FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET: Inflacam 5 mg/ml solution for injection for cattle and pigs
Maltese: FIL-PAKKETT: Inflacam 5 mg/ml soluzzjoni għall-injezzjoni għall-baqar u majjali.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight).
Maltese: Injezzjoni waħda fil-muskolu b'dożaġġ ta' 0.4 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 0,4 ml / 5 kg ta' piż tal-ġisem).
English: Each ml contains: 15 mg of meloxicam, 5 mg of sodium benzoate.
Maltese: U INGREDJENT(I) OĦRA Millilitru fih: 15 mg ta' meloxicam 5 mg ta' sodium benzoate
English: Smooth light yellow suspension
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni orali
English: Manufacturers responsible for the batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway,
Maltese: Manifattur responsabbli għall-ħrug tal-lott Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co.
English: Honey aroma
Maltese: Użu orali
English: Dogs.
Maltese: Żwiemel.
English: Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.
Maltese: Għas-serħan mill-infjammazzjoni u wġigħ f'mard muskolu-skeletriku li jkun kemm akut kif ukoll kroniku fiż-żwiemel jiżnu bejn 500 u 600 kg.
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Maltese: Meloxicam hu Mediċina Mhux Sterojdi Kontra l-Infjammazzjoni (NSAID) tal-klassi oxicam li taġixxi blinibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, kontra ttnixxija u antipiretiċi.
English: Fax.
Maltese: Klieb.
English: 20 sachets
Maltese: 20 qartas.
English: Inflacam 20 mg/ml solution for injection for cattle, pigs and horses
Maltese: VETERINARJU Inflacam 20 mg/ml soluzzjoni għall-injezzjoni għall-baqar, majjali u żwiemel.
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Maltese: Madwar 97% ta' meloxicam jeħel mal-proteini tal-plażma.
English: One ml contains:
Maltese: Millilitru fih:
English: Single intramuscular injection.
Maltese: Mhux applikabbli.
English: Each bottle is packed in a cardboard box with a 1 ml measuring syringe (barrel in polypropylene and plunger/piston in high density polyethylene).
Maltese: Kull flixkun huwa ppakkjat f'kaxxa tal-kartun b'siringa tal-kejl ta 'ml (barmil fil-polypropylene u planġer / piston f'polyethylene ta' densità baxxa).
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Maltese: 2.7 μg/ml wara 7.7 sigħat u 4 sigħat f'baqar żgħar u f'baqar li jkunu qed ireddgħu, rispettivament.
English: Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Maltese: Evita l-użu f'annimali li huma deidratati, ipovolaemiċi jew ipotensivi severament, li jkunu jeħtieġu idratazzjoni mill-ġdid permezz ta' injezzjoni, għax jista' jkun hemm riskju potenzjali ta' tossiċità talkliewi.
English: Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.
Maltese: Kull pillola li tintmagħad fiha jew 1 mg jew 2.5 mg ta' meloxicam, li jikkorrispondu għal doża ta' manteniment ta' kuljum għal kelb li għandu piż tal-ġisem ta' 10kg jew 25 kg rispettivament.
English: Therapeutic classification
Maltese: TAL-PRODOTT MEDIĊINALI
English: Granules in sachet.
Maltese: Soluzzjoni safra ċara.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams).
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdiċi (oxicams).
English: Glycine
Maltese: L-KITBA
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidratat, ipovolemiku jew ipotensiv, għax hemm riskju potenzjali ta' tossiċità renali.
English: Purified water
Maltese: Tessuti mmirati
English: Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ppakkjat għall-bejgħ: 5 snin.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Maltese: Meloxicam hu Mediċina Mhux Sterojdi Kontra l-Infjammazzjoni (NSAID) tal-klassi oxicam li taġixxi blinibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, kontra t-tnixxija, analġesiċi u antipiretiċi.
English: 100 sachets
Maltese: 100 qartas.
English: Special precautions for use in animals:
Maltese: Kodici ATC veterinarja:
English: Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure, have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) bħal nuqqas ta' aptit, rimettar, dijarea, demm moħbi fl-ippurgar, letarġija u insuffiċjenza tal-kliewi ġew irrappurtati xi kultant.
English: Musculo-skeletal disorders: single subcutaneous injection.
Maltese: Majjali Injezzjoni waħda ġol-muskoli.
English: If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm reazzjonijiet mhux mixtieqa, it-trattament għandu jitwaqqaf u għandu jittieħed il-parir ta' veterinarju.
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda jew ġol-vina, b'dożaġġ ta' 0.5 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 2.5 ml / 100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, skont kif ikun xieraq.
English: Ireland
Maltese: France
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Maltese: Wara l-għoti ta' żewġ dożi fil-muskoli ta' 0.4 mg ta' meloxicam/kg, intlaħaq valur Cmax ta' 1.9 μg/ml fi żmien siegħa fil-majjali.
English: Cats.
Maltese: Xejn.
English: Dosage
Maltese: KWANTITÀ
English: Horses: meat and offal: 5 days.
Maltese: Żwiemel: laħam u ġewwieni tal-annimali: 5 ijiem.
English: Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
Maltese: Meloxicam għandu marġni ta' sigurtà terapewtika żgħira fil-qtates, u sinjali kliniċi ta' doża eċċessiva jistgħu jkunu osservati f'livelli ta' doża eċċessiva relattivament żgħar.
English: Label for 10 ml and 20 ml vials
Maltese: Tikketta għal fliexken ta' 10 ml u 20 ml
English: If required, a second administration can be given after 24 hours.
Maltese: Jekk ikun meħtieġ, it-tieni doża tista' tingħata wara 24 siegħa.
English: NO ENTRY
Maltese: PROVVISTA
English: In the case of overdose, symptomatic treatment should be initiated.
Maltese: F'każ ta' doża eċċessiva, għandu jinbeda trattament sintomatiku.
English: Pigs: meat and offal: 5 days.
Maltese: Majjali Laħam u ġewwieni tal-annimali: 5 ijiem
English: Cardboard box containing 1 colourless glass injection vial of 20 ml, 50 ml or 100 ml.
Maltese: Kaxxa tal-kartun b'kunjett wieħed tal-ħġieġ għall-injezzjoni ta' 20 ml, 50 ml jew 100 ml, mingħajr kulur.
English: Isolated cases of adverse reactions typically associated with non-steroidal anti-inflammatory drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Maltese: Każijiet iżolati ta' reazzjonijiet avversi li ġeneralment huma assoċjati ma' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) kienu osservati fi provi kliniċi (urtikarja ħafifa, dijarea).
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Maltese: It-trattament għandu jitkompla darba kuljum bl-għoti orali (f'intervalli ta' 24 siegħa) bid-doża talmanteniment ta' 0.1 mg meloxicam/kg ta' piż tal-ġisem.
English: (see section 4.8)
Maltese: (ara sezzjoni 4.8)
English: Section 4.
Maltese: Sezzjoni 4.
English: Tuberculosis
Maltese: • Tuberkulożi
English: Endocarditis
Maltese: Endokardite
English: Tuberculosis, in combination treatment
Maltese: • Tuberkulożi, fi trattament ikkombinat
English: • Urethritis
Maltese: • Uretrite
English: • Infection in immunocompromised patients
Maltese: • Infezzjoni f'pazjenti immunokompromessi
English: • Complicated intra-abdominal infections.
Maltese: • Infezzjonijiet intraaddominali kkumplikati.
English: • Salmonella infections (carrier)
Maltese: • Infezzjonijiet ikkawżati minn salmonella (carrier)
English: A - Summary of product characteristics (SmPC)
Maltese: A - Sommarju tal-karatteristiċi tal-prodott (SmPC)
English: • Prophylaxis of infectious gastroenteritis (traveller's diarrhoea)
Maltese: • Profilassi ta' gastroenterite infettiva (dijarea tal-vjaġġaturi)
English: Vaginal infections
Maltese: Infezzjonijiet vaġinali
English: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Maltese: Tendinite u tiċrit ta' tendon (speċjalment imma mhux limitati għal Achilles tendon), kultant bilaterali, jistgħu jseħħu sa minn 48 siegħa mill-bidu tat-trattament b'quinolones u fluoroquinolones, u ġew irrappurtati li jseħħu anke sa diversi xhur wara t-twaqqif tattrattament.
English: chronic prostatitis,
Maltese: Test rakkomandat
English: • Acute exacerbation of chronic bronchitis (last line)
Maltese: • Aggravar akut ta' bronkite kronika (l-aħħar linja)
English: • Urosepsis (only applicable for i.v.
Maltese: • Urosepsis (applikabbli biss għal formulazzjoni i.v.)
English: • Tonsillitis Laryngitis Acute bronchitis Prophylaxis of travellers´ diarrhoea
Maltese: • Tonsillite Larinġite Bronkite akuta Profilassi ta' dijarea tal-vjaġġaturi
English: 1.2 Amendment of indications 1.2.1 For all quinolones/fluoroquinolones
Maltese: 1.2. Emenda ta' indikazzjonijiet 1.2.1 Għall-quinolones/fluoroquinolones kollha
English: • Complicated acute cystitis
Maltese: • Ċistite akuta kkumplikata
English: Nosocomial pneumonia
Maltese: Pulmonite nożokomjali
English: Skin and soft tissue infections o Skin and soft tissue infections o Gram negative infection of skin and soft tissue o Skin and soft tissues infections or infections of traumas from microbes such as Ε. coli, K. pneumoniae, Enterobacter, P. mirabilis and P. vulgaris, Providencia, Citrobacter, P. aeruginosa, S. aureus
Maltese: • Infezzjonijiet fil-ġilda u fit-tessut artab o Infezzjonijiet fil-ġilda u fit-tessut artab o Infezzjoni gram-negattiva fil-ġilda u fittessut artab o Infezzjonijiet fil-ġilda u fit-tessut artab jew infezzjonijiet ta' trawmi kkawżati minn mikrobi bħal Ε. coli, K. pneumoniae, Enterobacter, P. mirabilis u P. vulgaris, Providencia, Citrobacter, P. aeruginosa, S. aureus
English: Current category 1 indications in product information of moxifloxacin
Maltese: Indikazzjonijiet attwali ta' kategorija 1 fl-informazzjoni dwar il-prodott ta' moxifloxacin
English: • Infections of bone and joints (osteomyelitis caused by gram-negative microorganisms)
Maltese: • Infezzjonijiet fl-għadam u l-ġogi (osteomijelite kkawżata minn mikroorganiżmi gram-negattivi)
English: • Perioperative prophylaxis in invasive urological surgery
Maltese: • Profilassi perioperattiva f'operazzjoni uroloġika invażiva
English: • Pneumonia o Pneumonia, especially when caused by so-called "problematic" germs such as: E. coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella or Staphylococcus o Pneumonia, above all if it's caused by bacteria such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella or Staphylococcus
Maltese: • Pulmonite o Pulmonite, speċjalment meta kkawżata minn mikrobi hekk imsejħa “problematiċi” bħal: E. coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella jew Staphylococcus o Pulmonite, speċjalment jekk hi kkawżata minn batterja bħal Escherichia coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella jew Staphylococcus
English: • Pulmonary infections o Pulmonary infections (acute exacerbation of chronic bronchitis, exacerbation of cystic fibrosis, nosocomial pneumonia)
Maltese: • Infezzjonijiet pulmonari o Infezzjonijiet pulmonarji (aggravar akut ta' bronkite kronika, aggravar ta' fibrożi ċistika, pulmonite nożokomjali)
English: • Acute sinusitis (last line)
Maltese: • Sinożite akuta (l-aħħar linja)
English: • Acute pyelonephritis • Uncomplicated acute pyelonephritis
Maltese: • Pajlonefrite akuta • Pajlonefrite akuta mhux ikkumplikata
English: 1.1 Deletion of indications 1.1.1 For all quinolones/fluoroquinolones
Maltese: 1.1.1 Għall-quinolones/fluoroquinolones kollha
English: • Acute pyelonephritis and complicated urinary tract infections (see section 4.4)
Maltese: • Pajlonefrite akuta u infezzjonijiet ikkumplikati tal-passaġġ tal-awrina (ara sezzjoni 4.4).
English: 1.2.2 Additional amendments of indications for specific quinolones/fluoroquinolones
Maltese: 1.2.2 Emendi addizzjonali ta' indikazzjonijiet għal quinolones/fluoroquinolones speċifiċi
English: • Pulmonary infections o Pulmonary infections [such as: acute exacerbation of chronic bronchitis, exacerbation of cystic fibrosis, nosocomial pneumonia, pulmonary tuberculosis by resistant mycobacteria, especially in immunocompromised patients (minor anti-tuberculosis medicine)]
Maltese: • Infezzjonijiet pulmonari o Infezzjonijiet pulmonari [bħal: aggravar akut ta' bronkite kronika, aggravar ta' fibrożi ċistika, pulmonite nożokomjali, tuberkulożi pulmonari kkawżata minn mikobatterja reżistenti, speċjalment f'pazjenti b'sistema immuni kompromessa (mediċina minuri kontra t-tuberkulożi)]
English: Section 4.8: undesirable effects
Maltese: 3. Sezzjoni 4.8: Effetti mhux mixtieqa
English: • Malignant external otitis
Maltese: • Otite esterna malinna
English: • Gastroenteritis o bacterial gastroenteritis o Gastroenteritis o Acute bacterial gastroenteritis o bacterial enteritis o Acute bacterial gastroenteritis after stool culture and laboratory confirmation of the susceptibility of the causative organism to NOROCIN
Maltese: • Gastroenterite o gastroenterite kkawżata minn batterja o Gastroenterite o gastroenterite akuta kkawżata minn batterja o enterite kkawżata minn batterja o gastroenterite akuta kkawżata minn batterja wara koltura tal-ippurgar u konferma millaboratorju tas-suxxettibbiltà għal NOROCIN tal-organiżmu li kkawża
English: • Chronic sinusitis
Maltese: • Sinożite kronika
English: • Pulmonary tuberculosis by resistant mycobacteria, especially in immunocompromised patients (minor anti-tuberculosis medicine)
Maltese: • Tuberkulożi pulmonari kkawżata minn mikobatterja reżistenti, speċjalment f'pazjenti b'sistema immuni kompromessa (mediċina minuri kontra t-tuberkulożi)
English: • Simple uncomplicated cystitis.
Maltese: • Ċistite sempliċi mhux ikkumplikata.
English: • Prophylaxis after surgeries or interventions in the urogenital system o prophylaxis after surgeries or interventions in the urogenital system o Prophylaxis of recurrent urinary infections following trans-urethral surgery or trans rectal prostatic biopsy
Maltese: • Profilassi wara operazzjonijiet jew interventi fis-sistema uroġenitali o Profilassi wara operazzjonijiet jew interventi fis-sistema uroġenitali o Profilassi ta' infezzjonijiet urinarji ripetuti wara operazzjoni transuretrali jew bijopsija tal-prostata mir-rektum
English: • Infections of the gastrointestinal tract (e.g. travellers' diarrhoea)
Maltese: • Infezzjonijiet fil-passaġġ gastrointestinali (eż. dijarea talvjaġġaturi)
English: • Cholangitis
Maltese: • Kolanġite
English: External otitis
Maltese: Otite esterna
English: Section 2 Warnings and precautions
Maltese: Sezzjoni 2 Twissijiet u prekawzjonijiet
English: Infection of cerebrospinal fluid
Maltese: Infezzjoni tal-fluwidu ċerebrospinali
English: Medically incorrect indications
Maltese: Indikazzjonijiet medikament żbaljati
English: • Acute bacterial prostatitis
Maltese: • Infjammazzjoni akuta tal-prostata
English: Section 4.1: therapeutic indications
Maltese: Sezzjoni 4.1- indikazzjonijiet terapewtiċi
English: • Complicated intra-abdmonial infections o intra-abdominal infection o intra-abdominal and bile-ducts infections o Infections of abdominal cavity, including pelvic area o Abdominal cavity infections including of the pelvic bone o Infections of the abdomen and the lesser pelvis
Maltese: • Infezzjonijiet intraaddominali kkumplikati o infezzjonijiet intra-addominali u fil-kanali tal-bili o Infezzjonijiet fil-kavità addominali, inkluża l-parti pelvika o Infezzjonijiet fil-kavità addominali inkluż fl-għadma pelvika o Infezzjonijiet fl-addome u l-parti t'isfel talpelvi
English: • Acute sinusitis
Maltese: • Sinożite akuta
English: • Long term prophylaxis of recurrent urinary infections
Maltese: • Profilassi fit-tul ta' infezzjonijiet urinarji ripetuti
English: • Exacerbations of broncho-pulmonary infections in cystic fibrosis
Maltese: • Aggravar ta' infezzjonijiet bronkopulmonari f'fibrożi ċistika
English: • Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
Maltese: • Infezzjonijiet bronkopulmonari f'fibrożi ċistika kkawżati minn Pseudomonas aeruginosa
English: • Pharyngitis
Maltese: • Gonorrea
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including [product name], if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Maltese: M'għandekx tieħu mediċini antibatteriċi li fihom fluoroquinolone/quinolone, inkluż [isem ilprodott], jekk inti esperjenzajt kwalunkwe reazzjoni avversa serja fil-passat meta ħadt quinolone jew fluoroquinolone.
English: • Bronchial suppurations, in the absence of any parenchymal lesion: In subjects at risk (chronic alcoholism, smoking, subjects over 65 years)
Maltese: F'individwi f'riskju (alkoħoliżmu kroniku, tipjip, individwi 'l fuq minn 65 sena)
English: • Urinary tract infections o Urinary tract infections o Complicated and uncomplicated upper and lower urinary tract infections: cystitis, pyelitis, cystopyelitis o Upper and lower urinary tract infections, including cystitis, pyelitis and cystopyelitis caused by norfloxacin susceptible bacteria o Complicated and uncomplicated urinary tract infections o Acute urinary tract infections in men o Other lower urinary tract infections, including prostatic infections, and upper urinary tract infections with susceptible bacteria, in adults (i.e. other than uncomplicated acute cystitis) o Acute (except acute pyelonephritis) and chronic (except chronic complicated pyelonephritis) infections of urinary tract caused by sensitive microorganisms o Acute and chronic urinary tract infections, uncomplicated (cystitis, pyelitis) and complicated, excluding complicated pyelonephritis, acute or chronic o Acute infection of lower urinary tract infections in men o Acute lower urinary tract infection in men
Maltese: • Infezzjonijiet fl-apparat urinarju o Infezzjonijiet fl-apparat urinarju o Infezzjonijiet ikkumplikati u mhux ikkumplikati fil-passaġġ tal-awrina ta' fuq u t'isfel: cistite, pjelite, ċistopjelite o Infezzjonijiet fil-passaġġ tal-awrina ta' fuq u t'isfel, inkluż ċistite, pjelite u ċistopjelite kkawżati minn batterja suxxettibbli għal norfloxacin o Infezzjonijiet ikkumplikati u mhux ikkumplikati fil-passaġġ tal-awrina o Infezzjonijiet akuti fil-passaġġ tal-awrina flirġiel o Infezzjonijiet oħra fil-passaġġ tal-awrina t'isfel, inklużi infezzjonijiet tal-prostata, u infezzjonijiet fil-passaġġ tal-awrina ta' fuq ikkawżati minn batterja suxxettibbli, fl-adulti (jiġifieri minbarra ċistite akuta mhux ikkumplikata) o Infezzjonijiet akuti (minbarra pajlonefrite akuta) u kroniċi (minbarra pajlonefrite kkumplikata kronika) tal-passaġġ tal-awrina kkawżati minn mikroorganiżmi sensittivi o Infezzjonijiet akuti u kroniċi fil-passaġġ talawrina, mhux ikkumplikati (ċistite, pjelite) u kkumplikati, minbarra pajlonefrite kkumplikata, akuta jew kronika o Infezzjoni akuta fil-passaġġ tal-awrina t'isfel fl-irġiel o Infezzjoni akuta fil-passaġġ tal-awrina t'isfel fl-irġiel
English: The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Maltese: L-użu ta' [INN] għandu jiġi evitat f'pazjenti li esperjenzaw reazzjonijiet avversi serji filpassat meta użaw prodotti li fihom quinolone jew fluoroquinolone (ara sezzjoni 4.8).
English: • Prevention of traveller's diarrhoea Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone Septicaemia Selective decontamination of gastrointestinal tract in patients with compromised immune system Prevention of exacerbations in women with recurring urinary tract infections
Maltese: • Prevenzjoni ta' dijarea tal-vjaġġaturi Preparazzjonijiet ta' qabel l-operazzjoni għal otite kolesteatomatika kronika u otite kronika li tinxtered għall-għadam Settiċemija Dekontaminazzjoni selettiva tal-passaġġ gastrointestinali f'pazjenti b'sistema immuni kompromessa Prevenzjoni ta' aggravar f'nisa b'infezzjonijiet ripetuti fil-passaġġ tal-awrina
English: *Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see Section 4.4).
Maltese: *Każijiet rari ħafna ta' reazzjonijiet għall-mediċina serji, fit-tul (li jkomplu sa xhur jew snin), li jwasslu għal invalidità u li huma potenzjalment irriversibbli, li jaffettwaw diversi klassijiet tas-sistemi u tal-organi u sensi, kultant multipli (inklużi reazzjonijiet bħal tendinite, tiċrit ta' tendon, artralġja, uġigħ fl-estremitajiet, disturb fil-mixja, newropatiji assoċjati ma' parastesija, depressjoni, għeja, indeboliment fil-memorja, disturbi fl-irqad, u indeboliment fis-smigħ, fil-vista, fit-togħma u x-xamm) ġew irrappurtati f'assoċjazzjoni malużu ta' quinolones u fluoroquinolones f'xi każijiet irrispettivament minn fatturi ta' riskju li jeżistu minn qabel (ara Sezzjoni 4.4).
English: • Bone and joint infections (gram negative osteomyelitis)
Maltese: (osteomijelite gram-negattiva)
English: Prulifloxacin Current indications included in product information for prulifloxacin containing products
Maltese: Prulifloxacin Indikazzjonijiet attwali inklużi flinformazzjoni dwar il-prodott ta' prodotti li fihom prulifloxacin
English: • Prophylaxis of frequently repeating infections of urinary tract infections
Maltese: • Profilassi ta' infezzjoni urinarja ripetuta u frekwenti
English: Prevention of infection in surgical procedures
Maltese: Prevenzjoni ta' infezzjoni fi proċeduri kirurġiċi
English: Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis.
Maltese: Aggravar akut ta' marda kronika ostruttiva tal-pulmun inkluża bronkite kronika.
English: Ofloxacin Current indications in product information of ofloxacin containing products
Maltese: Ofloxacin Indikazzjonijiet attwali fl-informazzjoni dwar ilprodott ta' prodotti li fihom ofloxacin