natgillin/translations-raw huggingface dataset:
"Long- Term Intervention with Pravastatin in Ischemic Disease (LIPID)" var et multicenter, randomiseret, dobbeltblindet, placebokontrolleret studie, der sammenlignede effekten af pravastatin (40 mg en gang dagligt) med placebo hos 9014 patienter i aldersgruppen 31- 75 år i gennemsnitligt 5, 6 år med normale til forhøjede serum kolesterol værdier (baseline total- kolesterol = 155 til 271 mg/ dl [4, 0- 7, 0 mmol/ l], middel total- kolesterol = 219 mg/ dl [5, 66 mmol/ l]) og med variable triglycerid værdier på op til 443 mg/ dl [5, 0 mmol/ l] og med anamnestisk myokardieinfarkt eller ustabil angina pectoris i de foregående 3 til 36 måneder.
The "Cholesterol and Recurrent Events (CARE)" study was a randomised, double-blind, placebo- controlled study comparing, the effects of pravastatin (40 mg OD) on coronary heart disease death and nonfatal myocardial infarction for an average of 4.9 years in 4159 patients aged 21 to 75 years, with normal total cholesterol levels (baseline mean total cholesterol < 240 mg/dl), who had experienced a myocardial infarction in the preceding 3 to 20 months.
Hos pravastatin- behandlede patienter viste resultaterne:
Treatment with pravastatin significantly reduced:
- reduktion af den relative risiko for total mortalitet med 23% (p < 0, 0001) og kardiovaskulær
- the rate of a recurrent coronary event (either coronary heart disease death or nonfatal MI) by 24%
mortalitet med 25% (p < 0, 0001);
(p = 0.003, placebo 13.3%, pravastatin 10.4%);
- reduktion af den relative risiko for at skulle gennemgå myokardiale
- the relative risk of undergoing revascularisation procedures (coronary artery bypass grafting or
revaskulariseringsprocedurer (koronar arterie bypass transplantation eller perkutan transluminal koronar angioplastik) med 20% (p < 0, 0001);
percutaneous transluminal coronary angioplasty) by 27% (p < 0.001)., The relative risk of stroke was also reduced by 32% (p = 0.032), and stroke or transient ischaemic attack (TIA) combined by 27% (p = 0.02).
- reduktion af den relative risiko for stroke med 19% (p= 0, 048).
The benefit of the treatment on the above criteria is not known in patients over the age of 75 years, who could not be included in the CARE and LIPID studies.
Behandling med pravastatin reducerede signifikant:
In the absence of data in patients with hypercholesterolaemia associated with a triglyceride level of more than 4 mmol/L (3.5 g/L or more than 5 mmol/L (4.45 g/L) after following a diet for 4 or 8 weeks, in the CARE and LIPID studies, respectively, the benefit of treatment with pravastatin has not been established in this type of patients.
- antallet af tilbagevendende koronare hændelser (enten død pga. koronar hjertesygdom eller
In the CARE and LIPID studies, about 80% of patients had received ASA as part of their regimen.
ikke- fatalt MI) med 24% (p= 0, 003, placebo 13, 3%, pravastatin 10, 4%);
Heart and kidney transplantation
- den relative risiko for at skulle gennemgå revaskulariseringsprocedurer (koronar arterie bypass
The efficacy of pravastatin in patients receiving an immunosuppressant treatment following:
transplantation eller perkutan transluminal koronar angioplastik) med 27% (p < 0, 001).
Patients were
Den relative risiko for stroke blev også reduceret med 32% (p= 0, 032), og kombineret stroke eller forbigående iskæmisk tilfælde (TIA) blev reduceret med 27% (p= 0, 02).
treated concurrently with either pravastatin (20-40mg) or not, and a standard immunosuppressive regimen of cyclosporin, prednisone and aziathioprine.
Udbyttet af behandlingen efter de ovenfor nævnte kriterier er ikke kendt hos patienter > 75 år, som ikke kunne inkluderes i CARE og LIPID studierne.
- Renal transplant was assessed in one prospective not controlled, not randomised study (n=48) of 4
Pga. manglende data i henholdsvis CARE og LIPID studierne på patienter med hyperkolesterolæmi associeret med triglyceridværdier > 4 mmol/ l (3, 5 g/ l) eller > 5 mmol/ l (4, 45 g/ l) efter diæt i 4 eller 8 uger er udbyttet af pravastatin- behandling ikke fastslået hos denne patientgruppe.
In patients following kidney transplantation, pravastatin significantly reduced both the incidence of multiple rejection episodes and the incidence of biopsy-proved acute rejection episodes, and the use of pulse injections of both prednisolone and Muromonab-CD3.
I CARE og LIPID studierne fik ca.
Pharmacokinetic properties
80% af patienterne ASA som en del af deres behandlingsregime.
Pravastatin is administered orally in the active form.
CPMP/ 3257/ 03 Hjerte - og nyretransplantation
CPMP/6214/03
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Absorption:
cholesterol.
In vitro studier viste, at pravastatin transporteres ind i hepatocytter og, med betydeligt mindre indtag, i andre celler.
In vitro studies demonstrated that pravastatin is transported into hepatocytes and with substantially less intake in other cells.
I betragtning af denne betydelige første passage gennem leveren har plasma assays af pravastatin kun begrænset værdi til at forudsige den lipidsænkende effekt.
In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect.
Plasmakoncentrationerne er proportional med den administrerede dosis.
The plasma concentrations are proportional to the doses administered.
50% af det cirkulerende pravastatin bindes til plasma proteiner.
About 50% of circulating pravastatin is bound to plasma proteins.
0, 5 l/ kg.
The volume of distribution is about 0.5 l/kg.
En lille mængde pravastatin passerer over i human modermælk.
A small quantity of pravastatin passes into the human breast milk.
Pravastatin metaboliseres ikke signifikant ved cytokrom P450, ej heller synes det at være et substrat eller en inhibitor af P- glycoprotein men snarere et substrat af andre transportproteiner.
Pravastatin is not significantly metabolised by cytochrome P450 nor does it appear to be a substrate or an inhibitor of P-glycoprotein but rather a substrate of other transport proteins.
Efter peroral administration udskilles 20% af initialdosis i urinen og 70% i fæces.
Following oral administration, 20% of the initial dose is eliminated in the urine and 70% in the faeces.
Plasma halveringstid af peroralt pravastatin er 1, 5- 2 timer.
Plasma elimination half-life of oral pravastatin is 1.5 to 2 hours.
Efter intravenøs administration udskilles 47% af dosis via renal ekskretion og 53% via galde ekskretion og biotransformation.
After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation.
Størstedelen af det nedbrudte produkt af pravastatin er den 3- α - hydroxy isomeriske metabolit.
The major degradation product of pravastatin is the 3-α- hydroxy isomeric metabolite.
Denne metabolit har imellem 1/ 10 til 1/ 40 af HMG- CoA reduktase inhibitor aktiviteten af det oprindelige stof.
This metabolite has one-tenth to one-fortieth the HMG-CoA reductase inhibitor activity of the parent compound.
Den systemiske clearance af pravastatin er 0, 81 l/ h/ kg og den renale clearance er 0, 38 l/ h/ kg, hvilket indikerer tubulær sekretion.
The systemic clearance of pravastatin is 0.81 l/H/kg and the renal clearance is 0.38 l/H/kg indicating tubular secretion.
Patienter i risikogruppe:
Populations at risk:
Leversvigt:
Hepatic failure:
50% sammenlignet med patienter med normal leverfunktion.
Systemic exposure to pravastatin and metabolites in patients with alcoholic cirrhosis is enhanced by about 50% comparatively to patient with normal liver function.
Der blev ikke observeret nogle signifikante modifikationer hos patienter med let nyrefunktionsnedsættelse.
No significant modifications were observed in patients with mild renal impairment.
Svær og moderat renal insufficiens kan dog medføre en fordobling af den systemiske eksposition for pravastatin og dets metabolitter.
However severe and moderate renal insufficiency may lead to a two fold increase of the systemic exposure to pravastatin and metabolites.
EMEA 2004
5.3 Preclinical safety data
Baseret på konventionelle studier af sikkerhedsfarmakologi, toksicitet ved gentagne doseringer og reproduktionstoksicitet er deringen anden risiko for patienten end hvad der kan forventes på baggrund af den farmakologiske virkningsmekanisme.
Based on conventional studies of safety pharmacology, repeated dose toxicity and toxicity on reproduction, there are no other risks for the patient than those expected due to the pharmacological mechanism of action.
Studier med gentagne doseringer indikerer, at pravastatin kan inducere varierende grad af hepatotoksicitet og myopati; selvstændig indvirkning på disse væv blev generelt kun evident ved doser på ≥ 50 gange den maksimale humane mg/ kg dosis.
Repeated dose studies indicate that pravastatin may induce varying degrees of hepatotoxicity and myopathy; in general, substantive effects on these tissues were only evident at doses 50 or more times the maximum human mg/kg dose.
In vitro og in vivo genetiske toksikologistudier har ikke vist tegn på mutagent potentiale.
In vitro and in vivo genetic toxicology studies have shown no evidence of mutagenic potential.
Et 2 års karcinogenetisk museforsøg med pravastatindoser på 250 og 500 mg/ kg/ dag (≥ 310 gange den maksimale humane mg/ kg dosis) viser en statistisk signifikant stigning i forekomst af hepatocellulære karcinomer hos hanner og hunner samt lungeadenomer kun hos hunner.
In mice, a 2-year carcinogenicity study with pravastatin demonstrates at doses of 250 and 500 mg/kg/day (≥ 310 times the maximum human mg/kg dose), a statistically significant increases in the incidence of hepatocellular carcinomas in males and females, and lung adenomas in females only.
Et 2- års karcinogenetisk studie med rotter, der fik en dosis på 100 mg/ kg/ dag (= 125 gange den maksimale humane mg/ kg dosis), viser en statistisk signifikant øgning af hepatocellulært karcinom kun hos hanner.
In rats a 2-year carcinogenicity study demonstrates at a dose of 100mg/kg/day (125 times the maximum human mg/kg/dose) a statistically significant increase in the incidence of hepatocellular carcinomas in males only.
[To be implemented nationally]
[To be implemented nationally]
6. 3 Opbevaringstid
CPMP/6214/03 6.3 Shelf life
[To be implemented nationally]
Not all pack sizes may be marketed [To be implemented nationally]
[To be implemented nationally] CPMP/ 3257/ 03
[To be implemented nationally]
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
32/ 32
28/28
London, den 10. april 2006 EMEA/ 85968/ 2006
London, 10 April 2006 EMEA/ 85997/ 2006
SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE
SUMMARY INFORMATION ON REFERRAL OPINION
SAG I HENHOLD TIL ARTIKEL 30 I RÅDETS DIREKTIV 2001/ 83/ EF OM
PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/ 83/ EC FOR
Prograf og tilknyttede navne (se bilag I)
Prograf and associated names (See Annex I)
Tacrolimus er et immunosuppressivum af macrolid- typen, der farmakologisk tilhører klassen af calcineurin- hæmmere.
Tacrolimus is a macrolide immunosuppressant belonging to the pharmacological class of the calcineurin inhibitors.
Der var blevet godkendt forskellige produktresuméer (SPC) på grundlag af nationale beslutninger, der afveg fra tilladelserne i EU- medlemsstaterne.
Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States.
I henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, indbragte Fujisawa GmbH den 23. marts 2005 på vegne af samtlige indehavere af markedsføringstilladelser (se bilag 1 til udtalelsen) en sag for EMEA med henblik på at harmonisere de nationale produktresuméer for lægemidlet Prograf og tilknyttede navne.
On 23 march 2005, Fujisawa GmbH on behalf of all the Marketing Authorisation Holders (see Annex 1 of Opinion) presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the national SPCs of the medicinal product Prograf and associated names.
Efter at CHMP havde behandlet vurderingsrapporterne fra rapportøren/ medrapportøren, taget hensyn til den faglige drøftelse i udvalget og behandlet bemærkningerne fra indehaverne af markedsføringstilladelsen, var CHMP af den opfattelse, at Prograf og tilknyttede navne udviste et gunstigt benefit/ risk- forhold til følgende indikationer:
The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/ risk ratio of Prograf and associated names is considered to be positive in the following indications:
Profylakse af transplantatafstødning hjerteallotransplantat.
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.
Europa- Kommissionen traf en afgørelse den 10/ 04/ 2006.
A Decision was issued by the European Commission on 10/ 04/ 06.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGER( E), INDEHAVERE AF MARKEDSFØRINGSTILLADELSE( R) I MEDLEMSSTATERNE OG NORGE OG ISLAND
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
< Særnavn > < Navn >
Invented name
221- 227 A- 1140 Wien Østrig
Linzerstraße 221 – 227 1140 Vienna Austria
Koncentrat till infusionsvaeske, Intravenøs anvendelse opløsning
Concentrate for Solution for Infusion
Kapsel, hård Oral anvendelse
Oral use
61 D- 81673 München Tyskland
61 81673 München Germany
Box 25676 2003 Strovolos 1640 Nikosia Cypern
Box 25676 2003 Strovolos 1640 Nicosia
Astellas Pharma s. r. o Meteor Office Centre Park Sokolovská 100/ 94 186 00 Praha 8 Den Tjekkiske republik
Meteor Office Centre Park Sokolovská 100/ 94 186 00 Praha 8 Czech Republic
3 Tyskland
3 Germany
Astellas Pharma a/ s Naverland 4 2600 Glostrup Danmark
Astellas Pharma a/ s Naverland 4 2600 Glostrup Denmark
Tatoiou Street Lamia National Road 14671 Nea Erythrea Grækenland
Tatoiou Street Lamia National Road 14671 Nea Erythrea Greece
4 Grækenland
Greece
Tatoiou Street Lamia National Road 14671 Nea Erythrea Grækenland
Tatoiou Street Lamia NationalRoad 14671 Nea Erythrea Greece
Spanien
Intravenous use
Astellas Pharma S. A.
Spain
Paseo del Club Deportivo n° 1, Bloque 14 28223 Pozuelo de Alarcón (Madrid) Spanien
Astellas Pharma S. A Paseo del Club Deportivo n°1, Bloque 14 28223 Pozuelo de Alarcón (Madrid) Spain
5 Finland
5 Finland
61 81673 München Tyskland
61 81673 München Germany
6 Ungarn
6 Hungary
25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Irland
25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Ireland
25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Irland
25, The Courtyard, Kilcarbery Business Park Clondalkin, Dublin 22 Ireland
Astellas Pharma S. p. A Via delle Industrie 1 20061 Carugate (Milano) Italien
Via delle Industrie 1 20061 Carugate (Milano) Italy
7 Italien
7 Italy
Postbus 108 2350 AC Leiderdorp Nederlandene
Postbus 108 2350 AC Leiderdorp The Netherlands
8 Holland
8 The Netherlands
Astellas Farma Limitida Edifício Cinema Rua José Fontana, n°1, 1° andar 2770- 101 Paço de Arcos Portugal 2770- 101 Paço de Arcos Portugal
Astellas Farma Limitada Edifício Cinema Rua José Fontana, n° 1, 1° andar 2770-101 Paço de Arcos Portugal
Astellas Farma Limitida Edifício Cinema Rua José Fontana, n°1, 1° andar 2770- 101 Paço de Arcos Portugal
Astellas Farma Limitada Edifício Cinema Rua José Fontana, n° 1, 1° andar 2770-101 Paço de Arcos Portugal
10 Slovenien
10 Slovenia
Wolfova 1 1000 Ljubljana Slovenien
Wolfova 1 1000 Ljubljana Slovenia