FrancophonIA/ELRC3.0 huggingface dataset:
English: What Prolia contains
Croatian: Što Prolia sadrži
English: REMINDER STICKERS TEXT (included in pack)
Croatian: TEKST NA NALJEPNICI - PODSJETNIKU (uključena u pakiranju)
English: Remember: if you have any problems, please ask your doctor or healthcare provider for help and advice.
Croatian: Zapamtite: Ako imate ikakvih problema, upitajte Vašeg liječnika ili zdravstvenog radnika za pomoć i savjet.
English: While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
Croatian: Tijekom liječenja trebate održavati dobru oralnu higijenu i odlaziti na redovite stomatološke preglede.
English: • Prolia is given as an injection into the tissue just under the skin (subcutaneous injection).
Croatian: • Prolia se daje u obliku injekcije u tkivo odmah ispod kože (potkožna injekcija).
English: Following subcutaneous administration of a 1.0 mg/kg dose, which approximates the approved 60 mg dose, exposure based on AUC was 78% as compared to intravenous administration at the same dose level.
Croatian: Nakon supkutane primjene doze od 1,0 mg/kg, što približno odgovara odobrenoj dozi od 60 mg, izloženost temeljem površine ispod krivulje (AUC) bila je 78%, u usporedbi s intravenskom primjenom iste doze.
English: You should not take Prolia together with another medicine containing denosumab.
Croatian: Ne smijete uzimati lijek Prolia zajedno s drugim lijekom koji sadrži denosumab.
English: Proportion of women with fracture (%)+
Croatian: Udio žena s frakturom(%)+
English: The primary efficacy variable was percent change in lumbar spine BMD, fracture efficacy was not evaluated.
Croatian: Primarna mjera djelotvornosti bila je postotak promjene BMD lumbalne kralježnice, djelotvornost kod frakture nije procijenjena.
English: In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but it can occur later.
Croatian: Nakon stavljanja lijeka u promet zabilježena je teška simptomatska hipokalcijemija (uključujući smrtne slučajeve) (vidjeti dio 4.8) gdje se najveći broj slučajeva pojavio u prvim tjednima od početka liječenja, ali se može pojaviti i kasnije.
English: This indicates that Prolia should not alter the pharmacokinetics of medicinal products metabolised by CYP3A4.
Croatian: To upućuje na to da Prolia ne bi trebala mijenjati farmakokinetiku lijekova koje metabolizira CYP3A4.
English: Adolescent primates dosed with denosumab at 27 and 150 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Croatian: Adolescenti primata kojima je primijenjena doza denosumaba 27 i 150 puta veća (10 i 50 mg/kg doza) od kliničke izloženosti su imali abnormalne ploče rasta.
English: Patients must be adequately supplemented with calcium and vitamin D (see section 4.4).
Croatian: Bolesnici moraju biti dostatno opskrbljeni kalcijem i vitaminom D (vidjeti dio 4.4).
English: Your doctor or healthcare provider will show you or your carer how to use Prolia.
Croatian: Vaš će liječnik ili pružatelj medicinske skrbi pokazati Vama ili Vašem njegovatelju kako primjenjivati lijek Prolia.
English: Major osteoporotic fracture4 *p ≤ 0.05; **p = 0.0106 (secondary endpoint included in multiplicity adjustment), ***p ≤ 0.0001 + Event rates based on Kaplan-Meier estimates at 3 years.
Croatian: Značajna osteoporotička fraktura4 *p ≤ 0,05; **p = 0,0106 (sekundarna završna točka uključena u prilagodbu za multiciplitet), ***p ≤ 0,0001 + Učestalost događaja temeljem Kaplan-Meierove procjene tijekom tri godine.
English: Examples of the clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (see section 4.4).
Croatian: Primjeri kliničke manifestacije teške simptomatske hipokalcijemije su uključivali produženje QT intervala, tetaniju, napadaje i promijenjen mentalni status (vidjeti dio 4.4).
English: Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
Croatian: Sprječavanje RANKL/RANK interakcije inhibira stvaranje osteoklasta, njihovu funkciju i preživljavanje te stoga smanjuje resorpciju kosti u kortikalnoj i trabekularnoj kosti.
English: If you have questions about how to inject, please ask your doctor or healthcare provider for assistance.
Croatian: Ako imate pitanja o tome kako injicirati, molimo pitajte Vašeg liječnika ili drugog zdravstvenog radnika za pomoć.
English: DO NOT touch the needle or push the plunger.
Croatian: NE dirajte iglu te ne pritišćite klip.
English: Cellulitis1
Croatian: Celulitis1
English: DO NOT leave the syringe exposed to direct sunlight.
Croatian: NE ostavljajte štrcaljku izloženu direktnoj sunčevoj svjetlosti.
English: Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss.
Croatian: Operacija ili lijekovi koji sprečavaju proizvodnju estrogena ili testosterona, a koriste se u terapiji bolesnika s rakom dojke ili prostate, mogu također uzrokovati gubitak koštane mase.
English: Prolia increased lumbar spine BMD from baseline in 94.7% of men at 1 year.
Croatian: Prolia je povećala BMD lumbalne kralježnice od početnih vrijednosti kod 94,7% muškaraca unutar godine dana.
English: Fifty nine women participated in the bone biopsy sub-study at month 24 (n = 41) and/or month 84 (n = 22) of the extension study in postmenopausal women with osteoporosis.
Croatian: Pedeset devet žena je sudjelovalo u podstudiji biopsije kosti u 24. (n=41) i/ili 84. (n=22) mjesecu produžetka ispitivanja u postmenopauzalnih žena s osteoporozom.
English: Women should be advised not to become pregnant during and for at least 5 months after treatment with Prolia.
Croatian: Žene je potrebno savjetovati da ne zatrudne za vrijeme i barem 5 mjeseci po završetku liječenja lijekom Prolia.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Croatian: Ovo može biti znak oštećenja kosti u čeljusti (osteonekroza).
English: Long-term antiresorptive treatment (including both denosumab and bisphosphonates) may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures due to significant suppression of bone remodelling (see section 4.2).
Croatian: Dugoročna antiresorptivna terapija (uključujući i denosumab i bisfosfonate) može doprinijeti povećanom riziku od štetnih ishoda kao što su osteonekroza čeljusti i atipične frakture femura zbog značajne supresije preoblikovanja kostiju (vidjeti dio 4.2).
English: At the end of each dosing interval, CTX reductions were partially attenuated from maximal reduction of ≥ 87% to approximately ≥ 45% (range 45-80%), reflecting the reversibility of Prolia's effects on bone remodelling once serum levels diminish.
Croatian: Na kraju svakog razdoblja doziranja smanjenja CTX su djelomično oslabljena s maksimalnog smanjenja od ≥ 87% na približno ≥ 45% (raspon 45-80%), odražavajući reverzibilnost učinaka lijeka Prolia na preoblikovanje kostiju jednom nakon smanjenja vrijednosti razina u serumu.
English: Drug-related hypersensitivity reactions
Croatian: Reakcije preosjetljivosti povezane s lijekom
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving denosumab who present with ear symptoms including chronic ear infections.
Croatian: Mogućnost osteonekroze vanjskog slušnog kanala potrebno je razmotriti u bolesnika koji primaju denosumab, a koji imaju simptome koji zahvaćaju uho uključujući kronične infekcije uha.
English: There are no clinical data on the co-administration of denosumab and hormone replacement therapy (oestrogen), however the potential for a pharmacodynamic interaction is considered to be low.
Croatian: Ne postoje klinički podaci o istovremenoj primjeni denosumaba i hormonske nadomjesne terapije (estrogen), međutim, smatra se da je potencijal farmakodinamičke interakcije malen.
English: In this study, foetal lymph nodes were not examined.
Croatian: U ovom ispitivanju fetalni limfni čvorovi nisu pregledani.
English: Subjects with an eGFR < 30 mL/min/1.73 m2 were excluded from the study.
Croatian: Iz ovog ispitivanja isključeni su ispitanici s eGFR < 30 ml/min/1,73m2.
English: In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Croatian: U muškaraca s rakom prostate koji primaju hormonsku ablaciju, Prolia značajno umanjuje rizik od fraktura kralježaka.
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Poklopac igle napunjene štrcaljke sadrži suhu prirodnu gumu (derivat lateksa), koja može uzrokovati alergijske reakcije.
English: Your carer can also use the outer area of your upper arms.
Croatian: Vaš njegovatelj također može koristiti vanjsko područje nadlaktice.
English: Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Croatian: Denosumab ja sastavljen isključivo od aminokiselina i ugljikohidrata kao prirodni imunoglobulin te nije vjerojatno da će biti eliminiran putem jetrenih metaboličkih mehanizama.
English: • Do not shake.
Croatian: • Ne tresite.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Prolia administration.
Croatian: Tijekom liječenja invazivne stomatološke zahvate treba provesti tek nakon pažljivog razmatranja i izbjegavati ih neposredno blizu primjene lijeka Prolia.
English: • cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Croatian: • rak, komorbiditetna stanja (npr. anemija, koagulopatije, infekcija), pušenje.
English: • Inject the entire contents of the pre-filled syringe.
Croatian: • Injicirajte cijeli sadržaj napunjene štrcaljke.
English: Your doctor may decide that it is best for you or a carer to inject Prolia.
Croatian: Vaš liječnik može odlučiti da je bolje da Vi ili Vaš njegovatelj dajete injekcije lijeka Prolia.
English: The pre-filled syringe may be left outside the refrigerator to reach room temperature.
Croatian: Napunjenu štrcaljku možete ostaviti van hladnjaka kako bi dosegla sobnu temperaturu.
English: It is important that you or your carer do not give the injection unless training from your doctor or healthcare provider has been received.
Croatian: Važno je da niti Vi niti Vaš njegovatelj ne dajete injekcije ako niste obučeni od strane svog liječnika ili zdravstvenog radnika.
English: • rash,
Croatian: • osip,
English: Thirteen of these ONJ cases occurred in postmenopausal women with osteoporosis during the phase III clinical trial extension following treatment with Prolia for up to 10 years.
Croatian: Trinaest od ovih slučajeva ONČ se pojavilo u postmenopauzalnih žena s osteoporozom tijekom produžetka kliničkog ispitavanja faze III nakon liječenja lijekom Prolia do 10 godina.
English: Skin infections
Croatian: Infekcije kože
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala izravne ili neizravne štetne učinke u pogledu plodnosti (vidjeti dio 5.3).
English: Once your syringe has been left to reach room temperature (up to 25°C), it must be used within 30 days.
Croatian: Jednom kada je napunjena štrcaljka ostavljena kako bi dostigla sobnu temperaturu (do 25 °C), mora se iskoristiti unutar 30 dana.
English: This medicine contains 47 mg sorbitol in each mL of solution.
Croatian: Ovaj lijek sadrži 47 mg sorbitola u jednom ml otopine.
English: Efficacy and safety of Prolia once every 6 months for 1 year were investigated in 242 men aged 31-84 years.
Croatian: Ispitivana je djelotvornost i sigurnost lijeka Prolia primjenjivanog jednom svakih šest mjeseci tijekom razdoblja od jedne godine kod 242 muškarca u dobi od 31-84 godine.
English: No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 ml/min).
Croatian: Ne postoje podaci o bolesnicima s dugotrajnom sustavnom terapijom glukokortikoidima i s teškim oštećenjem funkcije bubrega (GFR < 30 ml/min).
English: • bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
Croatian: • Gubitka koštane mase koji je rezultat smanjenja količine hormona (testosteron) koje je uzrokovano operacijom ili terapijom lijekovima u bolesnika s rakom prostate.
English: In dose ranging studies, denosumab exhibited non-linear, dose-dependent pharmacokinetics, with lower clearance at higher doses or concentrations, but approximately dose-proportional increases in exposures for doses of 60 mg and greater.
Croatian: U ispitivanjima raspona doza denosumab je pokazao nelinearnu farmakokinetiku ovisnu o dozi, s nižim klirensom pri većim dozama ili koncentracijama, ali s povećanjima približno proporcionalnima dozi pri dozama 60 mg i većim.
English: If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Croatian: Ako uočite kapljicu krvi, možete ju nježno ukloniti pamučnom vaticom ili maramicom.
English: • poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
Croatian: • lošu oralnu higijenu, bolesti parodonta, slabo prianjajuće zubne proteze, povijest dentalne bolesti, invazivne stomatološke zahvate npr. vađenje zuba.
English: It can also occur in patients receiving glucocorticoids.
Croatian: Može se javiti i kod bolesnika koji primaju glukokortikoide.
English: Prolia treatment rapidly reduced the rate of bone turnover, reaching a nadir for the bone resorption marker serum type 1 C-telopeptides (CTX) (85% reduction) by 3 days, with reductions maintained over the dosing interval.
Croatian: Terapija lijekom Prolia brzo je smanjila brzinu pregradnje kosti dosežući najnižu vrijednost koštanog markera resorpcije u serumu C-telopeptida tipa 1 (CTX) (85% smanjenje) kroz tri dana, uz održanje smanjenja tijekom razdoblja doziranja.
English: 1 Includes clinical vertebral fractures and non-vertebral fractures.
Croatian: 1 Uključuje kliničke frakture kralježaka i nevertebralne frakture.
English: Therefore, treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition.
Croatian: Stoga, terapija denosumabom može poremetiti koštani rast u djece s otvorenim pločama rasta te može inhibirati nicanje zubi.
English: Effect on all clinical fractures Prolia significantly reduced fractures across all fracture types/groups (see table 3).
Croatian: Prolia je značajno smanjila frakture za sve tipove/skupine fraktura (vidjeti Tablicu 3).
English: • rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions).
Croatian: • osip koji se može pojaviti na koži ili rane u ustima (izbijanje lihenoidnih kožnih promjena uzrokovano lijekom).
English: In clinical trials, musculoskeletal pain was very common in both denosumab and placebo groups.
Croatian: U kliničkim ispitivanjima mišićno-koštana bol je bila vrlo česta u obje skupine, tj. u skupini s denosumabom i u placebo skupini.
English: Thirteen adjudicated cases of osteonecrosis of the jaw (ONJ) and two adjudicated cases of atypical fractures of the femur occurred during the extension study.
Croatian: Trinaest dokazanih slučajeva osteonekroze čeljusti (ONČ) i dva dokazana slučaja atipične frakture femura su se pojavila tijekom produžetka ispitivanja.
English: The risk of ONJ increased with duration of exposure to Prolia.
Croatian: Rizik od ONČ se povećao s razdobljem izloženosti lijeku Prolia.
English: Upon re-initiation, reductions in CTX by denosumab were similar to those observed in patients initiating primary denosumab treatment.
Croatian: Pri ponovnom uvođenju terapije smanjenja CTX-a zbog denosumaba su bila slična onima kao u bolesnika koji počinju s primarnom terapijom denosumabom.
English: Patients were randomised (1:1) to receive either Prolia 60 mg subcutaneously once every 6 months or oral risedronate 5 mg once daily (active control) for 2 years.
Croatian: Bolesnici su bili randomizirani (1:1) za primanje 60 mg lijeka Prolia supkutano jednom svakih 6 mjeseci ili 5 mg oralnog risedronata jednom dnevno (aktivna kontrola) tijekom 2 godine.
English: Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Prolia, considering the benefit of breast-feeding to the baby and the benefit of Prolia to the mother.
Croatian: Tada će Vam liječnik pomoći odlučiti trebate li prestati dojiti ili prestati uzimati lijek Prolia, uzimajući u obzir koristi dojenja za dijete i koristi lijeka Prolia za majku.
English: Atypical femoral fractures have also been reported in patients with certain co-morbid conditions (e.g. vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors).
Croatian: Atipične femoralne frakture zabilježene su i kod bolesnika s određenim komorbiditetnim stanjima (npr. nedostatak vitamina D, reumatoidni artritis, hipofosfatazija) i uz upotrebu određenih lijekova (npr. bisfosfonati, glukokortikoidi, inhibitori protonske pumpe).
English: Patients receiving Prolia may develop skin infections (predominantly cellulitis) leading to hospitalisation (see section 4.8).
Croatian: Bolesnici koji primaju lijek Prolia mogu razviti infekciju kože (pretežno celulitis) zbog koje mogu biti hospitalizirani (vidjeti dio 4.8).
English: Prolia significantly reduced the risk of new vertebral fractures at 1, 2 and 3 years (p < 0.0001) (see table 2).
Croatian: Prolia je značajno smanjila rizik od novih fraktura kralježnice tijekom prve, druge i treće godine (p < 0.0001) (vidjeti tablicu 2).
English: Patients should be encouraged to report symptoms indicative of hypocalcaemia.
Croatian: Bolesnike treba potaknuti na prijavu simptoma koji ukazuju na hipokalcijemiju.
English: If you become pregnant during treatment with Prolia or less than 5 months after stopping treatment with Prolia, please inform your doctor.
Croatian: Ako zatrudnite tijekom liječenja s lijekom Prolia ili za manje od 5 mjeseci nakon prestanka liječenja lijekom Prolia, molimo Vas obavijestite o tome svog liječnika.
English: Prolia is not recommended for use in pregnant women and women of child-bearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Prolia u trudnica niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 100 to 150 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity.
Croatian: U ispitivanjima toksičnosti za jednu i ponavljane doze denosumaba u makaki majmuna doze denosumaba koje su imale 100 do 150 puta veću sistemsku izloženost od preporučene doze za ljude nisu utjecale na kardiovaskularnu fiziologiju, mušku ili žensku reprodukciju ili proizvele toksičnost za određeni ciljni organ.
English: Remove the needle and let go of the skin.
Croatian: Izvucite iglu iz kože i pustite kožu.
English: If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8 for symptoms) calcium levels should be measured.
Croatian: Ako se kod nekog bolesnika tijekom liječenja pojavi sumnja na simptome hipokalcijemije (vidjeti dio 4.8 za simptome), potrebno je izmjeriti razinu kalcija.
English: Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.
Croatian: Denosumab je humano monoklonsko IgG2 protutijelo proizvedeno u staničnoj liniji sisavaca (stanice jajnika kineskog hrčka) tehnologijom rekombinantne DNA.
English: These events have also occurred without antiresorptive therapy.
Croatian: Ti su se događaji također pojavili bez terapije za liječenje poremećaja koštane resorpcije.
English: Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts.
Croatian: Denosumab je humano monoklonsko protutijelo (IgG2) usmjereno na RANKL za koji se veže visokim afinitetom i specifičnošću, sprječavajući aktivaciju njegovog receptora RANK na površini prekursora osteoklasta i na osteoklastima.
English: Rarely, patients receiving Prolia may have low calcium levels in the blood (hypocalcaemia).
Croatian: Rijetko, bolesnici koji primaju lijek Prolia mogu imati niske razine kalcija u krvi (hipokalcijemija).
English: Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
Croatian: U kliničkim ispitivanjima denosumab se primjenjivao u dozama do 180 mg svaka 4 tjedna (kumulativne doze do 1080 mg tijekom 6 mjeseci) i nisu zabilježene nikakve dodatne nuspojave.
English: Absolute risk reduction (%) (95% CI)
Croatian: Apsolutno smanjenje rizika (%) (95% CI)
English: In an interaction study, Prolia did not affect the pharmacokinetics of midazolam, which is metabolised by cytochrome P450 3A4 (CYP3A4).
Croatian: U ispitivanju interakcija Prolia nije utjecala na farmakokinetiku midazolama koji se metabolizira putem citokroma P450 3A4 (CYP3A4).
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog grupiranja po učestalosti i klasifikaciji organskog sustava nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: DO NOT use any Prolia that is left in the syringe.
Croatian: NE koristite lijek Prolia koji je preostao u štrcaljki.
English: Pain in extremity Musculoskeletal pain1
Croatian: Bol u ekstremitetima Mišićno-koštana bol1
English: • bone, joint, and/or muscle pain which is sometimes severe, • arm or leg pain (pain in extremity).
Croatian: • bol u kostima, zglobovima i/ili mišićima koja je ponekad teška, • bol u ruci ili nozi (bol u udovima).
English: Atypical femoral fractures have been reported in patients receiving denosumab (see section 4.8).
Croatian: Atipične femoralne frakture zabilježene su u bolesnika koji primaju denosumab (vidjeti dio 4.8).
English: During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.
Croatian: Tijekom liječenja denosumabom bolesnike treba savjetovati da prijave novu ili neobičnu bol u području bedara, kuka ili slabina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Prolia in all subsets of the paediatric population in the treatment of bone loss associated with sex hormone ablative therapy, and in subsets of the paediatric population below the age of 2 in the treatment of osteoporosis.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitavanja lijeka Prolia u svim podskupinama pedijatrijske populacije u terapiji gubitka koštane mase povezanog s terapijom smanjivanja spolnih hormona, te u podskupinama pedijatrijske populacije u dobi mlađoj od 2 godine kod terapije osteoporoze.
English: • pain, tingling or numbness that moves down your leg (sciatica),
Croatian: • bol, trnci ili utrnulost koja se širi niz nogu (išijas),
English: B Open the tray, peeling away the cover.
Croatian: B Otvorite podlogu skidanjem omota.
English: Your doctor has prescribed a Prolia pre-filled syringe for injection into the tissue just under the skin (subcutaneous).
Croatian: Vaš liječnik Vam je propisao Prolia napunjenu štrcaljku za injekciju u tkivo točno ispod kože (supkutano).