FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently, the potential benefit/risk ratio of Pravafenix should be closely assessed before treatment initiation and patients should be monitored for any signs of muscle toxicity.
Croatian: Slijedom navedenog potrebno je pažljivo procijeniti omjer korist/rizik primjene Paravafenixa prije početka liječenja, a bolesnike treba nadzirati na bilo kakve znakove mišićne toksičnosti.
English: In vitro and in vivo genetic toxicology studies have shown no evidence of mutagenic potential.
Croatian: Genetička toksikološka ispitivanja in vitro i in vivo nisu pokazala znakove mutagenog potencijala.
English: In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Croatian: U starijih bolesnika ukupni prividni plazmatski klirens fenofibrične kiseline nije promijenjen.
English: Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.
Croatian: Nakon liječenja Pravafenixom slijedi brzo smanjenje razina lipida u serumu, ali liječenje treba prekinuti ako se ne postigne odgovarajući odgovor unutar tri mjeseca.
English: Interactions relevant to fenofibrate
Croatian: Interakcije značajne za fenofibrat
English: Interaction between pravastatin and fusidic acid can lead to an increased risk of rhabdomyolysis.
Croatian: Interakcija između pravastatina i fusidatne kiseline može dovesti do povećanog rizika od rabdomiolize.
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).
Croatian: Odsustvo značajne farmakokinetičke interakcije s pravastatinom posebno je dokazana za nekoliko lijekova, posebice one koji su supstrati/inhibitori CYP3A4 npr. diltiazem, verapamil, itrakonazol, ketokonazol, inhibitori proteaze, sok od grejpa i inhibitori CYP2C9 (npr. flukonazol)
English: of fenofibric acid (point estimate) is of 30.94%, 10.9% and
Croatian: za fenofibričnu kiselinu (točka procjene) je 30,94%, 10,9% odnosno 68,71%.
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).
Croatian: Određeni predisponirajući faktori poput dobi > 70 godina, oštećenja bubrega, oštećenja jetre, hipotireoidizma, osobne anamneze mišićne toksičnosti sa statinom ili fibratom, nasljednih mišićnih poremećaja u osobnoj ili obiteljskoj anamnezi ili alkoholizma mogu povećati rizik od mišićne toksičnosti, stoga je u ovih bolesnika indicirano mjerenje CK prije započinjanja kombinirane terapije (vidjeti dolje).
English: 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).
Croatian: Još jednom analizom unaprijed određene podskupine identificirana je statistički značajna interakcija liječenja ovisno o spolu (p = 0,01) što ukazuje na moguće koristi liječenja kombiniranom terapijom kod muškaraca (p = 0,037), ali potencijalno veći rizik za primarni ishod kod žena liječenih kombiniranom terapijom u usporedbi sa monoterapijom simvastatinom (p = 0,069).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pravafenix in all subsets of the paediatric population in disorders of lipoprotein metabolism and other hyperlipidaemias (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Pravafenix u svim podskupinama pedijatrijske populacije s poremećajima metabolizma lipoproteina i drugih hiperlipidemija (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
Croatian: Postoje prijave o rabdomiolizi (uključujući neke sa smrtnim ishodom) u bolesnika koji su primali ovu kombinaciju
English: • Hypersensitivity.
Croatian: • Preosjetljivost.
English: The major degradation product of pravastatin is the 3-αhydroxy isomeric metabolite.
Croatian: Glavni produkt razgradnje pravastatina je 3-α-hidroksi izomerni metabolit.
English: Cholesterol is one of several fats found in your blood.
Croatian: Kolesterol je jedan od nekoliko vrsta masnoća koje nalazimo u našem tijelu.
English: When measured, CK levels should be interpreted in the context of other potential factors that can cause transient muscle damage, such as strenuous exercise or muscle trauma and repeated if necessary.
Croatian: Izmjerene, razine CK treba tumačiti u kontekstu drugih mogućih faktora koji mogu uzrokovati prolazno oštećenje mišića, poput iscrpljujuće tjelovježbe ili mišićne traume, te po potrebi mjerenje ponoviti.
English: • At the request of the European Medicines Agency;
Croatian: nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove;
English: Pravafenix contains a sugar called lactose.
Croatian: Pravafenix sadrži šećer zvan laktoza.
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.
Croatian: Pravastatin je kontraindiciran tijekom trudnoće i treba ga primjenjivati ženama reproduktivne dobi samo kad za takve bolesnice nije vjerojatno da će zatrudnjeti i koje su upoznate s potencijalnim rizikom.
English: Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.
Croatian: Liječenje treba prekinuti u slučaju procijenjenog klirensa kreatinina < 60 ml/min.
English: Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60 and 90 hard capsules.
Croatian: Poliamid-aluminij-PVC/aluminij blister pakiranja koja sadrže 30, 60 i 90 tvrdih kapsula.
English: 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).
Croatian: Fenofibrat je derivat fibrične kiseline čiji su modificirajući učinci na lipide prijavljenih u ljudi posredovani putem aktivacije peroksisom proliferator aktiviranog receptora tipa alfa (PPARα).
English: A small quantity of pravastatin passes into the human breast milk.
Croatian: Mala količina pravastatina prelazi u majčino mlijeko.
English: • Depression
Croatian: - depresija
English: • Memory loss
Croatian: • Gubitak pamćenja.
English: In both healthy subjects and patients with hypercholesterolaemia, pravastatin lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while HDL-cholesterol and apolipoprotein A are elevated.
Croatian: I u zdravih ispitanika i bolesnika s hiperkolesterolemijom pravastatin snižava sljedeće vrijednosti lipida: ukupni kolesterol, LDL kolesterol, apolipoprotein B, VLDL kolesterol i trigliceridi; dok su HDL kolesterol i apolipoprotein
English: In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid, antacids (when given one hour prior to pravastatin), nicotinic acid or probucol.
Croatian: U ispitivanjima interakcija nisu primijećene statistički značajne razlike u bioraspoloživosti kada se pravastatin primjenjivao s acetilsalicilnom kiselinom, antacidima (kada su dani jedan sat prije pravastatina), nikotinskom kiselinom ili probukolom.
English: Concomitant administration of pravastatin and ciclosporin leads to an approximately 4 fold increase in pravastatin systemic exposure.
Croatian: Istodobna primjena pravastatina i ciklosporina dovodi do povećanja od približno 4 puta većoj sistemsoj izloženosti pravastatinu.
English: Indigo carmine Black iron oxide Titanium dioxide Yellow iron oxide
Croatian: Ovojnica kapsule: želatina indigo karmin crni željezov oksid titanijev dioksid žuti željezov oksid
English: There is no relevant use of Pravafenix in the paediatric population (< 18 years old) for the indication of mixed dyslipidaemia (see section 4.3).
Croatian: Nema relevantne primjene Pravafenixa u pedijatrijskoj populaciji (< 18 godina) za indikaciju miješane dislipidemije (vidjeti dio 4.3).
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.
Croatian: HDL kolesterol se često naziva "dobrim" kolesterolom jer pomaže da se "loš" kolesterol ne nakuplja u stijenkama arterija i tako štiti od srčanih bolesti.
English: However in a multiple dose study, the results showed that the product is not bioequivalent because its bioavailability after multiple dosing is a 20% lower for the fenofibrate component of the combination.
Croatian: Rezultati ispitivanja višekratnog doziranja pokazuju da lijek nije bioekvivalentan, budući da je njegova bioraspoloživost nakon višekratnog doziranja 20% niža za komponentu fenofibrata ove kombinacije.
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
Croatian: - Osobna anamneza miopatije i/ili rabdomiolize sa statinima i/ili fibratima, ili potvrđeno povišenje kreatinin-fosfokinaze (CK) u serumu 5 puta iznad GGN tijekom prethodnog liječenja statinom
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.
Croatian: Ovo iz razloga što, u rijetkim slučajevima, problemi s mišićima mogu biti ozbiljni, uključujući razgradnju mišića s posljedičnim oštećenjem bubrega, a vrlo rijetko može nastupiti i smrt.
English: • Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture.
Croatian: • Razgradnja mišića (rabdomioliza), u nekim slučajevima problemi s tetivama, ponekad puknućem kao komplikacijom.
English: The following statements reflect the pharmacodynamic/pharmacokinetic properties of the individual active substances of Pravafenix.
Croatian: Sljedeće tvrdnje odnose se na farmakodinamička/farmakokinetička svojstva pojedine djelatne tvari Pravafenixa.
English: • 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.
Croatian: • Povišeni kolesterol u krvi, povišeni trigliceridi u krvi, povišen LDL, povišene gama glutamil transferaza (različiti jetreni enzimi), bol u jetri (bol u gornjem desnom dijelu trbuha s ili bez boli u leđima), povećanje tjelesne težine.
English: Following oral administration, 20% of the initial dose is eliminated in the urine and 70% in the faeces.
Croatian: Nakon peroralne primjene 20% inicijalne doze eliminira u mokraći a 70% stolicom.
English: There was no clinically significant decrease in bioavailability or therapeutic effect when pravastatin was administered one hour before or four hours after colestyramine or one hour before colestipol.
Croatian: Nije bilo klinički značajnog smanjenja bioraspoloživosti ili terapijskog učinka kada se pravastatin primijenio jedan sat prije ili četiri sata nakon kolestiramina ili jedan sat prije kolestipola.
English: • Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
Croatian: • Bol u mišićima i zglobovima (mialgija, artralgija), bol u leđima, promjene nekih laboratorijskih krvnih nalaza za pretrage mišićne funkcije.
English: It is rapidly absorbed; peak serum levels are achieved 1 to 1.5 hours after ingestion.
Croatian: Apsorbira se brzo, vršne razine u serumu postižu se 1 do 1,5 sati nakon uzimanja.
English: • Rashes, skin rash, itching, hives or reactions to sunlight or exposure to UV light (photosensitivity reactions), scalp/hair abnormality (including hair loss)
Croatian: • Osipi, kožni osip, svrbež, koprivnjača ili reakcije na sunčevu svjetlost ili na izlaganje UV svjetlu (fotosenzitivne reakcije), poremećaji vlasišta/kose (uključujući gubitak kose)
English: Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of
Croatian: Pomoću ovih mehanizama fenofibrat povećava lipolizu i eliminaciju trigliceridima bogatih čestica iz plazme tako da aktivira lipoprotein lipazu a smanjuje stvaranje apoproteina C-III.
English: In one of two interaction studies with pravastatin and erythromycin a statistically significant increase in the area under the curve (AUC) (70%) and Cmax (121%) of pravastatin was observed.
Croatian: U jednom od dva ispitivanja interakcija pravastatina i eritromicina primijećeno je statistički značajno povećanje površine ispod krivulje (AUC) (70%) i Cmax (121%) za pravastatin.
English: 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.
Croatian: Ispitivanja ponovljenih doza ukazuju da pravastatin može izazvati promjenjive stupnjeve hepatotoksičnosti i miopatije; općenito, znatni učinci na ova tkiva bili su očiti samo pri dozama od 50 i više puta višim od maksimalne doze za ljude u mg/kg.
English: In vitro studies demonstrated that pravastatin is transported into hepatocytes and with substantially less intake in other cells.
Croatian: Ispitivanja in vitro pokazala su da se pravastatin transportira u hepatocite s bitno manjim unosom u druge stanice.
English: Medicinal products metabolised by cytochrome P450
Croatian: Lijekovi koji se metaboliziraju putem citokroma P450
English: The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
Croatian: Rizik od miopatije, uključujući rabdomiolizu, može biti povećan istodobnom primjenom sistemske fusidatne kiseline sa statinima.
English: The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders.
Croatian: Najčešće prijavljene nuspojave tijekom terapije Pravafenixom su povišene transaminaze i gastrointestinalni poremećaji.
English: Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and
Croatian: Budući se lošije apsorbira na prazan želudac, Pravafenix treba uvijek uzimati s hranom (vidjeti dijelove 4.5. i 5.2).
English: Thromboembolism (pulmonary embolism, deep vein thrombosis)*
Croatian: Krvožilni poremećaji tromboembolije (plućna embolija, duboka venska tromboza)*
English: What you need to know before you take pravafenix
Croatian: Što morate znati prije nego počnete uzimati Pravafenix
English: Plasma elimination half-life of oral pravastatin is 1.5 to 2 hours.
Croatian: Poluvijek eliminacije peroralno uzetog pravastatina je 1,5 do 2 sata.
English: Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, and produces its lipid-lowering effect in two ways.
Croatian: Pravastatin je kompetitivni inhibitor 3-hidroksi-3-metilglutaril-koenzim A (HMG-KoA) reduktaze, enzima koji katalizira ranu sporu fazu biosinteze kolesterola, i time djeluje na snižavanje razine lipida na dva načina.
English: Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate.
Croatian: Dodatne informacije o pojedinim djelatnim tvarima fiksne kombinirane doze Pravafenix sadrži pravastatin i fenofibrat.
English: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m 2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines.
Croatian: Rizične bolesnike (glukoza natašte 5,6 do 6,9 mmol/l, BMI>30kg/m2, povišeni trigliceridi, hipertenzija) treba pratiti klinički i laboratorijski prema nacionalnim smjernicama.
English: Pravafenix is used if you are an adult with an elevated risk for heart disease and need to improve cholesterol and triglycerides fat levels in your blood when your ‘bad' cholesterol levels are being adequately controlled with pravastatin alone (a statin, a cholesterol-lowering medicine).
Croatian: Pravafenix se koristi ako ste odrasla osoba s povećanim rizikom za srčanu bolest i trebate popraviti razine kolesterola i triglicerida u svojoj krvi, a razine Vašeg "lošeg" kolesterola nisu odgovarajuće kontrolirane samo s pravastatinom (statin, lijek za snižavanje kolesterola).
English: - Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min).
Croatian: - Umjereno do teško oštećenje bubrega (definiran kao procijenjeni klirens kreatinina < 60 ml/min).
English: Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
Croatian: Farmakoterapijska skupina: lijekovi koji modificiraju lipide, inhibitori HMG KoA reduktaze u kombinaciji s drugim lijekovima koji modificiraju lipide, ATK oznaka: C10BA03
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.
Croatian: Ovo iz razloga što kolestiramin ili druge smole koje na sebe vežu žučne kiseline često smanjuju apsorpciju drugih lijekova ako se uzimaju vrlo blizu jedan s drugim, pa tako također mogu smanjiti i apsorpciju Pravafenixa.
English: Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Pravafenix are listed below.
Croatian: Dodatne nuspojave povezane s primjenom lijekova koji sadrže pravastatin i fenofibrat opažene u kliničkim ispitivanjima i iskustvu nakon stavljanja lijeka u promet, a koje se mogu javiti s Pravafenixom, navedene su u nastavku.
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.
Croatian: Ispitivanje lipida pod nazivom Akcija za kontroliranje kardiovaskularnog rizika kod oboljelih od dijabetesa (ACCORD) bila je randomizirana placebom kontrolirana studija koja je uključivala 5518 bolesnika s dijabetesom mellitusom tipa 2 koji su uz simvastatin dobijali i fenofibrat.
English: If you take indigestion remedies (used to neutralise acid in your stomach), take Pravafenix 1 hour after.
Croatian: Koristite li sredstva za liječenje probavnih tegoba (za neutralizaciju želučane kiseline), tada Pravafenix uzmite 1 sat nakon toga.
English: If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended.
Croatian: Ako se u ovih bolesnika sumnja na nasljednu mišićnu bolest ne preporučuje se ponovni početak terapije Pravafenixom.
English: Blood urea increased
Croatian: Pretrage povišena urea u krvi
English: Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Croatian: Pravastatin se ne metabolizira u klinički značajnom opsegu putem sustava citokroma P450.
English: The drug is excreted mainly in the urine.
Croatian: Lijek se uglavnom izlučuje mokraćom.
English: Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin.
Croatian: Prijavljeno je nekoliko teških slučajeva reverzibilnog oštećenja funkcije bubrega tijekom istodobne primjene fenofibrata i ciklosporina.
English: No studies in lactating animals have been conducted with Pravafenix.
Croatian: Nisu provedena ispitivanja s Pravafenixom na životinjama u laktaciji.
English: Caution should be exercised when Pravafenix is administered to patients with a history of liver disease or heavy alcohol ingestion.
Croatian: Nužan je oprez kada se Pravafenix primjenjuje bolesnicima koji u anamnezi imaju bolest jetre ili obilno konzumiraju alkohol.
English: The pharmacokinetics properties of Pravafenix are not completely identical to the co-administration of the existing monotherapies when taken with fat-meal or in fasting state.
Croatian: Farmakokinetička svojstva Pravafenixa nisu potpuno identična svojstvima istodobno primjenjivanih postojećih monoterapija kada se uzimaju s masnim obrokom ili natašte.
English: Mean (%)± SEb
Croatian: Srednja vrijednost (%)±
English: Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
Croatian: Skeletni mišić: znatna i stalna povišenja kreatinin fosfokinaze (KF) prijavljena su sporadično.
English: EU/1/11/679/007 14 hard capsules EU/1/11/679/004 30 hard capsules EU/1/11/679/005 60 hard capsules EU/1/11/679/006 90 hard capsules
Croatian: EU/1/11/679/007 14 tvrdih kapsula EU/1/11/679/004 30 tvrdih kapsula EU/1/11/679/005 60 tvrdih kapsula EU/1/11/679/006 90 tvrdih kapsula
English: Adverse reaction (fenofibrate)
Croatian: Nuspojava (fenofibrat)
English: The following statements reflect the information available on the individual active substances (fenofibrate and pravastatin).
Croatian: Sljedeće tvrdnje odražavaju dostupne za svaku djelatnu tvar posebno (fenofibrat i pravastatin).
English: Embryotoxic effects have been shown at doses in the range of maternal toxicity (see section 5.3).
Croatian: Embriotoksični učinci viđeni su pri dozama toksičnim za majku (vidjeti dio 5.3).
English: If confirmed, the treatment should definitively not be initiated (see section 4.3).
Croatian: Ako su vrijednosti i dalje povišene s liječenjem se ne smije započeti (vidjeti dio 4.3).
English: Pravafenix is used in addition to low fat diet in adults - To lower the level of your ‘bad' cholesterol (LDL cholesterol).
Croatian: Pravafenix se u odraslih dodatno koristi uz dijetu s niskim udjelom masnoća - za snižavanje razine "lošeg" kolesterola (LDL kolesterol).
English: 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.
Croatian: Ako Vam je liječnik propisao Pravafenix zajedno s kolestiraminom ili bilo kojim drugim smolama žučnih kiselina (lijekovi za snižavanje kolesterola), Pravafenix uzmite 1 sat prije ili 4 do 6 sati nakon smole žučnih kiselina.
English: LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque.
Croatian: LDL kolesterol često se naziva "lošim" kolesterolom jer se može nakupljati u stijenki arterija i tamo formirati naslage (plak).
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.
Croatian: Smole koje se vežu na žučne kiseline često smanjuju apsorpciju lijekova i kada se smole primjenjuju istodobno, fenofibrat treba uzeti 1 sat prije ili 4 do 6 sati nakon smole kako ne bi ometali apsorpciju fenofibrata.
English: The medicine must be discontinued because of the potential risk to the foetus.
Croatian: Uzimanje lijeka mora se prekinuti jer postoji rizik za plod.