FrancophonIA/ELRC3.0 huggingface dataset:
English: You may need to change your Natpar dose or stop the injections for a short time.
Slovenian: Morda boste morali spremeniti odmerek zdravila Natpar ali za kratek čas prenehati dobivati injekcije zdravila Natpar.
English: You only need to do this one time for each new pen.
Slovenian: To je treba za vsak nov peresnik narediti le enkrat.
English: What you need to know before you use Natpar 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Natpar 3.
English: Do not inject a double dose to make up for a forgotten dose.
Slovenian: Ne injicirajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Morda boste dobili dodatna zdravila za zdravljenje ali preprečevanje teh neželenih učinkov ali pa vam bodo naročili, da prenehate jemati katero od zdravil.
English: • Very common: high levels of calcium in your blood, which can occur more often when you start treatment with Natpar.
Slovenian: • Zelo pogosti: visoke ravni kalcija v krvi, ki so lahko pogostejše, ko začnete zdravljenje z zdravilom Natpar.
English: 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.
Slovenian: Pomembno: Po tem koraku je normalno, da iz kože ali konice igle izteče 1 ali 2 kapljici zdravila.
English: Before mixing
Slovenian: Pred mešanjem
English: • Very common: low levels of calcium in your blood; this can occur more often if you suddenly stop taking Natpar.
Slovenian: • Zelo pogosti: nizke ravni kalcija v krvi; te so lahko pogostejše, če nenadoma prenehate jemati zdravilo Natpar.
English: The recommended starting dose of Natpar is 50 micrograms per day.
Slovenian: Priporočeni začetni odmerek zdravila Natpar je 50 mikrogramov dnevno.
English: 1 • Check the expiration date (EXP) on the pen (See Figure A).
Slovenian: 1 • Preverite datum roka uporabnosti (EXP) na peresniku (glejte sliko A).
English: • Save the cap for later use.
Slovenian: • Pokrovček shranite za kasnejšo uporabo.
English: Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Natpar may trigger the development of antibodies.
Slovenian: Skladno s potencialnimi imunogenimi lastnostmi zdravil, ki vsebujejo peptide, lahko uporaba zdravila Natpar sproži razvoj protiteles.
English: 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.
Slovenian: 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.
English: Natpar should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Slovenian: Zdravilo Natpar je treba pri bolnikih z aktivno ali nedavno urolitiazo uporabljati previdno zaradi možnosti poslabšanja tega stanja.
English: The calcaemic response is sustained for more than 24 hours after administration.
Slovenian: Odziv ravni kalcija se obdrži več kot 24 ur po injiciranju.
English: This protects the medicine from light (See Figure Y).
Slovenian: S tem zdravilo zaščitite pred svetlobo (glejte sliko Y).
English: 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.
Slovenian: Varnost in klinična učinkovitost zdravila Natpar pri odraslih s hipoparatiroidizmom temeljita na 1 randomizirani, s placebom nadzorovani študiji, in odprti podaljšani študiji.
English: Can I re-use the pen needles?
Slovenian: Lahko igle peresnika ponovno uporabim?
English: Natpar must not be administered intravenously or intramuscularly.
Slovenian: Zdravilo Natpar se ne sme dajati intravensko ali intramuskularno.
English: Important: If the cartridge is hard to screw down all the way, tighten the needle and try to slowly screw down the cartridge again.
Slovenian: Pomembno: Če je vložek težko priviti do konca, močneje pritrdite iglo in poskušajte vložek ponovno počasi priviti navzdol.
English: Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA03
Slovenian: Farmakoterapevtska skupina: zdravila za uravnavanje homeostaze kalcija, paratiroidni hormoni in analogi; oznaka ATC: H05AA03
English: Important: To make capping easier, place the needle cap against an object or surface.
Slovenian: Pomembno: Za lažjo namestitev pokrovčka položite pokrovček igle ob predmet ali površino.
English: It is normal to see small air bubbles in the medicine.
Slovenian: Normalno je, da vidite v zdravilu majhne zračne mehurčke.
English: Not known (cannot be estimated from the available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: The risk for serious hypocalcaemia was greatest after the withdrawal of Natpar.
Slovenian: Tveganje za resno hipokalciemijo je bilo največje po opustitvi zdravljenja z zdravilom Natpar.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: What if I tighten the needle too much and it “clicks” and loosens?
Slovenian: Kaj naj naredim, če preveč pritrdim iglo, ki nato »klikne« in se zrahlja?
English: A risk to the pregnant woman or developing foetus cannot be excluded.
Slovenian: Tveganja za nosečnico ali razvijajoči se plod ni mogoče izključiti.
English: Concomitant use of Natpar with bisphosphonates is not recommended.
Slovenian: Sočasna uporaba zdravila Natpar z bisfosfonati ni priporočljiva.
English: • Get a new pen needle and set it next to the pen.
Slovenian: • Priskrbite novo iglo za peresnik in jo položite poleg peresnika.
English: • redness and pain at injection site
Slovenian: • rdečina in bolečina na mestu injiciranja
English: 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.
Slovenian: 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.
English: • seizures (fits) due to low levels of calcium in your blood
Slovenian: • epileptični napadi (krči) zaradi nizkih ravni kalcija v krvi
English: The powder is white and the solvent is a clear, colourless solution.
Slovenian: Prašek je bel, vehikel pa je bistra in brezbarvna raztopina.
English: Lower than 2 mmol/L
Slovenian: Manj kot 2 mmol/l
English: Warnings and precautions
Slovenian: Opozorila in varnostni ukrepi
English: Important: It is recommended to switch thighs every day for your injection site.
Slovenian: Pomembno: Priporočljivo je, da za mesto injiciranja vsak dan uporabite drugo stegno.
English: How do I throw away my pen?
Slovenian: Kako naj zavržem peresnik?
English: How do I clean my pen?
Slovenian: Kako naj peresnik očistim?
English: Severe hypercalcaemia may be a life-threatening condition requiring urgent medical care and careful monitoring (see section 4.4).
Slovenian: Huda hiperkalciemija je lahko smrtno nevarna ter zahteva nujno zdravstveno oskrbo in skrbno spremljanje (glejte poglavje 4.4).
English: Randomisation was followed by a 12-week Natpar titration phase and a 12-week Natpar dose maintenance phase.
Slovenian: Randomizaciji sta sledili 12-tedensko obdobje titriranja zdravila Natpar in 12-tedensko obdobje vzdrževanja odmerka zdravila Natpar.
English: The optimisation of parameters of calcium-phosphate metabolism should be in line with current therapeutic guidelines for the treatment of hypoparathyroidism.
Slovenian: Optimizacija parametrov presnove kalcija in fosfatov mora biti skladna z najnovejšimi terapevtskimi smernicami za zdravljenje hipoparatiroidizma.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Študije in vitro in in vivo so pokazale, da je očistek zdravila Natpar predvsem jetrni proces, medtem ko imajo ledvice manjšo vlogo.
English: What should I do if the medicine is cloudy, coloured, or contains particles?
Slovenian: Kaj naj naredim, če je zdravilo motno, obarvano ali vsebuje delce?
English: • Continue to point the needle straight down.
Slovenian: • Igla naj bo še naprej obrnjena naravnost navzdol.
English: No, do not re-use your pen needle.
Slovenian: Ne, igel peresnika ne smete ponovno uporabiti.
English: In order to further confirm the efficacy and safety of NATPAR in the treatment of patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone, the MAH should conduct a randomised controlled trial comparing NATPAR to Standard of Care and to alternative dosing according to an agreed protocol.
Slovenian: Za dodatno potrditev učinkovitosti in varnosti zdravila NATPAR pri zdravljenju bolnikov s kroničnim hipoparatiroidizmom, pri katerih bolezni ni mogoče ustrezno nadzorovati samo s standardno terapijo, mora imetnik dovoljenja za promet z zdravilom izvesti randomizirano nadzorovano preskušanje za primerjavo zdravila NATPAR s standardno oskrbo in z alternativnimi odmerjanji, skladno z dogovorjenimi protokoli.
English: Check the dose counter to see if there are any doses left, or check the “Discard On” date on the Medicine Tracker to see if it has been more than 14 days.
Slovenian: Poglejte na števec odmerkov, ali je ostal še kak odmerek, ali datum »Zavrzite dne« na Sledilniku zdravila, da vidite, ali je preteklo več kot 14 dni.
English: • Keep the pen needle in your skin and slowly count to 10 while continuing to hold down the blue button.
Slovenian: • Z iglo peresnika v koži počasi štejte do 10, medtem ko držite modri gumb.
English: • Email Shire at medinfoEMEA@shire.com.
Slovenian: • Pošljite e-sporočilo družbi Shire na medinfoEMEA@shire.com.
English: The cartridge is made of glass, with a rubber seal on top.
Slovenian: Vložek je izdelan iz stekla, z gumijastim tesnilom na vrhu.
English: • Let the injection site air dry.
Slovenian: • Mesto injiciranja naj se osuši na zraku.
English: What should I do if I accidentally push the yellow button before I'm supposed to?
Slovenian: Kaj naj naredim, če pomotoma prezgodaj pritisnem na rumeni gumb?
English: If the needle is not pointing straight up or the cartridge is screwed down too quickly during this step, medicine may leak from your pen.
Slovenian: Če igla ne gleda naravnost navzgor ali vložek v tem koraku prehitro privijete navzdol, lahko zdravilo izteka iz peresnika.
English: • Before attaching a new needle to your Natpar pen, check that the solution is clear and colourless.
Slovenian: • Preden namestite novo iglo na peresnik Natpar, preverite, ali je raztopina bistra in brezbarvna.
English: • Discard all pens on the “Discard On” date, 14 days after mixing (see Medicine Tracker).
Slovenian: • Vse peresnike zavrzite na datum »Zavrzite dne«, 14 dni po premešanju (glejte Sledilnik zdravila).
English: Excipient(s) with known effect Each dose contains 0.32 mg of sodium.
Slovenian: Pomožne snovi z znanim učinkom: En odmerek vsebuje 0,32 mg natrija.
English: • sodium hydroxide (for pH adjustment)
Slovenian: • natrijev hidroksid (za uravnavanje vrednosti pH)
English: In the kidney, PTH (1-84) increases renal tubular reabsorption of calcium and promotes phosphate excretion.
Slovenian: V ledvicah PTH (1-84) poveča ponovno absorpcijo kalcija v ledvične tubule in spodbuja izločanje fosfatov.
English: If you forget to use Natpar
Slovenian: Če ste pozabili uporabiti zdravilo Natpar
English: Your pen is to be used daily for 14 days and should be thrown away (discarded) 14 days after mixing, even if medicine remains in the pen.
Slovenian: Vaš peresnik se 14 dni uporablja vsak dan in ga morate po 14 dneh od zmešanja zavreči, tudi če je v peresniku še zdravilo.
English: You can pinch a fold of the skin if told by your doctor or nurse.
Slovenian: Lahko naredite kožno gubo, če vam je tako naročil zdravnik ali medicinska sestra.
English: Inject in the other thigh the following day and continue to alternate between the two.
Slovenian: Naslednji dan ga injicirajte v drugo stegno in stegni še naprej izmenjujte.
English: After mixing
Slovenian: Po mešanju
English: This hormone controls the amount of calcium and phosphate in the blood and urine.
Slovenian: Ta hormon nadzoruje količino kalcija in fosfata v krvi in urinu.
English: This will be done using tests to measure the level of calcium in your blood or urine.
Slovenian: To bo opravil s preiskavami za merjenje ravni kalcija v krvi ali urinu.
English: If your levels of parathyroid hormone are too low, you can have low blood calcium.
Slovenian: Če so vaše ravni paratiroidnega hormona prenizke, imate lahko nizko raven kalcija v krvi.
English: Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves.
Slovenian: Nizka raven kalcija lahko povzroči simptome v različnih delih telesa, vključno s kostmi, srcem, kožo, mišicami, ledvicami, možgani in živci.
English: For instructions on reconstitution of the medicinal product before administration and for using the pre-filled pen, see section 6.6 and the instructions included with the package leaflet.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem in za uporabo napolnjenega injekcijskega peresnika glejte poglavje 6.6 in navodilo za uporabo, ki je priloženo zdravilu.
English: For a list of symptoms of low calcium, see section 4.
Slovenian: Za seznam simptomov prenizke ravni kalcija glejte poglavje 4.
English: Sharing your pen or pen needles may give yourself or others a serious infection.
Slovenian: Z deljenjem svojega peresnika ali igel peresnika lahko resno okužite sebe ali druge.
English: Most of the hypocalcaemic events occurring in the clinical trials were mild to moderate in severity.
Slovenian: Večina hipokalciemičnih dogodkov, ki so nastopili v kliničnih preskušanjih, je bila blagih do zmernih.
English: Tighten the needle and make sure that the needle is on straight and the threads are lined up.
Slovenian: Iglo dobro pritrdite in se prepričajte, da je nameščena naravnost in da so navoji poravnani.
English: You may have screwed down the clear medicine cartridge too quickly, wait 5 minutes for the foaming to subside.
Slovenian: Morda ste brezbarvni vložek za zdravilo prehitro privili; počakajte 5 minut, da se penjenje umiri.
English: Before the pen is used for the first time, the medicine has to be mixed.
Slovenian: Pred prvo uporabo peresnika Natpar je treba zdravilo zmešati.
English: Above the upper limit of normal (ULN) (2.55 mmol/L)*
Slovenian: Nad zgornjo mejo normalne vrednosti (2,55 mmol/l)*
English: Save the cap for later use (See Figure D).
Slovenian: Pokrovček shranite za kasnejšo uporabo (glejte sliko D).
English: Your doctor will also decide if you should keep taking this medicine if you become pregnant or start breast-feeding while taking it.
Slovenian: Zdravnik se bo tudi odločil, ali smete nadaljevati uporabo tega zdravila, če v obdobju jemanja zdravila zanosite ali začnete dojiti.
English: Do not recycle your used sharps disposal container.
Slovenian: Rabljenih vsebnikov za odlaganje ostrih predmetov ne reciklirajte.
English: Following injection with Natpar, serum phosphate levels decrease proportionally to PTH(1-84) levels over the first 4 hours and persist over 24 hours post-injection.
Slovenian: Po injiciranju zdravila Natpar se koncentracije fosfata v serumu v prvih 4 urah znižujejo sorazmerno z ravnjo PTH(1-84) in ostanejo znižane več kot 24 ur po injiciranju.
English: • antibodies (produced by your immune system) to Natpar
Slovenian: • protitelesa (ki jih tvori imunski sistem) proti zdravilu Natpar
English: After you have mixed the medicine, the Natpar pen is ready for use and the medicine can be injected under the skin of your thigh.
Slovenian: Ko zmešate zdravilo, je peresnik Natpar pripravljen za uporabo in zdravilo lahko injicirate pod kožo v stegno.
English: What should I do if I lost the pen cap?
Slovenian: Kaj naj naredim, če sem pokrovček peresnika izgubil/-a?
English: Use in elderly patients
Slovenian: Uporaba pri starejših bolnikih
English: 25 micrograms - Purple 50 micrograms - Red 75 micrograms - Grey 100 micrograms - Blue
Slovenian: 25 mikrogramov - vijolična, 50 mikrogramov - rdeča, 75 mikrogramov - siva, 100 mikrogramov - modra.
English: Initiate treatment with 50 micrograms once daily as a subcutaneous injection in the thigh (alternate thigh every day).
Slovenian: Zdravljenje začnite s 50 mikrogrami enkrat na dan s subkutano injekcijo v stegno (izmenično vsak dan v drugo stegno).
English: Active vitamin D forms
Slovenian: Aktivne oblike vitamina D
English: At randomisation, active forms of vitamin D were reduced by 50% and patients were allocated to Natpar 50 micrograms daily or placebo.
Slovenian: Ob randomizaciji so zmanjšali odmerke aktivne oblike vitamina D za 50 % in bolnike razdelili v skupino, ki je prejemala 50 mikrogramov zdravila Natpar na dan ali placebo.
English: All adverse reactions identified in post-marketing experience are italicised.
Slovenian: Vsi neželeni učinki, ugotovljeni iz izkušenj iz obdobja trženja, so zapisani ležeče.
English: Parathyroid hormone receptors belong to the family of G-coupled protein receptors.
Slovenian: Receptorji za paratiroidni hormon spadajo v družino receptorjev, povezanih z G-proteini.
English: The dose of Natpar may be increased by 25 microgram increments approximately every 2 to 4 weeks, up to a maximum daily dose of 100 micrograms.
Slovenian: Odmerek zdravila Natpar se lahko poveča v korakih po 25 mikrogramov približno vsake 2 do 4 tedne, do največjega dnevnega odmerka 100 mikrogramov.
English: Natpar has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Natpar nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: This medicine has been given ‘conditional approval'.
Slovenian: Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet”.
English: 11 • Check if the yellow dose counter lines up with the number “14” (See Figure L).
Slovenian: 11 • Preverite, ali je rumeni števec odmerkov poravnan s številko »14« (glejte sliko L).
English: 4 • Hold the clear medicine cartridge with your fingers and point it straight up towards the ceiling.
Slovenian: 4 • Prozorni vložek z zdravilom držite s prsti in ga usmerite naravnost proti stropu.
English: The objective of this trial was to maintain serum calcium with Natpar while reducing or replacing oral calcium and active vitamin D. The study was a 24-week, randomised, double-blind, placebo-controlled, multicentre trial.
Slovenian: Cilj tega preskušanja je bil, da zdravilo Natpar ohrani raven kalcija v serumu ter hkrati zmanjša ali nadomesti peroralne odmerke kalcija in aktivnega vitamina D. Študija je bila 24-tedensko, randomizirano, dvojno slepo, s placebom nadzorovano, multicentrično preskušanje.
English: • pain in your muscles
Slovenian: • bolečine v mišicah
English: Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Slovenian: Zdravilo Natpar je indicirano za dopolnilno zdravljenje odraslih bolnikov s kroničnim hipoparatiroidizmom, ki ga ni mogoče ustrezno nadzorovati samo s standardno terapijo.
English: Other side effects include:
Slovenian: Drugi možni neželeni učinki vključujejo naslednje:
English: No osteosarcomas have been observed in clinical trials.
Slovenian: V kliničnih preskušanjih niso opazili osteosarkomov.
English: 5 • If the remaining liquid is colourless and today's date is before the “Discard On” date (See Medicine Tracker), go to Step 6.
Slovenian: 5 • Če je preostala tekočina brezbarvna in je današnji datum pred datumom »Zavrzite dne« (glejte Sledilnik zdravila), pojdite na korak 6.
English: Available pharmacology data in animals have shown excretion of Natpar in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični podatki pri živalih kažejo na izločanje zdravila Natpar v mleko (glejte poglavje 5.3).
English: If signs or symptoms of a serious hypersensitivity reaction occur, treatment with Natpar should be discontinued and hypersensitivity reaction should be treated according to the standard of care.
Slovenian: Če se pojavijo znaki ali simptomi resne preobčutljivostne reakcije, je treba zdravljenje z zdravilom Natpar prekiniti in preobčutljivostno reakcijo zdraviti v skladu s standardnim zdravljenjem.
English: In the kidney, parathyroid hormone and C-terminal fragments are cleared by glomerular filtration.
Slovenian: V ledvicah se nespremenjeni paratiroidni hormon in C-terminalni fragmenti učinkovito izločajo z glomerulno filtracijo.
English: The needle must be pointing down at all times until after the injection so that the air stays away from the needle.
Slovenian: Igla mora ves čas do konca injiciranja gledati navzdol, da se zrak igli ne približa.
English: If you push the yellow button accidentally or too soon, the blue button will pop out.
Slovenian: Če po nesreči ali prezgodaj pritisnete na rumeni gumb, se sprosti modri gumb.
English: A pharmacokinetic study in non-hypoparathyroidism subjects was conducted in 6 men and 6 women with moderate hepatic impairment (Child-Pugh Classification of 7-9 [Grade B]) as compared with a matched group of 12 subjects with normal hepatic function.
Slovenian: Farmakokinetično študijo pri preskušancih brez hipoparatiroidizma so opravili pri 6 moških in 6 ženskah z zmerno okvaro jeter (7-9 na Child-Pughovi lestvici [razred B]) v primerjavi z ujemajočo se skupino 12 preskušancev z normalnim delovanjem jeter.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke zdravilne učinkovine (učinkovin)