natgillin/translations-raw huggingface dataset:
The requirements for submission of PSURs 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 web-portal.
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh poznejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Take your next dose of Natpar at the usual time the next day.
Naslednji odmerek zdravila Natpar vzemite ob običajni uri naslednji dan.
C. Daily Injection
C. Dnevno injiciranje
Each pen must be used by only one patient.
Vsak peresnik sme uporabljati samo en bolnik.
No change
Ne spremenite
• Wash your hands with soap and water and dry them with a clean towel.
• Roke si umijte z milom in vodo ter jih osušite s čisto brisačo.
Date of latest renewal: 29 April 2019
Datum zadnjega podaljšanja : 29. april 2019
When you give your next scheduled injection, be sure that you hold the needle in your thigh for at least 10 seconds.
Ko si daste svojo naslednjo načrtovano injekcijo, držite iglo v stegnu vsaj 10 sekund.
• In the Medicine Tracker below (See Figure C):
• Spodaj v Sledilniku zdravila (glejte sliko C):
In the powder:
V prašku:
You may have used all the doses in your pen.
Morda ste porabili vse odmerke v peresniku.
Symptoms related to high or low calcium levels are included in the list below.
Simptomi, povezani z visokimi ali nizkimi ravnmi kalcija, so navedeni v seznamu spodaj.
Important: Small air bubbles in the liquid may not rise to the top.
Pomembno: Morda majhni zračni mehurčki v tekočini ne bodo prišli do površja.
These medicines include calcium or vitamin D.
Ta zdravila vključujejo kalcij in vitamin D.
17 Discard your used needles:
17 Odstranjevanje uporabljenih igel:
If you still cannot screw it down all the way, use a new needle.
Če ga še vedno ne morete popolnoma priviti, uporabite novo iglo.
Can I use different needles?
Lahko uporabim druge igle?
Natpar should not be used in children or adolescents under 18 years old.
Zdravilo Natpar se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
If you do not think you received your full dose, do not take another dose.
Če menite, da niste prejeli celotnega odmerka, ne uporabite drugega odmerka.
Consider increase after at least 2-4 weeks at a stable dose
Razmislite o povečanju po vsaj 2-4 tednih stabilnega odmerjanja.
Important: Carefully read Step 10 through Step 14 before injecting.
Pomembno: Pred injiciranjem natančno preberite korake 10 do 14.
If the expiration date is before today's date or is in the next two weeks, discard the pen and use a new pen.
Če je datum roka uporabnosti pred današnjim datumom ali je v naslednjih dveh tednih, peresnik zavrzite in uporabite nov peresnik.
Do not blow on it or fan it with your hand.
Ne pihajte vanj in ne mahajte z roko.
The safety and efficacy of Natpar in children less than 18 years of age have not yet been established.
Varnost in učinkovitost zdravila Natpar pri otrocih, mlajših od 18 let, še nista dokazani.
For the efficacy analysis, subjects that fulfilled three components of a three-part response criterion were considered responders.
Za analizo učinkovitosti so bili upoštevani kot odzivni tisti preskušanci, ki so izpolnjevali tri komponente tridelnega merila odzivnosti.
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in serijsko številko uporabljenega zdravila.
• Refer to the following Frequently Asked Questions.
• Glejte poglavje Pogosta vprašanja.
The other ingredients in the medicine (for all strengths) are:
Pomožne snovi v zdravilu (za vse jakosti) so:
Three of these patients had antibodies with neutralising activity; these patients maintained a clinical response with no evidence of immune-related adverse reactions.
Trije od teh bolnikov so imeli protitelesa z nevtralizacijsko aktivnostjo; ti bolniki so ohranili klinični odziv brez znakov neželenih učinkov, povezanih z imunostjo.
• need to pass urine often
• pogosta potreba po uriniranju
• Let go of the blue button.
• Spustite modri gumb.
• in blood tests, your doctor may see decreased levels of vitamin D and magnesium
• zdravnik lahko pri krvnih preiskavah ugotovi znižane ravni vitamina D in magnezija
Adjust first
Prilagodite najprej
• feeling nervous or anxious
• občutek živčnosti ali tesnobe
Tests and checks
Preiskave in pregledi
• fast or uneven heart beat*,
• hitro ali neenakomerno bitje srca*
• Confirm 25-OH vitamin D stores are sufficient.
• prepričajte se, da so zaloge 25-OH vitamina D dovolj velike;
Paediatric population Pharmacokinetic data in paediatric patients are not available.
Pediatrična populacija Farmakokinetični podatki pri pediatričnih bolnikih niso na voljo.
• Do not use this medicine for more than 14 days after it has been mixed.
• Po mešanju zdravila ne uporabljajte več kot 14 dni.
Very common (1/10) Common (1/100 to
Organski sistem Zelo pogosti (1/10) Pogosti (od 1/100 do
This confirms that your pen has not been primed yet.
To potrjuje, da peresnik še ni bil aktiviran.
Patients should be monitored until signs and symptoms resolve (see sections 4.3 and 4.8).
Bolnike je treba spremljati, dokler znaki in simptomi ne izzvenijo (glejte poglavji 4.3 in 4.8).
If you do not wait 10 seconds after pressing the blue button, you may not receive your full dose.
Če po tem, ko pritisnete na modri gumb, ne boste počakali 10 sekund, morda ne boste prejeli celotnega odmerka.
Decrease or discontinue**
Zmanjšajte ali opustite**
Figure C Medicine Tracker
Slika C Sledilnik zdravila
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
If your ability to concentrate is impaired, you should not drive or use machines until your ability to concentrate is improved.
Če je vaša sposobnost koncentracije oslabljena, ne smete voziti ali uporabljati strojev, dokler se ne izboljša.
Your doctor will check your calcium levels.
Zdravnik bo izmeril vaše ravni kalcija.
Your doctor may tell you to change the amount of calcium or vitamin D you take (in any form, including foods rich in calcium).
Zdravnik vam bo morda naročil, da spremenite količino kalcija in vitamina D, ki ju jemljete (v kakršni koli obliki, tudi hrane, bogate s kalcijem).
Other medicines and Natpar
Druga zdravila in zdravilo Natpar
Do not place the pen under water.
Peresnika ne dajajte pod vodo.
• pain in your arms and legs
• bolečine v rokah in nogah
What Natpar is and what it is used for 2.
Kaj je zdravilo Natpar in za kaj ga uporabljamo 2.
PTH (1-84) is the principal regulator of plasma calcium homeostasis.
PTH (1-84) je glavni regulator homeostaze kalcija v plazmi.
Natpar is not protein bound and has a low volume of distribution.
Zdravilo Natpar se ne veže na beljakovine in ima majhen volumen porazdelitve.
These 17 patients had low titre anti-PTH antibodies and, of these, 3 subsequently became antibody negative.
Teh 17 bolnikov je imelo nizke titre protiteles anti-PTH in 3 med njimi so pozneje imeli negativne teste protiteles.
Treatment should be supervised by a physician or other qualified healthcare professional experienced in the management of patients with hypoparathyroidism.
Zdravljenje mora nadzorovati zdravnik ali drug usposobljen zdravstveni delavec z izkušnjami pri zdravljenju bolnikov s hipoparatiroidizmom.
Continue following the instructions, being careful not to press the blue button until instructed to do so.
Še naprej upoštevajte navodila in bodite previdni, da ne pritisnete modrega gumba, dokler navodila tako ne velevajo.
If you forget to use Natpar (or cannot inject it at your usual time), use your injection as soon as you can but do not inject more than one dose in the same day.
Če ste pozabili uporabiti zdravilo Natpar (ali ga niste mogli uporabiti ob običajni uri), si ga injicirajte, takoj ko se spomnite, vendar ne injicirajte več kot enega odmerka v enem dnevu.
Try re-tightening the needle.
Iglo poskušajte ponovno pritrditi.
• When your sharps disposal container is two thirds full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
• Ko je vaš vsebnik za odlaganje ostrih predmetov do dveh tretjin poln, sledite lokalnim smernicam glede pravilnega načina za odstranjevanje vsebnika za odlaganje ostrih predmetov.
Do not touch the needle or the inside of the needle cap.
Ne dotikajte se igle ali notranjosti pokrovčka igle.
The apparent transient nature of antibodies to PTH is likely due to the low titre.
Navidezna prehodna narava protiteles proti PTH je verjetno posledica nizkega titra.
• Confirm serum magnesium is within the reference range.
• prepričajte se, da je koncentracija magnezija v serumu znotraj referenčnega razpona.
• Follow these instructions each time you use your pen to ensure that you do not skip any steps.
• Uporabite ta navodila za uporabo vsakič, ko uporabljate peresnik, da ne pozabite kakšnega koraka.
This means that further evidence on this medicinal product is awaited.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
The final clinical study report should be submitted by:
Končno poročilo o klinični študiji je treba predložiti do:
These effects are more likely to occur: - when first starting Natpar, - if you change your Natpar dose, - if you miss one of your daily injections, - if you stop taking Natpar for a short time or altogether.
Ti učinki so verjetnejši: - ko začnete uporabljati zdravilo Natpar, - če spremenite odmerek zdravila Natpar, - če izpustite eno od dnevnih injekcij, - če zdravilo Natpar prenehate uporabljati za krajši čas ali popolnoma.
What should I do if I heard a click when I pushed the blue button to give the injection, but the blue button did not stay down?
Kaj naj naredim, če sem zaslišal/-a klik, ko sem modri gumb potisnil/-a navzdol za injiciranje, vendar modri gumb ni ostal pritisnjen?
The MAH shall plan to include regular progress reports of the registry in the PSUR.
Imetnik dovoljenja za promet z zdravilom mora načrtovati, da bo redna poročila o napredku registra vključeval v PSUR.
Do not use this medicine after the expiry date which is stated on the pen and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na peresniku in škatli poleg oznake »EXP«.
This step mixes the powder and liquid.
S tem korakom se prašek in tekočina zmešata.
• Set your pen down and wait until the powder is dissolved and the liquid is colourless, or until 5 minutes have passed.
• Peresnik položite in počakajte, da se prašek raztopi in je tekočina brezbarvna, ali da mine 5 minut.
After reconstitution, the liquid must be colourless and practically free of foreign particles; parathyroid hormone (rDNA) must not be used if the reconstituted solution is cloudy, coloured, or contains visible particles.
Po rekonstituciji mora biti tekočina brezbarvna in praktično brez delcev; paratiroidni hormon (rDNA) se ne sme uporabljati, če je rekonstituirana raztopina motna ali obarvana, ali če vsebuje vidne delce.
Very common (may affect more than 1 in 10 people):
Zelo pogosti (lahko se pojavijo pri več kot 1 osebi od 10):
• Leave the needle cap on until you are ready to inject your medicine.
• Pokrovček igle pustite na igli, dokler niste pripravljeni na injiciranje zdravila.
FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a(4) Uredbe (ES) št. 726/2004 mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
• Gather your pen and other supplies needed as shown in the figure below and set them on a clean, flat surface.
• Peresnik in druge potrebščine zberite, kot je prikazano na spodnji sliki, in jih položite na čisto ter ravno površino.
What should I do if the medicine in the pen is frozen?
Kaj naj naredim, če je zdravilo v peresniku zamrznjeno?
• You may want to also write down the ”Date Mixed” and “Discard On” date in a place where you will remember, like a personal calendar or mobile device.
• Dobro je, če si »Datum mešanja« in datum »Zavrzite dne« zapišete tudi na mesto, kjer se boste tega spomnili, na primer v osebni koledar ali mobilno napravo.
• Store your pen away from heat and light.
• Peresnik shranjujte ločeno od vročine in svetlobe.
• fatigue and lack of energy*
• utrujenost in pomanjkanje energije*
Why does the dose counter show “14” after I have given an injection using a newly mixed pen?
Zakaj števec odmerkov kaže »14« po injiciranju z na novo zmešanim peresnikom?
After reconstitution, chemical and physical in-use stability of the solution has been demonstrated for up to 14 days when stored in a refrigerator (2°C - 8°C) and for up to 3 days when stored outside the refrigerator not above 25°C during the 14-day use period.
Po rekonstituciji raztopina ostane kemično in fizično stabilna do 14 dni, če je shranjena v hladilniku (2 °C-8 °C), in do 3 dni, če je v 14-dnevnem obdobju uporabe shranjena zunaj hladilnika pri temperaturi, ki ne presega 25 °C.
• allergic reactions (hypersensitivity), such as: swelling of the face, lips, mouth, or tongue;
• alergijske reakcije (preobčutljivost), kot so: otekanje obraza, ustnic, ust ali jezika, zasoplost,
Across all clinical studies in patients with hypoparathyroidism following treatment with Natpar for up to 4 years, the immunogenicity incidence rate was 17/87 (19.5%) and did not appear to increase over time.
V vseh kliničnih študijah pri bolnikih s hipoparatiroidizmom po zdravljenju z zdravilom Natpar, ki je trajalo do 4 leta, je bila stopnja pojavnosti imunogenosti 17/87 (19,5 %) in ni bilo videti, da bi se sčasoma povečala.
The clinical study report should be submitted by:
Poročilo o klinični študiji je treba predložiti do:
1 • If you just completed “New Pen Setup & Mixing” (Section B), go to Step 8 below.
1 • Če ste pravkar končali s »Pripravo novega injekcijskega peresnika in mešanjem zdravila« (poglavje B), pojdite na spodnji korak 8.
You may need to change your Natpar dose or stop the injections for a short time.
Morda boste morali spremeniti odmerek zdravila Natpar ali za kratek čas prenehati dobivati injekcije zdravila Natpar.
You only need to do this one time for each new pen.
To je treba za vsak nov peresnik narediti le enkrat.
What you need to know before you use Natpar 3.
Kaj morate vedeti, preden boste uporabili zdravilo Natpar 3.
Do not inject a double dose to make up for a forgotten dose.
Ne injicirajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Natpar did not adversely affect fertility or early embryonic development in rats, embryo-foetal development in rats and rabbits, or pre/post-natal development in rats.
Zdravilo Natpar ni negativno vplivalo na plodnost ali zgodnji embrionalni razvoj pri podganah, embrio-fetalni razvoj pri podganah in kuncih ali pred/postnatalni razvoj pri podganah.
You may be given medicines to treat or help prevent these side effects, or you may be asked to stop some of the medicines you are taking.
Morda boste dobili dodatna zdravila za zdravljenje ali preprečevanje teh neželenih učinkov ali pa vam bodo naročili, da prenehate jemati katero od zdravil.
• Very common: high levels of calcium in your blood, which can occur more often when you start treatment with Natpar.
• Zelo pogosti: visoke ravni kalcija v krvi, ki so lahko pogostejše, ko začnete zdravljenje z zdravilom Natpar.
Important: It is normal to see 1 or 2 drops of medicine leaking out of the skin or from the needle tip after this step.
Pomembno: Po tem koraku je normalno, da iz kože ali konice igle izteče 1 ali 2 kapljici zdravila.
Before mixing
Pred mešanjem
• Very common: low levels of calcium in your blood; this can occur more often if you suddenly stop taking Natpar.
• Zelo pogosti: nizke ravni kalcija v krvi; te so lahko pogostejše, če nenadoma prenehate jemati zdravilo Natpar.
The recommended starting dose of Natpar is 50 micrograms per day.
Priporočeni začetni odmerek zdravila Natpar je 50 mikrogramov dnevno.
1 • Check the expiration date (EXP) on the pen (See Figure A).
1 • Preverite datum roka uporabnosti (EXP) na peresniku (glejte sliko A).
• Save the cap for later use.
• Pokrovček shranite za kasnejšo uporabo.
Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Natpar may trigger the development of antibodies.
Skladno s potencialnimi imunogenimi lastnostmi zdravil, ki vsebujejo peptide, lahko uporaba zdravila Natpar sproži razvoj protiteles.
Rats treated with daily injections of Natpar for 2 years had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to a non-genotoxic mechanism.
Podgane, ki so 2 leti dobivale dnevne injekcije zdravila Natpar, so imele od odmerka odvisno povečano tvorbo kosti in povečano incidenco tumorjev kosti, vključno z osteosarkomom, najverjetneje zaradi negenotoksičnega mehanizma.
Natpar should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Zdravilo Natpar je treba pri bolnikih z aktivno ali nedavno urolitiazo uporabljati previdno zaradi možnosti poslabšanja tega stanja.
The calcaemic response is sustained for more than 24 hours after administration.
Odziv ravni kalcija se obdrži več kot 24 ur po injiciranju.
This protects the medicine from light (See Figure Y).
S tem zdravilo zaščitite pred svetlobo (glejte sliko Y).
The safety and clinical efficacy of Natpar in adults with hypoparathyroidism is derived from 1 randomised, placebo-controlled study and an open-label extension study.
Varnost in klinična učinkovitost zdravila Natpar pri odraslih s hipoparatiroidizmom temeljita na 1 randomizirani, s placebom nadzorovani študiji, in odprti podaljšani študiji.
Can I re-use the pen needles?
Lahko igle peresnika ponovno uporabim?
Natpar must not be administered intravenously or intramuscularly.
Zdravilo Natpar se ne sme dajati intravensko ali intramuskularno.
Important: If the cartridge is hard to screw down all the way, tighten the needle and try to slowly screw down the cartridge again.
Pomembno: Če je vložek težko priviti do konca, močneje pritrdite iglo in poskušajte vložek ponovno počasi priviti navzdol.
Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA03
Farmakoterapevtska skupina: zdravila za uravnavanje homeostaze kalcija, paratiroidni hormoni in analogi; oznaka ATC: H05AA03
Important: To make capping easier, place the needle cap against an object or surface.
Pomembno: Za lažjo namestitev pokrovčka položite pokrovček igle ob predmet ali površino.
It is normal to see small air bubbles in the medicine.
Normalno je, da vidite v zdravilu majhne zračne mehurčke.
Not known (cannot be estimated from the available data)
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
The risk for serious hypocalcaemia was greatest after the withdrawal of Natpar.
Tveganje za resno hipokalciemijo je bilo največje po opustitvi zdravljenja z zdravilom Natpar.
Study 2 is a long-term, open-label extension study of daily subcutaneous dosing of Natpar in hypoparathyroidism patients who completed prior studies with Natpar.
Študija 2 je dolgoročna, odprta podaljšana študija z dnevnim subkutanim odmerjanjem zdravila Natpar pri bolnikih s hipoparatiroidizmom, ki so pred tem dokončali študije z zdravilom Natpar.
The European Medicines Agency has deferred the obligation to submit the results of studies with Natpar in one or more subsets of the paediatric population in hypoparathyroidism (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Natpar za eno ali več podskupin pediatrične populacije s hipoparatiroidizmom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What if I tighten the needle too much and it “clicks” and loosens?
Kaj naj naredim, če preveč pritrdim iglo, ki nato »klikne« in se zrahlja?
A risk to the pregnant woman or developing foetus cannot be excluded.
Tveganja za nosečnico ali razvijajoči se plod ni mogoče izključiti.
Concomitant use of Natpar with bisphosphonates is not recommended.
Sočasna uporaba zdravila Natpar z bisfosfonati ni priporočljiva.
• Get a new pen needle and set it next to the pen.
• Priskrbite novo iglo za peresnik in jo položite poleg peresnika.
• redness and pain at injection site
• rdečina in bolečina na mestu injiciranja
Since neurologic symptoms may be a sign of uncontrolled hypoparathyroidism, patients with disturbances in cognition or attention should be advised to refrain from driving or using machines until symptoms have subsided.
Nevrološki simptomi so lahko znak nenadzorovanega hipoparatiroidizma, zato je treba bolnikom, ki imajo motnje kognicije ali pozornosti, svetovati, da ne smejo voziti ali upravljati strojev, dokler simptomi ne izginejo.
• seizures (fits) due to low levels of calcium in your blood
• epileptični napadi (krči) zaradi nizkih ravni kalcija v krvi
The powder is white and the solvent is a clear, colourless solution.
Prašek je bel, vehikel pa je bistra in brezbarvna raztopina.
Lower than 2 mmol/L
Manj kot 2 mmol/l
Warnings and precautions
Opozorila in varnostni ukrepi
Important: It is recommended to switch thighs every day for your injection site.
Pomembno: Priporočljivo je, da za mesto injiciranja vsak dan uporabite drugo stegno.
How do I throw away my pen?
Kako naj zavržem peresnik?
How do I clean my pen?
Kako naj peresnik očistim?
Severe hypercalcaemia may be a life-threatening condition requiring urgent medical care and careful monitoring (see section 4.4).
Huda hiperkalciemija je lahko smrtno nevarna ter zahteva nujno zdravstveno oskrbo in skrbno spremljanje (glejte poglavje 4.4).
Randomisation was followed by a 12-week Natpar titration phase and a 12-week Natpar dose maintenance phase.
Randomizaciji sta sledili 12-tedensko obdobje titriranja zdravila Natpar in 12-tedensko obdobje vzdrževanja odmerka zdravila Natpar.
The optimisation of parameters of calcium-phosphate metabolism should be in line with current therapeutic guidelines for the treatment of hypoparathyroidism.
Optimizacija parametrov presnove kalcija in fosfatov mora biti skladna z najnovejšimi terapevtskimi smernicami za zdravljenje hipoparatiroidizma.
Non-interventional post-authorisation safety study (PASS): In order to collect long-term data on clinical efficacy and safety, the MAH should submit the results of a study based on data deriving from a registry of patients with hypoparathyroidism and who are treated with NATPAR.
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za zbiranje dolgoročnih podatkov o klinični učinkovitosti in varnosti mora imetnik dovoljenja za promet z zdravilom predložiti rezultate študije, ki temelji na podatkih iz registra bolnikov s hipoparatiroidizmom, ki se zdravijo z zdravilom NATPAR.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Ireland.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Irska.
In vitro and in vivo studies demonstrated that the clearance of Natpar is primarily a hepatic process with a lesser role played by the kidneys.
Študije in vitro in in vivo so pokazale, da je očistek zdravila Natpar predvsem jetrni proces, medtem ko imajo ledvice manjšo vlogo.