FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Kako bi se potvrdile djelotvornost i sigurnost lijeka Crysvita u liječenju X-vezane hipofosfatemije (XLH) u djece u dobi između 1 i 4 godine, nositelj odobrenja treba dostaviti ažurirane rezultate ispitivanja UX023-CL205, otvorenog ispitivanja faze II za procjenu sigurnosti, farmakodinamike i djelotvornosti KRN23 u pedijatrijskih bolesnika s XLH-om.
English: Concurrent administration with oral phosphate, vitamin D analogues (see section 4.5).
Croatian: Istodobna primjena s peroralnim fosfatima i analozima vitamina D (vidjeti dio 4.5).
English: What CRYSVITA is
Croatian: Što je CRYSVITA
English: United Kingdom allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Croatian: Ujedinjeno Kraljevstvo allphamed PHARBIL Arzneimittel GmbH Hildebrandstr. 10-12
English: 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.
Croatian: U pedijatrijskim kliničkim ispitivanjima burosumab je primjenjivan bez toksičnosti koja ograničava dozu pri dozama do 2,0 mg/kg tjelesne težine, uz maksimalnu dozu od 90 mg svaka dva tjedna.
English: 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.
Croatian: U pedijatrijskom ispitivanju UX023-CL201, 52 pedijatrijska bolesnika s XLH-om u dobi od 5 do 12 godina (srednja vrijednost 8,5 godina; SD 1,87) liječena su 64 tjedna.
English: 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.
Croatian: Za sve bolesnike postojao je radiografski dokaz rahitisa na početku, a 12 bolesnika primalo je peroralni fosfat i analoge vitamina D u trajanju srednje vrijednosti (SD) od 16,7 (14,4) mjeseci.
English: If fasting serum phosphate is within the reference range for age, the same dose should be maintained.
Croatian: Ako je vrijednost fosfata u serumu natašte unutar referentnog raspona za dob, liječenje treba nastaviti jednakom dozom.
English: Adverse reactions in non-clinical studies with normal animals were observed at exposures which resulted in serum phosphate concentration greater than normal limits.
Croatian: U nekliničkim ispitivanjima na normalnim životinjama nuspojave su opažene pri izloženostima koje su rezultirale koncentracijom fosfata u serumu iznad normalnih granica.
English: Burosumab has not been studied in patients with renal impairment.
Croatian: Burosumab nije ispitivan u bolesnika s oštećenjem funkcije bubrega.
English: 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.
Croatian: U pedijatrijskom ispitivanju UX023-CL205, burosumab je procjenjivan u 13 bolesnika s XLH-om u dobi od 1 do 4 godine (srednja vrijednost 2,9 godina; SD 1,1) u trajanju od 40 tjedana.
English: 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%).
Croatian: Sadržaj alkalne fosfataze iz kosti u serumu bio je na početku 165 (52) µg/L [srednja vrijednost (SD)], a 115 (31) µg/L u 64. tjednu (srednja vrijednost promjene: -28,5%).
English: Skin and subcutaneous tissue disorder
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osip
English: 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.
Croatian: Gotovo svi bolesnici imali su na početku ispitivanja radiološki dokazan rahitis, a prije su primali peroralni fosfat i analoge vitamina D u trajanju kojem je srednja vrijednost (SD) bila 7 (2,4) godina.
English: RSS Total Score
Croatian: Ukupni rezultat RSS-a Početna srednja vrijednost (SD)
English: At initiation, fasting serum phosphate concentration should be below the reference range for age (see section 4.3).
Croatian: Na početku liječenja koncentracija fosfata u serumu natašte treba biti ispod referentnog raspona za dob (vidjeti dio 4.3).
English: Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23 and is produced by recombinant DNA technology using Chinese hamster ovary (CHO) mammalian cell culture.
Croatian: Burosumab je rekombinantno ljudsko monoklonsko IgG1 protutijelo protiv čimbenika rasta fibroblasta 23 (engl. fibroblast growth factor 23, FGF23), a proizvedeno je tehnologijom rekombinantne DNA u kulturi stanica sisavaca iz jajnika kineskog hrčka.
English: 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.
Croatian: Radiographic Global Impression of Change, RGI-C) kao relativna ocjenska ljestvica za usporedbu rahitisa u bolesnika prije i poslije liječenja na temelju ordinalne ljestvice od 7 stupnjeva za procjenu promjena istih abnormalnosti ocijenjenih RSS-om.
English: No specific fertility studies in animals with burosumab were conducted.
Croatian: Nisu provedena posebna ispitivanja učinka burosumaba na plodnost u životinja.
English: 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.
Croatian: U skupini koja je primala burosumab svaka 2 tjedna, srednja vrijednost (SD) koncentracije fosfata u serumu povećala se od 0,77 (0,13) mmol/L na početku do 1,07 (0,13) mmol/L u 40. tjednu i održala se do 64. tjedna na vrijednosti od 1,08 (0,14) mmol/L.
English: 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).
Croatian: Srednja vrijednost (SD) aktivnosti ukupne alkalne fosfataze u serumu iznosila je na početku 459 (105) U/L i smanjila se na 369 (76) U/L u 64. tjednu (-19,6%, p<0,0001).
English: 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.
Croatian: U ispitivanju UX023-CL205, srednja vrijednost (SD) koncentracije fosfata u serumu natašte povećala se od 0,81 (0,092) mmol/L na početku do 1,12 (0,158) mmol/L u 40. tjednu.
English: 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%).
Croatian: Srednja vrijednost (SD) aktivnosti ukupne alkalne fosfataze u serumu iznosila je na početku 549 (193,8) U/L i smanjila se na 335 (87,6) U/L u 40. tjednu (srednja vrijednost promjene: -36,3%).
English: Burosumab increased serum phosphate concentration and increased TmP/GFR).
Croatian: Burosumab je povisio koncentraciju fosfata u serumu i povećao omjer maksimalne tubularne reapsorpcije fosfata i brzine glomerularne filtracije (TmP/GFR).
English: 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.
Croatian: Kako bi se smanjio rizik od ektopične mineralizacije, kao ciljnu vrijednost fosfata u serumu natašte preporučuje se uzeti vrijednosti u donjem dijelu referentnog raspona normalnog za dob.
English: 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).
Croatian: Nakon 40 tjedana liječenja burosumabom, srednja vrijednost ukupnog RSS-a poboljšala se od 2,92 (1,367) na početku do 1,19 (0,522), što u odnosu na početnu vrijednost odgovara srednjoj vrijednosti promjene dobivenoj metodom najmanjih kvadrata (standardna pogreška, SE) od -1,73 (0,132) (p<0,0001).
English: Nervous system disorder
Croatian: Oštećenje funkcije bubrega
English: 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.
Croatian: U ispitivanjima reproduktivne i razvojne toksikologije provedenim na skotnim makaki majmunicama, u skotnih životinja koje su primile 30 mg/kg burosumaba opažena je umjerena mineralizacija posteljice, a razvila se u životinja s vršnom koncentracijom fosfata u serumu većom od približno 2,58 mmol/L.
English: 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.
Croatian: Rickets Severity Score, RSS), a to je radiografska metoda bodovanja razvijena prvenstveno za procjenu težine rahitisa povezanog s prehranom u kostima zapešća i koljena na temelju stupnja trošenja metafize, konkavnosti i udjela zahvaćene ploče rasta.
English: Marketing Authorisation Holder Kyowa Kirin Holdings B.V. Bloemlaan 2
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Kyowa Kirin Holdings B.V.
English: 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).
Croatian: Kako bi se smanjio rizik od ektopične mineralizacije, kao ciljnu vrijednost fosfata u serumu natašte preporučuje se uzeti vrijednosti u donjem dijelu referentnog raspona normalnog za dob (vidjeti dio 4.4).
English: The other ingredients are L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, and water for injections.
Croatian: Drugi sastojci su: L-histidin, D-sorbitol (E420), polisorbat 80, L-metionin, 10%-tna kloridna kiselina i voda za injekcije. (Dodatne informacije pogledajte u dijelu 2 „CRYSVITA sadrži sorbitol”).
English: CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection burosumab
Croatian: CRYSVITA 10 mg otopina za injekciju CRYSVITA 20 mg otopina za injekciju CRYSVITA 30 mg otopina za injekciju burosumab
English: Kyowa Kirin Co., Ltd. Takasaki Plant 100-1 Hagiwara-machi Takasaki
Croatian: 100-1 Hagiwara-machi
English: The negative change in the Rickets Severity Score reflects resolution of the x-ray appearance of rickets.
Croatian: Negativna promjena rezultata RSS-a pokazuje poboljšanje radiološkog izgleda rahitisa.
English: Vitamin D decreased
Croatian: Pretrage vrlo često snižen vitamin D
English: 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.
Croatian: Nakon 40 tjedana liječenja burosumabom, srednja vrijednost (standardna pogreška, SE) dobivena metodom najmanjih kvadrata za opći rezultat RGI-C bila je +2,33 (0,08) u svih 13 bolesnika (p<0,0001) što je dokazalo poboljšanje rahitisa.
English: Serum Phosphorus
Croatian: Fosfor u serumu
English: All 13 patients were considered RGI-C responders as defined by RGI-C global score ≥ +2.0.
Croatian: Na temelju općeg rezultata za RGI-C ≥ +2,0, smatralo se da je u svih 13 bolesnika u RGI-C-u postignut odgovor.
English: Your doctor will check the phosphate level in your blood and urine and may also do a renal ultrasound during your treatment in order to reduce the risk of hyperphosphataemia (too much phosphate in the blood) and ectopic mineralisation (a build up of calcium in tissues such as the kidneys).
Croatian: Kako bi se smanjio rizik od hiperfosfatemije (previše fosfata u krvi) i ektopične mineralizacije (nakupljanje kalcija u tkivima kao što su bubrezi), liječnik će Vam tijekom liječenja provjeravati razinu fosfata u krvi i mokraći, a možda će Vam napraviti i pregled bubrega ultrazvukom.
English: Oral phosphate and vitamin D analogues should be discontinued 1 week prior to initiation of treatment.
Croatian: D treba prekinuti 1 tjedan prije započinjanja liječenja.
English: 20 mg CARTON
Croatian: 20 mg KUTIJA
English: Increases in serum parathyroid hormone have been observed in some XLH patients during treatment with burosumab.
Croatian: U nekih bolesnika s XLH-om opažena su tijekom liječenja burosumabom povećanja paratireoidnog hormona u serumu.
English: Clear to slightly opalescent, colourless to pale brownish-yellowish solution.
Croatian: Bistra do blago opalescentna, bezbojna do blijedo smećkasto-žućkasta otopina.
English: Hyperphosphataemia
Croatian: Hiperfosfatemija
English: 30 mg CARTON
Croatian: 30 mg KUTIJA
English: What is X-Linked Hypophosphataemia (XLH)
Croatian: Što je X-vezana hipofosfatemija
English: The positive change in the RGI-C score reflects resolution of the x-ray appearance of rickets.
Croatian: Rezultati su sažeto prikazani u tablici 2. Pozitivna promjena rezultata RGI-C-a pokazuje poboljšanje radiološkog izgleda rahitisa.
English: 10 mg CARTON
Croatian: 10 mg KUTIJA
English: LS Mean change (SE) from baseline in total score a
Croatian: Promjena srednje vrijednosti (SE) dobivene metodom najmanjih kvadrata u odnosu na početnu, u ukupnom rezultatu a
English: Burosumab should be injected in the arm, abdomen, buttock or thigh.
Croatian: Burosumab se primjenjuje injekcijom u nadlakticu, trbuh, stražnjicu ili bedro.
English: Serum parathyroid hormone
Croatian: Paratireoidni hormon u serumu
English: How to store CRYSVITA
Croatian: Kako primjenjivati lijek CRYSVITA
English: Toothache
Croatian: Nuspojava
English: You may get skin reactions where the injection is given, see section 4 for more information.
Croatian: Vam se pojaviti kožne reakcije, pogledajte dodatne informacije u dijelu 4. Ako su te reakcije teške, obratite se liječniku.
English: Effect Size
Croatian: Mjera ishoda
English: 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.
Croatian: U kliničkim ispitivanjima provedenim u bolesnika s XLH-om koji su liječeni burosumabom kako bi se postigle normalne razine fosfata u serumu, nisu opažena nova ili klinički značajna pogoršanja nefrokalcinoze ili ektopične mineralizacije.
English: Periodic measurement of post prandial serum phosphate is advised.
Croatian: Savjetuje se periodički mjeriti koncentraciju fosfata u serumu poslije jela.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari Kyowa Kirin Co., Ltd.
English: Each vial contains 20 mg burosumab in 1 ml of solution.
Croatian: Jedna bočica sadrži 20 mg burosumaba u 1 mL otopine.
English: CRYSVITA should be given by injection under the skin in the arm, abdomen, buttock or thigh by your doctor or a trained healthcare provider.
Croatian: Lijek CRYSVITA davat će Vam liječnik ili za to osposobljen zdravstveni radnik, injekcijom pod kožu nadlaktice, trbuha, stražnjice ili bedra.
English: RGI-C Global Score LS Mean score (SE)
Croatian: Opći rezultat RGI-C-a Srednja vrijednost rezultata dobivena metodom najmanjih kvadrata (SE)
English: Northumberland Morpeth
Croatian: Northumberland
English: CRYSVITA 20 mg solution for injection
Croatian: CRYSVITA 20 mg otopina za injekciju
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Piramal Healthcare UK Limited
English: Each vial contains 30 mg burosumab in 1 ml of solution.
Croatian: Jedna bočica sadrži 30 mg burosumaba u 1 mL otopine.
English: Each vial contains 10 mg burosumab in 1 ml of solution.
Croatian: Jedna bočica sadrži 10 mg burosumaba u 1 mL otopine.
English: What is CRYSVITA used for
Croatian: Za što se CRYSVITA koristi
English: CRYSVITA 10 mg solution for injection
Croatian: CRYSVITA 10 mg otopina za injekciju
English: CRYSVITA 30 mg solution for injection
Croatian: CRYSVITA 30 mg otopina za injekciju
English: How much CRYSVITA you will be given
Croatian: Koliko ćete primiti lijeka CRYSVITA
English: Study UX023-CL201
Croatian: Ispitivanje UX023-CL201
English: Study UX023-CL205
Croatian: Ispitivanje UX023-CL205
English: CRYSVITA 30 mg injection burosumab
Croatian: CRYSVITA 30 mg otopina za injekciju burosumab
English: CRYSVITA 20 mg injection burosumab
Croatian: CRYSVITA 20 mg injekcija burosumab s.c.
English: CRYSVITA 10 mg injection burosumab
Croatian: CRYSVITA 10 mg injekcija burosumab s.c.
English: CRYSVITA 20 mg solution for injection burosumab
Croatian: CRYSVITA 20 mg otopina za injekciju burosumab
English: CRYSVITA 10 mg solution for injection burosumab
Croatian: CRYSVITA 10 mg otopina za injekciju burosumab
English: Dizziness may occur following administration of burosumab.
Croatian: Nakon primjene burosumaba može se pojaviti omaglica.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 10 mg BOČICA
English: +1.56 (0.1) (p<0.0001)
Croatian: +1,56 (0,1) (p<0,0001) +1,58 (0,1) (p<0,0001)
English: +1.66 (0.1) (p<0.0001)
Croatian: +1,66 (0,1) (p<0,0001) +1,47 (0,1) (p<0,0001)
English: 64 -1.00 (0.1) (p<0.0001)
Croatian: -1,00 (0,1) (p<0,0001) -0,84 (0,1) (p<0,0001)
English: EMA/249807/2015 EMEA/H/C/004009
Croatian: 24. travnja 2015. EMA/249807/2015 EMEA/H/C/004009
English: 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.
Croatian: Dostupan je kao gastrorezistetne kapsule (kapsule čiji se sastav ne razgrađuje u želucu i otpušta lijek u crijevima) sadržavajući 30 ili 60 mg duloksetina.
English: 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.
Croatian: U svojem dopisu kojim je obavijestila Agenciju o povlačenju, tvrtka je navela da povlači svoj zahtjev zbog problema s identifikacijom problema povezanih sa GCP-om.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio početnu dokumentaciju koju je proizvođač dostavio te je sastavio popis pitanja.
English: It works by preventing the neurotransmitters serotonin and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Croatian: Djeluje sprečavajući neurotransmitere serotonin i noradrenalin od ponovne apsorpcije u živčane stanice u mozgu i leđnoj moždini.
English: 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).
Croatian: Duloxetine Sandoz trebao se koristiti za liječenje velike depresije, boli uslijed dijabetske periferne neuropatije (oštećenja živaca u ektremitetima koje može nastupiti u bolesnika s dijabetesom) i generaliziranog anksioznog poremećaja (dugoročne anksioznosti ili nervoze uslijed svakodnevnih problema).
English: This means that Duloxetine Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Croatian: To znači da je Duloxetine Sandoz sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Cymbalta.
English: On 08 April 2015, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Duloxetine Sandoz, for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Croatian: Dana 08. travnja 2015., proizvođač Sandoz GmbH službeno je obavijestio Odbor za humane lijekove (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet za Duloxetine Sandoz, lijek za liječenje depresije, dijabetske živčane boli i generaliziranog anksioznog poremećaja.
English: Duloxetine Sandoz was developed as a ‘generic medicine'.
Croatian: Duloxetine Sandoz razvijen je kao „generički lijek”.
English: Because Duloxetine Sandoz is a generic medicine, the company had presented results of tests to determine that Duloxetine Sandoz is bioequivalent to the reference medicine, Cymbalta.
Croatian: Budući da je Duloxetine Sandoz generički lijek, tvrtka je dostavila rezultate testova kako bi se utvrdilo da je lijek Duloxetine Sandoz bioekvivalentan s referentnim lijekom, Cymbalta.
English: The company had not yet responded to the questions at the time of the withdrawal.
Croatian: U trenutku povlačenja proizvođač još nije dostavio svoje odgovore.
English: mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Croatian: Budući da su neurotransmiteri uključeni u održavanje dobrog raspoloženja i smanjivanje osjećaja boli, inhibirajući njihov ponovni unos u živčane stanice poboljšavaju se simptomi depresije, anksioznosti i neuropatske boli.
English: 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.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja, CHMP imao je razloga za zabrinutost vezano uz dva ispitivanja provedena kako bi se dokazala da je bioekvivaletnost između lijeka i referentnog lijeka provedena u skladu sa smjernicama za dobru klinički praksu (GCP) te da je privremeno mišljenje kao se ne može izdati odobrenje za lijek Duloxetine Sandoz za liječenje depresije, dijabetske živčane boli i generaliziranog poremećaja anksioznosti.
English: What is Duloxetine Sandoz?
Croatian: Što je Duloxetine Sandoz?
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters available for communication between the cells.
Croatian: Inhibirajući njihov ponovni unos, duloksetin povećava količinu ovih neurotransmitera
English: The active substance in Duloxetine Sandoz, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Croatian: Djelatna tvar lijeka Duloxetine Sandoz, duloksetin, je inhibitor ponovnog unosa serotonin noradrenalina.
English: Duloxetine Sandoz is a medicine that contains the active substance duloxetine.
Croatian: Duloxetine Sandoz je lijek koji sadrži djelatnu tvar duloksetin.
English: What was Duloxetine Sandoz expected to be used for?
Croatian: Za što se Duloxetine Sandoz trebao koristiti?
English: How is Duloxetine Sandoz expected to work?
Croatian: Kako je Duloxetine Sandoz trebao djelovati?
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Croatian: Put primjene Unutarnje pakovanje
English: This will help prevent dehydration.
Croatian: To će pomoći u sprečavanju dehidracije.
English: - Do not throw away any medicines via wastewater (or household waste).
Croatian: - Nikada nemojte nikakve lijekove bacati u otpadne vode (ili kućni otpad).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.