natgillin/translations-raw huggingface dataset:
Fibrinogen (g/l) *Sammenligning af behandlinger: Forskellen mellem LS-middelværdien for Feno 145 + Simva 20 og Simva 40 samt det tilknyttede konfidensinterval på 95 %
Fibrinogen (g/L) *Treatment Comparison: difference between the LS Means for Feno 145 + Simva 20 and Simva 40, as well as the associated 95% confidence interval
• overfølsomhedsreaktion over for Cholib med symptomer som: smerter eller inflammation (betændelseslignende reaktion) i led, inflammation i blodkar, usædvanligt mange blå mærker, frembrud på eller hævelse af huden, nældefeber, soleksem, feber, blussen, kortåndethed, utilpashed, lupuslignende sygdom (herunder udslæt, ledsygdomme og påvirkning af de hvide blodlegemer)
• Hypersensitivity reaction to Cholib with symptoms like: pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells)
Det gives for at sænke indholdet af triglycerider og øge indholdet af det gode kolesterol (HDL-kolesterol) hos patienter, hvis dårlige kolesterol (LDL-kolesterol) allerede kontrolleres med simvastatin alene i en dosis på 40 mg.
It is given to lower triglycerides and increase the good cholesterol (HDL cholesterol) in patients whose bad cholesterol (LDL cholesterol) is already controlled with simvastatin alone in a dose of 40 mg.
Samtidig administration af diltiazem og simvastatin forårsagede en 2,7 gange stigning i eksponeringen for simvastatinsyre, antageligt på grund af hæmning af CYP 3A4.
Concomitant administration of diltiazem and simvastatin caused a 2.7-fold increase in exposure of simvastatin acid, presumable due to inhibition of CYP 3A4.
• hvis du har brystsmerter eller får åndenød.
• you have chest pain and are feeling breathless.
Der er ikke udført prækliniske studier med fastdosiskombinationen Cholib.
No preclinical studies have been performed with the fixed dose combination Cholib.
• Kvinder
• Female gender
Efter 12 uger og 24 uger viste kombinationen af fenofibrat 145 mg og simvastatin 40 mg (F145/S40) superioritet over simvastatin 40 mg (S40) i forhold til reduktion af TG og øget HDL-kolesterol.
At 12 weeks and 24 weeks the combination of fenofibrate 145 mg and simvastatin 40 mg (F145/S40) showed superiority over simvastatin 40 mg (S40) for TG reduction and HDL-C increase.
• Samtidig administration af glecaprevir/pibrentasvir (se pkt.
• Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5)
Interaktioner, der er relevante for monoterapi CYP 3A4-hæmmere
Interactions relevant to monotherapies Inhibitors of CYP 3A4
Simvastatin er et inaktivt lacton, der nemt hydrolyseres in vivo til den tilsvarende beta-hydroxysyre, en potent HMG-CoA-reduktasehæmmer.
Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA reductase.
Indholder: lactose, saccharose, lecithin (afledt fra sojabønne (E322))
Contains: lactose, sucrose, lecithin (derived from soya bean (E322))
Bivirkninger (fenofibrat)
Adverse reactions (fenofibrate)
• stigning i glykosyleret hæmoglobin og blodsukker - (markører for blodsukkerkontrol ved diabetes mellitus) - vist ved prøver
• increase in “glycosylated haemoglobin” and blood glucose levels - markers for blood glucose control in diabetes mellitus - shown in tests
Samtidig administration af verapamil og simvastatin resulterede i en 2,3 gange stigning i eksponeringen for simvastatinsyre i plasma, antageligt delvist på grund af hæmning af CYP 3A4.
Concomitant administration of verapamil and simvastatin resulted in a 2.3-fold increase in plasma exposure to simvastatin acid, presumably due, in part, to inhibition of CYP 3A4.
Risikoen for myopati og rhabdomyolyse øges ved samtidig brug af amiodaron, amlodipin, diltiazem eller verapamil med simvastatin 40 mg pr. dag.
Amiodarone, amlodipine, diltiazem and verapamil The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, amlodipine, diltiazem or verapamil with simvastatin 40 mg per day.
En filmovertrukket tablet indeholder 194,7 mg lactose (som monohydrat), 145 mg saccharose og 0,8 mg lecithin (afledt fra sojabønne (E322)).
One film-coated tablet contains, 194.7 mg of lactose (as monohydrate), 145 mg of sucrose and 0.8 mg of lecithin (derived from soya bean (E322)).
Hiv-proteasehæmmere (f.eks. nelfinavir) Nefazodon
HIV protease inhibitors (e.g. nelfinavir) Nefazodone
• smerter i, rødme eller hævelse i benene - dette kan være tegn på en blodprop i benet (dyb venetrombose)
• pain, redness or swelling in the legs - these may be signs of a blood clot in the leg (deep vein thrombosis)
Gå til læge regelmæssigt for at holde øje med dit lipidniveau.
Your doctor can measure your lipids with a simple blood test. Visit your doctor regularly to keep track of your lipids level.
Butylhydroxyanisol (E320), lactose monohydrat, natriumlaurilsulfat, stivelse; pregelatineret (majsstivelse), docusatnatrium, saccharose, citronsyremonohydrat (E330), hypromellose (E464), crospovidon (E1202), magnesiumstearat (E572), silicificeret mikrokrystallinsk cellulose (bestående af mikrokrystallinsk cellulose og kolloid vandfri silica), ascorbinsyre (E300).
Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous), ascorbic acid (E300).
• mavesmerter - dette kan være tegn på betændelse i bugspytkirtlen (pancreatitis)
• stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
• forhøjet gamma-glutamyltransferase - (produceres af nyrerne) - vist ved prøver
• increase in “gamma-glutamyltransferase” - produced by the liver - shown in tests
Der har været rapporter om myopati og rhabdomyolyse ved samtidig administration af colchicin og simvastatin hos patienter med nyreinsufficiens.
There have been reports of myopathy and rhabdomyolysis with the concomitant administration of colchicine and simvastatin in patients with renal insufficiency.
• rifampicin (medicin mod tuberkulose)
• rifampicin (a medicine used to treat tuberculosis)
• hvis du har alvorlig lungesygdom
• you have severe lung disease
Hæmmere af BCRP (Breast Cancer Resistant Protein) Samtidig administration af lægemidler, der er hæmmere af BCRP, herunder produkter, som indeholder elbasvir eller grazoprevir, kan føre til øgede plasmakoncentrationer af simvastatin og en øget risiko for myopati (se pkt.
Inhibitors of Breast Cancer Resistant Protein (BCRP) Concomitant administration of medicinal products that are inhibitors of BCRP, including products containing elbasvir or grazoprevir, may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy (see sections 4.2 and 4.4).
Clarithromycin Telithromycin
Clarithromycin
* Sammenligning af behandling består af forskellen mellem LS-middelværdien for Feno 145 + Simva 40 og Simva 40 samt det tilknyttede 95 % CI.
*Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI.
En filmovertrukket tablet indeholder 160,1 mg lactose (som monohydrat), 145 mg saccharose, 0,7 mg lecithin (afledt fra sojabønne (E322)) og 0,17 mg Sunset Yellow FCF (E110)).
One film-coated tablet contains 160.1 mg of lactose (as monohydrate), 145 mg of sucrose, 0.7 mg of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset yellow FCF (E110).
• fordøjelsesproblemer (mavesmerter, kvalme, opkastning, diarré og luft i maven)
• digestive disturbances (stomach pain, nausea, vomiting, diarrhoea and flatulence)
Aluminium/aluminium blister Pakningsstørrelser: 10, 30 og 90 filmovertrukne tabletter.
Pack sizes: 10, 30 and 90 film-coated tablets.
• gulfarvning af huden og det hvide i øjnene (gulsot) eller en stigning i leverenzymer - dette kan være tegn på leverbetændelse (hepatitis og leversvigt)
• yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes - these may be signs of an inflamed liver (hepatitis and hepatic failure).
I det større studie sås en reduktion på 21 % (90 % CI 14%-27 %)i AUC for SVA efter gentagen, samtidig administration af simvastatin 40 mg og fenofibrat 145 mg om aftenen.
In the larger study a reduction of 21% (90% CI 14%-27%) in AUC of SVA was observed after repeated co-administration of simvastatin 40 mg and fenofibrate 145 mg in the evening.
Muskellidelser (f.eks. myalgi, muskelbetændelse, -spasme r og -svækkelse)
Muscle disorders (e.g. myalgia, myositis, muscular spasms and weakness)
Der må ikke tages mere endén Cholib 145 mg/20 mg pr. dag
Do not exceed one Cholib 145 mg/20 mg per day
• brystsmerter og åndenød - dette kan være tegn på en blodprop i lungerne (lungeemboli)
• chest pain and feeling breathless - these may be signs of a blood clot in the lung (pulmonary embolism)
Den sædvanlige dosis anbefales, undtagen ved nedsat nyrefunktion med en estimeret glomerulær filtrationshastighed på < 60 ml/min/1,73 m2, hvor Cholib er kontraindiceret (se pkt.
The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m where Cholib is contraindicated
Mekanismen bag simvastatins LDL-sænkende virkning kan involvere både reduktion af VLDL-kolesterolkoncentrationen og induktion af LDL-receptoren, hvilket fører til reduceret produktion og øget katabolisme af LDL-kolesterol.
The mechanism of the LDL lowering effect of simvastatin may involve both reduction of VLDL-C concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with simvastatin.
Feno 145 + Simva 40 Simva 40 Fibrinogen* (g/l) Feno 145 + Simva 40 Simva 40 * Sammenligning af behandling består af forskellen mellem LS-middelværdien for Feno 145 + Simva 40 og Simva 40 samt det tilknyttede 95 % CI.
Simva 40 Simva 40 Fibrinogen* (g/L) Feno 145 + Simva 40 Simva 40 *Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI.
Obstipation, dyspepsi
Constipation, dyspepsia rare
Cholib skal bruges med forsigtighed til patienter med let nyreinsufficiens, hvis estimerede glomerulære filtrationshastighed er 60-89 ml/min/1,73 m
Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m
Sådanne hæmmere inkluderer itraconazol, ketoconazol, posaconazol, erythromycin, clarithromycin, telithromycin, hiv-proteasehæmmere (f.eks. nelfinavir) og nefazodon.
Such inhibitors include itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (e.g. nelfinavir), and nefazodone.
1.237 forsøgspersoner fik samtidig behandling med fenofibrat og simvastatin, og 1.230 fik monoterapi med statin, alle administreret om aftenen.
Of these, 2,474 subjects were randomized for 24 weeks treatment, 1,237 subjects received fenofibrate and simvastatin co-administration and 1,230 subjects received statin monotherapy all administered in the evening.
Immunmedieret nekrotiserende myopati (se pkt.
Tendinopathy Immune-mediated necrotizing myopathy (see section 4.4)
Tal med lægen eller apotekspersonalet, hvis du er bekymret over det.
Check with your doctor or pharmacist if you are not sure.
• et fald i hæmoglobin (der transporterer ilten rundt i blodet) og hvide blodlegemer - vist ved prøver
• drop in haemoglobin (that carries oxygen in blood) and white blood cells- shown in tests
Nyrefunktion Cholib er kontraindiceret ved moderat til svært nedsat nyrefunktion (se pkt.
Renal function Cholib is contraindicated in moderate to severe renal impairment (see section 4.3).
• amiodaron (mod uregelmæssig hjerterytme) eller verapamil (mod forhøjet blodtryk,
• amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions)
Cholib indeholder:
What Cholib contains
Brug af anden medicin sammen med Cholib
Other medicines and Cholib:
TG (mmol/l) LDL-kolesterol (mmol/l)
TG (mmol/L) LDL-C (mmol/L)
Det geometriske gennemsnitlige maksimale plasmaniveau (Cmax) af det inaktive moderstof simvastatin var 2,7 ng/ml for fastdosiskombinationen Cholib 145 mg/20 mg tabletter og 3,9 ng/ml for den samtidige administration af separate tabletter med 145 mg fenofibrat og 20 mg simvastatin, som anvendt i det kliniske program.
The geomean maximum plasma level (Cmax) of the inactive parent simvastatin was 2.7 ng/mL for the fixed dose combination Cholib 145 mg/20 mg tablet and 3.9 ng/mL for the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program.
Din læge vil eventuelt også tage blodprøver for at kontrollere din leverfunktion, efter du er begyndt at tage Cholib.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Cholib.
Efter de første 12 ugers behandling viste kombinationen af fenofibrat 145 mg og simvastatin 20 mg superioritet over simvastatin 40 mg for reduktion af TG og øgning af HDL-kolesterol, men opfyldte ikke kriterierne for non-inferioritet for LDL-kolesterol.
After the first 12 weeks of treatment, the combination of fenofibrate 145 mg and simvastatin 20 mg showed superiority over simvastatin 40 mg for TG reduction and HDL-C increase but did not meet the criteria for non-inferiority on LDL-C.
Erektil dysfunktion
• erectile dysfunction
Kombination med itraconazol, ketoconazol, posaconazol, hiv-proteasehæmmere (f.eks. nelfinavir), erythromycin, clarithromycin, telithromycin og nefazodon er kontraindiceret (se pkt.
Combination with itraconazole, ketoconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated (see section 4.3).
Kontraindiceret med Cholib 145 mg/40 mg
Contraindicated with Cholib 145 mg/40 mg
Tag ikke Cholib
Do not take Cholib:
EU/1/13/866/001 10 filmovertrukne tabletter EU/1/13/866/002 30 filmovertrukne tabletter EU/1/13/866/005 90 filmovertrukne tabletter
EU/1/13/866/001 10 film-coated tablets EU/1/13/866/002 30 film-coated tablets EU/1/13/866/005 90 film coated tablets
• Samtidig administration af amiodaron, verapamil, amlodipin eller diltiazem (se pkt.
Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5) 4.4 Special warnings and precautions for use
• hiv-proteasehæmmere, f.eks. indinavir, nelfinavir, ritonavir og saquinarvir (mod hiv-infektion og aids)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir
Stevens-Johnsons syndrom, toksisk epidermal nekrolyse osv.)
Ste vens-Johnson syndrome, toxic epidermal necrolysis, etc.) Cutaneous hypersensitivity (e.g.
• øget indhold af kreatinin (et stof, der udskilles af nyrerne) i blodet
• Increase in the blood level of “creatinine” (substance excreted by the kidneys)
EU/1/13/866/003 10 filmovertrukne tabletter EU/1/13/866/004 30 filmovertrukne tabletter EU/1/13/866/006 90 filmovertrukne tabletter
EU/1/13/866/003 10 film-coated tablets EU/1/13/866/004 30 film-coated tablets EU/1/13/866/006 90 film coated tablets
Fra en ikke-signifikant yderligere reduktion på 1,2 % af LDL-kolesterol efter 12 uger, til en statistisk signifikant reduktion på 7,2 % efter 24 uger.
The combination F145/S40 showed superiority over S40 for LDL-C reduction only at 24 weeks from a non-significant additional 1.2% reduction of LDL-C at 12 weeks to a statistically significant 7.2% reduction at 24 weeks.
LDL-kolesterol
LDL-C
• forhøjet alkalisk fosfatase - (produceres af galdesystemet) - vist ved prøver
• increase in “alkaline phosphatase” - produced by the bile system - shown in tests
• hvis du har en nyresygdom
• you have kidney disease
Risikoen for myopati, inklusive rhabdomyolyse, kan blive forøget ved samtidig administration af fusidinsyre med statiner.
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
Forhøjet glykosyleret hæmoglobin
Glycosylated haemoglobin increased not known
• hvis du allerede tager følgende lægemidler:  danazol (et kunstigt hormon til behandling af endometriose)  ciclosporin (et lægemiddel, der ofte bruges til patienter, som har fået organtransplantation)  itraconazol, ketoconazol, fluconazol eller posaconazol (mod svampeinfektioner)  hiv-proteasehæmmere, f.eks. indinavir, nelfinavir, ritonavir og saquinarvir (mod hiv-infektion og aids)  erythromycin, clarithromycin eller telithromycin (mod bakterieinfektioner)  nefazodon (mod depression)  amiodaron (mod uregelmæssig hjerterytme) eller verapamil (mod forhøjet blodtryk, brystsmerter i forbindelse med hjertesygdom eller andre hjertetilstande)  antivirale midler mod hepatitis C, f.eks. elbasvir, grazoprevir, glecaprvire eller prbrentasvir (bruges til behandling af virusinfektion med hepatitis C)
• If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions) o hepatitis C antiviral agents such as elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)
4.4 og 4.5).
(See sections 4.4 and 4.5.)
Blod og lymfesystem Reduceret hæmoglobin Nedsat antal hvide blodlegemer
Haemoglobin decreased White blood cell count decreased rare
• Hvis du tager antivirale midler mod hepatitis C, f.eks. elbasvir eller grazoprevir (bruges til at behandle virusinfektion med hepatitis C)
• you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis
Sådan skal du tage Cholib
How to take Cholib
• hvis du allerede tager følgende lægemidler:  danazol (et kunstigt hormon til behandling af endometriose)  ciclosporin (et lægemiddel, der ofte bruges til patienter, som har fået organtransplantation)  itraconazol, ketoconazol, fluconazol eller posaconazol (mod svampeinfektioner)  hiv-proteasehæmmere, f.eks. indinavir, nelfinavir, ritonavir og saquinarvir (mod hiv-infektion og aids)  glecaprevir eller pibrentasvir (bruges til behandling af hepatitis C-virusinfektion  erythromycin, clarithromycin eller telithromycin (mod bakterieinfektioner)  nefazodon (mod depression)
• If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression)
I FIELD-studiet blev der rapporteret en statistisk signifikant stigning i forekomsten af lungeemboli (0,7 % i placebogruppen kontra 1,1 % i fenofibratgruppen, p=0,022) og en statistisk ikke-signifikant stigning i dyb venetrombose (placebo 1,0 %, 48/4900 patienter) kontra fenofibrat (1,4 %, 67/4895, p=0,074).
In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p=0.022) and a statistically non significant increase in deep vein thrombosis (placebo 1.0% 48/4900 patients) versus fenofibrate 1.4% (67/4895); p=0.074.
Lysfølsomhedsreaktioner
Photosensitivity reactions rare
Samtidig behandling
Treatment Group
• vedvarende muskelsvaghed
• muscle weakness that is constant
Poly(vinylalkohol); delvist hydrolyseret (E1203), titanidioxid (E171), talkum (E553b), lecithin (afledt fra sojabønne (E322)), xanthangummi (E415), jernoxid, rød (E172).
Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172).
kvinder, der forsøger at blive gravide eller har mistanke om, at de er gravide.
For these reasons, simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Potente CYP 3A4-hæmmere: Itraconazol
Potent CYP 3A4 inhibitors:
Som resultat af disse ændringer reduceres forholdene mellem total kolesterol og HDL-kolesterol samt mellem LDL- og HDL-kolesterol.
As a result of these changes the ratios of TC to HDL-C and LDL-C to HDL-C are reduced.
Nedsat hukommelse/ Hukommelsestab
Memory impairment/Memory loss rare
Forhøjet alkalisk fosfatase i blodet
Blood alkaline phosphatase increased rare
Tromboembolisme * I FIELD-studiet blev der rapporteret en statistisk signifikant stigning i forekomsten af lungeemboli (0,7 % [32/4.900 patienter] i placebogruppen kontra 1,1 % [53/4.895 patienter] i fenofibratgruppen, p=0,022) og en statistisk ikke-signifikant stigning i dyb venetrombose (placebo: 1,0 % [48/4.900 patienter] kontra fenofibrat 1,4 % [67/4.895 patienter], p=0,074).
Thromboembolism * In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% [32/4900 patients] in the placebo group versus 1.1% [53/4895 patients] in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0% [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p=0.074).
Procentvis ændring fra baseline til uge 12 og uge 24 for TG, LDL-kolesterol og HDL-kolesterol Fuld analyse af deltagerprøve
TG, LDL-C and HDL-C Percent Change from Baseline to 12 and 24 Weeks Full Analysis Subject Sample
Derfor er Cholib kontraindiceret under amning (se pkt.
Therefore, Cholib is contraindicated during breast-feeding (see section 4.3).
Hepatitis/gulsot Leversvigt
Hepatitis/jaundice Hepatic failure very rare
Samtidig administration af produkter, der er hæmmere af BCRP (f.eks. elbasvir og grazoprevir) kan føre til øgede plasmakoncentrationer af simvastatin og en øget risiko for myopati.
Concomitant administration of products that are inhibitors of BCRP (e.g., elbasvir and grazoprevir) may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy; therefore, a dose adjustment of simvastatin should be considered depending on the prescribed dose.
Der er rapporteret pancreatitis hos patienter, der tager fenofibrat (se pkt.
Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8).
Poly(vinylalkohol); delvist hydrolyseret (E1203), titanidioxid (E171), talkum (E553b), lecithin (afledt fra sojabønne (E322)), xanthangummi (E415), jernoxid, rød (E172), jernoxid, gul (E172), Sunset Yellow FCF (E110).
Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172), iron oxide yellow (E172), sunset yellow FCF (E110).
Imidlertid bør dosen af simvastatin ikke overstige 20 mg dagligt hos patienter, som samtidigt tager lægemidler, der indeholder elbasvir eller grazoprevir (se pkt.
Co- administration of elbasvir and grazoprevir with simvastatin has not been studied; however, the dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with products containing elbasvir or grazoprevir (see section 4.5).