natgillin/translations-raw huggingface dataset:
Non-clinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration. 
Neklinička ispitivanja pokazuju da palonosetron samo u vrlo visokim koncentracijama može blokirati ionske kanale uključene u ventrikularnu depolarizaciju i repolarizaciju te produljiti trajanje akcijskog potencijala.
In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine). 
U farmakokinetičkoj analizi populacije pokazalo se da ne postoji značajan učinak na klirens palonosetrona kada je primijenjen s induktorima CYP2D6 (deksametazon i rifampicin) i inhibitorima (uključujući amjodaron, celekoksib, klorpromazin, cimetidin, doksorubicin, fluoksetin, haloperidol, paroksetin, kinidin, ranitidin, ritonavir, sertralin ili terbinafin).
Other medicines and Palonosetron Hospira 
Drugi lijekovi i Palonosetron Hospira
What Palonosetron Hospira contains 
Što Palonosetron Hospira sadrži
20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy. 
Doza od 20 mikrograma/kg palonosetrona (maksimalna ukupna doza ne smije prelaziti 1500 mikrograma) daje se u obliku jedne intravenske infuzije u trajanju od 15 minuta, s početkom od približno 30 minuta prije početka kemoterapije.
The efficacy of Palonosetron Hospira in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy. 
Djelotvornost lijeka Palonosetron Hospira u sprječavanju mučnine i povraćanja izazvanih visoko emetogenom kemoterapijom može se povećati dodatnom primjenom kortikosteroida prije kemoterapije.
Hospira Enterprises B.V. Randstad 22-11 Almere NL-1316 BN The Netherlands 
Randstad 22-11 Almere NL-1316 BN Nizozemska
Median half-life was 29.5 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 μg/kg. 
Medijan poluvijeka iznosio je 29,5 sati u svim dobnim skupinama i nakon primjene doze od 20 µg/kg raspon mu je iznosio od otprilike 20 do 30 sati u svim dobnim skupinama.
A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 μg/kg (maximum 0.75 mg), palonosetron 20 μg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1. 
Ukupno 493 pedijatrijska bolesnika u dobi od 64 dana do 16,9 godina, koja su primala umjereno (69,2%) ili visoko emetogenu kemoterapiju (30,8%), liječena su palonosetronom u dozi od 10 µg/kg (najviše 0,75 mg), palonosetronom u dozi od 20 µg/kg (najviše 1,5 mg) ili ondansetronom (3 x 0,15 mg/kg , najveća ukupna doza 32 mg) 30 minuta prije početka emetogene kemoterapije u 1. ciklusu.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
The efficacy of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an intravenous ondansetron regimen. 
Djelotvornost palonosetrona u sprječavanju mučnine i povraćanja izazvanih kemoterapijom u pedijatrijskih bolesnika s karcinomom pokazala se u drugom ključnom ispitivanju neinferiornosti u kojemu se jedna intravenska infuzija palonosetrona uspoređivala s intravenskim režimom ondansetrona.
As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. 
Budući da palonosetron može produljiti vrijeme prolaska sadržaja kroz debelo crijevo, bolesnike s anamnezom konstipacije ili sa znakovima subakutne crijevne opstrukcije treba nakon primjene nadzirati.
In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarisation and to prolong action potential duration. 
U nekliničkim ispitivanjima palonosetron ima sposobnost blokade ionskih kanala uključenih u ventrikularnu depolarizaciju i repolaziraciju te može produljiti trajanje akcijskog potencijala.
After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/min and renal clearance was 53 ± 29 ml/min. 
U zdravih ispitanika, nakon jedne intravenske primjene u bolusu, ukupni tjelesni klirens palonosetrona iznosio je 173  73 ml/min a bubrežni klirens bio je 53  29 ml/min.
What you need to know before you are given Palonosetron Hospira 
Što morate znati prije nego počnete primjenjivati Palonosetron Hospira
Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations. 
Palonosetron ne inhibira i ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C). 
U nekliničkim ispitivanjima, palonosetron nije inhibirao antitumorsku aktivnost pet testiranih kemoterapeutika (cisplatin, ciklofosfamid, citarabin, doksorubicin i mitomicin C).
Ondansetron 32 milligrams (n= 221) 
Ondansetron 32 miligrama (n = 221)
Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters. 
Blago do umjereno oštećenje bubrežne funkcije ne utječe značajno na farmakokinetičke parametre palonosetrona.
The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical studies. 
Učinak palonosetrona na krvni tlak, brzinu srčanih otkucaja i parametre EKG-a uključujući QTc bio je usporediv s učinkom ondansetrona i dolasetrona u kliničkim ispitivanjima kemoterapijom izazvane mučnine i povraćanja.
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. 
250 mikrograma palonosetrona daje se u obliku jedne intravenske bolus injekcije, približno 30 minuta prije početka kemoterapije.
Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products. 
Palonosetron se sigurno primjenjivao s analgeticima, antiemeticima/sredstvima protiv mučnine, spazmoliticima i antikolinergičkim lijekovima.
Palonosetron Hospira should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration. 
Palonosetron Hospira se ne smije primjenjivati za sprječavanje ili liječenje mučnine i povraćanja u dane nakon kemoterapije, osim ako je to povezano sa sljedećom primjenom kemoterapije.
• The active substance is palonosetron (as hydrochloride). 
• Djelatna tvar je palonosetron (u obliku palonosetronklorida).
Also contains: mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, hydrochloric acid. 
Također sadrži manitol, dinatrijev edetat, natrijev citrat, citratnu kiselinu hidrat, vodu za injekcije, natrijev hidroksid i kloridnu kiselinu.
The safety and efficacy of palonosetron intravenously at single doses of 1 μg/kg and 3 μg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery. 
Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 1 µg/kg i 3 µg/kg uspoređivala se u prvom kliničkom ispitivanju provedenom na 150 bolesnika dobnih skupina >28 dana do 23 mjeseca (7 bolesnika), 2 do 11 godina (96 bolesnika) i 12 do 16 godina (47 bolesnika) koji su podvrgnuti elektivnom kirurškom zahvatu.
Single-dose intravenous palonosetron pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 μg/kg or 20 μg/kg. 
Farmakokinetički podaci za jednu i.v. dozu palonosetrona dobiveni su iz podskupine pedijatrijskih bolesnika s karcinomom (n = 280) koji su primili 10 µg/kg ili 20 µg/kg.
• difficulty urinating 
• teškoće pri mokrenju
In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m 2, carboplatin, cyclophosphamide ≤1,500 mg/m 2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone. 
U dva randomizirana, dvostruko slijepa ispitivanja na ukupno 1132 bolesnika na umjereno emetogenoj kemoterapiji koja je uključivala cisplatin ≤50 mg/m2, karboplatin, ciklofosfamid 1500 mg/m2 i doksorubicin 25 mg/m2, uspoređivan je palonosetron 250 mikrograma i 750 mikrograma s ondansetronom 32 mg (poluvijek 4 sata) ili dolasetronom 100 mg (poluvijek 7,3 sata) primijenjeno intravenski na dan 1, bez deksametazona.
The safety and efficacy of palonosetron intravenously at single doses of 3 μg/kg and 10 μg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy. 
Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina >28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika) koji su primali visoko ili umjereno emetogenu kemoterapiju.
After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45 
Nakon intravenske primjene palonosetrona 0,25 mg jedanput na dan tijekom 3 dana u 12 zdravih ispitanika, prosječna vrijednost ( SD) porasta koncentracije palonosetrona u plazmi od 1. do 3. dana iznosila je 110  45%.
Type I glass vial with a chlorobutyl rubber stopper and aluminium seal. 
I sa gumenim čepom od klorbutila i aluminijskom kapicom.
Gender does not affect the pharmacokinetics of palonosetron. 
Spol Spol ne utječe na farmakokinetiku palonosetrona.
Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin. 
Primijenjene emetogene kemoterapije uključivale su doksorubicin, ciklofosfamid (<1500 mg/m ifosfamid, cisplatin, daktinomicin, karboplatin i daunorubicin.
The recommended dose of Palonosetron Hospira is 250 micrograms given as a rapid injection into a vein. 
Preporučena doza lijeka Palonosetron Hospira je 250 mikrograma primijenjenog u obliku brze injekcije u venu.
Paediatric population No case of overdose has been reported in paediatric clinical studies. 
U pedijatrijskim kliničkim ispitivanjima nije zabilježen nijedan slučaj predoziranja.
24 - 120 hours 0 - 120 hours 
24 - 120 sati 0 - 120 sati a
• jerky body movements 
• trzaji tijela
Palonosetron Hospira may cause dizziness or tiredness. 
Palonosetron Hospira može uzrokovati omaglicu ili umor.
Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations. 
Na temelju ispitivanja in vitro, palonosetron ne inhibira ni ne inducira izoenzime citokroma P450 u klinički značajnim koncentracijama.
Dermatitis allergic, pruritus, skin disorder, urticaria 
Alergijski dermatitis, pruritus, kožni poremećaj, urtikarija
• low levels of calcium in the blood 
• niske razine kalcija u krvi
Electrocardiogram QT prolonged conduction disorder, sinus tachycardia 
Produljen QT elektrokardiograma, poremećaj provodljivosti, sinusna tahikardija
Age does not affect the pharmacokinetics of palonosetron. 
Dob ne utječe na farmakokinetiku palonosetrona.
Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 μg/kg in healthy subjects and in cancer patients. 
U zdravih ispitanika i u bolesnika s karcinomom, prosječna maksimalna koncentracija u plazmi (Cmax) i površina ispod krivulje koncentracija-vrijeme (AUC0-) obično su proporcionalne dozi u rasponu doze od 0,3-90 μg/kg.
Talk to your doctor or pharmacist before you are given Palonosetron Hospira: 
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego primijenite Palonosetron Hospira
Ondansetron 32 milligrams (n= 185) 
Ondansetron 32 miligrama (n = 185)
Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA05 
Farmakoterapijska skupina: Antiemetici i sredstva protiv mučnine, antagonisti serotonina (5HT3).
After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance. 
C]-palonosetrona, otprilike 80% doze izluči se unutar 144 sata u mokraći, pri čemu palonosetron predstavlja približno 40% primijenjene doze kao nepromijenjena djelatna tvar.
Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron 
Tablica 2: Postotak bolesnika a s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na dolasetron
• hiccups, flatulence, dry mouth or indigestion 
• štucanje, plinovi u crijevima (flatulencija), suhoća usta ili probavne tegobe
PK parameters expressed as Arithmetic mean (SD) Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 μg /kg and 20 μg /kg dose groups combined. 
Klirens i volumen distribucije u pedijatrijskih bolesnika izračunati su prilagođeno za težinu, kombinirano za obje dozne skupine od 10 g/kg i 20 g/kg.
The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing intravenous palonosetron (1 μg/kg, max 
Drugo pedijatrijsko ispitivanje bilo je multicentrično, dvostruko slijepo, dvostruko maskirano, randomizirano ispitivanje neinferiornosti s aktivnom kontrolom, provedeno na usporednim skupinama, u kojemu se jedna doza i.v. palonosetrona (1 µg/kg, najviše 0,075 mg) uspoređivala s i.v. ondansetronom.
• if you are using Palonosetron Hospira in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, 
- Ako uz Palonosetron Hospira primjenjujete druge lijekove koji mogu prouzročiti abnormalni srčani ritam, kao što su amiodaron, nikardipin, kinidin, moksifloksacin, eritromicin, haloperidol, klorpromazin, kvetiapin, tioridazin, domperidon.
Intent-to-treat cohort. 
Kohorta s namjerom liječenja.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %. 
U 11 bolesnika s rakom testisa, nakon intravenske primjene palonosetrona 0,25 mg jednom svaki drugi dan kroz 3 doze, prosječna vrijednost ( SD) porasta koncentracije u plazmi od 1. dana do 5. dana iznosila je 42  34%.
• if you have acute bowel obstruction or a history of repeated constipation; 
- Ako imate akutnu opstrukciju crijeva ili ponavljane zatvore stolice u prošlosti.
In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron. 
Metabolička in vitro ispitivanja pokazala su da je u metabolizam palonosetrona uključen enzim CYP2D6, a u manjoj mjeri izoenzimi CYP3A4 i CYP1A2.
Nervous system disorders Headache Dizziness 
Poremećaji živčanog sustava Glavobolja
How to store Palonosetron Hospira 
Kako čuvati Palonosetron Hospira
• numbness, burning, prickling or tingling sensations on the skin 
• utrnulost, osjećaj žarenja, bockanje, trnci po koži
• The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment). 
• Pomoćne tvari su manitol, dinatrijev edetat, natrijev citrat, citratna kiselina hidrat i voda za injekcije, natrijev hidroksid i kloridna kiselina.
<2 y 2 to <6 y 6 to <12 y 12 to <17 y μg/kg 
< 2 god 2 do < 6 god
Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 
Nositelj odobrenja Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgija
Table 1: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus ondansetron 
Tablica 1: Postotak bolesnika a s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na ondansetron
What Palonosetron Hospira looks like and contents of the pack Palonosetron Hospira solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with a chlorobutyl rubber stopper and aluminium cap, which contains 5 ml of the solution. 
Kako Palonosetron Hospira izgleda i sadržaj pakiranja Palonosetron Hospira otopina za injekciju bistra je bezbojna otopina, a dostupna je u pakiranju od jedne bočice stakla tip
For palonosetron no clinical data on exposed pregnancies are available. 
Nema kliničkih podataka o izloženosti palonosetronu u trudnoći.
Each vial of 5 ml of solution contains 250 micrograms of palonosetron. 
Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonosetrona.
Palonosetron 250 micrograms (n= 189) 
Palonosetron 250 mikrograma (n = 189)
Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence 
probavnog sustava gornjem dijelu trbuha, suha usta, flatulencija
Palonosetron 250 micrograms (n= 185) 
Palonosetron 250 mikrograma (n = 185)
Each ml of solution contains 50 micrograms palonosetron (as hydrochloride). 
Jedan ml otopine sadrži 50 mikrograma palonosetrona (u obliku palonosetronklorida).
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥60 mg/m2, cyclophosphamide >1,500 mg/m2 and dacarbazine, palonosetron 
U randomiziranom, dvostruko slijepom ispitivanju na ukupno 667 bolesnika na visoko emetogenoj kemoterapiji koja je uključivala cisplatin ≥60 mg/m2, ciklofosfamid >1500 mg/m2 i dakarbazin, uspoređivan je palonosetron 250 mikrograma i 750 mikrograma s ondansetronom 32 mg primijenjeno intravenski na dan 1.
Palonosetron Hospira250 micrograms solution for injection. 
Palonosetron Hospira 250 mikrograma otopina za injekciju.
• nosebleed 
• omaglica
Palonosetron Hospira 250 micrograms solution for injection palonosetron 
Palonosetron Hospira 250 mikrograma otopina za injekciju palonosetron
Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms. 
Povezano s primjenom palonosetrona u dozi od 750 mikrograma, zabilježena su dva slučaja konstipacije s fekalnom impakcijom, koja su zahtijevala hospitalizaciju.
Palonosetron Hospira 250 micrograms solution for injection palonosetron (as hydrochloride) 
Palonosetron Hospira 250 mikrograma otopina za injekciju Palonosetron (u obliku palonosetronklorida)
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride). 
Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonosetrona (u obliku palonosetronklorida).
Headache 
Poremećaji
Adults Cancer Patients 
Pedijatrijski bolesnici s karcinomom a Odrasli bolesnici s karcinomom
In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg). 
402 bolesnika su primila jednu dozu palonosetrona (3, 10 ili 20 mcg/kg) tijekom pedijatrijskih kliničkih ispitivanja radi sprječavanje mučnine i povraćanja povezanih s umjerenom ili visokom emetogenom kemoterapijom.
Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron 
Tablica 3: Postotak bolesnika a s odgovorom prema skupinama liječenja i fazi u ispitivanju visoko emetogene kemoterapije u odnosu na ondansetron Palonosetron 250 mikrograma (n = 223)
• pain at the site of infusion 
• bol na mjestu davanja infuzije.
This overview was last updated in 07-2018. 
Sažetak je posljednji je put ažuriran u 07-2018.
The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken with food. 
Dostupan je u obliku tableta (50 mg), a preporučena doza su dvije tablete dvaput dnevno uzete s hranom.
In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards. 
Osim toga, većinu bolesnika koji su bili uključeni u glavno ispitivanje pratilo se poslije toga do 24 mjeseca.
Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). 
Tuberkuloza je zaraza prouzročena bakterijom Mycobacterium tuberculosis (M. tuberculosis).
Although the main study was of short duration and the follow-up studies had shortcomings, the Agency considered that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration. 
Iako je glavno ispitivanje trajalo kratko, a nastavci ispitivanja imali su nedostatke, Agencija je zaključila da će se učinci koji su se pokazali nakon dva početna mjeseca liječenja vjerojatno nastaviti tijekom cijelog trajanja liječenja.
Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Deltyba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness. 
Agencija je navela da će kliničko ispitivanje koje je u tijeku pružiti potvrdu dugoročne učinkovitosti.
It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects. 
Primjenjuje se s ostalim lijekovima protiv tuberkuloze i to samo onda kada se standardni lijekovi ne mogu upotrebljavati jer je bolest na njih otporna ili zbog nuspojava tih lijekova.
What is Deltyba and what is it used for? 
Što je Deltyba i za što se koristi?
What measures are being taken to ensure the safe and effective use of Deltyba? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Deltyba?
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation 
Više informacija o statusu lijeka za rijetke bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation