FrancophonIA/ELRC3.0 huggingface dataset:
English: − Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines for this condition.
Croatian: − bilo kakvo bolesno stanje srca i krvnih žila ili tegobe sa srčanim ritmom (aritmija) ili se liječite lijekovima za to stanje.
English: Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.
Croatian: Degareliks nije ispitivan u bolesnika s anamnezom teške neliječene astme, anafilaktičkih reakcija ili teške urtikarije ili angioedema.
English: Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.
Croatian: Nuspojave na mjestu primjene injekcije najčešće su kod početne doze a manje česte kod doze održavanja.
English: Very rare (may affect up to 1 in 10,000 people) − injection site infection, abscess and necrosis
Croatian: Vrlo rijetke (mogu se pojaviti u do 1 na 10 000 osoba) − infekcija, absces i nekroza na mjestu primjene injekcije
English: Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge protection at initiation of therapy.
Croatian: Budući da degareliks ne uzrokuje nagli porast testosterona, prilikom započinjanja terapije nije potrebno dodati antiandrogen kao zaštitu od takvog porasta.
English: The injection site should vary periodically.
Croatian: Mjesto primjene potrebno je periodički mijenjati.
English: No formal drug-drug interaction studies have been performed.
Croatian: Nisu provedena formalna ispitivanja interakcija lijekova.
English: Myocardial infarction, cardiac failure
Croatian: infarkt miokarda, zatajenje srca
English: 46.4 ng/ml)
Croatian: P75 46,4 ng/ml)
English: Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year and 29% of patients after treatment with FIRMAGON for up to 5.5 years.
Croatian: Razvoj protutijela protiv degareliksa uočen je u 10% bolesnika nakon liječenja lijekom FIRMAGON u trajanju od godine dana i u 29% bolesnika nakon liječenja lijekom FIRMAGON u trajanju do 5,5 godina.
English: The long half-life after subcutaneous administration is a consequence of a very slow release of degarelix from the depot formed at the injection site(s).
Croatian: Dugi poluvijek nakon supkutane primjene posljedica je vrlo sporog otpuštanja degareliksa iz depoa koji nastaje na mjestu (mjestima) primjene injekcije.
English: Insomnia Depression, libido decreased*
Croatian: Psihijatrijski poremećaji nesanica depresija, smanjeni libido*
English: On the basis of the scientific conclusions for degarelix the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing degarelix is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za degareliks, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) degareliks nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Prostate specific antigen (PSA) levels are lowered by 64% two weeks after administration of degarelix, 85% after one month, 95% after three months, and remained suppressed (approximately 97%) throughout the one year of treatment.
Croatian: Razine prostata specifičnog antigena (PSA) smanjile su se nakon dva tjedna primjene degareliksa za 64%, nakon jednog mjeseca za 85%, nakon tri mjeseca za 95%, i ostale su snižene (približno 97%) tijekom cijele godine liječenja.
English: Always make sure to withdraw the precise volume and adjust for any air bubbles.
Croatian: Uvijek pazite da izvučete točan volumen i provodite postupak bez stvaranja mjehurića zraka.
English: Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section 4.4).
Croatian: U bolesnika s teškim oštećenjem funkcije jetre ili bubrega ispitivanja nisu provedena, pa je stoga potreban oprez (vidjeti dio 4.4).
English: Drug-related local irritation was noted in animals when degarelix was administered subcutaneously in high doses.
Croatian: Lokalna iritacija povezana s lijekom uočena je u životinja kada je degareliks primijenjen supkutano u visokim dozama.
English: There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney function impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika starije dobi ili onih s blagim ili umjerenim oštećenjem funkcije jetre ili bubrega (vidjeti dio 5.2).
English: The median time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.
Croatian: Medijan vremena do razine testosterona >1,5 ng/ml (iznad donje granice normalnog raspona) iznosio je 168 dana.
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Croatian: • edukacijski materijal • Sažetak opisa svojstava lijeka (SPC), Uputu o lijeku i Označavanje
English: 240 mg administered as two consecutive subcutaneous injections of 120 mg each
Croatian: 240 mg primijenjeno kao dvije uzastopne supkutane injekcije svaka od 120 mg
English: The risk of heart rhythm problems may be increased when using FIRMAGON.
Croatian: Rizik od tegoba sa srčanim ritmom može se povećati uz primjenu lijeka
English: The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (<1%).
Croatian: Prijavljeni događaji bili su uglavnom prolazni, blagog do umjerenog intenziteta, i zbog njih je liječenje prekinulo svega nekoliko bolesnika (<1%).
English: 8 cases of rhabdomyolysis have cumulativly been reported with degarelix.
Croatian: Kumulativno je prijavljeno 8 slučajeva rabdomiolize kod primjene degareliksa.
English: After reconstitution:
Croatian: Nakon pripreme:
English: Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy.
Croatian: Kardiovaskularna bolest Kardiovaskularna bolest, kao što je moždani udar i infarkt miokarda, zabilježena je u medicinskoj literaturi u bolesnika s terapijom deprivacije androgena.
English: Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise in bilirubin or clinical symptoms.
Croatian: Opažena su blaga, prolazna povišenja vrijednosti ALT i AST koja nisu bila praćena porastom bilirubina ili kliničkim simptomima.
English: Day 1 Day 3
Croatian: 1. dan 3. dan
English: If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly.
Croatian: Ako se prašak hvata za stijenku bočice iznad razine tekućine, bočicu možete malo nagnuti.
English: In female reproduction toxicity studies degarelix revealed findings expected from the pharmacological properties.
Croatian: U ispitivanjima reproduktivne toksičnosti u ženki, degareliks je pokazao rezultate kakvi se očekuju na temelju njegovih farmakoloških svojstava.
English: There is no relevant use of FIRMAGON in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Croatian: Nema relevantne primjene lijeka FIRMAGON u djece i adolescenata, namijenjenog za liječenje odraslih muških bolesnika s uznapredovalim hormonski ovisnim karcinomom prostate.
English: Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ml.
Croatian: Degareliks je učinkovit u postizanju i održavanju supresije testosterona znatno ispod razine medikamentne kastracije od 0,5 ng/ml.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.
English: In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were performed.
Croatian: U potvrdnom ispitivanju u kojemu je FIRMAGON uspoređivan s leuprorelinom, periodički je rađen EKG.
English: The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the initial phase of treatment has not been demonstrated.
Croatian: U inicijalnoj fazi liječenja klinička dobrobit degareliksa u usporedbi s leuprorelinom plus antiandrogen nije dokazana.
English: Тел: +359 2 807 5022 aquachim@aquachim.bg
Croatian: Tел: +359 2 807 5022 aquachim@aquachim.bg
English: Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients.
Croatian: Degareliks je sintetički hormonski blokator koji se primjenjuje za liječenje raka prostate u odraslih muških bolesnika.
English: 80 mg administered as one subcutaneous injection
Croatian: 80 mg primijenjeno kao jedna supkutana injekcija
English: Thus, Cmax and bioavailability tend to decrease with increasing dose concentration while the half-life is increased.
Croatian: Dakle, povećanjem koncentracije doze Cmax i bioraspoloživost pokazuju tendenciju smanjenja dok se poluvijek povećava.
English: • 20% had metastatic prostate cancer
Croatian: • 20% s metastatskim karcinomom prostate
English: respectively, of patients with normal values prior to treatment, following treatment with both medicinal products.
Croatian: bolesnika koji su prije liječenja imali normalne vrijednosti.
English: Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely.
Croatian: Stoga klinički značajne farmakokinetičke interakcije lijekova koji se metaboliziraju putem tih izoenzima nisu vjerojatne.
English: A ring of small air bubbles on the surface of the liquid is acceptable.
Croatian: Na površini tekućine može ostati prsten malih mjehurića zraka, što je prihvatljivo.
English: * Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Croatian: * Kemijska i fizikalna stabilnost lijeka u primjeni dokazana je u trajanju od 2 sata pri 25 ºC.
English: • 29% had locally advanced prostate cancer
Croatian: • 29% s lokalno uznapredovalim karcinomom prostate
English: In the degarelix 240/80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group.
Croatian: U skupini koja je liječena degareliksom 240/80 mg, 41 bolesnik (20%) prekinuo je ispitivanje u usporedbi s 32 bolesnika (16%) iz skupine koja je primala leuprorelin.
English: The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin.
Croatian: Primarni ishod ispitivanja bile su stope supresije testosterona nakon liječenja degareliksom ili leuprorelinom u trajanju od jedne godine.
English: FIRMAGON has not been studied in patients with a history of a corrected QT interval over 450 msec, in patients with a history of or risk factors for torsades de pointes and in patients receiving concomitant medicinal products that might prolong the QT interval.
Croatian: FIRMAGON nije ispitan u bolesnika s korigiranim QT intervalom iznad 450 ms u anamnezi, u bolesnika s anamnezom ili čimbenicima rizika za torsades de pointes te u bolesnika koji su istovremeno primali lijekove koji bi mogli produljiti QT interval.
English: A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
Croatian: Smanjena podnošljivost glukoze opažena je u muškaraca koji su orhidektomirani ili su bili liječeni agonistima GnRH-a.
English: Animal reproduction studies showed that degarelix caused infertility in male animals.
Croatian: Ispitivanja reprodukcije u životinja pokazala su da degareliks uzrokuje neplodnost u mužjaka.
English: − high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal heart beat, dyspnoea, peripheral oedema
Croatian: − visoki krvni tlak, promjene srčanog ritma, promjene u EKG-u (produljenje QT intervala), osjećaj nepravilnih otkucaja srca, otežano disanje, periferni edem
English: A population pharmacokinetics analysis of the data from the confirmatory Phase III study has demonstrated that the clearance of degarelix in patients with mild to moderate renal impairment is reduced by approximately 23%; therefore, dose adjustment in patients with mild or moderate renal impairment is not recommended.
Croatian: Podaci populacijske farmakokinetičke analize iz potvrdnog ispitivanja faze III pokazali su da se klirens degareliksa u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega smanjio za otprilike 23%; stoga se prilagodba doze ne preporučuje u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: − increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
Croatian: − povećana tjelesna težina, mučnina, proljev, povišene razine nekih jetrenih enzima
English: In vitro studies have shown that degarelix is not a substrate for the human CYP450 system.
Croatian: In vitro ispitivanja pokazala su da degareliks nije supstrat sustava CYP450 u ljudi.
English: Gently pull back the plunger to check if blood is aspirated.
Croatian: Laganim povlačenjem klipa štrcaljke prema natrag provjerite da krv nije aspirirana.
English: Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having serum testosterone levels corresponding to medical castration (T≤0.5 ng/ml) after three days and 100% after one month.
Croatian: Klinička ispitivanja pokazala su da supresija testosterona (T) nastupa odmah po primjeni početne doze, tako da u 96% bolesnika razine testosterona u serumu odgovaraju onima pri medikamentnoj kastraciji (T≤0,5 ng/ml) nakon tri dana, a u 100% bolesnika nakon mjesec dana.
English: • Risk Management Plan (RMP)The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: The reconstituted solution should be a clear liquid, free of undissolved matter.
Croatian: Rekonstituirana otopina mora biti bistra tekućina, bez neotopljenih čestica.
English: Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration.
Croatian: Tromjesečna terapija degareliksom (režim doziranja 240/80 mg) rezultirala je 37%-tnom redukcijom volumena prostate kako je to izmjereno transrektalnim ultrazvučnim snimanjem (TRUS) u bolesnika kojima je bila potrebna hormonska terapija prije radioterapije te u bolesnika koji su bili kandidati za medicinsku kastraciju.
English: A. Potamitis Medicare Ltd Τηλ: +357 22583333 a.potamitismedicare@cytanet.com.cy
Croatian: Potamitis Medicare Ltd Τηλ: +357 22583333 a.potamitismedicare@cytanet.com.cy
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava anemija*
English: − anaemia
Croatian: − anemija
English: Solvent for FIRMAGON Water for injections
Croatian: Otapalo za FIRMAGON Voda za injekcije
English: Both in vitro and in vivo studies showed no signs of QT prolongation.
Croatian: Ispitivanja in vitro i in vivo nisu pokazala znakove produljenja QT intervala.
English: Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Croatian: Kemijska i fizikalna stabilnost lijeka u primjeni dokazana je u trajanju od 2 sata pri 25 ºC.
English: A thorough QT study showed that there was no intrinsic effect of degarelix on QT/QTc interval (see section
Croatian: Iscrpna ispitivanja QT intervala pokazala su da nema intrinzičnog učinka degareliksa na QT/QTc interval (vidjeti dio 4.8).
English: The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.
Croatian: Redukcija volumena prostate bila je slična onoj postignutoj s goserelinom uz primjenu antiandrogena kao zaštite od znatnog povišenja razine testosterona.
English: It is unknown to what extent this decrease in haematological values was caused by the underlying prostate cancer and to what extent it was a consequence of androgen deprivation therapy.
Croatian: Nije poznato u kojoj je mjeri to smanjenje hematoloških parametara bilo prouzročeno osnovnom bolešću, tj. karcinomom prostate, a u kojoj je mjeri bilo posljedica liječenja deprivacijom androgena.
English: Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate cancer patients in the pivotal study CS21, AUC0-28 days was 635 (602-668) day*ng/ml, Cmax was 66.0 (61.071.0) ng/ml and occurred at tmax at 40 (37-42) hours.
Croatian: Nakon supkutane primjene 240 mg degareliksa u koncentraciji od 40 mg/ml bolesnicima s karcinomom prostate u ključnom ispitivanju CS21, vrijednost površine ispod krivulje, AUC0-28 dana, iznosila je 635 (602-668) dan*ng/ml, vršna koncentracija Cmax bila je 66,0 (61,0-71,0) ng/ml i dosegnuta je pri tmax od 40 sati (37-42 sata).
English: EU/1/08/504/001 Pack-size of 1 tray EU/1/08/504/003 Pack-size of 3 trays
Croatian: EU/1/08/504/001 pakiranje od 1 podloška EU/1/08/504/003 pakiranje od 3 podloška
English: − trouble sleeping, tiredness, dizziness, headache
Croatian: − teškoće sa spavanjem, umor, omaglica, glavobolja
English: The median time to testosterone recovery (>0.5 ng/mL, above castrate level) after discontinuation of treatment was 112 days (counted from start of monitoring period, i.e 28 days after last injection).
Croatian: Medijan vremena za oporavak testosterona (> 0,5 ng/ml, iznad razine kastrata) nakon prekida liječenja iznosio je 112 dana (računajući od početka razdoblja praćenja, tj. 28 dana nakon posljednje injekcije).
English: Table 1: Frequency of adverse drug reactions reported in 1,259 patients treated for a total of 1781 patient years (phase II and III studies) and from post-marketing reports
Croatian: Tablica 1: Učestalost nuspojava na lijek zabilježenih u 1259 bolesnika liječenih ukupno 1781 bolesnik godina (ispitivanja faze II i III) te nakon stavljanja lijeka u promet
English: The pharmacokinetics of degarelix has been investigated after single intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2).
Croatian: Farmakokinetika degareliksa ispitivana je nakon jednokratne intravenske primjene u ispitanika s blagim do umjerenim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: • 31% had localised prostate cancer
Croatian: • 31% s lokaliziranim karcinomom prostate
English: Development or aggravation of diabetes may occur; therefore diabetic patients may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy.
Croatian: Može doći do novonastalog dijabetesa ili pogoršanja postojećeg; stoga će u bolesnika s dijabetesom koji se liječe deprivacijom androgena možda biti potrebno učestalije mjerenje razine glukoze u krvi.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene od najozbiljnijih prema manje ozbiljnima.
English: Pack-size of 2 trays containing:
Croatian: Pakiranje od 2 podloška sadrži:
English: It caused a dosage dependent prolongation of the time to mating and to pregnancy, a reduced number of corpora lutea, and an increase in the number of pre- and post-implantation losses, abortions, early embryo/foetal deaths, premature deliveries and in the duration of parturition.
Croatian: Degareliks je prouzročio o dozi ovisno produljenje vremena do parenja i trudnoće, smanjenje broja žutih tijela i povećanje broja gubitaka zametka prije i poslije implantacije, pobačaja, ranih smrti zametka/ploda, prijevremenih okota i dulje trajanje okota.
English: Avoidance of testosterone surge
Croatian: Izbjegavanje naglog porasta testosterona
English: No signs of increased exposure in the hepatically impaired subjects were observed compared to healthy subjects.
Croatian: U ispitanika s oštećenjem funkcije jetre nisu bili opaženi znakovi povećane izloženosti u usporedbi sa zdravim ispitanicima.
English: Severe hypersensitivity.
Croatian: − teška preosjetljivost.
English: Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes.
Croatian: Mehanizam djelovanja Degareliks je selektivni antagonist gonadotropin oslobađajućeg hormona (GnRH), koji kompetitivnim i reverzibilnim vezanjem na hipofizne receptore za GnRH brzo smanjuje oslobađanje gonadotropina, luteinizirajućeg hormona (LH) i folikul stimulirajućeg hormona (FSH) te na taj način smanjuje lučenje testosterona (T) iz testisa.
English: Tiredness and dizziness are common side effects that may impair your ability to drive and use machines.
Croatian: Umor i omaglica česte su nuspojave koje mogu narušiti Vašu sposobnost upravljanja vozilima i strojevima.
English: Pack-size of 3 trays containing:
Croatian: Pakiranje od 3 podloška sadrži:
English: − Liver disease.
Croatian: − bolest jetre.
English: The study investigated the efficacy and safety of two different degarelix monthly dosing regimens with a starting dose of 240 mg (40 mg/ml) followed by monthly doses subcutaneous administration of 160 mg (40 mg/ml) or 80 mg (20 mg/ml), in comparison to monthly intramuscular administration of 7.5 mg leuprorelin in patients with prostate cancer requiring androgen deprivation therapy.
Croatian: U ispitivanju su ispitivane djelotvornost i sigurnost dvaju različitih mjesečnih doznih režima degareliksa s početnom dozom od 240 mg (40 mg/ml) nakon koje su slijedile supkutano primjenjivane mjesečne doze od 160 mg (40 mg/ml) ili 80 mg (20 mg/ml), u usporedbi s mjesečno primjenjivanom intramuskularnom dozom leuprorelina od 7,5 mg u bolesnika s karcinomom prostate kojima je bilo potrebno liječenje deprivacijom androgena.
English: Bone density has not been measured during treatment with degarelix.
Croatian: Gustoća kostiju nije bila mjerena za vrijeme liječenja degareliksom.
English: Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
Croatian: Bolesnici s postojećim ili sumnjom na poremećaj funkcije jetre nisu bili uključeni u dugotrajna klinička ispitivanja s degareliksom.
English: No injections should be given in areas where the patient will be exposed to pressure, e.g. around the belt or waistband or close to the ribs.
Croatian: Injekcije se ne smiju davati u dijelove tijela koji će biti izloženi pritisku, npr. oko struka, pojasa ili blizu rebara.
English: FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
Croatian: FIRMAGON je antagonist gonadotropin oslobađajućeg hormona (GnRH) indiciran za liječenje odraslih muških bolesnika s uznapredovalim hormonski ovisnim karcinomom prostate.
English: No significant metabolites were detected in plasma samples after subcutaneous administration.
Croatian: Nakon supkutane primjene u uzorcima plazme nisu nađeni značajni metaboliti.
English: Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen.
Croatian: Poznato je da je karcinom prostate hormonski ovisan i da odgovara na liječenje pri kojem se uklanja izvor androgena.
English: NOTE: • THE VIALS SHOULD NOT BE SHAKEN
Croatian: • BOČICE SE NE SMIJE TRESTI
English: • Instructions for administration
Croatian: • doziranje • upute za primjenu
English: The clearance of degarelix when administered as single intravenous doses (0.864-49.4 µg/kg) in healthy elderly men was found to be 3550 ml/h/kg.
Croatian: Ustanovljeno je da u zdravih muškaraca starije dobi, klirens degareliksa primijenjenog kao jednostruka intravenska doza (0,864-49,4 µg/kg) iznosi 35-50 ml/h/kg.