natgillin/translations-raw huggingface dataset:
I et prospektivt langtidsstudie (6- 15 måneders varighed, CLASS studiet), fik 5. 800 OA og 2. 200 RA patienter celecoxib 400 mg 2 gange daglig (4 gange og 2 gange den anbefalede dosis til henholdsvis OA og RA), ibuprofen 800 mg 3 gange daglig eller diclofenac 75 mg 2 gange daglig (begge i terapeutiske doser).
In a prospective long-term safety outcome study (6 to 15 month duration, CLASS study), 5,800 OA and 2,200 RA patients received celecoxib 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg TID or diclofenac 75 mg BID (both at therapeutic doses).
22% af de inkluderede patienter fik samtidig lavdosis acetylsalicylsyre (≤ 325 mg/ dag), primært som kardiovaskulær profylakse.
Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (≤ 325 mg/ day), 26 primarily for cardiovascular prophylaxis.
Også for den kombinerede NSAID- gruppe var der ingen statistisk signifikant forskel for komplicerede mavesår (relativ risiko 0, 77, 95%, CI 0, 41 - 1, 46, set over hele studieperioden).
Also for the combined NSAID group there was no statically significant difference for complicated ulcers (relative risk 0,77, 95% CI 0.41-1.46, based on entire study duration).
Ved det kombinerede endepunkt, komplicerede og symptomatiske mavesår, var hyppigheden i celecoxib- gruppen signifikant lavere i forhold til NSAID- gruppen (relativ risiko 0, 66, 95% CI 0, 45- 0, 97), men ikke mellem celecoxib og diclofenac.
For the combined endpoint, complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group, relative risk 0.66, 95% CI 0.45-0.97 but not between celecoxib and diclofenac.
De patienter, som fik celecoxib og lavdosis acetylsalicylsyre samtidig, oplevede 4 gange hyppigere komplicerede mavesår i forhold til dem, der fik celecoxib alene.
Those patients on celecoxib and concomitant low- dose acetylsalicylic acid experienced 4 fold higher rates of complicated ulcers as compared to those on celecoxib alone.
Hyppigheden af klinisk betydende fald i hæmoglobin (> 2 g/ dl), bekræftet ved gentagne målinger, var signifikant lavere hos patienter med celecoxib i forhold til NSAID- gruppen (relativ risiko 0, 29, 95% CI 0, 17- 0, 48).
The incidence of clinically significant decreases in haemoglobin (> 2 g/ dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95% CI 0.17- 0.48.
Igangværende kliniske studier:
Ongoing Clinical Trials:
Foreløbige sikkerhedsdata fra 3 langtidsstudier med celecoxib til patienter med sporadisk adenomatøs polypose eller patienter, som er i særlig risiko for at udvikle Alzheimers sygdom er tilgængelige.
Preliminary safety information from three long-term studies involving patients with Sporadic Adenomatous Polyps or who were predisposed to developing Alzheimer’ s disease treated with celecoxib is available.
I et af de 3, APC- studiet (Prevention of Sporadic Colorectal Adenomas with Celecoxib) ses en dosis- relateret øgning i kardiovaskulære hændelser (hovedsagelig myokardieinfarkt, MI) ved doser på 200 mg 2 gange daglig og 400 mg 2 gange daglig sammenlignet med placebo.
In one of the three studies, the APC (Prevention of Sporadic Colorectal Adenomas with Celecoxib), there was a dose-related increase in cardiovascular events (mainly myocardial infarction, MI) at celecoxib doses of 200 mg BID and 400 mg BID compared to placebo.
1 års behandling.
The increased risk became apparent after approximately 1 year of treatment.
Den relative risiko (RR) for det kombinerede endepunkt (kardiovaskulær død, MI eller slagtilfælde) var henholdsvis 3, 4 (95% CI 1, 4- 8, 5) for den høje dosis og 2, 5 (95% CI 1, 0- 6, 4) for den laveste dosis af celecoxib sammenlignet med placebo.
The relative risk (RR) for the composite endpoint (cardiovascular death, MI or stroke) was 3.4 (95% CI 1.4 - 8.5) for the higher dose and 2.5 (95% CI 1.0 - 6.4) for the lower dose of celecoxib, compared to placebo.
Den absolutte risiko for det kombinerede endepunkt var 3, 0% for den høje dosis af celecoxib, 2, 2% for den laveste dosis af celecoxib, og 0, 9 for placebo.
The absolute risk for the composite endpoint was 3.0% for the higher dose of celecoxib, 2.2% for the lower dose of celecoxib, and 0.9% for placebo.
2- 3 timer.
5.2 Pharmacokinetic properties Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Den interindividuelle variation i plasmakoncentrationen af celecoxib er ca. 10 foldig.
The inter-subject variability in the exposure of celecoxib is about 10-fold.
97% ved terapeutiske plasmakoncentrationer og celecoxib har ikke præference for binding til erytrocytterne.
Plasma protein binding is about 97% at therapeutic plasma concentrations and the drug is not preferentially bound to erythrocytes.
Hovedmetabolitterne, som findes i cirkulation, har ingen målelig COX- 1 eller COX- 2 hæmmende aktivitet.
The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
30 Celecoxib metaboliseres i leveren ved hydroxylering, oxidation og til dels glucuronidation.
Celecoxib is metabolised in the liver by hydroxylation, oxidation and some glucuronidation.
100% forhøjet.
The plasma concentration of celecoxib is approximately 100% increased in elderly women (> 65 years).
Behandlingen skal initieres med halvdelen af den anbefalede dosis hos patienter med moderat nedsat leverfunktion (serumalbumin 25 - 35 g/ l).
Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/ L).
Patienter med svær nedsat leverfunktion (serumalbumin under 25 g/ l) er ikke undersøgt, hvorfor celecoxib er kontraindiceret til denne patientgruppe.
Patients with severe hepatic impairment (serum albumin < 25 g/ l) have not been studied and celecoxib is contraindicated in this patient group.
Celecoxibs farmakokinetik er ikke undersøgt hos patienter med nedsat nyrefunktion, men det er usandsynligt, at den er meget ændret i denne patientgruppe.
The pharmacokinetics of celecoxib has not
Forsigtighed anbefales ved behandling af patienter med nedsat nyrefunktion.
27 been studied in patients with renal impairment but is unlikely to be markedly changed in these patients.
Svær nedsat nyrefunktion er en kontraindikation.
Thus caution is advised when treating patients with renal impairment.
5. 3 Prækliniske sikkerhedsdata
Severe renal impairment is contraindicated.
5 gange (rotter) og 3 gange (kaniner) højere end opnået ved behandling med den maksimalt anbefalede daglige dosis til mennesker (400 mg).
5.3 Preclinical safety data Conventional embryo-fetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat fetuses and of cardiovascular malformations in rabbit fetuses at systemic exposures to free drug approximately 5X (rat) and 3X (rabbit) higher than those achieved at the maximum recommended daily human dose (400 mg).
I et peri/ post- natalt forsøg med rotter, som inkluderede behandling i den organdannende periode, blev diafragmabrok også set.
Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Dyreforsøg med celecoxib i den tidlige fosterudvikling medførte abort i præ - og post implantationsperioden.
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
I et peri/ post- natalt rotteforsøg er der set toksicitet i afkommet.
In a peri-post natal study in rats, pup toxicity was observed.
I et 2- årigt toksicitetstudie med høje doser er der set en stigning i ikke- binyrebetinget trombose hos hanrotter.
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Kapsler 100 mg:
6.1 List of excipients Capsules 100 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Mærkningsblækket indeholder farvestoffet indigotin I (E 132).
Capsule shells contain gelatin, titanium dioxide E171; ink contains indigotine E132
31 Kapsler 200 mg:
Capsules 200 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Mærkningsblækket indeholder farvestoffet jernoxid (E 172).
Capsule shells contain gelatin, titanium dioxide E171; ink contains iron oxide E172.
6. 2 Uforligeligheder
6.2 Incompatibilities Not applicable.
6. 3 Opbevaringstid
6.3 Shelf-life 3 years.
Må ikke opbevares over 30°C.
6.4 Special precautions for storage Do not store above 30oC.
Klar PVC blister eller aluminiumblister.
6.5 Nature and content of container Clear or opaque PVC blisters or aluminium cold-formed blisters.
6. 6 Instruktioner vedrørende håndtering og destruktion
6.6 Instructions for use and handling, and disposal (if appropriate) No special requirements.
{navn og adresse} [Landets navn på eget sprog.
{Name and address} [Country name in the language of the text, NO telephone, fax numbers, e-mail
Telefonnummer, faxummer, e- mailadresse eller website]
28 addresses or websites.]
MARKEDSFØRINGSTILLADELSESNUMMER
8 MARKETING AUTHORISATION NUMBER(S)
[Punkt indsættes af indehaver af markedsføringstilladelsen, når markedsføringstilladelsen er udstedt]
[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
9 DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
[Punkt udfyldes af indehaver af markedsføringstilladelsen, når markedsføringstilladelsen er blevet udstedt eller fornyet]
[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.]
32 BILAG IV
29 ANNEX IV
33 Registreringsindehaverens opfølgende foranstaltninger
30 Follow-up measures of the Marketing Authorisation Holder
På CHMP’ s anmodning indvilgede indehaveren af markedsføringstilladelsen i at træffe følgende opfølgende foranstaltninger:
As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below:
Område Klinisk aspekt 1
Area Description Clinical 1
Beskrivelse Indehaveren af markedsføringstilladelsen forpligter sig til at foretage en global kardiovaskulær undersøgelse med henblik på at bekræfte den langsigtede kardiovaskulære sikkerhed ved Celecoxib.
The MAH commits to performing a global CV study to confirm long term CV safety of Celecoxib.
Desuden forpligter indehaveren af markedsføringstilladelsen sig til at fortsætte dialogen med EMEA/ CHMP med hensyn til undersøgelsens udformning.
Furthermore, the MAH commits to continue dialogue with EMEA/ CHMP with regard to study design
Indehaveren af markedsføringstilladelsen indsender en analyse af de spontane indberetninger om alle alvorlige hudreaktioner fra analysen af RegiSCAR - databasen og drøfter resultaterne yderligere med Rapporteur efter indsendelsen.
To submit an analysis of spontaneous reports for all serious skin reactions from the analysis of the RegiSCAR database and further discuss results with Rapporteur following submission.
Indehaveren af markedsføringstilladelsen fremlægger de endelige undersøgelsesrapporter for følgende langtids- APC/ Pre- SAP/ ADAPT - undersøgelser i deres fulde længde, når de foreligger.
To provide final study reports for the following long-term trials APC/ Pre- SAP/ ADAPT in full, when available.
Hvis der ikke foreligger komplette undersøgelsesrapporter, fremskaffer indehaveren af markedsføringstilladelsen publikationer/ dokumenter i stedet for undersøgelsesrapporten (- erne).
Where full study reports are not available to the MAH, it agrees to provide publications/ manuscripts in lieu of the study report(s).
Indehaveren af markedsføringstilladelsen indberetter fortsat alle bivirkninger på grundlag af den bivirkningsprofil, der er udledt af de placebokontrollerede undersøgelser, især langtidsundersøgelser og andre indberettede erfaringer efter udstedelsen af markedsføringstilladelsen, og foretager ændringer i produktresuméet i overensstemmelse med standardprocedurerne for indberetning i forbindelse med lægemiddelovervågning (PSUR, type II - variationer inden for den gensidige anerkendelsesprocedure).
To continue to report all ADR frequencies, based on the adverse reaction profile derived from placebo controlled studies, particularly the long-term studies as well as other post marketing experience and make changes to the SPC in accordance with standard Pharmacovigilance reporting and procedures (PSUR, Type II variation within MRP).
Indehaveren af markedsføringstilladelsen fremlægger resultaterne af alle igangværende epidemiologiske undersøgelser i overensstemmelse med opdateringer om igangværende post- marketingaktiviteter (f. eks. inden for PSUR’ er for Celebra).
To provide all ongoing epidemiological studies in accordance with updates on on-going post marketing activities (for example, within PSURs for Celebra).
LISTE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER, EMBALLAGE OG PAKNINGSSTØRRELSER I MEDLEMSSTATERNE BILAG I
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES
Indehaver af markedsføringstilladelse
Member State
Særnavn
Holder
Styrke Lægemiddelform
Invented name Strength
∅STRIG
Austria
Bayer Austria Gesellschaft G. m. b. H.
Bayer Austria Gesellschaft G. m. b. H.
Lerchenfelder Guertel 9- 11 A- 1164 Wien
Lerchenfelder Guertel 9-11 A-1164 Wien
Lipobay
Lipobay
0, 1 mg
0.1 mg
14, 20, 28, 30, 50, 98, 100 og 160 tabletter
14, 20, 28, 30, 50, 98, 100 and 160 tablets
0, 2 mg
0.2 mg
0, 4 mg
0.4 mg
Liposterol
Liposterol
CPMP/ 811/ 02
CPMP/ 8
EMEA 2002
 EMEA 2002
Bayer NV Louizalaan 143 B- 1050 Brussel Belgium
Bayer NV Louizalaan 143 B-1050 Brussel Belgium
Fournier Pharma S. A.
Fournier Pharma S. A.
Rue des Trois Arbres, 16b B- 1180 Bruxelles Belgium
Rue des Trois Arbres, 16b B-1180 Bruxelles Belgium
Cholstat
Cholstat
Bayer AG Monheim D- 51368 Leverkusen Germany
Bayer AG Monheim D-51368 Leverkusen Germany
CPMP/ 811/ 02
CPMP/ 811/ 0
28 og 98 tabletter
28 and 98 tablets
FINLAND
Finland
Bayer AG Monheim D- 51369 Leverkusen Germany
Bayer AG Monheim D-51369 Leverkusen Germany
14, 20, 28, 30, 50, 98, 100 and 160 tabletter
14, 20, 28, 30, 50, 98, 100 and 160 tablets
CPMP/ 811/ 02
CPMP/ 811/ 02
Fournier 9, rue Petitot F- 21000 Dijon
Fournier 9, rue Petitot F-21000 Dijon
14, 20, 28, 30, 50, 98, 100 tablets 160 tabletter (hospital)
14, 20, 28, 30, 50, 98, 100 tablets 160 tablets (hospital)
14, 20, 28 og 30 tabletter 50, 98, 100 og 160 tabletter (hospital)
14, 20, 28 and 30 tablets 50, 98, 100 and 160 tablets (hospital)
Bayer Pharma 13, rue Jean Jaurès F- 92807 Puteaux Cedex
Bayer Pharma 13, rue Jean Jaurès F-92807 Puteaux Cedex
Staltor
Staltor
14, 20, 28, 30, 50, 98, 100 tabletter 160 tabletter (hospital)
14, 20, 28, 30, 50, 98, 100 tablets 160 tablets (hospital)
Bayer Vital GmbH & Co.
Bayer Vital GmbH & Co.
KG Geb.
KG Geb.
D162 D- 51368 Leverkusen
D162 D-51368 Leverkusen
30, 50, 100 (OP) 10x16 (AP)
30, 50, 100 (OP) 10x16 (AP)
20, 30, 50, 100 (OP) 160 (AP) 20 (UM)
20, 30, 50, 100 (OP) 160 (AP) 20 (UM)
Bayer AG Pharma Deutschland D- 51368 Leverkusen
Bayer AG Pharma Deutschland D-51368 Leverkusen
Vazqol
Vazqol
Fournier Pharma GmbH Zenas Justus- von- Liebig- Str.
Fournier Pharma GmbH Justus-von-Liebig-Str.
16 D- 66280 Sulzbach
16 D-66280 Sulzbach
20, 30, 50, 100 (OP) 20 (UM)
20, 30, 50, 100 (OP) 20 (UM)
GRæKENLAND
Greece
Bayer Hellas ABEE Ακακίων 54Α GR- 15125 Μαρούσι Αθήνα
Bayer Hellas ABEE Ακακίων 54Α GR-15125 Μαρούσι Αθήνα
Lipoban
Lipoban
14, 28, 30, 50, 98 og 100 tabletter
14, 28, 30, 50, 98 and 100 tablets
Elpen AE 21ο χλµ Λεωφ.
Elpen AE 21ο χλ µ Λεωφ.
Μαραθώνα GR - 19009 Πικέρµι Αττική
Μαραθώνα GR- 19009 Πικέρ µι Αττική
Eltina
Eltina
ISLAND
Iceland
Bayer AG Bayerwerk D- 51368 Leverkusen Germany
Bayer AG Bayerwerk D-51368 Leverkusen Germany
Bayer PLC Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK, United Kingdom
Bayer PLC Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK, United Kingdom
Bayer PLC Bayer House Strawberry Hill Newbury Berkshire RG14 1JA UK, United Kingdom
Bayer PLC Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK, United Kingdom
Viale Certosa, 130 I- 20156 Milano
Viale Certosa, 130 I-20156 Milano
14, 28 og 98 tabletter
14, 28 and 98 tablets
Viale Certosa, 130
Viale Certosa, 130 I-20156 Milano
Blister
Oral use
EMEA 2002
Blister
160 tabletter
14, 20, 28, 30, 50, 98, 100 and 160 tablets
Fournier Pharma S. p. A.
Fournier Pharma S. p. A.
Via Cassanese, 224 I- 2090 Segrate Milano
Via Cassanese, 224 I-2090 Segrate Milano
Cervasta
Cervasta
Chiesi Farmaceutici S. p. A.
Chiesi Farmaceutici S. p. A.
Via Palermo, 26/ A I- 43100 Parma
Via Palermo, 26/ A I-43100 Parma
Stativa
Stativa
Chiesi Farmaceutici
Chiesi Farmaceutici S. p. A.
S. p. A.
Blister
50, 98, 100 og 160 tablets
14, 20, 28, 30, 50, 98, 100 and 160 tablets
LUXEMBOURG
Luxembourg
Bayer Belgium 143 Avenue Louise B- 1050 Bruxelles Belgium
Bayer Belgium 143 Avenue Louise B-1050 Bruxelles Belgium
Fournier Pharma 16b rue des Trois Arbres B- 1180 Bruxelles Belgium
Fournier Pharma 16b rue des Trois Arbres B-1180 Bruxelles Belgium
14, 20, 28, 30, 50, 98, og 100 tabletter
14, 20, 28, 30, 50, 98, and 100 tablets
Nijverheidsweg 26 NL- 3641 RR Mijdrecht
Nijverheidsweg 26 NL-3641 RR Mijdrecht
Filmovertrukket tablet Oral anvendelse
Film-coated tablets
HOLLAND
 EMEA 2002
PORTUGAL
Portugal
Fournier Farmacêutica Portugal Lda.
Fournier Farmacêutica Portugal Lda.
PRT Avenida Eng.
PRT Avenida Eng.
Duarte Pacheco Amoreiras P- 1070 Lisboa
Duarte Pacheco Amoreiras P-1070 Lisboa
PRT Lipobay Rua da Quinta do Pinheiro, 5 P- 2795 Carnaxide - Lisboa
Lipobay
14 og 28 tabletter
14 and 28 tablets
PRT Lipobay Rua da Quinta do Pinheiro, 5 P- 2795 Carnaxide - Lisboa
PRT Rua da Quinta do Pinheiro, 5 P-2795 Carnaxide - Lisboa
14, 28 og 56 tabletter
14, 28, and 56 tablets
Quimica Farmaceutica Bayer S. A. c/ Calabria 268 E- 08029 Barcelona
Quimica Farmaceutica Bayer Lipobay S. A. c/ Calabria 268 E-08029 Barcelona
Laboratorios Fournier SA Zenas micro Ronda de Poniente 16 E- 28760 Tres Cantos
Laboratorios Fournier SA Ronda de Poniente 16 E-28760 Tres Cantos
Bayer AG, Monheim D- 51368 Leverkusen Germany
Bayer AG, Monheim D-51368 Leverkusen Germany
Bayer AG, Monheim D- 51368 Leverkusen
Bayer AG, Monheim D-51368 Leverkusen Germany
Lipobay
Oral use
Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK
Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK
0, 2 mg
0.1 mg
UK
15
0, 4 mg
0.2 mg
Vaslip
Lipobay
0, 1 mg
0.3 mg
0, 2 mg
0.4 mg
Vaslip
Vaslip
0, 3 mg
0.1 mg
Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA –
Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK
UK
16
Liposterol
Vaslip
Bayer plc Bayer House Strawberry Hill Newbury
Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA – UK
Zenas
Liposterol
Berkshire RG14 1JA – UK
17
Zenas
Zenas
FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR TILBAGEKALDELSE AF MARKEDSFØRINGSTILLADELSER FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
CPMP/ 811/ 02 FAGLIGE KONKLUSIONER
CPMP/ 811/ 02 SCIENTIFIC CONCLUSIONS
INDEHOLDENDE CERIVASTATIN GODKENDT I HENHOLD TIL DEN GENSIDIGE ANERKENDELSESPROCEDURE.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CERIVASTATIN CONTAINING MEDICINAL PRODUCTS AUTHORISED UNDER THE MUTUAL RECOGNITION PROCEDURE.
Cerivastatin (Lipobay) er en HMG- CoA- reduktasehæmmer, som i henhold til det gensidige anerkendelsessystem er godkendt i Europa i doser på 0, 1- 0, 4 mg til behandling af hyperlipidæmi.
Cerivastatin (Lipobay) is an HMG CoA reductase inhibitor authorised in Europe through the Mutual Recognition system at doses of 0.1- 0.4mg for the treatment of hyperlipidaemia.
Advarsler om risikoen for myopati, herunder rabdomyolyse, samt advarsler om interaktion med gemfibrozil har været inkluderet i produktinformationen, siden der blev givet licens til Lipobay i EU.
Warnings about the risk of myopathy, including rhabdomyolysis, as well as warnings about the interaction with gemfibrozil have been included in product information since Lipobay was first licensed in the EU.
I USA blev der i 1999 tilføjet en særlig kontraindikation til produktinformationen mod ordinering sammen med gemfibrozil.
In the US a specific contra-indication against co-prescription with gemfibrozil was added to product information in 1999.
En europæisk opdatering af produktinformationen for Lipobay (Type II- variantion) var under behandling, da de spanske myndigheder udtrykte deres bekymring over en række indberetninger i Spanien af dødsfald som følge af rabdomyolyse i forbindelse med Lipobay.
The Europe-wide update of Lipobay product information (Type II variation), was under discussion when the Spanish authorities raised concerns about a number of reports in Spain of fatal cases of rhabdomyolysis in association with Lipobay.
Bekymringen gik på en mulig øget risiko for rabdomyolyse i forbindelse med behandling med cerivastatin – navnlig kombineret med gemfibrozil.
There were concerns about a possibly increased risk of rhabdomyolysis associated with the use of cerivastatin – particularly in combination with gemfibrozil.
Efter drøftelser mellem Det Forenede Kongerige som referencemedlemsstat for Lipobay, Spanien og indehaveren af markedsføringstilladelsen, Bayer, blev der den 25. / 26. juni indført en hastende sikkerhedsrestriktion.
Following discussions between the UK, as Reference Member State for Lipobay, Spain and the marketing authorisation holder (MAH), Bayer, an Urgent Safety Restriction took place on 25/ 26 June.
En kontraindikation mod samtidig behandling med cerivastatin og gemfibrozil, begrænsning af den maksimale dosis til 0, 4 mg samt understregning af vigtigheden af dosistitrering blev tilføjet.
The changes to the Summary of Product Characteristics (SPC) included the following: the introduction of a contraindication to the concomitant use of cerivastatin and gemfibrozil, restriction of the maximum dose to 0.4mg and reinforcement of the importance of dose titration.
Den 8. august 2001 meddelte Bayer, at man frivilligt suspenderede markedsføringen og distributionen af cerivastatin i både EU og USA, mens man afventede yderligere evaluering af risikoen for rabdomyolyse i forbindelse med behandling med cerivastatin.
On 8 August 2001 Bayer announced that it was voluntarily suspending its marketing and distribution of cerivastatin from both the European and US markets pending further evaluation of the risk of rhabdomyolysis associated with its use.
Den 19. september 2001 underrettede Portugal EMEA om en sag indbragt i henhold til artikel 15a i direktiv 75/ 319/ EØF (nu artikel 36 i direktiv 2001/ 83/ EF) vedrørende alle lægemidler indeholdende cerivastatin, som er godkendt i henhold til proceduren for gensidig anerkendelse.
On 19 September 2001, Portugal notified the EMEA of a referral under Article 15a of Directive 75/ 319/ EEC (now Article 36 of Directive 2001/ 83/ EC) regarding all cerivastatin containing medicinal products approved under a Mutual Recognition procedure.
Portugal krævede, at der blev gennemført en fuldstændig evaluering af risk/ benefit- forholdet på grund af mistanken om en mulig øget risiko for rabdomyolyse.
Portugal requested that a full assessment of the risk-benefit of cerivastatin be carried out because of concerns regarding a possible increased risk of rhabdomyolysis.
EFFEKTRESUMÉ
OVERVIEW OF EFFICACY
Effekten af lægemidler indeholdende cerivastatin blev drøftet i CPMP på grundlag af evalueringsrapporter fra rapportøren og med- rapportøren samt de data, der var fremlagt af indehaveren af markedsføringstilladelsen.
A discussion on the efficacy of cerivastatin containing medicinal products took place at CPMP based on the assessment reports of the Rapporteur and co-Rapporteur and the data presented by the MAH.
Hovedpunkterne er opsummeret nedenfor.
The main points are summarised below.