FrancophonIA/ELRC3.0 huggingface dataset:
English: In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline occur at 4.5 to 8.4 hours after the daily administration of the drug.
Maltese: Fil-bniedem, wara doża orali darba kuljum ta' 50 sa 200 mg għal 14-il jum, l-akbar konċentrazzjonijiet ta' sertraline filplażma jseħħu ma' 4.5 sa 8.4 sigħat wara l-għoti ta' kuljum tal-mediċina.
English: Film-Coated Tablets Oral use
Maltese: Indeboliment fil-funzjoni tal-fwied
English: It is recommended that sertraline should be discontinued for at least 7 days before starting treatment with a reversible MAOI (see section 4.3).
Maltese: Huwa rakomandat li Sertraline għandu jkun mwaqqaf mill-inqas 7 ijiem qabel ma jinbeda trattament b'MAOIs riversibbli (ara sezzjoni 4.3).
English: If adverse experience occurred in depression, OCD, panic disorder, PTSD and social anxiety disorder, body term reclassified by depression studies body term.
Maltese: Jekk l-esperjenza avversa seħħet f'depressjoni, OCD, disturb ta' paniku, PTSD u disturb tal-ansjetà soċjali, it-terminu tal-ġisem huwa kklassifikat mill-ġdid b'terminu tal-ġisem minn studji dwar iddepressjoni. †
English: However, a substantial amount of data did not reveal evidence of induction of congenital malformations by sertraline.
Maltese: Madankollu, ammont sostanzjali ta' informazzjoni ma żvelax evidenza ta' malformazzjonijiet konġenitali b'sertraline.
English: Glaucoma, Lacrimal Disorder, Scotoma, Diplopia,
Maltese: Glawkoma, Disturb tad-Dmugħ, Skotoma, Diplopja, Fotofobija, Hyphaema, Midrijasi*
English: Caution is advised in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function (e.g. anticoagulants, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs)) as well as in patients with a history of bleeding disorders (see section 4.5).
Maltese: Hemm bżonn ta' kawtela f'pazjenti li jkunu qed jieħdu SSRIs, partikolarment meta l-pazjenti fl-istess ħin ikunu qed jieħdu mediċini oħra magħrufa li jaffettwaw il-funzjoni tal-platelets (eż. mediċini kontra ilkoagulazzjoni tad-demm, phenothiazines u antipsikotiċi atipiċi u, ħafna antidipressanti triċikliċi, acetylsalicylic acid u mediċini anti-infjammatorju mhux sterojdali (NSAIDs)) kif ukoll f'pazjenti bi storja ta' disturbi ta' fsada (ara sezzjoni 4.5).
English: • Medicines to treat severe pain (e.g. tramadol).
Maltese: • Mediċini għall-kura tal-uġigħ qawwi (eż. tramadol).
English: As the capsule contains the excipient lactose (see section 6.1), patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Billi l-kapsula fiha l-lattożju bħala sustanza mhux attiva (ara sezzjoni 6.1), il-pazjenti bil-problema ereditarja rari tal-intolleranza għal galattożju, bid-defiċjenza tal-lattożju ta' Lapp jew bi problemi flassorbiment tal-glokożju-galattożju m'għandhomx jingħataw din il-mediċina.
English: Alanine
Maltese: Franza
English: Bone Disorder
Maltese: Komuni ħafna
English: Ethanol ingestion will result in an adverse reaction with disulfiram as long as serum levels of disulfiram persist, or the activity of acetaldehyde dehydrogenase is diminished.
Maltese: It-teħid mill-ħalq ta' l-ethanol jirriżulta f'reazzjoni avversa ma' disulfiram, sakemm il-livelli ta' disulfiram fis-serum jonqsu, jew lattività tal-acetaldehyde dehydrogenase tonqos.
English: Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.
Maltese: Sertraline m'għandu ebda affinità għar-riċetturi muskariniċi (kolinerġiċi), serotonerġiċi, dopaminerġiċi, adrenerġiċi, istaminerġiċi, GABA jew benzodiazepine.
English: Paroniria, Suicidal ideation/behavi our***
Maltese: Paronirja, Ħsibijiet/Imġiba Suwiċidali***
English: The following symptoms may occur in the neonate after maternal sertraline use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping.
Maltese: Is-sintomi li ġejjin jistgħu jseħħu fit-tarbija li titwieled wara użu matern ta' sertraline fl-istadji aktar tard tat-tqala: dwejjaq respiratorji, ċjanożi, apneja, aċċessjonijiet, instabilità fit-temperatura, diffikultà fit-tmigħ, rimettar, ipogliċemija, ipertonija, iperifflessija, rogħda, nervożiżmu, irritabilità, letarġija, biki kontinwu, ngħas u diffikultà biex jorqdu.
English: Sertraline did not produce either the stimulation and anxiety associated with d-amphetamine or the sedation and psychomotor impairment associated with alprazolam.
Maltese: Sertraline ma pproduċiex l-istimulazzjoni u l-ansjetà assoċjati ma' d-amphetamine jew is-sedazzjoni u l-indeboliment psikomotorili assoċjat ma' alprazolam.
English: How to store Zoloft.
Maltese: Qabel tieħu Zoloft.
English: The daily dose then may be increased in (2.5 ml) 50 mg increments over a period of weeks.
Maltese: Id-doża talġurnata tista' tiżdied f'inkrementi ta' (2.5 ml) 50 mg f'intervalli ta' mill-anqas ġimgħa, fuq perjodu ta' ġimgħat.
English: Withdrawal symptoms seen on discontinuation of sertraline treatment Discontinuation of sertraline (particularly when abrupt) commonly leads to withdrawal symptoms.
Maltese: Jidhru sintomi tat-twaqqif malli jitwaqqaf it-trattament b'sertraline It-twaqqif ta' sertraline (speċjalment meta f'daqqa) ħafna drabi jwassal għal sintomi tat-twaqqif.
English: The other 2 studies were negative.
Maltese: Iż-żewġ studji l-oħra kienu negattivi.
English: Zoloft and associated names (see Annex I) 25 mg hard capsules Zoloft and associated names (see Annex I) 50 mg hard capsules Zoloft and associated names (see Annex I) 100 mg hard capsules
Maltese: Zoloft u l-ismijiet assoċjati (ara Anness I) 50 mg kapsuli iebsin Zoloft u l-ismijiet assoċjati (ara Anness I) 50 mg kapsoli ebsin Zoloft u l-ismijiet assoċjati (ara Anness I) 50 mg kapsoli ebsin
English: At times, a slight haze may appear in the solution after mixing; this is normal.
Maltese: Kultant, tista' tidher daħna ħafifa fissoluzzjoni wara t-taħlit; dan huwa normali.
English: Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see section 4.5).
Maltese: Sertraline għandu jkun mwaqqaf għal 7 ijiem qabel ma jinbeda trattament b'inibituri tal-monoamine oxidase (MAOIs) irriversibbli (ara sezzjoni 4.5).
English: Hyponatremia
Maltese: FARMAKOLOĠIKU
English: It is therefore advised that when sertraline treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Maltese: Għalhekk huwa rakkomandat li meta ma jkunx meħtieġ aktar it-trattament b'sertraline, dan għandu jitwaqqaf b'mod gradwali bi tnaqqis tad-doża (ara sezzjonijiet 4.2 u 4.4).
English: There have been rare post-marketing reports describing patients with weakness, hyperreflexia, incoordination, confusion, anxiety and agitation following the use of sertraline and sumatriptan.
Maltese: Kien hemm rapporti rari wara t-tqegħid tal-prodott fis-suq li ddeskrivew pazjenti bi dgħufija, riflessi eċċessivi, nuqqas ta' koordinazzjoni, konfużjoni, ansjetà u aġitazzjoni wara l-użu ta' sertraline u sumatriptan.
English: The evidence in support of the MDD indication was considered acceptable, and the CHMP focused on the assessment of the evidence supporting the additional indication: “including depression accompanied by symptoms of anxiety, in patients with or without a history of mania”.
Maltese: L-evidenza li ssostni l-indikazzjoni tal-MDD kienet ikkunsidrata aċċettabbli, u s-CHMP iffoka fuq l-evalwazzjoni tal-evidenza li ssostni lindikazzjoni addizzjonali: “inkluż id-depressjoni akkumpanjata minn sintomi ta' ansjetà, f'pazjenti bi jew mingħajr storja ta' manija”.
English: Injury
Maltese: EFFETTI
English: Hepatic impairment
Maltese: Infezzjonijiet u Infestazzjonijiet Farinġite
English: • If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs (such as linezolid).
Maltese: • Jekk qed tieħu jew ħadt mediċini msejħa monoamine oxidase inhibitors (MAOIs bħal selegiline, moclobemide) jew mediċini jixbhu lill-MAOI (bħal linezolid).
English: Pharmacotherapeutic group: Selective serotonin reuptake inhibitors (SSRI), ATC code: N06 AB06 Sertraline is a potent and specific inhibitor of neuronal serotonin (5 HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals.
Maltese: L-użu f'pazjenti li jkunu qed jieħdu inibituri tal-monoamine oxidase (MAOIs) fl-istess ħin hu kontraindikat (ara sezzjoni 4.5) minħabba r-riskju tas-sindromu tas-serotonina, b'sintomi bħal aġitazzjoni, rogħda u temperatura tal-ġisem għolja.
English: Sore throat, anorexia, increased appetite, depression, feeling strange, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding, numbness and tingling, shaking, muscle tense, abnormal taste, lack of attention, visual disturbance, ringing in ears, palpitations, hot flush, yawning, abdominal pain, vomiting, constipation, upset stomach, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.
Maltese: Uġigħ fil-griżmejn, anoressija, żieda fl-aptit, depressjoni, tħossok stramb, ħmar il-lejl, ansjetà, aġitazzjoni, nervożiżmu, tnaqqis fl-interess sesswali, tgħażżiż tas-snien, tirżiħ u tingiż, rogħda, muskolu tens, togħma abnormali, nuqqas ta' attenzjoni, disturb fil-vista, żarżir fil-widnejn, palpitazzjonijiet, fwawar tal-menopawsa, titwib, uġigħ addominali, rimettar, stitikezza, stonku mqaleb, gass, raxx, żieda fl-għaraq, uġigħ fil-muskoli, disfunzjoni sesswali, disfunzjoni fl-erezzjoni, uġigħ fis-sider.
English: Oesophagitis, Dysphagia, Haemorrhoids, Salivary Hypersecretion, Tongue
Maltese: Esofaġite, Disfaġja, Murliti, Ħruġ eċċessiv ta' saliva, Disturb fl-ilsien, Tifwiq
English: Use the dropper provided to remove the required amount of sertraline oral concentrate and dilute with approximately 120 ml (one glass) of water, ginger ale, lemon/lime soda, lemonade or orange juice.
Maltese: Uża l-qattara pprovduta biex tneħħi l-ammont meħtieġ ta' sertraline konċentrat orali u tħalltu b'madwar 120 ml (tazza) ilma, ginger ale, soda bil-lumi/lajm, luminata jew meraq tal-larinġ.
English: The 25 mg regimen and the 50 mg regimen were equally tolerated.
Maltese: Ir-reġim ta' 25 mg u r-reġim ta' 50 mg kienu ttollerati indaqs.
English: Sertraline concentrate for oral solution must be diluted before use (see section 6.6).
Maltese: Sertraline konċentrat għal soluzzjoni orali jrid jiġi dilwit qabel l-użu (ara sezzjoni 6.6).
English: Important information about some of the ingredients of Zoloft:
Maltese: Struzzjonijiet biex tieħu Zoloft sewwa:
English: Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
Maltese: Rigward l-użu ta' sertraline fl-Indeboliment Epatiku u fl-Indeboliment Renali, is-CHMP qabel malformolazzjoni proposta mill-MAH għall-armonizzazzjoni.
English: Paediatric patients
Maltese: OCD Pedjatrika
English: Respiratory, Thoracic, and Mediastinal Disorders Yawning* Bronchospasm* , Dyspnoea, Epistaxis
Maltese: Uġigħ addominali* Rimettar*, Stitikezza* Dispepsja, Gass fl-istonku
English: The effect on anxiety is considered to be part of the antidepressant effect, and the indication can therefore not be granted.
Maltese: L-effett talansjetà huwa meqjus bħala parti mill-effett anti-depressanti, u għalhekk, l-indikazzjoni ma tistax tingħata.
English: Decrease in white blood cells, decrease in clotting cells, low thyroid hormones, endocrine problem, low blood salt, terrifying abnormal dreams, suicidal behaviour, muscular movement problems (such as moving a lot, tense muscles and difficulty walking), passing out, vision abnormal, bleeding problems (such as nose bleed, stomach bleeding, or blood in urine), pancreatitis, serious liver function problems, yellow jaundice, skin oedema, skin reaction to sun, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, swelling in legs, problems with clotting, and severe allergic reaction.
Maltese: Tnaqqis fiċ-ċelloli bojod tad-demm, tnaqqis fiċ-ċelloli ta' koagulazzjoni, ormoni tat-tirojde baxxi, problema endokrinali, melħ baxx fid-demm, ħolm abnormali tal-biża', imġiba suwiċidali, problemi fil moviment tal-muskoli (bħal ċaqliq eċċessiv, muskoli tensi u diffikultà biex timxi), ħass ħażin, vistaabnormali, problemi ta' fsada (bħal fġir, fsada fl-istonku, jew demm fl-awrina), pankreatite, problemi serji fil-funzjoni tal-fwied, suffejra, edema fil-ġilda, reazzjoni tal-ġilda għax-xemx, ħakk, uġigħ filġogi, bugħawwieġ, tkabbir tas-sider, irregolaritajiet mestrwali, nefħa fis-saqajn, problemi bit-tagħqid tad-demm, u reazzjoni allerġika severa.
English: Do not use Zoloft after the expiry date which is stated on the pack.
Maltese: Tużax Zoloft wara d-data ta' skadenza li tidher fuq il-pakkett.
English: Seizures may occur with sertraline therapy: sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.
Maltese: Jista' jkun hemm aċċessjonijiet waqt it-terapija b'sertraline: sertraline għandu jiġi evitat f'pazjenti b'epilessija instabbli u f'pazjenti b'epilessija kkontrollata.
English: Chest cold, runny nose, hallucination, feeling too happy, lack of caring, thinking abnormal, convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, dizziness while standing up, migraine, ear pain, fast heartbeat, high blood pressure, flushing, breathing difficulty, possible wheezing, shortness of breath, nose bleed, oesophageal problem, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping, eye swelling, purple spots on skin, hair loss, cold sweat, dry skin, hives, osteoarthritis, muscular weakness, back pain, muscle twitching, nighttime urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating, vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight decreased, weight increased.
Maltese: Kesħa fis-sider, imnieħer inixxi, alluċinazzjoni, tħossok ferħan iżżejjed, nuqqas ta' kura, ħsieb abnormali, konvulżjoni, kontrazzjonijiet tal-muskoli involontarji, koordinazzjoni abnormali, tiċċaqlaq ħafna, amnesija, tnaqqis fis-sensibilità, disturb fid-diskors, sturdament meta tqum bilwieqfa, emigranja, uġigħ fil-widnejn, taħbita mgħaġġla tal-qalb, pressjoni għolja tad-demm, fwawar, diffikultà biex tieħu n-nifs, tħarħir possibbli, qtugħ ta' nifs, problemi fl-esofagu, diffikultà biex tibla', murliti, żieda fis-saliva, disturb fl-ilsien, tifwiq, nefħa fl-għajnejn, tikek vjola fil-ġilda, twaqqigħ tax-xagħar, għaraq kiesaħ, ġilda xotta, ħorriqija, osteoartrite, dgħufija fil-muskoli, uġigħ fid-dahar, ġbid filmuskoli, tagħmel l-awrina bil-lejl, ma tkunx tista' tagħmel l-awrina, żieda fl-awrina, żieda filfrekwenza tal-awrina, problema biex tagħmel l-awrina, emorraġija mill-vaġina, disfunzjoni sesswali femminili, telqa, kesħa, deni, dgħufija, għatx, tnaqqis fil-piż, żieda fil-piż.
English: Nausea is the most common side effect.
Maltese: Effetti sekondarji li jista' jkollu.
English: While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide, concomitant administration of sertraline and pimozide is contraindicated (see section 4.3).
Maltese: Filwaqt li l-mekkaniżmu ta' din l-interazzjoni mhuwiex magħruf, minħabba l-indiċi terapewtiku dejjaq ta' pimozide, l-għoti simultanju ta' sertraline u pimozide huwa kontra-indikat (ara sezzjoni 4.3).
English: The safety profile of sertraline is acceptable and the CHMP concluded that the overall recommendation is to grant an indication for the treatment of panic disorder with the following wording:
Maltese: Il-profil ta' sigurtà ta' sertraline huwa aċċettabbli u s-CHMP ikkonkluda li r-rakkomandazzjoni ġenerali hi li tingħata indikazzjoni għat-trattament ta' disturbi ta' paniku bil-formolazzjoni li ġejja:
English: Use in children and adolescents under 18 years of age Sertraline should not be used in the treatment of children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder aged 6-17 years old.
Maltese: Sertraline m'għandux jintuża fit-trattament ta' tfal u adolexxenti ta' taħt it-18-il sena, ħlief għal pazjenti b'obsessive compulsive disorder ta' bejn 6 u 17-il sena.
English: The primary efficacy variables in the different studies were the Liebowitz Social anxiety Symptom Scale (LSAS) and the Duke Brief Social Anxiety disorder Scale (BSPS).
Maltese: Il-varjabbli dwar l-effikaċja primarji fl-istudji differenti kienu l-Iskala tas-Sintomi tal-ansjetà Soċjali Liebowitz (LSAS) u l-Iskala ta' disturb Qasir ta' Ansjetà Soċjali Duke (BSPS).
English: Akathesia and
Maltese: L-Awstrija
English: “Combined data from the 3 studies of PTSD in the general population found a lower response rate in males compared to females.
Maltese: “Dejta ikkombinata mit-tliet studji tal-PTSD fil-popolazzjoni ġenerali sabet rata ta' rispons aktar baxxa fl-irġiel meta mqabbla man-nisa.
English: Arthralgia, Muscle Cramps
Maltese: Frekwenza mhix magħrufa
English: Hyponatraemia may occur as a result of treatment with SSRIs or SNRIs including sertraline.
Maltese: Jista' jkun hemm livell baxx ta' sodju fid-demm minħabba t-trattament b'SSRIs jew SNRIs inkluż sertraline.
English: The MAH provided details of the clinical programme supporting this indication, consisting of four multi-centre, double blind, placebo-controlled clinical trials and one randomised withdrawal study.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ipprovda d-dettalji tal-programm kliniku li jappoġġja din l-indikazzjoni, magħmul minn erba' provi kliniċi, b'aktar minn ċentru wieħed, double blind, ikkontrollati bil-plaċebo u studju wieħed ta' rtirar b'mod każwali.
English: Dermatitis, Dermatitis Bullous, Rash Follicular, Hair Texture Abnormal, Skin Odour Abnormal
Maltese: Dermatite, Dermatite Bulluża, Raxx Follikulari, Tessut tax-xagħar mhux normali, riħa tal-ġilda mhux normali
English: Each ml of oral liquid contains 150.7 mg of alcohol.
Maltese: 7mg ta' alkoħol.
English: Withdrawal reactions:
Maltese: Id-doża li s-soltu tingħata hija:
English: Noting that MDD is considered to be a chronic or chronic intermittent condition where treatment is aimed at amelioration and possibly interruption of the natural course of the episode, the CHMP considered it unnecessary to accept this separate indication.
Maltese: Waqt li nnota li l-MDD hija meqjusa bħala kondizzjoni kronika jew kondizzjoni kronika intermittenti fejn it-trattament huwa immirat lejn titjib jew possibilment interruzzjoni tal-kors naturali tal-episodju, is-CHMP ikkunsidra li m'għandux għalfejn jaċċetta din l-indikazzjoni separata.
English: Hypertension*, Flushing
Maltese: Pressjoni għolja*, Fwawar
English: Section 4.2 - Posology and Method of Administration
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata
English: Hyperprolactina emia,
Maltese: Mestrwazzjoni esaġerata,
English: Obsessive Compulsive Disorder:
Maltese: Disturb ta' Ossessjoni Kompulsiva (F'pazjenti pedjatriċi)
English: The MAH submitted the clinical programme for the indication OCD, consisting of five short term double blind, placebo controlled clinical trials; one short term double blind non-placebo controlled study with an active comparator and two long term efficacy and safety studies.
Maltese: Il-MAH issottometta l-programm kliniku għall-indikazzjoni ta' OCD, li jikkonsisti f'ħames provi kliniċi double blind, ikkontrollati bi plaċebo; studju wieħed double blind mhux ikkontrollat bi plaċebo għal perjodu ta' żmien qasir b'komparatur attiv u żewġ studji dwar is-sigurtà u l-effikaċja għal perjodu ta' żmien twil.
English: Sertraline and N-desmethylsertraline are both extensively metabolized in man and the resultant metabolites excreted in faeces and urine in equal amounts.
Maltese: Sertraline jiġi metabolizzat estensivament, u l-eskrezzjoni fl-awrina tal-pillola mhix mibdula hi biss rotta minuri ta' tneħħija mill-ġisem.
English: Concentrate for Oral solution
Maltese: Konċentrat għal soluzzjoni orali
English: Withdrawal reactions when treatment is stopped are common, particularly if the treatment is stopped suddenly (see section 4 Possible side effects).
Maltese: Ir-reazzjonijiet tat-twaqqif meta titwaqqaf il-kura huma komuni, speċjalment jekk il-kura titwaqqaf f'daqqa (ara sezzjoni 4 Effetti sekondarji li jista' jkollu).
English: rare
Maltese: Tqala
English: Suicide-related behaviours (suicide attempt 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.
Maltese: Instab li l-imġiba suwiċidali (attentati ta' suwiċidju u ħsibijiet suwiċidali), u l-ostilità (predominantament agressjoni, imġiba ta' oppożizzjoni u rabja) kienu osservati iktar frekwentament fl-istudji kliniċi fost tfal u adolexxenti ttrattati b'antidipressanti meta mqabbla ma' dawk ittrattati bi plaċebo.
English: Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady state concentrations, which are achieved after one week of once-daily dosing.
Maltese: Konsistenti mal-half-life tal-eliminazzjoni terminali, hemm bejn wieħed u ieħor akkumulazzjoni doppja sal-konċentrazzjonijiet fissi, li jinkisbu wara ġimgħa ta' dożar darba kuljum.
English: Two previous additional open label extension studies (that were not submitted within the context of this dossier) showed serious AEs, some of which were possibly related to study drug, including severe aggressive reactions, nervousness and paranoid reactions, two severe grand mal seizures,
Maltese: Żewġ studji open label preċedenti addizzjonali ta' estensjoni (li ma ġewx sottomessi fi ħdan il-kuntest ta' dan id-dossier) wrew AEs serji, li wħud minnhom kienu possibbilment relatati mal-mediċina tal-istudju, inklużi reazzjonijiet aggressivi severi, nervożiżmu u reazzjonijiet paranojċi, żewġ attakki ta' puplesija grand mal severi, formazzjoni ta' ideat intensi ta' suwiċidju u omiċidju.
English: Choreoathetosis, Dyskinesia, Hyperaesthesia, Sensory Disturbance
Maltese: Koreoatetożi, Diskajneżja, Iperestesija, Disturb tas-Sensi
English: Zoloft must only be used to treat children and adolescents suffering from OCD aged 6-17 years old.
Maltese: L-istudju inkluda tfal u adolexxenti b'eta bejn 6-17-il sena.
English: The results submitted indicated that only 6 patients relapsed during the withdrawal phase of this study, 6% in placebo and 1% in the sertraline arm.
Maltese: Ir-riżultati sottomessi indikaw li 6 pazjenti biss irkadew waqt ilfażi ta' rtirar ta' dan l-istudju, 6% fil-fergħa tal-plaċebo u 1% fil-fergħa ta' sertraline.
English: Taking Zoloft together with the following medicines may cause serious side effects:
Maltese: It-teħid ta' Zoloft mal-mediċini li ġejjin jista' jikkawża effetti sekondarji serji:
English: 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.
Maltese: L-isturdament, id-disturbi sensorji (inkluża lparestesija), it-tfixkil fl-irqad (inkluża l-insomnja u l-ħolm intens), l-aġitazzjoni jew l-ansjetà, iddardir u r-remettar, ir-rogħda u l-uġigħ ta' ras huma l-iktar reazzjonijiet komuni rappurtati.
English: Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders.
Maltese: Trattament tad-disturb ta' paniku u OCD fit-tul, għandu jkun evalwat regolarment, minħabba li ma' hemmx evidenza ta' prevenzjoni ta' rikorrenza f'dawn il-kundizzjonijiet.