FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: danega palonosetrona so pridobili iz podskupine pediatričnih bolnikov z rakom (n=280), ki so prejeli 10 µg/kg ali 20 µg/kg.
English: • SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
Slovenian: • SSRI (selektivni zaviralci privzema serotonina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno s fluoksetinom, paroksetinom, sertralinom, fluvoksaminom, citalopramom, escitalopramom;
English: 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.
Slovenian: Zdravilo Palonosetron Hospira se ne sme uporabljati za preprečevanje ali zdravljenje navzee in bruhanja v dneh po kemoterapiji, razen če se ne uporabi zaradi dajanja naslednje kemoterapije.
English: Also contains: mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, hydrochloric acid.
Slovenian: Vsebuje tudi: manitol, dinatrijev edetat, natrijev citrat, citronsko kislino monohidrat, vodo za injekcije, natrijev hidroksid, klorovodikovo kislina.
English: 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.
Slovenian: Učinkovitost zdravila Palonosetron Hospira pri preprečevanju slabosti in bruhanja, povzročenih z visoko emetogenimi kemoterapijami, se poveča, če pred kemoterapijo dodamo kortikosteroid.
English: Efficacy after palonosetron 10 μg/kg compared to palonosetron 3 μg/kg was 54.1% and 37.1% respectively.
Slovenian: Učinkovitost po dajanju palonosetrona 10 µg/kg je bila 54,1 % in učinkovitost palonosetrona 3 µg/kg je bila 37,1 %.
English: What Palonosetron Hospira is and what it is used for
Slovenian: Kaj je zdravilo Palonosetron Hospira in za kaj ga uporabljamo
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Slovenian: Spodnja meja višja od -15 % dokazuje ne- manjvrednost zdravila Palonosetron Hospira proti primerjanemu zdravilu.
English: 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.
Slovenian: pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
English: 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.
Slovenian: pri enojnem odmerku 1 µg/kg in 3 µg/kg so primerjali v prvi klinični študiji s 150 bolniki v naslednjih starostnih skupinah: > 28 dni do 23 mesecev (7 bolnikov), 2 do 11 let (96 bolnikov) in 12 do 16 let (47 bolnikov) z elektivno operacijo.
English: 24 - 120 hours 0 - 120 hours
Slovenian: 24 - 120 ur 0 - 120 ur
English: Palonosetron Hospira may cause dizziness or tiredness.
Slovenian: Zdravilo Palonosetron Hospira lahko povzroča omotico ali utrujenost.
English: Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin.
Slovenian: Emetogene kemoterapije, ki so jih uporabljali, so vključevale doksorubicin, ciklofosfamid (<1500 mg/m ifosfamid, cisplatin, daktinomicin, karboplatin in davnorubicin.
English: 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 %.
Slovenian: Po intravenskem dajanju palonosetrona v odmerku 0,25 mg vsak drugi dan je po 3 odmerkih pri 11 bolnikih z rakom mod koncentracija v plazmi od 1. do 5. dne povprečno (± SD) zrasla za 42 ± 34 %.
English: Following single dose intravenous infusion of Palonosetron 20 μg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Slovenian: Po intravenski infuziji zdravila Palonosetron Hospira v enkratnem odmerku 20 µg/kg so bile najvišje koncentracije v plazmi (CT) na koncu 15-minutne infuzije v vseh starostnih skupinah zelo variabilne, so se pa nagibale k temu,
English: Uncommon ARs (≥1/1,000 to <1/100)
Slovenian: občasni neželeni učinki (≥1/1.000 do <1/100)
English: Each vial contains 250 micrograms palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml)
Slovenian: Ena viala vsebuje 250 mikrogramov palonosetrona (v obliki palonosetronijeveg klorida) v 5 ml (50 mikrogramov/ml).
English: Important information about some of the ingredients of Palonosetron Hospira This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Slovenian: Zdravilo Palonosetron Hospira vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'.
English: In clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Slovenian: V kliničnih študijah so opažali naslednje neželene učinke, ki jih je mogoče pripisati jemanju palonosetrona.
English: • abnormal heart rate
Slovenian: • nenormalen srčni utrip
English: • The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment).
Slovenian: Druge sestavine zdravila so manitol, dinatrijev edetat, natrijev citrat, citronska kislina monohidrat, voda za injekcije, natrijev hidroksid in klorovodikova kislina (za prilagoditev pH).
English: Common (may affect up to 1 in 10 people): • headache
Slovenian: Pogosti (lahko se pojavi pri manj kot 1 od 10 ljudi): • glavobol
English: Children and Adolescents (aged 1 month to 17 years) The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms.
Slovenian: Zdravnik bo določil odmerek, odvisen od telesne mase, največji odmerek pa je 1500 mikrogramov.
English: • numbness, burning, prickling or tingling sensations on the skin
Slovenian: • odrevenelost, občutek pečenja, zbadanja ali mravljinčenja na koži
English: 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
Slovenian: Po intravenskem dajanju palonosetrona 12 zdravim osebam v odmerku 0,25 mg enkrat na dan 3 dni je koncentracija palonosetrona v plazmi od 1. do 3. dne povprečno (± SD) zrasla za 110 ± 45 %.
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Slovenian: Srčne bolezni tahikardija, bradikardija, prezgodnji utripi, miokardna ishemija, sinusna tahikardiija, sinusna aritmija, nadprekatni prezgodnji utripi
English: Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.
Slovenian: Ker lahko palonosetron povzroči vrtoglavico, zaspanost in utrujenost, je potrebno bolnike, ki upravljajo s stroji, in voznike na te učinke opozoriti.
English: However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Slovenian: Toda, kot pri drugih 5-HT3 antagonistih je potrebna previdnost pri uporabi palonosetrona pri bolnikih,
English: 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.
Slovenian: C] - palonosetrona, se 80 % odmerka v 144 urah izloči v urinu, kjer je 40 % danega odmerka palonosetrona aktivna nespremenjena substanca.
English: The recommended dose of Palonosetron Hospira is 250 micrograms given as a rapid injection into a vein.
Slovenian: Odrasli Priporočeni odmerek zdravila Palonosetron Hospira 250 mikrogramov se daje kot hitra injekcija v veno.
English: 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
Slovenian: Drugo pediatrično preskušanje je bila multicentrična, dvojno slepa, dvojno zakrita randomizirana študija ne-manjvrednosti s paralelnimi skupinami, aktivnimi kontrolami in enkratnim odmerkom, v kateri so primerjali i.v.
English: • diarrhoea
Slovenian: • potovalna bolezen
English: Uncommon (may affect up to 1 in 100 people):
Slovenian: Občasni (lahko se pojavijo pri manj kot 1 od 100 ljudi):
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (lahko se pojavijo pri manj kot 1 od 10 ljudi):
English: • impaired vision or eye irritation
Slovenian: • motnje vida ali draženje oči
English: • hiccups, flatulence, dry mouth or indigestion
Slovenian: • kolcanje, vetrovi, suha usta ali slaba prebava
English: Intent-to-treat cohort.
Slovenian: Kohorta z namenom zdravljenja.
English: Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Slovenian: Bolezni imunskega sistema preobčutljivost, anafilaksija, anafilaktične/ anafilaktoidne reakcije in šok
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA05
Slovenian: Farmakoterapevtska skupina: Antiemetiki in zdravila proti slabosti, antagonisti serotoninskih 5-HT3 receptorjev.
English: 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
Slovenian: V randomizirani, dvojno slepi študiji, v kateri je sodelovalo 667 bolnikov, ki so prejemali visoko emetogeno kemoterapijo, ki je vključevala cisplatin >60 mg/m2, ciklofosfamid >1500 mg/m2 in dakarbazin, so primerjali odmerka 250 mikrogramov in 750 mikrogramov palonosetrona v primerjavi z ondansetronom 32 mg, danim prvi dan kemoterapije.
English: Table 1: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus ondansetron
Slovenian: Preglednica 1: Odstotek bolnikov a, ki reagirajo na zdravljenje glede na vrsto in stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z ondansetronom
English: Age does not affect the pharmacokinetics of palonosetron.
Slovenian: Starejša populacija Starost ne vpliva na farmakokinetiko palonosetrona.
English: 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.
Slovenian: ≤1500 mg/m2 in doksorubicin >25 mg/m2, so primerjali odmerka palonosetrona 250 mikrogramov in 750 mikrogramov v primerjavi z ondansetronom 32 mg (razpolovni čas 4 ure) ali dolasetronom 100 mg (razpolovni čas 7,3 ure), danih intravensko prvi dan kemoterapije, brez deksametazona.
English: 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.
Slovenian: Očistek in volumen porazdelitve pri pediatričnih bolnikih sta bila izračunana za skupino, združeno iz skupin z odmerkoma 10 µg /kg in 20 µg /kg, popravljeni za telesno maso.
English: Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron
Slovenian: Preglednica 2: Odstotek bolnikov a, ki reagirajo na zdravljenje glede na vrsto in stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z dolasetronom
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron (as hydrochloride)
Slovenian: Palonosetron Hospira 250 mikrogramov raztopina za injiciranje palonosetron (v obliki palonosetronijevega klorida)
English: Palonosetron 250 micrograms (n= 223)
Slovenian: Palonosetron 250 mikrogramov (n = 223)
English: Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron
Slovenian: Preglednica 3: Odstotek bolnikov a, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji visoko emetogene kemoterapije v primerjavi z ondansetronom
English: • The active substance is palonosetron (as hydrochloride).
Slovenian: Zdravilna učinkovina je palonosetron (v obliki palonosetronijevega klorida).
English: Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Slovenian: En ml raztopine vsebuje 50 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
English: How to store Palonosetron Hospira
Slovenian: Kako uporabljati zdravilo Palonosetron Hospira
English: What Palonosetron Hospira contains
Slovenian: Kaj vsebuje zdravilo Palonosetron Hospira
English: • coughing or shortness of breath
Slovenian: • kašelj ali kratka sapa
English: Palonosetron Hospira250 micrograms solution for injection.
Slovenian: Palonosetron Hospira 250 mikrogramov raztopina za injiciranje
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron
Slovenian: Palonosetron Hospira 250 mikrogramov raztopina za injiciranje palonosetron
English: • motion sickness
Slovenian: • omotica
English: Palonosetron 250 micrograms (n= 185)
Slovenian: Palonosetron 250 mikrogramov (n = 185)
English: Other medicines and Palonosetron Hospira
Slovenian: Shranjevanje zdravila Palonosetron Hospira
English: • dizziness
Slovenian: • driska.
English: Single use only
Slovenian: intravenska uporaba samo za enkratno uporabo
English: Common ARs (≥1/100 to<1/10)
Slovenian: Vrsta organskega sistema pogosti neželeni učinki (≥1/100 do<1/10)
English: Asthenia, pyrexia, fatigue, feeling hot, influenza like illness
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, zvišana telesna temperatura, utrujenost, občutek vročine, gripi podobna bolezen reakcija na mestu injiciranja*
English: • Keep this leaflet.
Slovenian: • srbeč kožni izpuščaj
English: Elimination
Slovenian: • zaprtje
English: haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, dispnea, epistaksa
English: • 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,
Slovenian: Preden boste prejeli zdravilo Palonosetron Hospira se posvetujte z zdravnikom ali farmacevtom: - če imate akutno zaporo črevesa ali anamnezo ponavljajočih se zaprtij; - če poleg zdravila Palonosetron Hospira uporabljate druga zdravila, ki lahko povzročijo motnje srčnega ritma, na primer amiodaron, nikardipin, kinidin, moksifloksacin, eritromicin, haloperidol, klorpromazin, kvetiapin, tioridazin, domperidon; - če imate osebno ali družinsko anamnezo sprememb srčnega ritma (podaljšanega intervala QT); - če imate druge težave s srcem; - če imate v krvi neravnovesje določenih mineralov, na primer kalija in magnezija, zaradi katerega se niste zdravili.
English: • difficulty urinating
Slovenian: • oteženo odvajanje vode
English: 0.075 mg) versus intravenous ondansetron.
Slovenian: palonosetron (1 µg/kg, največji odmerek 0,075 mg) z i.v.
English: In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards.
Slovenian: Poleg tega so večino bolnikov, ki so bili vključeni v glavno študijo, spremljali še največ 24 mesecev.
English: The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken with food.
Slovenian: Na voljo je v obliki tablet (50 mg), priporočeni odmerek pa sta dve tableti dvakrat na dan s hrano.
English: What measures are being taken to ensure the safe and effective use of Deltyba?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Deltyba?
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis).
Slovenian: Tuberkuloza je okužba, ki jo povzroča bakterija Mycobacterium tuberculosis (M. tuberculosis).
English: 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.
Slovenian: Uporablja se skupaj z drugimi zdravili za zdravljenje tuberkuloze in le takrat, kadar drugih standardnih zdravil ni mogoče uporabiti bodisi zaradi odpornosti bolezni proti njim bodisi zaradi njihovih neželenih učinkov.
English: 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.
Slovenian: Čeprav je bila glavna študija kratkoročna in so imele nadaljnje študije pomanjkljivosti, je agencija menila, da se učinki, ki so se pokazali po začetnih dveh mesecih zdravljenja, najverjetneje ohranijo v celotnem obdobju zdravljenja.
English: Deltyba must not be used in patients who have low levels of albumin (a blood protein).
Slovenian: Zdravilo Deltyba se ne sme uporabljati pri bolnikih, ki imajo nizke ravni albumina (krvne beljakovine).
English: The safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety.
Slovenian: Po njenem mnenju je varnostni profil obvladljiv in uvedenih je bilo več ukrepov za zmanjševanje tveganj, vključno s študijo za potrditev dolgoročne varnosti.
English: Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Deltyba so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
Slovenian: Agencija je menila, da bo klinična študija, ki trenutno poteka, potrdila dolgoročno učinkovitost.
English: Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines.
Slovenian: Zdravljenje s temi zdravili se mora nadaljevati po prenehanju zdravljenja z zdravilom Deltyba, kot določajo uradne smernice.
English: The most common side effects with Deltyba (which may affect more than 1 patient in 10) are nausea, vomiting, headache, insomnia (sleeping problems), dizziness, tinnitus (ringing or buzzing in the ears), blood tests showing low potassium levels in the blood, gastritis (inflammation of the stomach lining), decreased appetite and weakness.
Slovenian: Najpogostejši neželeni učinki zdravila Deltyba (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so siljenje na bruhanje, bruhanje, glavobol, nespečnost (težave s spanjem), omotica, tinitus (zvenenje ali šumenje v ušesih), krvni testi, ki kažejo nizke ravni kalija v krvi, gastritis (vnetje želodčne sluznice), zmanjšan tek in šibkost.
English: Deltyba received a marketing authorisation valid throughout the European Union on 28 April 2014.
Slovenian: Za zdravilo Deltyba je bilo 28. aprila 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that Deltyba's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Deltyba večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
English: Why is Deltyba authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Deltyba odobreno v EU?
English: Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 1 February 2008.
Slovenian: Tuberkuloza je v EU redka, zato je bilo zdravilo Deltyba 1. februarja 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments.
Slovenian: Učinke zdravila Deltyba so preučevali v eni glavni študiji s 481 odraslimi s tuberkulozo, ki je odporna proti standardnim zdravilom.
English: Deltyba is given for 6 months together with other tuberculosis medicines.
Slovenian: Zdravilo Deltyba se daje šest mesecev skupaj z drugimi zdravili za zdravljenje tuberkuloze.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Deltyba upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm).
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki v izpljunku (sluzi) niso več imeli bakterij.
English: What benefits of Deltyba have been shown in studies?
Slovenian: Kakšne koristi zdravila Deltyba so se pokazale v študijah?
English: As for all medicines, data on the use of Deltyba are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Deltyba stalno spremljajo.
English: What is Deltyba and what is it used for?
Slovenian: Kaj je zdravilo Deltyba in za kaj se uporablja?
English: An overview of Deltyba and why it is authorised in the EU
Slovenian: Pregled zdravila Deltyba in zakaj je odobreno v EU
English: Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Deltyba, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and ketomycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.
Slovenian: Čeprav delovanje delamanida ni jasno, je znano, da zavira tvorbo metoksi-mikolične in keto-mikolične kisline, dveh najpomembnejših sestavin celičnih sten M. tuberculosis, s čimer povzroči uničenje bakterij.
English: Deltyba has been given ‘conditional authorisation'.
Slovenian: Zdravilo Deltyba je pridobilo „pogojno dovoljenje za promet“.
English: For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Deltyba glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.