov ukázali, že niektorí pacienti s vysokým krvným tlakom začínajú liečbu etorikoxibom.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Zdravotníci by mali byť o týchto opatreniach informovaní komunikačným listom (List: Vážený zdravotnícky pracovník).
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.
Údaje z klinických štúdií ukázali klinicky významný liečebný účinok 90mg etorikoxibu v dávke raz denne pre indikáciu ankylozujúcej spondylitídy, no sú k dispozícii určité údaje, ktoré naznačujú, že účinné môžu byť aj nižšie dávky.
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.
Výbor CHMP preto odporučil, aby boli štúdie na stanovenie dávok realizované tak, aby sa dalo stanoviť, či by mohla byť liečba dávkou 60mg raz denne pre niektorých pacientov primeraná.
Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis.
Na základe posúdenia dostupných údajov CHMP usúdil, že prínos etorikoxibu vyvažuje riziká pri liečbe ankylozujúcej spondylitídy.
On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
Výbor CHMP 26. júna 2008 po posúdení údajov poskytnutých držiteľmi povolenia na uvedenie lieku na trh odporučil schválenie zmeny v povolení na uvedenie lieku na trh.
The list of product names concerned is given in Annex I.
Zoznam príslušných názvov produktu je uvedený v prílohe 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.
Vedecké závery sú uvedené v prílohe II, zmenené a doplnené informácie o lieku sú v prílohe III a podmienky povolenia na uvedenie lieku na trh sú v prílohe IV.
The final opinion was converted into a decision by the European Commission on 9 September 2008.
Konečné stanovisko bolo 9. septembra 2008 prepracované na rozhodnutie Európskej komisie.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Informácie uvedené v tomto dokumente a jeho prílohách odrážajú iba stanovisko výboru CHMP z 26. júna 2008.
The Member States’ competent authorities will continue to keep the product under regular review.
Príslušné úrady v členských štátoch budú pokračovať vo vykonávaní pravidelnej kontroly lieku.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
ZOZNAM NÁZVOV, FARMACEUTICKÝCH FORIEM, MNOŽSTVÁ ÚČINNÝCH LÁTOK V LIEKOCH, SPÔSOB PODÁVANIA, DRŽITELIA ROZHODNUTIA O REGISTRÁCII V ČLENSKÝCH ŠTÁTOCH
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 Členský štát
Pfizer Corporation Austria Ges. m. b. H.
Držiteľ rozhodnutia o registrácii
Invented name Sortis Sortis Sortis Sortis Lipitor Lipitor Lipitor Lipitor Zarator Zarator Zarator Zarator Lipitor Lipitor Lipitor Lipitor Sortis Sortis Sortis Sortis Lipitor Lipitor
Vymyslený názov
Strength 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg
Množstvo aktívnej látky Farmaceutická forma
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
Spôsob podávania
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
Rakúsko
Invented name Lipitor Lipitor Xarator Xarator Xarator Xarator Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Zarator Zarator Zarator Zarator Zarator Zarator Zarator Zarator
Sortis
Strength 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg
10 mg Filmom obalené tablety
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
Perorálne použitie
Marketing Authorisation Holder Pfizer AB Pfizer AB Pfizer AB Pfizer AB
Sortis
Invented name Lipitor Lipitor Lipitor Lipitor
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Strength 10mg 20mg 40mg 80mg
Perorálne použitie
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Rakúsko
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
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5 SCIENTIFIC CONCLUSIONS
Perorálne použitie
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATORVASTATIN (Sortis and associated names - see Annex I)
Rakúsko
The currently approved indications for atorvastatin are:
Pfizer Corporation Austria Ges. m. b. H.
- as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein
Sortis
- to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia an
80 mg Filmom obalené tablety
adjunct to other lipid-lowering treatments (e. g.
Perorálne použitie
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 )”.
Belgicko
At the December plenary meeting, the CHMP adopted a LoQ centred on the following points:
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1.
Perorálne použitie
3.
Belgicko
4.
Pfizer S. A.
5.
Lipitor
Evaluation of Clinical Efficacy
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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.
Perorálne použitie
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.
Belgicko
The appropriate place for dose
40 mg Filmom obalené tablety
Indeed, many of the patients were at low risk, particularly the females in ASCOT-LLA.
Perorálne použitie
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.
Belgicko
The CHMP recommended the granting of the type II variation to extend the indication.
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GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Perorálne použitie
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:
Dánsko
- It is proposed to add the following indication in section 4.1:
Pfizer ApS
In the primary prevention trials the dose was 10 mg/ day.
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-
Perorálne použitie
Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
Dánsko
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).
Pfizer ApS
The absolute and relative risk reduction effect of atorvastatin was as follows:
Zarator
Relative
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No. of
Perorálne použitie
Absolute
Dánsko
Risk
Pfizer ApS
Events
Zarator
Risk
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Reduction
Perorálne použitie
(Sortis vs
Dánsko
Reduction1
Pfizer ApS
Event
Zarator
(%)
Perorálne použitie
Placebo)
Fínsko
(%)
Pfizer Oy
p-value
Lipitor
Fatal CHD plus non-fatal MI Total cardiovascular events
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36%
Perorálne použitie
100 vs.
Fínsko
1.1%
Pfizer Oy
0.0005
Lipitor
and revascularization procedures Total coronary events 1
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20% 29%
Perorálne použitie
389 vs.
Fínsko
1.9% 1.4%
Pfizer Oy
0.0008 0.0006
Lipitor
CHD = coronary heart disease; MI = myocardial infarction.
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212 events, p=0.17 and 74 vs.
Perorálne použitie
82 events, p=0.51).
Fínsko
30 and 17 vs.
Pfizer Oy
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).
Lipitor
The absolute and relative risk reduction effect of atorvastatin were as follows:
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Relative
Perorálne použitie
No. of
Nemecko
Absolute
PARKE- DAVIS GmbH
Risk
Sortis
Events
Perorálne použitie
Risk
Nemecko
Reduction1
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Event Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA,
Perorálne použitie
(%)
Nemecko
p-value
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revascularisation, stroke) MI (fatal and non-fatal AMI, silent MI) Strokes (Fatal and non-fatal) 1
Perorálne použitie
37% 42% 48%
Nemecko
0.0010 0.0070 0.0163
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61 deaths in the atorvastatin group, p=0.0592).
Perorálne použitie
• no untoward safety findings related to the extension of the indication have been identified.
Grécko
10 ANNEX III
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SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Perorálne použitie
11 SUMMARY OF PRODUCT CHARACTERISTICS
2 Členský štát
NAME OF THE MEDICINAL PRODUCT
Držiteľ rozhodnutia o registrácii
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vymyslený názov
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Množstvo aktívnej látky Farmaceutická forma
Excipients:
Spôsob podávania
Each {PRODUCT NAME} 10 mg film-coated tablet contains 32.80 mg lactose monohydrate.
Grécko
For a full list of excipients, see section 6.1.
Pfizer Hellas AE
PHARMACEUTICAL FORM
Lipitor
Film-coated tablet White elliptical, film-coated tablets debossed "10" on one side and "PD 155" on the other.
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CLINICAL PARTICULARS
Perorálne použitie
4.1 Therapeutic indications
Grécko
Hypercholesterolaemia
Pfizer Hellas AE
{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.
Lipitor
LDL apheresis) or if such treatments are unavailable.
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Prevention of cardiovascular disease
Perorálne použitie
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.
Grécko
4.2 Posology and method of administration
Pfizer Hellas AE
The maximum dose is 80 mg once a day.
80 mg Filmom obalené tablety
Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Perorálne použitie
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).
Taliansko
Adapted from “ Prevention of coronary heart disease in clinical practice:
PARKE- DAVIS SpA
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
Xarator
The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
10 mg Filmom obalené tablety
The response is maintained during chronic therapy.
Perorálne použitie
Heterozygous familial hypercholesterolaemia
PARKE- DAVIS SpA
Patients should be started with {PRODUCT NAME} 10 mg daily.
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Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
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Homozygous familial hypercholesterolaemia
Perorálne použitie
Atorvastatin was administered at doses up to 80 mg/ day.
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LDL apheresis) in these patients or if such treatments are unavailable.
Perorálne použitie
Prevention of cardiovascular disease
Luxembursko
Dosage in patients with renal insufficiency
Perorálne použitie
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Luxembursko
Geriatric use
Pfizer S. A.
Efficacy and safety in patients older than 70 using recommended doses is similar to that seen in the general population.
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Pediatric use
Luxembursko
Pediatric use should only be carried out by specialists.
Pfizer S. A.
Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Lipitor
The recommended starting dose in this population is 10 mg of atorvastatin per day.
40 mg Filmom obalené tablety
The dose may be increased to 80 mg daily, according to the response and tolerability.
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4.3 Contraindications
Perorálne použitie
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.
Holandsko
Liver function tests should be performed before the initiation of treatment and periodically thereafter.
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{PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/ or have a history of liver disease.
Perorálne použitie
Skeletal muscle effects
Holandsko
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.
Pfizer bv
Before the treatment Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
Lipitor
If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.
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Creatine phosphokinase measurement Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult.
Perorálne použitie
Whilst on treatment − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
Holandsko
15 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Pfizer bv
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).
Lipitor
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine.
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4.5 Interaction with other medicinal products and other forms of interaction
Perorálne použitie
The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of ciclosporin, fibric acid derivatives, macrolide antibiotics including erythromycin, azole antifungals, or niacin and on rare occasions has resulted in rhabdomyolysis with renal dysfunction secondary to myoglobinuria.
Holandsko
Inhibitors of cytochrome P450 3A4
Pfizer bv
Atorvastatin is metabolized by cytochrome P450 3A4.
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Inhibitors of P-glycoprotein
Perorálne použitie
Atorvastatin and atorvastatin-metabolites are substrates of P-glycoprotein.
Portugalsko
Clarithromycin increased the Cmax and AUC of atorvastatin by 56% and 80% respectively.
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Itraconazole
Perorálne použitie
Concomitant administration of atorvastatin 40 mg and itraconazole 200 mg daily resulted in a 3-fold increase in atorvastatin AUC.
Portugalsko
Protease inhibitors
Laboratórios Pfizer, Lda
Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
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16 Grapefruit juice
Perorálne použitie
Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Portugalsko
Inducers of cytochrome P450 3A4
Laboratórios Pfizer, Lda