FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 Results from 26 week basal-bolus clinical trial in patients with type 1 diabetes
Slovenian: Preglednica 3: Rezultati 26-tedenskega kliničnega preskušanja bazalno-bolusnega zdravljenja pri bolnikih s sladkorno boleznijo tipa 1 Zdravilo Fiasp v času obroka + insulin detemir
English: The safety profile in very elderly patients (≥ 75 years) or patients with moderate to severe renal impairment or hepatic impairment is limited.
Slovenian: ali bolnikih z zmerno do hudo okvaro ledvic ali jeter je omejen.
English: Disodium phosphate dihydrate Arginine hydrochloride Nicotinamide (vitamin B3) Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: nikotinamid (vitamin B3), klorovodikovo kislino/natrijev hidroksid (za uravnavo pH) in vodo za injekcije.
English: Fiasp is a mealtime insulin for subcutaneous administration up to 2 minutes before the start of the meal, with the option to administer up to 20 minutes after starting the meal (see section 5.1).
Slovenian: Uporablja se ga subkutano do 2 minuti pred začetkom obroka, lahko pa se ga uporabi tudi v 20 minutah po začetku obroka (glejte poglavje 5.1).
English: • High blood sugar (hyperglycaemia) - If your blood sugar is too high, follow the guidance for high blood sugar in section 4 ‘Possible side effects'.
Slovenian: Če se koncentracija krvnega sladkorja preveč zviša, sledite navodilom za ukrepanje v primeru visokega krvnega sladkorja, opisanim v poglavju 4, "Možni neželeni učinki";
English: • cool pale skin
Slovenian: • hladna in bleda koža,
English: Changes under the skin where you use the injection (lipodystrophy): Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy).
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) Spremembe pod kožo na mestu injiciranja zdravila (lipodistrofija): podkožno maščevje na mestu injiciranja se lahko skrči (lipoatrofija) ali zadebeli (lipohipertrofija).
English: You may see a drop of insulin at the needle tip after injecting.
Slovenian: Po injiciranju lahko na konici igle opazite kapljico insulina.
English: One cartridge contains 300 units of insulin aspart in 3 mL solution.
Slovenian: En vložek vsebuje 300 enot insulina aspart v 3 ml raztopine.
English: Each cartridge contains 3 mL of solution.
Slovenian: En vložek vsebuje 3 ml raztopine.
English: Fiasp 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin aspart in 3 mL solution.
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v vložku En vložek vsebuje 300 enot insulina aspart v 3 ml raztopine.
English: Fiasp administered postmeal showed non-inferior glycaemic control compared to NovoRapid mealtime (ETD: 0.13% [-0.01; 0.26]95% CI).
Slovenian: uporabljenim po obroku, je bila neinferiorna v primerjavi z zdravilom NovoRapid, uporabljenim ob obroku (ETD: 0,13 % [-0,01; 0,26] 95 % IZ).
English: phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid/sodium hydroxide (for pH adjustment) and water for injections
Slovenian: fenol, metakrezol, glicerol, cinkov acetat, natrijev hidrogenfosfat dihidrat, argininijev klorid,
English: Keep the vial in the carton in order to protect from light.
Slovenian: Vialo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: Important information
Slovenian: DRUGI PODATKI
English: EU/1/16/1160/006 10 pens of 3 mL
Slovenian: EU/1/16/1160/011 10 vložkov s 3 ml
English: One pre-filled pen contains 300 units of insulin aspart in 3 mL solution.
Slovenian: En napolnjen injekcijski peresnik vsebuje 300 enot insulina aspart v 3 ml raztopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Fiasp 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku raztopina za injiciranje (FlexTouch)
English: What to do if you get high blood sugar
Slovenian: Ukrepanje v primeru visokega krvnega sladkorja
English: Elderly
Slovenian: MedDRA
English: • Pioglitazone used together with insulin - This may increase the risk of heart failure, see under ‘Other medicines and Fiasp' below.
Slovenian: V tem primeru se lahko poveča tveganje za razvoj srčnega popuščanja, glejte podpoglavje "Druga zdravila in zdravilo Fiasp" v nadaljevanju;
English: Talk to your doctor, pharmacist or nurse before using Fiasp.
Slovenian: Pred začetkom uporabe zdravila Fiasp se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Median total bolus insulin dose at trial end was similar for Fiasp and NovoRapid (change from baseline to end of trial: Fiasp: 0.21→0.49 units/kg/day and NovoRapid: 0.21→0.51 units/kg/day).
Slovenian: Spremembe medianega skupnega odmerka bazalnega insulina od izhodišča do konca preskušanja so bile primerljive pri zdravilu Fiasp (0,56→0,53 enot/kg/dan) in zdravilu NovoRapid (0,52→0,48 enot/kg/dan).
English: Fiasp 100 units/mL solution for injection in cartridge Needles and cartridges must not be shared.
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v vložku Igel in vložkov se ne sme deliti z drugimi.
English: If the insulin looks cloudy, do not use the pen.
Slovenian: Če je insulin moten, injekcijskega peresnika ne smete uporabiti.
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (Pre-filled pen (FlexTouch) - without blue box)
Slovenian: ŠKATLA ZA SKUPNO PAKIRANJE (Napolnjen injekcijski peresnik (FlexTouch) - brez modrega okenca)
English: (0.56→0.53 units/kg/day) and NovoRapid (0.52→0.48 units/kg/day).
Slovenian: 0,21→0,49 enot/kg/dan in zdravilo NovoRapid: 0,21→0,51 enot/kg/dan).
English: Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin.
Slovenian: Injekcijski peresnik je napolnjen injekcijski peresnik z gumbom za nastavitev odmerka insulina, ki vsebuje 300 enot insulina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Pre-filled pen (FlexTouch))
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Napolnjen injekcijski peresnik (FlexTouch))
English: Component of a multipack, cannot be sold separately
Slovenian: Ne sme se izdajati ločeno.
English: Injection/infus ion site reactions
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja/infun diranja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (VIAL - with blue box)
Slovenian: NALEPKA NA ZUNANJEM OVOJU SKUPNEGA PAKIRANJA (VIALA - z modrim okencem)
English: Fiasp pre-filled pen and needle (example) (FlexTouch)
Slovenian: Napolnjen injekcijski peresnik Fiasp in injekcijska igla (primer)
English: Fiasp dose
Slovenian: Odmerek zdravila Fiasp
English: • you start being sick (vomiting)
Slovenian: • siljenje na bruhanje (bruhanje),
English: Fiasp 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v vložku raztopina za injiciranje (Penfill)
English: • feeling or being sick (nausea or vomiting).
Slovenian: • siljenje na bruhanje ali bruhanje.
English: Median total bolus insulin dose at trial end was similar for mealtime Fiasp, postmeal Fiasp and mealtime NovoRapid (change from baseline to end of trial: mealtime Fiasp: 0.33→0.39 units/kg/day;
Slovenian: Mediani skupni odmerek bolusnega insulina ob koncu preskušanja je bil podoben pri uporabi zdravila Fiasp v času obroka, uporabi zdravila Fiasp po obroku in pri uporabi zdravila NovoRapid v času obroka (sprememba od izhodišča do konca preskušanja: zdravilo Fiasp v času obroka:
English: NovoRapid mealtime + insulin detemir
Slovenian: Zdravilo NovoRapid v času obroka + insulin detemir
English: Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Slovenian: Pred injiciranjem insulina s števcem in kazalnikom odmerka vedno preverite, koliko enot ste izbrali.
English: The pen can dial up to a maximum of 80 units.
Slovenian: Z injekcijskim peresnikom lahko izberete največ 80 enot.
English: Contents of the pack and other information What Fiasp contains
Slovenian: Shranjevanje zdravila Fiasp Vsebina pakiranja in dodatne informacije
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACK (Pre-filled pen (FlexTouch) - with blue box)
Slovenian: ŠKATLA ZA SKUPNO PAKIRANJE (Napolnjen injekcijski peresnik (FlexTouch) - z modrim okencem)
English: If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Slovenian: Če želite spremeniti običajno prehrano, se najprej posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Solution for injection Penfill
Slovenian: POSTOPEK UPORABE Penfill
English: • Pre-dinner dose should be adjusted according to the bedtime SMPG the previous day
Slovenian: • Odmerek pred večerjo je treba prilagoditi glede na vrednost SMPG pred spanjem prejšnjega dne.
English: Fiasp administered at mealtime provided significantly lower 1-hour and 2-hour postmeal glucose increment compared to NovoRapid administrated at mealtime.
Slovenian: Pri uporabi zdravila Fiasp v času obroka je bila koncentracija glukoze 1 uro in 2 uri po obroku statistično značilno manjša kot pri uporabi zdravila NovoRapid v času obroka.
English: Pack sizes of 1, 5 or a multipack with 2 x 5 pre-filled pens of 3 mL.
Slovenian: Pakiranja z 1 vialo z 10 ml, s 5 vialami z 10 ml ali skupno pakiranje, ki vsebuje 5 pakiranj po 1 vialo z
English: Fiasp 100 units/mL solution for injection in vial insulin aspart
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v viali insulin aspart
English: Keep the cartridge in the carton in order to protect from light.
Slovenian: Vložek shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: Fiasp 100 units/mL solution for injection in vial
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v viali
English: Use only clear, colourless solution
Slovenian: Raztopino uporabite le, če je bistra in brezbarvna.
English: Injection site reactions (including rash, redness, inflammation, pain and bruising) were reported in patients treated with Fiasp (1.3% vs. 1.0% in comparator).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Fiasp, so poročali o pojavu reakcij na mestu injiciranja, vključno z izpuščajem, rdečino, vnetjem, bolečinami in modricami (1,3 % med prejemniki zdravila
English: Please read these instructions carefully before using your FlexTouch pre-filled pen.
Slovenian: Pred uporabo napolnjenega injekcijskega peresnika FlexTouch natančno preberite ta navodila.
English: Can be stored in the refrigerator (2°C8°C).
Slovenian: Pred prvo uporabo: shranjujte v hladilniku (2 °C - 8 °C).
English: What to do if you get low blood sugar
Slovenian: Ukrepanje v primeru nizkega krvnega sladkorja
English: • Push the needle straight onto the pen.
Slovenian: • Iglo potisnite naravnost na injekcijski peresnik in jo trdno privijte.
English: Fiasp can be used for CSII in pumps suitable for insulin infusion and will cover both the bolus insulin requirement (approximately 50%) and basal insulin.
Slovenian: Pri takšni uporabi zdravilo pokriva tako potrebo po bolusnem insulinu (približno 50 %) kot bazalnem insulinu.
English: In the paediatric population lipodystrophy was reported with a frequency of 2.1% for Fiasp vs. 1.6% for NovoRapid.
Slovenian: V pediatrični populaciji je bila pogostnost lipodistrofije z zdravilom Fiasp
English: EU/1/16/1160/007 1 vial of 10 mL EU/1/16/1160/008 5 vials of 10 mL
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1160/007 1 viala z 10 ml
English: Fiasp 100 units/mL solution for injection in pre-filled pen Fiasp 100 units/mL solution for injection in cartridge Fiasp 100 units/mL solution for injection in vial
Slovenian: 6.5 Vrsta ovojnine in vsebina Fiasp 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: • Pre-lunch dose should be adjusted according to the pre-dinner SMPG the previous day
Slovenian: • Odmerek pred kosilom je treba prilagoditi glede na vrednost SMPG pred večerjo prejšnjega dne.
English: • Pre-breakfast dose should be adjusted according to the pre-lunch SMPG the previous day
Slovenian: • Odmerek pred zajtrkom je treba prilagoditi glede na vrednost SMPG pred kosilom prejšnjega dne.
English: Fiasp 100 units/mL solution for injection in vial Solution for injection.
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v viali raztopina za injiciranje
English: Hold the dose button down until the dose counter shows 0.
Slovenian: Pritisnite na potisni gumb in ga držite, dokler se števec odmerka ne vrne na 0.
English: Changes in median total basal insulin dose from baseline to end of trial were comparable for Fiasp
Slovenian: Mediani skupni odmerek bolusnega insulina ob koncu preskušanja je bil podoben pri zdravilu Fiasp in zdravilu NovoRapid (sprememba od izhodišča do konca preskušanja: zdravilo Fiasp:
English: 5 x 3 mL 10 x 3 mL
Slovenian: Penfill 5 x 3 ml
English: Fiasp is a mealtime insulin.
Slovenian: Zdravilo Fiasp je insulin za uporabo v času obroka.
English: Fiasp 100 units/mL solution for injection insulin aspart
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v vložku insulin aspart
English: If you do not check the flow, you may get too little insulin or no insulin at all.
Slovenian: Če pretoka ne boste preverili, lahko injicirate premajhno količino insulina ali celo nič, posledično pa se lahko koncentracija krvnega sladkorja zviša.
English: Solution for injection FlexTouch
Slovenian: Aplikacija z napolnjenim injekcijskim peresnikom (FlexTouch)
English: Keep the cartridge in the outer carton in order to protect from light.
Slovenian: Injekcijski peresnik shranjujte pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
English: Renal and hepatic impairment
Slovenian: Okvara ledvic in jeter
English: Time to maximum concentration and total insulin aspart exposure were all comparable between the abdomen, upper arm and the thigh.
Slovenian: Pri injiciranju zdravila v predelu trebuha, nadlakti ali stegna sta čas do največje koncentracije in skupna izpostavljenost insulinu primerljivi.
English: No statistical significant difference was shown between postmeal Fiasp and mealtime NovoRapid.
Slovenian: Med uporabo zdravila Fiasp po obroku in uporabo zdravila NovoRapid v času obroka ni bilo statistično pomembne razlike.
English: Fiasp 100 units/mL solution for injection in pre-filled pen insulin aspart
Slovenian: Fiasp 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (VIAL)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: • cold sweat
Slovenian: • suha usta,
English: Excipients
Slovenian: NovoRapid.
English: • Never share your pen or your needles with other people.
Slovenian: • Injekcijskega peresnika in igel si ne smete deliti z drugimi.
English: Examples
Slovenian: Primera:
English: Pharmacotherapeutic group: Drugs used in diabetes.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje s hitrim delovanjem.
English: Close glucose monitoring is recommended during the transfer from other mealtime insulins and in the initial weeks thereafter.
Slovenian: V času prehoda in še nekaj tednov po prehodu z drugih insulinov, ki se jih uporablja v času obroka, priporočamo skrbno spremljanje koncentracije glukoze.
English: EU/1/16/1160/010 5 cartridges of 3 mL EU/1/16/1160/011 10 cartridges of 3 mL
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1160/010 5 vložkov s 3 ml
English: EU/1/04/293/008
Slovenian: EMEA/H/C/575
English: NAME OF THE MARKETING AUTHORISATION HOLDER Dompé Biotec S.p.A.
Slovenian: Imetnik dovoljenja za promet je družba Dompé Biotec S.p.A.
English: PHARMACEUTICAL PARTICULARS
Slovenian: European Medicines Agency
English: Parareg should be taken with or shortly after food.
Slovenian: Zdravilo Parareg se jemlje s hrano ali takoj po zaužitju obroka.
English: Take special care with Parareg:
Slovenian: Druge informacije o zdravilu Parareg:
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The dosage of Parareg should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Slovenian: Odmerek zdravila Parareg je treba povečevati vsakih dva do štiri tedne do vrednosti 90 mg tri- ali štirikrat dnevno, kolikor je potrebno za znižanje ravni kalcija v krvi na normalno raven.
English: Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Slovenian: Ko je vzdrževalni odmerek določen, je treba ravni kalcija meriti enkrat na mesec, ravni paratiroidnega hormona pa vsakih en do tri mesece.
English: • DO NOT take Parareg if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Parareg.
Slovenian: Zdravila Parareg ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) cinakalcet ali katero koli drugo sestavino zdravila.
English: Parareg is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Slovenian: Na voljo je v obliki svetlozelenih ovalnih tablet (30, 60 ali 90 mg).
English: • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible.
Slovenian: • za zmanjšanje hiperkalciemije (visokih ravni kalcija v krvi) pri bolnikih s paratiroidnim karcinomom (rakom obščitnic) ali pri bolnikih s primarnim hiperparatiroidizmom, pri katerih odstranitev obščitnic ni možna, ali za katere zdravnik meni, da odstranitev obščitnic zanje ni primerna.
English: This can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
Slovenian: Posledica so lahko bolečine v kosteh in sklepih ter deformacije rok in nog.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 22 October 2004
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Parareg, veljavno po vsej Evropski uniji, odobrila dne 22. oktobra 2004.
English: If you are being treated for parathyroid cancer or primary hyperparathyroidism The usual starting dose for Parareg is 30 mg (one tablet) twice per day.
Slovenian: Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom je priporočeni začetni odmerek zdravila Parareg za odrasle 30 mg dvakrat dnevno.
English: This medicine has been prescribed for you.
Slovenian: Zdravilo se dobi samo na recept.
English: Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Slovenian: Cinakalcet deluje tako, da poveča občutljivost receptorjev za zaznavanje kalcija, ki se nahajajo na obščitnicah in uravnavajo izločanje paratiroidnega hormona.
English: The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
Slovenian: Zmanjšanje ravni paratiroidnega hormona privede do znižanja ravni kalcija v krvi.
English: Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg.
Slovenian: Ravni kalcija v krvi je treba meriti pogosto in v enem tednu po vsaki prilagoditvi odmerka zdravila Parareg.
English: Eighteen of 29 patients (62 %) with parathyroid carcinoma and 15 of 17 subjects (88 %) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Slovenian: Zdravilo Parareg je privedlo do znižanja ravni kalcija v krvi za več kot 1 mg/dl pri 62 % bolnikov z rakom (pri 18 bolnikih od 29) in pri 88 % bolnikov s primarnim hiperparatiroidizmom (pri 15 bolnikih od 17).
English: The recommended starting dose for adults is 30 mg once per day.
Slovenian: Pri sekundarnem hiperparatiroidizmu je priporočeni začetni odmerek za odrasle 30 mg enkrat dnevno.
English: The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Slovenian: To je stanje, pri katerem obščitnice v vratu tvorijo preveč paratiroidnega hormona (PTH).
English: Parareg may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Slovenian: Uporablja se lahko kot del zdravljenja, ki vključuje vezalce fosfatov ali sterole vitamina D.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
English: Secondary Hyperparathyroidism
Slovenian: • za zdravljenje sekundarnega hiperparatiroidizma.
English: PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
Slovenian: Ravni paratiroidnega hormona je treba izmeriti najmanj 12 ur po zaužitju odmerka in en do štiri tedne po vsaki prilagoditvi odmerka zdravila Parareg.
English: Parareg is a light green film-coated tablet.
Slovenian: Parareg je zdravilo, ki vsebuje zdravilno učinkovino cinakalcet.
English: The active substance is cinacalcet.
Slovenian: Zdravilna učinkovina v zdravilu Parareg, cinakalcet, je kalcimimetično sredstvo.
English: This leaflet was last approved in
Slovenian: Povzetek je bil nazadnje posodobljen 06-2008.
English: Very common side effects (seen in more than 1 in 10 people taking Parareg): • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Slovenian: Najpogostejša neželena učinka zdravila Parareg pri zdravljenju sekundarnega hiperparatiroidizma (opažena pri več kot 1 izmed 10 bolnikov) sta navzeja (slabost) in bruhanje.
English: In a key study,46 patients (29 with parathyroid carcinoma and 17 with primary HPT (who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
Slovenian: Zdravilo Parareg so preučevali tudi v študiji, ki je vključevala 46 bolnikov s hiperkalciemijo, od tega 29 bolnikov s paratiroidnim karcinomom in 17 bolnikov s primarnim hiperparatiroidizmom, pri katerih ni bilo mogoče odstraniti obščitnic ali pri katerih kirurška odstranitev obščitnic ni bila učinkovita.
English: The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
Slovenian: Odmerek se prilagodi vsake dva do štiri tedne v skladu z bolnikovimi ravnmi paratiroidnega hormona do maksimalno 180 mg enkrat dnevno.
English: Investigational studies have shown that CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dl [2.1 mmol/l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Parareg večje od z njim povezanih tveganj pri zdravljenju sekundarnega hiperparatiroidizma pri dializnih bolnikih s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju in za zmanjšanje hiperkalciemije pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom, pri katerih bi bila kirurška odstranitev obščitnic indicirana na osnovi ravni kalcija v krvi, vendar pa taka odstranitev zanje ni klinično ustrezna ali je kontraindicirana.
English: Bottle: 4 years.
Slovenian: Študije so trajale šest mesecev.
English: What Parareg contains
Slovenian: Kaj je zdravilo Parareg?