FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of Natpar following subcutaneous administration in the thigh of hypoparathyroidism subjects was consistent with that observed in healthy post-menopausal women who received parathyroid hormone in the thigh and abdomen.
Slovenian: Farmakokinetika zdravila Natpar po subkutanem injiciranju v stegno pri preskušancih s hipoparatiroidizmom je bila skladna s farmakokinetiko, ki so jo opazili pri zdravih ženskah po menopavzi, ki so prejemale paratiroidni hormon v stegno in trebuh.
English: Natpar is a synthetic form of parathyroid hormone that helps you keep calcium and phosphate levels in your blood and urine at a normal level.
Slovenian: Zdravilo Natpar je sintetična oblika paratiroidnega hormona, ki pomaga vzdrževati normalne ravni kalcija in fosfata v krvi in urinu.
English: Psychiatric disorders anxiety †, insomnia*
Slovenian: Psihiatrične motnje tesnoba †, nespečnost*
English: Try again to slowly screw down the cartridge.
Slovenian: Vložek poskušajte počasi priviti navzdol.
English: Suggested adjustments to Natpar, active vitamin D and calcium supplements based on serum calcium levels are provided below:
Slovenian: Spodaj so na voljo predlagane prilagoditve zdravila Natpar, aktivnega vitamina D in kalcijevih dopolnil, ki temeljijo na koncentracijah kalcija v serumu:
English: In addition, 87% (73/84) of patients treated with Natpar showed a ≥50% reduction in oral active vitamin D versus 45% (18/40) in the placebo group.
Slovenian: Poleg tega je 87 % (73/84) bolnikov, zdravljenih z zdravilom Natpar, izkazalo zmanjšanje peroralnega aktivnega vitamina D za ≥ 50 % v primerjavi s 45 % (18/40) v skupini, ki je prejemala placebo.
English: In the clinical studies, these reactions were generally mild to moderate in severity and transient, and were managed with adjustments of Natpar, calcium and/or active vitamin D doses (see sections 4.4 and 5.1).
Slovenian: V kliničnih študijah so bili ti učinki večinoma blagi do zmerni in prehodni, obravnavali pa so jih s prilagoditvami odmerkov zdravila Natpar, kalcija in/ali aktivnega vitamina D (glejte poglavji 4.4 in 5.1).
English: A decision must be made whether to discontinue breast-feeding or to discontinue therapy with Natpar, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prekinitvijo zdravljenja z zdravilom Natpar, pri čemer je treba pretehtati koristi dojenja za otroka in koristi zdravljenja za mater.
English: In these studies, Natpar was self-administered, with daily doses ranging from 25 to 100 micrograms per subcutaneous injection.
Slovenian: V teh študijah so si bolniki sami odmerjali zdravilo Natpar v dnevnih odmerkih od 25 do 100 mikrogramov na subkutano injekcijo.
English: There is a ‘soft' click when you push the blue button before you hear the ‘hard' click, which indicates that you have begun to deliver the medicine.
Slovenian: Ko pritisnete modri gumb in preden boste zaslišali »trdi« klik, boste zaslišali »mehki« klik, kar pomeni, da se je dovajanje zdravila začelo.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: If pre-dose serum calcium is >2.25 mmol/L, a starting dose of 25 micrograms can be considered.
Slovenian: Če je raven kalcija v serumu pred odmerkom > 2,25 mmol/l, pride v poštev začetni odmerek 25 mikrogramov.
English: There were no apparent differences in the serum total calcium concentration-time profiles between the 2 hepatic function groups.
Slovenian: V profilih skupne serumske koncentracije kalcija v času ni bilo očitnih razlik med skupinama preskušancev z različnim delovanjem jeter.
English: The glass dual-chamber cartridge inside the pen is made from type I glass with 2 bromobutyl rubber stoppers and a crimp cap (aluminium) with a bromobutyl rubber seal.
Slovenian: Vložek z dvema komorama, ki je shranjen v peresniku, je izdelan iz stekla tipa I z 2 gumijastima zamaškoma iz bromobutilne gume in objemno zaporko (iz aluminija) s tesnilom iz bromobutilne gume.
English: Natpar is given as a subcutaneous (under the skin) injection every day, using a pen to help you inject your medicine.
Slovenian: Zdravilo Natpar se daje vsak dan v obliki subkutane (podkožne) injekcije s peresnikom, ki vam pomaga injicirati zdravilo.
English: Effect on mineral metabolism
Slovenian: Vpliv na presnovo mineralov
English: Prior to initiating and during treatment with Natpar:
Slovenian: Pred začetkom zdravljenja z zdravilom Natpar in med njim:
English: Hypercalcaemia commonly occurred during the titration period, during which doses of oral calcium, active vitamin D, and Natpar were being adjusted.
Slovenian: Hiperkalciemija je pogosto nastopila med obdobjem titriranja, ko so prilagajali odmerke peroralnega kalcija, aktivnega vitamina D in zdravila Natpar.
English: Consider reducing or stopping Natpar and re-assess by means of serum calcium measurement
Slovenian: Razmislite o zmanjšanju odmerka ali prekinitvi zdravljenja z zdravilom Natpar in znova ocenite z meritvijo kalcija v serumu.
English: The MAH should collect data on clinical hard endpoints (bone, soft tissue calcifications and renal function), together with data on hypercalciuria and quality of life.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zbrati podatke o osnovnih kliničnih opazovanih dogodkih (kosti, kalcifikacije mehkih tkiv in delovanje ledvic), skupaj s podatki o hiperkalciuriji in kakovosti življenja.
English: • Check that the yellow dose counter lines up with the black dot (See Figure E).
Slovenian: • Preverite, ali je rumeni števec odmerkov poravnan s črno piko (glejte sliko E).
English: The calcium-raising effect of Natpar may diminish over time in some patients.
Slovenian: Učinek zdravila Natpar na povečanje koncentracije kalcija se lahko pri nekaterih bolnikih sčasoma zmanjša.
English: • Write today's date in the space next to “Date Mixed”.
Slovenian: • v prostor poleg »Datum mešanja« vpišite današnji datum;
English: Natpar is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - who are receiving or who have previously received radiation therapy to the skeleton - with skeletal malignancies or bone metastases - who are at increased baseline risk for osteosarcoma such as patients with Paget's disease of bone or hereditary disorders - with unexplained elevations of bone-specific alkaline phosphatase - with pseudohypoparathyroidism.
Slovenian: Zdravilo Natpar je kontraindicirano pri bolnikih: - ki so preobčutljivi na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; - ki se zdravijo ali so se v preteklosti zdravili z obsevanjem okostja; - z malignimi boleznimi kosti ali zasevki v kosteh; - ki imajo večje izhodiščno tveganje za osteosarkom, kot so bolniki s Pagetovo boleznijo kosti ali dednimi boleznimi; - z nepojasnjenimi zvišanimi ravnmi za kosti značilne alkalne fosfataze; - s psevdohipoparatiroidizmom.
English: 6 • To mix the medicine, slowly screw down the cartridge in a clockwise direction (See “Before” figure) until you hear and feel a “click” and the cartridge will no longer turn (See “After” figure).
Slovenian: 6 • Da zdravilo zmešate, počasi privijajte vložek navzdol v smeri urnega kazalca (glejte sliko »Prej«), dokler ne zaslišite klika in se vložek več ne obrača (glejte sliko »Potem«).
English: When you first start using Natpar, a trainer will guide you through how to mix your Natpar pen and give your injections.
Slovenian: Ko začnete prvič uporabljati peresnik Natpar, vas bo inštruktor vodil skozi postopek mešanja peresnika z zdravilom Natpar in postopek injiciranja.
English: Signs and symptoms potentially associated with hypocalcaemia that were observed in the clinical trials.
Slovenian: Znaki in simptomi, ki bi bili lahko povezani s hipokalciemijo, opaženi v kliničnih preskušanjih.
English: There are no data from the use of Natpar in pregnant women.
Slovenian: Podatkov o uporabi zdravila Natpar pri nosečnicah ni.
English: • increased level of calcium in your urine*
Slovenian: • zvišana raven kalcija v urinu*
English: A decision must be made whether to initiate or discontinue treatment with Natpar during pregnancy taking into account the known risks of therapy versus the benefit for the woman.
Slovenian: Pri sprejemanju odločitve o uvedbi ali ukinitvi zdravljenja z zdravilom Natpar med nosečnostjo je treba upoštevati znana tveganja pri zdravljenju v primerjavi s pričakovanimi koristmi za mater.
English: Peak plasma concentrations (mean Tmax) of Natpar occur within 5 to 30 minutes and a second usually smaller peak at 1 to 2 hours.
Slovenian: Najvišje plazemske koncentracije (povprečna vrednost Tmax) zdravila Natpar nastopijo v 5 do 30 minutah, z drugim, običajno manjšim vrhom po 1 do 2 urah.
English: This step primes your pen by removing the air from the cartridge.
Slovenian: S tem korakom iz vložka odstranite zrak in aktivirate svoj peresnik.
English: Natpar is suitable for patient self-administration.
Slovenian: Zdravilo Natpar je primerno za samoodmerjanje.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 2 pre-filled pens
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje 2 napolnjena injekcijska peresnika
English: Treatment with Natpar produces a decrease in urinary calcium excretion by 13 and 23% (50 and 100 microgram dose, respectively) to a nadir in the 3 to 6 hour time point, which returns to pre-dosing levels by 16 to 24 hours.
Slovenian: Zdravljenje z zdravilom Natpar povzroči zmanjšanje izločanja kalcija z urinom za 13 % pri odmerku 50 mikrogramov in 23 % pri odmerku 100 mikrogramov) z najnižjo točko po 3 do 6 urah in vrnitvijo na ravni pred odmerkom v 16 do 24 urah.
English: • Screw the needle straight onto the cartridge (See “Before” figure) until it is tightly attached (See “After” figure).
Slovenian: • Iglo privijte naravnost na vložek (glejte sliko »Prej«), dokler ni tesno pritrjena (glejte sliko »Potem«).
English: The aim of treatment with Natpar is to achieve a pre-dose serum calcium concentration of 2.0-2.25 mmol/L and an 8-12 hour post-dose serum calcium concentration <2.55 mmol/L.
Slovenian: Cilj zdravljenja z zdravilom Natpar je doseganje koncentracije kalcija v serumu pred odmerjanjem 2,0-2,25 mmol/l in koncentracije kalcija v serumu 8-12 ur po odmerjanju < 2,55 mmol/l.
English: In patients using calcium supplements, maintain calcium supplement dose.
Slovenian: Pri bolnikih, ki jemljejo kalcijeva dopolnila, ohranite odmerek teh dopolnil.
English: The response of serum calcium concentration to administration of Natpar should be monitored at intervals to detect this and the diagnosis of tachyphylaxis considered.
Slovenian: Občasno je treba spremljati odziv koncentracije kalcija na uporabo zdravila, da to zaznate in razmislite o diagnozi tahifilaksije.
English: Always store your pen in the refrigerator between 2°C to 8°C.
Slovenian: Peresnik vedno shranjujte v hladilniku pri temperaturi od 2 °C do 8 °C.
English: In patients using Natpar concomitantly with cardiac glycosides (such as digoxin or digitoxin), monitor serum calcium and cardiac glycoside levels and patients for signs and symptoms of digitalis toxicity (see section 4.5).
Slovenian: Pri bolnikih, ki uporabljajo zdravilo Natpar sočasno s srčnimi glikozidi (npr. digoksinom ali digitoksinom), je treba spremljati ravni kalcija in srčnih glikozidov v serumu ter znake in simptome toksičnosti digitalisa (glejte poglavje 4.5).
English: EXP Discard mixed pen after 14 days.
Slovenian: EXP Peresnik z zmešanim zdravilom zavrzite po 14 dneh.
English: Metabolism and nutrition disorders hypercalcaemia, hypocalcaemia hypomagnesaemia tetany
Slovenian: Presnovne in prehranske motnje hiperkalciemija, hipokalciemija hipomagneziemija tetanija
English: The mean maximum concentration (Cmax) of PTH following 100 micrograms parathyroid hormone (rDNA) in subjects with mild-to-moderate renal impairment (CLcr 30 to 80 mL/min) was approximately 23% higher than that observed in subjects with normal renal function.
Slovenian: Povprečna najvišja koncentracija (Cmax) PTH po 100 mikrogramih paratiroidnega hormona (rDNA) pri osebah z blago do zmerno okvaro ledvic (CLcr od 30 do 80 ml/min) je bila za približno 23 % višja kot pri preskušancih z normalnim delovanjem ledvic.
English: The maximum mean increases of serum calcium, which occurred at 12 hours, were approximately 0.125 mmol/L and 0.175 mmol/L with the 50 micrograms and 100 micrograms dose, respectively.
Slovenian: Najvišja povprečna zvišanja ravni kalcija v serumu, ki so nastopila po 12 urah, so bila pri odmerku 50 mikrogramov približno 0,125 mmol/l, pri odmerku 100 mikrogramov pa 0,175 mmol/l.
English: These side effects may be related to low level of calcium in your blood.
Slovenian: Ti neželeni učinki so lahko povezani z nizkimi ravnmi kalcija v krvi.
English: A minimal amount of Natpar is excreted in the milk of lactating rats.
Slovenian: V mleko podgan v laktaciji se izloča zelo majhna količina zdravila Natpar.
English: Figure L The setup of your pen is complete.
Slovenian: Slika L Priprava peresnika je končana.
English: In the placebo-controlled study, 9.5% (8/84) Natpar-treated patients and 15% (6/40) placebo-treated patients experienced an injection site reaction, all of which were mild or moderate in severity.
Slovenian: V študiji, nadzorovani s placebom, je 9,5 % (8/84) bolnikov, zdravljenih z zdravilom Natpar, in 15 % (6/40) bolnikov, ki so prejemali placebo, doživelo reakcijo na mestu injiciranja.
English: Calcium supplement
Slovenian: Kalcijevo dopolnilo
English: If needed, clean the pen by wiping the outside with a cloth dampened with water.
Slovenian: Peresnik po potrebi očistite tako, da zunanjost obrišete s krpo, navlaženo z vodo.
English: Natpar is a hormone replacement for adults with under-active parathyroid glands, a condition known as ‘hypoparathyroidism'.
Slovenian: Zdravilo Natpar je hormonski nadomestek za zdravljenje odraslih s premalo delujočimi obščitničnimi (paratiroidnimi) žlezami, tj. boleznijo, znano kot hipoparatiroidizem.
English: Clinical studies with Natpar did not include sufficient numbers of subjects aged 65 and over to determine whether response in these subjects is different from younger subjects.
Slovenian: Klinične študije z zdravilom Natpar niso vključevale zadostnega števila preskušancev, starih 65 let in več, da bi ugotovili, ali se odzivajo drugače kot mlajši.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: 8 • Use an alcohol wipe to clean the injection site area of the thigh (See Figure O).
Slovenian: 8 • Obrišite mesto za injiciranje na stegnu z alkoholno blazinico (glejte sliko O).
English: If the liquid is cloudy, is coloured, or contains visible particles, do not use your medicine.
Slovenian: Če je tekočina motna, obarvana ali vsebuje vidne delce, zdravila ne uporabite.
English: Do not throw away any medicines via household waste.
Slovenian: Zdravila ne smete odvreči med gospodinjske odpadke.
English: *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone.
Slovenian: * Paratiroidni hormon (rDNA), pridobljen v E. coli z uporabo tehnologije rekombinantne DNA, je identičen zaporedju 84 aminokislin endogenega humanega paratiroidnega hormona.
English: If post-dose serum calcium is >ULN, then first reduce active vitamin D and calcium supplements and monitor progress.
Slovenian: Če je koncentracija kalcija v serumu po odmerjanju > zgornjo mejo normalne vrednosti (ULN - upper limit of normal), najprej zmanjšajte aktivni vitamin D in kalcijeva dopolnila ter spremljajte napredovanje zdravljenja.
English: 5 • Hold the pen body with the needle pointing straight up towards the ceiling (See Figure G).
Slovenian: 5 • Telo peresnika držite tako, da gleda igla naravnost proti stropu (glejte sliko G).
English: Natpar is a protein that is not metabolised by and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g., cytochrome P450 isoenzymes).
Slovenian: Zdravilo Natpar je beljakovina, ki je jetrni mikrosomski encimi za presnovo zdravil (npr. izoencimi citokroma P450) ne presnavljajo in jih tudi ne zavira.
English: 18 • Put the pen cap back on your pen by pushing the cap until it clicks.
Slovenian: 18 • Pokrovček peresnika potisnite nazaj na peresnik tako, da pokrovček pritiskate, dokler ne klikne.
English: • headaches*
Slovenian: • glavoboli*
English: The mean percent change from baseline in oral calcium was -51.8% (SD 44.6) in subjects receiving Natpar compared to 6.5% (SD 38.5) in the placebo group (p<0.001).
Slovenian: Povprečna sprememba odstotka glede na izhodiščno vrednost v peroralnih odmerkih kalcija je bila -51,8 % (SD 44,6) pri preskušancih, ki so prejemali zdravilo Natpar, v primerjavi s 6,5 % (SD 38,5) v skupini s placebom (p < 0,001).
English: Increase
Slovenian: Povečajte
English: There are no data on the effects of Natpar on human fertility.
Slovenian: O vplivu zdravila Natpar na plodnost pri ljudeh ni podatkov.
English: Overdose can cause hypercalcaemia, the symptoms of which may include heart palpitations, ECG changes, hypotension, nausea, vomiting, dizziness and headache.
Slovenian: Preveliko odmerjanje lahko povzroči hiperkalciemijo, katere simptomi lahko vključujejo palpitacije, spremembe na EKG, hipotenzijo, navzeo, bruhanje, omotico in glavobol.
English: You must use a new pen needle for each injection.
Slovenian: Za vsako injekcijo morate uporabiti novo iglo peresnika.
English: If you experience any of these side effects, contact your doctor right away.
Slovenian: Če se pojavi kateri koli izmed teh neželenih učinkov, se takoj posvetujte z zdravnikom.
English: Breast-feeding It is unknown whether Natpar is excreted in human milk.
Slovenian: Dojenje Ni znano, ali se zdravilo Natpar izloča v materino mleko.
English: At the end of treatment, 46/84 (54.8%) patients treated with Natpar achieved the primary endpoint versus 1/40 (2.5%) with placebo (p<0.001).
Slovenian: Na koncu zdravljenja je 46/84 (54,8 %) bolnikov, zdravljenih z zdravilom Natpar, doseglo primarni opazovani dogodek v primerjavi z 1/40 (2,5 %) tistih, ki so prejemali placebo (p < 0,001).
English: Clinical studies of Natpar did not include sufficient numbers of subjects aged 65 and over to determine whether response in these subjects is different from younger subjects.
Slovenian: Klinične študije zdravila Natpar niso vključevale zadostnega števila preskušancev, starih 65 let in več, za ugotovitev, ali se odzivajo drugače kot mlajši.
English: Temporary or permanent discontinuation of Natpar treatment must be accompanied by monitoring of serum calcium levels and adjustment, as necessary, of exogenous calcium and/or active vitamin D (see section 4.4).
Slovenian: Začasno ali trajno prekinitev zdravljenja z zdravilom Natpar morata spremljati preverjanje ravni kalcija v serumu in po potrebi prilagoditev eksogenega kalcija in/ali aktivnega vitamina D (glejte poglavje 4.4).
English: What if I see air bubbles floating in the medicine or the medicine appears foamy after mixing?
Slovenian: Kaj naj naredim, če vidim v zdravilu zračne mehurčke ali se zmešano zdravilo speni?
English: • Do NOT use a pen that has been frozen.
Slovenian: • Peresnika, ki je bil zamrznjen, NE uporabljajte.
English: Hypersensitivity reactions, (dyspnoea, angioedema, urticaria, rash)
Slovenian: Preobčutljivostne reakcije (dispneja, angioedem, urtikarija, izpuščaj)
English: - if you are having or have had radiation therapy to the skeleton - if you have cancer of the bones or other cancer that has spread to your bones - if you are at increased risk of developing a bone cancer called osteosarcoma (for instance, if you have Paget's disease or other bone diseases) - if a blood test shows you have unexplained increases in bone alkaline phosphatase - if you have pseudohypoparathyroidism, a rare condition where the body does not respond adequately to the parathyroid hormone produced by the body
Slovenian: Ne uporabljajte zdravila Natpar - če ste alergični na paratiroidni hormon ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če se zdravite ali ste se v preteklosti zdravili z obsevanjem okostja; - če imate raka kosti ali drugo obliko raka, ki se je razširil na kosti; - če imate povečano tveganje za razvoj kostnega raka, imenovanega osteosarkom (na primer, če imate Pagetovo bolezen ali druge bolezni kosti); - če krvna preiskava pokaže, da imate nepojasnjeno zvišano raven kostne alkalne fosfataze; - če imate psevdohipoparatiroidizem, redko bolezen, pri kateri se telo neustrezno odziva na paratiroidni hormon, ki nastaja v telesu.
English: • If the liquid is cloudy, is coloured, or contains visible particles, do not use your medicine.
Slovenian: • Če je tekočina motna, obarvana ali vsebuje vidne delce, zdravila ne uporabite.
English: No studies were conducted in patients on renal dialysis.
Slovenian: Pri bolnikih na dializi niso opravili nobenih študij.
English: Following a single 100 micrograms subcutaneous dose, the mean Cmax and baseline-corrected Cmax values were 18% to 20% greater in the moderately impaired subjects than in those with normal function.
Slovenian: Po enem subkutanem odmerku 100 mikrogramov so bile povprečne vrednosti Cmax in vrednosti Cmax, popravljene glede na izhodišče, pri preskušancih z zmerno okvaro za 18 % do 20 % višje kot pri tistih z normalnim delovanjem.
English: • If needed, clean your pen by wiping the outside with a cloth dampened with water.
Slovenian: • Po potrebi peresnik očistite tako, da zunanjost obrišete s krpo, navlaženo z vodo.
English: Downward titration to a minimum of 25 micrograms can occur at any time.
Slovenian: Odmerek lahko kadar koli zmanjšate na do 25 mikrogramov.
English: • If the pen is empty (there is no liquid remaining, or the dose counter shows “0”) or today is the “Discard On” date noted on your Medicine Tracker, discard the pen and follow the instructions in “Getting Started” (Section A) with a new pen.
Slovenian: • Če je peresnik prazen (v njem ni več tekočine ali pa števec odmerkov kaže »0«) ali je danes dan »Zavrzite dne«, zabeležen na Sledilniku zdravila, peresnik zavrzite in sledite navodilom v »Kako začeti« (poglavje A) z novim peresnikom.
English: 9 • Hold the pen with the needle pointing straight down and tap the cartridge with the tip of your fingernail 3 to 5 times, or until air bubbles move away from the needle (See Figure P).
Slovenian: 9 • Peresnik držite tako, da je igla obrnjena naravnost navzdol in po vložku potrkajte s konico nohta 3- do 5-krat ali dokler se zračni mehurčki ne odmaknejo od igle (glejte sliko P).
English: Parathyroid hormone (rDNA) is injected using a pre-filled pen.
Slovenian: Paratiroidni hormon (rDNA) se injicira z napolnjenim injekcijskim peresnikom.
English: For any drug that affects serum calcium levels (e.g., lithium, thiazides), patients' serum calcium levels should be monitored.
Slovenian: Pri uporabi katerega koli zdravila, ki vpliva na koncentracijo kalcija v serumu (npr. litij, tiazidi), je treba spremljati bolnikovo koncentracijo kalcija v serumu.
English: It is normal to see small air bubbles in the liquid.
Slovenian: Normalno je, da v tekočini vidite majhne zračne mehurčke.
English: 11 • Press the yellow button until the blue button pops out (See Figure R).
Slovenian: 11 • Pritiskajte rumeni gumb, dokler se ne sprosti modri gumb (glejte sliko R).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, mutagenosti, toksičnosti za plodnost in razmnoževanje na splošno ne kažejo posebnega tveganja za človeka.
English: Figure X
Slovenian: Slika X
English: Investigations anti-PTH antibody positive, blood 25-hydroxycholecalcif erol decreased vitamin D decreased
Slovenian: Preiskave pozitiven rezultat testa za protitelesa proti PTH, znižanje ravni 25-hidroksiholekalcifer ola v krvi