FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site reactions such as swelling, erythema, pain, pruritus
Maltese: Sinjali u sintomi dispeptiċi, dijarea, dardir
English: The efficacy and safety of Xolair were demonstrated in two randomised, placebo-controlled phase III studies (study 1 and 2) in patients with CSU who remained symptomatic despite H1 antihistamine therapy at the approved dose.
Maltese: III randomizzati, kkontrollati bi plaċebo (studju 1 u 2) f'pazjenti b'CSU li baqgħu sintomatiċi minkejja t-terapija b'antiistamina
English: The effects of demographic characteristics and other factors on omalizumab exposure were evaluated based on population pharmacokinetics.
Maltese: L-effetti ta' karatteristiċi demografiċi u ta' fatturi oħrajn fuq l-espożizzjoni ta' omalizumab kiene evalwati skont il-farmakokinetiċi tal-popolazzjoni.
English: Syringe guard wings Plunger
Maltese: Disturbi vaskulari Mhux komuni
English: Table 6 includes results in the study 1 population.
Maltese: Tabella 6 tinkludi riżultati fil-popolazzjoni ta' studju 1.
English: 75 mg solution for injection in pre-filled syringe (10 x 1)
Maltese: 75 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (10 x 1)
English: What Xolair looks like and contents of the pack Xolair 75 mg powder and solvent for solution for injection is supplied as a white to off-white powder in a small glass vial together with an ampoule containing 2 ml of water for injections.
Maltese: Xolair 75 mg trab u solvent għal soluzzjoni għall-injezzjoni huwa fornut bħala trab abjad jagħti floffwajt f'kunjett żgħir tal-ħġieġ flimkien m'ampulla li fiha 2 ml ta' ilma għall-injezzjonijiet.
English: Analyses of these limited data suggest that no dose adjustments are necessary in patients with asthma for age (6-76 years), race/ethnicity, gender or body mass index (see section 4.2).
Maltese: Analiżi ta' dan it-tagħrif limitat jissuġġerixxi li m'hemmx bżonn isir tibdil fid-dożi għall-età (6-76 sena), razza/etniċità, sess jew Indiċi tal-Massa tal-Ġisem (ara sezzjoni 4.2).
English: Patients received Xolair at 75 mg, 150 mg or 300 mg or placebo by subcutaneous injection every 4 weeks for 24 and 12 weeks in studies 1 and 2, respectively, and 300 mg or placebo by subcutaneous injection every 4 weeks for 24 weeks in study 3.
Maltese: Il-pazjenti mogħtija Xolair f'doża ta' 75 mg, 150 mg jew 300 mg jew plaċebo permezz ta' injezzjoni minn taħt il-ġilda kull 4 ġimgħat għal 24 u 12-il ġimgħa fi studji 1 u 2, rispettivament, u 300 mg jew plaċebo permezz ta' injezzjoni minn taħt il-ġilda kull 4 ġimgħat għal 24 ġimgħa fi studju 3. L-istudji kollha wara kellhom perjodu ta' 16-il ġimgħa mingħajr trattament.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions.
Maltese: It-tneħħija ta' omalizumab ma tinvolvix mekkaniżmi ta' enżimi cytochrome P450, pompi ta' l-effluss u mekkaniżmi li jinvolvu t-twaħħil ma' proteini, għalhekk mhux probabli li jkun hemm nuqqas ta' qbil ma' prodotti mediċinali oħrajn.
English: Symptoms may include rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (voice box), windpipe or other parts of the body, fast heartbeat, dizziness and light-headedness, confusion, shortness of breath, wheezing or trouble breathing, blue skin or lips, collapsing and losing consciousness.
Maltese: Is-sintomi jistgħu jinkludu raxx, ħakk jew ħorriqija fuq il-ġilda, nefħa fil-wiċċ, xofftejn, ilsien, larinġi (il-kaxxa tal-vuċi) trakea jew f'partijiet oħra tal-ġisem, qalb tħabbat bil-għaġġla, sturdament jew rasek ħafifa, konfużjoni, qtugħ ta' nifs, tħarħir jew tbatija biex tieħu n-nifs, ġilda jew xofftejn koħol, taqa' mal-art u tintilef minn sensik.
English: Xolair 75 mg powder and solvent for solution for injection omalizumab
Maltese: Xolair 75 mg trab u solvent għal soluzzjoni għall-injezzjoni omalizumab
English: Allergic reactions type I
Maltese: Reazzjonijiet allerġiċi tat-tip I
English: The needle cap of the syringe may contain dry rubber (latex).
Maltese: It-tokka tal-labra tas-siringa jista' jkollha lastku xott (latex).
English: WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Maltese: IT-TIKKETTA TA' FUQ IL-KISJA TA' BARRA FUQ PAKKETTI MULTIPLI MIKSIJIN FIL-FOJL (INKLUŻA L-KAXXA Ċ-ĊELESTI)
English: Xolair 75 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 x 1) or 10 (10 x 1) pre-filled syringes.
Maltese: Xolair 75 mg soluzzjoni għall-injezzjoni huwa disponibbli f'pakketti li fihom siringa waħda mimlija għal-lest u f'pakketti b'ħafna li fihom 4 (4 x 1) jew 10 (10 x 1) siringi mimlija għal-lest.
English: There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of Xolair.
Maltese: Ma sarux studji dwar l-effetti ta' Xolair ma' prodotti mediċinali oħra jew ma' tilqim.
English: The general pharmacokinetic characteristics of omalizumab are similar in these populations.
Maltese: Il-karatteristiċi farmakokinetiċi ġenerali ta' omalizumab huma simili f'dawn il-popolazzjonijiet.
English: How to store Xolair
Maltese: X'fih Xolair
English: Xolair 150 mg powder and solvent for solution for injection omalizumab
Maltese: Xolair 150 mg trab u solvent għal soluzzjoni għall-injezzjoni omalizumab
English: 150 mg solution for injection in pre-filled syringe (6 x 1)
Maltese: 150 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (6 x 1)
English: Dose Syringes needed for the dose 75 mg 1 blue
Maltese: Doża Siringi meħtieġa għad-doża 75 mg 1 blu (75 mg)
English: In allergic patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant.
Maltese: F'pazjenti li kellhom riskju kroniku għoli ta' infezzjoni b'mard ta' l-elminti, prova kontrollata bi plaċebo wriet żieda żgħira fir-rata ta' l-infezzjoni b'omalizumab li ma kienitx statistikament sinifikanti.
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity.
Maltese: Ammont moderat ta' data dwar nisa tqal (bejn 300-1,000 riżultat tat-tqala) ibbażat fuq ir-reġistru tattqala u rapporti spontanji ta' wara t-tqegħid fis-suq, ma jindika l-ebda effett tossiku malformattiv jew effett tossiku fuq il-fetu/tarbija tat-twelid.
English: Parasitic infection
Maltese: Infezzjoni ta' parassiti
English: Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose.
Maltese: Imbotta l-arja, bżieżaq kbar, u s-soluzzjoni żejda sabiex tikseb id-doża ta' 0.6 ml li hemm bżonn.
English: Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily highdose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Maltese: Xolair huwa indikat bħala terapija kumplimentari sabiex jitjieb il-kontroll tal-ażma ta' pazjenti li jsofru b'ażma allerġika persistenti u qawwija li jkollhom test tal-ġilda posittiv jew reazzjoni in vitro għal xi allerġen perenni fl-arja u li jkollhom tnaqqis fil-funzjoni tal-pulmun (FEV1 <80%), kif ukoll sintomi frekwenti matul il-jum jew qawmien bil-lejl u li jkollhom numru ta' attakki ħorox tal-ażma u li jkunu qed jaggravaw għalkemm ikunu qed jieħdu dożi għoljin ta' kortikosterojdi li jittieħdu man-nifs kuljum, flimkien ma' agonist ta' beta2 li jaħdem fit-tul u li jittieħed man-nifs.
English: Omalizumab is excreted in breast milk in cynomolgus monkeys.
Maltese: Minbarra hekk, kien hemm emorraġġija akuta u infjammazzjoni fil-post ta' l-injezzjoni f'xadini cynomolgus.
English: 75 mg solution for injection in pre-filled syringe (4 x 1)
Maltese: 75 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (4 x 1)
English: Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities.
Maltese: Dożi sa 4,000 mg waħidhom li jingħataw għal ġol-vina ingħataw f'pazjenti mingħajr ma dehru effetti tossiċi li llimitaw id-doża.
English: In specifically-designed non-clinical fertility studies in non-human primates, including mating studies, no impairment of male or female fertility was observed following repeated dosing with omalizumab at dose levels up to 75 mg/kg.
Maltese: Fi studji tal-fertilità mhux kliniċi ddisinjati speċifikament f'primati li ma jinkludux il-bniedem, inklużi studji tal-akkopjament, ma ġietx osservata ħsara fuq il-fertilità tal-irġiel jew tan-nisa wara dożaġġ ripetut b'omalizumab f'livelli ta' dożi sa 75 mg/kg.
English: Syringe guard
Maltese: Ġwienaħ protettivi tassiringa
English: Results for the 300 mg are available for 9 patients at week 12 and 6 patients at week 24, and show a similar magnitude of response to omalizumab treatment compared to the adult population.
Maltese: Ir-riżultati għal 300 mg huma disponibbli għal 9 pazjenti fit12-il ġimgħa u għal 6 pazjenti fl-24 ġimgħa, u juru manjitudni simili fejn jidħol ir-rispons għattrattament b''malizumab imqabbel mal-popolazzjoni adulta.
English: Across all three studies, patients reported receiving on average 4 to 6 medications (including H1 antihistamines) for CSU symptoms prior to study enrollment.
Maltese: Fit-tliet studji kollha kemm huma, il-pazjenti rrappurtaw li ngħataw medja ta' 4 u 6 medikazzjonijiet (inkluż antiistamini
English: Children (under 6 years of age) Xolair should not be given to children under 6 years of age.
Maltese: Tfal (ta' età taħt is-6 snin) Xolair m'għandux jingħata lil tfal ta' età taħt is-6 snin.
English: Table 1 Conversion from dose to number of vials, number of injections and total injection volume for each administration
Maltese: Tabella 1 Konverżjoni minn doża għan-numru ta' kunjetti, numru ta' injezzjonijiet u t-total tal-volum ta' l-injezzjoni għal kull għotja ta' doża
English: Asthma exacerbations Rate per 28-week period % reduction, p-value for rate ratio
Maltese: Rata għal kull perijodu ta' 28ġimgħa
English: The in vitro histamine release from basophils isolated from Xolair-treated subjects was reduced by approximately 90% following stimulation with an allergen compared to pre-treatment values.
Maltese: Il-ħelsien in vitro ta' istamin minn bażofili ta' persuni li ngħataw Xolair naqset b'madwar 90% wara stimulazzjoni b'allerġen meta mqabbla mal-valuri li nkisbu qabel il-kura.
English: 1 x 150 mg vial
Maltese: Kunjett 1 x 150 mg
English: No effects on the breast-fed newborns/infants are anticipated.
Maltese: Mhux mistennija effetti fuq trabi tat-twelid/trabi li jkunu qed jiġu mreddgħa.
English: Omalizumab binds to IgE and prevents binding of IgE to FcRI (high-affinity IgE receptor), thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2agonist.
Maltese: Xolair jista' jintuża fi tfal u adoloxxenti ta' 6 snin u akbar, li diġà qed jingħataw mediċina għall-ażma, imma li s-sintomi tagħhom ta' l-ażma mhumiex ikkontrollati b'mediċini bħal inhalers b'doża għolja ta' sterojdi jew inhalers beta-agonisti.
English: 150 mg solution for injection in pre-filled syringe (10 x 1)
Maltese: 150 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (10 x 1)
English: Multipack: 4 (4 x 1) pre-filled syringes Multipack: 6 (6 x 1) pre-filled syringes Multipack: 10 (10 x 1) pre-filled syringes
Maltese: Soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Pakkett b'ħafna: 4 (4 x 1) siringi mimlija għal-lest Pakkett b'ħafna: 6 (6 x 1) siringi mimlija għal-lest Pakkett b'ħafna: 10 (10 x 1) siringi mimlija għal-lest
English: 75 mg a
Maltese: 24 ġimgħa
English: Description of selected adverse reactions pertinent to allergic asthma and CSU indications
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula f'każ ta' pazjenti b'indikazzjonijiet ta' ażma allerġika u CSU
English: ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3
Maltese: GĦOTI KULL ĠIMGĦATEJN ARA TABELLA 3
English: Needle cap
Maltese: TAGĦRIF
English: Pregnancy and breast-feeding
Maltese: Infezzjonijiet bil-parassiti
English: Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose.
Maltese: Imbotta l-arja, bżieżaq kbar jew soluzzjoni żejda ‘l barra sabiex tikseb id-doża ta' 1.2 ml meħtieġa.
English: In reproduction studies in cynomolgus monkeys, subcutaneous doses up to 75 mg/kg per week (at least 8 times the highest recommended clinical dose in mg/kg over a 4-week period) did not elicit maternal toxicity, embryotoxicity or teratogenicity when administered throughout organogenesis and did not elicit adverse effects on foetal or neonatal growth when administered throughout late gestation, delivery and nursing.
Maltese: Fi studji dwar ir-riproduzzjoni f'xadini cynomolgus, dożi mogħtija taħt il-ġilda sa 75 mg/kg kull ġimgħa (mill-inqas 8 darbiet l-ogħla doża klinika rakkomandata f'mg/kg fuq perijodu ta' 4 ġimgħat) ma kkawżawx tossiċità fl-omm, fl-embriju jew teratoġeniċità meta ngħataw waqt l-iżvilupp ta' lorgani u ma kellhomx effetti avversi fuq l-iżvilupp tal-fetu jew tal-wild li kien għadu kif twieled meta ngħata fl-aħħar żmien tat-tqala, ħlas u treddigħ.
English: P-value vs. placebo
Maltese: Tokka tal-labra p
English: 150 mg solution for injection in pre-filled syringe (4 x 1)
Maltese: 150 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest (4 x 1)
English: Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3).
Maltese: Omalizumab kien assoċjat ma' tnaqqis dipendenti fuq l-età fin-numru ta' plejtlets tad-demm fi primati li ma jinkludux il-bniedem, b'sensitività relattiva akbar f'annimali ta' età żgħira (ara sezzjoni 5.3).
English: Omalizumab binds to IgE and lowers free IgE levels.
Maltese: Omalizumab jeħel ma' IgE u jbaxxi l-livelli ta' IgE ħieles.
English: Omalizumab or placebo administered
Maltese: Solvent: soluzzjoni ċara u bla kulur
English: This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (12 years of age and older) who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines.
Maltese: Din il-mediċina tintuża biex tittratta urtikarja spontanja kronika f'adulti u adolexxenti (minn 12-il sena 'l fuq) li diġà qed jingħataw antiistamini imma li s-sintomi tagħhom ta' CSU mhumiex ikkontrollati sew b'dawn il-mediċini.
English: Administration of Xolair manufactured as a lyophilised or liquid formulation resulted in similar serum concentration-time profiles of omalizumab.
Maltese: L-għoti ta' Xolair immanifatturat bħala formolazzjoni lijofilizzata jew likwida rriżulta fi profili ta' konċentrazzjoni-ħin tas-serum ta' omalizumab simili.
English: For all six studies there was a statistically significant improvement from baseline in quality of life scores for Xolair patients versus the placebo or control group.
Maltese: Għas-sitt studji kollha, kien hemm titjib statistikament sinifikanti mill-linja bażika fil-punteġġi tal-kwalità tal-ħajja għall-pazjenti fuq Xolair kontra l-plaċebo jew il-grupp ta' kontroll.
English: Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.
Maltese: Is-sintomi jistgħu jinkludu uġigħ fil-muskoli, uġigħ u nefħa fil-ġogi, raxx, deni, telf tal-piż, u għeja.
English: Influenza-like illness, swelling arms, weight increase, fatigue *: Very common in children 6 to <12 years of age **: In children 6 to <12 years of age
Maltese: Komuni ħafna fi tfal ta' età minn 6 snin sa <12-il sena **:
English: Keep taking your current medicine for CSU during Xolair treatment.
Maltese: Kompli ħu l-mediċina ta' bħalissa għal CSU matul it-trattament b'Xolair.
English: Study 1
Maltese: Riżultati ta' studju 1
English: In addition, acute haemorrhage and inflammation were observed at injection sites in cynomolgus monkeys.
Maltese: Ma kienx hemm evidenza ta' rispons anafilattiku permezz ta' degranulazzjoni ta' ċelluli tat-tip mast fix-xadini cynomolgus.
English: Treatment with Xolair in this open label study led to a 61% reduction in clinically significant asthma exacerbation rate compared to current asthma therapy alone.
Maltese: Kura bi Xolair f'dan l-istudju openlabel wassal għal tnaqqis ta' 61% fl-aggravar ta' l-attakki ta' l-ażma b'valur kliniku sinifkanti meta mqabbel mat-terapija għall-ażma li kienet qed tingħata waħidha.
English: Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis.
Maltese: Xolair ma kienx studjat f'pazjenti li jsofru b'sindrome ta' iperimmunoglobulina E jew asperġillożi bronkopulmonari allerġika jew għall-użu preventiv ta' reazzjonijiet anafilattiċi, inklużi dawk li jkunu kawżati minn allerġija ta' l-ikel, dermatite atopika, jew rinite allerġika.
English: Xolair is not meant to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungus-related lung disease), food allergy, eczema or hay fever because Xolair has not been studied in these conditions.
Maltese: Xolair mhuwiex intenzjonat li jilqa' kontra jew jikkura kundizzjonijiet oħra tat-tip allerġiċi, bħal reazzjonijiet allerġiċi għall-għarrieda, sindrome ta' iperimmunoglobulina E (disturb immuni li jintiret), asperġillożi (marda tal-pulmun li għandha x'taqsam ma' fungu), allerġija għall-ikel, ekżema jew hay fever għax Xolair ma ġiex studjat f'dawn il-kondizzjonijiet.
English: The omalizumab group showed greater decreases in beta-agonist rescue medication use than the placebo group at the end of the 52-week treatment period, although the difference between treatment groups was not statistically significant.
Maltese: Il-grupp ta' omalizumab wera tnaqqis akbar fl-użu tal-mediċina ta' salvataġġ b'agonist ta' beta minn dak fil-grupp ta' plaċebo fi tmiem il-perjodu ta' 52 ġimgħa ta' kura, għalkemm id-differenza bejn ilgruppi ta' kura ma kinitx statistikament sinifikanti.
English: Solvent ampoule: Clear, colourless type I glass ampoule containing 2 ml water for injections.
Maltese: Ċar, ampulla tal-ħġieġ tat-tip I bla kulur li fiha 2 ml ta' ilma għall-injezzjonijiet.
English: Xolair 75 mg powder for solution for injection omalizumab
Maltese: Xolair 75 mg trab għal soluzzjoni għall-injezzjoni omalizumab
English: 0.5 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper and needle cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.5 ml ta' soluzzjoni ġo siringa mimlija għal-lest f'tubu ċilindriku tas-siringa (ħġieġ tat-tip I) b'labra (tal-azzar li ma jissaddadx) imwaħħla miegħu, tapp tal-planġer (tat-tip I) u għatu tal-labra.
English: 1495 - 131 Algés Portugal
Maltese: 1495 - 131 Algés Portugall
English: 105 Reykjavik Iceland
Maltese: 105 Reykjavik Islanda
English: 28760 Tres Cantos Madrid Spain
Maltese: 28760 Tres Cantos Madrid Spanja
English: Ljubljana Knezov stradon 90 1000 Ljubljana Slovenia
Maltese: Ljubljana Knezov stradon 90 1000 Ljubljana Slovenja
English: 37135 Verona Italy
Maltese: 37135 Verona Italja
English: Grunwaldzka 189, 60-322 Poznan, Poland.>
Maltese: Grunwaldzka 189, 60-322 Poznan, Polonja.>
English: Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spain.>
Maltese: Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spanja.>
English: Albert-Schweitzer-Gasse 6 A-1140 Wien Austria
Maltese: Albert-Schweitzer-Gasse 6, A-1140 Wien
English: Stevens-Johnson Syndrome.
Maltese: Sindrome Stevens-Johnson.
English: The active substance is lamotrigine.
Maltese: Is-sustanza attiva hi lamotrigine.
English: aggression, irritability.
Maltese: aggressjoni, irritabilita'
English: The difference was not statistically significant: 26.3%, CI95% -2.6% <> 50.2%, p=0.07.
Maltese: 3%, CI95%2.6% <> 50.2%, p=0.07.
English: Hungary GlaxoSmithKline Kft. 1124Bp.
Maltese: GlaxoSmithKline Kft. 1124Bp.
English: MOM Park, Gesztenyes torony Hungary
Maltese: 43. MOM Park, Gesztenyes torony Ungerija
English: Norway GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo
Maltese: Norveġja GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo
English: Pharmacotherapeutic group: other antiepileptics, ATC code: N03AX09.
Maltese: Grupp farmakoterapewtiku: anti-epilettiċi oħra, kodiċi ATC:N03AX09.
English: Inclusion criterion
Maltese: Kriterju ta' inklużjoni
English: The volume of distribution is 0.92 to 1.22 L/kg.
Maltese: 92 sa 1.22 L/kg.
English: Lithuania The Wellcome Foundation Limited
Maltese: Romanija The Wellcome Foundation Limited
English: Manufacturer: <Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom.>
Maltese: Manufattur: <Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Renju Unit.>
English: Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
Maltese: Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex Franza
English: Sweden GlaxoSmithKline AB Box 516
Maltese: GlaxoSmithKline AB Box 516
English: Denmark GlaxoSmithKline Pharma A/S Nykaer 68
Maltese: Danimarka GlaxoSmithKline Pharma A/S Nykaer 68
English: GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist The Netherlands
Maltese: GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist Olanda
English: GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex
Maltese: GlaxoSmithKline Export Ltd 980 Great West Road Brentford
English: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy
Maltese: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate jew zonisamide, li jintużaw għall-epilessija
English: Risk related to lamotrigine
Maltese: Riskju relatat ma' lamotrigine
English: Trading as GlaxoSmithKline UK Stockley Park West Uxbridge
Maltese: Fil-kummerċ GlaxoSmithKline UK Stockley Park West Uxbridge
English: The following convention has been utilised for the classification of undesirable effects:- Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000).
Maltese: Is-sistema li ġejja ġiet utilizzata għall-klassifikazzjoni ta' effetti mhux mixtieqa:- Komuni ħafna (>1/10), komuni (>1/100, <1/10), mhux komuni (>1/1000, <1/100), rari (>1/10,000, <1/1000), rari ħafna
English: 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 100 tablets
Maltese: 30 pillola 50 pillola 60 pillola 56 pillola 90 pillola 100 pillola
English: Therapeutic Indications (SPC section 4.1)
Maltese: Indikazzjonijiet Terapewtiċi (SPC sezzjoni 4.1)
English: Major manic episode Lamotrigine Lithium Placebo Lamotrigine Lithium Placebo
Maltese: Episodju ta' mania maġġuri Lamotrigine Lithium Plaċebo Lamotrigine Lithium Plaċebo
English: Watch out for important symptoms
Maltese: Oqgħod attent għal sintomi importanti
English: “Epilepsy
Maltese: "Epilessija
English: The decrease after 48 weeks of treatment was 10% from 41 to 37 mL/min between the young and elderly groups.
Maltese: It-tnaqqis wara 48 ġimgħa ta' trattament kien ta' 10% minn 41 sa 37 mL/min bejn il-gruppi żgħar u kbar.