FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Other drugs for obstructive airway diseases, inhalants; Glucocorticoids ATC code: R03 BA01.
Maltese: Il-ħin tan-nebulizzazzjoni u d-doża mwassla huma dipendenti fuq ir-rata tal-fluss, il-volum tal-kompartiment tan-nebulizzazzjoni u lvolum tal-mili.
English: The systemic absorption of the main active metabolite B17MP arises from both lung deposition and oral absorption of the swallowed dose.
Maltese: Assorbiment sistemiku tal-metabolit attiv prinċipali B17MP iseħħ kemm mid-depożizzjoni fil-pulmun kif ukoll mill-assorbiment orali tad-doża li tinbela'.
English: Following intravenous dosing, the disposition of BDP and its active metabolite, B17MP, are characterised by high plasma clearance (150 and 120 L/h respectively), with a small volume of distribution at steady state for BDP (20 L) and larger tissue distribution for its active metabolite (424 L).
Maltese: Wara doża mogħtija fil-vini, ildispożizzjoni ta' BDP u tal-metabolit attiv tiegħu, B17MP, hija kkaratterizzata minn tneħħija għolja mill-plażma (150 u 120
English: The benefits of the corticosteroid treatment and the possible risks on the growth suppression must be carefully weighed against one another.
Maltese: Il-benefiċċji ta' trattament b'kortikosterojd u r riskji possibbli ta' soppressjoni tat-tkabbir għandhom jiġu meqjusa b'attenzjoni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {INVENTED NAME} 400 mcg
Maltese: IVVINTAT} 400 mikrogramma darba jew darbtejn kuljum (400
English: Comparable improvements over baseline were reported at study end for the two treatment groups in morning pulmonary expiratory flow rate (primary endpoint), clinical symptoms scores and the use of rescue salbutamol.
Maltese: Titjib komparabbli fuq illinja bażi kien irrappurtat fl-aħħar tal-istudju għaż-żewġ gruppi ta' trattament fit-testijiet tal-funzjoni pulmonari, punteġġi ta' sintomi kliniċi u l-użu ta' salbutamol bħala salvataġġ.
English: Adrenal suppression**
Maltese: Soppressjoni adrenali
English: Patients with adrenal suppression are steroid dependent and have to be treated accordingly with supplementary systemic glucocorticosteroids.
Maltese: Pazjenti b'soppressjoni adrenali huma dipendenti fuq sterojdi u għandhom jiġu ttrattati kif xieraq bi glukokortikosterojdi sistemiċi supplimentari.
English: Breathe normally.
Maltese: Ħu n-nifs b'mod normali.
English: In this case, empty the contents of the ampoule into the nebuliser bowl then add the quantity of sterile sodium chloride 9 mg/ml (0.9%) solution that your doctor has told you to use.
Maltese: Għandha tiżdied il-kwantità ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride meħtieġa.
English: {INVENTED NAME} is indicated for the:
Maltese: IVVINTAT} huwa indikat għall:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {INVENTED NAME} 800 mcg
Maltese: IVVINTAT} 800 mikrogramma darba jew darbtejn kuljum (800
English: In any case, beclometasone dipropionate should be administered without discontinuing the systemic treatment; after approximately one week, the latter should be gradually reduced (the size of the reduction should correspond to the maintenance dose of the systemic steroid), patient should be checked at regular intervals (in particular, adrenocortical function tests should be carried out) and dose of inhaled beclometsone dipropionate should be adjusted according to the results obtained.
Maltese: F'kull każ, beclometasone dipropionate għandu jingħata mingħajr ma jitwaqqaf it-trattament sistemiku; wara madwar ġimgħa, dan tal-aħħar għandu jitnaqqas gradwalment (id-daqs tat-tnaqqis għandu jikkorrispondi mad-doża ta' manteniment talisterojd sistemiku), il-pazjent għandu jiġi ċċekkjat f'intervalli regolari (b'mod partikolari, għandhom jitwettqu testijiet tal-funzjoni adrenokortikali) u d-doża ta' beclometsone dipropionate meħud man-nifs għandha tiġi aġġustata skont ir-riżultati miksuba.
English: There is an approximately linear increase in systemic exposure of the active metabolite B17MP with increasing inhaled dose.
Maltese: Hemm żieda bejn wieħed u ieħor lineari fl-esponiment sistemiku għall-metabolit attiv B17MP b'żieda fid-doża meħuda man-nifs.
English: • You are being, or have ever been, treated for tuberculosis (TB).
Maltese: • Qed tiġi ttrattat jew xi darba ġejt ittrattat għat-tuberkulosi (TB - tuberculosis).
English: {INVENTED NAME} contains the active substance beclometasone dipropionate.
Maltese: IVVINTAT} fih is-sustanza attiva beclometasone dipropionate.
English: CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension
Maltese: IVVINTAT} 800 mikrogramma suspensjoni għan-nebulizzatur
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Each ampoule contains 800 micrograms beclometasone dipropionate anhydrous in 2 ml.
Maltese: IVVINTAT} 800 mikrogramma, għandha tintuża il-marka talgradazzjoni fuq il-kunjett biex tkejjel nofs id-doża (li tikkorrispondi għal 400 mikrogramma f'1 ml).
English: The potency of B17MP is approximately 30-fold higher than the parent compound.
Maltese: Il-qawwa ta' B17MP hija madwar 30 darba ogħla minn dik tal-kompost oriġinali.
English: Efficacy and safety of nebulised beclometasone dipropionate in the treatment of severe persistent asthma in infants and young children aged 6 months to 6 years, in comparison to budesonide suspension for nebulization was assessed in a multicentre, randomized, controlled open-labelled study for 14 weeks.
Maltese: L-effikaċja u s-sigurtà ta' CLENIL fit-trattament ta' ażżma persistenti u severa fi trabi u tfal żgħar meta mqabbla ma' suspensjoni għan-nebulizzazzjoni ta' budesonide kienu evalwati fi studju b'aktar minn ċentru wieħed, randomised, ikkontrollat u open-label.
English: The renal excretion of BDP and its metabolites is negligible, faecal excretion is the major route of BDP elimination mainly as polar metabolites.
Maltese: It-tneħħija mill-kliewi ta' BDP u tal-metaboliti tiegħu hija negliġibbli, it-tneħħija fl-ippurgar hija r-rotta ewlenija għall-eliminazzjoni ta' BDP l-aktar bħala metaboliti polari.
English: After inhaling the prescribed dose patients should rinse their mouth with water to minimise the risk of oropharyngeal thrush (see section 4.4).
Maltese: Wara li jieħdu d-doża preskritta man-nifs il-pazjenti għandhom ilaħalħu ħalqhom bl-ilma biex jitnaqqas ir-riskju ta' traxx fil-ħalq u fil-farinġi (ara sezzjoni 4.4).
English: Hepatic and renal functions remained within normal values.
Maltese: Il-funzjoni tal-fwied u tal-kliewi baqgħet fil-firxa tal-valuri normali.
English: No significant effect on morning serum cortisol levels was reported in asthmatic patients after a 3-week treatment period of 1600 and 3200 µg per day b.i.d.
Maltese: Ma kien irrappurtat l-ebda effett sinifikanti fuq il-livelli ta' kortisol fis-serum filgħodu f'pazjenti ażżmatiċi wara perjodu ta' trattament ta' tliet ġimgħat b'1600 u 3200 µg kuljum mogħtija permezz ta' nebulizzatur.
English: Each ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml.
Maltese: IVVINTAT} 400 mikrogramma suspensjoni għan-nebulizzatur beclometasone dipropionate
English: Each polyethylene ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml.
Maltese: Kull kunjett ta' 1 ml fih 400 mikrogramma ta' beclometasone dipropionate anidru.
English: • cold sores (herpes simplex) painful blisterlike vesicles on your lips and in your mouth
Maltese: • dardir (tħossok imdardar) u weġghat fl-istonku.
English: What {INVENTED NAME} contains
Maltese: IVVINTAT} u l-kontenut tal-pakkett
English: The full EPAR for Blitzima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The study showed that Blitzima and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Blitzima and 73% (43 of 59 patients) with MabThera.
Maltese: L-istudju wera li Blitzima u MabThera kellhom effetti kumparabbli fuq is-sintomi tal-artrite: wara 24 ġimgħa, il-proporzjon ta' pazjenti li kellhom titjib ta' 20 % fil-punteġġ tas-sintomi (imsejjaħ ACR20) kien ta' 74 % (114 minn 155 pazjent) bi Blitzima u ta' 73 % (43 minn 59 pazjent) b'MabThera.
English: Blitzima contains the active substance rituximab.
Maltese: Blitzima fih issustanza attiva rituximab.
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Blitzima and 90% (63 of 70 patients) with Rituxan.
Maltese: F'dan l-istudju deher titjib f'96 % tal-każijiet (67 minn 70 pazjent) bi Blitzima u 90 % (63 minn 70 pazjent) b'Rituxan.
English: This is a summary of the European public assessment report (EPAR) for Blitzima.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Blitzima.
English: The reference medicine for Blitzima is MabThera.
Maltese: Ilmediċina ta' referenza għal Blitzima hija MabThera.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML).
Maltese: Effetti sekondarji serji oħra jinkludu riattivazzjoni talepatite B (ritorn ta' infezzjoni attiva preċedenti fil-fwied bil-virus tal-epatite B) u infezzjoni fil-moħħ severa rari magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML).
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels.
Maltese: • granulomatożi b'polianġite (GPA jew granulomatożi ta' Wegener) u polianġite mikroskopika (MPA), li huma kondizzjonijiet infjammatorji tal-vażi tad-demm.
English: Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Blitzima to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Maltese: Evidenza ulterjuri ġiet minn studji ta' sostenn, inkluż wieħed li involva 121 pazjent b'linfoma folliklari avvanzata, fejn iż-żieda ta' Blitzima mal-mediċini tal-kimoterapija kienet tal-inqas effettiva daqs iżżieda ta' Rituxan, il-verżjoni Amerikana ta' MabThera.
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Maltese: • linfoma follikulari u linfoma diffuża mhux ta' Hodgkin b'ċelloli B kbar (żewġ tipi ta' linfomi mhux ta' Hodgkin, kanċer tad-demm);
English: Why is Blitzima approved?
Maltese: Għaliex ġiet approvat Blitzima?
English: Other information about Blitzima
Maltese: Informazzjoni oħra dwar Blitzima
English: The active substance in Blitzima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Maltese: Is-sustanza attiva f'Blitzima, rituximab, hija antikorp monoklonali (tip ta' proteina) imfassal biex jagħraf u jeħel ma' proteina msejħa CD20 preżenti fuq il-wiċċ taċ-ċelloli B (tipi ta' ċelloli bojod taddemm).
English: Blitzima is a ‘biosimilar medicine'.
Maltese: Blitzima huwa 'mediċina bijosimili'.
English: What are the risks associated with Blitzima?
Maltese: X'inhuma r-riskji assoċjati ma' Blitzima?
English: Laboratory studies comparing Blitzima with MabThera have shown that the active substance in Blitzima is highly similar to that in MabThera in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Blitzima ma' MabThera wrew li s-sustanza attiva f'Blitzima hija simili ħafna għal dik f'MabThera f'termini ta' struttura, purità u attività bijoloġika.
English: This means that Blitzima is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Blitzima huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-'mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Maltese: Huwa disponibbli bħala konċentrat sabiex issir soluzzjoni li għandha tingħata permezz ta' infużjoni (dripp) ġo vina.
English: The company that markets Blitzima will provide doctors and patients using the medicine for non-cancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Maltese: Il-kumpanija li tqiegħed Blitzima fis-suq ser tipprovdi lit-tobba u lill-pazjenti li jużaw il-mediċina għal kundizzjonijiet mhux tal-kanċer b'materjal edukattiv inkluż informazzjoni dwar il-ħtieġa li l-mediċina tingħata fejn ikun hemm disponibbli faċilitajiet għar-risuxxitazzjoni u dwar ir-riskju ta' infezzjoni, inkluż PML.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Maltese: Meta rituximab jeħel ma' CD20, jikkawża l-mewt taċ-ċelloli B, li jgħin fil-linfoma u fis-CLL, fejn iċ-ċelloli B ikunu saru kanċerużi.
English: Studies have also shown that giving Blitzima produces similar levels of the active substance in the body to giving MabThera.
Maltese: L-istudji wrew ukoll li lgħoti ta' Blitzima jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' MabThera.
English: In addition, Blitzima has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Maltese: 372 pazjent bl-artrite rewmatojde attiva (marda infjammatorja).
English: In addition, a study comparing Blitzima to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Maltese: Barra minn hekk, studju li jqabbel Blitzima ma' MabThera f'pazjenti b'artrite rewmatojde (li jista' jappoġġja l-użu tiegħu f'disturbi infjammatorji oħra bħal GPA u MPA) wera li ż-żewġ mediċini huma effettivi b'mod simili, u studju ta' sostenn fil-linfoma follikulari wera effettività fil-kanċer.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Blitzima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Blitzima għandu struttura, purità u attività bijoloġika simili ħafna għal MabThera u jiġi distribwit bl-istess mod fil-ġisem.
English: Blitzima is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Maltese: Blitzima huwa mediċina li tintuża fl-adulti għall-kura tal-kanċers tad-demm u tal-kondizzjonijiet infjammatorji li ġejjin:
English: For the full list of side effects reported with Blitzima, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrappurtati bi Blitzima, ara l-fuljett ta' tagħrif.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Maltese: L-effetti sekondarji l-aktar komuni b'rituximab huma reazzjonijiet relatati mal-infużjoni (bħal deni, dehxie u rogħda) li jseħħu fil-maġġoranza tal-pazjenti bil-kanċer u f'aktar minn 1 minn kull 10 pazjenti b'GPA jew MPA meta ssir l-ewwel infużjoni.
English: National Digital Park Citywest Business Campus Dublin 24
Maltese: National Digital Park Citywest Business Campus Dublin 24 l-Irlanda
English: • Sedatives (diazepam).
Maltese: • Sedattivi (diazepam).
English: levomepromazine and olanzapine).
Maltese: levomepromazine u olanzapine).
English: de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) SPAIN
Maltese: Avda. de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) SPANJA
English: Coma*,
Maltese: Koma*,
English: Vetenskapsvägen 10 191 90 Sollentuna Sweden
Maltese: Vetenskapsvägen 10 191 90 Sollentuna l-iSvezja
English: (For symptoms, see section 4.
Maltese: (Għas-sintomi, ara sezzjoni 4.
English: Pfizer Holding France 23-25 avenue du Dr Lannelongue 75014 PARIS
Maltese: Pfizer Holding France 23-25 avenue du Dr Lannelongue 75014
English: Common (≥1/100 to
Maltese: Komuni (≥1/100 to
English: Rare (≥1/10000 to
Maltese: Rari (≥1/10000 to
English: Kennedy L-1855 Luxembourg
Maltese: Avenue J.F. Kennedy L-1855 Lussemburgu
English: • Serotonin Syndrome.
Maltese: • Sindromu tas-Serotonin.
English: Zoloft contains the active ingredient sertraline.
Maltese: Zoloft fih is-sustanza attiva sertraline.
English: Sertraline concentrate for oral solution contains 12% ethanol (see sections 4.3 and 4.5), glycerol and butylhydroxytoluene.
Maltese: Sertraline konċentrat għal soluzzjoni orali fih 12% ethanol (ara sezzjonijiet 4.3 u 4.5), glycerol u butylhydroxytoluene.
English: • Diueretics.
Maltese: • Dijuretiċi.
English: Other serotonergic drugs See section 4.4.
Maltese: Mediċini serotonerġiċi oħra Ara sezzjoni 4.4.
English: Section 4.1 - Indications: Depression (MDD)
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi: Depressjoni (MDD)
English: In addition, the MAH proposed harmonised wordings for sections 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 as well as for sections 5.1, 5.2 and 5.3.
Maltese: Barra minn hekk, il-MAH ippropona formolazzjonijiet għas-sezzjonijiet 4.4, 4.5, 4.6, 4.7, 4.8 u 4.9 kif ukoll għas-sezzjonijiet 5.1, 5.2 u 5.3.
English: • Herbal medicine containing St. John's Wort (Hypericum perforatum).
Maltese: John's Wort (Hypericum perforatum).
English: Table 1: Adverse Reactions
Maltese: Tabella 1: Reazzjonijiet Avversi
English: Adolescents and elderly
Maltese: L-adoloxxenti u l-adulti
English: The half-life of N-desmethylsertraline is in the range of 62 to 104 hours.
Maltese: Il-half-life ta' N-desmethylsertraline hija filmedda ta' 62 sa 104 sigħat.
English: Sertraline does not act as an inhibitor of CYP 3A4, CYP 2C9, CYP 2C19, and CYP 1A2 to a clinically significant degree.
Maltese: Sertraline ma jaħdimx bħala inibitur ta' CYP 3A4, CYP 2C9, CYP 2C19, and CYP 1A2 klinikament relevanti
English: Very common (≥1/10): Headache (22%), insomnia (21%), diarrhoea (11%) and nausea (15%).
Maltese: Komuni ħafna (≥1/10): Uġigħ ta' ras (22%), nuqqas ta' rqad (21%), dijarea (11%) u dardir (15%).
English: Drugs Metabolized by Cytochrome P450
Maltese: Mediċini Metabolizzati miċ-Ċitokromu P450
English: Vaginal Haemorrhage, Female Sexual Dysfunction
Maltese: Emorraġija mill-vaġina, Disfunzjoni sesswali femminili
English: Post traumatic stress disorder (PTSD)
Maltese: • Il-post traumatic stress disorder (PTSD)
English: Paediatric-onset OCD shares important similarities with the adult disorder but also shows important differences.
Maltese: Il-bidu pedjatriku tal-OCD jikkondividi similaritajiet importanti mad-disturb fl-adulti iżda juri wkoll differenzi importanti.
English: Gynaecomastia, Menstrual Irregularities
Maltese: Ginekomastja, Irregolaritajiet mestrwali
English: Depression and Obssessive Compulsive Disorder For depression and OCD, the usual effective dose is (2.5 ml) 50 mg/day.
Maltese: Depressjoni u Obssessive Compulsive Disorder Għad-depressjoni u l-OCD, id-doża effettiva tas-soltu hija (2.5 ml) 50 mg/kuljum.
English: Distribution Approximately 98% of the circulating drug is bound to plasma proteins.
Maltese: Distribuzzjoni Madwar 98% tal-mediċina fiċ-ċirkolazzjoni teħel mal-proteini tal-plażma.
English: Capsules, hard
Maltese: Kapsuli iebsin
English: Contraindicated
Maltese: Kontra-indikati
English: Patients randomized to sertraline showed significantly greater improvement than those randomised to placebo on the Children's Yale-Brown Obsessive Compulsive Scale CY-BOCS (p =0.005) the NIMH Global Obsessive Compulsive Scale (p=0.019), and the CGI Improvement (p =0.002) scales.
Maltese: Il-pazjenti randomizzati għal sertraline wrew titjib sostanzjalment ikbar minn dawk randomizzati għal plaċebo fuq iċ-Children's Yale-Brown Obsessive Compulsive Scale CY-BOCS (p=0.005), in-NIMH Global Obsessive Compulsive Scale (p=0.019), u l-iskali ta' Titjib CGI (p=0.002).
English: Oedema Peripheral
Maltese: Edema periferali
English: “Sertraline is indicated for the treatment of major depressive episodes.
Maltese: “Sertraline hija indikata għat-trattament ta' episodji depressivi maġġuri.
English: Pfizer Hellas A.E., 243 Messoghion Ave., 154 51 Ν. Psychiko, Athens Greece
Maltese: Pfizer Hellas A.E., 243 Messoghion Ave., 154 51 Ν. Psychiko, Athens Greċja
English: Electroconvulsive therapy
Maltese: Terapija elettrokonvulsiva
English: This has been confirmed by in-vivo interaction studies with CYP3A4 substrates (endogenous cortisol, carbamazepine, terfenadine, alprazolam), CYP2C19 substrate diazepam, and CYP2C9 substrates tolbutamide, glibenclamide and phenytoin.
Maltese: Dan kien ikkonfermat bi studji tal-interazzjoni in vivo b'sostratti CYP 3A4 (kortisol indiġenu, carbamazepine, terfenadine, alprazolam), sostratt ta' CYP2C19 diazpeam, u sostratti CYP2C9 tolbutamide, glibenclamide u phenytoin.
English: Chronic dosing with sertraline 50 mg daily showed moderate elevation (mean 23%-37%) of steady-state desipramine plasma levels (a marker of CYP 2D6 isozyme activity).
Maltese: Id-dożar kroniku b'sertraline 50 mg kuljum wera żieda moderata (medja 23%-37%) fil-livelli stabbli ta' desipramine fil-plażma (indikatur ta' attività tal-isoenzima CYP 2D6).
English: • Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old).
Maltese: • L-obsessive compulsive disorder (OCD) (fl-adulti u fi tfal u adoloxxenti ta' bejn 6 u 17-il sena).
English: Zoloft together with MAOIs.
Maltese: Tużax Zoloft ma' MAOIs.
English: Aminotransferarase Increased*, Aspartate Aminotransferase Increased*, Semen Abnormal
Maltese: Żieda fl-alanine aminotransferarase *, Żieda fl-aspartate aminotransferase Increased*.
English: Sertraline concentrate for oral solution contains 20 mg/ml of sertraline.
Maltese: Sertraline konċentrat għal soluzzjoni orali fih 20 mg/ml ta' sertraline.
English: Sertraline exhibits dose proportional pharmacokinetics in the range of 50 to 200 mg.
Maltese: Sertraline juri farmakokinetiċi proporzjonali mal-doża fil-medda ta' 50 sa 200 mg.
English: Peripheral Ischaemia
Maltese: Iskemija periferali
English: In the two positive general population trials, the male and female sertraline vs. placebo responder rates were similar (females: 57.2% vs 34.5%; males: 53.9% vs 38.2%).
Maltese: Fiż-żewġ studji posittivi tal-popolazzjoni in ġenerali, ir-rati ta' rispons bejn rġiel u nisa fuq sertraline vs. dawk fuq placebo kienu simili (nisa 57.2% vs 34.5%; irġiel: 53.9% vs 38.2%).
English: Sertraline may act as a mild-moderate inhibitor of CYP 2D6.
Maltese: Sertraline jista' jaġixxi bħala inibitur ħafif-moderat ta' CYP 2D6.
English: Pfizer Luxembourg SARL Rond-Point du Kirchberg 51 Avenue J.F.
Maltese: Pfizer Luxembourg SARL Rond-Point du Kirchberg 51 Avenue J.F. Kennedy L-1855 Lussemburgu
English: Monoamine Oxidase Inhibitors
Maltese: Inibituri tal-Monoamine Oxidase
English: The pharmacokinetic profile in adolescents or elderly is not significantly different from that in adults between 18 and 65 years.
Maltese: Il-profil farmakokinetiku fl-adoloxxenti jew l-anzjani mhuwiex differenti b'mod sinifikanti minn ta' persuni adulti bejn 18 u 65 sena.
English: The following adverse reactions were reported from controlled trials (n=281 patients treated with sertraline):
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrappurtati minn provi kkontrollati (n=281 pazjent ittrattati b'sertraline).
English: • Medicines to treat epilepsy (phenytoin).
Maltese: • Mediċini għall-kura tal-epilessija (phenytoin).