natgillin/translations-raw huggingface dataset:
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
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.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Hiponatriemija je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti- diuretic hormone secretion, SIADH).
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Depresija, samomorilne misli in vedenje
21 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.
20 Čeprav zdravilo DULOXETINE BOEHRINGER INGELHEIM ni indicirano za zdravljenje depresije, njegova zdravilna učinkovina (duloksetin) obstaja tudi kot antidepresiv.
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.
21 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.
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. 4).
Pregnancy There are no data on the use of duloxetine in pregnant women.
22 Nosečnost Podatkov o uporabi duloksetina pri nosečnicah ni.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy 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.
Photo- sensitivity reactions 25
Izpuščaj Povečano nagnjenje k modricam Nočno znojenje Hladen znoj
Stevens-Johnson Syndrome Angioneurotic oedema
Fotosenzitivno stne reakcije Kontaktni dermatitis Urtikarija
Dermatitis contact Urticaria
Stevens - Johnsonov sindrom Angionevrotič ni edem
Hypo- thyroidism Metabolism and Nutrition Disorders
Hiperglikemija (poročana
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
24 zlasti pri diabetičnih bolnikih) Sindrom neustreznega izločanja antidiuretičneg a hormona Hiponatriemija
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
25 Prekinitev zdravljenja z duloksetinom (še zlasti, če je nenadna) pogosto povzroči odtegnitvene simptome.
Infections and infestations Laryngitis Vascular Disorders
27 Laringitis Žilne bolezni Sinkopa2
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Prekinitev zdravljenja z duloksetinom (še zlasti, če je nenadna) pogosto povzroči odtegnitvene 28 simptome.
Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behaviour in a model of persistent pain.
29 V številnih predkliničnih modelih nevropatske in vnetne bolečine je duloksetin normaliziral prag za bolečino ter zmanjšal za bolečino značilno vedenje v modelu vztrajne bolečine.
At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
30 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.
31 Okvarjeno delovanje jeter: zmerno okvarjeno delovanje jeter (razred Child Pugh B) je vplivalo na farmakokinetiko duloksetina.
33 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
6.2 Incompatibilities
32 6. 2 Inkompatibilnosti
34 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules
DULOXETINE BOEHRINGER INGELHEIM 30 mg trde gastrorezistentne kapsule
Hepatic impairment DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Okvarjeno delovanje jeter Zdravila DULOXETINE BOEHRINGER INGELHEIM pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4. 3 in 5. 2).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3)..
34 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). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
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).
Concomitant use of DULOXETINE BOEHRINGER INGELHEIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
Zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4. 5).
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i. e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Zdravila DULOXETINE BOEHRINGER INGELHEIM ne smemo uporabljati v kombinaciji s fluvoksaminom, ciprofloksacinom ali enoksacinom (tj. močnimi zaviralci CYP1A2), saj kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4. 5).
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 je treba pri bolnikih z manijo v anamnezi ali z diagnozo bipolarne motnje in/ ali epileptičnimi napadi uporabljati previdno.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing DULOXETINE BOEHRINGER INGELHEIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Midriaza V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila DULOXETINE BOEHRINGER INGELHEIM bolnikom s povišanim intraokularnim tlakom ali s tveganjem za akutni glavkom z zaprtim zakotjem potrebna previdnost.
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Za bolnike s hudo okvarjenim delovanjem
For patients with severe renal impairment, see section 4.3. ee section 4.2 for information on patients with mild or moderate renal dysfunction.
Za podatke o bolnikih z blago ali zmerno okvarjenim delovanjem ledvic glejte poglavje 4. 2.
Use with antidepressants 37 Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
Sočasna uporaba z antidepresivi Pri uporabi zdravila DULOXETINE BOEHRINGER INGELHEIM v kombinaciji z antidepresivi je potrebna previdnost.
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).
Šentjanževka Ob sočasni uporabi zdravila DULOXETINE BOEHRINGER INGELHEIM in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
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 Čeprav zdravilo DULOXETINE BOEHRINGER INGELHEIM ni indicirano za zdravljenje depresije, njegova zdravilna učinkovina (duloksetin) obstaja tudi kot antidepresiv.
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 zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
Hiponatremija Ob dajanju zdravila DULOXETINE BOEHRINGER INGELHEIM so redko poročali o hiponatremiji, zlasti pri starejših.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Hiponatriemija
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
36 je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti- diuretic hormone secretion, SIADH).
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 23% of patients taking placebo.
V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45% bolnikov, ki so jemali zdravilo DULOXETINE BOEHRINGER INGELHEIM in pri 23% bolnikov, ki so dobivali placebo.
38 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.
Consequently, caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Zato je pri jemanju zdravila DULOXETINE BOEHRINGER INGELHEIM v kombinaciji z drugimi osrednje delujočimi zdravili in snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.
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.
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 pa mora po prenehanju jemanja zdravila DULOXETINE BOEHRINGER INGELHEIM preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4. 3).
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
37 Pri selektivnih reverzibilnih MAOI, denimo moklobemidu, je tveganje za serotoninski sindrom manjše.
However, the concomitant use of DULOXETINE BOEHRINGER INGELHEIM with selective, reversible MAOIs is not recommended (see section 4.4).
Vendar pa sočasno uporabo zdravila DULOXETINE BOEHRINGER INGELHEIM s selektivnimi reverzibilnimi MAOI odsvetujemo (glejte poglavje 4. 4).
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.
Če zdravilo DULOXETINE BOEHRINGER INGELHEIM uporabljamo sočasno s serotoninergičnimi antidepresivi, kot so SSRI, tricikličnimi antidepresivi, denimo, klomipraminom ali amitriptilinom, šentjanževko (Hypericum perforatum), venlafaksinom ali triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost.
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, denimo s fluvoksaminom (glejte poglavje 4. 3).
As with other serotoninergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Zdravilo
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
38 DULOXETINE BOEHRINGER INGELHEIM naj se v nosečnostu uporablja le, če možna korist upravičuje možno tveganje za plod.
4.7 Effects on ability to drive and use machines 40 No studies on the effects on the ability to drive and use machines have been performed.
Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvedli.
Tinnitus 1
39
Vertigo Ear pain
Glavkom
Frequency not
Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
common
Zehanje
known
Epistaksa Stisnjeno grlo
Hypertensive crisis Hypertension
Ortostatska hipotenzija2 Zvišan krvni
General Disorders and Administration Site Conditions
Hipertenzivna kriza Hipertenzija
Very
tlak Hladni periferni deli Splošne težave in spremembe na mestu aplikacije
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and
Reakcije, o katerih najpogosteje poročajo so omotica, senzorične motnje (vključno s parestezijo), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), agitacija ali tesnobnost, slabost in/ ali bruhanje, tresenje, glavobol, razdražljivost, driska, hiperhidroza in vrtoglavica.
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.
41 Navadno so pri SSRI in SNRI ti dogodki blagi do zmerni in samoomejujoči, vendar so pri nekaterih bolnikih lahko resni in/ ali trajajo dlje.
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) 44 having diabetic neuropathic pain for at least 6 months.
Učinkovitost duloksetina kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12- tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom
Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
42 pri odraslih (starih od 22 do 88 let), ki so imeli bolečino diabetične nevropatije vsaj 6 mesecev.
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.
Bolnike, ki so izpolnjevali diagnostična merila za veliko depresivno epizodo, smo iz teh preskušanj izključili.
45 Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
43 višje vrednosti Cmax in AUC duloksetina v primerjavi z zdravimi osebami.
Edible Green Ink contains:
Užitno zeleno črnilo vsebuje: črni železov oksid - sintetični (E172)
46 Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol Shellac.
44 rumeni železov oksid - sintetični (E172) propilenglikol šelak
DULOXETINE BOEHRINGER INGELHEIM 30 mg is available in packs of 7, 28 and 98 capsules.
Zdravilo DULOXETINE BOEHRINGER INGELHEIM 30 mg je na voljo v pakiranju po 7, 28 in 98 kapsul.
DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules
DULOXETINE BOEHRINGER INGELHEIM 60 mg trde gastrorezistentne kapsule
49 Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
Okvarjeno delovanje ledvic Pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic (očistek kreatinina 30 do 80 ml/ min) odmerka ni treba prilagajati.
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
46 uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/ min; glejte poglavje 4. 3).
Use with antidepressants Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
Sočasna uporaba z antidepresivi Pri uporabi zdravila DULOXETINE BOEHRINGER INGELHEIM v kombinaciji z antidepresivi je potrebna previdnost.
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
48 je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti- diuretic hormone secretion SIADH).
51 Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Prekinitev zdravljenja Ob prekinitvi zdravljenja se lahko pojavijo odtegnitveni simptomi, še zlasti, če je prekinitev nenadna (glejte poglavje 4. 8).
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
49 Pri selektivnih reverzibilnih MAOI, denimo moklobemidu, je tveganje za serotoninski sindrom manjše.
52 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 SSRI (denimo paroksetin, fluoksetin) uporabljali sočasno s serotoninergičnimi zdravili, so v redkih primerih poročali o serotoninskem sindromu.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
50 DULOXETINE BOEHRINGER INGELHEIM naj se v nosečnostu uporablja le, če možna korist upravičuje možno tveganje za plod.
Breast feeding 53 Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Dojenje Na osnovi študije 6 doječih bolnic, ki niso dojile svojih otrok, se duloksetin zelo slabo izloča v materino mleko.
Weight decrease
Srčne bolezni
Weight increase Creatinine
Zmanjšanje telesne mase
Blood cholesterol increased
Povečanje telesne mase Zvišanje kreatinin - fosfokinaze
phosphokinase increase
Zvišanje krvnega holesterola
Tinnitus 1
51
Photo- sensitivity reactions Increased tendency to bruise
Fotosenzitivno stne reakcije Povečano nagnjenje k modricam Kontaktni dermatitis Urtikarija Hladen znoj
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
Ortostatska hipotenzija2 Zvišan krvni
General Disorders and Administration Site Conditions
tlak Hladni periferni deli Splošne težave in spremembe na mestu aplikacije
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.
53 Navadno so pri SSRI in SNRI ti dogodki blagi do zmerni in samoomejujoči, vendar so pri nekaterih bolnikih lahko resni in/ ali trajajo dlje.
57 Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Poročali so o primerih prevelikega odmerjanja duloksetina samega ali v kombinaciji z drugimi zdravili, s 4800 mg odmerki duloksetina.
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Učinkovitost duloksetina kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12- tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom
Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
54 pri odraslih (starih od 22 do 88 let), ki so imeli bolečino diabetične nevropatije vsaj 6 mesecev.
58 Duloxetine is administered as a single enantiomer.
Duloksetin dajemo kot enojni enantiomer.
Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
55 višje vrednosti Cmax in AUC duloksetina v primerjavi z zdravimi osebami.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/ kg/ day), but these were considered to be secondary to 59 hepatic microsomal enzyme induction.
Mišje samice, ki so duloksetin prejemale 2 leti, so imele povišano incidenco hepatocelularnih adenomov in karcinomov samo pri visokem odmerku (144 mg/ kg/ dan), vendar za te velja, da se pojavijo sekundarno zaradi indukcije jetrnih mikrosomskih encimov.
Edible White Ink contains:
Užitno belo črnilo vsebuje:
Titanium Dioxide (E171) Propylene glycol Shellac Povidone.
56 titanov dioksid (E171) propilenglikol šelak povidon
60 DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
Zdravilo DULOXETINE BOEHRINGER INGELHEIM 60 mg je na voljo v pakiranjih po 28 in 98 kapsul.
61 ANNEX II
57 DODATEK II
62 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
58 A IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in Edition 4.0 dated 30.07.2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 4. 0 z dne 30. 07. 2007 predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje pred prihodom zdravila na trg in dokler bo zdravilo na tržišču.