FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo asenapine appears to be at most a weak inhibitor of CYP2D6.
Maltese: In vivo, asenapine jidher li hu primarjament inibitur dgħajjef ta' CYP2D6.
English: Because of its α1-adrenergic antagonism with potential for inducing orthostatic hypotension (see section 4.4), Sycrest may enhance the effects of certain antihypertensive agents.
Maltese: Minħabba l-antagoniżmu tiegħu għar riċetturi α1-adrenerġiċi bil-potenzjal li jikkaġuna pressjoni tad-demm baxxa ortostatika (ara sezzjoni 4.4), Sycrest jista' jkabbar l-effetti ta' ċerti mediċini kontra l-pressjoni għolja.
English: In adolescents, the 10 mg twice daily dose did not result in increased exposure compared to 5 mg twice daily.
Maltese: Fl-adolexxenti, id-doża ta' 10 mg darbtejn kuljum ma rriżultatx f'żieda flespożizzjoni meta mqabbla ma' doża ta' 5 mg darbtejn kuljum.
English: Sycrest 10 mg sublingual tablets
Maltese: Sycrest 10 mg pilloli għal taħt l-ilsien
English: In vitro studies indicate that asenapine weakly inhibits CYP2D6.
Maltese: Studji in vitro jindikaw li asenapine jinibixxi CYP2D6 b'mod dgħajjef.
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Maltese: Prodotti mediċinali bi proprjetajiet antagonistiċi ta' riċettur ta' dopamine ġew assoċjati mal-induzzjoni ta' diskinesija tardiva kkaratterizzata minn movimenti rittmiċi u involontarji, il-biċċa l-kbira tal-ilsien u/jew talwiċċ.
English: Increasing the dose from 5 to 10 mg twice daily (a two-fold increase) results in less than linear (1.7 times) increases in both the extent of exposure and maximum concentration.
Maltese: Li żżid id-doża minn 5 għal 10 mg darbtejn kuljum (żieda tad-doppju tad-doża), tirriżulta f'żidiet li huma inqas minn lineari (1.7 darbiet) kemm fil-grad kif ukoll fl-espożizzjoni u l-konċentrazzjoni massima.
English: The incidences of the ADRs associated with asenapine therapy are tabulated below.
Maltese: L-inċidenzi ta' ADRs assoċjati ma' terapija b'asenapine huma elenkati hawn taħt.
English: The mean daily dose usually ranges between 1000 and 2000 mg <valproate>.
Maltese: Id-doża medja ta' kuljum normalment tvarja bejn 1 000 u 2 000 mg <valproate>.
English: Nausea, sedation, extrapyramidal disorders.
Maltese: Tqalligħ, sedazzjoni, disturbi ekstrapiramidali.
English: Manic episodes in bipolar disorder:
Maltese: Episodji ta' manija f'mard bipolari:
English: - Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive.
Maltese: -Manija, fejn tista' tħossok eċċitat ħafna, ewforiku, aġitat, entużjast jew iperattiv.
English: SUMMARY OF PRODUCT CHARACTERISITICS
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: The continuation of treatment after manic episode could be considered in patients who have responded to <valproate> for acute mania.
Maltese: Il-kontinwazzjoni tal-kura wara episodju ta' manija tista' tiġi kkunsidrata f'pazjenti li rrispondew għal <valproate> f'manija akuta.
English: Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Maltese: Trattament ta' episodju ta' manija f'mard bipolari meta lithium huwa kontra-indikat jew mhuwiex ittollerat.
English: Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Maltese: Id-doża medja ta' kuljum Id-dożi rakkomandati normalment ivarjaw bejn 1000 mg u 2000 mg kuljum.
English: HOW TO TAKE {INVENTED NAME}
Maltese: X'INHU {ISEM
English: The initial recommended daily dose is 750 mg.
Maltese: Id-doża ta' kuljum inizjali rrakkomandata hija ta' 750 mg.
English: AMENDMENTS TO BE INCLUDED IN SECTIONS OF THE PACKAGE LEAFLET FOR VALPROIC ACID /VALPROATE CONTAINING PRODUCTS, AS RELEVANT
Maltese: TAL-PRODOTT GĦAL PRODOTTI LI FIHOM VALPROIC ACID U/JEW SODIUM VALPROATE, KIF INHU RILEVANTI
English: In addition, in clinical trials a starting dose of 20 mg <valproate>/kg body weight has also shown an acceptable safety profile.
Maltese: Barra dan, fil-provi kliniċi, doża inizjali ta' 20 mg <valproate>/kg ta' piż tal-ġisem uriet ukoll profil ta' sigurtà aċċettabbli. Formulazzjonijiet li jerħu l-mediċina bil-mod jistgħu jingħataw darba jew darbtejn kuljum.
English: AMENDMENTS TO BE INCLUDED IN SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR VALPROIC ACID/VALPROATE CONTAINING MEDICINAL PRODUCTS, AS RELEVANT
Maltese: EMENDI LI GĦANDHOM JIĠU INKLUŻI FIS-SEZZJONIJIET TAL-FULJETT TA' TAGĦRIF GĦAL PRODOTTI LI FIHOM VALPROIC ACID U/JEW SODIUM VALPROATE, KIF INHU RILEVANTI
English: A meta-analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Maltese: Analiżi ta' ħafna studji kkontrollati bil-plaċebo u magħmula b'mod arbitrarju ta' mediċini antiepilettiċi wkoll uriet żieda żgħira fir-riskju ta' mġiba u ideat ta' suwiċidju.
English: Initial dose The recommended initial daily dose is 750 mg.
Maltese: Id-doża inizjali Fil-bidu, id-doża rakkomandata hija ta' 750 mg kuljum.
English: The safety and efficacy of {invented name} for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.
Maltese: Is-sigurtà u l-effikaċja ta' [isem ivvintat] għall-kura ta' episodji ta' manija f'mard bipolari ma ġewx evalwati f'pazjenti taħt it-18-il sena.
English: Patients receiving daily doses higher than 45mg/kg/day body weight should be carefully monitored.
Maltese: Pazjenti li kuljum jirċievu dożi akbar minn 45mg/kg/jum ta' piż tal-ġisem għandhom jiġu mmonitorjati b'attenzjoni.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for <active substance>.
Maltese: Ilmekkaniżmu ta' dan ir-riskju mhuwiex magħruf u t-tagħrif disponibbli ma jeskludix il-possibbiltà ta' żieda fir-riskju għal <sustanza attiva>.
English: Pregnancy and breast-feeding
Maltese: Fit-tfal u fl-adolexxenti:
English: Take special care with {INVENTED NAME}
Maltese: Oqgħod attent ħafna b'{ISEM
English: If you are a woman of child-bearing age, you have to use effective contraception during treatment.
Maltese: Jekk inti mara f'età li tista' toħroġ tqila, trid tuża kontraċezzjoni effettiva waqt il-kura.
English: WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {Invented name} is a medicine for the treatment of (…) and mania.
Maltese: IVVINTAT} huwa mediċina għall-kura ta (…) u manija.
English: Mania occurs in an illness called “bipolar disorder”.
Maltese: Manija sseħħ f'marda li tissejjaħ “marda bipolari”.
English: This medicine should not be used during pregnancy and in women of child-bearing potential unless clearly necessary (i.e. in situations where other treatments are ineffective or not tolerated).
Maltese: Din il-mediċina m'għandiex tintuża waqt it-tqala u f'nisa li jistgħu joħorġu tqal ħlief meta hemm bżonn ċar (jiġifieri f'sitwazzjonijiet fejn trattamenti oħra mhux effettivi jew mhux ittollerati).
English: Continuation of treatment of manic episodes in bipolar disorder should be adapted individually using the lowest effective dose.
Maltese: Il-kontinwazzjoni tal-kura f'episodji ta' manija f'mard bipolari għandha tiġi adattata skont l-individwu billi tintuża l-anqas doża effettiva.
English: Children and adolescents under 18 years of age: {Invented name} should not be used in children and adolescents under 18 years of age for the treatment of mania.
Maltese: IVVINTAT} m'għandux jintuża fit-tfal u fl-adolexxenti taħt it-18-il sena.
English: Kemistvägen 1B, Box 1150, 18311 Täby, Sweden
Maltese: Novartis Sverige AB Kemistvägen 1B, Box 1150, 18311 Täby, Sweden
English: United Kingdom Novartis Pharmaceuticals UK Limited Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Maltese: Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom
English: 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex
Maltese: 2 & 4, rue Lionel Terray, 92500
English: 12 km of National Road Athens, Lamia N° 1, 14451 Metamorphosis, Athens Greece
Maltese: 12 km of National Road Athens, Lamia N° 1, 14451
English: Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47 Hungary
Maltese: Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43
English: 90429 Nuernberg Germany
Maltese: 90429 Nuernberg
English: Novartis Pharma GmbH Stella-Klein Loew-Weg 17 1020 Vienna
Maltese: Novartis Pharma GmbH Stella-Klein Loew-Weg 17 1020
English: 8 , Quinta da Beloura 2710-444 Sintra Portugal
Maltese: Rua do Centro Empresarial, Edif. 8 , Quinta da Beloura 2710-444
English: Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø Denmark
Maltese: Novartis Healthcare A/S Lyngbyvej 172, 2100
English: Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo
Maltese: In-Norveġja Novartis Norge AS Postboks 4284
English: Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde Belgium
Maltese: Medialaan, 40 bus 1, 1800 Vilvoorde
English: Czech Republic Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129
Maltese: Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129 140 00 Prague 4
English: Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, N° 764 08013 Barcelona
Maltese: Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, N° 764
English: RH12 5 Ab - Horsham (West Sussex) United Kingdom
Maltese: Novartis Europharm Ltd Wimblehurst Road RH12 5 Ab - Horsham (West Sussex)
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, kompożizzjoni farmaċewtika, qawwa tal-prodott mediċinali, metodu ta' amministrazzjoni, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Femara 2.5mg Filmcoated Tablets
Maltese: Femara 2.5mg Film-coated Tablets
English: Luxembourg Novartis Pharma GmbH Roonstraße 25
Maltese: Il-Lussemburgu Novartis Pharma GmbH Roonstraße 25
English: Femara 2.5mg Tablets 2.5 mg
Maltese: Femara 2,5mg Filmtabletten 2.5 mg
English: Femara 2,5mg filmtabletta
Maltese: Femara 2,5mg filmtabletta 2.5 mg
English: INFORMATION IN BRAILLE ZIMULTI
Maltese: INFORMAZZJONI BIL-BRAILLE ZIMULTI
English: EU/1/06/345/001 EU/1/06/345/002 EU/1/06/345/003 EU/1/06/345/004 EU/1/06/345/005 EU/1/06/345/006 EU/1/06/345/010 EU/1/06/345/011
Maltese: EU/1/06/345/001 EU/1/06/345/002 EU/1/06/345/003 EU/1/06/345/004
English: Table 1:
Maltese: Tabella 1
English: Very common (≥10%); Common (≥ 1, <10%); Uncommon (≥ 0.1, <1%); Rare (≥ 0.01, <0.1%); Very rare (<0.01%), Not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 10%); komuni (≥ 1, < 10%); mhux komuni (≥ 0.1, < 1%); rari (≥ 0.01, < 0.1%); rari ħafna (< 0.
English: The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p<0.001).
Maltese: Id-differenza kienet statistikament sinifikanti (Differenza 7.9% CI95% 6.6%; 9.2%, p<0.001).
English: The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p<0.001).
Maltese: Id-differenza kienet statistikament sinifikanti (Differenza -13.3% CI95%16.5; -10.2% p<0.001).
English: Suicidal ideation Aggressiveness Aggressive behaviour
Maltese: Mard emozzjonali Formazzjoni ta'idejat suwiċidali Aggresività Mġiba aggresiva
English: The active ingredient of ZIMULTI is rimonabant.
Maltese: Is-sustanza attiva ta' ZIMULTI huwa rimonabant.
English: Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italy
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, Franza sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), L-Italja Fuq il-fuljett ta' tagħrif tal-prodott medicinali għandu jkun hemm l-isem u l-indirizz tal-manifattur responsabbli għall-ħrug tal-lott konċernat.
English: ZIMULTI is contraindicated during breast-feeding (see section 4.3).
Maltese: ZIMULTI huwa kontraindikat waqt it-treddigħ (ara sezzjon 4.3).
English: The percentage of patients reaching HbA1c <7% was 51% in the rimonabant group and 35% in the placebo group.
Maltese: Il-persentaġġ ta' pazjenti li laħqu il-livell ta' HBA1c <7% kien ta' 51% għall grupp ta' rimonabant u 35% għall grupp tal-plaċebo.
English: ZIMULTI is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Maltese: ZIMULTI huwa disponibbli f'folja ta' 14, 28, 30, 56, 84, 90 u 98 pilloli, f'folji imtaqqbin doża waħda, doża waħda li fihom 70 x 1 pillola, u fi fliexken bojod tal-plastik li fihom 28, 98 u 500 pillola.
English: The in vitro human plasma protein binding of rimonabant is high (>99.9%) and non-saturable over a wide concentration range.
Maltese: Ir-rabta ta' rimonabant mal-proteini tal-plażma fil-bniedem in vitro huwa għoli (> 99.9%) u ma jistax ikun issaturat fuq medda wiesa' ta' konċentrazzjoni.
English: Diabetic study
Maltese: • Pazjenti dijabetiċi
English: In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p<0.001).
Maltese: F'studju investigattiv ieħor (Serenade) f'pazjenti naïve li kellhom id-dijabete tip 2 u li kienu qed ibatu mill-obeżità, il-bidla assoluta fil-livelli ta' HBA1c (b'linja bażi ta' 7.9% għaz-zewġ gruppi) wara sitt xhur kien -0.8 b'rimonabant 20 mg u -0.3 bil-plaċebo (Differenza -0.51 CI95% -0.78, -0.24 p<0.001).
English: In clinical studies, ZIMULTI 20 mg was taken in the morning usually before breakfast.
Maltese: Fi studji kliniċi, 20 mg ta' ZIMULTI ittieħdu filgħodu, normalment qabel ilkolazzjon.
English: Anger
Maltese: SUQ
English: Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ZIMULTI include: upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint sprain.
Maltese: Stonku mqalleb, rimettar, problemi fl-irqad, nervożiżmu, depressjoni, irritabilità, sturdament, dijarrea, anzjetà, ħakk, tagħriq eċċessiv, bugħawwieġijiet u spażmu tal-muskoli, għejja, tbenġil, uġigħ fl-għeruq u infjammazzjoni tagħhom (tendonitis), tnaqqis fil-memorja, uġigħ fid-dahar (xjatika), tibdil fil-ħass (inqass ħass jew sensazzjoni abnormali ta' ħruq jew tingiż) ta' l-idejn u s-saqajn, sħanat, waqgħat, linfluwenza u tfekkik ta'ġog.
English: The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p<0.001).
Maltese: Id-differenza medja ta' bidla fil-piz tal-ġisem bejn il-gruppi ta' 20mg u lplaċebo kien ta' 3.8 kg (CI95% -5.0, -2.6 p<0.001).
English: (See section 4.3 and 4.8).Obesity is a condition that can be associated with depressive disorders.
Maltese: (Ara sezzjoni 4.3 u 4.8).
English: Weight loss at two years was 5.1 kg for patients who received ZIMULTI 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p<0.001).
Maltese: It-tnaqqis fil-piż ma tmiem is-sentejn kien ta' 5.1 kg għallpazjenti li ħadu 20 mg ZIMULTI, u 1.2 kg għall-plaċebo (Differenza -3.8 kg; CI95% -4.4, -3.3; p<0.001).
English: A mean weight loss of 6.5 kg from baseline to one year was shown for ZIMULTI 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3;-4.4, p< 0.001).
Maltese: Intwera telf medju ta' 6.5 kg fil-piż mil-linja bażi sa sena għal 20 mg ta' ZIMULTI, kontra t-telf medju ta' 1.6 kg għall-plaċebo (Differenza -4.9 kg CI95% -5.3; -4.4, p<0.001).
English: Nausea
Maltese: Sulluzzu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun magħmula ghal 14, 28, 30, 56, 70, 84, 90 u 98 pilloli miksija b'rita fil-folji
English: Patients had a BMI ≥30 kg/m² or BMI>27 kg/m² with hypertension and/or dyslipidemia at inclusion.
Maltese: BMI > 27 kg/m2, akkompanjat ma' pressjoni għolja tad-demm u/jew abnormalitajiet fil-livelli taxxaħmijiet fid-demm.
English: Caution is advised during concomitant use of ZIMULTI and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Maltese: (bħal ketoconazole, ritonavir, telithromycin, clarithromycin u nefazodone).
English: Do not use ZIMULTI after the expiry date which is stated on the outer packaging after EXP.
Maltese: Tużax ZIMULTI wara d-data ta' skadenza li tidher fuq il-kartuna wara EXP.
English: What ZIMULTI looks like and contents of the pack ZIMULTI 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
Maltese: Id-Dehra ta' ZIMULTI u l-kontenuti tal-pakkett ZIMULTI 20 mg huwa fornit bħala pilloli bojod taħt forma ta' qatra dmugħ, u miksija b'rita, imnaqqxin bin-numru “20” fuq faċċata waħda.
English: Laboratory adverse events ZIMULTI has not been shown to alter laboratory test values.
Maltese: Grajjiet avversi fit-testijiet tal-laboratorju ZIMULTI ma ntweriex li effetwa ir-riżultati tat-testiijiet tal-laboratorju.
English: Generally ZIMULTI 20 mg had no significant effect on Total-C or LDL-C levels.
Maltese: Bhala regola 20 mg ta' ZIMULTI ma kellux effett fuq il-livelli totali ta' C jew ta' LDL-C.
English: ZIMULTI 20 MG FILM-COATED TABLETS (RIMONABANT)
Maltese: TAL-PRODOTT MEDIĊINALI ZIMULTI 20 mg pilloli miksija b'rita rimonabant
English: At one year a mean weight loss of 5.3 kg was shown for ZIMULTI 20 mg versus a loss on placebo of 1.4 kg (Difference -3.9 kg CI95% -4.6;-3.3 p<0.001).
Maltese: Wara sena, intwera tnaqqis medju fil-piż ta' 5.3 kg b' ZIMULTI 20 mg meta mqabbel mat-tnaqqis ta' 1.4 kg bil-plaċebo (Differenza -3.9 kg CI95% -4.6;-3.3 p<0.001).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/345/007
Maltese: FIS-SUQ EU/1/06/345/007
English: Memory loss Dizziness Hypoaesthesia Sciatica Paresthesia
Maltese: Sintomi ta' paniku Rabja Disforija
English: Since ZIMULTI tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Maltese: Peress li l-pilloli ta' ZIMULTI għandhom il-lattosju, pazjenti b'mard rari ereditarju ta' intolleranza ghall- galattosju, id-defiċjenza tal-lactase tat-tip Lapp jew in-nuqqas ta' assorbiment tal-glukosju u lgalattosju, m'għandhomx jieħdu din il-mediċina.
English: NAME OF THE MEDICINAL PRODUCT ZIMULTI 20 mg film-coated tablets rimonabant
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU ZIMULTI 20 mg pilloli miksija b'rita (rimonabant)
English: The activity of ZIMULTI is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
Maltese: Il-kawtela hija irrakkomandata fl-użu simultanju ta' ZIMULTI u inibituri qawwija ta' CYP3A4
English: NAME OF THE MEDICINAL PRODUCT ZIMULTI 20 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI ZIMULTI 20 mg pilloli miksija b'rita
English: At two years, the difference in total weight loss between ZIMULTI and placebo was -4.2 kg (CI95% -5.0;-3.4, p<0.001).
Maltese: Fl-ahhar tas-sentejn iddifferenza fil-piż totali bejn ZIMULTI u l-plaċebo kienet ta' -4.2 kg (CI95% -5.0;
English: ZIMULTI should be used with caution in patients over 75 years of age (see section 4.4).
Maltese: ZIMULTI għandu jintuża b'kawtela f'pazjenti ta' 'l fuq minn 75 sena (ara sezzjoni 4.4).
English: The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥1%) or considered clinically relevant (for events <1%).
Maltese: It-tabella li tmiss (tabella 1) turi r-reazzjonijiet avversi kollha, dovuti għat-trattament, minn studji ikkontrollati bil-plaċebo, f'pazjenti ittrattati għal telf fil-piż u mard ħafif metaboliku relatat, meta dawn kellhom inċidenza statistikament sinifikanti, akbar mir-rata korrispondenti bil-plaċebo, (għal grajjiet ta' ≥ 1%), jew ikkunsidrati klinikament rilevanti (għal grajjiet ta' < 1%)
English: Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than in proportion to dose above 20 mg.
Maltese: Firrigward tal-parametri riproduttivi, f'doża ta' 30 mg/kg, ma kienux innotati xi differenzi bejn lannimali ittrattati u dawk li ma kienux.
English: In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with metformin or sulfonylurea improvements in HbA1c and body weight were observed.
Maltese: Fl-istudji investigattivi dwar il-pazjenti li kellhom id-dijabete tip 2 (RIO-Diabetes), u li kienu jiżnu aktar minn normal, jew kienu qed ibatu mill-obeżità, it-trattament bil-metformin jew bis-sulfonylurea ġew innotati titjib fil-HbA1c u fil-piż tal-ġisem.
English: ZIMULTI 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications.
Maltese: ZIMULTI 20 mg ġie evalwat għas-sigurtà f'madwar 2500 pazjent, li kienu irreġistrati fi studji li indirizzaw l-effetti metaboliċi u t-telf fil-piż, ta' pazjenti li jiżnu aktar milli suppost u li jbatu millobeżità, kif ukoll f'madwar 3800 pazjent għall-kondizzjonijiet oħra.
English: No dosage adjustment is required in elderly (see section 5.2).
Maltese: M'hemmx bżonn ta' aggustamenti fid-doża fl-anzjani (ara sezzjoni 5.2).
English: HOW TO STORE ZIMULTI
Maltese: KIF TAĦŻEN ZIMULTI
English: Name and address of the manufacturers responsible for batch release
Maltese: DETENTURI TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: Do not take ZIMULTI
Maltese: X'INHU ZIMULTI
English: Grunwaldzka 189 60-322 Poznan Poland
Maltese: Grunwaldzka 189 60-322 Poznan Il-Polonja
English: MISCELLANEOUS Sorbitol solution (3.2g , 10.2 g, 13.4 g)/ Lamivudine
Maltese: Soluzzjoni ta' sorbitol (3.2g , 10.2 g, 13.4 g)/ Lamivudine
English: Priory Street
Maltese: Priory Street, Ware,
English: Zidovudine AUC ↓12%
Maltese: L-AUC ta' Zidovudine ↓12%
English: INFORMATION IN BRAILLE combivir
Maltese: INFORMAZZJONI BIL-BRAILLE combivir
English: NAME OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Maltese: FIS-SUQ ViiV Healthcare BV
English: Do not take Combivir:
Maltese: Tiħux Combivir:
English: Look out for important symptoms
Maltese: Oqogħod attent għal sintomi importanti
English: • inflammation of the pancreas (pancreatitis)
Maltese: • infjammazzjoni tal-frixa (pankrejatite)
English: Laboratorios ViiV Healthcare, S.L.
Maltese: ViiV Healthcare S.r.l.
English: • tablet core; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide
Maltese: • Il-qalba tal-pillola; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide
English: Hertfordshire, SG12 0DJ, United Kingdom or
Maltese: Hertfordshire, SG12 0DJ, Ir-Renju Unit jew
English: Monitor phenytoin concentrations.
Maltese: Immonitorja l konċentrazzjonijiet ta' phenytoin.
English: Both medicinal products are metabolised intracellularly to their active moieties, lamivudine 5'-triphosphate (TP) and zidovudine 5'-TP respectively.
Maltese: Iż-żewġ prodotti mediċinali jiġu metabolizzati fiċ-ċelluli, għas-sustanza attiva, lamivudine 5'- trifosfat (TP) u zidovudine 5'-TP rispettivament.
English: The bioavailability of oral lamivudine in adults is normally between 80-85% and for zidovudine 60-70%.
Maltese: lamivudine li jittieħed mill-ħalq fl-adulti hi normalment bejn it-80-85% u għal zidovudine 60-70%.