natgillin/translations-raw huggingface dataset:
Bolezni prebavil napihnjenost trebuha, bolečina v trebuhu, bolečina v zgornjem delu trebuha, zaprtost, driska, suha usta, dispepsija, kolcanje, napenjanje, navzea, neugodje v trebuhu, bruhanje pogosti
Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
ŠTEVILKA SERIJE
BATCH NUMBER
V isti študiji so poročali o statistično pomembnem povečanju pogostosti pojavljanja pljučne embolije (0,7 % v skupini, ki je prejemala placebo, v primerjavi z 1,1 % v skupini, ki je prejemala fenofibrat; p = 0,022) in o statistično nepomembnem povečanju pogostosti globoke venske tromboze (1,0 % v skupini, ki je prejemala placebo (48/4.900 bolnikov), v primerjavi z 1,4 % v skupini, ki je prejemala fenofibrat (67/4.895); p =
In the same 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 thromboses (placebo: 1.0 % [48/4,900 patients] versus fenofibrate 1.4% [67/4,895 patients]; p = 0.074).
MOŽNI NEŽELENI UČINKI
Possible side effects
Nosečnost in dojenje
Pregnancy and breast-feeding
To morate storiti, ker so težave z mišicami(mednje spada razpadanje mišic, ki povzroča poškodbe ledvic) v zelo redkih primerih (lahko se pojavijo pri največ 1 od 10.000 bolnikov) lahko resne; v zelo redkih primerih je prišlo do smrti.
This is because on very rare occasions (may affect up to 1 in 10,000 people), muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.
Neprozorne bele plastenke iz polietilena visoke gostote (HDPE), ki vsebujejo 14, 30, 60 in 90 trdih kapsul.
Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
in kostmi lahko uporabljate peroralno ali na koži, za protin in bolečine med menstruacijo pa peroralno) fotoalergijo (alergijsko reakcijo, ki jo povzroča sončna svetloba ali izpostavljenost UV-svetlobi) ali fototoksične reakcije (poškodbe kože, ki jih povzroča izpostavljenost soncu ali UV-svetlobi), - če imate bolezen žolčnika, - če imate težave
- You have had photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain) - You suffer from gallbladder disease.
Bolniki, ki so prejemali zdravilo Pravafenix 40 mg/160 mg, so bili primerjani s tistimi, ki so prejemali pravastatin 40 mg: zdravilo Pravafenix je v večji meri kot pravastatin 40 mg pomembno znižal holesterol zaradi lipoproteinov nevisoke gostote, holesterol zaradi lipoproteinov nizke gostote in trigliceride ter pomembno zvišal holesterol lipoproteinov visoke gostote (tabela).
Patients receiving Pravafenix 40 mg/160 mg were compared to those receiving pravastatin 40 mg: Pravafenix significantly lowered non-HDL-C, LDL-C, TG and significantly increased HDL-C to a greater extent than pravastatin 40 mg (table).
Holesterol HDL pogosto imenujemo „dobri“ holesterol, ker pomaga preprečevati kopičenje „slabega“
HDL cholesterol is often called ‘good' cholesterol because it helps keep the ‘bad' cholesterol from building up in the arteries and because it protects against heart disease.
Bolezni sečil povečan kreatinin v krvi, zmanjšan ledvični očistek kreatinina, povečan ledvični očistek kreatinina, odpoved ledvic občasni
Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure
neznana
Not known
so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Pravafenix v primerjavi
Pravafenix versus PRAVASTATIN
Holelitiaza
Cholelithiasis
Izvedena je bila farmakokinetična študija po enem odmerku zdravila Pravafenix pri teščih
A pharmacokinetic study after a single dose administration of Pravafenix has been performed in fed and fasting condition.
V te študije so v Evropi in ZDA zajeli skupno 1637 bolnikov, ki se niso dobro odzvali na zdravljenje z monoterapijo
In total, these studies enrolled 1,637 patients who have not had an adequate response to treatment with pravastatin 40 mg monotherapy or simvastatin 20 mg in Europe and in the USA.
Če vas skrbi, koliko alkohola lahko med jemanjem
If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
FARMACEVTSKA OBLIKA IN VSEBINA 60 trdih kapsul
PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
s hrano, saj na tešče ne bo tako dobro delovala.
It is important to take the capsule with food, as it won't work as well if your stomach is empty.
Fusidna kislina
Fusidic acid
Kadar se smole jemljejo sočasno, je treba fenofibrat vzeti eno uro prej ali od 4 do 6 ur kasneje kot smolo, tako da absorpcija fenofibrata ni ovirana.
Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate.
Laktoza
Lactose
s prvim prehodom skozi jetra, ki so primarno mesto njegovega delovanja ter primarno mesto za sintezo holesterola in čiščenje holesterola LDL.
After absorption, 66% of pravastatin undergoes a first-pass extraction through the liver, which is the primary site of its action and the primary site of cholesterol synthesis and clearance of LDLcholesterol.
To morate narediti, ker holestiramin ali druge smole, ki vežejo žolčno kislino, pogosto poslabšajo absorpcijo zdravil, če med njihovim zaužitjem in zaužitjem zdravil preteče premalo časa, in tako motijo
This is because colestyramine or other bile acid binding resins frequently reduce the absorption of medicines when taken too closely together and so may impede the absorption of Pravafenix.
ZA PROMET EU/1/11/679/001-007
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007
s pretrganjem zelo redki rabdomioliza imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.)
Immune-mediated necrotizing myopathy (see section 4.4).
Pred odločitvijo o začetku zdravljenja z zdravilom Pravafenix je treba oceniti ledvično funkcijo (glejte poglavje 4.4 Bolezni sečil).
Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders).
Vpliv kombinacije na sposobnost razmnoževanja v študijah ni bil raziskan.
The combination has not been tested in reproductive toxicity studies.
občasni rabdomioliza, ki je lahko povezana z akutno odpovedjo ledvic po mioglobinuriji, miopatija (glejte poglavje 4.4); miozitis, polimiozitis. posamezni primeri okvar kit, pri katerih včasih pride do zapleta
Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see section 4.4); myositis, polymyositis.
V študijah vplivov na sposobnost razmnoževanja niso ne pri fenofibratu ne pri pravastatinu opazili učinkov na plodnost (glejte poglavje 5.3)
No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Musculoskeletal and connective tissue disorders
Skeletna mišičnina: redko so zabeležili izrazit in stalen porast kreatin-fosfokinaze (KF). Med bolniki,
Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
tip 1500, hidroksipropilceluloza, makrogol 20 000.
Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
FARMACEVTSKA OBLIKA IN VSEBINA 30 trdih kapsul
PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Če ravni aspartat-aminotransferaze (AST) in alanin-aminotransferaze (ALT) presežejo trikratno
Special attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) exceed 3 times the ULN and persist.
S sistemom citokroma P450 pravastatin ni presnovljen v klinično pomembni meri.
Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Zdravilo Pravafenix je kontraindicirano pri bolnikih z zmerno do hudo okvaro ledvic (ki je določena z očistkom kreatinina < 60 ml/min).
Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.)
Ne jemljite zdravila Pravafenix, če dojite.
Do not take Pravafenix if you are breast-feeding.
Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgija
Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Zelo redki neželeni učinki (pojavijo se lahko največ pri 1 od 10.000 bolnikov)
Very rare side effects (may affect up to 1 in 10,000 people)
Študije o interakcijah zdravila Pravafenix niso bile narejene, vendar sočasno jemanje zdravilnih učinkovin pri bolnikih v kliničnih študijah ni povzročilo nobenih nepričakovanih interakcij. Spodnje navedbe odražajo dostopne podatke o posameznih zdravilnih učinkovinah (fenofibratu in pravastatinu).
There have been no formal interaction studies for Pravafenix; however the concomitant use of the active substances in patients in clinical studies has not resulted in any unexpected interactions.
Nekateri dokazi kažejo, da statini kot razred zdravil povišajo raven glukoze in lahko pri nekaterih bolnikih z velikim
Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate.
se odmerkih kažejo, da lahko pravastatin sproži različne stopnje hepatotoksičnosti in miopatije; v splošnem so bili znatni učinki na ta tkiva opazni šele pri odmerkih, ki so znašali 50-kratnik največjega odmerka pri človeku v mg/kg ali več. Genetske toksikološke študije in vitro in in vivo niso našle dokazov za mutageni potencial.
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.
Zdravilo Pravafenix je pri zmerni do hudi okvari ledvic kontraindicirano (poglavje 4.3).
Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Ravni trigliceridov LDL in VLDL se znižajo. Skupni učinek je zmanjšano razmerje med lipoproteini nizke in zelo nizke gostote ter lipoproteini visoke gostote.
The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
FARMACEVTSKA OBLIKA IN VSEBINA 14 trdih kapsul
PHARMACEUTICAL FORM AND CONTENTS 14 hard capsules
s katerokoli drugo smolo, ki veže žolčno kislino (zdravilom za zniževanje holesterola), vzemite zdravilo Pravafenix eno uro pred smolo ali 4 do 6 ur po njej.
When your doctor has prescribed Pravafenix along with colestyramine or any other bile acid binding resins (medicines for lowering cholesterol), take Pravafenix 1 hour before, or 4 to 6 hours after the resin.
s pravastatinom v odmerkih 250 in 500 mg/kg/dan (> 310-kratnika največjega odmerka pri človeku v mg/kg) pokazala statistično pomembno povečanje incidence hepatocelularnih karcinomov pri samcih in samicah ter adenomov pljuč samo pri samicah.
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), statistically significant increases in the incidence of hepatocellular carcinomas in males and females, and lung adenomas in females only.
Sladkorna bolezen
Diabetes Mellitus
učinki na živčevje: omotica (občutek nestabilnosti), glavobol, motnje spanja (vključno s težavami pri spanju in nočnimi morami), občutek zbadanja (parestezija),
• Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances
tudi biliarna ciroza in aktivna jetrna bolezen, vključno z nepojasnjenimi trajno zvišanimi vrednostmi parametrov pri testih jetrne funkcije (vključno z zvišano serumsko transaminazo), ki so višje od trikratne zgornje meje normalnih vrednosti (ZMN) (glejte poglavje 4.4).
- Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3
Kinetične raziskave po uporabi enkratnega odmerka in neprekinjenem zdravljenju
Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
60 trdih kapsul
60 hard capsules
Kapsule so na voljo v pretisnih omotih iz poliamidaaluminija-PVC/aluminija, ki vsebujejo 30, 60 in 90 trdih kapsul, in v neprozornih belih plastenkah
The capsules are supplied in Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60, or 90 capsules, and in opaque white plastic bottles containing either 14, 30, 60 or 90 capsules.
Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe samega pravastatina in samega fenofibrata.
Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually.
V prvih 12 mesecih kombiniranega zdravljenja je sistematično priporočljivo rutinsko spremljanje kreatin-fosfokinaze na vsake 3 mesece, po tem začetnem obdobju pa je odločitev o tem prepuščena zdravniku.
Routine monitoring of CK is systematically recommended every 3 months during the first 12 months of the combination therapy and let to the appreciation of the clinician beyond this initial period.
Ne prenehajte z jemanjem zdravila Pravafenix, dokler se ne posvetujete z zdravnikom.
If you stop taking Pravafenix Do not stop taking Pravafenix without first discussing it with your doctor.
Tveganje za miopatijo, vključno z rabdomiolizo, se lahko poveča pri sistemskem zdravljenju
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
90 trdih kapsul
90 hard capsules
Tveganje za toksične učinke na mišice je povečano, če se fibrat in inhibitor reduktaze 3-hidroksi-3
The risk of muscle toxicity is increased when a fibrate and a 3-hydroxy-3-methyl-glutarylCoenzyme A (HMG-CoA) reductase inhibitor are administered together.
to kombinacijo, so poročali o rabdomiolizi (vključno s smrtnimi izidi).
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
s simvastatinom v monoterapiji za sestavljen primarni izid (razmerje tveganja [RT] 0,69, 95 % IZ 0,49-0,97, p = 0,03; absolutno zmanjšanje tveganja: 4,95 %).
mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; absolute risk reduction: 4.95%).
transaminaz padle na izhodiščno vrednost, ne da bi bilo
In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation.
Natrijev pravastatinat
Pravastatin sodium
30 trdih kapsul
30 hard capsules
Fenofibrat je derivat fibrične kisline (fibrat), katerega vpliv na lipide, o katerem poročajo pri ljudeh, se posreduje z aktivacijo
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα).
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
Uncommon side effects (may affect up to 1 in 100 people)
Bolnike je treba opozoriti, da nemudoma sporočijo, če v mišicah pride do kakršnihkoli nepojasnjenih bolečin, občutljivosti, oslabelosti ali krčev.
Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness or cramps.
Obe učinkovini sta zdravili, ki vplivata na holesterol/lipide.
Both are cholesterol/lipid modifying medicines.
Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
The frequencies of adverse reactions are ranked according to the following: Very common ( ≥ 1/10),
Na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih
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.
vnetje mišic (miozitis), oslabelost mišic ali mišični krči.
• Muscle inflammation (myositis), muscular cramps and weakness.
Lastnost fenofibrata, da znižuje koncentracijo lipidov, ki je bila opažena v klinični praksi, je bila pojasnjena in vivo pri transgenskih miših in
The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated
Z VARNO IN UČINKOVITO UPORABO
Clinical efficacy and safety
s klaritromicinom so opazili statistično pomembno zvišanje površine pod krivuljo (110 %) in
In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
Pravastatin in fenofibrat sta, tako kot druge učinkovine za zniževanje lipidov, povezana z nastankom mialgije, miopatije, zelo redko pa tudi rabdomiolize, ki lahko ali pa ne vodi k zmanjšanemu delovanju ledvic. Rabdomioliza je akutno in potencialno
As with other lipid lowering substances, pravastatin or fenofibrate have been associated with the onset of myalgia, myopathy and very rarely rhabdomyolysis with or without secondary renal insufficiency.
V plazmi, v kateri je glavni metabolit fenofibratna kislina, ni zaznati nobenega nespremenjenega fenofibrata.
No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid.
simptomi vnetja jeter (hepatitisa), med katerimi so lahko rahlo porumenela koža in beločnice
• Inflammation of the liver (hepatitis), symptoms of which may be mild yellowing of the skin and whites of the eyes (jaundice), abdominal pain and itching.
tedna v odstotkih za bolnike, zdravljene z zdravilom Pravafenix 40 mg/160 mg ali pravastatinom 40 mg enkrat dnevno
Mean percent changes from baseline to week 12 for patients treated with Pravafenix 40 mg/160 mg or Pravastatin 40 mg once daily
- z zdravili za preprečevanje krvnih strdkov, kot so varfarin, fluindion, fenprokomon ali acenokumarol (antikoagulanti), - z antibiotikom, kot sta eritromicin ali klaritromicin, ki se uporabljata za zdravljenje okužb, ki jih povzročajo bakterije,
- Medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol
Zato je mogoče zdravila, ki jih sistem citokroma P450 presnavlja ali pa so njegovi zaviralci, dodajati stabilni
This is why medicinal products that are metabolised by, or are inhibitors of, the cytochrome P450 system can be added to a stable regimen of pravastatin without causing significant changes in the plasma levels of pravastatin, as have been seen with other statins.
Drugi neželeni učinki
Other Side effects
neobičajen srčni utrip (palpitacije), nastanek krvnih strdkov v venah (globoka venska tromboza)
• Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
LDL, zvišana koncentracija gama-glutamil transferaze (različnih jetrnih encimov), bolečine v jetrih (bolečine v zgornjem desnem predelu
• Increased blood cholesterol, increased blood triglycerides, increased LDL, increased gamma glutamyl transferase (various liver enzymes), liver pain (upper right abdominal pain with or without pain in the back), increased weight.
- za znižanje ravni „slabega“ holesterola (holesterola LDL); zdravilo to doseže tako, da zniža raven skupnega holesterola in maščobnih snovi, imenovanih trigliceridi, v krvi,
It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
sum na dedno bolezen mišic, začenjanje ponovnega zdravljenja z zdravilom Pravafenix ni priporočljivo.
If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended.
bolečine v mišicah (mialgija, artralgija), bolečina v hrbtu, spremembe v nekaterih laboratorijskih krvnih preiskavah delovanja mišic, • težave z vidom, kot je zamegljen ali dvojni vid,
• Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
Pri bolnikih, pri katerih se oceni, da je sistemska uporaba fusidne kisline nujna, je treba prekiniti zdravljenje
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
IME IMETNIKA DOVOLJENJA
NAME OF THE MARKETING AUTHORISATION HOLDER
Pri bolnikih, starejših od 75 let, so na voljo le omejeni podatki o varnosti,
Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised.
telovadba, zmanjšanje telesne mase) za zdravljenje odraslih bolnikov z mešano hiperlipidemijo in visokm tveganjem za kardiovaskularne bolezni, za zmanjševanje vrednosti trigliceridov in višanje vrednosti holesterola HDL, v primeru, ko so vrednosti holesterola LDL ustrezno nadzirane z monoterapijo
Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy.
Vsaka trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Zdravilo Pravafenix je v študiji enkratnega odmerka bioekvivalenten sočasno uporabljenima fenofibratu in pravastatinu.
Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
DODATEK II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Pravastatin je učinkovitejši pri zniževanju holesterola LDL in skupnega holesterola, na trigliceride in holesterol HDL pa ima le zmeren učinek.
Pravastatin is more effective in reducing LDL-C and total cholesterol but presents only modest effects on TG and HDL-C while fenofibrate is very effective in decreasing TG and increasing HDL-C, but with few effects on LDL-C.
- s holestiraminom/holestipolom (zdravilom za zniževanje holesterola), saj vpliva na to, kako zdravilo Pravafenix deluje, - s ciklosporinom (zdravilom, ki se pogosto uporablja pri bolnikih po presaditvi organa),
- Ciclosporin (a medicine often used in organ transplant patients).
so povečanje vrednosti transaminaz in bolezni prebavil.
Hepatobiliary disorders Transaminases increased.
Analiza druge predhodno določene podskupine, opredeljene kot statistično značilna interakcija med zdravljenjem in spolom (p = 0,01), kaže na možne koristi zdravljenja
Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Fenofibratna kislina se ne odstrani
Fenofibric acid is not eliminated by haemodialysis.