FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism by which posaconazole exerts fungicidal action involves the selective inhibition of the enzyme lanosterol 14-demethylase (CYP51) involved in ergosterol biosynthesis in yeasts and filamentous fungi.
Maltese: Il-mekkaniżmu li bih posakonażol jeżerċita l-azzjoni fungiċida jinvolvi l-inibizzjoni selettiva tal-enżima lanosterol 14demethylase (CYP51) involuta fil-bijosintesi ta' ergosterol fil-fungi u fil-fungi filamentużi.
English: One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole.
Maltese: Qatra waħda fiha 267 μg ta' orbifloxacin, 27 μg ta' mometasone furoate u 27 μg ta' posakonażol.
English: Minimum Inhibitory Concentrations vs. Orbifloxacin - Summary Pathogen
Maltese: Orbifloxacin - Summarju Patoġenu
English: 17.5 mL and 35.1 mL: 28 days
Maltese: 17.5 mL u 35.1 mL : 28 ġurnata.
English: PACKAGE SIZE 8.8 mL
Maltese: Flixkun 8.8 mL
English: Systemic absorption of the active ingredients was determined in single-dose studies with [14C]orbifloxacin, [3H]-mometasone furoate and [14C]-posaconazole contained within the Posatex formulation and placed into the ear canals of normal Beagle dogs.
Maltese: L-assorbiment sistemiku tal-ingredjenti attivi kien stabbilit fi studji dwar dożi waħidhom b'[14C]-orbifloxacin, [3H]-mometasone furoate u [14C]-posakonażol li kienu ġol-formulazzjoni ta' Posatex u li tqiegħdu fil-kanali tal-widnejn ta' klieb Beagle normali.
English: The bactericidal action of orbifloxacin results from interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV which are needed for the synthesis and maintenance of bacterial DNA.
Maltese: L-azzjoni batteriċida ta' orbifloxacin tirriżulta mill-interferenza tal-enżimi DNA topoisomerejs II (DNA-ġajrejs) u DNA topoisomerejs IV li huma meħtieġa għas-sintesi u l-manteniment tad-DNA tal-batterja.
English: Posaconazole is a broad-spectrum triazole antifungal agent.
Maltese: Posakonażol hija sustanza bi spectrum antifungali wiesgħa tal-klassi triazole..
English: Orbifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative organisms.
Maltese: Orbifloxacin għandu attività in vitro kontra firxa wiesgħa ta' organiżmi Gram-pożittivi u Gramnegattivi.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: 8.8 mL: 7 days
Maltese: 2 snin Żmien li l-prodott jibqa' tajjeb wara li jkun infetaħ l-ippakjar immedjat: 8.8 mL : 7 ijiem
English: Pharmacotherapeutic group: Otologic - Corticosteroids and anti-infectives in combination.
Maltese: Otoloġiċi - Kortikosterojdi u anti-infettiv flimkien Kodici ATC veterinarja:
English: Orbifloxacin is a synthetic broad-spectrum bactericidal agent classified as a quinolone carboxylic acid derivative, or more specifically, a fluoroquinolone.
Maltese: Orbifloxacin hu sustanza batteriċida sintetika bi spektrum wiesgħa li hi kklassifikata bħala kwinolon, derivattiv tal-aċidu karbossiliku, jew iktar speċifikament, fluorokwinolon.
English: The in vitro activity of orbifloxacin against pathogens isolated from clinical cases of canine otitis externa in an EU field trial conducted in 2000 - 2001 was:
Maltese: L-attività in vitro ta' orbifloxacin kontra patoġeni iżolati minn każijiet kliniċi ta' otite esterna fil-klieb fi provi ta' l-UE li saru fil-beraħ fl-2000-2001 kienet:
English: Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of treatment will result in a complete return to normal adrenal response.
Maltese: L-għoti tad-doża rakkomandata (4 qatriet f'kull widna) 5 darbiet kuljum għal 21 jum konsekuttiv lil klieb li jiżnu 7.6 sa 11.4 kg, ikkawża tnaqqis żgħir fir-rispons tal-kortisol tas-serum wara l-għoti ta' lormon adrenokortikotropiku (ACTH) f'test tal-istimulazzjoni ACTH.
English: In in vitro tests, posaconazole has shown fungicidal activity against most of the approximately 7,000 strains of yeast and filamentous fungi tested.
Maltese: F'testijiet in vitro, posakonażol wera attività fungiċidali kontra l-biċċa l-kbira tal-madwar 7,000 razza ta' fungi u fungi filamentużi li ġew ittestjati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 8.8 mL
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa 8.8 mL
English: Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Maltese: Kura ta' otite esterna akuta u aggravamenti akuti ta' otite esterna repetittivi, assoċjati ma' batterji suxxettibbli għal orbifloxacin u fungi suxxettibbli għal posakonazol, b'mod partikulari Malassezia pachydermatis.
English: Dogs weighing 2 - 15 kg, apply 4 drops to the ear once a day.
Maltese: Għal klieb li jiżnu 2-15 kg: applika 4 qatriet ġol-widna darba kuljum.
English: Quinolone class veterinary medicinal products have been associated with cartilage erosions in weightbearing joints and other forms of arthropathy in immature animals of various species.
Maltese: Il-prodotti mediċinali veterinarji tal-klassi ta' kwinolon kienu assoċjati ma' tgħawwir fil-qarquċa ta' ġogi li jerfgħu l-piż u forom oħrajn ta' artropatija f'annimali immaturi ta' diversi speċi.
English: Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Maltese: Għal klieb li jiżnu 15 kg jew iżjed: applika 8 qatriet ġol-widna darba kuljum.
English: Cross-resistance across the fluoroquinolone class of antibiotics is common.
Maltese: Reżistenza inkroċjata fil-klassi ta' antibijotiċi florokwinolon hi komuni.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Maltese: Il-grad ta' assorbiment minn ġol-ġilda ta' mediċini topiċi hu stabbilit minn ħafna fatturi li jinkludu l-integrità tal-barriera epidermali.
English: White HDPE bottle with a white LDPE cap, a natural or white LDPE applicator and a sheath.
Maltese: Flixkun tal-HDPE abjad b'għatu abjad tal-LDPE, applikatur ta' lewn naturali jew abjad LDPE u għant.
English: Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
Maltese: Tużax f'każ ta' sensittività eċċessiva għal xi waħda mis-sustanzi tal-prodott mediċinali veterinarju, għall-kortikosterojdi, għal sustanzi antifungali azole oħrajn jew għal florokwinolons oħra.
English: Paraffin liquid
Maltese: Likwidu tal-paraffin
English: Dogs weighing less than 2 kg, apply 2 drops to the ear once a day.
Maltese: Għal klieb li jiżnu inqas minn 2 kg: applika 2 qatriet ġol-widna darba kuljum.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing.
Maltese: L-użu fit-tul u intensiv ta' preparazzjoni ta' kortikosterojdi topiċi hi magħrufa li tikkawża effetti lokali u sistemiċi, li jinkludu t-trażżin tal-funzjoni adrenali, traqqiq tal-ġilda u dewmien fil-fejqan tal-feriti.
English: PHARMACEUTICAL FORM Ear drops suspension White to off-white viscous suspension
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni ta' qtar tal-widnejn
English: Inflammation can increase the percutaneous absorption of veterinary medicinal products.
Maltese: L-infjammazzjoni tista' żżid l-assorbiment minn ġol-ġilda ta' prodotti mediċinali veterinarji.
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Maltese: Qabel ma l-prodott mediċinali veterinarju jiġi applikat, il-kanal estern tas-smigħ irid jiġi eżaminat bir-reqqa biex ikun żgurat li t-tanbur tal-widna ma jkunx imtaqqab, sabiex ikun evitat ir-riskju tattrasmissjoni tal-infezzjoni lill-parti tan-nofs tal-widnejn u biex tiġi evitata ħsara lill-apparat tal-koklea u dak vestibulari.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 17.5 mL
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 17.5 mL
English: Manufacturer for the batch release:
Maltese: Sustanzi mhux attivi:
English: Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin.
Maltese: Studji fil-laboratorju fuq il-ġriewi urew evidenza ta' arthropaty wara amministrazzjoni sistemika ta' orbifloxacin. Fluoroquinolones huma magħrufa li jaqsmu il-plaċenta u jinfirxu fil-ħalib.
English: Do not use in case of hypersensitivity to the active substances, to any of the ingredients, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
Maltese: Tużax f'każ ta' sensittività eċċessiva għas-sustanzi attivi għal xi waħda mis-sustanzi, għallkortikosterojdi, għal sustanzi antifungali azole oħrajn jew għal florokwinolons oħrajn.
English: PACKAGE SIZE 17.5 mL
Maltese: Flixkun 17.5 mL u 35.1 mL
English: Mild erythematous lesions have been observed.
Maltese: Evita kuntatt mal-ġilda.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/002
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/081/002
English: Disposal: read the package leaflet
Maltese: KONDIZZJONIJIET U RESTRIZZJONIJIET OĦRA TALAWTORIZZAZZJONI
English: In case of accidental exposure, rinse the affected area with copious quantities of water.
Maltese: Otite batterjali u fungali ta' spiss tkun sekondarja fin-natura.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/001
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/081/001
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex ear drops suspension for dogs
Maltese: Aħsel idejk sewwa wara li tuża il-prodott mediċinali veterinarju.
English: The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs.
Maltese: L-użu ta' preparazzjonijiet awrikolari jista' jkun assoċjat ma' indeboliment fis-smigħ, li normalment ikun temporanju, u li jseħħ primarjament fi klieb xjuħ.
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodu ta' Tiżmim Mhux applikabbli
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex ear drops for dogs
Maltese: L-użu tal-prodott mediċinali veterinarju mhuxrakkomandat waqt it-treddigħ.
English: Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: Decrease of the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the molecule's binding site.
Maltese: Ittnaqqis fil-permeabilità tal-ħajt tal-batterja, l-espressjoni tal-pompa ta' effluss, jew il-mutazzjoni ta' enżimi li huma responsabbli għas-sit tat-twaħħil tal-molekula.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 17.5 mL and 35.1 mL
Maltese: Kaxxa 17.5 mL u 35.1 mL.
English: PACKAGE LEAFLET FOR: Posatex ear drops suspension dogs
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: METHOD AND ROUTE OF ADMINISTRATION For auricular use only.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għal użu fil-widnejn biss.
English: 5% Gel
Maltese: 5% Ġel
English: Via Gadames 57 20151 Milano Italy
Maltese: Via Gadames 57 20151 Milano Italja
English: J. Lea 208
Maltese: Lea 208
English: 30-133 Kraków Poland
Maltese: 30-133 Kraków Polonja
English: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul.
Maltese: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J.
English: Pojezierska 99 91-342 Łódź Poland
Maltese: Pojezierska 99 91-342 Łódź Polonja
English: Emilii Plater 53 00-113 Warszawa Poland
Maltese: Emilii Plater 53 00-113 Warszawa Polonja
English: 64250 Cambo les Bains France
Maltese: 64250 Cambo les Bains Franza
English: 145 64, Kifisia Greece
Maltese: 145 64, Kifisia Greċja
English: PSC 170 00 Holesovice Czech Republic
Maltese: PSC 170 00 Holesovice Republika Ċeka
English: UCB Magyarország Kft. Árpád fejedelem útja 26-28 1023 Budapest Hungary
Maltese: Árpád fejedelem útja 26-28 1023 Budapest Ungerija
English: Ag. Dimitriou 63 17456, Alimos, Athens Greece
Maltese: Dimitriou 63 17456, Alimos, Athens Greċja
English: Nat. Road Athens-Lamia 14564, K. Kifisia Greece
Maltese: Nat. Road Athens-Lamia 14564, K. Kifisia Greċja
English: UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany
Maltese: UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Ġermanja
English: Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom
Maltese: Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB Renju Unit
English: United Kingdom UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE
Maltese: UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE Renju Unit
English: Luxembourg UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
Maltese: Luxemburgu UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
English: Czech Republic
Maltese: Republika Slovakka
English: 1,6 mg/g Syrup
Maltese: 1,6 mg/g Mistura
English: UCB Pharma B.V. Lage Mosten 33
Maltese: UCB Pharma B.V. Lage Mosten 33 4822 NK BREDA Olanda
English: Hydroxyzinum VP 10 mg
Maltese: Hydroxyzinum VP
English: 02600 ESPOO Finland
Maltese: ESPOO Finlandja
English: Syrup
Maltese: Svezja
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, l-applikanti, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Slovak Republic UCB s.r.o Thámova 13
Maltese: UCB s.r.o
English: 84 (3 x 28 capsules) (multipack)
Maltese: 84 (3 x 28 kapsula) (pakkett b'ħafna)
English: Route of administration
Maltese: 7 kapsuli
English: Hepatic impairment.
Maltese: Indeboliment epatiku.
English: Severe renal impairment.
Maltese: Indeboliment sever renali.
English: Alcoholism, drug addiction.
Maltese: Alkoħoliżmu, dipendenza fuq id-drogi.
English: TRADEMARK is a non-steroidal anti-inflammatory drug (“NSAID”), with pain-killing and feverlowering properties.
Maltese: TRADEMARK hu mediċina mhux sterojdi kontra l-infjammazzjoni (“NSAID”), li fiha proprjetajiet li jtaffu l-uġigħ u li jbaxxu d-deni.
English: However, Nimesulide 100mg Tablets/granules is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Maltese: Madankollu, Nimesulide 100 mg Pilloli/granijiet mhuwiex sostitut għal acetylsalicylic acid għal profilassi kardjovaskulari.
English: Severe coagulation disorders.
Maltese: Disturbi severi tal-koagulazzjoni.
English: History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Maltese: Storja medika ta' reazzjonijiet ta' sensittività eċċessiva (eż. bronkospażmu, rinite, urtikarja) b'risposta għal acetylsalicylic acid jew mediċini oħrajn mhux sterojdi kontra l-infjammazzjoni.
English: Symptomatic treatment of painful osteoarthritis (see section 4.2).
Maltese: Kura sintomatika ta' osteoartrite bl-uġigħ (ara sezzjoni 4.2).
English: Treatment of acute pain (see section 4.2).
Maltese: Kura ta' uġigħ akut (ara sezzjoni 4.2).
English: Impaired renal function: on the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min), while Nimesulide 100mg Tablets/granules is contraindicated in case of severe renal impairment (creatinine clearance < 30ml/min) (see sections 4.3 and 5.2).
Maltese: Indeboliment fil-funzjoni renali: fuq il-bażi farmakokinetika, l-ebda aġġustament fid-dożaġġ mhu meħtieġ f'pazjenti b'indeboliment renali minn ħafif sa moderat (tneħħija tal-krejatinina ta' 30-80 ml/min), filwaqt li Nimesulide 100 mg Pilloli/granijiet hu kontra-indikat f'każ ta' indeboliment sever renali (tneħħija tal-krejatinina ta' < 30 ml/min) (ara sezzjonijiet 4.3 u 5.2).
English: Do not give TRADEMARK to a child aged less than 12.
Maltese: Tagħtix TRADEMARK lil tifel/tifla ta' inqas minn 12-il sena.
English: - are hypersensitive (allergic) to nimesulide or any of the other ingredients of TRADEMARK; - have had allergic reactions (e.g. wheezing, runny or blocked nose, hives or nettle rash) after aspirin or other non-steroidal anti-inflammatory drugs; - had a reaction to nimesulide affecting the liver in the past; - are taking other medicines that are known to affect the liver, e.g. paracetamol or any other pain killers or NSAID treatment - are taking drugs of addiction, or have developed a habit that makes you dependent on drugs or other substances - are a regular heavy drinker (alcohol), - if you have liver disease or increased liver enzymes - have a peptic ulcer (stomach or duodenal ulcer) now or had one in the past; - have had bleeding from the stomach or bowel; - have had bleeding into the brain (a stroke); - have any other problem with bleeding or any problems due to your blood not clotting; - have heart failure or a kidney disorder (poor kidney function) or any liver disorder; - are suffering from fever or flu (feeling generally achy, unwell, chills or shivering or have a temperature); - are in the last 3 months of pregnancy; - are breastfeeding.
Maltese: TRADEMARK; - kellek reazzjonijiet allerġiċi (eż. tħarħir, imnieħer inixxi jew imblukkat, urtikarja jew raxx bħal dak ikkawżat mill-ħurrieq) wara li ħadt l-aspirina jew mediċini oħrajn kontra l-infjammazzjoni li mhumiex sterojdi; - kellek reazzjoni għal nimesulide fil-passat li affettwat il-fwied; - qed tieħu mediċini oħrajn li hu magħruf li jaffettwaw il-fwied, eż. paracetamol jew kwalunkwe mediċini oħrajn kontra l-uġigħ jew kura bl-NSAIDs - qed tieħu drogi li jikkawżaw dipendenza, jew żviluppajt drawwa li ġġiegħlek tkun dipendenti fuq id-drogi jew sustanzi oħrajn - tixrob ħafna (alkoħol) b'mod regolari, - jekk għandek mard tal-fwied jew żieda fl-enzimi tal-fwied - għandek ulċera peptika (ulċera tal-istonku jew duwodenali) issa, jew kellek waħda fil-passat; - kellek ħruġ ta' demm mill-istonku jew l-imsaren; - kellek ħruġ ta' demm fil-moħħ (puplesija); - għandek kwalunkwe problema oħra ta' ħruġ ta' demm jew kwalunkwe problemi minħabba li d demm tiegħek mhux jagħqad.
English: Hepatic impairment: the use of Nimesulide 100mg Tablets/granules is contraindicated in patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment epatiku: l-użu ta' Nimesulide 100 mg Pilloli/granijiet hu kontra-indikat f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: The decision to prescribe nimesulide should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Maltese: Id-deċiżjoni li tingħata riċetta għal nimesulide għandha tkun ibbażata fuq evalwazzjoni tar-riskji totali tal-pazjent individwali (ara sezzjonijiet 4.3 u 4.4).
English: Take special care with TRADEMARK
Maltese: QABEL MA' TIEĦU TRADEMARK
English: Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including gastrointestinal haemorrhage and perforation, impaired renal, cardiac and hepatic function.
Maltese: Il-pazjenti anzjani huma partikularment suxxettibbli għall-effetti avversi ta' NSAIDs, li jinkludu emorraġija u perforazzjoni gastrointestinali, indeboliment tal-funzjoni renali, kardijaka u epatika.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS)
Maltese: TA' PRODOTTI MEDIĊINALI LI FIHOM NIMESULIDE (FORMULAZZJONIJIET SISTEMIĊI)
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS)
Maltese: TAS-SOMMARJU TAL-KARATTERISTIĊI TA' PRODOTTI MEDIĊINALI LI FIHOM NIMESULIDE (FORMULAZZJONIJIET SISTEMIĊI)
English: Children (< 12 years): Nimesulide 100mg Tablets/granules is contraindicated in these patients (see also section 4.3).
Maltese: Tfal (< 12-il sena): Nimesulide 100 mg Pilloli/granijiet hu kontra-indikat f'dawn il-pazjenti (ara wkoll sezzjoni 4.3).
English: Nimesulide should be used with caution in patients with gastrointestinal disorders, including history of peptic ulceration, history of gastrointestinal haemorrhage, ulcerative colitis or Crohn's disease.
Maltese: Nimesulide għandu jintuża bl-attenzjoni f'pazjenti b'disturbi gastro-intestinali, li jinkludu storja medika ta' ulċera peptika, storja medika ta' emorraġija gastrointestinali, kolite ulċerattiva jew tal-marda ta' Crohn.
English: The third trimester of pregnancy and breastfeeding (see sections 4.6 and 5.3).
Maltese: It-tielet trimestru tat-tqala u t-treddigħ (ara wkoll sezzjonijiet 4.6 u 5.3).
English: The risk of undesirable effects may be reduced by using Nimesulide 100mg Tablets/granules for the shortest possible duration (see section 4.2)
Maltese: Ir-riskju tal-effetti mhux mixtieqa jista' jitnaqqas bl-użu ta' Nimesulide 100 mg Pilloli/granijiet għallinqas tul ta' żmien possibbli (ara sezzjoni 4.2)
English: BEFORE YOU TAKE TRADEMARK Do not use TRADEMARK if you:
Maltese: Tużax TRADEMARK jekk:
English: Adolescents (from 12 to 18 years): on the basis of the kinetic profile in adults and on the pharmacodynamic characteristics of nimesulide, no dosage adjustment in these patients is necessary.
Maltese: Adolexxenti (minn 12 sa 18-il sena): fuq il-bażi tal-profil kinetiku fl-adulti u fuq il-karatteristiċi farmakodinamiċi ta' nimesulide, l-ebda aġġustament fid-dożaġġ f'dawn il-pazjenti mhu meħtieġ.
English: Patients who experience symptoms compatible with hepatic injury during treatment with Nimesulide 100mg Tablets/granules (e.g. anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or patients who develop abnormal liver function tests should have treatment discontinued.
Maltese: Pazjenti li jkollhom sintomi li huma kompatibbli ma' ħsara epatika matul il-kura b'Nimesulide 100 mg Pilloli/granijiet (eż. anoreksja, nawseja, rimettar, uġigħ ta' żaqq, għeja kbira, awrina skura) jew pazjenti li jiżviluppaw testijiet talfunzjoni tal-fwied b'riżultat anormali, għandhom iwaqqfu l-kura.
English: Nimesulide 100mg Tablets/granules should be used for the shortest possible duration, as required by the clinical situation.
Maltese: Nimesulide 100 mg Pilloli/granijiet għandhom jintużaw għall-inqas tul ta' żmien possibbli, kif meħtieġ mis-sitwazzjoni klinika.
English: Rarely Nimesulide 100mg Tablets/granules has been reported to be associated with serious hepatic reactions, including very rare fatal cases (see also section 4.8).
Maltese: B'mod rari, Nimesulide 100 mg Pilloli/granijiet kienu rrappurtati li kienu assoċjati ma' reazzjonijiet epatiċi serji, li jinkludu każijiet fatali rari ħafna (ara wkoll sezzjoni 4.8).
English: The usual dose is 1 <unit> of 100 mg twice a day after a meal.
Maltese: Id-doża tas-soltu hi 1 <unità> ta' 100 mg darbtejn kuljum wara l-ikel.