FrancophonIA/ELRC3.0 huggingface dataset:
English: Contractions Involuntary*, Coordination Abnormal, Hyperkinesia, Amnesia, Hypoaesthesia* , Speech Disorder, Dizziness Postural, Migraine*
Maltese: Konvulżjoni*, Kontrazzjonijie t fil-Muskoli Involontarji*, Koordinazzjoni Abnormali, Iperkinesija, Amnesija, Ipoestesija*, Disturb fidDiskors, Sturdament Posturali, Emigranja*
English: Hepatic Function Abnormal
Maltese: Funzjoni tal-fwied abnormali
English: Abnormal Bleeding (such as epistaxis, gastrointestinal bleeding or haematuria)
Maltese: Fsada abnormali (bħal epitassi, fsada gastrointestinali jew ematurja)
English: Section 4.1 - Indications: Obsessive Compulsive Disorder (OCD) (In adults)
Maltese: Disturb ta' Ossessjoni Kompulsiva (OCD) (Fl-adulti)
English: Reversible, non-selective MAOI (linezolid)
Maltese: MAOI's riversibbli mhux selettivi
English: 25 + 50 mg (initiation pack)
Maltese: 25 mg 50 mg 100 mg 25 + 50 mg (pakkett talbidu)
English: Clinical relevant interactions may occur with other CYP 2D6 substrates with a narrow therapeutic index like class 1C antiarrhythmics such as propafenone and flecainide, TCAs and typical antipsychotics, especially at higher sertraline dose levels.
Maltese: Jista' jkun hemm interazzjonijiet kliniċi rilevanti ma' substrati oħra ta' CYP 2D6 li għandhom indiċi terapewtiku dejjaq bħall-antiarritmiċi tal-klassi IC fosthom propafenone u flecainide, TCAs u antipsikotiċi tipiċi, speċjalment f'livelli ta' dożi għoljin ta' sertraline.
English: In steady state for the 200 mg dose, the sertraline plasma levels in the 6-12 year old group were approximately 35% higher compared to the 13-17 year old group, and 21% higher compared to adult reference group.
Maltese: Fl istat fiss għad-doża ta' 200 mg, il-livelli ta' sertraline fil-plażma fil-grupp ta' 6-12 -il sena kienumadwar 35% ogħla meta mqabbel mal-grupp ta' 13-17 -il sena, u 21% ogħla meta mqabbel mal-grupp ta' referenza adult.
English: Paraesthesia*, Tremor, Hypertonia, Dysgeusia, Disturbance in Attention,
Maltese: Parasteżija*, Rogħda, Ipertonija, Disgewżja, Disturb flAttenzjoni,
English: Reproductive System and Breast Disorders** Ejaculation
Maltese: Disturbi fis-sistema riproduttiva u fis-sider** Nuqqas ta' ejakulazzjo ni (14%)
English: Abnormal Clinical
Maltese: Semen abnormali
English: Menorrhagia, Atrophic
Maltese: Anaphylactoid, Reazzjoni
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA [Timtela mill-pajjiż]
English: “Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders”.
Maltese: “It-trattament kontinwat fid-disturb ta' paniku u l-OCD għandu jiġi evalwat regolarment, billi għal dawn id-disturbi ma ntwerietx prevenzjoni għar-rikaduti”.
English: For OCD, short term, 1-12 week studies only *** Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 4.4).
Maltese: Għall-OCD, perjodu qasir, studji ta' 1-12 -il ġimgħa biss *** Ġew irrappurtati każijiet ta' ħsibijiet u komportamenti suwiċidali waqt terapija b'sertraline jew kmieni wara t-twaqqif tat-trattament (ara sezzjoni 4.4.).
English: Pharmacokinetics in specific patient groups
Maltese: Farmakokinetiċi fi gruppi speċifiċi ta' pazjenti
English: Renal impairment
Maltese: Kienu rrappurtati
English: Haematochezia, Stomatitis, Tongue ulceration, Tooth Disorder, Glossitis, Mouth Ulceration
Maltese: Haematochezia, Stomatite, Tiġriħ flilsien, Disturb fissnien, Glossite, Tiġriħ fil-ħalq
English: Prevention of recurrence of major depressive episodes.
Maltese: Il-prevenzjoni ta' tqanqil mill-ġdid jew rikorrenza ta' episodji dipressivi maġġuri.
English: Seizures
Maltese: IPPREŻENTATI
English: In a placebo-controlled, double-blind randomized study of the comparative abuse liability of sertraline, alprazolam and d-amphetamine in humans, sertraline did not produce positive subjective effects indicative of abuse potential.
Maltese: Fi studju double-blind, randomizzat, ikkontrollat bilplaċebo, tal-possibbiltà komparattiva ta' abbuż ta' sertraline, alprazolam u d-amphetamine filbnedmin, sertraline ma pproduċiex effetti suġġettivi pożittivi li jindikaw potenzjal ta' abbuż.
English: The CHMP considered that because no placebo was used, it is difficult to put the observed adverse events into perspective.
Maltese: Is-CHMP ikkunsidra li minħabba li ma ntużax plaċebo, huwa diffiċli li l-avvenimenti avversi osservati jiġu mpoġġija f'perspettiva.
English: The design is largely adequate but because this trial is performed in patients with recurrent depressive episodes, the adequate wording of the SPC should mention the description of patient populations and previous episodes in section 5.1.
Maltese: Id-disinn huwa adegwat ferm iżda minħabba li din il-prova issir f'pazjenti b'episodji depressivi rikorrenti, il-formolazzjoni adegwata talSPC għandha ssemmi d-deskrizzjoni tal-popolazzjonijiet tal-pazjent u episodji preċedenti f'sezzjoni 5.1.
English: Frequency not Known
Maltese: Rari ħafna
English: Vulvuvaginitis, Balanoposthitis, Genital Discharge, Priapism*, Galactorrhoea*
Maltese: Balanoposthitis, Tnixxija millġenitali, Priapiżmu*, G*
English: Somnolenc e (13%), Headache
Maltese: Uġigħ ta' ras (21%)*
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Maltese: Informazzjoni minn provi kliniċi wriet riskju akbar ta' mġiba suwiċidali f'persuni adulti ta' anqas minn 25 sena b'kundizzjonijiet psikjatriċi li ġew ittrattati b'antidipressant.
English: Symptoms of overdose include serotonin-mediated side effects such as somnolence, gastrointestinal disturbances (such as nausea and vomiting), tachycardia, tremor, agitation and dizziness.
Maltese: Is-sintomi ta' doża eċċessiva jinkludu effetti sekondarji medjati mis-serotonin fosthom ngħas, disturbi gastro-intestinali (bħal dardir u rimettar), takikardija, rogħda, aġitazzjoni u sturdament.
English: Switching from Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants or antiobsessional drugs
Maltese: Qlib minn Inibituri Selettivi tal-Assorbiment mill-ġdid tas-Serotonina (SSRIs), antidipressanti jew mediċini ta' kontra l-ossessjoni
English: With the condition that the following text is inserted in section 5.1 of the SPC:
Maltese: Bil-kondizzjoni li t-test li ġej jiddaħħal fis-sezzjoni 5.1 tal-SPC.
English: Depression*, Depersonalisatio n, Nightmare, Anxiety*, Agitation*, Nervousness, Libido
Maltese: Depressjoni*, Spersonalizzazzj oni, Ħmar il-lejl, Ansjetà*, Aġitazzjoni*, Nervożiżmu, Tnaqqis filLibido*, Tgħażżiż tassnien
English: Osteoarthritis, Muscular Weakness, Back Pain, Muscle Twitching
Maltese: Uġigħ fil-muskoli Osteoartrite, Indeboliment fil-muskoli,
English: Common (≥1/100 to <1/10): Chest pain, mania, pyrexia, vomiting, anorexia, affect lability, aggression, agitation, nervousness, disturbance in attention, dizziness, hyperkinesia, migraine, somnolence, tremor, visual disturbance, dry mouth, dyspepsia, nightmare, fatigue, urinary incontinence, rash, acne, epistaxis, flatulence.
Maltese: Komuni (≥1/100 sa <1/10): Uġigħ fis-sider, manija, deni, rimettar, anoressija, tibdil fil-burdata, aggressjoni, aġitazzjoni, nervożiżmu, disturb fl-attenzjoni, sturdament, iperkinesija, emigranja, ngħas, rogħda, disturb fil-vista, ħalq xott, dispepsja, ħmar il-lejl, għeja, inkontinenza tal-awrina, raxx, akne, epitassi, gass fl-istonku.
English: A review of the trials included in this dossier indicated that there were two trials that included patients with a bipolar disorder and one with depression accompanied by symptoms of anxiety.
Maltese: Reviżjoni tal-provi inklużi f'dan id-dossier indikat li kien hemm żewġ provi li inkludew pazjenti b'marda bipolari u wieħed b'depressjoni akkumpanjata b'sintomi ta' ansjetà.
English: Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT agonists Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission such as tryptophan or fenfluramine or 5-HT agonists, or the herbal medicine, St John's Wort (hypericum perforatum), should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction.
Maltese: Mediċini serotonerġiċi oħra e.g. tryptophan, fenfluramine u agonisti tal-5-HT L-amministrazzjoni ta' sertraline ma' mediċini oħra li jsaħħu l-effett tan-newrotrażmissjoni serotonerġika bħal tryptophan jew fenfluramine jew agonisti tal-5-HT, jew il-mediċina tal-ħxejjex, St John's Wort (hypericum perforatum), għandha ssir b'kawtela u kemm jista' jkun tiġi evitata minħabba l-potenzjal għal interazzjoni farmakodinamika.
English: Irreversible (non-selective) MAOIs (selegiline)
Maltese: MAOI's Irriversibbli mhux selettivi
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jassiguraw li l-kondizzjonijiet segwenti jiġu sodisfatti mid-Detenturi tal-Awtorizzazzjoni għatTqegħid fis-Suq.
English: Diverticulitis, Gastroenteritis, Otitis Media
Maltese: Infjammazzjoni taddivertikulu, Gastroenterite, Otite tal-Widna tan-Nofs
English: At clinical doses, sertraline blocks the uptake of serotonin into human platelets.
Maltese: B'dożi kliniċi, sertraline jimblokka t-teħid ta' serotonin fil-plejtlits umani.
English: All studies included patients with Obsessive Compulsive Disorder (OCD) according to DSM-III or III-R.
Maltese: L-istudji kollha nkludew pazjenti b'Disturb ta' Ossessjoni Kompulsiva (OCD) skont DSM-III jew III-R.
English: Moreover, with respect to safety, no data was submitted on endocrine parameters, effects on cognition and other maturation parameters.
Maltese: Barra minn hekk, fir-rigward tas-sigurtà, ma ġiet ippreżentata l-ebda dejta dwar parametri endokrinali, effetti dwar il-konjizzjoni u parametri oħra tal-maturità.
English: Nervous System Disorders
Maltese: Disturbi fis-sistema nervuża Sturdament
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Maltese: Fil-pazjenti li jiżviluppaw dawn is-sintomi, żieda fid-doża tista' tkun ta' detriment.
English: Intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorder, aggression, paranoia, suicidal thoughts, sleep walking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensation, sensory disturbance, glaucoma, tear problem, spots in front of eyes, double vision, light hurts eye, blood in the eye, enlarged pupils, heart attack, slow heart beat, heart problem, poor circulation of arms and legs, closing up of throat, breathing fast, breathing slow, difficulty talking, hiccups, blood in stool, sore mouth, tongue ulceration, tooth disorder, tongue problem, mouth ulceration, problems with liver function, skin problem with blisters, hair rash, hair texture abnormal, skin odour abnormal, bone disorder, decreased urination, urinary incontinence, urinary hesitation, excessive vaginal bleeding, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge, hernia, injection site scarring, drug tolerance decreased, difficulty walking, abnormal laboratory tests, semen abnormal, injury, relaxation of blood vessels procedure.
Maltese: Problema bl-intestini, infezzjoni fil-widnejn, kanċer, glandoli minfuħin, kolesterol għoli, zokkor baxx fid-demm, sintomi fiżiċi minħabba tensjoni jew emozzjonijiet, dipendenza fuq id-droga, disturb psikotiku, aggressjoni, paranojja, ħsibijiet dwar suwiċidju, sonnambuliżmu, ejakulazzjoni kmieni, koma, movimenti abnormali, diffikultà biex tiċċaqlaq, żieda fis-sensazzjoni, disturb tas-sensi, glawkoma, problema bid-dmugħ, tikek quddiem l-għajnejn, vista doppja, id-dawl iweġġa' l-għajnejn, demm fl-għajnejn, ħbub tal-għajnejn imkabbra, attakk tal-qalb, taħbita tal-qalb bil-mod, problema filqalb, ċirkolazzjoni ħażina fl-idejn u s-saqajn, għeluq tal-gerżuma, nifs mgħaġġel, nifs bil-mod, diffikultà biex titkellem, sulluzzu, demm fl-ippurgar, ħalq misluħ, tiġriħ fl-ilsien, disturb fis-snien, disturb fl-ilsien, tiġriħ fil-ħalq, problemi bil-funzjoni tal-fwied, problemi tal-ġilda bl-infafet, follikulite, tessut tax-xagħar abnormali, riħa tal-ġilda mhux normali, disturb fl-għadam, tnaqqis flawrina, inkontinenza tal-awrina, eżitazzjoni tal-awrina, fsada eċċessiva mill-vaġina, parti xotta talvaġina, pene u prepuzju aħmar u juġgħa, tnixxija mill-ġenitali, erezzjoni twila, tnixxija mis-sider, ftuq, titbigħ fil-post tal-injezzjoni, tnaqqis fit-tolleranza għall-mediċina, diffikultà biex timxi, testijiet tallaboratorju abnormali, semen abnormali, korriment, proċedura għar-rilassament tal-vini u l-arterji.
English: Adolescents could be dosed like adults.
Maltese: L-adoloxxenti jistgħu jingħataw dożi bħall-adulti.
English: Disorder, Eructation
Maltese: Disfunzjoni sesswali, Disfunzjoni talerezjoni
English: Sertraline must not be used in combination with irreversible (non-selective) MAOIs such as selegiline.
Maltese: Sertraline m'għandux jintuża flimkien ma' MAOIs irreversibli mhux selettivi.
English: Abdominal Pain* Vomiting*, Constipation* Dyspepsia, Flatulence
Maltese: Spażmu filbronki*, Dispneja, Epitassi
English: • Medicines to treat excessive stomach acid and ulcers (cimetidine).
Maltese: • Mediċini għall-kura tal-aċidu żejjed fl-istonku u l-ulċeri (cimetidine).
English: Czech Republic Pfizer s.r.o., Stroupežnického 17
Maltese: Pfizer s.r.o., Stroupežnického 17 150 00 Praha 5
English: There are no clinical studies establishing the risks or benefits of the combined use of ECT and sertraline.
Maltese: M'hemmx studji kliniċi li jistabilixxu r-riskji jew il-benefiċċji tal-użu kombinat tal-ECT u sertraline.
English: For CY-BOCs the mean baseline and change from baseline scores for the placebo group was 22.25 ± 6.15 and -3.4 ± 0.82, respectively, while for the sertraline group, the mean baseline and change from baseline scores were 23.36 ± 4.56 and -6.8 ± 0.87, respectively.
Maltese: Il-perċentwali ta' dawk li wieġbu għat-trattament (definiti bħala dawk il-pazjenti li ma kellhomx rikaduta) fil-gruppi ta' sertraline u l-plaċebo kienu 83.4% u 60.8%, rispettivament.
English: Rare side effects (occurs in between 1 and 10 out of 10.000 patients):
Maltese: Effetti sekondarji rari (iseħħu f'bejn 1 u 10 minn kull 10.
English: Respiratory Tract Infection, Rhinitis
Maltese: Infezzjoni filParti ta' Fuq tal-Apparat Respiratorju, Rinite
English: The mean half-life of sertraline is approximately 26 hours (range 22-36 hours).
Maltese: Il-half-life medja ta' sertraline hija madwar 26 siegħa (medda 22-36 siegħa).
English: Withdrawal symptoms seen on discontinuation of sertraline treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Maltese: Sintomi tat-twaqqif li dehru ma' twaqqif ta' trattament b'sertraline Is-sintomi tat-twaqqif meta jitwaqqaf it-trattament huma komuni, partikolarment meta t-twaqqif isir f'daqqa (ara sezzjoni 4.8).
English: Possible Side Effects).
Maltese: Effetti Sekondarji li Jista' Jkollu).
English: Zoloft and associated names (see Annex I) 20 mg/ml concentrate for oral solution
Maltese: Zoloft u l-ismijiet assoċjati (ara Anness I) 20 mg/ml konċentrat għal soluzzjoni orali
English: Sertraline had no effect on the beta-adrenergic blocking ability of atenolol.
Maltese: Sertraline ma weriex potenzjal għall-abbuż.
English: StevensJohnson syndrome and epidermal necrolysis, Angioedema, Face Oedema, Photosensitivity , Skin Reaction, Pruritus
Maltese: Rapporti rari ta' reazzjonijiet serji tal-ġilda (SCAR): eż. syndrome ta' Stevens-Johnson u nekroliżi epidermika, Anġjoedema, Edema fil-wiċċ, Sensittività għad-dawl, Reazzjoni talġilda, Ħakk
English: Efficacy is not shown in paediatric major depressive disorder.
Maltese: Ma ntwerietx effikaċja fid-disturb ta' depressjoni maġġuri pedjatrika.
English: Oliguria, Urinary Incontinence*, Urinary Hesitation
Maltese: Inkontinenza talawrina*, Eżitazzjoni
English: Zoloft and associated names (see Annex I) 25 mg film coated tablets Zoloft and associated names (see Annex I) 50 mg film coated tablets Zoloft and associated names (see Annex I) 100 mg film coated tablets
Maltese: Zoloft u l-ismijiet assoċjati (ara Anness I) 25 mg pilloli miksijin b'rita Zoloft u l-ismijiet assoċjati (ara Anness I) 50 mg pilloli miksijin b'rita Zoloft u l-ismijiet assoċjati (ara Anness I) 100 mg pilloli miksijin b'rita
English: • If you are allergic (hypersensitive) to sertraline or any of the other ingredients of Zoloft.
Maltese: • Jekk int allerġiku/a (tbati minn sensittività eċċessiva) għal sertraline jew sustanzi oħra ta' Zoloft.
English: Cases of serum sodium levels lower than 110 mmol/l have been reported.
Maltese: Ġew rappurtati każijiet tal-livelli ta' sodju fid-demm iktar baxxi minn 110 mmol/l.
English: • Epilepsy or a history of seizures.
Maltese: • Epilessija jew storja ta' aċċessjonijiet.
English: Concomitant intake of pimozide is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' pimozide hu kontra-indikat (ara sezzjoni 4.5).
English: Other drug interactions, digoxin, atenolol, cimetidine Co-administration with cimetidine caused a substantial decrease in sertraline clearance.
Maltese: Reazzjonijiet ma' mediċini oħra, digoxin, atenolol, cimetidine L-għoti ma' cimetidine kkawża tnaqqis sostanzjali fit-tneħħija ta' sertraline.
English: The risk of bleeding may be increased when medicines acting on platelet function (e.g. NSAIDs, acetylsalicylic acid and ticlopidine) or other medicines that might increase bleeding risk are concomitantly administered with SSRIs, including sertraline (see section 4.4).
Maltese: Ir-riskju ta' fsada jista' jiżdied meta mediċini li jaħdmu fuq il-funzjoni tal-plejtlits (eż. NSAIDs, aċidu aċitilsaliċiliku u ticlopidine) jew mediċini oħra li jistgħu jżidu r-riskju ta' fsada jingħataw ma' SSRIs, fosthom sertraline (ara sezzjoni 4.4).
English: Evidence was found that the early postnatal mortality was due to in-utero exposure after day 15 of pregnancy.
Maltese: Instabet evidenza li lmortalità kmieni wara t-twelid kienet dovuta għal esponiment fl-utru wara jum 15 tat-tqala.
English: The CHMP considered that the lack of any evidence suggesting a difference between children and adults is not equivalent to establishing that the disorder is identical in the 2 groups.
Maltese: Is-CHMP ikkunsidra li n-nuqqas ta' evidenza li tissuġġerixxi differenza bejn it-tfal u ladulti mhuwiex ekwivalenti sabiex jiġi stabbilit li d-disturb huwa identiku fiż-żewġ gruppi.
English: The usual dose is:
Maltese: Tqala u treddigħ:
English: Leucopaenia, Thrombocytopa enia
Maltese: Uġigħ fiddahar, Ġbid talmuskoli
English: Movement Disorders (including extrapyramidal symptoms such as hyperkinesia, hypertonia, teeth grinding or gait abnormalities), Syncope.
Maltese: Disturbi filMoviment (fosthom sintomi ekstrapiramidali bħalliperkinesija, ipertonija, tgħażżiż tassnien jew abnormalitajiet fil-pass), Sinkope
English: In patients with liver damage, the half life of sertraline is prolonged and AUC is increased three fold (see sections 4.2 and 4.4).
Maltese: F'pazjenti bi ħsara fil-fwied, il-half-life ta' sertraline titwal u l-AUC tiżdied bi tliet darbiet (ara sezzjonijiet 4.2 u 4.4).
English: In over 600 paediatric patients treated with sertraline, the overall profile of adverse reactions was generally similar to that seen in adult studies.
Maltese: F'iżjed minn 600 pazjent pedjatriku ttrattati b'sertraline, il-profil ġenerali tar-reazzjonijiet avversi kien ġeneralment simili għal dak li deher fl-istudji fuq l-adulti.
English: The CHMP considered that because anxiety is an inherent part of the depression disorder, a decrease in Hamilton anxiety can not be seen as separate due to possible interactions with improvement of depression.
Maltese: Is-CHMP ikkunsidra li minħabba li l-ansjetà hija parti inerenti tad-disturb ta' depressjoni, it-tnaqqis mill-ansjetà ta' Hamilton ma jistax jidher bħala separat minħabba l-interazzjonijiet possibbli mat-titjib tad-depressjoni.
English: This medicinal product contains 12 % ethanol (alcohol) and must be diluted before use.
Maltese: Din il-mediċina fiha 12% ethanol (alkoħol) u għandu jkun miżjud bl-ilma qabel l-użu.
English: The CHMP agreed that overall, the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder) MDD and does not present any new issues.
Maltese: Is-CHMP qabel li b'mod ġenerali, is-sigurtà ta' sertraline fit-trattament tal-PTSD hija simili għal dik ta' disturb depressiv kbir (MDD) u ma tippreżenta ebda kwistjoni ġdida.
English: The co-administration of sertraline 200 mg daily did not potentiate the effects of alcohol, carbamazepine, haloperidol, or phenytoin on cognitive and psychomotor performance in healthy subjects; however, the concomitant use of sertraline and alcohol is not recommended.
Maltese: L-għoti fl-istess ħin ta' sertraline 200 mg kuljum ma żiedx l-effetti tal-alkolħol, carbamazepine, haloperidol, jew phenytoin fuq il-prestazzjoni konoxxittiva u psikomotorili f'individwi b'saħħithom; madankollu, l-użu flimkien ta' sertraline u l-alkoħol mhuwiex rakkomandat.
English: The safety and efficacy of sertraline (50-200 mg/day) was examined in the treatment of non-depressed children (6-12 years old) and adolescent (13-17 years old) outpatients with obsessive compulsive disorder (OCD).
Maltese: Is-sigurtà u l-effikaċja ta' sertraline (50-200 mg/kuljum) ġiet eżaminata fit-trattament ta' tfal mhux depressi (6-12 -il sena) u outpatients adoloxxenti (13-17 -il sena) b'obsessive compulsive disorder (OCD). Wara introduzzjoni ta' ġimgħa fuq plaċebo single blind, il-pazjenti ġew assenjati b'mod każwali għal 12-il ġimgħa ta' trattament b'doża flessibbli b'sertraline jew plaċebo.
English: Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible (non-selective) MAOI (see section 4.3).
Maltese: Sertraline għandu jkun mwaqqaf mill-inqas 7 ijiem qabel ma jinbeda trattament b'MAOIs irriversibbli mhux selettivi (ara sezzjoni 4.3).
English: Belgium PFIZER S.A. Boulevard de la Plaine, 17 1050 Brussels
Maltese: Boulevard de la Plaine, 17 1050 Brussels
English: In a placebo-controlled trial in normal volunteers, the co-administration of sertraline with lithium did not significantly alter lithium pharmacokinetics, but did result in an increase in tremor relative to placebo, indicating a possible pharmacodynamic interaction.
Maltese: Fi prova kkontrollata bil-plaċebo fuq voluntiera normali, l-għoti flimkien ta' sertraline u l-litju ma biddilx b'mod sinifikanti l-farmakokinetiċi tal-litju, iżda rriżulta f'rogħda akbar meta mqabbel malplaċebo, li tindika interazzjoni farmakodinamika possibbli.
English: In accord with its selective inhibition of 5-HT uptake, sertraline does not enhance catecholaminergic activity.
Maltese: Konformi mal-inibizzjoni selettiva tiegħu tat-teħid ta' 5-HT, sertraline ma jżidx l-attività katekolaminerġika.
English: Biotransformation Sertraline undergoes extensive first-pass hepatic metabolism.
Maltese: Bijotrasformazzjoni Sertraline jgħaddi minn metaboliżmu epatiku estensiv tal-ewwel passaġġ.
English: Taking other medicines:
Maltese: Kategorija farmakoterapewtika:
English: Content (concentration)
Maltese: U KONTENUT [Timtela mill-pajjiż]
English: • Medicines to treat pain/arthritis (Non steroidal antiinflammatory drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).
Maltese: • Mediċini għall-kura tal-uġigħ/artrite (Mediċini anti-infjammatorji mhux sterojdi (NSAID)
English: Serious liver events (including hepatitis, jaundice and liver failure)
Maltese: Episodji serji fil-fwied (fosthom epatite, suffejra u insuffiċjenza tal-fwied)