FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Maltese: Minħabba nuqqas ta' esperjenza rilevanti, il-kura b'roflumilast m'għandhiex tinbeda, jew kura eżistenti b'roflumilast għandha titwaqqaf f'pazjenti b'mard immunoloġiku sever (eż. infezzjoni bl-HIV, sklerosi multipla, lupus erythematosus, lewkoenċefalopatija multifokali progressiva), mard sever akut u infettiv, kanċers (ħlief karċinoma taċ-ċelluli bażali), jew pazjenti li jkunu qed jiġu kkurati bi prodotti mediċinali immunosoppressivi (i.e. methotrexate, azathioprine, infliximab, etanercept, jew kortikosterojdi orali li għandhom jittieħdu għal żmien twil; ħlief kortikosterojdi sistemiċi għal żmien qasir).
English: Caution is necessary in Child-Pugh A patients (see section 4.2).
Maltese: Il-kawtela hi meħtieġa f'pazjenti li qegħdin f'Child-Pugh A (ara sezzjoni 4.2).
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95%CI: 7.5% to 33.1%).
Maltese: Fis-sotto-grupp ta' pazjenti bi storja medika ta' aggravamenti frekwenti, (mill-inqas 2 aggravamenti matul l-aħħar sena), ir-rata ta' aggravamenti kienet ta' 1.526 b'roflumilast u 1.941 bi plaċebo li tikkorrispondi għal tnaqqis fir-riskju relattiv ta' 21.3% (95%CI:
English: More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95%CI: 1.19 to 1.65).
Maltese: Aktar pazjenti fil-grupp ta' roflumilast (27.6%) milli fil-grupp tal-plaċebo (19.8%) irtiraw waqt l-istudju tal-mediċina minħabba kwalsijasi raġuni (rata ta' proporzjon: 1.40; 95%CI:
English: The rate of severe exacerbations was reduced in the overall patient group (rate ratio: 0.76; 95% CI: 0.60 to 0.95) with a rate of 0.24 per patient/year compared to a rate of 0.32 per patient/year in patients treated with placebo.
Maltese: Ir-rata ta' aggravar sever tnaqqas fil-grupp ta' pazjenti globali (rata ta' proporzjon: 0.76; 95% CI: 0.60 sa 0.95) b'rata ta' 0.24 kull pazjent/sena meta mqabbel ma' rata ta' 0.
English: The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Maltese: Il-farmakokinetika ta' roflumilast 250 mikrogramma mogħti darba kuljum kienet ittestjata f'16-il pazjent li kellhom indeboliment tal-fwied minn ħafif sa moderat, ikklassifikati bħala Child-Pugh A u B.
English: Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in study M2-127 or tiotropium in study M2-128.
Maltese: Il-kura b'roflumilast jew bi plaċebo żdiedet ma' kura kontinwa bi bronkodilatur li jaġixxi għal żmien twil, b'mod partikulari salmeterol fi studju M2-127 jew tiotropium fi studju M2-128.
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets
Maltese: 10 pilloli miksija b'rita 30 pillola miksija b'rita 90 pillola miksija b'rita
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkat fis-sezzjoni 6.1.
English: Following intravenous or oral administration of radiolabeled roflumilast, about 20% of the radioactivity was recovered in the faeces and 70% in urine as inactive metabolites.
Maltese: Wara l-għoti ġo vina jew l-għoti orali ta' roflumilast radjutikkettat, madwar 20% tar-radjuattività kienet irkuprata fl-ippurgar u 70% fl-awrina bħala metaboliti inattivi.
English: Uncommon side effects (may affect up to 1 in 100 people) - trembling, sensation of spinning head (vertigo), dizziness - sensation of rapid or irregular heartbeat (palpitations) - gastritis, vomiting - reflux of stomach acid to the gullet (acid regurgitations), indigestion - rash - muscle pain, muscle weakness or cramps - back pain - feeling of weakness or tiredness, feeling unwell.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100) - rogħda, tħoss rasek iddur bik (mejt), sturdament - tħoss taħbit mgħaġġel jew irregolari tal-qalb (palpitazzjonijiet) - gastrite, rimettar - rifluss tal-aċidu tal-istonku għal ġol-gerżuma (rigurġitazzjonijiet tal-aċidu), indiġestjoni - raxx - uġigħ, dgħufija muskolari jew bugħawwieġ fil-muskoli - uġigħ fid-dahar - sensazzjoni ta' dgħufija jew għeja; ma tħossokx tajjeb.
English: That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females; o Patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).
Maltese: o Popolazzjonijiet speċjali li għandhom żieda fl-inibizzjoni għal PDE4 bħal nisa suwed li ma jpejpux; oPazjenti kkurati fl-istess ħin b'inibituri ta' CYP1A2/2C19/3A4(bħal fluvoxamineu cimetidine) jew b'inibituri ta' CYP1A2/3A4 (bħal enoxacin).
English: The observed adverse reactions for roflumilast in Study RO-2455404-RD were in line with those already included in section 4.8.
Maltese: Ir-reazzjonijiet avversi osservati għal roflumilast fi Studju RO-2455-404-RD kienu f'konformità ma' dawk li diġà ġew inklużi f'sezzjoni
English: Common side effects (may affect up to 1 in 10 people) - diarrhoea, nausea, stomach ache - weight decrease, decreased appetite - headache
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 f'10) - dijarea, tqalligħ, uġigħ f;-istonku - tnaqqis fil-piż, nuqqas t'aptit - uġigħ ta' ras
English: Libertek has been studied in clinical trials for up to one year.
Maltese: Libertek ġie studjat fi provi kliniċi għal sa perjodu ta' sena.
English: In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension.
Maltese: Fi studji ta' fażi 1, is-sintomi li ġejjin ġew osservati f'rata miżjuda wara dożi orali waħidhom ta' 2,500 mikrogramma u doża waħda ta' 5,000 mikrogramma (għaxar darbiet tad-doża rakkomandata): uġigħ ta' ras, mard gastrointestinali, sturdament, palpitazzjonijiet, mejt, tidlik tal-ġilda minħabba l-għaraq u pressjoni arterjali baxxa.
English: A total of 1935 patients were randomised to double-blind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Maltese: Total ta' 1935 pazjent ġew magħżula b'mod każwali għal mediċina double-blind u madwar 70% kienu qed jużaw antagonista muskariniku li jaġixxi għal żmien twil (LAMA) matul il-kors tal-prova.
English: Rare side effects (may affect up to 1 in 1,000 people) - male breast enlargement - decreased sense of taste - respiratory tract infections (excluding pneumonia) - bloody stools, constipation - elevation of liver or muscle enzymes (seen in blood tests) - wheals (urticaria).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 f'1000) - tkabbir tas-sider fl-irġiel - tnaqqis fis-sens tat-togħma - infezzjonijiet tal-apparat respiratorju (li jeskludu l-pnewmonja) - ippurgar bid-demm, stitikezza - żieda tal-enzimi tal-fwied jew tal-muskoli (osservati fit-testijiet tad-demm) - nefħa fil-ġilda (urtikarja).
English: • Copies of the patient card to be given to patients or caregivers before they receive Libertek
Maltese: • Kopji tal-kard tal-pazjent li jridu jingħataw lill-pazjenti jew dawk li jipprovdu l-kura qabel ma jirċievu Libertek
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g..multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertekshould not be initiated or should be stopped in these patients.
Maltese: In-nuqqas ta' esperjenza f'pazjenti b'infezzjoni bl-HIV jew epatite attiva, b'mard immunoloġiku sever (eż. sklerosi multipla, lupus eritematuż, lewkoenċefalopatija multifokali) jew li jkunu kkurati b'terapija immunosoppressiva (minbarra kortikosterojdi sistemiċi għal żmien qasir) u li Libertekm'għandux jinbeda jew għandu jitwaqqaf f'dawn il-pazjenti.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: Jekk tinsa tieħu Libertek
English: The plasma AUC of the N-oxide metabolite on average is about 10-fold greater than the plasma AUC of roflumilast.
Maltese: L-AUC tal-plażma tal-metabolit N-oxide bħala medja hi ta' madwar 10 darbiet aktar mill-AUC tal-plażma ta' roflumilast.
English: The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Maltese: Libertek ma ġiex studjat f'pazjenti b'insuffiċjenza konġestiva tal-qalb (NYHA grad 3 u 4); għaldaqstant, mhuwiex rakkomandat f'din il-popolazzjoni.
English: Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin) may reduce the therapeutic efficacy of roflumilast.
Maltese: Għalhekk, l-użu ta' inducers qawwija ta' enzimi ta' ċitokrom P450 (eż. phenobarbital, carbamazepine, phenytoin) tista' tnaqqas l-effikaċja terapewtika ta' roflumilast.
English: Respiratory tract infections (excluding Pneumonia)
Maltese: Infezzjonijiet tal-apparat respiratorju (ħlief il-Pnewmonja)
English: Co-administration with an antacid (combination of aluminium hydroxide and magnesium hydroxide) did not alter the absorption or pharmacokinetics of roflumilast or its N-oxide.
Maltese: L-għoti flimkien ma' antaċidu (kumbinazzjoni ta' aluminium hydroxide u magnesium hydroxide) ma bidilx l-assorbiment jew il-farmakokinetika ta' roflumilast jew tal-N-oxide tiegħu.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Libertek (see section 4.3).
Maltese: Pazjenti b'indeboliment moderat jew sever epatiku ikklassifikat bħala Child-Pugh B jew Ċ m'għandhomx jieħdu Libertek (ara sezzjoni 4.3).
English: The effect of Libertek may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Maltese: L-effett ta' Libertek jista' jitnaqqas jekk jittieħed flimkien ma' rifampicin (mediċina antibijotika) jew ma' phenobarbital, carbamazepine jew phenytoin (mediċini li normalment jingħataw riċetta għalihom għall-kura ta' epilessija).
English: Libertek is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Maltese: Libertek jintuża bħala terapija ta' manteniment ta' COPD severa fl-adulti li fil-passat tagħhom kellhom sintomi li marru għall-agħar b'mod frekwenti (dawk li jissejħu taħrix) u li għandhom bronkite kronika..
English: What Libertek looks like and contents of the pack Libertek 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Maltese: Libertek 500 mikrogramma pilloli miksija b'rita huma sofor, pilloli miksija b'rita b'forma tal-ittra D, imnaqqxa b'‘D' fuq naħa waħda.
English: Libertek tablets contain lactose.
Maltese: Il-pilloli Libertek fihom lactose.
English: Seventeen (1.8%) patients in the roflumilast group and 18 (1.9%) patients in the placebo group died during the double-blind treatment period due to any reason and 7 (0.7%) patients in each group due to a COPD exacerbation.
Maltese: Sbatax-il (1.8%) pazjent fil-grupp ta' roflumilast u tmintax-il (1.9%) pazjent fil-grupp tal-plaċebo mietu waqt il-perijodu ta' trattament double-blind minħabba raġunijiet kwalsijasi u 7 (0.7%) pazjenti f'kull grupp minħabba aggravar ta' COPD. Il-proporzjon ta' pazjenti li esperjenzaw tal-anqas każ avvers wieħed waqt il-perijodu ta' trattament double-blind kien ta' 648 (66.9%) pazjent u 572 (59.2%) pazjent fil-gruppi ta' roflumilast u tal-plaċebo, rispettivament.
English: In a human spermatogenesis study, roflumilast 500 micrograms had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period.
Maltese: Fi studju dwar l-ispermatoġenesi fil-bniedem, roflumilast 500 mikrogramma ma kellu l-ebda effetti fuq il-parametri tas-semen jew ormoni riproduttivi matul il-perjodu ta' kura ta' 3 xhur u wara l-perjodu ta' 3 xhur mingħajr kura.
English: The one-year studies included patients with a history of severe to very severe COPD [FEV1 (forced expiratory volume in one second) ≤50% of predicted] associated with chronic bronchitis, with at least one documented exacerbation in the previous year and with symptoms at baseline as determined by cough and sputum score.
Maltese: L-istudji li damu sena kienu jinkludu pazjenti bi storja medika ta' COPD minn sever sa sever ħafna [FEV1 (volum respiratorju sfurzat f'sekonda) ta' ≤50% ta' dak imbassar] assoċjat ma' bronkite kronika, b'mill-inqas aggravament wieħed dokumentat fis-sena ta' qabel u b'sintomi fil-linja bażi kif stabbilit minn punteġġ ta' sogħla u sputum.
English: The European Medicines Agency has waived the obligation to submit the results of studies with roflumilast in all subsets of the paediatric population in chronic obstructive pulmonary disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea dwar il-Mediċini ddifferiet l-obbligi li jiġu ppresentati riżultati tal-istudji b'roflumilast f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika b'mard pulmonari ostruttiv kroniku (ara sezzjoni 4.2 għal informazzjoni fuq l-użu pedjatriku).
English: The tested dose of fluvoxamine was 50 mg. A combination of roflumilast with these active substances might lead to an increase of exposure and persistent intolerability.
Maltese: Kumbinazzjoni ta' roflumilast ma' dawn is-sustanzi attivi tista' twassal għal żieda fl-espożizzjoni u intollerabilità persistenti.
English: Other medicines and Libertek
Maltese: Mediċini oħra u Dexas
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tan-nifs, mediċini sistemiċi oħrajn għal mard ostruttiv tal-passaġġi tan-nifs, Kodiċi ATC:
English: Since roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal.
Maltese: Billi roflumilast jeħel ħafna mal-proteina, l-emodijalisi mhix mistennija li tkun metodu effiċjenti għat-tneħħija tiegħu.
English: The numbers of patients who died due to any reason were equal for those treated with placebo or roflumilast (42 deaths each group; 2.7% each group; pooled analysis).
Maltese: In-numri ta' pazjenti li mietu minħabba kwalunkwe raġuni kien l-istess bħal ta' dawk ikkurati bi plaċebo jew b'roflumilast (42 mewt f'kull grupp; 2.7% minn kull grupp; analiżi miġbura).
English: All patients should be informed about the risks of Libertek and the precautions for safe use and should be given a patient card before starting Libertek.
Maltese: Ir-riskju ta' mard psikjatriku bħal nuqqas ta' rqad, ansjetà, u dipressjoni f'pazjenti li jkunu qed jirċievu Libertek u r-riskju potenzjali ta' suwiċidju.
English: Description of selected adverse reactions * In clinical studies and post-marketing experience, rare instances of suicidal ideation and behaviour, including suicide, were reported.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula * Fl-istudji kliniċi u l-esperjenza ta' wara t-tqegħid tal-prodott fis-suq, kienu rrappurtati każijiet rari ta' ħsibijiet u mġiba suwiċidali, inkluż suwiċidju.
English: Streptococcus A, B, C and G
Maltese: Streptococcus A, B, C u G
English: Approximate cefuroxime concentration (mg/mL)**
Maltese: Konċentrazzjoni approssimattiva ta' cefuroxime (mg/mL)**
English: France - Zinnat
Maltese: Franza - Zinnat
English: S=susceptible, R=resistant.
Maltese: S= suxxettibbli, R= reżistenti.
English: Dose mg
Maltese: Doża mg
English: 250 to 1000 mg.
Maltese: 250 u 1000 mg.
English: Contraceptive pills
Maltese: Pilloli kontraċettivi
English: This will reduce the risk of possible problems.
Maltese: Dan inaqqas ir-riskju ta' xi problemi li jista' jkun hemm.
English: Staphylococcus aureus (methicillin-suscpetible) $ Streptococcus pyogenes
Maltese: Staphylococcus aureus (suxxettibbli għall-methicillin) $ Streptococcus pyogenes
English: Adults and children ≥ 40 kg
Maltese: Adulti u tfal  40 kg
English: Streptococcus mitis (viridans group)
Maltese: Streptococcus mitis (grupp viridans)
English: 5% Dextrose Injection BP
Maltese: Injezzjoni ta' 5% Dextrose BP
English: Gastrointestinal disorders gastrointestinal disturbance pseudomembranous colitis
Maltese: Disturbi gastrointestinali disturb gastrointestinali kolite psewdomembranuża
English: T1/2 (hrs)
Maltese: T1/2 (sigħat)
English: The following convention has been utilised for the classification of frequency: 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 and not known (cannot be estimated from the available data).
Maltese: Il-konvenzjoni li ġejja ntużat għallklassifikazzjoni tal-frekwenza: 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; rari ħafna < 1/10,000 u mhux magħruf (ma tistax tittieħed stima middata disponibbli).
English: Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection; Potassium Chloride (10 and 40
Maltese: Heparin (10 u 50 unità/ml) f'injezzjoni ta' Sodium Chloride 0.9%; Potassium Chloride (10 u
English: M/6 Sodium Lactate Injection
Maltese: Injezzjoni ta' M/6 Sodium Lactate
English: Compound Sodium Lactate Injection BP (Hartmann's Solution).
Maltese: Injezzjoni ta' Compound Sodium Lactate BP (Soluzzjoni ta' Hartmann).
English: Ringer's Injection USP
Maltese: Injezzjoni ta' Ringer USP
English: Italy - Curoxim
Maltese: L-Italja - Curoxim
English: Lactated Ringer's Injection USP
Maltese: Injezzjoni ta' Lactated Ringer USP
English: 2 Breakpoint relates to a dosage of 1.5 g × 3 and to E. coli, P. mirabilis and Klebsiella spp.
Maltese: 2 Il-breakpoint hija marbuta ma' doża ta' 1.5 g × 3 u għal E. coli, P. mirabilis u l-ispeċijiet Klebsiella biss.
English: • positive Coomb's test.
Maltese: • riżultat pożittiv għat-test ta' Coombs.
English: Children < 40kg
Maltese: Tfal < 40kg
English: Morganella morganii Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens Gram-positive anaerobes: Clostridium difficile Gram-negative anaerobes: Bacteroides fragilis
Maltese: L-ispeċijiet Acinetobacter Morganella morganii Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens Anerobi pożittivi għal Gram: Clostridium difficile Anerobi negattivi għal Gram:
English: Cefuroxome sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Maltese: Cefuroxome sodium huwa kumpatibbli ma' soluzzjonijiet akweji li fihom sa 1% lidocaine hydrochloride.
English: • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic,
Maltese: • Profilassi kontra infezzjonijiet f'operazzjonijiet gastrointestinali (inkluż esofagali), ortopediċi,
English: (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
Maltese: (Dawn jistgħu jkunu sinjali tas-sindrome ta' Stevens-Johnson jew nekroliżi tossika tal-epidermide).
English: 6 mL at least 15mL 15 mL*
Maltese: 6 mL mill-inqas 15mL 15 mL*
English: Cefuroxime is usually active against the following microorganisms in vitro.
Maltese: Ġeneralment cefuroxime jkun attiv kontra l-mikroorganiżmi li ġejjin in vitro.
English: Zinacef may reduce the effectiveness of the contraceptive pill.
Maltese: Zinacef jista' jnaqqas l-effikaċja tal-pillola kontraċettiva.
English: 5% Dextrose and 0.45% Sodium Chloride Injection 5% Dextrose and 0.225% Sodium Chloride Injection 10% Dextrose Injection
Maltese: Injezzjoni ta' 5% Dextrose u 0.45% Sodium Chloride Injezzjoni ta' 5% Dextrose u 0.225% Sodium Chloride Injezzjoni ta' 10% Dextrose
English: Cefuroxime sodium breakpoints
Maltese: Breakpoints ta' cefuroxime sodium
English: • severe allergic reaction.
Maltese: • reazzjoni allerġika qawwija.
English: 10% Invert Sugar in Water for Injection
Maltese: 10% Invert Sugar f'Ilma għall-Injezzjoni
English: Important information about excipients
Maltese: Informazzjoni importanti dwar l-eċċipjenti
English: • Acute exacerbations of chronic bronchitis.
Maltese: • Aggravament akut ta' bronkite kronika.
English: mEqL) in 0.9% Sodium Chloride Injection.
Maltese: 40 mEkL) f'Injezzjoni ta' 0.9% Sodium Chloride Injection.
English: Enterobacteriaceae1 Staphylococcus spp.
Maltese: Enterobacteriaceae1 Speċijiet ta'staphylococcus
English: Microbiological susceptibility
Maltese: Suxxettibiltà mikrobijoloġika
English: Surgical prophylaxis for cardiovascular and oesophageal operations
Maltese: Profilassi kirurġika għal operazzjonijiet kardjovaskulari u esofagali
English: 1.5 g with the induction of anaesthesia.
Maltese: 1.5 g mal-ikkaġunar tal-anestesija.
English: 4 The beta-lactam susceptibility of beta-haemolytic streptococci groups A, B, C and G is inferred from the penicillin susceptibility.
Maltese: Wieħed jista' jiddeduċi s-suxxettibilità tal- streptokokki beta-emolitiċi tal-gruppi A, B, C u G għall-beta lactam mis-suxxettibilità għall-penicillin. 5
English: • Intra-abdominal infections (see section 4.4).
Maltese: • Infezzjonijiet ġol-addome (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: antibacterials for systemic use, Second-generation cephalosporins, ATC code: J01DC02
Maltese: Kategorija farmakoterapewtika: antibatteriċi għal użu sistemiku, Cephalosporins tat-tieni ġenerazzjoni, Kodiċi ATC:
English: Maximum dose: 6 g per day.
Maltese: L-ogħla doża: 6 g kuljum.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar il-preparazzjoni tal-prodott mediċinali qabel ma' jingħata, ara sezzjoni 6.6.
English: Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed.
Maltese: Jista' jiġi ossevat tfixkil ħafif ma' metodi ta' tnaqqis tar-ram (metodu ta' Benedict, ta' Fehling, Clinitest).
English: 1.5 g Monovial powder for solution for infusion Belgium, Luxembourg - Zinacef Italy - Curoxim
Maltese: 1.5 g kunjett għal użu wieħed trab għal soluzzjoni għall-infużjoni Il-Belġju, il-Lussemburgu - Zinacef L-Italja - Curoxim Monovial
English: Immune system disorders drug fever, interstitial nephritis, anaphylaxis, cutaneous vasculitis
Maltese: Disturbi fis-sistema immuni deni mill-mediċina, nefrite talinterstizju, anafilassi, vaskulite talġilda
English: Patients with known hypersensitivity to cephalosporin antibiotics.
Maltese: Pazjenti magħrufa li għandhom sensittività eċċessiva għall-antibijotiċi cephalosporin.
English: Paediatric population The safety profile for cefuroxime sodium in children is consistent with the profile in adults.
Maltese: Il-profil ta' sigurtà ta' cefuroxime sodium fit-tfal hija konsistenti mal-profil fl-adulti.