qanastek/EMEA-V3 huggingface dataset:
Do not use DUKORAL after the expiry date which is stated on the carton.
Tużax DUKORAL wara d- data ta ’ skadenza li tidher fuq il- kartuna.
What DUKORAL contains
X’ fih DUKORAL: − Is- sustanzi attivi huma:
Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated).
25x109 batterji * ta ’ kull wieħed mir- razzez ta ’ V. cholerae O1 li ġejjin: bijo- tip klassiku Inaba (inattivat bis- sħana), bijo- tip Inaba El Tor (inattivat bil- formalina), bijo- tip klassiku Ogawa (inattivat bis- sħana), bijo- tip klassiku Ogawa (inattivat bil- formalina).
Recombinant cholera toxin B subunit (rCTB) 1 mg. *bacterial content prior to inactivation
Subunità ta ’ tossina B tal- kolera rikombinanti (rCTB) 1 mg. * kontenut ta ’ batterji qabel l- inattivazzjoni
- The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium
- Is- sustanzi l- oħra fis- suspensjoni tal- vaċċin huma sodium dihydrogen phosphate, disodium
hydrogen phosphate, sodium chloride and water for injections.
hydrogen phosphate, sodium chloride u ilma għall- injezzjonijet.
- The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate,
- Il- granijiet li jfexfxu fihom sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin
saccharin sodium, sodium citrate and raspberry flavour.
sodium, sodium citrate u essenza tat- tut.
What DUKORAL looks like and contents of the pack DUKORAL is presented as a suspension and effervescent granules for oral suspension.
DUKORAL jiġi bħala suspensjoni u granijiet li jfexfxu għal suspensjoni orali.
The vaccine is a whitish suspension supplied in a vial.
Il- vaċċin huwa suspensjoni ta ’ lewn bajdani li jiġi fornut f’ kunjett.
The sodium hydrogen carbonate is white effervescent granules with a raspberry flavour supplied in a sachet.
Sodium hydrogen carbonate huwa granijiet li jfexfxu bojod b’ essenza tat- tut fornuti f' qartas.
DUKORAL is available in packs of 1, 2 and 20 doses.
DUKORAL issibu f’ pakketti ta ’ 1, 2 u 20 doża.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali
Marketing Authorisation Holder and Manufacturer SBL Vaccin AB, 105 21 Stockholm, Sweden.
SBL Vaccin AB, 105 21 Stokkolma, l- Iżvezja.
This leaflet was last approved in MM/ YYYY
Dan il- fuljett kien approvat l- aħħar f’ XX/ SSSS
What is Duloxetine Boehringer Ingelheim?
X' inhu Duloxetine Boehringer Ingelheim?
Duloxetine Boehringer Ingelheim is a medicine containing the active substance duloxetine.
Duloxetine Boehringer Ingelheim huwa mediċina li fiha s- sustanza attiva duloxetine.
It is available as gastroresistant capsules (blue:
Huwaa disponibbli f' forma ta 'kapsuli gastroreżistenti (blu:
20 mg; white and blue:
20 mg; bojod u blu:
30 mg; orange:
30 mg; oranġjo:
40 mg; green and blue:
40 mg; ħodor u blu:
This prevents the active substance being destroyed by the acid in the stomach.
"Gastroreżistenti" tfisser li l- kontenut tal- kapsuli jgħaddi mill- istonku u jibqa 'intatt sa meta jilħaq il- musrana.
This medicine is the same as Ariclaim, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Ariclaim, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Ariclaim has agreed that its scientific data can be used for Duloxetine Boehringer Ingelheim.
Il - kumpanija li tipproduċi Ariclaim qablet li t- tagħrif xjentifiku tagħha jista 'jintuża għal Duloxetine Boehringer Ingelheim.
What is Duloxetine Boehringer Ingelheim used for?
Għal xiex jintuża Duloxetine Boehringer Ingelheim?
Duloxetine Boehringer Ingelheim is used to treat: • moderate to severe stress urinary incontinence (SUI) in women.
Duloxetine Boehringer Ingelheim jintuża għat- trattament: • tal- inkontinenza urinarja minn sforz (SUI - stress urinary incontinence) minn moderata għal gravi fin- nisa.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising. • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
SUI sseħħ meta l- awrina tiskappa involontarjament matul l- isforz fiżiku jew wara li tisgħol, tidħaq, tagħtas, tgħolli oġġetti jew tagħmel eżerċizzji fiżiċi. • tal- uġigħ minħabba newropatija periferika dijabetika (ħsara lin- nervituri tal- estremitajiet li tista 'sseħħ f' pazjenti bid- dijabete).
How is Duloxetine Boehringer Ingelheim used?
Kif jintuża Duloxetine Boehringer Ingelheim?
For SUI, the recommended dose of Duloxetine Boehringer Ingelheim is 40 mg twice a day.
Għal SUI, id- doża rakkomandata ta 'Duloxetine Boehringer Ingelheim hija 40 mg darbtejn kuljum.
Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Xi pazjenti jistgħu jiksbu benefiċċju minn trattament inizjali b' doża ta '20 mg darbtejn kuljum għal ġimagħtejn qabel ma jgħaddu għad- doża rakkomandata ta' 40 mg, biex inaqqsu n- nawżea (dardir) u l - isturdament.
Combining Duloxetine Boehringer Ingelheim with pelvic floor muscle training may provide additional benefit.
Li tgħaqqad Duloxetine Boehringer Ingelheim ma 'programm ta' eżerċizzju tal - muskolatura tal- qiegħ pelviku (pelvic floor) jista 'jagħti aktar benefiċċju.
For diabetic neuropathic pain, the recommended dose is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Għall- uġigħ newropatiku dijabetiku, id- doża rakkomandata hija 60 mg darba kuljum, iżda xi pazjenti aktarx jeħtieġu doża aktar qawwija ta '120 mg kuljum.
The response to treatment should be assessed two months after starting treatment.
Ir- rispons għat- trattament għandu jiġi valutat xahrejn wara l- bidu tat- trattament.
Duloxetine Boehringer Ingelheim can be taken with or without food.
Duloxetine Boehringer Ingelheim jista 'jittieħed kemm fuq stonku vojt kif ukoll le.
The benefit of treatment should be re-assessed at regular intervals.
Il- benefiċċju tat - trattament għandu jiġi valutat mill- ġdid f' intervalli ta 'żmien regolari.
Duloxetine Boehringer Ingelheim should be used with caution in elderly patients.
Duloxetine Boehringer Ingelheim għandu jintuża b' kawtela fil- pazjenti anzjani.
It should not be used in patients who have certain problems with their liver or severe kidney problems.
Il- mediċina ma għandiex tintuża f' pazjenti li għandhom problemi gravi bil- fwied jew bil- kliewi.
The dose should be reduced gradually when stopping treatment.
Id- doża għandha titnaqqas gradwalment meta t - trattament jieqaf.
How does Duloxetine Boehringer Ingelheim work?
Kif jaħdem Duloxetine Boehringer Ingelheim?
The active substance in Duloxetine Boehringer Ingelheim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Is- sustanza attiva fi Duloxetine Boehringer Ingelheim, duloxetine, hija inibitur tal- assorbiment mill - ġdid tas- serotonina u tan- noradrenalina (serotonin- noradrenaline re- uptake inhibitor).
It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Dan jaħdem billi jipprevjeni lin- newrotrasmettituri 5- idrossitriptamina (5- hydroxytrypamine, imsejħa wkoll serotonina) u n- noradrenalina milli jerġgħu jiġu assorbiti fiċ- ċelluli nervużi fil- moħħ u fis- sinsla tad - dahar.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
In- newrotrasmettituri huma sustanzi kimiċi li jippermettu li ċ- ċelluli nervużi jikkomunikaw ma 'xulxin.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Billi jimblokka l- assorbiment mill- ġdid, duloxetine iżżid l- ammont ta 'dawn in - newrotrasmettituri fl- ispazji bejn dawn iċ- ċelluli nervużi, u b' hekk iżżid il- livell ta' komunikazzjoni bejn iċ- ċelluli.
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
L- azzjoni ta 'duloxetine fi SUI mhijiex ċara, iżda jitqies li, billi żżid il- livelli ta' 5- idrossitripamina e noradrenalina fil- livell tan- nervituri li jikkontrollaw il- muskolatura tal- uretra (il- kanal li jgħaqqad il - bużżieqa ma 'barra), duloxetine tikkawża għeluq tal- uretra aktar bis- saħħa waqt il- bużżieqa timtela bl - awrina.
By closing the urethra more powerfully, Duloxetine Boehringer Ingelheim prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Billi jagħlaq l- uretra aktar bis- saħħa, Duloxetine Boehringer Ingelheim jipprevjeni t- telf involontarju ta 'awrina waqt sforz fiżiku bħas- sogħla jew id- daħk.
Since these neurotransmitters are also involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may also improve the symptoms of neuropathic pain.
Billi dawn in- newrotrasmettituri huma wkoll involuti fit- tnaqqis tas- sensazzjoni ta 'wġigħ, il- fatt li jimpedixxu l- assorbiment mill- ġdid tagħhom fiċ- ċelluli nervużi aktarx jgħin ukoll biex itaffi s- sintomi tal- uġigħ newropatiku.
How has Duloxetine Boehringer Ingelheim been studied?
Kif ġie studjat Duloxetine Boehringer Ingelheim?
For the treatment of SUI, Duloxetine Boehringer Ingelheim has been studied in a total of 2,850 women.
Għat- trattament ta 'SUI, Duloxetine Boehringer Ingelheim ġie studjat f' total ta' 2, 850 mara.
The four main studies involved 1,913 women and lasted 12 weeks, comparing Duloxetine Boehringer Ingelheim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
L- erba 'studji prinċipali involvew 1, 913- il mara u damu 12- il ġimgħa u qabblu Duloxetine Boehringer Ingelheim (l- aktar bħala doża 40 mg darbtejn kuljum) mal- plaċebo (trattament finta).
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Il- kejl ewlieni tal- effikaċja kienu l- frekwenza tal- episodji ta 'inkontinenza (IEF, jiġifieri l- għadd ta' episodji ta 'inkontinenza kull ġimgħa) imniżżla fuq djarju tal- pazjenti u l- punteġġ tal- pazjenti fuq il- bażi ta' kwestjonarju ta 'kwalità tal- ħajja speċifiku għall- inkontinenza (I- QOL).
For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Għat- trattament tal- uġigħ newropatiku dijabetiku, Duloxetine Boehringer Ingelheim ġie eżaminat f' żewġ studji li damu 12- il ġimgħa fuq 809 adulti dijabetiċi li ħassew uġigħ kuljum għal talanqas sitt xhur.
The effectiveness of three different doses of Duloxetine Boehringer Ingelheim was compared with that of placebo.
L- effikaċja ta 'tliet dożi differenti ta' Duloxetine Boehringer Ingelheim tqabblet ma 'dik tal - plaċebo.
The main measure of effectiveness was the change in the severity of pain each week, as recorded by the patients on an 11-point scale in daily diaries.
Il- kejl ewlieni tal- effikaċja kien il- bidla fil- gravità tal- uġigħ kull ġimgħa, kif imniżżel mill - pazjenti fuq skala ta '11- il punt fi djarju ta' kuljum.
What benefit has Duloxetine Boehringer Ingelheim shown during the studies?
Liema benefiċċji wera Duloxetine Boehringer Ingelheim waqt l- istudji mwettqa?
In all four studies of SUI, the patients treated with Duloxetine Boehringer Ingelheim had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Fl- erba 'studji kollha ta' SUI, il- pazjenti ttrattati b' Duloxetine Boehringer Ingelheim kellhom anqas episodji ta 'inkontinenza wara 12- il ġimgħa, b' madwar erbgħa jew ħames episodji anqas kull ġimgħa meta mqabbel mal- frekwenza reġistrata l- istudju.
The IEF decreased by 52% in the Duloxetine Boehringer Ingelheim group, compared with a decrease of 33% in the placebo-treated group.
L- IEF naqset bi 52% fil- grupp ta 'Duloxetine Boehringer Ingelheim, kontra tnaqqis ta' 33% fil- grupp ittrattat bil- plaċebo.
The I-QOL questionnaire scores were also improved in the Duloxetine Boehringer Ingelheim group compared with the placebo group.
Il- punteġġi tal - kwestjonarju I- QOL tjiebu wkoll fil- grupp tal- pazjenti ttrattati b' Duloxetine Boehringer Ingelheim meta mqabbel mal- grupp ittrattat bil- plaċebo.
Duloxetine Boehringer Ingelheim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Duloxetine Boehringer Ingelheim irriżulta aktar effikaċi mill- plaċebo biss fil- pazjenti li kellhom iktar minn 14- il episodju ta 'inkontinenza fil- ġimgħa (SUI minn moderata għal gravi) fil- bidu tal- istudju.
For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Għat- trattament tal- uġigħ newropatiku dijabetiku, Duloxetine Boehringer Ingelheim f' dożi ta '60 mg darba jew darbtejn kuljum irriżulta aktar effikaċi mill- plaċebo biex inaqqas l- uġigħ.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Duloxetine Boehringer Ingelheim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Fiż- żewġ studji, it- tnaqqis tal- uġigħ deher mill- ewwel ġimgħa ta 'trattament sa perjodu massimu ta' 12- il ġimgħa u l - pazjenti ttrattati b' Duloxetine Boehringer Ingelheim kellhom punteġġ ta 'wġigħ bejn 1. 17 u 1. 45 punt anqas minn dawk il- pazjenti ttrattati bil- plaċebo.
What is the risk associated with Duloxetine Boehringer Ingelheim?
X' inhuma r- riskji assoċjati b' Duloxetine Boehringer Ingelheim?
The most common side effects with Duloxetine Boehringer Ingelheim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
L- effetti sekondarji l- aktar komuni b' Duloxetine Boehringer Ingelheim fit- trattament ta 'SUI (li dehru f' aktar minn pazjent 1 minn kull 10) huma nawżea, ħalq xott, stitikezza u għeja.
Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Fil- parti l- kbira tal - każijiet dawn kienu effetti ħfief jew moderati, li dehru fil- bidu tat- trattament u naqsu hekk kif kompla t- trattament.
The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), nausea and dry mouth.
L- effetti sekondarji l- aktar komuni fit- trattament tal- uġigħ newropatiku dijabetiku (li dehru f' aktar minn pazjent 1 minn 10) huma wġigħ ta 'ras, ħedla tan- ngħas, nawżea u ħalq xott.
For the full list of all side effects reported with Duloxetine Boehringer Ingelheim, see the Package Leaflet.
Għal lista sħiħa tal- effetti sekondarji kollha rrappurtati b' Duloxetine Boehringer Ingelheim, ara l- Fuljett ta 'Tagħrif.
Duloxetine Boehringer Ingelheim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Duloxetine Boehringer Ingelheim ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal duloxetine jew għal xi ingredjenti oħra.
Duloxetine Boehringer Ingelheim should not be used in patients with certain types of liver disease or with severe kidney disease.
Duloxetine Boehringer Ingelheim ma għandux jintuża 2/ 3 f' pazjenti b' ċerti tipi ta 'mard tal- fwied jew f' pazjenti b' mard gravi tal- kliewi.
Duloxetine Boehringer Ingelheim should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Duloxetine Boehringer Ingelheim ma għandux jintuża flimkien ma 'inibituri tal- monoamino ossidażi (monoamine oxidase inhibitors, grupp ta' antidepressivi), fluvoxamine (antidipressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta 'antibijotiċi).
Treatment should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
It- trattament ma għandux jinbeda f' pazjenti bi pressjoni tad- demm għolja mhux kontrollata, minħabba riskju ta 'kriżi ipertensiva (meta l- pressjoni tad- demm titla' f' daqqa u tkun perikoluża).
2/ 3 Why has Duloxetine Boehringer Ingelheim been approved?
Għaliex ġie approvat Duloxetine Boehringer Ingelheim?
The Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Boehringer Ingelheim’ s benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Duloxetine Boehringer Ingelheim huma ogħla mir- riskji tiegħu għat- trattament ta' SUI minn moderata għal gravi u tal- uġigħ newropatiku periferiku dijabetiku f' adulti.
The Committee recommended that Duloxetine Boehringer Ingelheim be given marketing authorisation.
Il- Kumitat irrakkomanda li Duloxetine Boehringer Ingelheim jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Duloxetine Boehringer Ingelheim:
Aktar tagħrif dwar Duloxetine Boehringer Ingelheim:
The European Commission granted a marketing authorisation valid throughout the EU for Duloxetine Boehringer Ingelheim to Boehringer Ingelheim International GmbH on 8 October 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Duloxetine Boehringer Ingelheim għal Boehringer Ingelheim International GmbH fit 8 ta 'Ottubru 2008.
The full EPAR for Duloxetine Boehringer Ingelheim is available here.
L- EPAR sħiħ għal Duloxetine Boehringer Ingelheim jista 'jiġi kkonsultat hawn.
Name
Isem inventat
Gastro-resistant capsule, hard
Kapsula gastro- reżistenti, iebsa
DULOXETINE BOEHRINGER INGELHEIM 40 mg hard gastro-resistant capsules.
DULOXETINE BOEHRINGER INGELHEIM 40 mg kapsuli ibsin gastro- reżistenti
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Kull kapsula fiha 40 mg ta ’ duloxetine (bħala hydrochloride).
For a full list of excipients, see section 6.1.
Sustanzi mhux attivi: sucrose 11. 5 mg Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Hard gastro-resistant capsule.
Kapsula iebsa gastro- reżistenti.
Opaque orange body, imprinted with ’ 40mg’ and an opaque blue cap, imprinted with ‘ 9545’.
Il- parti prinċipali oranġjo opak, stampat b ’ '40 mg' u għatu ċelesti opak, stampat b ’ '9545'.
DULOXETINE BOEHRINGER INGELHEIM is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
4. 1 Indikazzjonijiet terapewtiċi
Treatment of diabetic peripheral neuropathic pain in adults.
Kura ta ’ wġigħ newropatiku periferiku tad- dijabete fl- adulti.
Stress Urinary Incontinence:
Inkontinenza Awrinarja minħabba Sforz:
The recommended dose of DULOXETINE BOEHRINGER INGELHEIM is 40 mg twice daily without regard to meals.
Id- doża rrakkomandata ta ’ DULOXETINE BOEHRINGER INGELHEIM hija ta '40 mg darbtejn kuljum u mingħajr bżonn li tittieħed fuq l- ikel.
After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy.
Wara 2- 4 ġimgħat ta 'kura, il- pazjenti għandhom jerġgħu jiġu eżaminati sabiex jiġu evalwati l- benefiċċju u t- tollerabilità tat- terapija.
Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily.
Xi pazjenti jistgħu jibbenefikaw billi jibdew il- kura b’ doża ta ’ 20 mg darbtejn kuljum għal ġimgħatejn qabel ma jżidu d - doża għal dik rakkomandata ta ’ 40 mg darbtejn kuljum.
Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.
Il- fatt li tibda b’ doża aktar baxxa jista ’ jnaqqas għalkemm mhux jelimina r- riskju ta ’ tqalligħ u sturdament.
However, limited data are available to support the efficacy of DULOXETINE BOEHRINGER INGELHEIM 20 mg twice daily.
Madankollu, it- tagħrif disponibbli huwa limitat biex tkun aċċertata l- effikaċja ta ’ DULOXETINE BOEHRINGER INGELHEIM 20 mg darbtejn kuljum.
A 20 mg capsule is also available.
Kapsula ta ’ 20 mg hija wkoll disponibbli.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ DULOXETINE BOEHRINGER INGELHEIM ma kinitx evalwata għal tul ta ’ żmien ta ’ aktar minn 3 xhur fi studji kliniċi kkontrollati bil- plaċebo.
The benefit of treatment should be re-assessed at regular intervals.
Il- benefiċċju tal- kura għandu jerġa ’ jiġi evalwat f’ intervalli regolari.
Combining DULOXETINE BOEHRINGER INGELHEIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Jista ’ jkun aktar effettiv li tassoċja DULOXETINE BOEHRINGER INGELHEIM ma ’ programm ta ’ eżerċizzji biex jissaħħu l- muskoli tal- qiegħ tal- pelvis (PFMT), milli tuża wieħed minnhom biss.
It is recommended that consideration be given to concomitant PFMT.
Huwa rakkomandat li jkun ikkunsidrat li fl- istess żmien tal- kura b’ DULOXETINE BOEHRINGER INGELHEIM ikun hemm ukoll programm ta’ PFMT.
The medicinal product response should be evaluated after 2 months ’ of treatment.
2 Wara xahrejn ta ’ kura għandu jiġi valutat ir- rispons għall- prodott mediċinali.
Additional response after this time is unlikely (see 5.1).
Mhux mistenni li jkun hemm rispons addizzjonali wara dan il- perijodu (ara 5. 1).
2 The therapeutic benefit should regularly (at least every three months) be reassessed.
Il- benefiċċju terapewtiku għandu jerġa ’ jiġi valutat regolarment (mill- anqas kull tliet xhur).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
Insuffiċjenza tal- fwied DULOXETINE BOEHRINGER INGELHEIM m’ għandhux jintuża f’ pazjenti b’ mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjoni 4. 3).
Renal insufficiency:
Insuffiċjenza renali:
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
M’ hemmx bżonn ta 'tibdil fid- doża għall- pazjenti b’ disfunzjoni renali ħafifa jew moderata (tneħħija tal- krejatinina ta ’ 30 sa 80 ml/ min).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jiġi użat f’ pazjenti b’ indeboliment renali gravi (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3)
Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age.
F’ pazjenti anzjani mhux irrakkomandat li jsir aġġustament tad- doża fuq bażi ta ’ età biss.
Caution should be exercised when treating the elderly
Trid toqgħod attent meta tkun qiegħed tikkura l- anzjani.
There is no experience in children (see section 4.4).
M’ hemm ebda esperjenza fit- tfal (ara sezzjoni 4. 4)
Abrupt discontinuation should be avoided.
Twaqqif tal- kura Għandu jigi evitat twaqqif f’ salt.
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).
Meta l- kura b’ DULOXETINE BOEHRINGER INGELHEIM tkun ser titwaqqaf id- doża għandha tiġi mnaqqsa gradwalment fuq perijodu ta ’ mill- anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir- riskju ta ’ reazzjonijiet ta ’ rtirar (ara sezzjonijiet 4. 4 u 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.
Jekk ifeġġu sintomi intollerabbli wara tnaqqis fid- doża jew wara twaqqif tal- kura, jista ’ jiġi kkunsidrat li terġa ’ tinbeda d- doża preċedenti ordnata.
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jiġi użat flimkien ma ’ Monoamine Oxidase Inhibitors irriversibbli u mhux selettivi – MAOIs (ara sezzjoni 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).
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jiġi użat flimkien ma ’ inibituri ta ’ CYP1A2, bħal fluvoxamine, ciprofloxacin jew enoxacine peress li dan iwassal għal konċentrazzjonijiet elevati ta ’ duloxetine fil- plażma (ara sezzjoni 4. 5).
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
Indeboliment sever renali (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 4).
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).
Huwa kontra- indikat li tinbeda l- kura b’ DULOXETINE BOEHRINGER INGELHEIM f’ pazjenti bi pressjoni għolja mhux ikkontrollata li tista ’ tesponi l- pazjenti għal riskju potenzjali ta ’ kriżi ipertensiva (ara sezzjonijiet 4. 4 u 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 u aċċessjonijiet DULOXETINE BOEHRINGER INGELHEIM għandu jiġi użat b’ attenzjoni f’ pazjenti b’ passat ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
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).
3 L- użu ta ’ DULOXETINE BOEHRINGER INGELHEIM flimkien ma ’ antidepressivi (speċjalment ma ’ SSRI, SNRI u MAOIs riversibbli) mhuwiex rakkomandat (ara iżjed l- isfel “ Depressjoni, formazzjoni ta ’ ħsibijiet ta ’ suwiċidju u mġiba u Sezzjoni 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).
St. John’ s wort L- effetti mhux mixtieqa jistgħu jkunu aktar komuni meta DULOXETINE BOEHRINGER INGELHEIM jintuża fl- istess ħin ma ’ preparazzjonijiet magħmulin mill- ħxejjex li jkun fihom St. John’ s wort (Hypericum perforatum).
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow- angle glaucoma.
Midrijasi Ġiet irrapurtata midrijasi b’ assoċjazzjoni ma ’ duloxetine, għaldaqstant, duloxetine għandu jiġi ordnat b’ attenzjoni f’ pazjenti bi pressjoni għolja fl- għajn, jew f’ dawk b’ riskju ta ’ glawkoma tat- tip narrow angle akuta.
Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension.
Każijiet ta ’ kriżi ipertensiva b’ duloxetine ġew irrapurtati, speċjalment f’ pazjenti li diġà kellhom l- ipertensjoni.
Therefore, in patients with known hypertension and/ or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Għaldaqstant, f’ pazjenti li hu magħruf li għandhom l- ipertensjoni u/ jew mard tal- qalb ieħor, huwa rrakkomandat li l - pressjoni tad- demm tinżamm taħt osservazzjoni, speċjalment fl- ewwel xahar ta ’ kura.
Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
Duloxetine għandu jintuża b’ attenzjoni f’ pazjenti li l- kundizzjonijiet tagħhom jistgħu jiġu kompromessi b’ żieda fir- rata ta ’ taħbit il- qalb jew żieda fil- pressjoni tad- demm.
Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
Għandha tingħata attenzjoni wkoll meta duloxetine jiġi użat ma ’ prodotti mediċinali li jistgħu jdgħajjfu l- metaboliżmu tiegħu (ara sezzjoni 4. 5).
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Indeboliment renali Pazjenti b’ indeboliment renali sever, li għandhom bżonn emodijaliżi (tneħħija tal- krejatinina < 30 ml/ min) ikollhom żieda fil- konċentrazzjoni ta ’ duloxetine fil- plażma.
For patients with severe renal impairment, see section 4.3.
Għal pazjenti b’ indeboliment renali sever, ara sezzjoni 4. 3.
See section 4.2 for information on patients with mild or moderate renal dysfunction.
Ara sezzjoni 4. 2 għal informazzjoni f’ pazjenti b’ disfunzjoni renali ħafifa jew moderata.
Haemorrhage There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/ norepinephrine reuptake inhibitors (SNRIs).
Emorraġija Kien hemm rapporti tà fsada mhux normali, bħal ekimożi, purpura u emorraġija gastro- intestinali b’ inibituri selettivi ta’ ġbir mill- ġdid ta ’ serotonin (SSRIs) u inibituri ta ’ ġbir mill- ġdid ta ’ serotonin / norepinephrine (SNRIs).
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
Hija rrakkomandata l- attenzjoni f’ pazjenti li qed jieħdu sustanzi kontra l - koagulazzjoni tad- demm u/ jew prodotti mediċinali magħrufa li jaffettwaw il- funzjoni tal- plejtlets, u f’ pazjenti b ’ tendenzi ta ’ fsada magħrufa.
Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Twaqqif tal- kura Huma komuni s- sintomi ta ’ rtirar meta l- kura tiġi mwaqqfa, partikolarment jekk it- twaqqif isir f’ daqqa waħda (ara sezzjoni 4. 8).
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.
Fi provi kliniċi effetti avversi bit- twaqqif tal- kura f’ daqqa seħħew f’ madwar 44% ta ’ pazjenti b’ kura ta ’ DULOXETINE BOEHRINGER INGELHEIM u 24% ta ’ pazjenti li ħadu l- plaċebo.
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.
Ir- riskju ta’ sintomi ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
The most commonly reported reactions are listed in section 4.8.
L- aktar reazzjonijiet komuni li ġew irrapurtati huma mniżżlin f’ sezzjoni 4. 8.
Generally the symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Ġeneralment dawn is- sintomi jkunu ħfief għal moderati, madankollu, f’ xi pazjenti jistgħu jkunu ta ’ intensità qawwija.
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.
Is- soltu dawn jidhru fl- ewwel ftit jiem tat- twaqqif tal - kura, iżda kien hemm rapporti rari ħafna ta ’ dawn is- sintomi f’ pazjenti li involontarjament kienu nsew jieħdu d- doża.
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Ġeneralment dawn is- sintomi jgħaddu waħidhom u s- soltu jieqfu fi żmien ġimgħatejn, għalkemm f’ xi individwi jistgħu jdumu aktar (2- 3- xhur jew aktar).
It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient’ s needs (see section 4.2).
Għalhekk huwa rrakkomandat li f’ twaqqif tal- kura b’ duloxetine jiġi mnaqqas bil- ftit il- ftit fuq perijodu ta ’ mhux anqas minn ġimgħatejn, skond il- bżonnijiet tal- pazjent (ara sezzjoni 4. 2).
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
4 Iponatrimja Iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, meta jkun qed jingħata DULOXETINE BOEHRINGER INGELHEIM.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Tinħtieġ attenzjoni f’ pazjenti b’ riskju akbar ta ’ iponatrimja; bħal anzjani, pazjenti b’ ċirrożi jew diżidratati, jew pazjenti fuq kura ta ’ dijuretiċi.
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
L- iponatrimja tista ’ tiġi kkawżata minn sindrome ta ’ sekrezzjoni mhux f’ loku ta ’ ormon anti- dijuretiku (SIADH).
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.
Depressjoni, mġiba u formazzjoni ta ’ ħsibijiet suwiċidali Għalkemm DULOXETINE BOEHRINGER INGELHEIM m’ huwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
Depression is 4 associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Id- depressjoni hija assoċjata ma ’ riskju akbar ta ’ ħsibijiet suwiċidali, ħsara lill- persuna nnifisha, u suwiċidju (avvenimenti marbuta ma ’ suwiċidju).
This risk persists until significant remission occurs.
Dan ir- riskju jippersisti sakemm iseħħ tnaqqis sinifikanti tad - depressjoni.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Billi waqt l- ewwel ftit ġimgħat jew aktar ta ’ kura jista ’ ma jseħħx titjib, il- pazjenti għandhom jiġu osservati bir- reqqa sakemm dan it- titjib iseħħ.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Hija esperjenza klinika ġenerali li r - riskju ta ’ suwiċidju jista ’ jiżdied fl- istadji bikrijin ta ’ fejqan.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Huwa magħruf li pazjenti b’ passat ta ’ avvenimenti marbuta ma ’ suwiċidju jew dawk li juru ammont sinifikanti ta ’ hsibijiet ta ’ suwiċidju qabel ma tibda l- kura huma f’ riskju ogħla li jkollhom ħsibijiet ta ’ suwiċidju jew ta ’ mġiba suwiċidali u għandhom jiġu sorveljati bir- reqqa waqt il- kura.
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).
Analiżi ta ’ numru ta ’ studji kliniċi kkontrollati bil - plaċebo ta ’ prodotti mediċinali antidepressivi li ntużaw f’ disturbi psikjatriċi wrew riskju ogħla ta ’ mġiba suwiċidali bl- antidipressivi meta mqabbla ma ’ plaċebo f’ pazjenti iżgħar minn 25 sena.
Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Każijiet ta ’ ħsibijiet ta ’ suwiċidju u mġiba ta ’ tendenza għal suwiċidju ġew irrapportati waqt il- kura b’ duloxetine jew ftit wara t- twaqqif tal- kura (ara sezzjoni 4. 8). It- tobba għandhom iħeġġu lill- pazjenti sabiex jirrappurtaw kull hsieb jew sentiment ta ’ dwejjaq jew sintomu depressiv f’ kull ħin.
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.
Jekk waqt il- kura b’ DULOXETINE BOEHRINGER INGELHEIM, il- pazjent jiżviluppa sintomi ta ’ aġitazzjoni jew sintomi depressivi, għandu jittieħed parir mediku speċjalizzat, peress li d- depressjoni hija kundizzjoni medika serja.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of DULOXETINE BOEHRINGER INGELHEIM is recommended (see Section 4.2).
(ara Sezzjoni 4. 2).
DULOXETINE BOEHRINGER INGELHEIM should not be used in the treatment of children and adolescents under the age of 18 years.
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jintuża fil- kura ta ’ tfal u adolexxenti taħt it- 18- il sena.
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Imġiba assoċjata mas- suwiċidju (attentati ta ’ suwiċidju u ħsibijiet ta ’ suwiċidju), u ostilità (l- aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss fi provi kliniċi fuq tfal u adolexxenti kkurati b’ anti - depressivi meta mqabbla ma ’ dawk ikkurati bi plaċebo.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Fit- tfal u fl- adolexxenti, it- tagħrif dwar is - sigurtà fit- tul f’ dak li jirrigwarda l- iżvilupp tal- ġisem, il- maturazzjoni u l- iżvilupp konjittiv u ta ’ l - imġiba, huwa nieqes.
The use of more than one of these products concomitantly should be avoided.
Prodotti mediċinali li fihom duloxetine Duloxetine huwa użat taħt trejdmarks differenti f’ ħafna indikazzjonijiet (kura ta ’ uġigħ newropatiku tad- dijabete, episodji depressivi maġġuri kif ukoll inkontinenza ta ’ l- awrina minħabba sforz). L- użu fl - istess ħin ta ’ aktar minn wieħed minn dawn il- prodotti għandu jiġi evitat.
Hepatitis/ increased liver enzymes Cases of liver injury, including severe elevations of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Epatite/ żieda fl- enzimi tal- fwied B’ duloxetine ġew irrappurtati każijiet ta ’ ħsara fil- fwied, fosthom żidiet b’ mod serju ta ’ enzimi tal - fwied (> 10 darbiet il- limitu ta ’ fuq tan- normal), epatite u suffejra (ara sezzjoni 4. 8).
Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Duloxetine għandu jintuża b’ attenzjoni f’ pazjenti li jkunu fuq kura b’ prodotti mediċinali oħra assoċjati ma ’ ħsara fil- fwied.
Akathisia/ psychomotor restlessness The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Akatiżja/ irrekwitezza psikomotorja L- użu ta ’ duloxetine ġie assoċjat ma ’ żvilupp ta ’ akatiżja, ikkaraterrizzata minn irrekwitezza soġġettivament mhux pjaċevoli jew ta ’ sofferenza u mill- ħtieġa ta ’ tħarrik spiss flimkien ma ’ nuqqas ta ’ ħila li wieħed joqgħod bilqiegħda jew ma jitħarrikx.
Sucrose DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
5 Sucrose DULOXETINE BOEHRINGER INGELHEIM kapsuli gastro- reżistenti ibsin fihom sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fructose, assorbiment ħażin ta ’ glucose- galactose jew insuffiċjenza ta ’ sucrose- isomaltase m’ għandhomx jieħdu din il- mediċina.
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.
Inibituri ta ’ Monoamine Oxidase (MAOIs): minħabba r- riskju ta ’ sindrome ta ’ serotonin, DULOXETINE BOEHRINGER INGELHEIM m’ għandux jintuża flimkien ma ’ inibituri ta ’ monoamine oxidase (MAOIs) irriversibbli u mhux selettivi, jew fi żmien ta ’ mill- anqas 14- il ġurnata minn meta ġiet sospiża l- kura b’ xi 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).
Fuq il- bażi tal- half- life ta ’ duloxetine, għandhom jgħaddu mill- anqas 5 ijiem minn meta twaqqaf DULOXETINE BOEHRINGER INGELHEIM qabel jinbeda xi MAOI (ara sezzjoni 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.
Sindrome ta ’ serotonin: f’ każijiet rari, ġie rrappurtat sindrome ta ’ serotonin f’ pazjenti li jużaw SSRIs (per eżempju paroxetine, fluoxetine) fl- istess ħin ma ’ prodotti mediċinali serotoninerġiċi.
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.
Wieħed għandu joqgħod attent meta DULOXETINE BOEHRINGER INGELHEIM jintuża fl- istess ħin ma ’ antidepressivi serotoninerġiċi bħal SSRI’ s, triċikliċi bħal clomipramine jew amitriptyline, St. John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
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).
Prodotti mediċinali li jaffettwaw is- CNS: hija rakkomandata l- attenzjoni meta DULOXETINE BOEHRINGER INGELHEIM jintuża flimkien ma ’ sustanzi jew prodotti mediċinali oħra li jaġixxu fuq is- sistema nervuża ċentrali, li jinkludi l- alkoħol u prodotti mediċinali sedattivi (benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital u l- antistaminiċi sedattivi)
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71%, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
L- AUC fiss ta ’ tolterodine (2 mg darbtejn kuljum) tiżdied b’ 71% meta jingħata flimkien ma ’ duloxetine (40 mg darbtejn kuljum), iżda ma jaffettwax il- farmakokinetika tal- metabolu attiv tiegħu 5- hydroxyl u mhux irrakkomandat li jsir aġġustament ta ’ doża.
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).
Hu rrakkomandat li DULOXETINE BOEHRINGER INGELHEIM jingħata b’ attenzjoni jekk jittieħed flimkien ma ’ prodotti mediċinali li huma fil- biċċa l- kbira metabolizzati minn CYP2D6 (risperidone, anti- depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
Oral contraceptives and other steroidal agents: results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Kontraċettivi orali u sustanzi sterojdi oħra: riżultati ta ’ studji in vitro juru li duloxetine ma jistimolax l- attività katalitika ta ’ CYP3A.
Anticoagulants and antiplatelet agents:
Sustanzi kontra l- koagulazzjoni tad- demm u kontra l- plejtlets:
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding.
Għandha tingħata attenzjoni meta duloxetine jingħata flimkien ma ’ sustanzi kontra l- koagulazzjoni tad- demm b’ mod orali u ma ’ sustanzi kontra l- plejtlets minħabba riskju potenzjali akbar ta ’ fsada.
Furthermore, increases in INR values have been reported when duloxetine was co-administered with warfarin.
Barra dan, żidiet fil- valuri ta ’ l- INR ġew irrappurtati meta duloxetine ngħata flimkien ma ’ warfarin.
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.
Effetti ta ’ prodotti mediċinali oħra fuq duloxetine Mediċini kontra l- aċtu fl- istonku u antagonisti ta ’ H2: it- teħid ta ’ duloxetine flimkien ma ’ mediċini kontra l- aċidu fl- istonku li fihom aluminium u magnesium jew ma ’ famotidine ma kellhiex effett sinifikanti fuq ir- rata jew il- miżura ta ’ assorbiment ta ’ duloxetine wara li ngħatat doża orali ta ’ 40 mg.
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.
Inibituri ta ’ CYP1A2: billi CYP1A2 huwa involut fil- metaboliżmu ta ’ duloxetine, bl- użu fl- istess ħin ta ’ duloxetine ma ’ inibituri qawwija ta ’ CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta ’ duloxetine.
Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
Fluvoxamine (100 mg darba kuljum), inibitur qawwi ta ’ CYP1A2, naqqas it -
Therefore DULOXETINE BOEHRINGER INGELHEIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Għaldaqstant, DULOXETINE BOEHRINGER INGELHEIM m’ għandux jingħata flimkien ma ’ inibituri qawwija ta ’ CYP1A2 bħal fluvoxamine (ara sezzjoni 4. 3).
Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Analiżi farmakokinetiċi tal- popolazzjoni juru li min ipejjep għandu kważi 50% anqas konċentrazzjonijiet fil- plażma ta ’ duloxetine meta mqabbel ma ’ min ma jpejjipx
Pregnancy There are no data on the use of duloxetine in pregnant women.
Tqala M’ hemmx tagħrif fuq l- użu ta ’ duloxetine fin- nisa waqt it- tqala.
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Studji fl- annimali wrew tossiċità fuq is- sistema riproduttiva f’ livelli ta ’ esponiment sistemiku (AUC) ta ’ duloxetine anqas mill- massimu ta ’ l- espożizzjoni klinika (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali għall- bnedmin mhux magħruf.
As with other serotoninergic medicinal product, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Bħal ma jiġri f’ prodotti mediċinali serotinerġiċi oħra, sintomi ta ’ sospensjoni jistgħu jseħħu fit- tarbija tat- twelid wara li duloxetine jintuża fl- omm viċin it- tmiem tat- tqala.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy 6 only if the potential benefit justifies the potential risk to the foetus.
DULOXETINE BOEHRINGER INGELHEIM għandu jintuża biss fit- tqala jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
In- nisa għandhom jingħataw parir li javżaw lit- tabib tagħhom jekk isiru tqal jew jekk għandhom l- intenzjoni li jsiru tqal waqt it- terapija.