FrancophonIA/ELRC3.0 huggingface dataset:
English: • Set the top of the case aside.
Slovenian: • Odložite pokrov etuija.
English: Place inhaler back in storage case and close tightly.
Slovenian: Spravite inhalator spet v etui in ga dobro zaprite.
English: Children below the age of 13 years may be more likely to cough when treated with TOBI Podhaler compared with older subjects.
Slovenian: Pri zdravljenju z zdravilom TOBI Podhaler so otroci, stari manj kot 13 let, bolj nagnjeni h kašlju kot starejše osebe.
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of TOBI Podhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential.
Slovenian: Glede na profil interakcij tobramicina pri intravenski in aerosolni uporabi sočasna in/ali zaporedna uporaba zdravila
English: Only TOBI Podhaler capsules are to be used in the Podhaler device.
Slovenian: Z inhalatorjem Podhaler se sme uporabljajti samo kapsule TOBI Podhaler.
English: (To be displayed only on the inner lid of the intermediate carton of multipack) Read the package leaflet before use.
Slovenian: (besedilo, ki je natisnjeno samo na notranjem zavihku vmesne škatle skupnega pakiranja) Pred uporabo preberite priloženo navodilo.
English: FEV1 should be measured before and after inhalation of TOBI Podhaler.
Slovenian: TOBI Podhaler in po njej je treba izmeriti FEV1.
English: Store in the original package in order to protect from moisture and only remove immediately before use.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in vzemite iz ovojnine šele tik pred uporabo.
English: • Only use the capsules with the inhaler provided in this pack.
Slovenian: • Kapsule uporabljajte samo s priloženim inhalatorjem.
English: In the active-controlled open-label study, patients aged 20 years and older tended to discontinue more frequently with TOBI Podhaler than with the nebuliser solution; discontinuations due to adverse events accounted for about half of the discontinuations with each formulation.
Slovenian: V aktivno kontrolirani odprti študiji so bolniki, stari 20 let in več, nekoliko pogosteje prekinili zdravljenje z zdravilom TOBI Podhaler kot z raztopino za nebulator.
English: Do not push capsule through foil.
Slovenian: Kapsul ne potiskajte skozi zaščitno folijo.
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients aged 6 to 66 years estimated the apparent serum clearance of tobramycin to be 14 litres/h.
Slovenian: ki so stari od 6 do 66 let, je ocenjeni navidezni očistek tobramicina iz seruma 14 litrov na uro.
English: (To be displayed only on the inner lid of the outer carton of unit pack) Read the package leaflet before use.
Slovenian: (besedilo, ki je natisnjeno samo na notranjem zavihku zunanje škatle skupnega pakiranja) Pred uporabo preberite priloženo navodilo.
English: • For inhalation use only.
Slovenian: • Zdravilo je namenjeno samo za inhaliranje.
English: Adverse reactions specifically associated with overdose of TOBI Podhaler have not been identified.
Slovenian: Ugotavljali niso nobenih neželenih učinkov, ki bi jih povzročilo prav preveliko odmerjanje zdravila TOBI Podhaler.
English: TOBI Podhaler 28 mg inhalation powder, hard capsules
Slovenian: TOBI Podhaler 28 mg prašek za inhaliranje, trde kapsule
English: • Vomiting, nausea
Slovenian: • bruhanje, občutek slabosti
English: Mylan Ireland Limited Tel: +353 87 1694982
Slovenian: Tel: +353 87 1694982
English: BGP Products AB Tel: +46 8 555 227 07
Slovenian: Tel: +46 8 555 227 07
English: You should not take the following medicines while you are taking TOBI Podhaler:
Slovenian: Kadar jemljete zdravilo TOBI Podhaler, ne smete jemati naslednjih zdravil:
English: Clinical studies with inhaled tobramycin solution (TOBI) have shown a small increase in tobramycin, amikacin and gentamicin Minimum Inhibitory Concentrations for P. aeruginosa isolates tested.
Slovenian: TOBI) so se pri testiranih izolatih bakterije P. aeruginosa minimalne inhibitorne koncentracije tobramicina, amikacina in gentamicina nekoliko zvišale.
English: How long to take TOBI Podhaler
Slovenian: Kako dolgo je treba jemati zdravilo TOBI Podhaler
English: Patients with haemoptysis (>60 ml) were excluded from the clinical studies so no data exist on the use of TOBI Podhaler in these patients.
Slovenian: niso vključevali v klinične študije, zato podatki o uporabi zdravila TOBI Podhaler pri teh bolnikih niso na voljo.
English: Observed benefits on lung function and P. aeruginosa suppression should be assessed in the context of the patient's tolerance of TOBI Podhaler.
Slovenian: Koristnost zdravljenja z izboljšanjem pljučne funkcij in zmanjšanjem števila bakterij P. aeruginosa je treba presojati skupno s prenašanjem zdravila TOBI Podhaler.
English: TOBI Podhaler capsules must always be stored in the blister to protect from moisture and only removed immediately before use.
Slovenian: Za zagotovitev zaščite pred vlago je treba kapsule zdravila TOBI Podhaler vedno shranjevati v pretisnem omotu in jih vzeti iz njega šele tik pred uporabo.
English: Contains 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride and sulphuric acid (for pH adjustment).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje 1,2-distearoil-sn-glicero-3-fosfoholin (DSPC), kalcijev klorid in žveplovo kisino (za uravnavanje pH).
English: See also “Monitoring of serum tobramycin concentrations” below.
Slovenian: Glejte tudi "Spremljanje koncentracij tobramicina v serumu" v nadaljevanju.
English: In the event of accidental oral ingestion of TOBI Podhaler capsules, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Slovenian: V primeru nehotenega zaužitja kapsule zdravila TOBI Podhaler je toksično delovanje le malo verjetno,
English: Pseudomonas aeruginosa Haemophilus influenzae Staphylococcus aureus Insusceptible Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
Slovenian: Haemophilus influenzae Staphylococcus aureus neobčutljivi
English: • Loss of voice
Slovenian: • sprememba okusa v ustih • izguba glasu
English: In both studies, there was a trend for a recovery of P. aeruginosa density after the 28 days off-treatment period, which was reversed after a further 28 days on-treatment.
Slovenian: aeruginosa, ki pa se je po 28-dnevnem obdobju zdravljenja spet obrnil.
English: Capsule card
Slovenian: Kapsul zdravila
English: TOBI Podhaler 28 mg inhalation powder, hard capsules tobramycin
Slovenian: TOBI Podhaler 28 mg prašek za inhaliranje, trde kapsule tobramicin
English: (To be displayed only on the inner lid of the outer carton of multipack) Read the package leaflet before use.
Slovenian: (besedilo, ki je natisnjeno samo na notranjem zavihku zunanje škatle posamičnega pakiranja) Pred uporabo preberite priloženo navodilo!
English: Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (-1.61 log10 CFUs), as did the nebuliser solution (-0.77 log10 CFUs).
Slovenian: Do statistično značilnega zmanjšanja gostote bakterij P. aeruginosa v izpljunku (-1,61 log10 kolonijskih enot) je prišlo pri zdravljenju z zdravilom TOBI Podhaler 28 dni, pa tudi z uporabo raztopine za nebulator (-0,77 log10 kolonijskih enot).
English: • Discard all the empty capsules.
Slovenian: • Prazne kapsule zavrzite.
English: Cough was reported with use of TOBI Podhaler in clinical studies.
Slovenian: Pri uporabi zdravila TOBI Podhaler v kliničnih študijah so poročali o kašlju.
English: Additional information
Slovenian: Drugi viri informacij
English: • Always hold the device with the mouthpiece pointing down when piercing the capsule.
Slovenian: • Pri prediranju kapsule vedno držite inhalator z ustnikom navzdol.
English: • Risk Management plan (RMP)
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČ • Načrt za obvladovanje tveganj (RMP)
English: Mylan Healthcare Norge AS Tlf: +47 66 75 33 00
Slovenian: Tlf: +47 66 75 33 00
English: • Put the capsule back into the inhaler chamber (step 6).
Slovenian: Če kapsula ni videti predrta: • jo vstavite nazaj v ležišče na inhalatorju (korak št. 6).
English: Ototoxicity, manifested as both auditory toxicity (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides.
Slovenian: Pri uporabi parenteralnih aminoglikozidov so poročali o ototoksičnosti, tako o toksičnem delovanju na sluh (o slabšanju sluha) kot o vestibularni toksičnosti.
English: In the placebo-controlled study with TOBI Podhaler, the adverse reactions for which reported frequency was higher with TOBI Podhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.
Slovenian: V s placebom kontrolirani študiji z zdravilom TOBI Podhaler so bili neželeni učinki bolečine v ustih in žrelu, motnje okušanja in hripavost, bolj pogosti pri bolnikih, ki so prejemali zdravilo TOBI Podhaler, kot pri tistih, ki so prejemali placebo.
English: Package leaflet: Information for the user TOBI Podhaler 28 mg inhalation powder, hard capsules tobramycin
Slovenian: Navodilo za uporabo TOBI Podhaler 28 mg prašek za inhaliranje, trde kapsule tobramicin
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: This necessitates sputum concentrations of tobramycin after inhalation to be about ten-fold above the minimum inhibitory concentration (MIC) or higher for P. aeruginosa suppression.
Slovenian: Izmeček pri cistični fibrozi zavira lokalno biološko delovanje inhaliranih aminoglikozidov, zato morajo biti koncentracije tobramicina v slini po inhalaciji vsaj desetkrat višje od minimalne inhibitorne koncentracije (MIK), da bi zdravilo lahko zmanjšalo število bakterij P. aeruginosa.
English: Nephrotoxicity has been reported with the use of parenteral aminoglycosides.
Slovenian: Pri uporabi parenteralnih aminoglikozidov so poročali o toksičnosti za ledvice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WEEKLY INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: TEDENSKA VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ "BLUE BOX" PODATKOV)
English: • Place inhaler back in storage case • Twist the top of the case in a clockwise direction until it is closed tighly.
Slovenian: • Pokrov etuija privijte v smeri urinega kazalca, dokler ni trdno zaprt.
English: If your underlying lung disease seems worse while taking TOBI Podhaler, tell your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila TOBI Podhaler, kot bi smeli Če ste vdihnili preveč zdravila TOBI Podhaler, čimprej obvestite zdravnika.
English: After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, sputum Cmax of tobramycin was 1047 ± 1080 µg/g (mean ± SD).
Slovenian: Po inhalaciji enkratnega odmerka 112 mg zdravila TOBI Podhaler (štiri 28-miligramske kapsule) pri bolnikih s cistično fibrozo, je bila najvišja koncentracija tobramicina v izpljunku (Cmax)
English: Take TOBI Podhaler twice a day, every day for 28 days
Slovenian: 28 dni jemljite zdravilo TOBI Podhaler vsak dan dvakrat na dan naslednjih 28 dni ne jemljite zdravila TOBI Podhaler krog ponavljajte
English: Bronchospasm can occur with inhalation of medicinal products and has been reported with TOBI Podhaler in clinical studies.
Slovenian: Bronhospazem Pri inhalaciji zdravil lahko pride do bronhospazma, o katerem so poročali tudi pri uporabi zdravila
English: • Always keep the TOBI Podhaler capsules and device in a dry place.
Slovenian: • Kapsule zdravila TOBI Podhaler in inhalator shranjujte na suhem mestu.
English: Mylan EPD Kft. Tel: +36 1 465 2100
Slovenian: Tel: +36 1 465 2100
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK (INCLUDING BLUE BOX)
Slovenian: ZUNANJA ŠKATLA POSAMIČNEGA PAKIRANJA (VKLJUČNO Z "BLUE BOX" PODATKI)
English: In the patients aged <20 years the increase from baseline percent predicted FEV1 was larger: 11.3% for TOBI Podhaler and 6.9% for the nebuliser solution after 3 cycles.
Slovenian: 11,3 % pri uporabi zdravila TOBI Podhaler in 6,9 % pri uporabi raztopine za nebulator.
English: Mylan Products Ltd. Tel: +44 1707 853000
Slovenian: Tel: +44 1707 853000
English: What you need to know before you take TOBI Podhaler Do not take TOBI Podhaler
Slovenian: jemanje zdravila TOBI Podhaler brez jemanja zdravila TOBI Podhaler
English: Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.
Slovenian: naj pri uporabi zdravila pomagajo negovalci in z nadzorovanjem nadaljujejo tako dolgo, da se otroci naučijo ustrezno uporabljati inhalator Podhaler povsem samostojno.
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction.
Slovenian: Pri predpisovanju zdravila TOBI Podhaler bolnikom z ugotovljeno ledvično disfunkcijo ali s sumom nanjo je potrebna previdnost.
English: Put the pierced side of the capsule in first.
Slovenian: Kapsulo vstavite s predrtim delom naprej.
English: Tobramycin serum concentrations may be helpful in monitoring overdosage.
Slovenian: Pri spremljanju posledic prevelikega odmerjanja si je mogoče pomagati z določanjem koncentracije tobramicina v serumu.
English: Where patients are receiving several different inhaled medicinal products and chest physiotherapy, it is recommended that TOBI Podhaler is taken last.
Slovenian: Pri bolnikih, ki uporabljajo več različnih inhalacijskih zdravil in metod dihalne fizioterapije, je priporočljivo, da vzamejo zdravilo TOBI Podhaler kot zadnje po uporabi drugih inhalacijskih zdravil in/ali metod dihalne fizioterapije.
English: How much TOBI Podhaler to take
Slovenian: Koliko zdravila TOBI Podhaler je treba uporabljati
English: See also “Monitoring of serum tobramycin concentrations” above.
Slovenian: Glejte tudi "Spremljanje koncentracij tobramicina v serumu" v predhodnem besedilu.
English: Separate the morning and evening doses from the capsule card. Peel back the foil from the capsule card to reveal one TOBI Podhaler capsule and remove it from the card.
Slovenian: S tablice s kapsulami odstranite zaščitno folijo, tako da odkrijete samo eno kapsulo TOBI
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction.
Slovenian: Pri predpisovanju zdravila TOBI Podhaler bolnikom z ugotovljeno slušno ali vestibularno disfunkcijo ali s sumom na katero od njiju, je potrebna previdnost.
English: Do not overtighten (2).
Slovenian: • Ustnik trdno privijte kolikor gre, vendar ga ne zategnite preveč (2).
English: Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after inhalation of TOBI Podhaler.
Slovenian: Do tega lahko pride takoj po inhalaciji zdravila TOBI Podhaler.
English: Mylan EPD bvba/sprl Tél/Tel: +32 2 658 61 00
Slovenian: Tél/Tel: +32 2 658 61 00
English: • Do not swallow TOBI Podhaler capsules.
Slovenian: • Kapsul zdravila TOBI Podhaler ne smete pogoltniti.
English: BGP Products UAB Tel: +370 5 205 1288
Slovenian: Tel: +370 5 205 1288
English: Replace the mouthpiece and screw it on firmly until it stops.
Slovenian: Ponovno namestite ustnik in ga kolikor gre trdno privijte.
English: Once removed from the capsule card (blister), a capsule should be used immediately.
Slovenian: Kapsulo je treba uporabiti takoj po tem, ko jo vzamete iz tablice s kapsulami (iz pretisnega omota).
English: When to take TOBI Podhaler
Slovenian: Kdaj jemati zdravilo TOBI Podhaler
English: Nephrotoxicity was not observed during TOBI Podhaler clinical studies.
Slovenian: V kliničnih študijah z zdravilom TOBI Podhaler niso opažali toksičnega delovanja na ledvice.
English: • Stand the inhaler upright in the base of the case.
Slovenian: • Postavite inhalator navpično v spodnji del etuija.
English: Oropharnygeal pain
Slovenian: Pseudomonas aeruginosa
English: • Replace the mouthpiece and screw it on firmly until it stops.
Slovenian: • Ponovno namestite ustnik in ga kolikor gre trdno privijte.
English: How TOBI Podhaler works
Slovenian: Kako deluje zdravilo TOBI Podhaler
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of TOBI Podhaler therapy.
Slovenian: Po vsakih šestih zaključenih ciklusih zdravljenja z zdravilom TOBI Podhaler je potrebno ponovno preveriti koncentraciji sečnine in kreatinina.
English: Wheezing
Slovenian: Dojenje
English: How to store TOBI Podhaler
Slovenian: Shranjevanje zdravila TOBI Podhaler
English: Dysphonia
Slovenian: • zadihanost
English: Just before use, remove the Podhaler device from its case.
Slovenian: Inhalator Podhaler vzemite iz etuija tik pred uporabo.
English: Mylan Healthcare GmbH Tel: +49 6172 888 01
Slovenian: Tel: +49 6172 888 01
English: Do not swallow.
Slovenian: PRETISNI OMOTI
English: Inside your TOBI Podhaler weekly pack
Slovenian: Vsebina tedenskega pakiranja zdravila TOBI Podhaler
English: BGP PRODUCTS SRL Tel.: +40 372 579 000
Slovenian: Tel.: +40 372 579 000
English: How to take TOBI Podhaler
Slovenian: Kako uporabljati zdravilo TOBI Podhaler
English: Sulfuric acid (for pH adjustment)
Slovenian: Bolnikov s hemoptizo (>60 ml)
English: Malaise
Slovenian: občutljivi
English: • Always keep the capsules in the capsule card until when you need to use them.
Slovenian: • Kapsule do uporabe pustite v tablici s kapsulami.
English: Latuda lurasidone
Slovenian: Latuda lurasidon
English: The recommended starting dose is 37 mg once a day, taken with food at approximately the same time of the day.
Slovenian: Priporočeni začetni odmerek je 37 mg enkrat na dan, ki se jemlje skupaj s hrano vsak dan ob približno istem času.
English: What measures are being taken to ensure the safe and effective use of Latuda?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Latuda?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Latuda on 21 March 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Latuda, veljavno po vsej Evropski uniji, izdala dne 21. marca 2014.
English: Latuda has been investigated in six main studies.
Slovenian: Zdravilo Latuda so proučevali v šestih glavnih študijah.
English: Latuda is available as tablets (18.5, 37 and 74 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Latuda je na voljo v obliki tablet (18,5, 37 in 74 mg) in se izdaja le na recept.
English: Depending on the patient's response and the judgement of the treating doctor, the dose can be increased up to a maximum dose of 148 mg once a day.
Slovenian: Odmerek se lahko na osnovi bolnikovega odziva in presoje lečečega zdravnika poveča do največjega odmerka 148 mg enkrat na dan.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Slovenian: Živčni prenašalci so kemične snovi, ki omogočajo medsebojno komunikacijo med živčnimi celicami.
English: The full EPAR and risk management plan summary for Latuda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Latuda sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the change in the patient's symptoms, measured using a standard scale for schizophrenia called ‘positive and negative syndrome scale' (PANSS).
Slovenian: Glavno merilo učinkovitosti je bila sprememba bolnikovih simptomov, ki so jo izmerili s standardno lestvico za shizofrenijo, imenovano „lestvica pozitivnih in negativnih sindromov“ (positive and negative syndrome scale - PANSS).
English: Other information about Latuda
Slovenian: Druge informacije o zdravilu Latuda
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Latuda's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Latuda večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Latuda.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Latuda.
English: What benefits of Latuda have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Latuda izkazalo v študijah?
English: A risk management plan has been developed to ensure that Latuda is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Latuda je bil pripravljen načrt obvladovanja tveganj.
English: It is used to treat adults with schizophrenia, a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Slovenian: Uporablja se za zdravljenje odraslih s shizofrenijo, ki je duševna bolezen z vrsto simptomov, med katerimi so nepovezano razmišljanje in govorjenje, halucinacije (bolnik sliši ali vidi stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
English: It is not intended to provide practical advice on how to use Latuda.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Further analyses of the results were carried out by the company, which supported the short-term benefits of treatment with Latuda.
Slovenian: Družba je izvedla dodatne analize rezultatov, ki so potrdile kratkoročne koristi zdravljenja z zdravilom Latuda.
English: Why is Latuda approved?
Slovenian: Zakaj je bilo zdravilo Latuda odobreno?
English: Latuda must not be used together with medicines known as ‘strong CYP3A4 inhibitors' or ‘strong CYP3A4 inducers', which may affect the levels of lurasidone in the blood.
Slovenian: Zdravilo Latuda se ne sme uporabljati skupaj z drugimi zdravili, imenovanimi „močni zaviralci CYP3A4“ in „močni induktorji CYP3A4“, saj bi lahko vplivali na ravni lurasidona v krvi.
English: The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia (a constant urge to move) and somnolence (sleepiness).
Slovenian: Najpogostejša neželena učinka zdravila Latuda (ki lahko prizadeneta več kot 1 osebo od 10) sta akatizija (neprestana potreba po gibanju) in somnolenca (zaspanost).
English: What is Latuda and what is it used for?
Slovenian: Kaj je zdravilo Latuda in za kaj se uporablja?
English: In these studies, different doses of Latuda were shown to be more effective than placebo, lowering the PANSS score by up to 16 points more than placebo; however, this effect was not consistently demonstrated for each dose and it was not possible to observe a consistent dose-response relationship.
Slovenian: Te študije so pokazale, da so bili različni odmerki zdravila Latuda učinkovitejši od placeba, saj so oceno po PANSS znižali za do 16 točk več kot placebo, vendar tega učinka niso dosledno dokazali pri vseh odmerkih, prav tako ni bilo mogoče opaziti dosledne povezave med odmerkom in odzivom.
English: What are the risks associated with Latuda?
Slovenian: Kakšna tveganja so povezana z zdravilom Latuda?
English: For more information about treatment with Latuda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Latuda preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5hydroxytryptamine (also called serotonin) and noradrenaline.
Slovenian: Lurasidon večinoma prepreči delovanje receptorjev za živčne prenašalce dopamin, 5-hidroksitriptamin (imenovan tudi serotonin) in noradrenalin.
English: Latuda is a medicine that contains the active substance lurasidone.
Slovenian: Latuda je zdravilo, ki vsebuje zdravilno učinkovino lurasidon.