natgillin/translations-raw huggingface dataset:
Grapefruit juice should be avoided (see section 4.5).
Treba izbjegavati sok od grejpa (vidjeti dio 4.5).
For these reasons, simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Iz tih razloga, simvastatin se ne smije primjenjivati u žena koje su trudne, pokušavaju zatrudnjeti ili sumnjaju da su trudne.
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
• Poznata fotoalergija ili fototoksična reakcija tijekom liječenja fibratima ili ketoprofenom
If any of the previously listed serious side effects happen, stop taking Cholib and tell your doctor immediately or go to the emergency room at your nearest hospital - you may need urgent medical treatment.
Ako se pojavi bilo koja od prethodno navedenih ozbiljnih nuspojava, prestanite uzimati Cholib i odmah obavijestite liječnika ili se uputite na hitnu pomoć u najbližu bolnicu - možda trebate hitnu medicinsku pomoć.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Terapija statinom smije se ponovo nastaviti nakon sedam dana od zadnje doze fusidatne kiseline.
• If you have pancreatitis (inflamed pancreas which causes abdominal pain), which is not caused by high levels of fats in the blood
• Ako imate pankreatitis (upalu gušterače koja uzrokuje bol u trbuhu), a koja nije uzrokovana visokim razinama masnoća u krvi
If myopathy is suspected for any other reason, treatment should be discontinued.
Ako se iz bilo kojeg drugog razloga sumnja na miopatiju, potrebno je prekinuti liječenje.
• If you are allergic to fenofibrate or simvastatin or any of the other ingredients of Cholib (listed in section 6)
• ako ste alergični na fenofibrat ili simvastatin ili bilo koje druge sastojke Choliba (navedeni u dijelu 6)
• Do not take Cholib if you are breast-feeding or plan to breast-feed your baby, because it is not known if the medicine passes into breast milk.
• Nemojte uzimati Cholib ako dojite ili planirate dojiti Vaše dijete, jer nije poznato prelazi li lijek u majčino mlijeko.
In normal volunteers, the plasma exposure to simvastatin acid was decreased by 93% with concomitant administration of rifampicin.
U normalnih dobrovoljaca, izloženost simvastatinskoj kiselini u plazmi smanjena je za 93% kod istodobne primjene rifampicina.
If you have taken more Cholib than you should or if someone else has taken your medicine, tell your doctor or pharmacist or contact your nearest hospital
Ako ste uzeli više Choliba nego što ste trebali ili ako je netko drugi uzeo Vaš lijek, obavijestite liječnika ili ljekarnika ili se obratite najbližoj bolnici.
Cholib therapy has not been associated with bleeding in patients not taking anticoagulants.
Terapija Cholibom nije povezana s krvarenjem u bolesnika koji ne uzimaju antikoagulanse.
This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Rizik je, međutim, manji od koristi statina u smanjivanju vaskularnog rizika, stoga to ne smije biti razlog za prekid liječenja statinom.
Cholib should be used with caution in patients who consume substantial quantities of alcohol.
Cholib je potrebno primjenjivati s oprezom u bolesnika koji konzumiraju znatne količine alkohola.
You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Postoji rizik da razvijete šećernu bolest ako imate visoke razine šećera i masnoća u krvi, ako imate prekomjernu tjelesnu težinu i povišeni krvni tlak.
The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites.
Glavni metaboliti simvastatina prisutni u ljudskoj plazmi su beta-hidroksi kiselina i četiri dodatna aktivna metabolita.
Posology The recommended dose is one tablet per day.
Doziranje Preporučena doza je jedna tableta dnevno.
Niacin (nicotinic acid) ≥ 1 g/day
Niacin (nikotinska kiselina) ≥1 g/dan
The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing.
Rizik od miopatije povezane uz visoku dozu (80 mg) simvastatina iznosi općenito oko 1 %, bez genetskog testiranja.
• specific lung disease with difficulties breathing (called interstitial lung disease)
• specifična bolest pluća s teškoćom pri disanju (zove se intersticijska bolest pluća)
The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Povećani rizik venskih trombotičnih događaja može biti povezan s povećanom razinom homocisteina, faktorom rizika za nastanak tromboze i drugim neidentificiranim faktorima.
• Alcohol abuse
• Alkoholizam
Cholesterol is one of several fats found in your blood.
Kolesterol je jedna od nekoliko masnoća prisutnih u Vašoj krvi.
• Paediatric population (age below 18 years)
• Pedijatrijska populacija (u dobi do 18 godina)
• trouble sleeping
• poremećaj spavanja
The risk of myopathy with statins and fibrates is known to be related to the dose of each component and to the nature of the fibrate.
Poznato je da je rizik od miopatije sa statinima i fibratima povezan s dozom svake komponente i s vrstom fibrata.
Myopathy**
Miopatija**
The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing.
Farmakokinetika jednokratnih i višestrukih doza simvastatina pokazala je da nema akumulacije lijeka nakon višestrukog doziranja.
Mean plasma half-life: the plasma elimination half-life of fenofibric acid is approximately 20 hours.
Srednja vrijednost poluvijeka u plazmi: poluvijek eliminacije fenofibrične kiseline iz plazme je približno 20 sati.
Gamma-glutamyltransferase increase rare
Povišenje gama-glutamil-transferaze rijetko
Therefore, fenofibrate in Cholib may be taken without regard to meals.
Stoga se fenofibrat u Cholibu smije uzimati bez obzira na obroke.
An average of only 0.3% of the intravenous dose was excreted in urine as inhibitors.
Prosječno se 0,3% intravenske doze izluči u mokraći kao inhibitori.
• erectile dysfunction
• erektilna disfunkcija
• you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid
• ako uzimate, ili ako ste uzeli ili dobili u posljednjih 7 dana lijek koji se zove fusidatna kiselina
If you forget to take Cholib
Ako ste zaboravili uzeti Cholib
If an overdose is suspected, symptomatic treatment and appropriate supportive measures should be provided as required.
Ako se sumnja na predoziranje, potrebno je osigurati simptomatsiko liječenje i prikladne potporne mjere.
Co-administration of this combination may cause increased plasma concentrations of both agents.
Istodobna primjena te kombinacije može uzrokovati povećanu koncentraciiju oba lijeka u plazmi.
Overall, 7,583 subjects with mixed dyslipidemia entered a 6 week statin run-in period.
Ukupno 7583 ispitanika s miješanom dislipidemijom ušlo je u 6-tjedno razdoblje uvođenja statina.
If a patient has previously experienced a muscle disorder on a fibrate or a statin, treatment with a different member of the class should only be initiated with caution.
Ako je bolesnik prethodno imao mišićni poremećaj na fibrat ili statin, liječenje drugim lijekom iste klase smije se započeti samo uz oprez.
• Uncontrolled hypothyroidism
• Nekontrolirana hipotireoza
Therefore, close clinical monitoring of such patients taking colchicine and Cholib is advised.
Stoga se savjetuje pažljivo kliničko praćenje takvih bolesnika kada uzimaju kolhicin i Cholib.
The corresponding risk is 0.3% in patients having the most common genotype (TT) (See section
Odgovarajući rizik je 0,3% u bolesnika s najčešćim genotipom (TT) (vidjeti dio 5.2).
• you or a close family member have a muscle problem which runs in the family
• ako Vi ili bliski član obitelji imate nasljedni problem s mišićima
If Creatine Kinase levels are significantly elevated at baseline (> 5 x ULN), levels should be re-measured within 5 to 7 days later to confirm the results.
Ako su početne vrijednosti kreatin kinaze značajno povišene (>5 x GGN), potrebno je ponovno izmjeriti razine unutar 5 do 7 dana radi potvrđivanja rezultata.
Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
Fenofibrat i simvastatin povećavaju učinke antagonista vitamina K i mogu povećati rizik od krvarenja.
It is unknown whether fenofibrate, simvastatin and/or their metabolites are excreted in human milk.
Nije poznato izlučuju li se fenofibrat, simvastatin i/ili njihovi metaboliti u majčino mlijeko.
What Cholib contains
Što Cholib sadrži
This is because on rare occasions, there have been cases of serious muscle problems including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
To je zato što su u rijetkim slučajevima problemi s mišićima bili ozbiljni, uključujući razgradnju mišića, što može dovesti do oštećenja bubrega ili, u vrlo rijetkim slučajevima, čak do smrti.
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
• Kronični ili akutni pankreatitis, osim u slučaju akutnog pankreatitisa zbog teške hipertrigliceridemije
Simvastatin is taken up actively into the hepatocytes by the transporter OATP1B1.
Simvastatin se aktivno unosi u hepatocite transporterom OATP1B1.
It is particularly important to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Osobito je važno da obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
There are no adequate data from the use of fenofibrate in pregnant women.
Nema odgovarajućih podataka o primjeni fenofibrata kod trudnica.
LS (less square mean) SD (standard deviation)
LS (srednja vrijednost najmanjih kvadrata), SD (standardna devijacija)
Paresthesia, dizziness, peripheral neuropathy rare
Parestezija, omaglica, periferna neuropatija rijetko
Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
Njezine pojavne značajke uključuju dispneju, neproduktivni kašalj i pogoršanje općeg zdravlja (umor, gubitak težine i vrućica).
Talk to your doctor or pharmacist before taking Cholib if:
Obratite se svom liječniku ili ljekarniku prije nego uzmete Cholib:
• rashes, itching, red patches on the skin
• osipi, svrbež, crvene mrlje po koži
In the available clinical data, the effect on LDL-C reduction was not considered to be significantly different to simvastatin monotherapy when LDL-C is controlled at the time of initiating treatment.
U dostupnim kliničkim podacima se ne smatra da se učinak na smanjenje LDL-C-a značajno razlikuje od monoterapije simvastatinom kada se LDL-C kontrolira na početku liječenja.
Fenofibrate has no or negligible influence on the ability to drive and use machines.
Fenofibrat ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Your doctor should do a blood test before you start taking Cholib.
Vaš liječnik Vas treba uputiti na pretragu krvi prije nego počnete uzimati Cholib.
Non-HDL-C (mmol/L) -9.79 (21.32)
Ne-HDL-C (mmol/l) -9,79 (21,32)
Fenofibrate Acute toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Fenofibrat Ispitivanja akutne toksičnosti nisu dala značajne informacije o specifičnoj toksičnosti fenofibrata.
Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).
Potrebno je pratiti odgovor na terapiju određivanjem vrijednosti lipida u serumu (ukupni kolesterol (UK), LDL-C, trigliceridi (TG)).
Following an intravenous injection of the beta-hydroxyacid metabolite, its half-life averaged 1.9 hours.
Nakon intravenske injekcije beta-hidroksi kiseline, poluvijek je u prosjeku 1,9 sati.
10 film-coated tablets 30 film-coated tablets 90 film coated tablets
10 filmom obloženih tableta 30 filmom obloženih tableta 90 filmom obloženih tableta
Week 0 to Week 12
Od 0. tjedna do 12. tjedna
Reduced function can occur as the result of inhibition by interacting medicines (eg ciclosporin) or in patients who are carriers of the SLCO1B1 c.521T>C genotype.
Smanjena funkcija se može pojaviti kao rezultat inhibicije lijekovima koji stupaju u interakciju (npr. ciklosporin) ili u bolesnika koji su nositelji genotipa SLCO1B1 c.521T>C.
Like all medicines, Cholib can cause side effects, although not everybody gets them.
Moguće nuspojave Kao i svi lijekovi, Cholib može uzrokovati nuspojave iako se one neće javiti kod svakoga.
• If while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an anti-inflammatory medicine called “ketoprofen”)
• Ako ste, dok ste uzimali druge lijekove, imali alergijsku reakciju ili oštećenje kože na sunčevo ili UV svjetlo (ti lijekovi sadrže druge fibrate i protuupalni lijek koji se zove "ketoprofen")
Creatine Kinase should not be measured following strenuous exercise or in the presence of any plausible alternative cause of Creatine Kinase increase as this makes value interpretation difficult.
Kreatin kinazu ne treba mjeriti nakon iscrpljujuće tjelovježbe ili u prisutnosti bilo kojeg mogućeg drugog uzroka povišenja kreatin kinaze jer to otežava tumačenje vrijednosti.
Transaminase levels have to be monitored before treatment begins, every 3 months during the first 12 months of treatment and thereafter periodically.
Potrebno je pratiti razine transaminaza prije početka liječenja, svaka 3 mjeseca tijekom prvih 12 mjeseci liječenja i perodično nakon toga.
• Increase in blood levels of “homocysteine” (too much of this amino acid in the blood is related to a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established)
• Povišenje razina "homocisteina" u krvi (prevelika količina ove aminokiseline u krvi povezana je s višim rizikom od koronarne bolesti srca, moždanog udara i bolesti perifernih krvnih žila, iako nije utvrđena uzročno posljedična veza)
Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
Kinetička ispitivanja nakon primjene jednokratne doze i kontinuiranog liječenja pokazala su da se lijek ne akumulira.
Contraindicated with Cholib
Kontraindicirano s Cholibom
If Creatine Kinase levels are significantly elevated at baseline (> 5 x ULN), treatment should not be started.
Ako su početne razine kreatin kinaze značajno povišene (>5 x GGN), liječenje se ne smije započeti.
Do not use Cholib after the expiry date which is stated on the carton and the blister after EXP.
Cholib se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i blisteru iza oznake EXP.
When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus) and diagnosis is confirmed by laboratory testing, Cholib therapy should be discontinued.
Kada se pojave simptomi koji ukazuju na hepatitis (npr. žutica, svrbež) i dijagnozu potvrde laboratorijski testovi, potrebno je prekinuti terapiju Cholibom.
Reversible effects on fertility have been observed in animals (see section 5.3).
U životinja su opaženi reverzibilni učinci na plodnost (vidjeti dio 5.3).
Thromboembolism (pulmonary embolism, deep vein thrombosis)*
Tromboembolija (plućna embolija, duboka venska tromboza)*
Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate.
Fenofibrat se pretežno izlučuje u obliku fenofibrične kiseline i njenog glukuronidnog konjugata.
• Previous history of muscular toxicity with a statin or a fibrate
• Prethodna mišićna toksičnost sa statinom ili fibratom
Cholib The respective effects of simvastatin and fenofibrate are complementary.
Cholib Pojedinačni učinci simvastatina i fenofibrata su komplementarni.
Pack sizes: 10, 30 and 90 film-coated tablets.
Veličine pakiranja: 10, 30 i 90 filmom obloženih tableta.
Niacin (nicotinic acid)
Niacin (nikotinska kiselina)
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojave lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
The tablets are provided in carton boxes with blisters containing 10, 30 or 90 tablets.
Tablete su dostupne u kutijama s blisterima koji sadrže 10, 30 ili 90 tableta.
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.
HDL kolesterol često se naziva "dobrim" kolesterolom zato što pomaže u sprečavanju nakupljanja "lošeg" kolesterola u arterijama i zato što štiti od bolesti srca.
Blood creatinine increased (see sections 4.3 and 4.4)
Povišenje kreatinina u krvi (vidjeti dijelove 4.3 i 4.4)
Based on conventional animal studies regarding pharmacodynamics, repeated dose toxicity, genotoxicity and carcinogenicity, there are no other risks for the patient than may be expected on account of the pharmacological mechanism.
Na temelju rezultata konvencionalnih ispitivanja farmakodinamike, toksičnosti ponovljene doze, genotoksičnosti i karcinogenosti provedenih na životinjama, nema drugih rizika za bolesnika osim onih koji se mogu očekivati kao posljedica farmakološkog mehanizma djelovanja.
Reversible ulcers and erosions in the gastro-intestinal tract occurred in dogs treated during 3 months at exposures approximately 7-fold the clinical AUC.
Reverzibilni ulkusi i erozije u gastointestinalnom traktu pojavile su se u pasa liječenih tijekom 3 mjeseca pri izloženosti otprilike 7 puta većim od kliničkog AUC-a.
The European Medicines Agency has waived the obligation to submit the results of studies with Cholib in all subsets of the paediatric population in combined dyslipidaemia (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Cholib u svim podskupinama pedijatrijske populacije s miješanom dislipidemijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Cholib: Cholib contains fenofibrate and simvastatin, which have different modes of action as described above.
Cholib sadrži fenofibrat i simvastatin, koji imaju različite načine djelovanja, kao što je opisano u prethodnom tekstu.
Prescribing recommendations for interacting substances are summarised in the table below (see also sections 4.2 and 4.3).
Preporuke za propisivanje lijekova s interakcijama sažete su u donjoj tablici (vidjeti također dijelove 4.2 i 4.3).
• Moderate to severe renal insufficiency (estimated glomerular filtration rate
• Umjerena do teška insuficijencija bubrega (procijenjena brzina glomerularne filtracije
Some patients have experienced the following serious side effects whilst taking fenofibrate or simvastatin (both active substances in Cholib):
Neki su bolesnici imali sljedeće ozbiljne nuspojave dok su uzimali fenofibrat ili simvastatin (obje djelatne tvari u Cholibu):
At maximally tolerated doses in both the rat and the rabbit, simvastatin produced no fetal malformations, and had no effects on fertility, reproductive function or neonatal development.
Kod štakora i kunića, najviše podnošljive doze simvastatina nisu uzrokovale malformacije fetusa niti su utjecale na plodnost, reproduktivnu funkciju ili neonatalni razvoj.
Therefore, the dose of Cholib should not exceed 145 mg/20 mg daily in patients taking amiodarone, amlodipine, diltiazem or verapamil.
Stoga doza Choliba ne smije prijeći 145 mg/20 mg dnevno u bolesnika koji uzimaju amiodaron, amlodipin, diltiazem ili verapamil.
• infection of the upper respiratory tract
• infekcija gornjih dišnih puteva
Consult the prescribing information of all concomitantly used drugs to obtain further information about their potential interactions with simvastatin and/or the potential for enzyme or transporter alterations and possible adjustments to dose and regimens.
Proučite informacije o propisivanju svih lijekova koji se uzimaju istodobno kako biste dobili više informacija o njihovim mogućim interakcijama sa simvastatinom i/ili potencijalu za utjecaj na enzime ili transportne proteine, te o mogućim prilagodbama doze i režima doziranja.
If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib.
Ako se bilo što od navedenog odnosi na Vas, razgovarajte s Vašim liječnikom ili ljekarnikom prije uzimanja Choliba.
Erectile dysfunction not known
Erektilna disfunkcija nepoznato
• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4)
• Preosjetljivost na djelatne tvari, kikiriki, soju ili neku od pomoćnih tvari navedenih u dijelu 6.1 (također vidjeti dio 4.4)
This adverse reaction should be taken into account when driving vehicles or using machines under Cholib therapy.
Potrebno je voditi računa o toj nuspojavi prilikom upravljanja vozilima ili rada na strojevima za vrijeme terapije Cholibom.
Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis.
Nužan je oprez u bolesnika s predisponirajućim faktorima za rabdomiolizu.
There are no clinical data on fertility from the use of Cholib.
Nema kliničkih podataka o plodnosti uz primjenu Choliba.
Alanine- aminotransferase increased
Povišenje alanin-aminotransferaze često
Patients receiving co-administration of Cholib and drugs metabolised by CYP 2C19, CYP 2A6, or especially CYP 2C9 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Bolesnici koji primaju istodobno Cholib i lijekove metabolizirane putem CYP 2C19, CYP 2A6 ili naročito CYP 2C9 s uskim terapijskim indeksom moraju biti pažljivo praćeni i, ako je potrebno, preporučuje se prilagodba doze tih lijekova.
• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis) (very rare)
• ozbiljna alergijska reakcija koja uzrokuje otežano disanje ili omaglicu (anafilaksija) (vrlo rijetko)
Studies on mutagenicity of fenofibrate have been negative.
Ispitivanja mutagenosti fenofibrata dala su negativne rezultate.
Cholib is used in adults at high risk of problems like heart attack and stroke who have high blood levels of 2 types of fats (triglycerides and LDL cholesterol).
Cholib se koristi u odraslih s visokim rizikom od problema poput srčanog udara i moždanog udara s visokim razinama 2 vrste masnoća (trigliceridi i LDL kolesterol) u krvi.
The repeated administration of simvastatin 40 or 80 mg, the highest dose registered, did not affect the plasma levels of fenofibric acid at steady state.
Ponovljena primjena 40 ili 80 mg simvastatina, najviše registrirane doze, nije utjecala na razine fenofibrične kiseline u plazmi u stanju dinamičke ravnoteže.
• hypersensitivity (allergic) reactions including swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema) (rare)
• reakcije preosjetljivosti (alergijske reakcije) uključujući: oticanje lica, jezika i grla, što može uzrokovati otežano disanje (angioedem) (rijetko)
If it is suspected a patient has developed interstitial lung disease, Cholib therapy should be discontinued.
Ako postoji sumnja da je bolesnik razvio intersticijsku bolest pluća, potrebno je prekinuti terapiju Cholibom.
• If you are pregnant or breast-feeding
• Ako ste trudni ili dojite
Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin.
Najviša koncentracija aktivnih inhibitora u plazmi postiže se približno 1-2 sata nakon primjene simvastatina.
Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - France.
Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - Francuska.
Gemfibrozil, Other statins and fibrates
Gemfibrozil, drugi statini i fibrati