natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the EU for Duloxetine Boehringer Ingelheim to Boehringer Ingelheim International GmbH on 8 October 2008.
Evropska Komisija je dovoljenje za promet z zdravilom Duloxetine Boehringer Ingelheim, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim International GmbH dne 8. oktobra 2008.
DULOXETINE BOEHRINGER INGELHEIM 40 mg hard gastro-resistant capsules.
DULOXETINE BOEHRINGER INGELHEIM 40 mg trde gastrorezistentne kapsule
DULOXETINE BOEHRINGER INGELHEIM is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
4. 1 Terapevtske indikacije
The recommended dose of DULOXETINE BOEHRINGER INGELHEIM is 40 mg twice daily without regard to meals.
Priporočeni odmerek zdravila DULOXETINE BOEHRINGER INGELHEIM je 40 mg dvakrat dnevno ne glede na obroke.
However, limited data are available to support the efficacy of DULOXETINE BOEHRINGER INGELHEIM 20 mg twice daily.
Vendar pa so na voljo le omejeni podatki, ki potrjujejo učinkovitost zdravila DULOXETINE BOEHRINGER INGELHEIM 20 mg dvakrat dnevno.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM has not been evaluated for longer than 3 months in placebo-controlled studies.
Učinkovitosti zdravila DULOXETINE BOEHRINGER INGELHEIM v študijah, kontroliranih s placebom, niso vrednotili dlje kot 3 mesece.
Combining DULOXETINE BOEHRINGER INGELHEIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Kombiniranje jemanja zdravila DULOXETINE BOEHRINGER INGELHEIM s programom treninga mišic medeničnega dna (pelvic floor muscle training, PFMT) je lahko bolj učinkovito, kot če metodi zdravljenja uporabljamo posamezno.
The medicinal product response should be evaluated after 2 months ’ of treatment.
Odziv na zdravilo je treba ovrednotiti po 2 mesecih zdravljenja.
2 The therapeutic benefit should regularly (at least every three months) be reassessed.
2 Terapevtsko korist redno (vsaj enkrat na vsake tri mesece) ocenjujemo.
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
Okvarjeno delovanje jeter Zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati pri bolnikih z obolenjem jeter, katerega posledica je okvarjeno delovanje jeter (glejte poglavje 4. 3).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
Zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/ min; glejte poglavje 4. 3).
When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Ob prenehanju zdravljenja z zdravilom DULOXETINE BOEHRINGER INGELHEIM je treba odmerek zdravila v obdobju najmanj enega do dveh tednov postopoma zmanjševati, da zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4. 4 in 4. 8).
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
Zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati v kombinaciji z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4. 5).
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati v kombinaciji z zaviralci CYP1A2, kot so fluvoksamin, ciprofloksacin ali enoksacin, ker kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4. 5).
The initiation of treatment with DULOXETINE BOEHRINGER INGELHEIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Uvedba zdravljenja z zdravilom DULOXETINE BOEHRINGER INGELHEIM je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4. 4 in 4. 8).
Mania and Seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija in epileptični napadi Zdravilo DULOXETINE BOEHRINGER INGELHEIM moramo pri bolnikih z manijo v anamnezi ali diagnozo bipolarne motnje in/ ali epileptičnimi napadi uporabljati previdno.
Use with antidepressants The use of DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).
Sočasna uporaba z antidepresivi Uporabe zdravila DULOXETINE BOEHRINGER INGELHEIM v kombinaciji z antidepresivi (zlasti v kombinaciji s SSRI, SNRI in reverzibilnimi MAOI) ne priporočamo (glejte spodaj “ Depresija, samomorilne misli in vedenje ” in poglavje 4. 5).
3 St John’ s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
3 Šentjanževka Ob sočasni uporabi zdravila DULOXETINE BOEHRINGER INGELHEIM in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 24% of patients taking placebo.
V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45% bolnic, ki so jemale zdravilo DULOXETINE BOEHRINGER INGELHEIM in pri 23% bolnic, ki so dobivale placebo.
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.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Hiponatriemija Ob dajanju zdravila DULOXETINE BOEHRINGER INGELHEIM so redko poročali o hiponatriemiji, zlasti pri starejših. Previdnost je potrebna pri bolnikih z večjim tveganjem za hiponatriemijo; denimo pri starejših, bolnikih s cirozo, dehidriranih bolnikih ali bolnikih, ki jemljejo diuretike.
Depression, suicidal ideation and behaviour Although DULOXETINE BOEHRINGER INGELHEIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depresija, samomorilne misli in vedenje
Depression is 4 associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
4 Čeprav zdravilo DULOXETINE BOEHRINGER INGELHEIM ni indicirano za zdravljenje depresije, njegova zdravilna učinkovina (duloksetin) obstaja tudi kot antidepresiv.
This risk persists until significant remission occurs.
Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanje in samomorilnosti (s samomorom povezani dogodki).
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Med zdravljenjem z duloksetinom ali kmalu po prenehanju zdravljenja so poročali o primerih samomorilnih misli in samomorilnega vedenja (glejte poglavje 4. 8).
If while on DULOXETINE BOEHRINGER INGELHEIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Če bolnik med zdravljenjem z zdravilom DULOXETINE BOEHRINGER INGELHEIM postane agitiran ali razvije simptome depresije, se je treba posvetovati s specialistom, depresija je namreč resno bolezensko stanje.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of DULOXETINE BOEHRINGER INGELHEIM is recommended (see Section 4.2).
V primeru, da se zdravnik odloči za farmakološko zdravljenje z antidepresivi, svetujemo postopno ukinjanje zdravila DULOXETINE BOEHRINGER INGELHEIM (glejte poglavje 4. 2).
DULOXETINE BOEHRINGER INGELHEIM should not be used in the treatment of children and adolescents under the age of 18 years.
Zdravila DULOXETINE BOEHRINGER INGELHEIM pri otrocih in mladostnikih, mlajših od 18 let, ne smemo uporabljati.
Sucrose DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
Saharoza DULOXETINE BOEHRINGER INGELHEIM trde gastrorezistentne kapsule vsebujejo saharozo.
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.
Monoamine oxidase inhibitors (MAOIs): due to the risk of serotonin syndrome, DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
5 Zaviralci monoaminooksidaze (MAOI): zaradi nevarnosti za serotoninski sindrom zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati v kombinaciji z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze (MAOI) ali v 14 dneh po prenehanju zdravljenja z MAOI.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping DULOXETINE BOEHRINGER INGELHEIM before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina mora po prenehanju jemanja zdravila DULOXETINE BOEHRINGER INGELHEIM preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4. 3).
5 Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Serotoninski sindrom: pri bolnikih, ki so uporabljali SSRI (npr. paroksetin, fluoksetin) sočasno s serotoninergičnimi zdravili, so v redkih primerih poročali o serotoninskem sindromu.
Caution is advisable if DULOXETINE BOEHRINGER INGELHEIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Priporoča se previdnost pri sočasni uporabi zdravila DULOXETINE BOEHRINGER INGELHEIM s serotoninergičnimi antidepresivi, kot so SSRI, tricikličnimi antidepresivi, kot sta klomipramin ali amitriptilin, šentjanževko (Hypericum perforatum), venlafaksinom ali triptani, tramadolom, petidinom in triptofanom.
CNS medicinal products: caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Zdravila CŽS: če se zdravilo DULOXETINE BOEHRINGER INGELHEIM jemlje v kombinaciji z drugimi osrednje delujočimi zdravili ali snovmi, vključno z alkoholom in pomirjevali (benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbitalom, sedativnimi antihistaminiki), priporočamo previdnost.
Caution is advised if DULOXETINE BOEHRINGER INGELHEIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Če zdravilo DULOXETINE BOEHRINGER INGELHEIM dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of DULOXETINE BOEHRINGER INGELHEIM with aluminium- and magnesium-containing antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Učinki drugih zdravil na duloksetin Antacidi in antagonisti H2: sočasno dajanje zdravila DULOXETINE BOEHRINGER INGELHEIM z antacidi, vsebujočimi aluminij in magnezij, ali s famotidinom ni imelo pomembnega učinka na hitrost ali obseg absorpcije duloksetina po dajanju 40 mg peroralnega odmerka.
Inhibitors of CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of DULOXETINE BOEHRINGER INGELHEIM with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Zaviralci CYP1A2: ker je CYP1A2 vpleten v presnovo duloksetina, je verjetno, da bo sočasna uporaba zdravila DULOXETINE BOEHRINGER INGELHEIM z močnimi zaviralci CYP1A2 povzročila višje koncentracije duloksetina.
Therefore DULOXETINE BOEHRINGER INGELHEIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Zato zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo dajati skupaj z močnimi zaviralci CYP1A2, kot je fluvoksamin (glejte poglavje 4. 3).
Pregnancy There are no data on the use of duloxetine in pregnant women.
6 Nosečnost Podatkov o uporabi duloksetina pri nosečnicah ni.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy 6 only if the potential benefit justifies the potential risk to the foetus.
Zdravilo DULOXETINE BOEHRINGER INGELHEIM naj se v nosečnostu uporablja le, če možna korist upravičuje možno tveganje za plod.
As the safety of duloxetine in infants is not known, the use of DULOXETINE BOEHRINGER INGELHEIM while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila DULOXETINE BOEHRINGER INGELHEIM med dojenjem.
DULOXETINE BOEHRINGER INGELHEIM may be associated with sedation and dizziness.
Zdravilo DULOXETINE BOEHRINGER INGELHEIM je lahko povezano s sedacijo in omotico.
The most commonly reported adverse events in patients treated with DULOXETINE BOEHRINGER INGELHEIM in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Neželeni učinki, o katerih so pri bolnicah, zdravljenih z zdravilom DULOXETINE BOEHRINGER INGELHEIM v kliničnih preskušanjih o SUI in drugih boleznih spodnjih sečil, najpogosteje poročali, so bili slabost, suha usta, utrujenost in zaprtje.
Common
Zelo pogosti Preiskave
Frequency not known
Občasni
common
Redki
Investigations Cardiac Disorders
Pogostnost ni znana
Weight decrease Weight increase Blood cholesterol increased
Zmanjšanje telesne mase Povečanje telesne mase Zvišanje krvnega holesterola
Creatinine phosphokinase increase
Zvišanje kreatinin - fosfokinaze
Supra-ventricular arrhythmia, mainly atrial fibrillation
Supra - ventrikularna aritmija, zlasti
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia
Bolezni živčevja
Poor quality of sleep Disturbance in attention Nervousness Dysgeusia
atrijska fibrilacija
Dyskinesia Myoclonus
Očesne bolezni
Serotonin syndrome Psychomotor restlessness Convulsions AkathisiaExtrapyramidal symptoms
Glavobol Omotica Tremor Letargija Zaspanost Parestezija
Eye Disorders
Slaba kvaliteta spanja Motnje pozornosti Živčnost Disgevzija
Blurred vision
Diskinezija Mioklonus
Visual disturbance Mydriasis
Serotoninski sindrom Psihomotoričn i nemir Konvulzije Akatizija Ekstrapiramid ni simptomi
Glaucoma
Zamegljen vid
Ear and Labyrinth Disorders
Motnje vida Midriaza
Vertigo
Glavkom
Urine flow decreased Polyuria
Odlašanje Slabši curek uriniranja urina Disurija Poliurija Nokturija Nenormalen vonj urina
Rash Increased tendency to bruise
Izpuščaj Povečano nagnjenje k modricam Nočno znojenje Hladen znoj
Photo- sensitivity reactions Dermatitis
Fotosenzitivno stne reakcije Kontaktni dermatitis Urtikarija
8
Bolezni mišično- skeletnega sistema in vezivnega tkiva Bolezni endokrinega sistema Presnovne in prehranske motnje
Very Common Uncommon Rare Very
Mišični krč Napetost mišic Mišično - skeletna bolečina Trizem Hipotiroidize m
Frequency not known
Trzanje mišic
Night sweats Cold sweat
Zmanjšanje apetita
Muscle twitching
Dehidracija
Endocrine disorders
Hiperglikemija (poročana
Hypo- thyroidism Metabolism and Nutrition Disorders
Infekcijske in parazitske bolezni Žilne bolezni
Appetite decreased
Laringitis Sinkopa2
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
8 zlasti pri diabetičnih bolnikih) Sindrom neustreznega izločanja antidiuretičneg a hormona Hiponatriemija
Reproductive System and Breast Disorders Menopausal symptoms
Nespečnost Anksioznost
Gynaecological haemorrhage
Motnje spanja sanje Agitacija Apatija
Insomnia Anxiety Sleep disorder Agitation Libido decreased
Zmanjšanje Bruksizem libida Nenormalen orgazem
Cases of tinnitus have also been reported after treatment discontinuation.
2 O primerih ortostatske hipotenzije in sinkope so poročali zlasti ob začetku zdravljenja.
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
9 Prekinitev zdravljenja z duloksetinom (še zlasti, če je nenadna) pogosto povzroči odtegnitvene simptome.
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with DULOXETINE BOEHRINGER INGELHEIM were: nausea; headache, dry mouth and somnolence.
Neželeni učinki, katere so pri bolnikih z bolečino diabetične nevropatije, zdravljenih z zdravilom DULOKSETIN BOEHRINGER INGELHEIM, najpogosteje opažali, so bili: slabost, glavobol, suha usta in zaspanost.
Investigations
Srčne bolezni
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Glavobol (13, 8%) Zaspanost (10, 7%)
Dyskinesia Poor quality sleep Nervousness Myoclonus Disturbance in attention Dysgeusia
Diskinezija Slaba kvaliteta spanja Živčnost Mioklonus Motnje
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
Serotoninski sindrom Konvulzije Akatizija Psihomotoričn i nemir
Visual disturbance Mydriasis
pozornosti Disgevzija
Tinnitus 1
Glavkom
Respiratory, thoracic and mediastinal disorders
Ušesne bolezni, vključno z motnjami labirinta
Yawning
Tinitus1
Epistaxis Throat tightness
Vrtoglavica Ušesna bolečina
Gastrointestinal
Zehanje
Disorders
Epistaksa Stisnjeno grlo
Uncommon
Nenormalen vonj urina
Dehydration SIADH Hypo-natremia
Infekcijske in parazitske bolezni
Infections and infestations Laryngitis Vascular Disorders
11 Laringitis Žilne bolezni Sinkopa2
Hyper- sensitivity
Bolezni imunskega
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Prekinitev zdravljenja z duloksetinom (še zlasti, če je nenadna) pogosto povzroči odtegnitvene 12 simptome.
Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behaviour in a model of persistent pain.
13 V številnih predkliničnih modelih nevropatske in vnetne bolečine je duloksetin normaliziral prag za bolečino ter zmanjšal za bolečino značilno vedenje v modelu vztrajne bolečine.
The clinical benefit of DULOXETINE BOEHRINGER INGELHEIM compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Klinične koristi zdravila DULOXETINE BOEHRINGER INGELHEIM v primerjavi s placebom pri bolnicah z blago SUI, definirano tako v randomiziranih preskušanjih kot tistih z IEF < 14 na teden, niso dokazali.
In these women, DULOXETINE BOEHRINGER INGELHEIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
Pri teh ženskah zdravilo DULOXETINE BOEHRINGER INGELHEIM morda ne daje koristi, v primerjavi s tistimi, kot jih dosegamo z bolj konzervativnimi vedenjskimi posredovanji.
DULOXETINE BOEHRINGER INGELHEIM and Prior Continence Surgery: there are limited data that suggest that the benefits of DULOXETINE BOEHRINGER INGELHEIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
Zdravilo DULOXETINE BOEHRINGER INGELHEIM in predhodno kirurško zdravljenje inkontinence: omejeni podatki kažejo, da koristi zdravila DULOXETINE BOEHRINGER INGELHEIM pri bolnicah s stresno urinsko inkontinenco, ki so bile predhodno operirane zaradi inkontinence, niso zmanjšane.
DULOXETINE BOEHRINGER INGELHEIM and Pelvic Floor Muscle Training (PFMT): during a 12- week blinded, randomised, controlled study, DULOXETINE BOEHRINGER INGELHEIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
Zdravilo DULOXETINE BOEHRINGER INGELHEIM in trening mišic medeničnega dna (Pelvic Floor Muscle Training, PFMT): v 12- tedenski slepi, randomizirani, kontrolirani študiji je zdravilo DULOXETINE BOEHRINGER INGELHEIM pokazalo večja znižanja IEF v primerjavi ali s placebom ali s samim PFMT.
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition- specific quality of life measures than DULOXETINE BOEHRINGER INGELHEIM alone or PFMT alone.
Kombinirano zdravljenje (duloksetin + PFMT) je pokazalo večje izboljšanje tako pri porabi predlog kot pri merilih kakovosti življenja, specifičnih za stanje, kot samo zdravilo DULOXETINE BOEHRINGER INGELHEIM ali samo PFMT.
At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
14 približno 65% bolnikov, zdravljenih z duloksetinom, smo zabeležili vsaj 30% poročano zmanjšanje bolečine v primerjavi s 40% pri bolnikih, ki so prejemali placebo.
Hepatic insufficiency: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
15 Okvarjeno delovanje jeter: zmerno okvarjeno delovanje jeter (razred Child Pugh B) je vplivalo na farmakokinetiko duloksetina.
Hypromellose Acetate Succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate.
Vsebina kapsule: hipromeloza hipromeloza acetat sukcinat saharoza sladkorne kroglice smukec titanov dioksid (E171) trietilcitrat
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac.
Užitno črnilo: črni železov oksid - sintetični (E172) propilenglikol
173 D-55216 Ingelheim am Rhein, Germany.
173 D- 55216 Ingelheim am Rhein, Nemčija.
DULOXETINE BOEHRINGER INGELHEIM 20 mg hard gastro-resistant capsules.
DULOXETINE BOEHRINGER INGELHEIM 20 mg trde gastrorezistentne kapsule
19 The therapeutic benefit should regularly (at least every three months) be reassessed.
18 Terapevtsko korist redno (vsaj enkrat na vsake tri mesece) ocenjujemo.
20 St John’ s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
19 Šentjanževka Ob sočasni uporabi zdravila DULOXETINE BOEHRINGER INGELHEIM in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 24% of patients taking placebo.
V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45% bolnic, ki so jemale zdravilo DULOXETINE BOEHRINGER INGELHEIM in pri 23% bolnic, ki so dobivale placebo.