natgillin/translations-raw huggingface dataset:
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP:”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake "EXP:".
- if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na delamanid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
carbamazepine). 
karbamazepin).
Frequent ECG monitoring should be performed. 
EKG je treba pogosto spremljati.
These four patients were only receiving two other medicinal products in addition to delamanid. 
Ti štirje bolniki so razen delamanida prejemali le še dve drugi zdravili.
Before you start taking Deltyba, and during the treatment, your doctor may check your heart's electrical activity using an ECG (electrocardiogram) machine (electrical recording of the heart). 
Preden začnete jemati zdravilo Deltyba in med zdravljenjem bo morda zdravnik preveril električno aktivnost vašega srca z elektrokardiogramom (EKG) (beleženje električne aktivnosti srca).
DO NOT stop taking the tablets unless your doctor tells you to. 
NE prenehajte jemati zdravila, razen če vam je zdravnik tako naročil.
The PRAC requests a cumulative review of this risk in next PSUR, using appropriate PT terms, in order to assess whether an update of the risk is needed. 
Odbor PRAC zahteva kumulativni pregled tega tveganja v naslednjem poročilu PSUR z uporabo ustreznih prednostnih izrazov za oceno potrebe po posodobitvi navedb o tem tveganju.
• Increase of libido 
• povečan libido
Delamanid highly binds to all plasma proteins with a binding to total proteins of ≥99.5%. 
Delamanid se močno veže na vse beljakovine v plazmi s skupno vezavo na beljakovine ≥ 99,5 %.
Hereford, HR3 5PG United Kingdom 
Hereford, HR3 5PG Velika Britanija
Deltyba may cause harm to an unborn baby. 
Zdravilo Deltyba lahko škodi nerojenemu otroku.
• Changes found in investigations (electrocardiogram, ECG) of the heart 
• spremembe, ugotovljene pri preiskavah srca (elektrokardiogram, EKG)
The Educational material for Healthcare Providers (HCPs) shall address the following key elements: 
Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje ključne elemente:
Deltyba is not suitable for children under age 18. 
Zdravilo Deltyba ni primerno za otroke, stare manj kot 18 let.
Treatment with delamanid should not be initiated in patients with the following risk factors unless the possible benefit of delamanid is considerd to outweigh the potential risks. 
Zdravljenja z delamanidom se ne sme uvesti pri bolnikih z naslednjimi dejavniki tveganja, razen če so možne koristi delamanida ocenjene kot večje od možnih tveganj.
Liver disorders is categorised as an important potential risk. 
Tveganje bolezni jeter je sedaj razvrščeno med pomembna možna tveganja.
• Itchy or red skin including around the hair roots. 
• srbeča ali rdeča koža, vključno z lasnimi koreninami
Delamanid is not excreted in urine. 
Delamanid se ne izloča v urin.
Delamanid and/or its metabolites have the potential to affect cardiac repolarisation via blockade of hERG potassium channels. 
Delamanid in/ali njegovi presnovki lahko vplivajo na repolarizacijo srca z blokiranjem hERG kalijevih kanalov.
Delamanid does not show cross-resistance with any of the currently used anti-tuberculosis drugs. 
Delamanid ne kaže navzkrižne odpornosti z nobenim od zdravil proti tuberkulozi, ki se trenutno uporabljajo.
• Feeling of emotional and mental discomfort 
• občutek čustvenega in duševnega nelagodja
Resistance to delamanid 
Odpornost na delamanid
Your doctor will weigh up the benefits to you against the risks to your baby of taking Deltyba whilst you are pregnant. 
Vaš zdravnik bo ocenil prednosti za vas glede na tveganja za otroka, povezane z jemanjem zdravila Deltyba, če ste noseči.
There are no data on treatment with delamanid for more than 24 consecutive weeks. 
Podatkov o zdravljenju z delamanidom, ki traja dlje kot 24 zaporednih tednov, ni.
However, since the concentrations in the gut can potentially be much greater than these multiples of the Cmax, there is a potential for delamanid to have an effect on these transporters. 
Ker pa je lahko koncentracija v črevesju veliko večja kot ti večkratniki Cmax, lahko delamanid vpliva na te prenašalce.
If a QTcF >500 ms is observed either before the first dose of delamanid or during delamanid treatment, treatment with delamanid should either not be started or should be discontinued. 
Če se pred prvim odmerkom delamanid ali med zdravljenjem z delamanidom opazi QTcF > 500 ms, zdravljenja z delamanidom ni dovoljeno začeti ali ga je treba prekiniti.
In lactating rats, the Cmax for delamanid in breast milk was 4-fold higher than that of the blood. 
Pri podganah v laktaciji je bila Cmax za delamanid v mleku 4-krat višja kot v krvi.
Albeit, some reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related manner. 
Vendar pa so nekatere reakcije opazili z večjo pogostnostjo, stopnja povečanja podaljšanja intervala QT pa se je povečala v odvisnosti od odmerka.
Stopping too early could allow the bacteria to recover and to become resistant to delamanid. 
Predčasno prenehanje jemanja bi bakteriji omogočilo, da okreva, in postane odporna za delamanid.
• you have been told that you have heart problems, for example a slow heart rhythm (bradycardia) or have a history of heart attack (myocardial infarction) 
• povedali so vam, da imate težave s srcem, na primer počasen srčni ritem (bradikardijo) ali imate srčni napad (miokardni infarkt) v anamnezi
Delamanid plasma exposure increases less than proportionally with increasing dose. 
Izpostavljenost delamanida v plazmi se zvišuje manj kot sorazmerno z večanjem odmerkom.
- Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia. 
- Motnje elektrolitov, zlasti hipokaliemija, hipokalciemija ali hipomagneziemija.
Therefore the potential for drug-drug interactions of clinical significance to occur with delamanid and the possible consequences, including the total effect on the QTc interval, cannot be predicted with confidence. 
Zato možnosti klinično pomembnega delovanja med zdravili, ki bi se lahko pojavilo z delamanidom, in njegovih posledic, vključno s skupnim učinkom na interval QTc, ni mogoče z gotovostjo predvideti.
Two sensitivity analyses were conducted - a last-observation-carried-forward (LOCF) analysis and an analysis using “bookending” methodology (which required that the previous and subsequent cultures were both observed negative cultures to impute a negative result, otherwise a positive result was imputed). 
Izvedeni sta bili dve analizi občutljivosti - analiza zadnjega opazovanja (LOCF, last-observation-carried-forward) in analiza z metodo »knjiženja« (angl. bookending, po kateri sta morali biti za pripis negativnega rezultata prejšnja in naslednja kultura negativni, sicer je rezultat veljal za pozitivnega).
Concentrations of the identified metabolites progressively increase to steady state after 6 to 10 weeks. 
Koncentracije opredeljenih presnovkov se postopoma večajo do stanja dinamičnega ravnovesja po 6 do 10 tednih.
In-vitro studies showed that delamanid and metabolites did not have any effect on the transporters MDR1(pgp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 and BSEP, at concentrations of approximately 5 to 20 fold greater than the Cmax at steady state. 
V študijah in-vitro so opazili, da delamanid in presnovki niso vplivali na prenašalce MDR1 (p-gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 in BSEP, pri koncentracijah, približno 5- do 20-krat višjih kot Cmax v stanju dinamičnega ravnovesja.
• Regional pain 
• regionalna bolečina
Less than 5% of an oral dose of delamanid is recovered from urine. 
Manj kot 5 % peroralnega odmerka je najti v urinu.
- if you are taking medicines that strongly induce a certain liver enzyme called “CYP450 3A4” (e.g. 
- če jemljete zdravila, ki močno inducirajo določen jetrni encim, imenovan »CYP450 3A4« (npr.
On the basis of the scientific conclusions for delamanid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing delamanid is unchanged subject to the proposed changes to the product information. 
Na podlagi znanstvenih zaključkov za delamanid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) delamanid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Mild renal impairment (50 mL/min < CrCLN < 80 mL/min) does not appear to affect delamanid exposure. 
Kaže, da blaga ledvična okvara (50 ml/min < CrCLN < 80 ml/min) ne vpliva na izpostavljenost delamanidu.
It is recommended that electrocardiograms (ECG) should be obtained before initiation of treatment and monthly during the full course of treatment with delamanid. 
Priporoča se, da se elektrokardiogram (EKG) opravi pred začetkom zdravljenja in nato vsak mesec ves čas zdravljenja delamanidom.
In-vitro studies showed that delamanid did not inhibit CYP450 isozymes. 
V študijah in-vitro so opazili, da delamanid ne zavira izoencima CYP450.
The identified metabolites do not show anti-mycobacterial activity but some contribute to QTc prolongation, mainly DM6705. 
Opredeljeni presnovki ne kažejo aktivnosti proti mikobakterijam, vendar pa nekateri prispevajo k podaljšanju intervala QTc, pretežno DM-6705.
If the QTc interval duration exceeds 450/470 ms for male/female patients during delamanid treatment, these patients should be administered more frequent ECG monitoring. 
Če trajanje intervala QTc med zdravljenjem z delamanidom preseže 450/470 ms za moške/ženske bolnike, je treba te bolnike pogosteje spremljati s pomočjo EKG-ja.
• if you have a condition called congenital long QT syndrome or have a serious heart disease or problems with heart rhythm. 
• če imate stanje, imenovano sindrom prirojenega podaljšanega intervala QT ali resno bolezen srca ali težave s srčnim ritmom
• Drug use during pregnancy 
• uporaba zdravila med nosečnostjo
Aluminium/Aluminium blister: 48 tablets. 
Pretisni omot aluminij/aluminij: 48 tablet
It is recommended that delamanid is administered by directly observed therapy (DOT). 
Priporoča se, da se delamanid daje kot neposredno nadzorovano zdravljenje (DOT, directly observed therapy).
Frequency very common 
Pogostnost zelo pogosti
• Allergic conjunctivitis 
• alergijski konjunktivitis
• Adjustment disorder with depressed mood 
• motnje prilagajanja z depresivnim razpoloženjem
• Nerve damage causing numbness or pain (burning) or tingling feeling in hands or feet 
• okvara živcev, ki povzroči odrevenelost ali bolečino (žarenje) ali mravljinčenje v rokah in nogah
Both showed a 13-day shorter median time to SCC in the delamanid + OBR group (p=0.0281 for LOCF and p=0.0052 for “bookending”). 
Obe sta pokazali 13 dni krajši mediani čas do SCC v skupini delamanid + OBR (p = 0,0281 za LOCF in p = 0,0052 za »knjiženje«).
However, if it is nearly time for the next dose, just skip the missed dose. 
Če je že skoraj čas za naslednji odmerek, preskočite odmerek, ki ste ga pozabili vzeti.
Delamanid resistance emerged in 4 of 341 patients (1.2%) randomised to receive delamanid for 6 months in Trial 213. 
Odpornost na delamanid se je pojavila pri 4 od 341 bolnikih (1,2 %), randomiziranih za 6-mesečno prejemanje delamanida v preskušanju 213.
All missing cultures up to the time of SCC were assumed to be positive cultures in the primary analysis. 
V primarni analizi velja, da so vse manjkajoče kulture do časa izvedbe SCC pozitivne.
The educational material for Patients to be provided via the HCPs to reinforce and supplement the information provided in the patient information leaflet. 
Izobraževalno gradivo za bolnike bodo razdeljevali zdravstveni delavci z namenom okrepitve in dopolnitve informacij, ki so na voljo v navodilu za uporabo.
* The frequency for these events was lower for the combined delamanid plus OBR group in comparison to the placebo plus OBR group. 
* Pogostnost teh dogodkov je bila nižja pri skupini s kombinacijo delamanida in OBR v primerjavi s skupino s placebom in OBR.
• Abnormal values for blood investigations related to coagulation (prolonged APPT) 
• nenormalne vrednosti krvnih preiskav glede koagulacije (podaljšan APPT)
The frequency of the side effects listed below is defined using the following definitions: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people 
Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov pogosti: pojavijo se pri največ 1 od 10 bolnikov občasni: pojavijo se pri največ 1 od 100 bolnikov
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Deltyba are provided with educational material. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravstveni delavci, ki zdravilo Deltyba predpisujejo, izdajajo, z njim rokujejo ali ga dajejo, seznanjeni z izobraževalnim gradivom.
• Abnormal blood values related to the function of the liver, biliary system or pancreas 
• nenormalne vrednosti v krvi, povezane z delovanjem jeter, žolčnega sistema ali trebušne slinavke
• Increase in immature red blood cells 
• zvišanje nezrelih rdečih krvnih celic
• Panic attacks 
• napadi panike
QTc prolongation is very closely correlated with the major delamanid metabolite DM-6705. 
Podaljšanje intervala QTc zelo tesno korelira z glavnim presnovkom delamanida, DM-6705.
Within each System Organ Class, adverse reactions are listed under frequency categories of very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
(≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki, <1/10.000, neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
What Deltyba is and what it is used for 
Kaj je zdravilo Deltyba in za kaj ga uporabljamo
- Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction. 
- Vsakršna bolezen srca, ki poveča nagnjenost k aritmijam, kot je huda hipertenzija, hipertrofija levega prekata (vključno s hipertrofično kardiomiopatijo) ali kongestivna srčna odpoved, ki jo spremlja zmanjšan iztisni delež levega prekata.
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority and implement it prior to launch. 
Imetnik dovoljenja za promet z zdravilom se mora v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva in ga uvesti pred prihodom na trg.
However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily. 
Vendar pa so dodatni klinični podatki pokazali, da je bil pri bolnikih, ki so prejemali 200 mg dvakrat na dan, tj. 400 mg delamanida na dan, splošni profil varnosti primerljiv s tistim pri bolnikih, ki so prejeli priporočeni odmerek
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. 
Bolniki z redkimi dednimi težavami neprenašanja galaktoze, laponsko obliko zmanjšane aktivnosti laktaze ali slabo absorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
Effects of Deltyba on other medicinal products 
Učinki zdravila Deltyba na druga zdravila
Delamanid given in combination with the anti-HIV-medicines, tenofovir disoproxil, lopinavir/ritonavir and efavirenz, did not affect the exposure to these medicinal products. 
Delamanid v kombinaciji z zdravili proti HIV-u, tj. tenofovir dizoproksilom, lopinavirom/ritonavirom in efavirenzom, ni vplival na izpostavljenost tem zdravilom.
The time to SCC for the group randomised to 100 mg BID was also found to be faster than for the group randomised to receive placebo + OBR (p=0.0056). 
Čas do SCC v skupini, ki je bila randomizirana za prejemanje 100 mg BID, je bil prav tako krajši kot pri skupini, ki je bila randomizirana za prejemanje placeba + OBR (p = 0,0056).
• Painful urination 
• boleče uriniranje
Contents of the pack and other information What Deltyba contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Deltyba
No studies have been performed in paediatric patients. 
Pediatrična populacija Študij pri pediatričnih bolnikih niso opravili.
Posology The recommended dose for adults is 100 mg twice daily for 24 weeks. 
Odmerjanje Priporočeni odmerek za odrasle je 100 mg dvakrat na dan, ki se jemlje 24 tednov.
• Shaking (tremor) 
• tresenje (tremor)
There are very limited data from the use of delamanid in pregnant women. 
Podatki o uporabi delamanida pri nosečnicah so zelo omejeni.
Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate). 
Pomožne snovi z znanim učinkom: ena filmsko obložena tableta vsebuje 100 mg laktoze (v obliki laktoze monohidrata).
The analyses of SCC were conducted on the modified intent to treat population which included patients who had positive cultures at baseline and the isolate was resistant to both isoniazid and rifampicin, i.e., had MDR TB. 
Analize konverzije kulture izpljunka (SCC, sputum culture conversion) so bile izvedene na modificirani populaciji z namenom zdravljenja (angl. intent to treat), ki je vključevala bolnike, ki so imeli ob izhodišču zdravljenja pozitivne kulture, izolat pa je bil odporen na izoniazid in rifampicin, tj. so imeli MDR TB.
The complete metabolic profile of delamanid has not yet been elucidated, and there is a potential for drug interactions with other co-administered medications, if significant unknown metabolites are discovered. 
Celotnega presnovnega profila delamanida še niso pojasnili, zato obstaja možnost za medsebojno delovanje z drugimi sočasno uporabljenimi zdravili, če se odkrijejo znatni neznani presnovki.
In mycobacteria, the in vitro frequencies of spontaneous resistance to delamanid were similar to those for isoniazid, and were higher than those for rifampicin. 
Pri mikobakteriji so bile pogostnosti spontane odpornosti na delamanid in vitro podobne kot pri isoniazidu ter višje kot pri rifampicinu.
Deltyba contains lactose monohydrate. 
Zdravilo Deltyba vsebuje laktozo monohidrat.
There are no clinical data on the effects of delamanid on fertility in humans. 
Ni kliničnih podatkov o vplivu delamanida na plodnost pri ljudeh.
Anti-HIV medicines 
Zdravila proti HIV-u
Delamanid has been evaluated in two, double-blind, placebo controlled trials for the treatment of MDR TB. 
Delamanid so ovrednotili v dveh dvojno slepih, s placebom nadzorovanih preskušanjih za zdravljenje MDR TB.
Such patients should receive very frequent monitoring of ECG throughout the full delamanid treatment period. 
Te bolnike je treba zelo pogosto spremljati s pomočjo EKG-ja v celotnem obdobju zdravljenja z delamanidom.
What you need to know before you take Deltyba Do not take Deltyba: 
Kaj morate vedeti, preden boste vzeli zdravilo Deltyba Ne jemljite zdravila Deltyba:
• Papules (small skin elevations) 
• papule (dvig majhnega dela kože nad ravnjo kože)
Treatment of overdose should involve immediate measures to remove delamanid from the gastrointestinal tract and supportive care as required. 
Zdravljenje prevelikega odmerjanja mora vključevat takojšnje ukrepe za odstranitev delamanida iz prebavil in podporno nego, kot je potrebno.
For patients receiving 100 mg delamanid + OBR twice daily, the frequency was 8.1% (frequency category common) in comparison to a frequency of 6.3% in patients receiving placebo + OBR twice daily. 
Pri bolnikih, ki so prejemali 100 mg delamanida + OBR dvakrat na dan je bila pogostnost 8,1 % (kategorija pogostnosti pogosti) v primerjavi s pogostnostjo 6,3 % pri bolnikih, ki so prejemali placebo + OBR dvakrat na dan.
Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters. 
Zdravilo Deltyba je na voljo v pakiranjih po 48 filmsko obloženih tablet v aluminij/aluminij pretisnih omotih.
In clinical trials resistance to delamanid has been defined as any growth in the presence of a delamanid concentration of 0.2 μg/mL that is greater than 1% of that on drug-free control cultures on Middlebrook 7H11 medium. 
V kliničnih preskušanjih so odpornost na delamanid opredelili kot vsakršno rast v prisotnosti koncentracije delamanida 0,2 μg/ml, ki je večja kot 1 % pri kontrolnih kulturah brez učinkovine v gojišču Middlebrook
Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis. 
Zdravljenje z delamanidom mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi na več zdravil odporne Mycobacterium tuberculosis.
It is also recommended that serum electrolytes, e.g. potassium, are obtained at baseline and corrected if abnormal. 
Priporoča se tudi, da se ob izhodišču pridobijo vrednosti elektrolitov v serumu, npr. kalija, ki jih je treba popraviti, če so nenormalne.
- if you are taking HIV-medicines containing lopinavir/ritonavir, or saquinavir. 
- če jemljete zdravila za zdravljenje okužbe s HIV-om, ki vsebujejo lopinavir/ritonavir ali sakvinavir.
• Urine retention 
• zadrževanje urina
All QTcF prolongations above 60 ms were associated with concomitant fluoroquinolone use. 
Sočasna uporaba delamanida s kinoloni Vsa podaljšanja QTcF za več kot 60 ms so bila povezana s sočasno uporabo fluorokinolonov.
The identified metabolites of delamanid do not show anti-mycobacterial activity. 
Opredeljeni presnovki delamanida niso pokazali antimikobakterijskega delovanja.
Because a potential risk to the breast-feeding infant cannot be ruled out , it is recommended that women should not breastfeed during treatment with Deltyba. 
Ker možnega tveganja za dojenega otroka zaradi zdravljenja z delamanidom ni mogoče izključiti, ženske med zdravljenjem z zdravilom Deltyba ne smejo dojiti.
• Increase of certain white blood cells (eosinophilia) 
• zvišanje nekaterih belih krvnih celic (eozinofilija)
Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis. 
Zdravilo Deltyba vsebuje zdravilno učinkovino delamanid, antibiotik za zdravljenje tuberkuloze pljuč, ki jo povzroča bakterija, ki je drugi antibiotiki, ki se najpogosteje uporabljajo za zdravljenje tuberkuloze, ne morejo uničiti.
Special Considerations Cardiac risk factors 
Dejavniki tveganja za srce
• Balance disorder 
• motnje ravnotežja
Co-administration of delamanid with a strong inhibitor of CYP3A4 (lopinavir/ritonavir) was associated with a 30% higher exposure to the metabolite DM-6705, which has been associated with QTc prolongation. 
Sočasna uporaba delamanida z močnimi zaviralci CYP3A4 (lopinavir/ritonavir) je bila povezana s 30 % višjo izpostavljenostjo presnovku DM-6705, kar je povezano s podaljšanjem QTc.
Deltyba is not recommended in pregnant women or in women of childbearing potential unless they are using a reliable form of contraception. 
Zdravila Deltyba ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, razen če uporabljajo učinkovito metodo kontracepcije.
- Taking medicinal products that are known to prolong the QTc interval. 
- Jemanje zdravil, za katera je znano, da podaljšujejo interval QTc.
- if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine). 
- če jemljete nekatera zdravila za zdravljenje alergijskih reakcij (npr. terfenadin, astemizol, mizolastin).
If you take more Deltyba than you should 
Če ste vzeli večji odmerek zdravila Deltyba, kot bi smeli
• Problems with sleeping 
• težave z uspavanjem in spanjem
• you have liver disease or kidney disease. 
• če imate bolezen jeter ali bolezen ledvic