natgillin/translations-raw huggingface dataset:
Do not drive or use any tools or machines until you know how Duloxetine Lilly affects you.
Ne vozite in ne upravljajte z orodji ali stroji, dokler ne veste, kako zdravilo Duloksetin Lilly vpliva na vas.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms (see section 5.1).
Če se na podlagi klinične potrebe za zdravljenje vseeno odločimo, moramo bolnika skrbno spremljati za primer pojava samomorilnih simptomov (glejte poglavje 5.1).
Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
Bolnike, ki so izpolnjevali diagnostična merila za veliko depresivno epizodo, smo iz teh preskušanj izključili.
A free airway should be established.
Vzpostaviti je treba prehodno dihalno pot.
Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Upoštevaje prekrivanje razpona vrednosti očistka, farmakokinetične razlike zaradi spola ne upravičujejo priporočila za uporabo nižjega odmerka pri ženskah.
Dose escalation should be based upon clinical response and tolerability.
Zvišanje odmerka mora biti osnovano na kliničnem odgovoru in prenosljivosti.
The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Ocenjen dnevni odmerek pri dojenčku na osnovi mg/kg je približno 0,14 % vrednosti odmerka pri materi (glejte poglavje 5.2).
These effects are normally mild to moderate and often disappear after a few weeks.
Ti učinki so običajno blagi do zmerni in pogosto v nekaj tednih izzvenijo.
You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Prosite ga lahko tudi, da naj vas opozori, če meni, da se je depresija ali anksioznost poslabšala ali ga skrbijo spremembe v vašem vedenju.
This may be due to the noradrenergic effect of duloxetine.
To je lahko posledica noradrenergičnega učinka duloksetina.
There are no adequate data on the use of duloxetine in pregnant women.
Ustreznih podatkov o uporabi duloksetina pri nosečnicah ni.
− are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
- jemljete fluvoksamin, ki se običajno uporablja za zdravljenje depresije, ciprofloksacin ali enoksacin, ki se uporablja za zdravljenje nekaterih okužb
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in intervence, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
9 Estimated frequency based on all clinical trial data.
9 Ocenjena pogostnost temelji na vseh podatkih kliničnih preskušanj.
Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Ugotavljali so farmakokinetične razlike med mlajšimi in starejšimi ženskami (≥ 65 let) (pri starejših se AUC poviša za približno 25 %, razpolovni čas pa je daljši za približno 25 %), vendar obseg teh sprememb ni tolikšen, da bi upravičil prilagajanje odmerka.
• tinnitus (hearing sound in the ear when there is no external sound)
• zamegljen vid • tinitus (zvonjenje v ušesih, kljub temu da ni zunanjega zvoka)
• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions
• resne alergične reakcije, ki povzročajo težave pri dihanju ali omotico z oteklim jezikom ali ustnicami, alergične reakcije
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Lilly, you should see your doctor.
Ta zdravila povečajo tveganje za neželene učinke; če se pojavi kakršenkoli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Duloksetin Lilly, obiščite zdravnika.
In addition, these conditions may be co-morbid with major depressive disorder.
Dodatno so ta stanja lahko sočasna z veliko depresivno motnjo.
Clinical response rates (50% or greater improvement in pain) were analysed according to whether or not the patient experienced somnolence during treatment.
Stopnje kliničnega odziva (50 % ali večje zmanjšanje bolečine) smo razčlenili na podlagi tega, ali je bolnik med zdravljenjem izkusil zaspanost.
The relevance of this mouse data to humans is unknown.
Pomen teh podatkov pri miših za ljudi ni znan.
Physicians should encourage patients to report any distressing thoughts or feelings at any time.
Zdravniki naj spodbujajo bolnike, da o kakih stisko povzročujočih mislih ali občutkih nemudoma kadarkoli poročajo.
• lack of appetite
• zmanjšanje apetita
Hepatitis/increased liver enzymes
Hepatitis/povišane vrednosti jetrnih encimov
• generalised anxiety disorder (chronic feeling of anxiety or nervousness)
• generalizirane anksiozne motnje (kroničen občutek tesnobe ali nervoznosti)
There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain)
V prizadetem področju lahko pride do izgube zaznavanja, ali občutki, denimo dotik, toplota, mraz ali pritisk povzročijo bolečino.)
The risk of withdrawal symptoms seen with SSRI's and SNRI's may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Tveganje za pojav odtegnitvenih simptomov opaženih pri SSRI in SNRI je odvisno od številnih dejavnikov, med drugim od trajanja zdravljenja in predpisanega odmerka ter stopnje zmanjševanja odmerka zdravila.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
CNS medicinal products: The risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Zdravila CŽS: tveganja uporabe duloksetina v kombinaciji z drugimi zdravili, ki delujejo na CŽS, niso sistematično vrednotili, razen v primerih, opisanih v tem poglavju.
• throat inflammation that causes a hoarse voice
• vnetje grla, ki povzroči hripav glas
In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients.
Pri bolnikih z nezadostnim odgovorom moramo odmerek zvišati na 60 mg, kar je običajen vzdrževalni odmerek pri večini bolnikov.
In patients who develop these symptoms, increasing the dose may be detrimental.
Za bolnike z omenjenimi simptomi je večanje odmerka lahko škodljivo.
• fast and/or irregular heart beat
• hitro ali nepravilno bitje srca
However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations.
Vendar pa ni kliničnih dokazov, ki bi kazali, da lahko bolnikom, ki se na priporočeni začetni odmerek ne odzovejo, povišanja odmerka koristijo.
Duloxetine is approximately 96% bound to human plasma proteins.
Duloksetin se veže na človeške plazemske beljakovine v približno 96 %.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Ženskam je treba svetovati, naj obvestijo zdravnika, če med zdravljenjem zanosijo ali načrtujejo nosečnost.
It may make you feel sleepy or dizzy.
Lahko povzroči občutek zaspanosti ali omotice.
Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Ne začnite jemati niti ne prenehajte jemati katerihkoli zdravil, vključno s tistimi, ki ste jih kupili brez recepta, in pripravkov rastlinskega izvora, ne da bi se pred tem posvetovali z zdravnikom.
The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Iste previdnostne ukrepe, ki jih izvajamo pri zdravljenju bolnikov z veliko depresivno motnjo, moramo torej izvajati tudi pri zdravljenju bolnikov z drugimi psihiatričnimi motnjami.
Specific in vivo drug interaction studies have not been performed.
Specifične študije in vivo medsebojnega delovanja zdravil niso bile opravljene.
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
Ti simptomi običajno niso resni in v nekaj dneh izzvenijo, vendar se posvetujte z zdravnikom, če imate simptome, ki vam povzročajo težave.
If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.
Če ima vaš dojenček ob rojstvu kateregakoli od teh simptomov ali vas skrbi dojenčkovo zdravje, se obrnite na zdravnika ali babico, ki vam bosta znala svetovati.
In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
V študijah na živalih duloksetin ni vplival na plodnost pri moških, pri ženskah pa so bili učinki opaženi le pri odmerkih, ki so povzročili toksičnost za mater.
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
V primeru, da se ob zmanjšanju odmerka ali prekinitvi zdravljenja pojavijo nevzdržni simptomi, je treba razmisliti o ponovni uvedbi prej predpisanega odmerka.
The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
Absolutna peroralna biološka uporabnost duloksetina dosega vrednosti od 32 do 80 % (povprečje 50 %).
The majority of cases have occurred either at birth or within a few days of birth.
Do večine primerov je prišlo ob rojstvu ali v nekaj dneh po tem.
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Farmakokinetika duloksetina kaže veliko variabilnost med osebki (na splošno 50-60 %), deloma zaradi spola, starosti, kajenja in stanja presnavljanja s CYP2D6.
• problems getting an erection, changes in ejaculation
• težave z erekcijo, spremembe v ejakulaciji
If your doctor has prescribed Duloxetine Lilly for a patient under 18 and you want to discuss this, please go back to your doctor.
Če je zdravnik predpisal zdravilo Duloksetin Lilly bolniku, mlajšemu od 18 let, in se želite o tem pogovoriti, se, prosimo, obrnite na zdravnika.
The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Lilly.
Odmerek bo morda prilagojen do 120 mg na dan, glede na vaš odziv na zdravilo Duloksetin Lilly.
Some patients who stop taking Duloxetine Lilly suddenly have had symptoms such as:
Nekateri bolniki, ki so nenadoma prenehali jemati zdravilo Duloksetin Lilly, so imeli simptome, kot so:
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Večinoma se pojavijo v prvih dneh po prekinitvi zdravljenja, vendar so o njih redko poročali tudi pri bolnikih, ki so nenamerno izpustili odmerek zdravila.
Other psychiatric conditions for which Duloxetine Lilly is prescribed can also be associated with an increased risk of suicide-related events.
Druga psihiatrična stanja, za katera predpisujemo zdravilo Duloksetin Lilly so tudi lahko povezana z večjim tveganjem za pojav dogodkov povezanih s samomorom.
The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
Primarna mera izida je bilo tedensko povprečje 24-urne povprečne bolečine, kar smo zbrali iz dnevnih dnevnikov bolnikov na podlagi 11točkovne Likertove lestvice.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse.
Po utrditvi odziva na antidepresivno zdravilo je priporočljivo nadaljevati zdravljenje še nekaj mesecev, da se izognemo relapsu.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
2O primerih ortostatske hipotenzije in sinkope so poročali zlasti ob začetku zdravljenja.
Taking a MAOI together with many prescription medicines, including Duloxetine Lilly, can cause serious or even life-threatening side effects.
Jemanje MAOI skupaj z mnogimi zdravili na recept, vključno z zdravilom Duloksetin Lilly, lahko povzroči resne ali celo smrtno nevarne neželene učinke.
The no-adverse effect level was determined to be 20 mg/kg/day.
Meja, pri kateri ni bilo neželenih učinkov, je bila 20 mg/kg/dan.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoze-izomaltaze ne smejo jemati tega zdravila
Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Velike depresivne motnje in generalizirana anksiozna motnja: depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanje in samomorilnosti (s samomorom povezani dogodki).
• suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
• samomorilno vedenje, manija (prevelika aktivnost, bežeče misli in zmanjšana potreba po spanju), halucinacije, agresivnost in jeza
Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Prav tako se moramo zavedati, da imajo bolniki, mlajši od 18 let, večje tveganje za neželene učinke, denimo poskus samomora, samomorilne misli in sovražnost (zlasti nasilnost, nasprotovalno vedenje in jezo), kadar jemljejo zdravila iz te skupine.
Duloxetine Lilly with food, drink and alcohol
Zdravilo Duloksetin Lilly skupaj s hrano, pijačo in z alkoholom
Each capsule may contain up to 111 mg sucrose.
Ena kapsula lahko vsebuje do 111 mg saharoze.
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling of the face or throat (angioedema)
• Stevens-Johnsonov sindrom (resna bolezen z mehurji na koži, ustih, očeh in genitalijah), resne alergične reakcije, ki povzročijo otekanje obraza ali grla (angioedem)
Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Duloksetin v standardnih testih ni bil genotoksičen in pri podganah ni bil kancerogen.
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Prekinitev zdravljenja z duloksetinom (še zlasti, če je nenadna) pogosto povzroči odtegnitvene simptome.
4 Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
4O primerih agresije in jeze so poročali zlasti ob začetku zdravljenja in po prekinitvi zdravljenja.
Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic).
Primeri MAOI vključujejo moklobemid (antidepresiv) in linezolid (antibiotik).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte se z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Epidemiološki podatki kažejo, da uporaba SSRI v nosečnosti, še posebej v pozni nosečnosti, lahko povečala tveganje za primarno pljučno hipertenzijo pri novorojenčkih (PPHN - persistent pulmonary hypertension in the newborn).
A conclusion on the overall benefit/risk in this age group has not been established (see also sections 4.2 and 4.8).
Zaključek glede splošnih koristi/tveganj pri tej starostni skupini ni bil podan (glejte tudi poglavji 4.2
Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Med moškimi in ženskami so ugotovili farmakokinetične razlike (očitni plazemski očistek je pri ženskah približno 50 % nižji).
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
Duloksetin ima velik volumen porazdelitve, zato ni verjetno, da bi bile forsirana diureza, hemoperfuzija in izmenjevalna perfuzija koristne.
• increased blood pressure, flushing
• povišan krvni tlak, zardevanje
In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above).
Pri bolnikih s sočasnimi veliki depresivnimi motnjami je začetni in vzdrževalni odmerek 60 mg enkrat na dan (prosimo glejte tudi priporočila za odmerjanje zgoraj).
Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Peroralni kontraceptivi in druge steroidne učinkovine: rezultati študij in vitro kažejo, da duloksetin ne inducira katalitske aktivnosti CYP3A.
1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
1O primerih konvulzij in o primerih tinitusa so poročali tudi po prekinitvi zdravljenja.
The study included a 10 week placebo-controlled acute phase, followed by an 18 week extension treatment period.
Študija je vključevala 10-tedensko akutno fazo, kontrolirano s placebom, ki ji je sledilo 18-tedensko obdobje podaljšanega zdravljenja.
Weight increased to match other children and adolescents of their age and sex after 6 months of treatment.
Telesna masa se je po šestih mesecih zdravljenja izenačila z otroki in mladostniki njihove starosti in spola.
• Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine Lilly.
• Obvestite zdravnika, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Duloksetin
Blood pressure and heart rate
Krvni tlak in srčna frekvenca
Do not stop taking Duloxetine Lilly, or change your dose, without talking to your doctor.
Ne prenehajte jemati zdravila Duloksetin Lilly in ne spreminjajte odmerka, ne da bi se posvetovali z zdravnikom.
During the 10-week acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], placebo 1/220 [0.5%]).
Med 10-tedenskim obdobjem akutnega zdravljenja so poročali o samomorilnem vedenju (duloksetin 0/333 [0%], fluoksetin 2/225 [0,9%], placebo 1/220 [0,5%]).
In people with diabetic neuropathic pain it can take some weeks before you feel better.
Pri bolnikih z bolečino diabetične nevropatije lahko traja več tednov, preden se vaše počutje izboljša.
A flexible dose regimen was used in this study, to allow for slow dose escalation from 30 mg once daily to higher doses (maximum 120 mg once daily).
V tej študiji so uporabili fleksibilen režim odmerjanja, ki je omogočal počasno dviganje odmerka s 30 mg enkrat na dan do višjih odmerkov (največ 120 mg enkrat na dan).
In patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
Pri bolnikih z nezadostnim odgovorom na 60 mg odmerek lahko razmislimo o zvišanju do 90 mg ali 120 mg.
Studies in juvenile rats reveal transient effects on neurobehaviour, as well as significantly decreased body weight and food consumption; hepatic enzyme induction; and hepatocellular vacuolation at 45 mg/kg/day.
Študije na mladih podganah kažejo na prehodne učinke na nevrološki vedenjski vzorec ter na znatno zmanjšanje telesne mase in uživanje hrane, indukcijo jeternih encimov in hepatocelularno vakuolacijo pri 45 mg/kg/dan.
No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered.
Specifičnega antidota za duloksetin ne poznamo, vendar v primeru pojava serotoninskega sindroma pretehtamo možnost uvedbe specifičnega zdravljenja (s ciproheptadinom in/ali nadzorom temperature).
If your doctor thinks that you no longer need Duloxetine Lilly he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Če bo zdravnik menil, da zdravila Duloksetin Lilly ne potrebujete več, vam bo naročil-a, da pred prenehanjem zdravljenja 2 tedna postopoma znižujte svoj odmerek.
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/or prolonged.
Navadno so pri SSRI in SNRI ti dogodki blagi do zmerni in samoomejujoči, vendar so pri nekaterih bolnikih lahko resni in/ali trajajo dlje.
Major Depressive Disorder: Duloxetine Lilly was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Velike depresivne motnje: zdravilo Duloksetin Lilly so preučevali v kliničnem programu, v katerem je sodelovalo 3.158 bolnikov (1.285 bolniških let izpostavljenosti), ki so izpolnjevali merila DSM-IV za veliko depresivno motnjo.
Hyponatraemia may be due to a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Hiponatriemija je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti-diuretic hormone secretion, SIADH).
You should use Duloxetine Lilly only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Zdravilo Duloksetin Lilly lahko uporabljate le po tem, ko ste se o možnih koristih in morebitnih možnih tveganjih za vašega nerojenega otroka pogovorili z zdravnikom.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7)
Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.
Pretisni omot iz polivinilklorida (PVC), polietilena (PE) in poliklorotrifluoroetilena (PCTFE), zaprt z aluminijasto folijo.
Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Zmerno okvarjeno delovanje jeter (razred Child Pugh B) je vplivalo na farmakokinetiko duloksetina.