natgillin/translations-raw huggingface dataset:
Indehaveren af markedsføringstilladelsen blev anmodet om at foreslå og videnskabeligt underbygge en fælles EU- tilgang, idet teksten vedrørende kontraindikationer ikke var harmoniseret medlemsstaterne imellem, specielt vedrørende anvendelse til patienter med: • (alvorlige) lever - og nyresygdomme og sygdomme i galdeblæren.
Special warnings and precautions for use After an assessment of the documentation provided by the MAH and an evaluation of the current EU- wide clinical practices relating to the use of Lopid, the most suitable harmonised Section 4.4 Special Warnings and Precautions for Use text was approved (See Annex III).
En nyligt rapporteret interaktion med stoffet repaglinid er blevet føjet til kontraindikationerne.
The risk of muscle disorders (myopathy/ rhabdomyolysis) and the special warnings and special precautions for use in case of concomitant administration of HMG CoA reductase inhibitors were further emphasised in the harmonised SPC.
Kombinationen af gemfibrozil med repaglinid medførte en 8- dobling af eksponeringen for repaglinid, hvilket medførte hypoglykæmi.
In addition, recently reported interactions with other medicinal products have been added to the SPC for Lopid.
Efter vurdering af dokumentationen fra indehaveren af markedsføringstilladelsen og evaluering af den aktuelle kliniske praksis i hele EU med hensyn til anvendelsen af Lopid anses følgende for at være den mest egnede harmoniserede tekst til afsnit 4. 3 om kontraindikationer:
Interaction with other medicinal products and other forms of interaction After an assessment of the documentation provided by the MAH and an evaluation of the current EU- wide clinical practices relating to the use of Lopid, the most suitable harmonised Section 4.5 Interaction with other medicinal products and other forms of interaction (See Annex III).
CHMP/ 1268/ 04 4. 3 Kontraindikationer
In addition, CHMP/ 1268/ 04
12/ 23
13/ 22
Nedsat leverfunktion.
recently reported interactions with other medicinal products have been added to the SPC for Lopid.
Patienter, der tidligere har haft fotoallergi eller fototoksicitetsreaktioner ved behandling med fibrater.
The risk of interaction with other medicinal products (esp. with those products metabolised through CYP2C9 and CYP2C8) was further emphasised in the harmonised SPC.
Desuden er en nylig indberettet interaktion med andre lægemidler føjet til produktresuméet for Lopid.
All other sections of the SPC were harmonised as a result of the referral procedure (except See Below; Administrative Issues).
Endelig mente CPMP, at alle præsentationsformer kan være nyttige til behandling af patienterne i de godkendte indikationer.
Finally, the CPMP considered that all presentations may be useful to treat the patients in the approved indications.
Risk/ benefit- overvejelser På grundlag af den dokumentation, der er fremlagt af indehaveren af markedsføringstilladelsen, og de faglige drøftelser i CPMP er CPMP af den opfattelse, at risk/ benefit- forholdet for Lopid er positivt ved anvendelse i forbindelse med:
Benefit/ Risk considerations Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/ risk ratio of Lopid is favourable for use relating to:
Lopid som et supplement til diæt og anden ikke- farmakologisk behandling (dvs. motion, vægttab) i forbindelse med:
Lopid as an adjunct to diet and other non-pharmacological treatment (e. g. exercise, weight reduction) for the following:
Behandling af dyslipidæmi Blandet dyslipidæmi kendetegnet ved hypertriglyceridæmi og/ eller lavt HDL- kolesterol.
Treatment of dyslipidemia Mixed dyslipidaemia characterised by hypertriglyceridaemia and/ or low HDL-cholesterol.
BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉERNE CHMP/ 1268/ 04 Ud fra følgende betragtninger:
GROUNDS FOR AMENDMENT CHARACTERISTICS
13/ 23
THE
EMEA 2004
SUMMARY(IES) OF
• formålet med indbringelsen af sagen var at
PRODUCT
harmonisere produktresuméet,
Whereas,
• det produktresumé, der er foreslået af indehaveren af markedsføringstilladelsen, er blevet vurderet på grundlag af den fremlagte dokumentation og de faglige drøftelser i CPMP, • der er i produktresuméet blevet medtaget vigtige nye oplysninger om interaktionen med flere lægemidler,
• the scope of the referral was the harmonisation of the Summaries of Products Characteristics, • the Summary of Products Characteristic proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, • Important new information on interactions with several medicinal products was included in the SPC,
Produktresuméet fremgår af bilag III til udtalelsen om Lopid og tilknyttede navne (se bilag I).
the CPMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III of the Opinion for Lopid and associated names (see Annex I).
De forskelle, som blev identificeret på tidspunktet for indbringelsen af sagen, er blevet afhjulpet.
The divergences identified at the start of the referral have been resolved.
Dette er det SPC, der var bilag til Europa- Kommissionens beslutning vedrørende denne artikel 30 arbitreringssag vedrørende lægemidler indeholdende gemfibrozil.
This SPC is the one that was Annexed to the Commission Decision on this Article 30 referral for gemfibrozil containing medicinal products.
< (LOPID og andre navne) > < (styrke) > mg < tabletter > < kapsler > < granulater > < filmovertrukne tabletter > < overtrukne tabletter >
< (LOPID and associated names) > < (strength) > mg< tablets > < capsules > < granules > < film-coated tablets > < coated tablets >
[Se Annex I.
[See Annex I.
Implementeres nationalt]
To be implemented nationally]
1 kapsel indeholder 300 mg gemfibrozil.
Each capsule contains 300 mg gemfibrozil.
1 filmovertrukken tablet indeholder 450 mg, 600 mg eller 900 mg gemfibrozil Hjælpestoffer se pkt.
Each film-coated tablet contains 450 mg, 600 mg or 900 mg gemfibrozil.
< Kapsler > < Filmovertrukne tabletter > < Tabletter > < Granulater > < Overtrukne tabletter >
< Capsule > < Film-coated tablet > < Tablet > < Granules > < Coated tablet >
Primær forebyggelse Reduktion i kardiovaskulær morbiditet hos mænd med øget ikke- HDL kolesterol og ved høj risiko for en første kardiovaskulær hændelse, især når et statin ikke er egnet eller ikke tåles (se pkt.
Primary prevention Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is considered inappropriate or is not tolerated (see section 5.1).
5. 1).
4.2.
Før gemfibrozil initieres, skal der så godt som muligt kontrolleres for andre medicinske lidelser, som f. eks. hypothyroidisme og diabetes mellitus, og patienterne skal sættes på en standard lipidsænkende diæt, som skal fortsættes under behandlingen.
Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment.
Lopid bør indtages oralt.
Lopid should be taken orally.
Voksne Dosis er 900- 1200 mg dagligt.
Adult The dose range is 900 mg to 1200 mg daily.
Den eneste dosis, der har dokumenteret effekt på morbiditet er 1200 mg dagligt.
The only dose with documented effect on morbidity is 1200 mg daily.
Dosis på 1200 mg indtages som 600 mg 2 gange dagligt ½ time før morgenmaden og ½ time før aftensmaden.
The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.
Dosis på 900 mg indtages som enkeltdosis ½ time før aftensmaden.
The 900 mg dose is taken as a single dose half an hour before the evening meal.
CHMP/ 1268/ 04 Børn og unge
CHMP/ 1268/ 04 Elderly (over 65 years old) As for adults
Gemfibrozilbehandling er ikke undersøgt hos børn.
Gemfibrozil therapy has not been investigated in children.
Lopid bør ikke anvendes til børn, da der ikke er tilstrækkelig dokumentation.
Due to the lack of data the use of Lopid in children is not recommended.
Nedsat nyrefunktion Hos patienter med mild til moderat nedsat nyrefunktion (glomerulær filtrationshastighed på henholdsvis 50- 80 og 30 - < 50 ml/ min/ 1, 73 m2) er startbehandlingen 900 mg dagligt, og nyrefunktionen bør vurderes før dosis øges.
Renal impairment In patients with mild to moderate renal impairment (Glomerular filtration rate 50 - 80 and 30 - < 50 ml/ min/ 1.73 m2, respectively), start treatment at 900 mg daily and assess renal function before increasing dose.
4. 3).
Lopid should not be used in patients with severely impaired renal function (see section 4.3).
Nedsat leverfunktion Gemfibrozil er kontraindiceret ved nedsat leverfunktion (se pkt.
Hepatic impairment Gemfibrozil is contraindicated in hepatic impairment (see section 4.3).
4. 3).
4.3.
Overfølsomhed over for gemfibrozil eller et eller flere af hjælpestofferne.
Hypersensitivity to gemfibrozil or any of the excipients.
4. 5).
History of/ or pre-existing gall bladder or biliary tract disease, including gallstones Concomitant use of repaglinide (see section 4.5).
Patienter, der tidligere i anamnesen, har haft fotoallergi eller fototoksiske reaktioner under behandling med fibrater.
Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.
Muskellidelser (myopati/ rhabdomyolyse) Der er rapporteret myositis, myopati og markant forhøjet kreatininphospokinase (CPK) i forbindelse med gemfibrozil.
Muscle disorders (myopathy/ rhabdomyolysis) There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil.
Rhabdomyolyse er set i sjældne tilfælde.
Rhabdomyolysis has also been reported rarely.
Muskelskader må overvejes hos patienter, der får diffus myalgi, muskelømhed og/ eller markant forhøjet muskel CPK- værdier (> 5 gange den øvre normalgrænse); under disse tilstande skal behandlingen seponeres.
Muscle damage must be considered in any patient presenting with diffuse myalgia, muscle tenderness and/ or marked increase in muscle CPK levels (> 5x ULN); under these conditions treatment must be discontinued.
Samtidig HMG- CoA reduktasehæmmere Risikoen for muskelskader kan øges ved samtidig indtagelse af HMG- CoA reduktasehæmmre.
Concomitant HMG CoA reductase inhibitors The risk of muscle damage may be increased in the event of combination with an HMG-CoA reductase inhibitor.
4. 5) og dosisjustering kan være nødvendig.
Pharmacokinetic interactions may also be present (see also section 4.5) and dosage adjustments may be necessary.
Fordelen ved yderligere ændringer i lipidniveauer ved kombination af gemfibrozil og HMG- CoA reduktasehæmmere bør omhyggeligt opvejes mod den potentielle risiko ved sådanne kombinationer, og klinisk monitorering anbefales.
The benefit of further alterations in lipid levels by the combined use of gemfibrozil and HMG-CoA reductase inhibitors should be carefully weighed against the potential risks of such combinations and clinical monitoring is recommended.
Kreatininphosphokinase (CPK) niveau bør måles før start af en sådan kombinationsbehandling hos patienter med præ- disponerede faktorer for rhamdomyolyse, som f. eks.: • Nedsat nyrefunktion • Hypothyroidisme • Alkoholmisbrug • Alder > 70 år • Personlig eller familiær anamnese af hereditær muskellidelse • Tidligere muskeltoksisitet med andre fibrater eller HMG- CoA reduktasehæmmere i anamnesen.
A creatine phosphokinase (CPK) level should be measured before starting such a combination in patients with pre-disposing factors for rhabdomyolysis as follows: • renal impairment • hypothyroidism • alcohol abuse • age > 70 years • personal or family history of hereditary muscular disorders • previous history of muscular toxicity with another fibrate or HMG-CoA reductase inhibitor
Brug hos patienter med galdestensdannelse Gemfibrozil kan øge kolesteroludskillelsen i galden, og dermed øge potentialet for galdestensdannelse.
Use in patients with gallstone formation Gemfibrozil may increase cholesterol excretion into the bile raising the potential for gallstone formation.
Tilfælde af cholelithiasis er set under gemfibrozilbehandling.
Cases of cholelithiasis have been reported with gemfibrozil therapy.
Hvis der er mistanke om cholelithiasis, bør galdeblæren undersøges.
If cholelithiasis is
CHMP/ 1268/ 04 Monitorering af serumlipider
CHMP/ 1268/ 04
Under behandling med gemfibrozil er det nødvendigt jævnligt at monitorere serumlipider.
Monitoring serum lipids Periodic determinations of serum lipids are necessary during treatment with gemfibrozil.
Undertiden kan en paradoksal stigning i (total og LDL) kolesterol opstå hos patienter med hypertriglyceridæmi.
Sometimes a paradoxical increase of (total and LDL) cholesterol can occur in patients with hypertriglyceridaemia.
Hvis respons er utilstrækkeligt efter 3 måneders behandling med anbefalede doser, bør behandlingen seponeres og alternative behandlingsmuligheder overvejes.
If the response is insufficient after 3 months of therapy at recommended doses treatment should be discontinued and alternative treatment methods considered.
Monitorering af leverfunktionen Der er set stigninger i ALAT, ASAT, alkalisk fosfatase, LDH, kreatinkinase (CK) og bilirubin.
Monitoring liver function Elevated levels of ALAT, ASAT, alkaline phosphatase, LDH, CK and bilirubin have been reported.
Disse er sædvanligvis reversible, når gemfibrozil seponeres.
These are usually reversible when gemfibrozil is discontinued.
Derfor bør leverfunktionen undersøges jævnligt.
Therefore liver function tests should be performed periodically.
Gemfibrozilbehandling bør seponeres, hvis disse abnormiteter varer ved.
Gemfibrozil therapy should be terminated if abnormalities persist.
Monitorering af blodtælling I de første 12 måneder af gemfibrozilbehandlingen anbefales jævnligt blodtælling.
Monitoring blood counts Periodic blood count determinations are recommended during the first 12 months of gemfibrozil administration.
4. 8).
Anaemia, leucopenia, thrombocytopenia, eosinophilia and bone marrow hypoplasia have been reported rarely (see section 4.8).
4. 3 og 4. 5)
Interactions with other medicinal products (see also sections 4.3 and 4.5).
Samtidig brug af CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 og UGTA3 substrater Interaktionsprofilen af gemfibrozil er kompleks, og fører til en øget eksponering af mange lægemidler, hvis de anvendes sammen med gemfibrozil.
The interaction profile of gemfibrozil is complex resulting in increased exposure of many medicinal products if administered concomitantly with gemfibrozil.
4. 5).
Gemfibrozil potently inhibits CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 and UGTA3 enzymes (see section 4.5)
Samtid brug af hypoglykæmiske midler Der er set hypoglykæmiske reaktioner, når gemifibrozil anvendes sammen med hypoglykæmiske midler (orale midler og insulin).
Concomitant use with hypoglycaemic agents There have been reports of hypoglycaemic reactions after concomitant use with gemfibrozil and hypoglycaemic agents (oral agents and insulin).
Det anbefales, at monitorere glucoseniveauerne.
Monitoring of glucose levels is recommended.
Samtidig brug af orale antikoagulantia Gemfibrozil kan forstærke virkningen af orale antikoagulantia, hvorfor omhyggelig monitorering af doserne af disse midler er nødvendig.
Concomitant oral anticoagulants Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoaglant dosing.
Forsigtighed tilrådes, hvis antikoagulantia gives sammen med gemfibrozil.
Caution should be exercised when anticoagulants are given in conjunction with gemfibrozil.
Det kan være nødvendigt at reducere dosis af det antikoagulerende middel for at vedligeholde protrombintiden (se pkt.
The dosage of the anticoagulant may need to be reduced to maintain desired prothrombin time levels (see Section 4.5.)
4. 5).
4.5.
Interaktionsprofilen af gemfibrozil er kompleks.
The interaction profile of gemfibrozil is complex.
In vivo forsøg viser, at gemfibrozil er en potent hæmmer af CYP2C8 (et enzym, der er vigtig for metabolismen af f. eks. repaglinid, rosiglitazon og paclitaxel).
In vivo studies indicate that gemfibrozil is a potent inhibitor of CYP2C8 (an enzyme important for the metabolism of e. g. repaglinide, rosiglitazone and paclitaxel).
4. 4).
In vitro studies have shown that gemfibrozil is a strong inhibitor of CYP2C9 (an enzyme involved in the metabolism of e. g. warfarin and glimepiride), but also of CYP 2C19, CYP1A2 and UGTA1 and UGTA3 (see Section 4.4).
4. 3).
Repaglinide The combination of gemfibrozil with repaglinide is contra-indicated (see Section 4.3).
Samtidig anvendelse resulterer i en 8 gange stigning i repaglinid- plasmakoncentrationen, sandsynligvis på grund af hæmningen af CYP2C8 enzymet, som dermed fører til hypoglykæmiske reaktioner.
Concomitant administration has resulted in 8-fold increase in repaglinide plasma concentration probably by inhibition of the CYP2C8 enzyme, resulting in hypoglycaemic reactions.
Rosiglitazon Kombinationsbehandling med gemfibrozil og rosiglitazon bør anvendes med forsigtighed.
Rosiglitazone The combination of gemfibrozil with rosiglitazone should be approached with caution.
4. 4).
Co- administration with rosiglitazone has resulted in 2.3-fold increase in rosiglitazone systemic exposure, probably by inhibition of the CYP2C8 isozyme (see section 4.4).
Gemfibrozil kan også påvirke farmakokinetikken af simvastatin, lovastatin, pravastatin og rosuvastatin.
Gemfibrozil has also been reported to influence the pharmacokinetics of simvaststin, lovastatin, pravastatin and rosuvastatin.
Gemfibrozil forårsager næsten en 3 gange stigning i AUC af simvastatinsyren formodentlig på grund af hæmning af glucoronideringen via UGTA1 og UGTA3, og en 3 gange stigning i pravastatins AUC, som måske skyldes interferens med transportproteiner.
Gemfibrozil caused an almost 3-fold increased in AUC of simvastatin acid possibly due to inhibition of glucoronidation via UGTA1 and UGTA3, and a 3-fold increase in pravastatin AUC which may be due to interference with transport proteins.
Et studie med raske frivillige forsøgspersoner viser, at samtidig anvendelse af en enkeltdosis rosuvastatin på 80 mg og gemfibrozil (600 mg 2 gange dagligt) resulterer i en 2, 2 gange stigning i den gennemsnitlige Cmax og en 1, 9 gange stigning i den gennemsnitlige AUC af rosuvastatin.
One study indicated that the co-administration of a single rosuvastatin dose of 80 mg to healthy volunteers on gemfibrozil (600 mg twice daily) resulted in a 2.2-fold increase in mean Cmax and a 1.9-fold increase in mean AUC of rosuvastatin.
4. 4).
Oral anticoagulants Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoagulant dosing (see section 4.4).
Bexaroten Samtidig anvendelse af gemfibrozil og bexaroten kan ikke anbefales.
Bexarotene Concomitant administration of gemfibrozil with bexarotene is not recommended.
En populationsanalyse af plasmabexarotenkoncentrationer hos patienter med kutan T- cellelymfom (CTCL) viser, at samtidig anvendelse af gemfibrozil resulterer i en væsentlig stigning i plasmakoncentrationerne af bexaroten.
A population analysis of plasma bexarotene concentrations in patients with cutaneous T-cell lymphoma (CTCL) indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.
Galdesyre - anionbyttere Gemfibrozils biotilgængelighed kan nedsættes, når det anvendes samtidig med anionbyttere, som f. eks. colestipol.
Bile Acid – Binding Resins Reduced bioavailability of gemfibrozil may result when given simultaneously with resin-granule drugs such as colestipol.
Det anbefales at indtage midlerne forskudt med mindst 2 timers interval.
Administration of the products two hours or more apart is recommended.
Graviditet Der er ikke tilstrækkelig data for anvendelse af Lopid til gravide.
Pregnancy There are no adequate data on use of Lopid in pregnant women.
5. 3).
Animal studies are insufficiently clear to allow conclusions to be drawn on pregnancy and foetal development (see section 5.3).
Lopid bør ikke anvendes til gravide, medmindre det er klart nødvendigt.
Lopid should not be used during pregnancy unless it is clearly necessary.
Amning Der foreligger ingen dokumentation for udskillelse af gemfibrozil i modermælk.
Lactation There are no data on excretion of gemfibrozil in milk.
Lopid bør ikke anvendes i ammeperioden.
Lopid should not be used when breast feeding.
Der er ikke foretaget undersøgelser af evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
Der kan opstå isolerede tilfælde af svimmelhed og visuelle forstyrrelser, som kan påvirke evnen til at køre bil.
In isolated cases dizziness and visual disturbances can occur which may negatively influence driving.
7% af patienterne.
Most commonly reported adverse reactions are of gastrointestinal character and are seen in approximately 7% of the patients.
Disse bivirkninger fører sædvanligvis ikke til seponering af behandlingen.
These adverse reactions do not usually lead to discontinuation of the treatment.
Bivirkningerne er anført efter hyppighed i henhold til følgende:
Adverse reactions are ranked according to frequency using the following convention:
Meget almindelig (> 1/ 10), almindelig (> 1/ 100, < 1/ 10), ikke almindelig (> 1/ 1, 000, < 1/ 100), sjælden (> 1/ 10. 000, < 1/ 1. 000), meget sjælden (< 1/ 10. 000), inklusive enkeltstående rapporter:
Very common (> 1/ 10), Common (> 1/ 100 ,< 1/10), Uncommon (> 1/ 1,000 ,< 1/100), Rare (> 1/ 10,000, < 1/ 1,000), Very rare (< 1/ 10,000), including isolated reports:
Alvorlig anæmi.
Platelet, bleeding and clotting disorders Rare: thrombocytopenia.
Leukopoeni, eosinofili, knoglemarvshypoplasi.
Rare: severe anaemia.
Der er set et selvbegrænsende, lille fald i hæmoglobin og hæmatokrit ved initiering af gemfibrozilbehandling.
Self-limiting, mild haemoglobin and haematocrit decrease have been observed on initiating gemfibrozil therapy.
Lidelser i det centrale og perifere nervesystem Almindelig:
White cell and reticuloendothelial system disorders Rare: leucopoenia, eosinophilia, bone marrow hypoplasia.
Sjælden:
Central and peripheral nervous system Common: vertigo, headache.
Svimmelhed, somnolens, paræstesi, perifer neuritis, nedsat libido.
Rare: dizziness, somnolence, paresthesia, peripheral neuritis, decreased libido.
Sløret syn.
Vision disorders Rare: blurred vision.
Atrieflimren.
Heart rate and rhythm disorders Uncommon: atrial fibrillation.
Almindelig:
Gastro-intestinal system disorders Very common: dyspepsia.
Abdominal smerte, diarré, flatulens, kvalme, opkastning, obstipation.
Common: abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation.
Pancreatitis, akut appendicitis.
Rare: pancreatitis, acute appendicitis.
Kolestatisk ikterus, forstyrrelser i leverfunktion, hepatitis, cholelithiasis, cholecystitis.
Liver and biliary system disorders Rare: cholestatic jaundice, disturbed liver function, hepatitis, cholelithiasis, cholecystitis.
Eksem, udslæt.
Skin and appendages disorders Common: eczema, rash.
Eksfoliativ dermatitis, dermatitis, kløe, alopeci.
Rare: exfoliative dermatitis, dermatitis, pruritus, alopecia.
Arthralgi, synovitis, myalgi, myopati, myasteni, smerter i ekstremiteter og myositis ledsaget af stigning i kreatinkinase (CK), rhabdomyolyse.
Musculoskeletal disorders Rare: arthralgia, synovitis, myalgia, myopathy, myasthenia, painful extremities and myositis accompanied by increase in creatine kinase (CK), rhabdomyolysis.
Impotens.
Urinary system disorders Rare: impotence.
Sjælden:
Body as a whole-general disorders Common: fatigue.
Fotosensitivitet, angioødem, laryngal ødem, urticaria.
Rare: photosensitivity, angioedema, laryngeal edema, urticaria.
Der er set overdosering.
Overdose has been reported.
Kvalme og opkastning.
Non-specific symptoms reported were nausea and vomiting.
Patienterne kom sig fuldstændig.
The patients fully recovered.
Symptomatisk behandling bør gives i tilfælde af overdosering.
Symptomatic supportive measures should be taken if overdose occurs.
Serum- lipidsænkende middel Kemisk undergruppe:
Serum-lipid lowering agent Chemical subgroup: