natgillin/translations-raw huggingface dataset:
The other ingredients are L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, and water for injections.
Druge sestavine so L-histidin, D-sorbitol (E420), polisorbat 80, L-metionin, 10 %, klorovodikova kislina in voda za injekcije.
What CRYSVITA is and what it is used for What you need to know before you use CRYSVITA How to use CRYSVITA
Kaj je zdravilo CRYSVITA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo CRYSVITA Kako uporabljati zdravilo CRYSVITA Možni neželeni učinki
United Kingdom allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Velika Britanija allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
If fasting serum phosphate is within the reference range for age, the same dose should be maintained.
Če so serumski fosfati na tešče v referenčnih mejah za bolnikovo starost, je potrebno vzdrževati isti odmerek.
Your serum parathyroid hormone level will also be checked from time to time.
Občasno vam bodo kontrolirali tudi raven serumskega paratiroidnega hormona.
It is possible that CRYSVITA could cause dizziness and affect you being able to ride a bike, use any tools or machines or to drive.
Vpliv na sposobnost upravljanja vozil, vožnje s kolesom in upravljanja strojev Možno je, da bi zdravilo CRYSVITA lahko povzročilo omotico in vplivalo na vašo sposobnost vožnje s kolesom, uporabe orodja ali strojev ali upravljanja motornih vozil.
CRYSVITA is used to treat X-linked hypophosphataemia (XLH).
Zdravilo CRYSVITA se uporablja za zdravljenje na kromosom X vezane hipofosfatemije (X-linked hypophosphatemia - XLH).
Radiographic Global Impression of Change (RGI-C) As a complement to the RSS system to assess the severity of paediatric rickets in Study UX023CL201, the RGI-C is a relative rating scale that compares a patient's rickets before and after treatment utilising a 7-point ordinal scale to evaluate change in the same abnormalities rated in the RSS.
Rentgenološki globalni vtis sprememb (Radiographic Global Impression of Change - RGI-C) RGI-C, dopolnilo sistemu RSS za ocenjevanje izraženosti pediatričnega rahitisa v študiji UX023CL201, je lestvica relativnega ocenjevanja, ki primerja bolnikov rahitis pred zdravljenjem in po njem, uporablja pa ordinatno lestvico s 7 točkami za ocenjevanje istih abnormalnosti, ki se ocenjujejo z RSS.
With the subcutaneous route of administration, a direct PK-PD relationship between serum burosumab concentrations and increases in serum phosphate concentration is observed and well described by an Emax/EC50 model.
Pri subkutani poti uporabe zdravila so ugotovili neposredno FK-FD razmerje med koncentracijo burosumaba v serumu in zvišanjem serumske koncentracije fosfatov, ki ga dobro opisuje model Emax/EC50.
Rickets Severity Score (RSS)
Ocena izraženosti rahitisa (RSS)
Burosumab may have a minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Burosumab ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
The recommended starting dose is 0.4 mg/kg of body weight and the normal maintenance dose is 0.8 mg/kg burosumab given every two weeks.
Priporočeni začetni odmerek je 0,4 mg/kg telesne mase, normalni vzdrževalni odmerek pa je 0,8 mg/kg.
Periodic measurement of serum parathyroid hormone is advised.
Priporočljivo je redno določanje serumskega paratiroidnega hormona.
CRYSVITA contains sorbitol This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Zdravilo CRYSVITA vsebuje sorbitol To zdravilo vsebuje 45,91 mg sorbitola na vialo, kar je enako 45,91 mg/ml.
To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age.
Za zmanjšanje tveganja ektopične mineralizacije je priporočljivo, da se vzame za cilj spodnji del normalnega referenčnega razpona serumskih fosfatov na tešče za starost.
Burosumab is a recombinant human monoclonal antibody (IgG1) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23).
Burosumab je rekombinantno človeško monoklonsko protitelo (IgG1), ki se veže na fibroblastni rastni faktor 23 (fibroblast growth factor 23 - FGF23) in zmanjšuje njegovo aktivnost.
Burosumab must be discontinued if serious hypersensitivity reactions occur and appropriate medical treatment should be initiated.
Če se pojavijo resne preobčutljivostne reakcije, morate ukiniti burosumab in uvesti ustrezno zdravljenje.
Fasting serum phosphate should be measured 4 weeks after dose adjustment.
Serumske fosfate na tešče je treba meriti 4 tedne po prilagoditvi odmerka.
At initiation, fasting serum phosphate concentration should be below the reference range for age (see section 4.3).
Ob uvedbi mora biti koncentracija serumskih fosfatov na tešče pod referenčno vrednostjo za starost (glejte poglavje 4.3).
In preclinical studies, ectopic mineralisation has been observed in normal animals, most frequently in the kidney, given burosumab at doses that resulted in serum phosphate concentrations greater than 2.58 mmol/L (see section 5.3).
V predkliničnih študijah so opazili ektopično mineralizacijo pri normalnih živalih, najpogosteje v ledvicah, ki so jim dajali burosumab v odmerkih, ki so povzročili koncentracije serumskih fosfatov, višje od 2,58 mmol/l (glejte poglavje 5.3).
All patients had radiographic evidence of rickets at baseline and twelve patients had received oral phosphate and vitamin D analogues for a mean (SD) duration of 16.7 (14.4) months.
Vsi bolniki so imeli v izhodišču rentgenološke znake rahitisa in dvanajst bolnikov je prejemalo peroralni fosfat in analoge vitamina D povprečno (SD) 16,7 (14,4) meseca.
Bone-derived serum alkaline phosphatase content was 165 (52) μg/L [mean (SD)] at Baseline and 115 (31) μg/L at Week 64 (mean change: -28.5%).
Vsebnost serumske alkalne fosfataze, pridobljene iz kostnega tkiva, je bila 165 (52) μg/l [srednja vrednost (SD)] v izhodišču in 115 (31) μg/l v 64. tednu (povprečna sprememba: -28,5 %).
Burosumab has been administered in paediatric clinical trials without dose limiting toxicity using doses up to 2.0 mg/kg body weight with a maximal dose of 90 mg every two weeks.
V pediatričnih kliničnih preskušanjih so dajali burosumab, ne da bi se pojavila toksičnost, ki bi omejevala odmerke, v odmerkih do 2,0 mg/kg telesne mase z največjim odmerkom 90 mg na dva tedna.
In Study UX023-CL205, mean (SD) fasting serum phosphate concentration increased from 0.81 (0.092) mmol/L at baseline to 1.12 (0.158) mmol/L at Week 40.
V študiji UX023-CL205 se je srednja (SD) serumska koncentracija fosfatov na tešče zvišala z 0,81 (0,092) mmol/l v izhodišču na 1,12 (0,158) mmol/l v 40. tednu.
Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).
Serumski fosfati na tešče nad normalno zgornjo mejo za starost zaradi tveganja hiperfosfatemije (glejte poglavje 4.4).
Concurrent administration with oral phosphate, vitamin D analogues (see section 4.5).
Sočasna uporaba s peroralnim fosfatom ali analogi vitamina D (glejte poglavje 4.5).
In the reproductive and developmental toxicology study performed in pregnant cynomolgus monkeys, moderate mineralisation of the placenta was seen in pregnant animals given 30 mg/kg of burosumab and occurred in animals with peak serum phosphate concentration greater than approximately 2.58 mmol/L.
V študiji reproduktivne in razvojne toksikologije, ki so jo opravili na brejih opicah cinomolgus, so ugotovili zmerno mineralizacijo posteljice pri brejih živalih, ki so jim dali 30 mg/kg burosumaba in ki se je pojavila pri živalih, ki so imele največje koncentracije serumskih fosfatov, ki so bile večje od približno 2,58 mmol/l.
Nearly all patients had radiographic evidence of rickets at baseline and had received prior oral phosphate and vitamin D analogues for a mean (SD) duration of 7 (2.4) years.
Skoraj vsi bolniki so imeli v izhodišču rentgenološke znake rahitisa in so predhodno prejemali peroralni fosfat in analoge vitamina D povprečno (SD) 7 (2,4) let.
After 40 weeks of treatment with burosumab, mean total RSS improved from 2.92 (1.367) at baseline to 1.19 (0.522), corresponding to a change from baseline in LS mean (SE) change of -1.73 (0.132) (p<0.0001).
Po 40 tednih zdravljenja z burosumabom se je srednja celotna RSS izboljšala od 2,92 (1,367) v izhodišču na 1,19 (0,522), kar je ustrezalo spremembi od izhodišča povprečne (SE) spremembe po metodi najmanjših kvadratov na -1,73 (0,132) (p < 0,0001).
For subcutaneous use.
Način uporabe Za subkutano uporabo.
How to use CRYSVITA
Kako uporabljati zdravilo CRYSVITA
• you already have a high level of phosphate in your blood (“hyper-phosphataemia”)
• če že imate visoko koncentracijo fosfatov v krvi (“hiperfosfatemija”); • če imate hudo bolezen ledvic ali odpoved ledvic.
Other medicines and CRYSVITA Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The clearance of burosumab is dependent on body weight and estimated to be 0.290 L/day and 0.136 L/day in a typical adult (70 kg) and paediatric (30 kg) XLH patient, respectively, with corresponding disposition half-life (t1/2) in the serum of approximately 19 days.
Ocenjujejo, da je pri tipičnem odraslem bolniku (70 kg) z XLH 0,290 l/dan, pri tipičnem pediatričnem bolniku (30 kg) z XLH pa 0,136 l/dan, temu ustrezna razpolovna doba (t1/2) v serumu pa je približno 19 dni.
In the group that received burosumab every 2 weeks, mean (SD) serum phosphate concentration increased from 0.77 (0.13) mmol/L at baseline, to 1.07 (0.13) mmol/L at Week 40 and was maintained to Week 64 at 1.08 (0.14) mmol/L.
V skupini, ki je prejemala burosumab vsaka 2 tedna, se je srednja (SD) serumska koncentracija fosfatov zvišala z 0,77 (0,13) mmol/l v izhodišču na 1,07 (0,13) mmol/l v 40. tednu, zvišanje je trajalo do 64. tedna pri 1,08 (0,14) mmol/l.
The severity of paediatric rickets in Study UX023-CL201 was measured using the RSS, a radiographic scoring method developed originally to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, concavity, and the proportion of the growth plate affected.
Ocena izraženosti rahitisa (Rickets Severity Score - RSS) Izraženost pediatričnega rahitisa v študiji UX023-CL201 so merili z RSS, rentgenološko metodo ocenjevanja, ki so jo v začetku razvili za ocenjevanje izraženosti prehranskega rahitisa v zapestjih in kolenih na podlagi stopnje metafizne obrabe, konkavnosti in deleža prizadete rastne plošče.
Burosumab was detected in serum from fetuses indicating that burosumab was transported across the placenta to the fetus.
Burosumab so dokazali v serumu plodov, kar kaže na to, da je burosumab prešel skozi placento v plod.
MedDRA System Organ Class
Organski sistemi po MedDRA Skupina pogostnosti
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Piramal Healthcare UK Limited
Each vial contains either 10, 20 or 30 mg of burosumab.
Ena viala vsebuje 10 mg, 20 mg ali 30 mg burosumaba.
Serum parathyroid hormone
Serumski paratiroidni hormon
In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 4 years old, the MAH should submit the updated results of study UX023-CL205, an open-label, phase 2 study to assess the safety, pharmacodynamics, and efficacy of KRN23 in paediatric patients with XLH.
Do bo imetnik dovoljenja za promet z zdravilom potrdil učinkovitost in varnost zdravila Crysvita za zdravljenje na kromosom X vezane hipofosfatemije (XLH) pri otrocih, starih od 1 do 4 leta, bo moral predložiti posodobljene rezultate študije UX023-CL205, odprte študije 2. faze za oceno varnosti, farmakodinamike in učinkovitosti KRN23 pri pediatričnih bolnikih z XLH.
Radiographic Global Impression of Change (RGI-C) After 40 weeks of treatment with burosumab, the LS mean (SE) RGI-C Global score was +2.33 (0.08) in all 13 patients (p < 0.0001) demonstrating healing of rickets.
Po 40 tednih zdravljenja z burosumabom je bil povprečni (SE) rezultat globalne ocene RGI-C po metodi najmanjših kvadratov +2,33 (0,08) pri vseh 13 bolnikih (p < 0,0001), kar kaže na ozdravitev rahitisa.
Mean (SD) serum total alkaline phosphatase activity was 459 (105) U/L at baseline and decreased to 369 (76) U/L at Week 64 (-19.6%, p < 0.0001).
Srednja (SD) serumska skupna aktivnost alkalne fosfataze je bila 459 (105) e/l v izhodišču, do 64. tedna se je znižala na 369 (76) e/l (-19,6 %, p < 0,0001).
Burosumab should be injected in the arm, abdomen, buttock or thigh.
Burosumab je treba injicirati v nadlaket, trebuh, zadnjico ali stegno.
In paediatric Study UX023-CL201, 52 paediatric patients aged 5 to 12 years (mean 8.5 years; SD 1.87) with XLH were treated for 64 weeks.
V pediatrični študiji UX023-CL201 so 64 tednov zdravili 52 pediatričnih bolnikov z XLH, starih 5 to 12 let (povprečje 8,5 let; SD 1,87).
In paediatric Study UX023-CL205, burosumab was evaluated in 13 XLH patients, aged 1 to 4 years (mean 2.9 years; SD 1.1) for 40 weeks.
V pediatrični študiji UX023-CL205 so 40 tednov ocenjevali burosumab pri 13 bolnikih z XLH, starih od 1 do 4 leta (povprečje 2,9 leta; SD 1,1).
In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 12 years old, the MAH should conduct and submit the results of study UX023-CL301, a randomized, open-label, phase 3 Study to assess efficacy, safety and pharmacodynamics of the anti-FGF23 antibody, KRN23, versus oral phosphate and active vitamin D in paediatric patients with XLH.
Do bo imetnik dovoljenja za promet z zdravilom potrdil učinkovitost in varnost zdravila Crysvita za zdravljenje na kromosom X vezane hipofosfatemije (XLH) pri otrocih, starih od 1 do 12 let, bo moral izvesti študijo UX023-CL301, randomizirano, odprto študijo 3. faze za oceno učinkovitosti, varnosti in farmakodinamike protitelesa proti FGF23, KRN23, v primerjavi s peroralnim fosfatom in aktivnim vitaminom D pri pediatričnih bolnikih z XLH, in predložiti njene rezultate.
Burosumab has not been studied in patients with renal impairment.
Pri bolnikih z okvaro ledvic burosumaba niso proučevali.
To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age (see section 4.4).
Za zmanjšanje tveganja ektopične mineralizacije je priporočljivo, da se vzame za cilj spodnji del normalnega referenčnega razpona serumskih fosfatov na tešče za zadevno starost (glejte poglavje 4.4).
This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Pomožna snov z znanim učinkom To zdravilo vsebuje 45,91 mg sorbitola na vialo, kar je enako 45,91 mg/ml.
X-Linked Hypophosphataemia (XLH) is a genetic disease.
Kaj je na kromosom X vezana hipofosfatemija (XLH) Na kromosom X vezana hipofosfatemija (XLH) je dedna bolezen.
Mean (SD) serum total alkaline phosphatase activity was 549 (193.8) U/L at baseline and decreased to 335 (87.6) U/L at Week 40 (mean change: -36.3%).
Srednja (SD) serumska skupna aktivnost alkalne fosfataze je bila 549 (193,8) e/l v izhodišču, do 40. tedna pa se je zmanjšala na 335 (87,6) e/l (srednja sprememba: -36,3 %).
The negative change in the Rickets Severity Score reflects resolution of the x-ray appearance of rickets.
Negativna sprememba ocene izraženosti rahitisa odraža izboljšanje rentgenološke slike rahitisa.
Twenty six of 52 patients received burosumab every two weeks (Q2W) at an average dose (min, max) of 0.73 (0.3, 1.5), 0.98 (0.4, 2.0) and 1.04 (0.4, 2.0) mg/kg at weeks 16, 40 and 60 respectively, and up to a maximum dose of 2.0 mg/kg.
Povprečni (najmanjši, največji) odmerek je bil 0,73 (0,3, 1,5), 0,98 (0,4, 2,0) oziroma 1,04 (0,4, 2,0) mg/kg v 16., 40. oziroma 60. tednu, in sicer do največjega odmerka 2,0 mg/kg.
CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection burosumab
CRYSVITA 10 mg raztopina za injiciranje CRYSVITA 20 mg raztopina za injiciranje CRYSVITA 30 mg raztopina za injiciranje burosumab
30 mg VIAL
30 mg VIALA
Baseline Mean (SD)
Srednje izhodišče (SD)
10 mg VIAL
10 mg VIALA
Periodic measurement of post prandial serum phosphate is advised.
Svetuje se redno določanje serumskih fosfatov po obrokih.
Clear to slightly opalescent, colourless to pale brownish-yellowish solution.
Bistra do rahlo opalescentna, brezbarvna do bledo rjavkasto-rumenkasta raztopina.
Burosumab increased serum phosphate concentration and increased TmP/GFR).
Burosumab je zvišal koncentracijo fosfatov v serumu in zvečal kvocient maksimalne tubulne reabsorpcije fosfata/hitrost glumerulne filtracije (TmP/GFR).
Serum Phosphorus
serumski fosfati
20 mg VIAL
20 mg VIALA
Marketing Authorisation Holder Kyowa Kirin Holdings B.V. Bloemlaan 2
Imetnik dovoljenja za promet z zdravilom Kyowa Kirin Holdings B.V.
LS Mean change (SE) from baseline in total score a
Srednja sprememba (SE) od izhodišča z metodo najmanjših kvadratov v celotni oceni a
RGI-C Global Score LS Mean score (SE)
Globalna ocena RGI-C Srednja ocena (SE)
Each vial contains 45.91 mg sorbitol.
Pomožna snov z znanim učinkom: Ena viala vsebuje 45,91 mg sorbitola.
In adult clinical trials no dose limiting toxicity has been observed using doses up to 1.0 mg/kg or a maximal total dose of 128 mg every 4 weeks.
V kliničnih preskušanjih pri odraslih pri uporabi odmerkov do 1,0 mg/kg ali največjega skupnega odmerka 128 mg na 4 tedne niso ugotovili toksičnosti, ki bi omejevala odmerke.
Dose decrease
Zmanjšanje odmerka
Vitamin D decreased
Preiskave zelo pogosti znižan vitamin D
Neither new or clinically meaningful worsening of nephrocalcinosis nor ectopic mineralisation have been observed in clinical trials of patients with XLH treated with burosumab to achieve normal serum phosphate levels.
V kliničnih preskušanjih pri bolnikih z XLH, zdravljenih z burosumabom za doseganje normalne koncentracije serumskih fosfatov, niso ugotovili niti nove niti klinično pomembnega poslabšanja nefrokalcinoze ali ektopične mineralizacije.
CRYSVITA contains the active substance burosumab.
Zdravilo CRYSVITA vsebuje učinkovino burosumab.
What CRYSVITA contains
Kaj vsebuje zdravilo CRYSVITA
How CRYSVITA works
Kako zdravilo CRYSVITA deluje
Skin and subcutaneous tissue disorder
Bolezen kože in podkožja zelo pogosti izpuščaj
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Kyowa Kirin Co., Ltd.
CRYSVITA should be given by injection under the skin in the arm, abdomen, buttock or thigh by your doctor or a trained healthcare provider.
Zdravilo CRYSVITA mora dajati zdravnik ali usposobljen zdravstveni delavec z injekcijo pod kožo nadlakti, trebuha, zadnjice ali stegna.
What CRYSVITA is
Kaj je zdravilo CRYSVITA
Dose increase
Zvečanje odmerka
30 mg CARTON
30 mg ŠKATLA
How to store CRYSVITA
Shranjevanje zdravila CRYSVITA
If a dose is missed, talk to your doctor straight away.
Če niste prejeli odmerka zdravila CRYSVITA Če je bil en odmerek izpuščen, se nemudoma posvetujte z zdravnikom.
Study UX023-CL201
Študija UX023-CL201
Study UX023-CL205
Študija UX023-CL205
CRYSVITA 20 mg solution for injection
CRYSVITA 20 mg raztopina za injiciranje
20 mg CARTON
20 mg ŠKATLA
Each vial contains 30 mg burosumab in 1 ml of solution.
Ena viala vsebuje 30 mg burosumaba v 1 ml raztopine.
Toothache
Imunogenost
Each vial contains 20 mg burosumab in 1 ml of solution.
Ena viala vsebuje 20 mg burosumaba v 1 ml raztopine.
CRYSVITA 10 mg solution for injection
CRYSVITA 10 mg raztopina za injiciranje
Each vial contains 10 mg burosumab in 1 ml of solution.
Ena viala vsebuje 10 mg burosumaba v 1 ml raztopine.
CRYSVITA 30 mg solution for injection
CRYSVITA 30 mg raztopina za injiciranje
Musculoskeletal and connective tissue disorders
Infekcijske in parazitske bolezni zelo pogosti zobni absces
• shortness of breath
• pospešen srčni utrip,
10 mg CARTON
10 mg ŠKATLA
What is CRYSVITA used for
Za kaj zdravilo CRYSVITA uporabljamo
CRYSVITA 20 mg injection burosumab
CRYSVITA 20 mg raztopina za injiciranje burosumab
CRYSVITA 30 mg injection burosumab
CRYSVITA 30 mg raztopina za injiciranje burosumab
Myalgia
shema
CRYSVITA 10 mg solution for injection burosumab
CRYSVITA 10 mg raztopina za injiciranje burosumab
Keep CRYSVITA out of the sight and reach of children.
Zdravilo CRYSVITA shranjujte nedosegljivo otrokom!
o redness or rash o pain or itching o swelling o bleeding or bruising
o rdečino ali izpuščaj,
+1.66 (0.1) (p<0.0001)
40 +1,66 (0,1) (p < 0,0001) +1,47 (0,1) (p < 0,0001)
+1.56 (0.1) (p<0.0001)
64 +1,56 (0,1) (p < 0,0001) +1,58 (0,1) (p < 0,0001)
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
EMA/249807/2015 EMEA/H/C/004009
24. april 2015 EMA/249807/2015 EMEA/H/C/004009
It was to be available as gastroresistant capsules (capsules whose contents are not broken down in the stomach and release the medicine in the intestine) containing 30 or 60 mg of duloxetine.
Na voljo naj bi bilo v obliki gastrorezistentnih kapsul (kapsul, katerih vsebina se ne razgradi v želodcu, temveč sproščajo zdravilo v črevesju) s 30 ali 60 mg duloksetina.
It works by preventing the neurotransmitters serotonin and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Deluje tako, da preprečuje ponovni prevzem živčnih prenašalcev serotonina in noradrenalina v živčne celice v možganih in hrbtenjači.
This means that Duloxetine Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Cymbalta.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of the identification of GCP issues.
V dopisu, s katerim je družba obvestila agencijo o umiku vloge, je navedla, da vlogo umika zaradi ugotovljenih težav v zvezi z dobro klinično prakso.
Duloxetine Sandoz was to be used to treat major depression, pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes) and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Zdravilo Duloxetine Sandoz naj bi se uporabljalo za zdravljenje velike depresivne motnje, bolečin zaradi diabetične periferne nevropatije (poškodbe živcev v okončinah, ki se lahko pojavijo pri bolnikih s sladkorno boleznijo) in generalizirane anksiozne motnje (dolgotrajne anksioznosti ali živčnosti zaradi vsakdanjih zadev).
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns about whether the two studies conducted to show bioequivalence between the medicine and the reference product had been carried out in accordance with guidelines for Good Clinical Practice (GCP) and was of the provisional opinion that Duloxetine Sandoz could not have been approved for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Na podlagi pregleda podatkov je Odbor v času umika izrazil določene zadržke glede tega, ali sta bili študiji, ki sta bili opravljeni z namenom dokazati biološko enakovrednost obravnavanega in referenčnega zdravila, izvedeni v skladu s smernicami za dobro klinično prakso ter je začasno menil, da zdravila Duloxetine Sandoz ni mogoče odobriti za zdravljenje depresije, diabetične periferne nevropatije in generalizirane anksiozne motnje.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters available for communication between the cells.
Duloksetin z zaviranjem ponovnega prevzema navedenih živčnih prenašalcev povečuje njuno količino, ki je na voljo za sporazumevanje med celicami.