qanastek/EMEA-V3 huggingface dataset:
As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other agents, such as MAO-inhibitors, that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Bħal ma jiġri b’ sustanzi serotonerġiċi oħrajn, is- sindrome ta ’ serotonin, kundizzjoni li potenzjalment hi ta ’ periklu għall- ħajja, tista ’ sseħħ matul il- kura b’ venlafaxine, partikolarment bl- użu fl- istess ħin ta ’ mediċini oħrajn, bħal inibituri ta ’ MAO, li jistgħu jaffettwaw is- sistema tan- newrotrasmettitur serotonerġiku (ara sezzjonijiet 4. 3 u 4. 5).
Serotonin syndrome symptoms may include mental status changes (e. g., agitation, hallucinations, coma), autonomic instability (e. g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e. g., hyperreflexia, incoordination) and/ or gastrointestinal symptoms (e. g., nausea, vomiting, diarrhoea).
23 Is- sintomi tas- sindrome ta ’ serotonin jistgħu jinkludu tibdil fl- istat mentali (eż., aġitazzjoni, alluċinazzjonijiet, koma), instabilità awtonomika (eż., takikardija, pressjoni tad- demm instabbli, ipertermija), aberrazzjonijiet newromuskolari (eż., iperrefleksja, nuqqas ta ’ koordinazzjoni) u/ jew sintomi gastrointestinali (eż., nawseja, rimettar, dijarea).
Narrow-angle glaucoma
Glawkoma ta ’ angolu dejjaq
Mydriasis may occur in association with venlafaxine.
Il- midrijasi tista ’ sseħħ b’ rabta ma ’ venlafaxine.
It is recommended that patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) be closely monitored.
Hu rakkomandat li pazjenti bi pressjoni intraokulari għolja, jew pazjenti li qegħdin f’ riskju għal glawkoma akuta ta ’ angolu dejjaq (glawkoma tat- tip angle- closure) ikunu mmonitorjati mill- qrib.
Dose-related increases in blood pressure have been commonly reported with venlafaxine.
Żidiet marbuta mad- doża fil- pressjoni tad- demm kienu rrappurtati b’ mod komuni b’ venlafaxine.
In some cases, severely elevated blood pressure requiring immediate treatment has been reported in postmarketing experience.
F’ xi każijiet, pressjoni tad- demm għolja b’ mod sever li kienet teħtieġ kura immedjata, kienet irrappurtata fl- esperjenza ta ’ wara l- bejgħ.
All patients should be carefully screened for high blood pressure and pre- existing hypertension should be controlled before initation of treatment.
Il- pazjenti kollha għandhom ikunu skrinjati għal pressjoni tad- demm għolja, u pressjoni għolja li tkun teżisti minn qabel għandha tkun ikkontrollata qabel il- bidu tal- kura.
Blood pressure should be reviewed periodically, after initiation of treatment and after dose increases.
Il- pressjoni tad- demm għandha tkun evalwata perjodikament, wara l- bidu tal- kura u wara żidiet fid - doża.
Caution should be exercised in patients whose underlying conditions might be compromised by increases in blood pressure, e. g., those with impaired cardiac function.
Għandha tingħata attenzjoni f’ pazjenti li l- kundizzjonijiet diġà eżistenti tagħhom jistgħu jkunu kompromessi minn żidiet fil- pressjoni tad- demm, eż. dawk b’ indeboliment tal- funzjoni kardijaka.
Heart rate
Rata tat- taħbit tal- qalb
Increases in heart rate can occur, particularly with higher doses.
Żidiet fir- rata ta ’ taħbit tal- qalb jistgħu jseħħu, partikolarment b’ dożi ogħla.
Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate.
Għandha tingħata attenzjoni f’ pazjenti li l- kundizzjonijiet diġà eżistenti tagħhom jistgħu jkunu kompromessi minn żidiet fir- rata tat- taħbit tal- qalb.
Cardiac disease and risk of arrhythmia
Mard kardijaku u riskju ta ’ arritmija
Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease.
Venlafaxine ma kienx evalwat f’ pazjenti bi storja medika riċenti ta ’ infart mijokardijaku jew mard instabbli tal- qalb.
Therefore, it should be used with caution in these patients.
Għaldaqstant, għandu jintuża bl- attenzjoni f’ dawn il- pazjenti.
In postmarketing experience, fatal cardiac arrhythmias have been reported with the use of venlafaxine, especially in overdose.
Fl- esperjenza ta ’ wara l- bejgħ, arritmiji kardijaċi fatali kienu rrappurtati bl- użu ta venlafaxine, speċjalment f’ każ ta ’ doża eċċessiva.
The balance of risks and benefits should be considered before prescribing venlafaxine to patients at high risk of serious cardiac arrhythmia.
Il- bilanċ tar- riskji u l- benefiċċji għandu jkun ikkunsidrat qabel ma tingħata riċetta għal venlafaxine lil pazjenti li qegħdin f’ riskju għoli ta ’ arritmija kardijaka serja.
Convulsions may occur with venlafaxine therapy.
Il- konvulżjonijiet jistgħu jseħħu bit- terapija ta ’ venlafaxine.
As with all antidepressants, venlafaxine should be introduced with caution in patients with a history of convulsions, and concerned patients should be closely monitored.
Bħall- anti- dipressanti kollha, venlafaxine għandu jinbeda bl- attenzjoni f’ pazjenti bi storja medika ta ’ konvulżjonijiet, u pazjenti kkonċernati għandhom ikunu mmonitorjati mill- qrib.
Treatment should be discontinued in any patient who develops seizures.
Il- kura għandha titwaqqaf fi kwalunkwe pazjent li jiżviluppa l- aċċessjonijiet.
25 Hyponatraemia
Iponatremija
Cases of hyponatraemia and/ or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur with venlafaxine.
Każijiet ta ’ iponatremija u/ jew tas- Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion, jistgħu jseħħu b’ venlafaxine.
This has most frequently been reported in volume-depleted or dehydrated patients.
Dan kien irrappurtat bl- iktar mod frekwenti f’ pazjenti li jkollhom nuqqas fil- volum tal- likwidi tal- ġisem jew li kienu diżidratati.
Elderly patients, patients taking diuretics, and patients who are otherwise volume-depleted may be at greater risk for this event.
Pazjenti anzjani, pazjenti li jkunu qed jieħdu d- dijuretiċi, u pazjenti li b’ xi mod ieħor ikollhom nuqqas fil- volum tal- likwidi tal - ġisem jistgħu jkunu f’ riskju akbar għal dan l- avveniment.
Abnormal bleeding
Ħruġ anormali ta ’ demm
Medicinal products that inhibit serotonin uptake may lead to reduced platelet function.
Prodotti mediċinali li jinibixxu l- assorbiment ta ’ serotonin jistgħu jwasslu għal tnaqqis fil- funzjoni tal- plejtlits.
The risk of skin and mucous membrane bleeding, including gastrointestinal haemorrhage, may be increased in patients taking venlafaxine.
24 Ir- riskju ta ’ ħruġ ta ’ demm fil- ġilda u l- membrana mukuża, inkluż emorraġija gastrointestinali, jista ’ jiżdied f’ pazjenti li jkunu qed jieħdu venlafaxine.
As with other serotonin-reuptake inhibitors, venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors.
Kif jiġri b’ mediċini oħrajn li jinibixxu l - assorbiment mill- ġdid ta ’ serotonin, venlafaxine għandu jintuża bl- attenzjoni f’ pazjenti li huma predisposti għal ħruġ ta ’ demm, li jinkludu pazjenti li jkunu qed jieħdu mediċini kontra l - koagulazzjoni tad- demm u inibituri tal- plejtlits.
Serum cholesterol
Kolesterol fis- serum
Clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients treated for at least 3 months in placebo-controlled clinical trials.
Żidiet klinikament rilevanti fil- kolesterol fis- serum kienu rrekordjati f’ 5. 3% tal- pazjenti li kienu kkurati b’ venlafaxine u 0. 0% tal- pazjenti li kienu kkurati bil- plaċebo għal mill- inqas 3 xhur fi provi kliniċi kkontrollati bil- plaċebo.
Measurement of serum cholesterol levels should be considered during long-term treatment.
Il- kejl tal- livelli tal- kolesterol fis- serum għandu jkun ikkunsidrat matul il- kura fit- tul.
Co-administration with weight loss agents
L- għoti flimkien ma ’ sustanzi li jnaqqsu l- piż
The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established.
Is- sigurtà u l- effikaċja tat- terapija b’ venlafaxine meta jingħata flimkien ma ’ sustanzi li jnaqqsu l- piż, inkluż phentermine, ma kinux stabbiliti.
Co-administration of venlafaxine and weight loss agents is not recommended.
L- għoti flimkien ta ’ venlafaxine u sustanzi li jnaqqsu l- piż mhuwiex rakkomandat.
Venlafaxine is not indicated for weight loss alone or in combination with other products.
Venlafaxine mhuwiex indikat għal telf fil- piż waħdu, jew flimkien ma ’ prodotti oħrajn.
Mania/ hypomania
Manija/ ipomanija
Mania/ hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine.
Il- manija/ ipomanija jistgħu jseħħu fi proporzjon żgħir ta ’ pazjenti b’ disturbi fil- burdata, li rċivew anti- dipressanti, li jinkludu venlafaxine.
As with other antidepressants, venlafaxine should be used cautiously in patients with a history or family history of bipolar disorder.
Bħala ma jiġri b’ anti- dipressanti oħrajn, venlafaxine għandu jintuża bl- attenzjoni f’ pazjenti bi storja medika, jew storja medika tal- familja, ta ’ disturbi bipolari.
Aggression
Aggressjoni
Aggression may occur in a small number of patients who have received antidepressants, including venlafaxine.
L- aggressjoni tista ’ sseħħ f’ numru żgħir ta ’ pazjenti li jkunu rċivew l- anti- dipressanti, li jinkludu venlafaxine.
This has been reported under initiation, dose changes and discontinuation of treatment.
Din kienet irrappurtata fil- bidu tal- kura, meta sar xi tibdil fid- doża u meta twaqqfet il - kura.
As with other antidepressants, venlafaxine should be used cautiously in patients with a history of aggression.
Bħal ma jiġri b’ anti- dipressanti oħrajn, venlafaxine għandu jintuża bl- attenzjoni f’ pazjenti bi storja medika ta ’ aggressjoni.
Discontinuation of treatment
It- twaqqif tal- kura
Withdrawal symptoms, when treatment is discontinued, are common, particularly if discontinuation is abrupt (see section 4.8).
Is- sintomi ta ’ meta tieqaf tieħu l- mediċina, meta titwaqqaf il- kura, huma komuni, partikularment jekk it- twaqqif isir f’ daqqa (ara sezzjoni 4. 8).
In clinical trials, adverse events seen on treatment discontinuation (tapering and post-tapering) occurred in approximately 31% of patients treated with venlafaxine and 17% of patients taking placebo.
Fil- provi kliniċi, l- avvenimenti avversi li kienu osservati meta twaqqfet il- kura (mat- twaqqif gradwali u wara t- twaqqif gradwali) seħħew f’ madwar 31% tal - pazjenti kkurati b’ venlafaxine u fi 17% tal- pazjenti li kienu qed jieħdu l- plaċebo.
26 The risk of withdrawal symptoms may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta ’ sintomi ta ’ meta tieqaf tieħu l- mediċina jistgħu jiddependu minn diversi fatturi, li jinkludu t- tul ta ’ żmien u d- doża tat- terapija, u r- rata ta ’ tnaqqis fid- doża.
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor and headache are the most commonly reported reactions.
Sturdament, disturbi sensorjali (li jinkludu parestesija), disturbi fl- irqad (li jinkludu nuqqas ta ’ rqad u ħolm intens), aġitazzjoni jew ansjetà, nawseja u/ jew rimettar, tregħid u wġigħ ta ’ ras huma l- iktar reazzjonijiet rrappurtati b’ mod komuni.
Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity.
Ġeneralment, dawn is- sintomi huma minn ħfief sa moderati; madankollu, f’ xi pazjenti dawn jistgħu jkunu severi fl- intensità.
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.
Normalment iseħħu matul l- ewwel ftit jiem mit- twaqqif tal- kura, iżda kien hemm rapporti rari ħafna ta ’ sintomi bħal dawn f’ pazjenti li qabżu doża bi żball.
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 huma limitati minnhom infushom u normalment ifiequ fi żmien ġimagħtejn, għalkemm f’ xi individwi jistgħu jdumu aktar (2- 3 xhur jew aktar).
It is therefore advised that venlafaxine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient’ s needs (see section 4.2).
Għalhekk hu rakkomandat li venlafaxine jitnaqqas gradwalment fuq perjodu ta ’ diversi ġimgħat jew xhur meta tkun ser titwaqqaf il- kura, skond il- ħtiġijiet tal- pazjent (ara sezzjoni 4. 2).
Akathisia/ psychomotor restlessness
25 Akatisija/ nuqqas ta ’ kwiet psikomotorju fil- ġisem
The use of venlafaxine 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.
L- użu ta ’ venlafaxine kien assoċjat ma ’ l- iżvilupp ta ’ akatisija, ikkaratterizzata minn nuqqas ta ’ kwiet fil- ġisem li huwa suġġettivament mhux pjaċevoli jew ta ’ dwejjaq, u l- ħtieġa li tiċċaqlaq ta ’ spiss akkompanjata minn nuqqas ta ’ ħila li toqgħod bilqiegħda jew bilwieqfa mingħajr ma titħarrek.
This is most likely to occur within the first few weeks of treatment.
Dan hu l- aktar mistenni li jseħħ matul l- ewwel ftit ġimgħat tal- kura.
In patients who develop these symptoms, increasing the dose may be detrimental.
F’ pazjenti li jiżviluppaw dawn is- sintomi, li żżid id- doża jista ’ jkun ta ’ ħsara.
Dry mouth is reported in 10% of patients treated with venlafaxine.
Il- ħalq xott hu rrappurtat f’ 10% tal- pazjenti kkurati b’ venlafaxine.
This may increase the risk of caries, and patients should be advised upon the importance of dental hygiene.
Dan jista ’ jżid ir- riskju ta ’ taħsir tas- snien u l- pazjenti għandhom jingħataw parir dwar l- importanza ta ’ l- indafa tas- snien.
Monoamine Oxidase Inhibitors (MAOI)
Inibituri ta ’ Monoamine Oxidase (MAOI)
Irreversible non-selective MAOIs Venlafaxine must not be used in combination with irreversible non-selective MAOIs.
MAOIs irriversibbli u mhux selettivi Venlafaxine m’ għandux jintuża flimkien ma ’ MAOIs irriversibbli u mhux selettivi.
Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non- selective MAOI.
Venlafaxine m’ għandux jinbeda għal mill- inqas 14- il jum wara t- twaqqif tal- kura b’ MAOI irriversibbli u mhux selettiv.
Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI (see sections 4.3 and 4.4).
Venlafaxine għandu jitwaqqaf għal mill- inqas 7 ijiem qabel ma tinbeda l- kura b’ MAOI irriversibbli u mhux selettiv (ara sezzjonijiet 4. 3 u 4. 4).
Reversible, selective MAO-A inhibitor (moclobemide) Due to the risk of serotonin syndrome, the combination of venlafaxine with a reversible and selective MAOI, such as moclobemide, is not recommended.
Inibitur ta ’ MAO- A riversibbli u selettiv (moclobemide) Minħabba r- riskju tas- sindrome ta ’ serotonin, il- kumbinazzjoni ta ’ venlafaxine ma ’ MAOI riversibbli u selettiv, bħal moclobemide, mhijiex rakkomandata.
Following treatment with a reversible MAO-inhibitor, a shorter withdrawal period than 14 days may be used before initiation of venlafaxine treatment.
Wara l- kura b’ inibitur riversibbli ta ’ MAO, perjodu iqsar minn 14- il- jum minn meta tieqaf tieħu l- mediċina jista ’ jintuża qabel il- bidu tal- kura b’ venlafaxine.
It is recommended that venlafaxine should be discontinued for at least 7 days before starting treatment with a reversible MAOI (see section 4.4).
Hu rakkomandat li venlafaxine għandu jitwaqqaf għal mill- inqas 7 ijiem qabel ma tinbeda l- kura b’ MAOI riversibbli (ara sezzjoni 4. 4).
Reversible, non-selective MAOI (linezolid) The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with venlafaxine (see section 4.4).
MAOI riversibbli u mhux selettiv (linezolid) L- antibijotiku linezolid hu MAOI dgħajjef, riversibbli u mhux selettiv u m’ għandux jingħata lil pazjenti kkurati b’ venlafaxine (ara sezzjoni 4. 4).
Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI and started on venlafaxine, or have recently had venlafaxine therapy discontinued prior to initiation of an MAOI.
Reazzjonijiet avversi severi kienu rrappurtati f’ pazjenti li dan l- aħħar waqqfu l- kura b’ MAOI u bdew il- kura b’ venlafaxine, jew li dan l- aħħar waqqfu t- terapija b’ venlafaxine qabel il- bidu ta ’ terapija b’ MAOI.
These reactions have included tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, and hyperthermia with features resembling neuroleptic malignant syndrome, seizures, and death.
Dawn ir- reazzjonijiet kien jinkludu tregħid, myoclonus, dijaforesi, nawseja, rimettar, fwawar, sturdament, u ipertermija b’ karatteristiċi li jixbhu lis- sindrome malinn newroleptiku, aċċessjonijiet, u mewt.
27 Serotonin syndrome
Is- sindrome ta ’ serotonin
As with other serotonergic agents, serotonin syndrome may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, or St.
Bħal ma jiġri b’ mediċini serotonerġiċi oħrajn, is- sindrome ta ’ serotonin jista ’ jseħħ bil- kura ta ’ venlafaxine, partikolarment bl- użu fl- istess ħin ta ’ mediċini li jistgħu jaffettwaw lis- sistema tan - newrotrasmettitur serotonerġiku (li jinkludu triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, jew St.
John's Wort [Hypericum perforatum]), with medicinal agents which impair metabolism of serotonin (including MAOIs), or with serotonin precursors (such as tryptophan supplements).
John’ s Wort [Hypericum perforatum]), ma ’ sustanzi mediċinali li jindebolixxu l- metaboliżmu ta ’ serotonin (li jinkludu MAOIs), jew ma ’ prekursuri ta ’ serotonin (bħal supplimenti ta ’ tryptophan).
If concomitant treatment of venlafaxine with an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Jekk il- kura fl- istess ħin b’ venlafaxine ma ’ SSRI, SNRI jew agonist tar- riċettur ta ’ serotonin (triptan) tkun klinikament meħtieġa, hu rakkomandat li ssir osservazzjoni bl- attenzjoni tal- pazjent, partikolarment matul il- bidu tal- kura u meta jkun hemm żidiet fid- doża.
The concomitant use of venlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended (see section 4.4).
L- użu fl- istess ħin ta ’ venlafaxine ma ’ prekursuri ta ’ serotonin (bħal supplimenti ta ’ tryptophan) mhuwiex rakkomandat (ara sezzjoni 4. 4).
CNS-active substances
26 Sustanzi attivi tas- CNS
The risk of using venlafaxine in combination with other CNS-active substances has not been systematically evaluated.
Ir- riskju li tuża venlafaxine flimkien ma ’ sustanzi attivi oħrajn tas- CNS ma kienx evalwat b’ mod sistematiku.
Consequently, caution is advised when venlafaxine is taken in combination with other CNS-active substances.
Konsegwentement, hu rakkomandat li tintuża l- attenzjoni meta venlafaxine jittieħed flimkien ma ’ sustanzi attivi tas- CNS oħrajn.
Venlafaxine has been shown not to increase the impairment of mental and motor skills caused by ethanol.
Intwera li venlafaxine ma jżidx l- indeboliment tal- ħiliet mentali u tal- moviment ikkawżat mill - ethanol.
However, as with all CNS-active substances, patients should be advised to avoid alcohol consumption.
Madankollu, bħalma jiġri bis- sustanzi attivi tas- CNS kollha, il- pazjenti għandhom jingħataw parir biex jevitaw il- konsum ta ’ l- alkoħol.
Effect of other medicinal products on venlafaxine
Effetti ta ’ prodotti mediċinali oħrajn fuq venlafaxine
Ketoconazole (CYP3A4 inhibitor) A pharmacokinetic study with ketoconazole in CYP2D6 extensive (EM) and poor metabolisers (PM) resulted in higher AUC of venlafaxine (70% and 21% in CYP2D6 PM and EM subjects, respectively) and O-desmethylvenlafaxine (33% and 23% in CYP2D6 PM and EM subjects, respectively) following administration of ketoconazole.
Ketoconazole (inibitur ta ’ CYP3A4) Studju farmakokinetiku b’ ketoconazole f’ metabolizzaturi estensivi (EM) u batuti (PM) ta ’ CYP2D6, irriżulta f’ AUC ogħla ta ’ venlafaxine (70% u 21% f’ individwi CYP2D6 PM u EM, rispettivament) u ta ’ O- desmethylvenlafaxine (33% u 23% f’ suġġetti CYP2D6 PM u EM, rispettivament) wara l- għoti ta ’ ketoconazole.
Concomitant use of CYP3A4 inhibitors (e. g., atazanavir, clarithromycin, indinavir, itraconazole, voriconazole, posaconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, telithromycin) and venlafaxine may increase levels of venlafaxine and O-desmethylvenlafaxine.
L- użu fl- istess ħin ta ’ inibituri ta ’ CYP3A4 (eż. atazanavir, clarithromycin, indinavir, itraconazole, voriconazole, posaconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, telithromycin) u venlafaxine jista ’ jżid il- livelli ta ’ venlafaxine u ta ’ O- desmethylvenlafaxine.
Therefore, caution is advised if a patient’ s therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly.
Għalhekk, l- attenzjoni hi rakkomandata jekk it- terapija tal- pazjent tkun tinkludi inibitur ta ’ CYP3A4 u venlafaxine fl- istess ħin.
Effect of venlafaxine on other medicinal products
L- effett ta ’ venlafaxine fuq prodotti mediċinali oħra
Lithium Serotonin syndrome may occur with the concomitant use of venlafaxine and lithium (see Serotonin syndrome).
Lithium Is- sindrome ta ’ serotonin jista ’ jseħħ bl- użu fl- istess ħin ta ’ venlafaxine u lithium (ara Is- sindrome ta ’ serotonin).
Diazepam Venlafaxine has no effects on the pharmacokinetics and pharmacodynamics of diazepam and its active metabolite, desmethyldiazepam.
Diazepam Venlafaxine m’ għandu l- ebda effetti fuq il- farmakokinetika u l- farmakodinamika ta ’ diazepam u l - metabolit attiv tiegħu, desmethyldiazepam.
Diazepam does not appear to affect the pharmacokinetics of either venlafaxine or O-desmethylvenlafaxine.
Ma jidhirx li diazepam jaffettwa l- farmakokinetika kemm ta ’ venlafaxine jew ta ’ O- desmethylvenlafaxine.
It is unknown whether a pharmacokinetic and/ or pharmacodynamic interaction with other benzodiazepines exists.
Mhux magħruf jekk teżistix interazzjoni farmakokinetika u/ jew farmakodinamika ma ’ benzodiazepines oħrajn.
28 Imipramine Venlafaxine did not affect the pharmacokinetics of imipramine and 2-OH-imipramine.
Imipramine Venlafaxine ma affettwax il- farmakokinetika ta ’ imipramine u 2- OH- imipramine.
There was a dose-dependent increase of 2-OH-desipramine AUC by 2.5 to 4.5-fold when venlafaxine 75 mg to 150 mg daily was administered.
Kien hemm żieda li tiddependi mid- doża fl- AUC ta ’ 2- OH- desipramine ta ’ bejn 2. 5 sa 4. 5 darbiet aktar meta venlafaxine 75 mg sa 150 mg ngħata kuljum.
Imipramine did not affect the pharmacokinetics of venlafaxine and O-desmethylvenlafaxine.
Imipramine ma affettwax il- farmakokinetika ta ’ venlafaxine u ta ’ O- desmethylvenlafaxine.
Caution should be exercised with co-administration of venlafaxine and imipramine.
Għandha tingħata attenzjoni bl- għoti flimkien ta ’ venlafaxine u imipramine.
Haloperidol A pharmacokinetic study with haloperidol has shown a 42% decrease in total oral clearance, a 70% increase in AUC, an 88% increase in Cmax, but no change in half-life for haloperidol.
Haloperidol Studju farmakokinetiku b’ haloperidol wera tnaqqis ta ’ 42% fit- tneħħija orali totali, żieda ta ’ 70% fl - AUC, żieda ta ’ 88% fis- Cmax, iżda l- ebda tibdil fil- half- life għal haloperidol.
This should be taken into account in patients treated with haloperidol and venlafaxine concomitantly.
Dan għandu jkun ikkunsidrat f’ pazjenti li jkunu kkurati b’ haloperidol u venlafaxine fl- istess ħin.
Risperidone Venlafaxine increased the risperidone AUC by 50%, but did not significantly alter the pharmacokinetic profile of the total active moiety (risperidone plus 9-hydroxyrisperidone).
Risperidone Venlafaxine żied l- AUC ta ’ risperidone b’ 50%, iżda ma bidilx b’ mod sinifikanti l- profil farmakokinetiku tal- moiety attiva totali (risperidone flimkien ma ’ 9- hydroxyrisperidone).
Metoprolol Concomitant administration of venlafaxine and metoprolol to healthy volunteers in a pharmacokinetic interaction study for both medicinal products resulted in an increase of plasma concentrations of metoprolol by approximately 30-40% without altering the plasma concentrations of its active metabolite, α -hydroxymetoprolol.
27 Metoprolol L- għoti fl- istess ħin ta ’ venlafaxine u metoprolol lil voluntiera b’ saħħithom fi studju dwar l - interazzjoni farmakokinetika għaż- żewġ prodotti mediċinali rriżulta f’ żieda tal- konċentrazzjonijiet fil - plażma ta ’ metoprolol b’ madwar 30- 40% mingħajr l- ebda tibdil fil- konċentrazzjonijiet fil- plażma tal - metabolit attiv tiegħu, α- hydroxymetoprolol.
The clinical relevance of this finding in hypertensive patients is unknown.
Ir- rilevanza klinika ta ’ din is- sejba f’ pazjenti bi pressjoni għolja mhijiex magħrufa.
Metoprolol did not alter the pharmacokinetic profile of venlafaxine or its active metabolite, O-desmethylvenlafaxine.
Metoprolol ma bidilx il- profil farmakokinetiku ta ’ venlafaxine jew tal - metabolit attiv tiegħu, O- desmethylvenlafaxine.
Caution should be exercised with co-administration of venlafaxine and metoprolol.
Għandha tingħata attenzjoni meta venlafaxine jingħata flimkien ma ’ metoprolol.
Indinavir A pharmacokinetic study with indinavir has shown a 28% decrease in AUC and a 36% decrease in Cmax for indinavir.
Indinavir Studju dwar il- farmakokinetika b’ indinavir wera tnaqqis ta ’ 28% fl- AUC u tnaqqis ta ’ 36% fis- Cmax għal indinavir.
Indinavir did not affect the pharmacokinetics of venlafaxine and O-desmethylvenlafaxine.
Indinavir ma affettwax il- farmakokinetika ta ’ venlafaxine u O- desmethylvenlafaxine.
There are no adequate data from the use of venlafaxine in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ venlafaxine f’ nisa waqt it- tqala.
Venlafaxine must only be administered to pregnant women if the expected benefits outweigh any possible risk.
Venlafaxine għandu jingħata biss lil nisa tqal jekk il- benefiċċji mistennija jkunu jiżbqu kwalunkwe riskju possibbli.
As with other serotonin reuptake inhibitors (SSRIs/ SNRIs), discontinuation symptoms may occur in the newborns if venlafaxine is used until or shortly before birth.
Bħala kwalunkwe inibituri oħrajn ta ’ l- assorbiment mill- ġdid ta ’ serotonin (SSRIs/ SNRIs), jistgħu jseħħu sintomi minħabba t- twaqqif tal- mediċina fit- trabi tat- twelid jekk venlafaxine jintuża sat- twelid, jew sa ftit qabel it- twelid.
Some newborns exposed to venlafaxine late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalisation.
Xi trabi tat- twelid esposti għal venlafaxine sa tard fit- tielet trimestru, żviluppaw kumplikazzjonijiet li kienu jeħtieġu tube feeding, appoġġ respiratorju jew dħul l- isptar għal tul ta ’ żmien.
Such complications can arise immediately upon delivery.
Dawn il- kumplikazzjonijiet jistgħu jinħolqu immedjatament mal- ħlas.
The following symptoms may be observed in neonates if the mother has used an SSRI/ SNRI late in pregnancy: irritability, tremor, hypotonia, persistent crying, and difficulty in sucking or in sleeping.
Is- sintomi li ġejjin jistgħu jiġu osservati fi trabi tat- twelid jekk l- omm tkun użat SSRI/ SNRI tard fit - tqala: irritabilità, tregħid, ipotonija, biki persistenti, u diffikultà biex isoffu jew fl- irqad.
29 These symptoms may be due to either serotonergic effects or exposure symptoms.
Dawn is - sintomi jistgħu jkunu kkawżati jew minħabba effetti serotonerġiċi jew minħabba effetti minħabba l - espożizzjoni.
In the majority of cases, these complications are observed immediately or within 24 hours after partus.
Fil- maġġoranza tal- każijiet, dawn il- kumplikazzjonijiet ikunu osservati immedjatament jew fi żmien 24 siegħa wara l- ħlas.
Venlafaxine and its active metabolite, O-desmethylvenlafaxine, are excreted in breast milk.
Venlafaxine u l- metabolit attiv tiegħu, O- desmethylvenlafaxine, jitneħħew fil- ħalib tas- sider.
A risk to the suckling child cannot be excluded.
Ma jistax jiġi eskluż riskju lit- tarbija li tkun qed terda ’.
Therefore, a decision to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Efexor depot should be made, taking into account the benefit of breast-feeding to the child and the benefit of Efexor depot therapy to the woman.
Għalhekk għandha tittieħed deċiżjoni li t- treddigħ jitkompla/ jitwaqqaf jew li t- terapija b’ Efexor depot titkompla/ titwaqqaf, billi jkun ikkunsidrat il - benefiċċju tat- treddigħ lit- tarbija u l- benefiċċju tat- terapija ta ’ Efexor depot lill- mara.
Any psychoactive medicinal product may impair judgment, thinking, and motor skills.
Kwalunkwe prodott mediċinali psikoattiv jista ’ jindebolixxi l- ġudizzju, il- ħsieb, u l- ħiliet tal - moviment ta ’ dak li jkun.
Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery.
Għalhekk, kwalunkwe pazjent li jkun qed jieħu venlafaxine għandu jkun imwissi dwar il- ħila tiegħu li jsuq jew li jħaddem makkinarju perikoluż.
The most commonly (> 1/ 10) reported adverse reactions in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).
L- iktar reazzjonijiet avversi rrappurtati b’ mod komuni (> 1/ 10) fi studji kliniċi kienu nawseja, ħalq xott, uġigħ ta ’ ras u għaraq (li jinkludi għaraq matul il- lejl).
Adverse reactions are listed below by system organ class and frequency.
Ir- reazzjonijiet avversi huma elenkati hawn taħt skond il- klassi ta ’ l- organi tas- sistema tal- ġisem u skond il- frekwenza.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), not known (cannot be estimated from the available data).
28 Il- frekwenzi huma definiti kif ġej: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10%), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), mhux magħrufa (ma tistax tittieħed stima mid - dejta disponibbli)
Body System
Sistema tal - Ġisem
Not Known
Mhux Magħrufa
Common Haematological / Lymphatic
Sistema Ematoloġika / Limfatika
Ecchymosis, Gastrointestinal haemorrhage
Ekkimożi, Emorraġija gastrointestinali
Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia, Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Ħruġ ta ’ demm mill- membrana mukuża, Titwil fil- ħin ta ’ kemm idum ħiereġ id - demm, Tromboċitopenja, Diskrasiji tad - demm, (li jinkludu agranuloċitosi, anemija aplastika, newtropenja u panċitopenja)
Metabolic/ Nutritional
Disturbi Metaboliċi / tan- Nutriment
Serum cholesterol increased, Weight loss
Żieda fil- kolesterol fis - serum, Telf fil- piż
Weight gain
Żieda fil- piż
Abnormal liver function tests, Hyponatraemia, Hepatitis, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Prolactin increased
Testijiet tal - funzjoni tal- fwied b’ riżultat anormali, Iponatremija, Epatite, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Żieda fil- Prolactin
30 Body System
Sistema Nervuża
Very
Ħalq xott (10. 0%),
Common
Ħolm anormali, Nuqqas ta ’ libido, Sturdament,
Uncommon
Apatija, Alluċinazzjonijiet
Not Known
Akatisija / Nuqqas ta ’
Common Nervous
Sindrome Malinn Newroleptiku
Dry mouth (10.0%), Headache (30.3%)*
Uġigħ ta ’ ras (30. 3%) *
Abnormal dreams, Decreased libido, Dizziness, Increased muscle tonus (hypertonia), Insomnia, Nervousness, Paresthesia, Sedation, Tremor, Confusion, Depersonalisation
Żieda fit- tonus tal - muskoli (ipertonija), Nuqqas ta ’ rqad, Nervożità, Parestesija, Sedazzjoni, Tregħid, Konfużjoni, Dipersonalizzazzjoni
Apathy, Hallucinations, Myoclonus, Agitation, Impaired coordination and balance
, Myoclonus, Aġitazzjoni, Indeboliment fil - koordinazzjoni u l- bilanċ
Akathisia/ Psychomotor restlessness, Convulsion, Manic reaction
kwiet psikomotorj u f’ ġismek, Konvulżjoni, Reazzjoni Manika
Neuroleptic Malignant Syndrome (NMS), Serotonergic syndrome, Delirium, Extrapyramidal reactions (including dystonia and dyskinaesia), Tardive dyskinaesia, Suicidal ideation and behaviours**
(NMS), Sindrome Serotonerġiku, Delirju, Reazzjonijiet Extrapiramidali (li jinkludu distonja u diskinesija), Diskinesija tardiva, Ħsieb biex jitwettaq suwiċidju u mġiba suwiċidali **
Special Senses
Sensi Speċjali
Abnormality of accommodation, Mydriasis, Visual disturbance,
Anormalità ta ’ l - akkomodazzjoni, Midrijasi, Disturb tal - vista
Altered taste sensation, Tinnitus
29 Sistema tal - Ġisem
Angle-closure glaucoma
Komuni Pressjoni għolja,
Cardiovascular
Mhux Magħrufa
Hypertension, Vasodilatation (mostly hot flashes/ flushes), Palpitations
Vażodilatazzjoni (l -
Postural hypotension, Syncope, Tachycardia
tiddependi mill -
Hypotension, QT prolongation, Ventricular fibrillation, Ventricular tachycardia (including torsade de pointes)
Fibrillazzjoni ventrikulari, Takikardija Ventrikulari (li tinkludi torsade de pointes)
Respiratory
Sistema Respiratorja
Pulmonary eosinophilia
Eosinofilja pulmonari
Digestive
Sistema Diġestiva
Nausea (20.0%)
Nawseja (20. 0%)
Appetite decreased (anorexia), Constipation, Vomiting
Nuqqas t’ aptit (anoreksja), Stitikezza, Rimettar
Bruxism, Diarrhoea
Tgħażżiż involontarju tas - snien, Dijarea
Skin
Il- Ġilda
Sweating (includin g night sweats) [12.2%]
Għaraq (li jinkludi għaraq matul il - lejl) [12. 2%]
Rash, Alopecia
Raxx, Alopeċja
Erythema multiforme, Toxic epidermal necrolysis, Stevens- Johnson syndrome, Pruritus, Urticaria
Eritema multiforme, Nekrolisi epidermali tossika, Sindrome ta ’ Stevens - Johnson, Ħakk, Urtikarja
Musculoskeletal
Sistema Muskolu - skeltrali
Rhabdomyolysis
Ejakulazzjoni/ orgażmu
31 Body System
Rabdomijolosi
Common
Sistema
Uncommon
anormali (irġiel),
Not Known
Orgażmu
Common Urogenital
Uroġenitali
Abnormal ejaculation/ orgas m (males), Anorgasmia, Erectile dysfunction (impotence), Urination impaired (mostly hesitancy), Menstrual disorders associated with increased bleeding or increased irregular bleeding (e. g., menorrhagia, metrorrhagia), Pollakiuria
Anorgażmija, Disfunzjoni erettili (impotenza), Indeboliment meta tagħmel l- awrina (l - aktar dewmien biex tibda tagħmel l- awrina), Disturbi tal - mestrwazzjoni assoċjati ma ’ żieda fil- ħruġ tad - demm jew żieda fil - ħruġ ta ’ demm irregolari (eż., mestrwazzjoni esaġerata, tnixxija anormali tad- demm mill- ġuf), pollakijurja
Abnormal orgasm (females), Urinary retention
anormali (nisa), Żamma ta ’ l - awrina
Body as a Whole
Il- Ġisem Kollu Kemm Hu
Asthenia (fatigue), Chills
Astenja (għeja kbira), Tkexkix ta ’ bard
Photosensitivit y reaction
Reazzjoni tas - sensittività għad - dawl
*In pooled clinical trials, the incidence of headache was 30.3% with venlafaxine versus 31.3% with placebo. **Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 4.4).
* Fi provi kliniċi miġbura, l- inċidenza ta ’ wġigħ ta ’ ras kienet ta ’ 30. 3% b’ venlafaxine kontra 31. 3% bil- plaċebo. ** Każijet ta ’ formazzjoni ta ’ ħsieb biex jitwettaq suwiċidju u mġiba suwiċidali kienu rrappurtati waqt it- terapija b’ venlafaxine jew kmieni wara t- twaqqif tal- kura (ara sezzjoni 4. 4).
Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms.
30 It- twaqqif ta ’ venlafaxine (partikularment meta jsir f’ daqqa) ġeneralment iwassal għal sintomi ta ’ meta tieqaf tieħu l- mediċina.
Dizziness, sensory disturbances (including paraethesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache and flu syndrome are the most commonly reported reactions.
Sturdament, disturbi sensorjali (li jinkludu parestesija), disturbi fl- irqad (li jinkludu nuqqas ta ’ rqad u ħolm intens), aġitazzjoni jew ansjetà, nawseja u/ jew rimettar, tregħid, uġigħ ta ’ ras u s- sindrome ta ’ l- influwenza huma l- iktar reazzjonijiet li huma rrappurtati b’ mod komuni.
Generally, these events are mild to moderate and are self-limiting; however, in some patients, they may be severe and/ or prolonged.
Ġeneralment, dawn l- avvenimenti jkunu minn ħfief sa moderati u huma limitati minnhom infushom; madankollu, f’ xi pazjenti, dawn jistgħu jkun severi u/ jew idumu żmien twil.
It is therefore advised that when venlafaxine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Għalhekk hu rakkomandat li meta l- kura b’ venlafaxine ma tkunx meħtieġa aktar, għandu jsir it- twaqqif gradwali tad- doża (ara sezzjonijiet 4. 2 u 4. 4).
In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults.
B’ mod ġenerali, il- profil tar- reazzjonijiet avversi ta ’ venlafaxine (fi provi kliniċi kkontrollati bil - plaċebo) fit- tfal u fl- adolexxenti (età minn 6 sa 17) kien simili għal dak li kien osservat fl- adulti.
As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed (see section 4.4).
Bħal fil- każ ta ’ l- adulti, kienu osservati nuqqas t’ aptit, telf fil- piż, żieda fil- pressjoni tad- demm, u żieda fil - kolesterol fis- serum (ara sezzjoni 4. 4).
In paediatric clinical trials the adverse reaction suicidal ideation was observed.
Fi provi kliniċi pedjatriċi, ir- reazzjoni avversa ta ’ formazzjoni ta ’ ħsieb biex jitwettaq suwiċidju kienet osservata.
There were also increased reports of hostility and, especially in major depressive disorder, self-harm.
Kien hemm ukoll żieda fir- rapporti ta ’ ostilità u, b’ mod speċjali f’ każijiet ta ’ disturb dipressiv, li wieħed jagħmel ħsara lilu nnifsu.
Particularly, the following adverse reactions were observed in paediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.
Partikularment, ir- reazzjonijiet avversi li ġejjin kienu osservati f’ pazjenti pedjatriċi: uġigħ ta ’ żaqq, aġitazzjoni, dispepsja, ekkimożi, tifriġ, u mijalġja.
In postmarketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/ or other medicinal products.
Fl- esperjenza ta ’ wara l- bejgħ, doża eċċessiva b’ venlafaxine kienet irrappurtata l- biċċa l- kbira flimkien ma ’ l- alkoħol u/ jew prodotti mediċinali oħrajn.
The most commonly reported events in overdose include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis,
L- iktar avvenimenti rrappurtati b’ mod komuni f’ każ ta ’ doża eċċessiva jinkludu takikardija, tibdil fil- livell ta ’ koxjenza (li jvarja minn ngħas sa koma), midrijasi, konvulżjoni, u rimettar.
Other reported events include electrocardiographic changes (e. g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, vertigo, and death.
Avvenimenti oħrajn li kienu rrappurtati jinkludu tibdil elettrokardjografiku (eż. titwil ta ’ l- intervall tal- QT, bundle branch block, titwil tal- QRS), takikardija ventrikulari, bradikardija, pressjoni baxxa, sturdament, u mewt.
Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants.
Studji retrospettivi ppubblikati jirrappurtaw li doża eċċessiva ta ’ venlafaxine tista ’ tkun marbuta ma ’ żieda fir- riskju ta ’ riżultati fatali meta mqabbla ma ’ dik osservata fi prodotti anti- dipressanti SSRI, iżda hi iktar baxxa minn dik għal anti- dipressanti triċikliċi.
Epidemiological studies have shown that venlafaxine- treated patients have a higher burden of suicide risk factors than SSRI patients.
Studji epidemjoloġiċi wrew li pazjenti kkurati b’ venlafaxine għandhom tagħbija ogħla ta ’ fatturi ta ’ riskju għal suwiċidju milli minn pazjenti SSRI.
The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristics of venlafaxine-treated patients, is not clear.
Il- grad sa fejn is- sejba ta ’ żieda fir- riskju ta ’ riżultati fatali jista ’ jkun attribwit għat- tossiċità ta ’ venlafaxine f’ każ ta ’ doża eċċessiva, meta mqabbel ma ’ xi karatteristiċi ta ’ pazjenti kkurati b’ velafaxine, mhuwiex ċar.
Prescriptions for venlafaxine should be written for the smallest quantity of the medicinal product consistent with good patient management in order to reduce the risk of overdose.
Riċetti għal venlafaxine għandhom jinkitbu għall- iżgħar kwantità tal - prodott mediċinali li hi konsistenti ma ’ immaniġġjar tajjeb tal- pazjent sabiex jitnaqqas ir- riskju ta ’ doża eċċessiva.
Recommended treatment
Kura rakkomandata
General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored.
Miżuri ġenerali ta ’ appoġġ u sintomatiċi huma rakkomandati; ir- rittmu kardijaku u sinjali vitali jridu jkunu mmonitorjati.
When there is a risk of aspiration, induction of emesis is not recommended.
Meta jkun hemm riskju ta ’ aspirazzjoni, l- induzzjoni ta ’ l- emesi mhijiex rakkomandata.
Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients.
Il- ħasil gastriku jista ’ jkun indikat jekk jitwettaq dritt wara l- bligħ jew f’ pazjenti sintomatiċi.
Administration of activated charcoal may also limit absorption of the active substance.
L- għoti ta ’ faħam attivat jista ’ wkoll jillimita l- assorbiment tas- sustanza attiva.
Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.
Dijuresi sfurzata, dijalisi, emoperfużjoni u skambju tat- trasfużjoni mhumiex mistennija li jkunu ta ’ benefiċċju.
No specific antidotes for venlafaxine are known.
M’ hemm l- ebda antidoti speċifiċi disponibbli għal venlafaxine.
Other antidepressants - ATC code:
Anti- Dipressanti Oħrajn, Kodiċi ATC:
The mechanism of venlafaxine's antidepressant action in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system.
Hu maħsub li l- mekkaniżmu ta ’ l- azzjoni anti- dipressanti ta ’ venlafaxine fil- bnedmin hu marbut mal - potentiation tiegħu ta ’ l- attività tan- newrotrasmettituri fis- sistema nervuża ċentrali.
Preclinical studies have shown that venlafaxine and its major metabolite, O-desmethylvenlafaxine (ODV), are inhibitors of serotonin and noradrenaline reuptake.
Studji ta ’ qabel l - użu kliniku wrew li venlafaxine u l- metabolit maġġuri tiegħu, O- desmethylvenlafaxine (ODV), huma inibituri ta ’ l- assorbiment mill- ġdid ta ’ serotonin u noradrenaline.
Venlafaxine also weakly inhibits dopamine uptake.
Venlafaxine jinibixxi wkoll b’ mod dgħajjef l- assorbiment ta ’ dopamine.
Venlafaxine and its active metabolite reduce β -adrenergic responsiveness after both acute (single dose) and chronic administration.
Venlafaxine u l- metabolit attiv tiegħu jnaqqsu r- rispons β- adrenerġiku, wara kemm l- għoti akut (doża waħda) kif ukoll kroniku.
Venlafaxine and ODV are very similar with respect to their overall action on neurotransmitter reuptake and receptor binding.
Venlafaxine u ODV huma simili ħafna fir- rigward ta ’ azzjoni totali tagħhom fuq l- assorbiment mill- ġdid tan- newrotrasmettituri u t- twaħħil mar- riċettur.
Venlafaxine has virtually no affinity for rat brain muscarinic, cholinergic, H1-histaminergic or α 1-adrenergic receptors in vitro.
Venlafaxine m’ għandu kważi l- ebda affinità għar- riċetturi muskariniċi, kolinerġiċi, H1- istaminerġiċi jew α1- adrenerġici fil- moħħ tal- firien in vitro.
Pharmacological activity at these receptors may be related to various side effects seen with other antidepressant medicinal products, such as anticholinergic, sedative and cardiovascular side effects.
L- attività farmakoloġika f’ dawn ir- riċetturi tista ’ tkun marbuta ma ’ diversi effetti sekondarji li kienu osservati ma ’ prodotti mediċinali anti- dipressanti oħrajn, bħal effetti sekondarji antikolinerġiċi, sedattivi u kardjovaskulari.
Venlafaxine does not possess monoamine oxidase (MAO) inhibitory activity.
Venlafaxine m’ għandux attività inibitorja għal monoamine oxidase (MAO).
In vitro studies revealed that venlafaxine has virtually no affinity for opiate or benzodiazepine sensitive receptors.
Studji in vitro żvelaw li venlafaxine m’ għandu kważi l- ebda affinità għal riċetturi li huma sensittivi għall- opiate jew benzodiazepine.
The efficacy of venlafaxine prolonged-release as a
L- effikaċja ta ’ venlafaxine li jerħi b’ mod immedjat bħala kura għal episodji dipressivi maġġuri kienet murija f’ ħames provi kliniċi randomised, double- blind u kkontrollati bil- plaċebo, li damu żmien qasir, minn 4 sa 6 ġimgħat, għal dożi sa 375 mg/ kuljum.
33 treatment for major depressive episodes was established in two placebo-controlled, short-term studies for 8 and 12 weeks duration, which included a dose range of 75 to 225 mg/ day.
L- effikaċja ta ’ venlafaxine li jerħi bil- mod bħala kura għal episodji dipressivi maġġuri, kienet stabbilita f’ żewġ studji kkontrollati bil- plaċebo, li damu 8 u 12- il ġimgħa, li kienu jinkludu medda ta ’ doża ta ’ 75 sa 225 mg/ kuljum.
In one longer-term study, adult outpatients who had responded during an 8-week open trial on venlafaxine prolonged-release (75, 150, or 225 mg) were randomised to continuation of their same venlafaxine prolonged-release dose or to placebo, for up to 26 weeks of observation for relapse.
Fi studju li dam għal żmien itwal, pazjenti adulti outpatients li kienu rrispondew matul prova miftuħa li damet 8 ġimgħat fuq venlafaxine li jintreħa bil- mod (75, 150, jew 225 mg) kienu randomised biex ikomplu fuq l- istess doża ta ’ venlafaxine li jintreħa bil- mod jew fuq il- plaċebo, sa 26 ġimgħa ta ’ osservazzjoni għal rikaduta.
In a second longer-term study, the efficacy of venlafaxine in prevention of recurrent depressive episodes for a 12-month period was established in a placebo-controlled double-blind clinical trial in adult outpatients with recurrent major depressive episodes who had responded to venlafaxine treatment (100 to 200 mg/ day, on a b. i. d. schedule) on the last episode of depression.
Fit- tieni studju li kien itwal, l- effikaċja ta ’ venlafaxine fil- prevenzjoni ta ’ episodji dipressivi rikorrenti għal perjodu ta ’ 12- il xahar, kienet stabbilita fi prova klinika ikkontrollata bil- plaċebo u double- blind f’ pazjenti adulti outpatients li kellhom episodji dipressivi maġġuri rikorrenti, u li kienu rrispondew għall- kura b’ venlafaxine (100 sa 200 mg/ kuljum, fuq skeda b. i. d.) fl- aħħar episodju tad- dipressjoni.
The efficacy of venlafaxine prolonged-release capsules as a treatment for generalised anxiety disorder (GAD) was established in two 8-week, placebo-controlled, fixed-dose studies (75 to 225 mg/ day), one 6-month, placebo-controlled, fixed-dose study (75 to 225 mg/ day), and one 6-month, placebo-controlled, flexible-dose study (37.5, 75, and 150 mg/ day) in adult outpatients.
L- effikaċja tal- kapsuli ta ’ venlafaxine li jerħu l- mediċina bil- mod bħala kura għal disturb ta ’ ansjetà ġeneralizzata (Generalized Anxiety Disorder - GAD) kienet stabbilita f’ żewġ studji li damu 8 ġimgħat li kienu kkontrollati bil- plaċebo, li fihom ingħatat doża fissa (75 sa 225 mg/ kuljum), studju li dam 6 xhur, ikkontrollat bil- plaċebo, li fih ingħatat doża fissa (75 sa 225 mg/ kuljum), u studju li dam 6 xhur, ikkontrollat bil- plaċebo, li fih ingħatat doża flessibbli (37. 5, 75 u 150 mg/ kuljum) f’ pazjenti adulti outpatients.
While there was also evidence for superiority over placebo for the 37.5 mg/ day dose, this dose was not as consistently effective as the higher doses.
Filwaqt li kien hemm ukoll evidenza għal superjorità fuq il- plaċebo għad- doża ta ’ 37. 5 mg/ kuljum, din id- doża ma kinitx effettiva b’ mod konsistenti daqs kemm kienu d- dożi ogħla.
Social anxiety disorder
32 Disturb ta ’ ansjetà soċjali