FrancophonIA/ELRC3.0 huggingface dataset:
English: This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct medicinal product effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.
Bulgarian: s hudo hipertrigliceridemijo, kar je neposredna posledica zdravila, ali pa gre za sekundarni pojav, ki nastane zaradi kamna ali usedline v biliarnem traktu, ki ovira žolčevod.
English: Since current safety and efficacy data are based upon administration with food and with dietary restrictions, it is recommended that Pravafenix is administered with food.
Bulgarian: Ker trenutni podatki o varnosti in učinkovitosti temeljijo na jemanju skupaj s hrano in upoštevanju dietnih omejitev, se priporoča jemanje zdravila Pravafenix skupaj s hrano (glejte poglavji 4.2 in 5.2).
English: INFORMATION IN BRAILLE Pravafenix
Bulgarian: PODATKI V BRAILLOVI PISAVI Pravafenix
English: The absorption of fenofibrate is increased when administered with food.
Bulgarian: Fenofibrat se bolje absorbira, če se jemlje skupaj s hrano.
English: The major degradation product of pravastatin is the 3-αhydroxy isomeric metabolite.
Bulgarian: Glavni produkt razgradnje pravastatina je izomerni metabolit 3-α-hidroksi. Ta metabolit
English: Rhabdomyolysis is an acute potentially fatal condition of skeletal muscle, which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 times the ULN) leading to myoglobinuria.
Bulgarian: smrtno stanje skeletnih mišic. Razvije se lahko kadarkoli med zdravljenjem, zanjo pa je značilen masiven razkroj mišic, povezan z znatnim zvišanjem kreatin-fosfokinaze (ponavadi > 30- ali 40-kratnik ZMN), ki vodi v mioglobinurijo.
English: If it is suspected a patient has developed interstitial lung disease, Pravafenix therapy should be discontinued.
Bulgarian: Če obstaja sum, da se je pri bolniku razvila intersticijska pljučna bolezen, je treba zdravljenje z zdravilom Pravafenix prekiniti.
English: The recommended dose is one capsule taken daily during the evening meal.
Bulgarian: Priporočeni odmerek je ena kapsula na dan, ki se zaužije med večernim obrokom.
English: The effects of Pravafenix 40 mg/160 mg were confirmed in a similar multicenter, 64-week trial including a 12 week randomized, double-blind phase in a study performed in the USA and comparing Pravafenix 40 mg/160 mg to Fenofibrate 160 mg monotherapy and Pravastatin 40 mg monotherapy in patients with mixed dyslipidaemia.
Bulgarian: Učinki zdravila Pravafenix 40 mg/160 mg so bili potrjeni v podobnem multicentričnem 64-tedenskem preskušanju, ki je vključevalo 12-tedensko randomizirano, dvojno slepo študijo, ki je potekala v ZDA in je primerjala zdravilo Pravafenix 40 mg/160 mg z monoterapijo
English: When the blood flow is blocked, the result can be a heart attack or stroke.
Bulgarian: Prekinitev dotoka krvi lahko povzroči srčni infarkt ali možgansko kap.
English: This results in an increase in the number of LDL-receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL-cholesterol.
Bulgarian: Zato se poveča število receptorjev za LDL na površinah celic, pospeši se receptorsko posredovani katabolizem, krožeči holesterol LDL pa očisti.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Bulgarian: spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Mean (%)± SEb p-valuec
Bulgarian: (%) ± SEb vrednost pc
English: The absence of a significant pharmacokinetic interaction with pravastatin has been specifically demonstrated for several medicinal products, particularly those that are substrates/inhibitors of CYP3A4 e.g. diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice and CYP2C9 inhibitors (e.g. fluconazole).
Bulgarian: s pravastatinom je še posebej dokazana pri posameznih zdravilih, zlasti pri tistih, ki so substrati/zaviralci encima CYP3A4, npr. pri diltiazemu, verapamilu, itrakonazolu, ketokonazolu, zaviralcih proteaz, soku grenivke in zaviralcih encima CYP2C9 (npr. flukonazolu).
English: If you forget to take Pravafenix
Bulgarian: Če ste pozabili vzeti zdravilo Pravafenix
English: Pravafenix contains a sugar called lactose.
Bulgarian: Zdravilo Pravafenix vsebuje sladkor, imenovan laktoza.
English: As with other lipid lowering medicinal products, moderate increases in transaminase levels have been reported in some patients treated with pravastatin or fenofibrate.
Bulgarian: Tako kot pri drugih zdravilih za zniževanje lipidov so pri nekaterih bolnikih, ki so se zdravili
English: Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60 and 90 hard capsules.
Bulgarian: Pretisni omoti iz poliamida-aluminija-PVC/aluminija, ki vsebujejo 30, 60 in 90 trdih kapsul.
English: This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Bulgarian: Pomembnost tega tveganja pa je manjša od pomembnosti zmanjšanja vaskularnega tveganja pri uporabi statinov, zato to ne
English: If you are not sure, talk to your doctor or pharmacist before taking Pravafenix.
Bulgarian: Če niste prepričani, se preden začnete jemati zdravilo Pravafenix, posvetujte z zdravnikom ali farmacevtom.
English: However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances may occur during treatment.
Bulgarian: s stroji pa se je treba zavedati, da se lahko med zdravljenjem pojavijo vrtoglavica ali motnje vida.
English: This leaflet was last approved in
Bulgarian: Navodilo je bilo nazadnje revidirano dne
English: This is because, on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.
Bulgarian: To morate storiti, ker so težave z mišicami v redkih primerih (mednje spada razpadanje mišic, ki povzroča poškodbe ledvic) lahko resne; v zelo redkih primerih je prišlo do smrti.
English: DATE OF REVISION OF THE TEXT
Bulgarian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu
English: This metabolite has one-tenth to one-fortieth the HMG-CoA reductase inhibitor activity of the parent compound.
Bulgarian: ima od ene desetine do ene štiridesetine aktivnosti zaviralca reduktaze HMG-CoA matične spojine.
English: Therefore, as far as pravastatin is contra indicated (see below), Pravafenix is contraindicated during pregnancy (see section 4.3).
Bulgarian: Ker je pravastatin kontraindiciran (glejte spodaj), je tudi zdravilo Pravafenix med nosečnostjo kontraindicirano (glejte poglavje 4.3).
English: The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Bulgarian: treba naročiti, naj se takoj posvetujejo z zdravnikom, če se pri njih pojavijo kakršni koli simptomi mišične oslabelosti, bolečin ali preobčutljivosti.
English: There are no data from the combined use of pravastatin and fenofibrate in pregnant women.
Bulgarian: O kombinirani uporabi pravastatina in fenofibrata pri nosečnicah ni podatkov.
English: Pancreatitis
Bulgarian: Pankreatitis
English: If cholelithiasis is suspected, gallbladder studies are indicated.
Bulgarian: Če obstaja sum na holelitiazo, je treba opraviti preiskave žolčnika.
English: Your doctor will monitor you while you are taking this medicine.
Bulgarian: Med jemanjem tega zdravila bo zdravnik pri vas opravljal spremljanje.
English: Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
Bulgarian: neproduktiven kašelj in poslabšanje splošnega zdravstvenega stanja (utrujenost, hujšanje in vročina).
English: Certain predisposing factors such as age > 70, renal impairment, hepatic impairment, hypothyroidism, personal history of muscular toxicity with a statin or fibrate, personal or familial history of hereditary muscular disorders or alcohol abuse may increase the risk of muscular toxicity and therefore CK measurement is indicated before starting the combination therapy in these patients (see below).
Bulgarian: Nekateri predispozicijski dejavniki, na primer starost nad 70 let, okvara ledvic, okvara jeter, hipotiroidizem, toksični učinki statina ali fibrata na mišice v osebni anamnezi, dedne mišične motnje v osebni ali družinski anamnezi ali zloraba alkohola, lahko povečajo tveganje za toksične učinke na mišice.
English: The bioavailability of pravastatin is higher after a single dose administration of the test product Fenofibrate/Pravastatin 160/40 mg in fasting conditions than after a single dose of the product in fed conditions.
Bulgarian: Biološka uporabnost pravastatina je višja po uporabi enega odmerka testnega zdravila fenofibrat/pravastatin 160/40 mg na tešče v primerjavi z enim odmerkom zdravila pri neteščih bolnikih.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Bulgarian: POGOJI ALI OMEJITVE V ZVEZI
English: In exceptional circumstances, where prolonged systemic fusidic acid is needed e.g for the treatment of severe infections, the need for co-administration of pravastatin and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Bulgarian: s fusidno kislino, npr. za zdravljenje hudih okužb, je sočasna uporaba pravastatina in fusidne kisline upoštevna le v posameznih primerih in pod strogim zdravniškim nadzorom.
English: The bioavailability of fenofibric acid is lower in fasting conditions after a single dose administration of the Fenofibrate-Pravastatin 160/40 mg combination.
Bulgarian: Biološka uporabnost fenofibratne kisline na tešče je nižja po uporabi enega odmerka kombinacije fenofibrata in pravastatina 160/40 mg.
English: Four multicenter studies with either Pravafenix 40 mg/160 mg or Pravastatin 40 mg or Simvastatin 20 mg were conducted: 3 studies included a 12 week randomized, double-blind, active controlled period with an open-label extension phase and one was a 24-week open-label study.
Bulgarian: s simvastatinom 20 mg: 3 študije so vključevale 12-tedensko randomizirano, dvojno slepo, aktivno nadzorovano študijo z odprto podaljšano fazo, ena pa je bila 24-tedenska odprta študija.
English: You should tell your doctor immediately if it happens.
Bulgarian: Če se to zgodi, o tem takoj obvestite zdravnika.
English: Apo B (g/L)
Bulgarian: Apoprotein B (g/l)
English: Receptor type α (PPARα).
Bulgarian: s peroksisomskim proliferatorjem aktiviranega receptorja α (PPARα).
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Bulgarian: Med zdravljenjem z nekaterimi statini oziroma po njem so zelo redko poročali o imunsko posredovani nekrotizirajoči miopatiji (IMNM).
English: Belgium
Bulgarian: Belgija
English: Fenofibrate cannot be eliminated by haemodialysis.
Bulgarian: Fenofibrata iz telesa ni mogoče odstraniti s hemodializo.
English: Liver reactions: Marked and persistent increases of serum transaminases have been reported infrequently.
Bulgarian: Neželeni učinki na jetrih: redko so zabeležili izrazit in stalen porast serumskih transaminaz.
English: - Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase (CK) elevation above 5 times the ULN under previous statin treatment
Bulgarian: statinov in/ali fibratov v osebni anamnezi ali potrjeno zvišanje kreatin-fosfokinaze, ki je bilo med prejšnjim zdravljenjem
English: • Breathing problems including persistent cough/or shortness of breath or fever.
Bulgarian: težave z dihanjem, vključno z dolgotrajnim kašljem/ali oteženo dihanje ali zvišana telesna temperatura,
English: Clinical and biochemical monitoring of patients receiving this combination is recommended.
Bulgarian: Pri bolnikih, ki prejemajo to kombinacijo, je priporočeno
English: Pravastatin is contraindicated during pregnancy and should be administered to women of childbearing potential only when such patients are unlikely to conceive and have been informed of the potential risk.
Bulgarian: Pravastatin je med nosečnostjo kontraindiciran in se lahko daje ženskam v rodni dobi le, če je malo verjetno, da bodo te bolnice zanosile, in če so bile obveščene o možnem tveganju. Pri ženskah v rodni dobi se priporoča posebna previdnost, s čimer naj se zagotovi, da pravilno razumejo možno tveganje, povezano z zdravljenjem
English: Dietary restrictions instituted before therapy should be continued.
Bulgarian: Dietne omejitve, vpeljane pred zdravljenjem, je treba upoštevati tudi med zdravljenjem.
English: Do not take Pravafenix if - You are allergic to fenofibrate, pravastatin, or any of the other ingredients of this medicine (listed in section 6).
Bulgarian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO PRAVAFENIX Ne jemljite zdravila Pravafenix - če ste alergični na fenofibrat, pravastatin ali katerokoli sestavino zdravila Pravafenix (navedeno v poglavju 6),
English: Indigo carmine Black iron oxide Titanium dioxide Yellow iron oxide
Bulgarian: titanov dioksid , rumeni železov oksid.
English: 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.
Bulgarian: sladkorne bolezni, če imate visoke ravni sladkorjev in maščob v krvi, imate čezmerno telesno maso in visok krvi tlak.
English: In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect.
Bulgarian: ima koncentracija pravastatina v plazmi le omejeno vrednost pri predvidevanju vpliva na zniževanje koncentracije lipidov.
English: Over time, this plaque build-up can lead to a clogging of your arteries.
Bulgarian: Slednje lahko sčasoma pripeljejo do zožitve arterij.
English: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5,518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin.
Bulgarian: to Control Cardiovascular Risk in Diabetes) je bila randomizirana, s placebom kontrolirana študija pri 5.518 bolnikih
English: Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and
Bulgarian: Pravafenix na prazen želodec slabše absorbira, ga je treba vedno vzeti skupaj s hrano (glejte poglavji 4.5 in 5.2).
English: It is recommended to systematically assess the estimated creatinine clearance at the initiation of the treatment and every 3 months during the first 12 months of the combination therapy then let to the appreciation of the clinician beyond this period.
Bulgarian: sistematično ocenjevanje očistka kreatinina na začetku zdravljenja in na vsake 3 mesece, po tem obdobju pa je odločitev o tem prepuščena zdravniku.
English: Myopathy must be considered in any patient presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps.
Bulgarian: Na miopatijo je treba pomisliti pri kateremkoli bolniku, ki v mišicah čuti nepojasnjene simptome, na primer bolečino, občutljivost, oslabelost ali krče.
English: Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
Bulgarian: 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
English: BATCH NUMBER
Bulgarian: ŠTEVILKA SERIJE
English: 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).
Bulgarian: 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 =
English: Possible side effects
Bulgarian: MOŽNI NEŽELENI UČINKI
English: Pregnancy and breast-feeding
Bulgarian: Nosečnost in dojenje
English: 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.
Bulgarian: 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.
English: Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
Bulgarian: Neprozorne bele plastenke iz polietilena visoke gostote (HDPE), ki vsebujejo 14, 30, 60 in 90 trdih kapsul.
English: - 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.
Bulgarian: 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
English: 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).
Bulgarian: 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).
English: 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.
Bulgarian: Holesterol HDL pogosto imenujemo „dobri“ holesterol, ker pomaga preprečevati kopičenje „slabega“
English: Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure
Bulgarian: Bolezni sečil povečan kreatinin v krvi, zmanjšan ledvični očistek kreatinina, povečan ledvični očistek kreatinina, odpoved ledvic občasni
English: Not known
Bulgarian: neznana
English: 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.
Bulgarian: so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Pravafenix versus PRAVASTATIN
Bulgarian: Pravafenix v primerjavi
English: Cholelithiasis
Bulgarian: Holelitiaza
English: A pharmacokinetic study after a single dose administration of Pravafenix has been performed in fed and fasting condition.
Bulgarian: Izvedena je bila farmakokinetična študija po enem odmerku zdravila Pravafenix pri teščih
English: 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.
Bulgarian: V te študije so v Evropi in ZDA zajeli skupno 1637 bolnikov, ki se niso dobro odzvali na zdravljenje z monoterapijo
English: If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
Bulgarian: Če vas skrbi, koliko alkohola lahko med jemanjem
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Bulgarian: FARMACEVTSKA OBLIKA IN VSEBINA 60 trdih kapsul
English: It is important to take the capsule with food, as it won't work as well if your stomach is empty.
Bulgarian: s hrano, saj na tešče ne bo tako dobro delovala.
English: Fusidic acid
Bulgarian: Fusidna kislina
English: 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.
Bulgarian: 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.
English: Lactose
Bulgarian: Laktoza
English: 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.
Bulgarian: s prvim prehodom skozi jetra, ki so primarno mesto njegovega delovanja ter primarno mesto za sintezo holesterola in čiščenje holesterola LDL.
English: 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.
Bulgarian: 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
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007
Bulgarian: ZA PROMET EU/1/11/679/001-007
English: Immune-mediated necrotizing myopathy (see section 4.4).
Bulgarian: s pretrganjem zelo redki rabdomioliza imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.)
English: Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders).
Bulgarian: Pred odločitvijo o začetku zdravljenja z zdravilom Pravafenix je treba oceniti ledvično funkcijo (glejte poglavje 4.4 Bolezni sečil).
English: The combination has not been tested in reproductive toxicity studies.
Bulgarian: Vpliv kombinacije na sposobnost razmnoževanja v študijah ni bil raziskan.
English: Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see section 4.4); myositis, polymyositis.
Bulgarian: 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
English: No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Bulgarian: V študijah vplivov na sposobnost razmnoževanja niso ne pri fenofibratu ne pri pravastatinu opazili učinkov na plodnost (glejte poglavje 5.3)
English: Musculoskeletal and connective tissue disorders
Bulgarian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
Bulgarian: Skeletna mišičnina: redko so zabeležili izrazit in stalen porast kreatin-fosfokinaze (KF). Med bolniki,