FrancophonIA/ELRC3.0 huggingface dataset:
English: Two further studies compared adding Byetta or an insulin to metformin and sulphonylureas.
Maltese: Żewġ studji oħra qabblu ż-żieda ta' Byetta jew iż-żieda ta' insulina mal-metformina u mas-sulfonilureas.
English: Byetta has been studied in eight main studies involving a total of around 3,000 patients whose blood glucose was not adequately controlled with other antidiabetes medicines.
Maltese: Byetta ġie studjat fi tmien studji ewlenin li involvew kważi 3,000 pazjent li ma kellhomx iz-zokkor fiddemm ikkontrollat kif xieraq minn mediċini antidijabetiċi oħra.
English: It is used together with other antidiabetes medicines in patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines.
Maltese: Dan jintuża flimkien ma' mediċini antidijabetiċi oħra f'pazjenti li ma għandhomx il-livelli taz-zokkor fid-demm ikkontrollati kif xieraq bid-dożaġġi tollerati massimi tal-mediċini l-oħra.
English: The CHMP decided that Byetta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Byetta huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of all side effects reported with Byetta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati b'Byetta, ara l-fuljett ta' tagħrif.
English: When adding Byetta to a sulphonylurea or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels).
Maltese: Meta Byetta jingħata ma' sulfonilureas jew mal-insulina bażali, ittabib għandu mnejn jeħtieġ li jnaqqas id-doża tas-sulfonilurea jew tal-insulina bażali għax ikun hemm riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Pegasus Laboratories Ireland Limited 10 McCurtain Hill
Maltese: Pegasus Laboratories Ireland Limited 10
English: Artificial beef flavour Silica, colloidal anhydrous Calcium hydrogen phosphate dihydrate Magnesium stearate
Maltese: Silica, colloidal anhydrous Calcium hydrogen phosphate dihydrate Magnesium stearate
English: Lot {number}
Maltese: Jiskadi {xahar/sena}
English: Do not use the product in conjunction with other serotonergic agents (e.g. sertraline) and monoamine oxidase inhibitors (MAOIs) [e.g., selegiline hydrochloride (L-deprenyl), amitraz] or tricyclic amines (TCAs) (e.g. amitriptyline and clomipramine).
Maltese: M'għandekx tuża Reconcile flimkien ma' mediċini serotonerġiċi oħra (eż. sertraline) u impedituri ta' monoamine oxidase (MAOI) [eż. selegiline hydrochloride (L-deprenyl), amitraz] jew amines triċikliċi (TCAs) (eż. amitriptyline u clomipramine).
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: - Urinary tract disorders (cystitis, urinary incontinence, urinary retention, stranguria); central nervous system signs (incoordination, disorientation) (common).
Maltese: - Disturbi tal-passaġġ tal-awrina (ċistite, inkontinenza awrinarja, żamma tal-awrina, strangurija); sinjali fis-sistema nervuża ċentrali (nuqqas ta' koordinazzjoni, disorjentazzjoni) (komuni).
English: Microcrystalline cellulose Sucrose (as compressible sugar ) Crospovidone
Maltese: Microcrystalline cellulose
English: Norfluoxetine plasma levels slowly appeared in plasma and were slowly eliminated with t½ values ranging from 44.2 to 48.9 hours on day 21.
Maltese: Livelli fil-plażma ta' norfluoxetine u kienu eliminati bil-mod b'valuri t½ li jvarjaw minn 44.2 sa 48.9 siegħa f'jum 21.
English: Tablet strength (mg)
Maltese: Qawwa tal-pillola (mg)
English: Elimination studies in dogs have shown that 29.8% and 44% of the dose were excreted in urine and faeces, respectively by 14 days following dosing.
Maltese: Studji ta' eliminazzjoni fil-klieb urew li 29.8% u 44% tad-doża ġiet eliminata fl-awrina u fl-ippurgar rispettivament sa 14-il jum wara li tkun ingħatat id-doża.
English: Do not use in dogs weighing less than 4 kg.
Maltese: Tużax fuq klieb li jiżnu inqas minn 4 kg.
English: Date of first authorisation: 08.07.2008 Date of last renewal: 13/07/2018
Maltese: Data tal-aħħar tiġdid: 13.7.2018
English: The maximum plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) for fluoxetine were approximately dose proportional between 0.75 and 1.5 mg/kg, with a greater than dose proportional increase at 3 mg/kg.
Maltese: Il-konċentrazzjoni massima fil-plażma (Cmax) u l-erja taħt il kurva ta' konċentrazzjoni fil-plażma mal-ħin (AUC) għal fluoxetine kienu kważi proporzjonali fiddożi ta' 0.75 u 1.5 mg/kg, bi żieda proporzjonali akbar fid-doża ta' 3 mg/kg.
English: Reconcile 64 mg: fluoxetine 64 mg (equivalent to 72.34 mg fluoxetine hydrochloride)
Maltese: Reconcile 64 mg:Fluoxetine 64.mg (ekwivalenti għal 72.34 mg fluoxetine hydrochloride)
English: - Decreased appetite (including anorexia); lethargy (very common).
Maltese: - Tnaqqis fl-aptit (li jinkludi anoreksja); letarġija (komuni ħafna).
English: INDICATION(S) METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Clinical studies have shown that a beneficial response has been demonstrated for up to 8 weeks treatment with fluoxetine.
Maltese: Studji kliniċi wrew rispons benefiċjali meta ngħata trattament bi fluoxetine sa 8 ġimgħat.
English: Fluoxetine is metabolised to norfluoxetine, an equipotent SSRI that contributes to the efficacy of the veterinary medicinal product.
Maltese: Fluoxetine huwa metabolizzat għal norfluoxetine, SSRI ekwipotenti li jikkontribwixxi għall-effikaċja tal-prodott mediċinali veterinarju.
English: Pharmacotherapeutic group: selective serotonin reuptake inhibitors (SSRI) ATCvet code: QNO6ABO3
Maltese: Grupp farmako-terapewtiku: impedituri selettivi tal-assorbiment mill-ġdid ta' serotonin (SSRI).
English: White high density polyethylene (HDPE) bottle with a child resistant closure, cotton colier and a desiccant canister.
Maltese: Flixkun wieħed tal-poli-etilin (HDPE) ta' lewn bajdani b'għatu reżistenti għat-tfal, cotton colier u desiccant canister.
English: Plasma levels readily declined with mean t½ values ranging from 4.6 to 5.7 hours on day 1 and from 5.1 to 10.1 hours on day 21.
Maltese: Il-livelli fil-plażma niżlu malajr b'valuri medji ta' t½ li kienu jvarjaw minn 4.6 sa 5.7 sigħat fl-1 jum u minn 5.1 sa 10.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 8mg, 16 mg, 32 mg and 64 mg
Maltese: Pakkett ta' barra 8mg, 16 mg, 32 mg u 64 mg
English: Fluoxetine is largely metabolised by the P-450 enzyme system, although the precise isoform in dogs is unknown.
Maltese: Fluoxetine huwa prinċipalment metabolizzat bis-sistema ta' enzimi P-450, għalkemm l-iżoform preċiż fil-klieb mhux magħruf.
English: Keep the bottle tightly closed in order to protect from moisture.
Maltese: Barra minn hekk, ġiet osservata mġiba aggressiva.
English: Reconcile 8 mg: fluoxetine 8 mg (equivalent to 9.04 mg fluoxetine hydrochloride) Reconcile 16mg: fluoxetine 16 mg (equivalent to 18.08mg fluoxetine hydrochloride) Reconcile 32 mg: fluoxetine 32 mg (equivalent to 36.16 mg fluoxetine hydrochloride)
Maltese: Reconcile 8 mg: Fluoxetine 8 mg (ekwivalenti għal 9.04 mg fluoxetine hydrochloride) Reconcile 16 mg: Fluoxetine 16 mg (ekwivalenti għal 18.08 mg fluoxetine hydrochloride) Reconcile 32 mg: Fluoxetine 32 mg (ekwivalenti għal 36.16 mg fluoxetine hydrochloride)
English: After administration, fluoxetine readily appeared in plasma with mean Tmax values ranging from 1.25 to 1.75 hours on day 1 and from 2.5 to 2.75 hours on day 21.
Maltese: Wara l-għoti, fluoxetine deher malajr fil-plażma b'valuri ta' Tmax medji li jvarjaw minn 1.25 sa 1.75 sigħat fl-1 jum u minn 2.5 sa 2.75 sigħat fil-21 jum.
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 30 oC.
English: Reconcile should not be given concomitantly with veterinary medicinal products that lower the seizure threshold (e.g. phenothiazines such as acepromazine or chlorpromazine).
Maltese: Il-prodott m'għandux jingħata fl-istess ħin ma' prodotti mediċinali veterinarji li jistgħu jnaqqsu l limitu tal-attakki tal-qamar (eż. phenothiazines bħal acepromazine jew chlorpromazine).
English: Fluoxetine is largely metabolised by the liver.
Maltese: Fluoxetine huwa prinċipalment metabolizzat bil-fwied.
English: 8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride) 16mg fluoxetine (as 18.08mg fluoxetine hydrochloride) 32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride) 64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
Maltese: 8 mg fluoxetine (bħala 9.04 mg fluoxetine hydrochloride) 16 mg fluoxetine (bħala 18.08 mg fluoxetine hydrochloride) 32 mg fluoxetine (bħala 36.16 mg fluoxetine hydrochloride) 64 mg fluoxetine (bħala 72.34 mg fluoxetine hydrochloride)
English: The tablets are packaged in HDPE bottles, each bottle containing 30 tablets with a cotton coiler and desiccant canister.
Maltese: Il-pilloli huma ppakkjati fi fliexken HDPE, kull flixkun ikun fih 30 pillola, b'cotton coiler u desiccant canister.
English: Following the last dose administration, fluoxetine and norfluoxetine plasma levels declined steadily in a log-linear fashion.
Maltese: Wara l-aħħar amministrazzjoni tad-doża, il-livelli tal-plażma ta' fluoxetine u norfluoxetine naqsu b'mod konsistenti b'mod log-lineari.
English: Chewable tablet.
Maltese: Pillola li jintmagħdu.
English: Reconcile 16 mg tablets: 4205
Maltese: Reconcile pilloli ta' 8 mg: 4203 Reconcile pilloli ta' 16 mg: 4205 Reconcile pilloli ta' 32 mg: 4207 Reconcile pilloli ta' 64 mg: 4209
English: Dogs.
Maltese: kg.
English: Reconcile 8 mg tablet Reconcile 16 mg tablet Reconcile 32 mg tablet Reconcile 64 mg tablet
Maltese: Reconcile pillola ta' 8 mg Reconcile pillola ta' 16 mg Reconcile pillola ta' 32 mg Reconcile pillola ta' 64 mg
English: Shelf-life after first opening the container: 30 days.
Maltese: Żmien kemm il-prodott jibqa' tajjeb wara l-ewwel ftuħ tal-kontenitur: 30 jum.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label -8 mg, 16 mg, 32 mg, 64 mg
Maltese: Tikketta tal-flixkun-8mg, 16 mg, 32 mg, 64 mg
English: As a result of inhibiting serotonin uptake, fluoxetine enhances serotonergic neurotransmission and produces functional effects resulting from increased activation of serotonin receptors.
Maltese: Bħala riżultat tal-inibizzjoni tat-teħid ta' serotonin, fluoxetine jintensifika n-newrotrasmissjoni serotonerġika u jipproduċi effetti funzjonali li jirriżultaw mill-attivazzjoni ogħla ta' riċettur ta' serotonin.
English: - Panting, seizures, vomiting (rare).
Maltese: - Lehġa, attakki tal-qamar, rimettar (rari).
English: Treatment should be stopped if seizures occur.
Maltese: It-trattament għandu jitwaqqaf jekk ikun hemm puplesija.
English: In a 21 day study, fluoxetine was administered daily at a dose of 0.75, 1.5 and 3.0 mg/kg body weight to laboratory Beagles.
Maltese: Fi studju li dam sejjer 21 jum, fluoxetine ġie amministrat kuljum f'dożi ta' 0.75, 1.5 u 3.0 mg/kg ta'
English: In humans, the most common symptoms associated with overdosage include seizures, somnolence, nausea, tachycardia, and vomiting.
Maltese: Fil-bniedem, l-aktar sintomi komuni assoċjati ma' doża eċċessiva jinkludu attakki talqamar, ngħas, dardir, takikardja, u remettar.
English: - Weight loss/loss of condition; mydriasis (uncommon).
Maltese: - Telf fil-piż/telf fil-kundizzjoni; midrijasi (mhux komuni).
English: Do not use in case of hypersensitivity to fluoxetine or other Selective Serotonin Re-Uptake Inhibitors (SSRIs) or to any of the excipients.
Maltese: Tużax f'każijiet ta' sensittività eċċessiva għal fluoxetine jew Impedituri Selettivi oħra tal-Assorbiment mill-ġdid ta' Serotonin (Selective Serotonin Re-uptake Inhibitors - SSRI).
English: Norfluoxetine Cmax and AUC were generally dose proportional but these values were 3 to 4 fold higher on day 21 than on day 1.
Maltese: Cmax u AUC ta' norfluoxetine kienu ġeneralment proporzjonali għad-doża imma dawn il-valuri kienu minn 3 sa 4
English: Reconcile 8 mg chewable tablets for dogs Reconcile 16 mg chewable tablets for dogs Reconcile 32 mg chewable tablets for dogs Reconcile 64 mg chewable tablets for dogs fluoxetine
Maltese: Reconcile 8 mg pilloli li jintmagħdu għal klieb Reconcile 16 mg pilloli li jintmagħdu għal klieb Reconcile 32 mg pilloli li jintmagħdu għal klieb Reconcile 64 mg pilloli li jintmagħdu għal klieb fluoxetine
English: Reconcile 8 mg: Fluoxetine 8 mg (equivalent to 9.04 mg fluoxetine hydrochloride) Reconcile 16mg: Fluoxetine 16 mg (equivalent to 18.08mg fluoxetine hydrochloride) Reconcile 32 mg: Fluoxetine 32 mg (equivalent to 36.16 mg fluoxetine hydrochloride) Reconcile 64 mg: Fluoxetine 64 mg (equivalent to 72.34 mg fluoxetine hydrochloride)
Maltese: Reconcile 32 mg: fluoxetine 32 mg (ekwivalenti għal 36.16 mg fluoxetine hydrochloride) Reconcile 64 mg: fluoxetine 64 mg (ekwivalenti għal 72.34 mg fluoxetine hydrochloride)
English: Number of tablets per day
Maltese: Numru ta' pilloli kuljum
English: EXP {month/year} Once opened use within 30 days.
Maltese: Ladarba miftuħ użaw fi żmien 30 jum.
English: In clinical studies these side effects were stopped immediately upon intravenous administration of a standard dose of diazepam.
Maltese: doża standard ta' diazepam.
English: As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours (vocalisation and inappropriate defaecation and/or urination) and only in combination with behavioural modification techniques.
Maltese: Bħala għajnuna fit-trattament ta' disturbi relatati mas-separazzjoni ta' klieb, manifestati b'distruzzjoni u mġiba mhux xierqa (vokalizzazzjoni u ppurgar u/jew għamil ta' awrina fejn mhux suppost).
English: Paglitaz contains lactose monohydrate
Maltese: Paglitaz fih lactose monohydrate
English: Paglitaz contains pioglitazone.
Maltese: Paglitaz fih pioglitazone.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal ġestjoni tar-riskju (RMP)
English: Reporting of side effects
Maltese: Rappurtar tal effetti sekondarji
English: Excipient with known effect: Each tablet contains 176.46 mg of lactose (see section 4.4).
Maltese: Kull pillola fiha 176.46 mg ta' lactose (ara sezzjoni 4.4).
English: EXPIRY DATE
Maltese: DATA TA' SKADRNZA
English: Paglitaz tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: Il-pilloli Paglitaz fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lill-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
English: Environmental Risk Assessment (ERA) : no environmental impact is anticipated from the clinical use of pioglitazone.
Maltese: Rapport ta' Stima tar-Riskju Ambjentali (ERA): l-ebda impatt ambjentali huwa antiċipat mill-użu kliniku ta' pioglitazone.
English: Excipient with known effect: Each tablet contains 264.68 mg of lactose (see section 4.4).
Maltese: Kull pillola fiha 264.68 mg ta' lactose (ara sezzjoni 4.4).
English: Frequencies are defined as: - Very common ( 1/10) - Common ( 1/100 to < 1/10) - Uncommon ( 1/1,000 to < 1/100) - Rare ( 1/10,000 to < 1/1,000) - Very rare (< 1/10,000) - Not known (cannot be estimated from the available data)
Maltese: - Komuni ħafna (≥ 1/10) - Komuni (≥ 1/100 sa < 1/10) - Mhux komuni (≥ 1/1,000 sa < 1/100) - Rari (≥ 1/10,000 sa< 1/1,000);
English: Paglitaz 30 mg tablets
Maltese: Paglitaz 30 mg pilloli
English: Paglitaz 45 mg tablets
Maltese: Paglitaz 45 mg pilloli
English: as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
Maltese: bħala monoterapija - f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) li mhumiex ikkontrollati sew minn dieta u eżerċizzju li għalihom metformin mhux adattat minħabbla kontraindikazzjonijiet jew intolleranza bħala terapija doppja mill-ħalq f'taħlita ma' - metformin, f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) b'kontroll gliċemiku insuffiċjenti minkejja monoterpija b'metformin fl-ogħla doża ttollerata - mediċina tat-tip sulphonylurea, f'pazjenti adulti li wrew intolleranza għal metformin jew li għalihom metformin huwa kontraindikat, b'kontroll gliċemiku insuffiċjenti minkejja monoterpija b'mediċina tat-tip sulphonylurea fl-ogħla doża ttollerata bħala terapija tripla mill-ħalq f'taħlita ma' - metformin u mediċina tat-tip sulphonylurea, f'pazjenti adulti (speċjalment pażjenti b'piż żejjed)
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Maltese: Disturbi fil-metabolizmu u n-nutrizzjoni ipoglicemija mhux komuni komuni ħafna żieda fl-aptit mhux komuni
English: Paglitaz 45 mg tablets Pioglitazone
Maltese: Paglitaz 45 mg pilloli Pioglitazone
English: Paglitaz 15 mg tablets
Maltese: Paglitaz 15 mg pilloli
English: Paglitaz 15 mg tablets Pioglitazone
Maltese: Paglitaz 15 mg pilloli Pioglitazone
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Maltese: komuni (jistgħu jaffettwaw sa persuna 1 f'10) - infezzjoni respiratorja - vista mhux normali - żieda fil-piż - tirżiħ mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100) - infjammazzjoni tas-sinus (sinusite) - diffikultà biex torqod (insomnija)
English: What Paglitaz contains - The active substance is pioglitazone.
Maltese: X'fih Paglitaz - Is-sustanza attiva hija pioglitazone.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċna wara d-data ta' meta tiskadi li tidher fuq il-pakkett wara ‘EXP'.
English: Paglitaz 30 mg tablets Pioglitazone
Maltese: Paglitaz 30 mg pilloli Pioglitazone
English: 14 tablets: EU/1/11/721/001 28 tablets: EU/1/11/721/002 30 tablets: EU/1/11/721/003 56 tablets: EU/1/11/721/004 60 tablets: EU/1/11/721/005 90 tablets: EU/1/11/721/006 98 tablets: EU/1/11/721/007
Maltese: EU/1/11/721/006 98 pillola:
English: 14 tablets: EU/1/11/721/015 28 tablets: EU/1/11/721/016 30 tablets: EU/1/11/721/017 56 tablets: EU/1/11/721/018 60 tablets: EU/1/11/721/019 90 tablets: EU/1/11/721/020 98 tablets: EU/1/11/721/021
Maltese: EU/1/11/721/020 98 pillola:
English: White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Maltese: Pilloli tondi u bojod għal kważi bojod bi truf imċandrin u intaljati bi “15” fuq naħa waħda (dijametru 7.0 mm).
English: Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 45 mg pioglitazone (bħala hydrochloride).
English: Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 15 mg pioglitazone (bħala hydrochloride).
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Maltese: Disturbi fissistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi mhux magħruf mhux magħruf mhux magħruf mhux magħruf mhux magħruf
English: 14 tablets: EU/1/11/721/008 28 tablets: EU/1/11/721/009 30 tablets: EU/1/11/721/010 56 tablets: EU/1/11/721/011 60 tablets: EU/1/11/721/012 90 tablets: EU/1/11/721/013 98 tablets: EU/1/11/721/014
Maltese: EU/1/11/721/013 98 pillola:
English: When Paglitaz is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Maltese: Meta Paglitaz jittieħed flimkien ma' mediċini oħra użati għall-kura tad-dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it-tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal-mediċini tiegħek.
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin administration site conditions oedema very common fatigue uncommon
Maltese: Kura b'pioglitazone intweriet li tnaqqas il-ħruġ ta' glucose mill-fwied u żżid it-tneħħijja periferali ta' glucose f'każ ta' reżistenza għall-insulina.
English: Eye disorders visual disturbance common common uncommon
Maltese: Disturbi gastrointestinali gass mhux komuni
English: Other medicines and Paglitaz
Maltese: Kif taħżen paglitaz
English: What Paglitaz looks like and contents of the pack White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Maltese: Pilloli tondi bojod għal kważi bojod bi truf imċanfrin u li fuqhom hemm intaljat “15” fuq naħa waħda (dijametru ta' 7.0 mm).
English: Date of first authorisation: 21 March 2012 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 21ta' Marzu 2012 Data tal-aħħar tiġdid: JJ xahar SSSS
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Maltese: Disturbi fis-sistema nervuża ipoesteżija uġigħ ta' ras mhux komuni sturdament insonnja mhux komuni mhux komuni mhux komuni
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin visual disturbance common common uncommon macular oedema not known not known not known not known not known
Maltese: Taħlita ma' metformin ma' Sulphonylurea ma' metformin u sulphonylurea ma' insulina sistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi mhux magħruf mhux magħruf mhux magħruf mhux magħruf mhux magħruf
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Sodium Chloride
English: 1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
Maltese: 1supplimentat minn AS04C li fih: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL)
English: EU/1/04/0299/003
Maltese: EU/1/04/0299/001 EU/1/04/0299/002 EU/1/04/0299/003
English: Immune system disorders: Rare: allergy
Maltese: Disturbi fis-sistema immuni: Rari: allerġija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/0299/001 - pack of 1 with separate needle EU/1/04/0299/002 - pack of 1 without needle EU/1/04/0299/003 - pack of 10 without needles
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/0299/001 - pakkett ta' 1 b'labra separata EU/1/04/0299/002 - pakkett ta' 1 mingħajr labra EU/1/04/0299/003 - pakkett ta' 10 mingħajr labar
English: • The active substance in 1 dose (0.5 ml) of Fendrix is: Hepatitis B surface antigen 1, 2, 3
Maltese: • Is-sustanza attiva f'doża waħda (0.5 ml) ta' Fendrix hi: L-antiġenu ta' barra ta' l-epatite B1, 2, 3