qanastek/EMEA-V3 huggingface dataset:
Cefuroximaxetil 125, coated tablets 125 mg
Cefuroximaxetil 125, pilloli miksija 125 mg
Cefuroximaxetil 125 contain 150.36 mg cefuroxime axetil which is equivalent to 125 mg cefuroxime per tablet
Cefuroximaxetil 125 fih 150. 36 mg ta ’ cefuroxime axetil li hu ekwivalenti għal 125 mg ta ’ cefuroxime f’ kull pillola
Cefuroxime axetil 125 mg coated tablets contain 0.2 mg aspartame.
Sustanza mhux attiva:
Cefuroxime axetil 500 mg coated tablets contain 0.4 mg aspartame.
Cefuroxime axetil 125 mg pilloli miksija fihom 0. 2 mg ta ’ aspartame.
For a full list of excipients: see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi: ara sezzjoni 6. 1.
Coated tablets
Pilloli miksija b’ rita
white to slightly yellowish, biconvex, oblong tablets
pilloli ta ’ kulur li hu minn abjad sa ftit isfar, bikonvessi, oblungi
Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
Cefuroxime axetil hu indikat għall- kura ta ’ infezzjonijiet minn ħfief sa moderatament severi kkawżati minn mikro- organiżmi li huma suxxettibbli għal cefuroxime, bħal:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
- infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq: infjammazzjoni akuta tal- widna tan- nofs,
- acute bronchitis, acute exacerbations of chronic bronchitis
- bronkite akuta, aggravament akut ta ’ bronkite kronika
- lower uncomplicated urinary tract infections: cystitis
- infezzjonijiet mhux ikkumplikati fin- naħa t’ isfel ta ’ l- apparat urinarju: ċistite
- skin and soft tissue infections: furunculosis, pyoderma and impetigo
- infezzjonijiet tal- ġilda u tat- tessut artab: furunkolosi, pijoderma u impetigo
- treatment of early stage Lyme disease (stadium I) and subsequent prevention of late
- il- kura tal- marda ta ’ Lyme fl- istadju bikri (stadju I) u l- prevenzjoni sussegwenti ta ’
complications in adults and children above 12 years of age.
kumplikazzjonijiet li jseħħu aktar tard fl- adulti u t- tfal li għandhom aktar minn 12- il sena.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata konsiderazzjoni lill- gwida uffiċjali dwar l- użu adattat ta ’ mediċini anti- batteriċi.
Cefuroxime axetil tablets are coated to mask their taste: they should not be chewed.
Il- pilloli Cefuroxime axetil huma miksija biex tittaffa t- togħma tagħhom: m’ għandhomx jintmagħdu.
The usual duration of therapy is 7 days (ranging from 5 to 10 days).
It- tul tas- soltu tat- terapija hu ta ’ 7 ijiem (li jvarja minn 5 sa 10 ijiem).
In case of pharyngotonsillitis caused by Streptococcus pyogenes a therapy duration of at least 10 days is indicated.
F’ każ ta ’ faringotonsillite ikkawżata minn Streptococcus pyogenes, tul tat- terapija ta ’ mill- anqas 10 ijiem hu indikat.
The duration of treatment of early Lyme disease should be 20 days.
It- tul ta ’ żmien tal- kura tal- marda ta ’ Lyme fl- istadju bikri għandu jkun ta ’ 20 jum.
In order to achieve optimum absorption cefuroxime axetil tablets should be taken shortly after meals.
Biex twettaq l- aħjar assorbiment, il- pilloli cefuroxime axetil għandhom jittieħdu ftit wara l- ikel.
The dosage depends on the severity of the infection.
Id- dożaġġ jiddependi fuq is- severità ta ’ l- infezzjoni.
For severe infections parenteral forms of cefuroxime are recommended.
Għal infezzjonijiet severi, forom parenterali ta ’ cefuroxime huma rakkomandati.
Where appropriate cefuroxime axetil is effective when used following initial parenteral cefuroxime sodium in the treatment of pneumonia and acute exacerbations of chronic bronchitis.
Fejn ikun xieraq, cefuroxime axetil hu effettiv meta jintuża wara cefuroxime sodium parenterali inizjali fil- kura tal- pnewmonja u l- aggravament akut ta ’ bronkite kronika.
8 Dosage schedule for tablets:
8 Adulti u adolexxenti fuq it- 12- il sena
Upper respiratory tract infections
Infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq
250 (– 500) mg twice daily
250 (– 500) mg darbtejn kuljum
Lower respiratory tract infections
Infezzjonijiet ta ’ l- apparat respiratorju t’ isfel
500 mg twice daily
500 mg darbtejn kuljum
Lower uncomplicated urinary tract infections
Infezzjonijiet mhux ikkumplikati fin- naħa t’ isfel ta ’ l- apparat urinarju
125 – 250 mg twice daily
125 – 250 mg darbtejn kuljum
Skin and soft tissue infections
Infezzjonijiet ikkumplikati tal- ġilda u tat- tessut artab
250 – 500 mg twice daily
250 – 500 mg darbtejn kuljum
Early Lyme disease
Marda ta ’ Lyme fl- istadju bikri.
500 mg twice daily during 20 days
500 mg darbtejn kuljum fuq 20 jum
Children from 5 to 12 years of age
Tfal minn 5 sa 12- il sena
Above-mentioned indications, if relevant for this group of children
L- indikazzjonijiet imsemmija hawn fuq, jekk inhuma rilevanti għal dan grupp ta ’ tfal
Acute otitis media
Infjammazzjoni akuta tal- widna tan- nofs
250 mg twice daily
250 mg darbtejn kuljum
Cefuroxime axetil tablets are not suitable for use in children under the age of 5.
Tfal taħt il- 5 snin Il- pilloli Cefuroxime axetil mhumiex adattati għall- użu fi tfal taħt l- età ta ’ 5 snin.
For patients in this age group it is advised to use an oral suspension.
Għall- pazjenti f’ dan il- grupp ta ’ età, hu rakkomandat li tuża suspensjoni orali.
There is no experience in children under 3 months of age.
M’ hemmx esperjenza fi tfal ta ’ taħt it- 3 xhur.
Dosage regimen in renal impairment, in dialysis patients and elderly:
Kors dożaġġ fl- indeboliment tal- kliewi, fid- dijalisi tal- pazjenti u fl- anzjani:
No special precautions are necessary in patients with renal impairment, or in elderly patients if the daily dosage does not exceed 1 gram.
L- ebda prekawzjonijiet speċjali m’ huma meħtieġa f’ pazjenti b’ indeboliment tal- kliewi, jew f’ pazjenti anzjani jekk id- dożaġġ ta ’ kuljum ma jaqbiżx il- 1 gramma.
In patients with renal impairment and creatinine clearance below 20 ml/ min cefuroxime axetil tablets should be dosed carefully.
F’ pazjenti b’ indeboliment renali, u bi tneħħija tal- krejatinina taħt 20 ml/ min, id- dożaġġ tal- pilloli cefuroxime axetil għandu jingħata bl - attenzjoni.
Patients undergoing haemodialysis will require a supplementary dose of cefuroxime at the end of each dialysis treatment.
Pazjenti li jkunu fuq l- emodijalisi ser ikunu jeħtieġu doża supplimentari ta ’ cefuroxime fit - tmiem ta ’ sessjoni ta ’ dijalisi.
Hypersensitivity to cefuroxime, other cephalosporins or to any of the excipients.
Sensittività eċċessiva għal cefuroxime, għal cephalosporins jew għal sustanzi mhux attivi.
Previous immediate and / or severe hypersensitivity reaction to a penicillin or to any other type of beta- lactammedicinal products.
Reazzjoni ta ’ sensittività eċċessiva fil- passat u/ jew immedjata għal penicillin jew għal kwalunkwe tip ieħor ta ’ prodotti mediċinali beta- lactam.
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
Jekk wara l- għoti ta ’ cefuroxime axetil, iseħħu reazzjonijiet tas- sensittività, l- użu tiegħu għandu jitwaqqaf immedjatament, u tkun stabbilita kura adattata Kura speċjali hi indikata f’ pazjenti li jkollhom reazzjoni allerġika għal penicillins jew beta- lactams oħrajn.
As with other broad spectrum antibiotics, prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (e. g., candida, enterococci and clostridium diffficile, which may require interruption of treatment.
Bħal fil- każ ta ’ antibijotiċi broad spectrum oħrajn, l- użu fit- tul ta ’ cefuroxime axetil jista ’ jirriżulta fi tkabbir eċċessiv ta ’ organiżmi mhux suxxettibbli (eż., candida, enterococci u clostridium diffficile, li jista ’ jkollhom bżonn ta ’ interruzzjoni fil- kura.
In patients who develop severe diarrhoea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account.
F’ pazjenti li jiżviluppaw dijarea severa matul jew wara l- użu ta ’ cefuroxime axetil, ir- riskju ta ’ kolite psewdomembranuża li tkun ta ’ periklu għall- ħajja, għandu jkun ikkunsidrat.
The use of cefuroxime axetil should be discontinued and the appropriate treatment established.
L- użu ta ’ cefuroxime axetil għandu jitwaqqaf u tkun stabbilita kura adattata.
The use of preparations inhibiting the intestinal peristaltism is contra-indicated (see section 4.8).
L- użu ta ’ preparazzjonijiet li jinibixxu l - peristaltiżmu intestinali hu kontra- indikat (ara sezzjoni 4. 8).
A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase.
9 Il- kura ta ’ 20 jum tal- marda ta ’ Lyme tista ’ tikkawża l- frekwenza li tiżviluppa d- dijarea biex tiżdied.
9 Long term use of cefuroxime axetil may lead to an excess of pathogens resistant to cefuroxime axetil.
L- użu fit- tul ta ’ cefuroxime axetil jista ’ jwassal għal eċċess ta ’ patoġeni reżistenti għal cefuroxime axetil.
It is of high importance that the patient is carefully checked.
Hu ta ’ importanza kbira li l- pazjent ikun iċċekkjat.
If a superinfection occurs during treatment, appropriate measures should be taken (see section 4.8).
Jekk isseħħ superinfezzjoni matul il- kura, għandhom jittieħdu miżuri adattati (ara sezzjoni 4. 8).
The use of cefuroxime axetil is not recommended in patients with severe intestinal tract disorders accompanied by vomiting and diarrhoea, since in these situations a sufficient absorption can not be guaranteed.
L- użu ta ’ cefuroxime axetil mhux rakkomandat f’ pazjenti b’ disturbi severi fl- apparat intestinali akkompanjati minn rimettar u dijarea, għax f’ dawn is- sitwazzjonijiet, l- assorbiment suffiċjenti jista ’ ma jkunx garantit.
Administration of a parenteral formulation of cefuroxime should be considered.
L- għoti ta ’ formulazzjoni parenterali ta ’ cefuroxime għandu jkun ikkunsidrat.
The Jarisch-Herxheimer reaction has been reported following cefuroxime axetil treatment of Lyme disease.
Ir- reazzjoni ta ’ Jarisch- Herxheimer kienet irrappurtata wara l- kura b’ cefuroxime axetil tal- marda ta ’ Lyme.
The reaction results directly from the bactericidal activity of cefuroxime axetil on the spirochaete Borrelia burgdorferi.
Ir- reazzjoni rriżultat direttament mill- attività batteriċidjali ta ’ cefuroxime axetil fuq l - ispirochaete Borrelia burgdorferi.
Patients should be informed of this common and usually self-limited reaction being a consequence of antibiotic treatment of Lyme disease.
Il- pazjenti għandhom ikunu infurmati dwar din reazzjoni li hi komuni u normalment limitata minnha nfisha, li sseħħ bħala konsegwenza tal- kura antibijotika tal - marda ta ’ Lyme.
Simultaneous use of medicines enhancing the pH of the stomach is not recommended (see section 4.5).
L- użu fl- istess ħin ta ’ mediċini li jtejbu l- pH ta ’ l- istonku, mhuwiex rakkomandat (ara sezzjoni 4. 5).
There is no clinical experience with the use of cefuroxime axetil in children under the age of 3 months.
M’ hemmx esperjenza klinika bl- uzu ta ’ cefuroxime axetil fi tfal li għandhom inqas minn 3 snin.
With respect to the treatment of early Lyme disease there is only clinical experience with children from the age of 12 and with adults.
Fir - rigward tal- kura tal- marda ta ’ Lyme fl- istadju bikri, hemm biss esperjenza klinika fi tfal minn 12- il sena ’ l fuq u fl- adulti.
Special care should be taken with phenylketonuric patients because of the aspartame containing coating.
Għandha tingħata attenzjoni speċjali lil pazjenti bil- fenilketonurja minħabba l- kisja tal- pillola li fiha l - aspartame.
Cefuroximaxetil 125 contains 0,2 mg aspartame per tablet
Cefuroximaxetil 125 fih 0. 2 mg ta ’ aspartame f’ kull pillola
Either the glucose oxidase or the hexokinase methods are recommended to determine the blood and plasma glucose levels in patients receiving cefuroxime axetil.
Kemm il- metodi tal- glucose oxidase jew tal- hexokinase huma rakkomandati biex jistabbilixxu l- livelli tal- glucose fid- demm u fil- plażma f’ pazjenti li jkunu qed jirċievu cefuroxime axetil.
Cefuroxime does not interfere in the alkaline picrate assay for creatinine (see section 4.5).
Cefuroxime ma jinterferixxix fl- assaġġ ta ’ l- alkaline picrate għall- krejatinina (ara sezzjoni 4. 5).
During the treatment with cefuroxime sodium, some children have experienced slight to moderate hearing loss.
Matul il- kura b’ cefuroxime sodium, xi tfal kellhom telf fis- sens tas- smigħ li kien minn ħafif sa moderat.
Simultaneous use of medicines enhancing the pH of the stomach decreases the bioavailability of cefuroxime axetil.
L- użu fl- istess ħin ta ’ mediċini li jtejbu l- pH ta ’ l - l- istonku, inaqqas il- bijodisponibilità ta ’ cefuroxime axetil.
It is recommended to avoid this combination (see section 4.4).
Hu rakkomandat li tevita din il- kumbinazzjoni (ara sezzjoni 4. 4).
Since bacteriostatic drugs may interfere with the bactericidal action of cephalosporins, it is advisable to avoid giving tetracyclines, macrolides, or chloramphenicol in conjunction with cefuroxime axetil.
Minħabba li mediċini batterjostatiċi jistgħu jinterferixxu ma ’ l- azzjoni batteriċidjali tas- cephalosporins, hu rakkomandat li l- għoti ta ’ tetracyclines, macrolides, jew chloramphenicol flimkien ma ’ cefuroxime axetil jiġi evitat.
The concomitant administration of probenicid can produce higher and sustained concentrations of cefuroxime in the serum and in the bile.
L- għoti fl- istess ħin ta ’ probenicid jista ’ jipproduċi konċentrazzjonijiet ogħla u sostnuti ta ’ cefuroxime fis - serum u fil- bila.
Cefuroxime may interfere with the determination of glucose in urine with copper containing reagentia (Benedict- or Fehling-solution, Clinitest).
Cefuroxime jista ’ jinterferixxi mad- determinazzjoni tal- glucose fil- awrina b’ copper containing reagentia (soluzzjoni Benedict jew Fehling, Clinitest).
For the determination of blood- and plasma sugar levels in patients receiving cefuroxime axetil, the glucose-oxidase- or hexokinase method is recommended (see section 4.4).
Biex ikunu stabbiliti l- livelli taz- zokkor fid- demm u fil - plażma, f’ pazjenti li jkunu qed jirċievu cefuroxime axetil, il- metodu glucose- oxidase jew hexokinase hu rakkomandat (ara sezzjoni 4. 4).
The use of cefuroxime axetil may be accompanied by a false positive Coombs test.
L- użu ta ’ cefuroxime axetil jista ’ jkun akkompanjat minn test ta ’ Coombs li jagħti riżultat pożittiv falz.
This may interfere with the performance of cross matching tests with blood (see section 4.8).
Dan jista ’ jinterferixxi mal- prestazzjoni ta ’ testijiet cross matching bid- demm (ara sezzjoni 4. 8).
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics, aminoglycosides, or amphotericin as these combinations increases the risk of nephrotoxicity.
10 L- antibijotiċi cephalosporin f’ dożaġġ qawwi għandhom jingħataw bl- attenzjoni lil pazjenti li jkunu qed jirċievu dijuretiċi qawwija, aminoglycosides, jew amphotericin, għax dawn il- kumbinazzjonijiet iżidu r - riskju ta ’ nefrotossiċità.
10 Use in pregnancy There are not sufficient data on the use of cefuroxime axetil during pregnancy to assess its possible harmfulness.
L- użu waqt it- tqala M’ hemmx informazzjoni biżżejjed dwar l- użu ta ’ cefuroxime axetil matul it- tqala, biex tkun evalwata l- ħsara possibbli li jista ’ jagħmel.
So far, animal tests have not yielded evidence of harmfulness.
S’ issa, it- testijiet fuq l- annimali ma taw l- ebda evidenza ta ’ ħsara.
Cefuroxime crosses the placenta.
Cefuroxime jgħaddi minn ġol- plaċenta.
Cefuroxime axetil should not be used during pregnancy unless considered essential by the physician.
Cefuroxime axetil m’ għandux jintuża matul it- tqala ħlief jekk ikun ikkunsidrat essenzjali mit- tabib.
Use during lactation Cefuroxime is excreted to a small degree in human milk; breast feeding should be avoided in women using cefuroxime axetil.
L- użu waqt it- treddigħ Cefuroxime jitneħħa f’ ammonti żgħar fil- ħalib uman; it- treddigħ għandu jkun evitat min- nisa li jkunu qed jużaw cefuroxime axetil.
There are no studies of the effect of cefuroxime axetil on the ability to drive and to handle machines.
M’ hemm l- ebda studji dwar l- effett ta ’ cefuroxime axetil fuq il- ħila biex issuq u tħaddem il- magni.
However, any effects are not to be expected.
Madankollu, l- ebda effetti m’ huma mistennija.
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))
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))
Rare Pseudomembranous colitis As with other antibiotics prolonged use may lead to secondary superinfections caused by insusceptible organisms, e. g.
Rari Kolite psewdomembranuża Bħal fil- każ ta ’ antibijotiċi oħrajn, l- użu fit- tul jista ’ jwassal għal superinfezzjonijiet sekondarji kkawżati minn organiżmi insuxxetibbli eż.
Candida, Enterococci and Clostridium difficile (see section 4.4).
Candida, Enterococci u Clostridium difficile (ara sezzjoni 4. 4).
Blood and the lymphatic system disorders Rare Decreased haemoglobin concentration, eosinophilia, leucopenia, neutropenia and thrombocytopenia Very rare Haemolytic anaemia
Disturbi tad- demm u tas- sistema limfatika Rari Tnaqqis fil- konċentrazzjoni ta ’ l- emoglobina, eosinofilja, lewkopenja, newtropenja u tromboċitopenja Rari ħafna Anemija emolitika
Common Jarisch-Herxheimer reaction following cefuroxime axetil treatment of Lyme disease (see section 4.4).
Komuni Reazzjoni ta ’ Jarisch- Herxheimer wara l- kura b’ cefuroxime tal- marda ta ’ Lyme (ara sezzjoni 4. 4).
Rare Serum sickness Very rare Anaphylaxis
Rari Marda tas- serum Rari ħafna Anafilassi
Nervous system disorders Uncommon Headache, dizziness Very rare Restlessness, nervousness, confusion
Mhux Komuni Uġigħ ta ’ ras, sturdament Rari ħafna Nuqqas ta ’ kwiet f’ ġismek, nervożità, konfużjoni
Gastrointestinal disorders:
11 Disturbi gastro- intestinali:
Common Diarrhoea, nausea and vomiting.
Komuni Dijarea, nawseja u rimettar.
The frequency of diarrhoea is related to the administered dose and may rate up to 10% with tablets.
Il- frekwenza tad- dijarea hi marbuta mad- doża li tingħata u tista ’ tkun sa 10% bil- pilloli.
13%) at prolonged treatment of 20 days of early Lyme disease.
L- inċidenza hu ogħla (madwar 13%) waqt il- kura fit- tul ta ’ 20 jum tal- marda ta ’ Lyme fl- istadju bikri.
11 Hepato-biliary disorders:
Disturbi fil- fwied u fil- marrara:
Rare Transient increases of hepatic enzyme levels (AST, ALT and LDH) and serum bilirubin.
Rari Żidiet temporanji ta ’ livelli ta ’ l- enzimi epatiċi (AST, ALT u LDH) u bilirubina fis- serum.
Very rare Jaundice.
Rari ħafna Suffejra.
Common Skin rashes, urticaria, pruritus.
Komuni Raxx tal- ġilda, urtikarja, ħakk.
Very rare Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Rari ħafna Eritema multiforme, sindrome ta ’ Stevens- Johnson u nekrolisi epidermali tossika
Renal and urinary disorders Common Increased levels of creatinine and urea in serum, especially in patients with impaired renal function.
Disturbi fil- kliewi u fis- sistema urinarja Komuni Żieda fil- livelli tal- krejatinina u ta ’ l- urea fis- serum, speċjalment f’ pazjenti b’ indeboliment fil- funzjoni renali.
Uncommon Acute interstitial nephritis
Mhux Komuni Nefrite interstizjali akuta
Rare Drug fever
Rari Deni minħabba l- mediċina
Investigations The use of cefuroxime axetil may be accompanied by a false positive Coombstest.
Investigazzjonijiet L- użu ta ’ cefuroxime axetil jista ’ jkun akkompanjat minn test ta ’ Coombs li jagħti riżultat pożittiv falz.
This may interfere with the performance of cross matching tests with blood (see 4.5.
Dan jista ’ jinterferixxi mal- prestazzjoni ta ’ testijiet cross matching bid- demm (ara 4. 5.
Interactions).
Interazzjonijiet).
Overdose of cephalosporins may cause cerebral irritancy leading to convulsions.
Doża eċċessiva ta ’ cephalosporins tista ’ tikkawża irritazzjoni ċerebrali li twassal għal konvulżjonijiet.
In case of overdose cefuroxime serum levels can be reduced by haemodialysis and peritoneal dialysis.
F’ każ ta ’ doża eċċessiva, il- livelli ta ’ cefuroxime fis- serum jistgħu jitnaqqsu permezz ta ’ l- emodijalisi u dijalisi peritoneali.
Pharmacotherapeutic group: cephalosporins and related substances, ATC-Code:
Kategorija farmakoterapewtika: cephalosporins u sustanzi relatati, Kodiċi ATC:
Mode of action Cefuroxime axetil owes its in vivo bactericidal activity to the parent compound cefuroxime.
Mod ta ’ azzjoni Cefuroxime axetil jaf l- attività batteriċidjali tiegħu in vivo lill- kompost prinċipali cefuroxime.
All cephalosporins (β -lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis.
Ic- cephalosporins kollha (antibijotiċi β- lactam) jinibixxu l- produzzjoni tal- ħajt taċ- ċelluli u huma inibituri selettivi tas- sintesi ta ’ peptidoglycan.
The initial step in drug action consists of binding of the drug to cell receptors, called Penicillin-Binding Proteins.
Il- pass inizjali ta ’ l- azzjoni tal- mediċina tikkonsisti fit - twaħħil tal- mediċina mar- riċetturi taċ- ċelluli, imsejħa Proteini li Jeħlu mal- Penicillin.
After a β -lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked.
Wara li l - antibijotiku β- lactam ikun weħel ma ’ dawn ir- riċetturi, ir- reazzjoni tat- transpeptidation tkun inibita, u s- sintesi tal- peptidoglycan tkun imblukkata.
Bacterial lysis is the end result.
Il- lisi batterjali hi r- riżultat finali.
Mechanism of resistance Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms: • hydrolysis by beta-lactamases.
12 Mekkaniżmu tar- reżistenza Ir- reżistenza batterjali għal cefuroxime tista ’ tkun minħabba wieħed jew aktar mill- mekkaniżmi li ġejjin: • idrolisi minn beta- lactamases.
Cefuroxime may be efficiently hydrolysed by certain of the extended-spectrum beta-lactamases (ESBLs) and by the chromosomally-encoded (AmpC) enzyme that may be induced or stably derepressed in certain aerobic gram-negative bacterial species • reduced affinity of penicillin-binding proteins for cefuroxime
Cefuroxime jista ’ idrolizzat b’ mod effiċjenti minn ċerti extended- spectrum beta- lactamases (ESBLs) u mill- enzima chromosomally- encoded (AmpC) li tista ’ tkun ikkaġunata jew stably derepressed f’ ċerti speċi batterjali gram- negattivi aerobiċi • affinità mnaqqsa ta ’ proteini li jeħlu mal- penicillin għal cefuroxime • l- impermeabilità tal- membrana ta ’ barra, li tirrestrinġi l- aċċess ta ’ cefuroxime għal proteini li jeħlu mal- penicillin f’ organiżmi gram- negattivi • pompi ta ’ l- effluss tal- mediċina
Methicillin-resistant staphylococci (MRS) are resistant to all currently available β -lactam antibiotics including cefuroxime.
Methicillin- resistant staphylococci (MRS) huma reżistenti għall- antibijotiċi β- lactam kollha li huma disponibbli bħalissa li jinkludu cefuroxime.
Penicillin-resistant Streptococcus pneumoniae are cross-resistant to cephalosporins such as cefuroxime through alteration of penicillin binding proteins.
Streptococcus pneumoniae li huma reżistenti għall- penicillin, għandhom reżistenza inkroċjata għas - cephalosporins, bħal cefuroxime permezz tal- bidla tal- proteini li jeħlu mal- penicillin.
Beta-lactamase negative, ampicillin resistant (BLNAR) strains of H. influenzae should be considered resistant to cefuroxime despite apparent in vitro susceptibility.
Beta- lactamase negattiv, razez reżistenti għal ampicillin (BLNAR) ta ’ H. influenzae għandhom ikunu kkunsidrati li huma reżistenti għal cefuroxime minkejja s- suxxettibbilità apparenti in vitro.
Strains of Enterobacteriaceae, in particular Klebsiella spp. and Escherichia coli that produce ESBLs (extended spectrum β -lactamase) may be clinically resistant to therapy with cephalosporins despite apparent in vitro susceptibility and should be considered as resistant.
Razez ta ’ Enterobacteriaceae, b’ mod partikulari Klebsiella spp. u Escherichia coli li jipproduċu ESBLs (extended spectrum β- lactamase) jistgħu jkunu klinikament reżistenti għat- terapija b’ cephalosporins minkejja s- suxxettibbilità apparenti in vitro, u għandhom ikunu kkunsidrati bħala reżistenti.
According to the NCCLS (National Committee on Clinical Laboratory Standards) in 2001 the following breakpoints have been defined for cefuroxime axetil:
Skond l- NCCLS (National Committee on Clinical Laboratory Standards) fl- 2001, dawn il- breakpoints li ġejjin kienu definiti għal cefuroxime axetil:
Enterobacteriaceae: ≤ 4 µg/ ml susceptible, ≥ 32 µg/ ml resistant Staphylococcus spp.: ≤ 4 µg/ ml susceptible, ≥ 32 µg/ ml resistant Haemophilus spp.: ≤ 4 µg/ ml susceptible; ≥ 16 µg/ ml resistant Streptococcus pneumoniae: ≤ 1 µg/ ml susceptible, ≥ 4 µg/ ml resistant Streptococcus spp. other than S. pneumoniae:
Enterobacteriaceae: ≤ 4 µg/ ml suxxettibbli, ≥ 32 µg/ ml reżistenti Staphylococcus spp.: ≤ 4 µg/ ml suxxettibbli, ≥ 32 µg/ ml reżistenti Haemophilus spp.: ≤ 4 µg/ ml suxxettibbli, ≥ 16 µg/ ml reżistenti Streptococcus pneumoniae: ≤ 1 µg/ ml suxxettibbli, ≥ 4 µg/ ml reżistenti Streptococcus spp. ħlief S. pneumoniae:
Streptococcal isolates susceptible to penicillin (MIC90 ≤ 0.12 µg/ ml) may be considered susceptible to cefuroxime.
Streptococcal isolates suxxettibbli għal penicillin (MIC90 ≤ 0. 12 µg/ ml) jistgħu jkunu kkunsidrati li huma suxxettibbli għal cefuroxime.
Susceptibility:
Suxxettibbilità:
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Il- prevalenza tar- reżistenza tista ’ tvarja ġeografikament u maż- żmien għal speċi magħżula, u informazzjoni lokali dwar ir- reżistenza hi mixtieqa, partikularment meta infezzjonijiet severi jkunu jiġu kkurati.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Parir espert għandu jinkiseb fejn ikun hemm bżonn meta l- prevalenza lokali tar- reżistenza hi tali li l- utilità tal- mediċina hi dubjuża f’ mill- inqas xi tipi ta infezzjonijiet.
Commonly susceptible species
Speċi li huma suxxettibbli b’ mod komuni
Aerobes, Gram positive:
Aerobi, Gram- pożittivi:
Staphylococcus aureus (methicillin-susceptible) Coagulase-negative staphylococci (methicillin- susceptible) Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Aerobes, Gram negative:
Staphylococcus aureus (suxxettibbli għal methicillin) Staphylococci negattivi għal coagulase (suxxettibbli għal methicillin) Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes
13 Borrelia burgdorferi.
13 Aerobi, Gram- negattivi:
Species for which resistance may be a problem Acinetobacter species Citrobacter species Enterobacter species Morganella morganii Resistant Bacteroides fragilis Clostridium difficile Enterococci Listeria monocytogenes Proteus vulgaris Pseudomonas species Serratia species
Speċi li għalihom ir- reżistenza tista ’ tkun problema Speċi Acinetobacter Speċi Citrobacter Speċi Enterobacter Morganella morganii Reżistenti Bacteroides fragilis Clostridium difficile Enterococci Listeria monocytogenes Proteus vulgaris Speċi Pseudomonas Speċi Serratia
After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood causing the release of the active compound cefuroxime into the circulation.
Wara l- għoti mill- ħalq, cefuroxime axetil ikun assorbit mill- apparat gastrointestinali u idrolizzat malajr fil- mukuża intestinali u fid- demm, u jikkawża l- ħruġ tal- kompost attiv cefuroxime fiċ- ċirkolazzjoni.
Optimum absorption occurs when Cefuroximaxetil is taken shortly after a meal (50-60%).
L- aħjar assorbiment iseħħ meta Cefuroximaxetil jittieħed ftit wara xi ikla (50- 60%).
Under these circumstances maximum serum concentration is achieved after 2-3 hours.
Taħt dawn iċ- ċirkustanzi, il- konċentrazzjoni massima fis- serum intlaħqet wara 2- 3 sigħat.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed.
Cefuroxime hu ddistribwit ħafna fil- ġisem, u jinkludi l- fluwidu tal- plewra, l- isputum, l- għadam, il- fluwidu sinovjali, u l- aqueous humour, iżda jilħaq konċentrazzjonijiet terapewtiċi biss fis - CSF meta l- meninġi jkunu infjammati.
About 50% of cefuroxime in the circulation is bound to plasma proteins.
Madwar 50% ta ’ cefuroxime fiċ- ċirkolazzjoni jeħel mal - proteini tal- plażma.
It diffuses across the placenta and has been detected in breast milk.
Jgħaddi minn ġol- plaċenta u kien osservati fil- ħalib tas- sider.
Cefuroxime is not metabolised.
Cefuroxime ma jkunx metabolat.
Most of the dose of cefuroxime is excreted unchanged.
Il- biċċa l- kbira tad- doża ta ’ cefuroxime titneħħa mhux mibdula.
About 50% is excreted by glomerular filtration and about 50% through renal tubular secretion within 24 hours, with the majority being eliminated within 6 hours; high concentrations are achieved in the urine.
Madwar 50% titneħħa permezz tal- filtrazzjoni glomerulari u madwar 50% permezz tat- tnixxija tubulari tal- kliewi fi żmien 24 siegħa, bil- maġġoranza tagħha li titneħħa fi żmien 6 sigħat; konċentrazzjonijiet għolja jintlaħqu fl - awrina.
Small amounts of cefuroxime are excreted in bile.
Ammonti żgħar ta ’ cefuroxime jitneħħew fil- bila.
Probenecid competes with cefuroxime for renal tubular secretion resulting in higher and more prolonged plasma concentrations of cefuroxime.
Probenecid jikkompeti ma ’ cefuroxime għat- tnixxija tubulari mill- kliewi, li tirriżulta f’ konċentrazzjonijiet ta ’ cefuroxime fil- plażma li jkunu ogħla u aktar fit- tul.
The plasma half-life ranges between 60 and 90 minutes and is prolonged in patients with renal impairment and in neonates.
Il- half- life tal- plażma tvarja bejn 60 u 90 minuta u tkun iktar f’ pazjenti b’ indeboliment tal- kliewi u fit - trabi tat- twelid.
Dialysis causes the decrease of cefuroxime serum levels.
Id- dijaliżi tikkawża t- tnaqqis tal- livelli ta ’ cefuroxime fis- serum.
Preclinical effects were observed in dosages far above the maximal human dosage which are therefore hardly relevant for the clinical use of cefuroxime axetil.
L- effetti ta ’ qabel l- użu kliniku kienu osservati f’ dożaġġi li kienu bil- wisq ogħla mid- doża massima fil- bniedem, u għalhekk ma tantx huma rilevanti għall- użu kliniku ta ’ cefuroxime axetil.
Core: sodium lauryl sulphate, copovidone, croscarmellose sodium (E468), magnesium stearate (E 470B), colloidal anhydrous silica (E551), granulated mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), talc (E553B).
Qalba: sodium lauryl sulphate, copovidone, croscarmellose sodium (E468), magnesium stearate (E 470B), colloidal anhydrous silica (E551), granulated mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), talc (E553B).
14 Coat: mannitol (E421), soluble starch (potato), talc (E553B), titanium dioxide (E171), aspartame (E951)
Kisja: mannitol (E421), soluble starch (potato), talc (E553B), titanium dioxide (E171), aspartame (E951)
Al/ Al strip:
Strixxa Al/ Al:
36 months
36 xahar Folja (Al/ Al) 36 xahar
Store in the original packaging Al/ Al blister:
Aħżen fil- pakkett oriġinali Folja (Al/ Al):
Store in the original packaging
Aħżen fil- pakkett oriġinali
Al/ Al strip packaging Al/ Al blister packaging
Ippakkjar ta ’ l- istrixxa Al/ Al Ippakkjar tal- folja Al/ Al
8, 10, 12, 14, 24 tablets
8, 10, 12, 14, 24 pillola
[See Annex I – to be completed nationally]
[Ara Anness I – biex timtela mill- pajjiż partikolari]
[to be completed nationally]
[biex timtela mill- pajjiż partikolari]
Cefuroximaxetil 250, coated tablets 250 mg
Cefuroximaxetil 250, pilloli miksija 250 mg
Cefuroximaxetil 250 contain 300.72 mg cefuroxime axetil which is equivalent to 250 mg cefuroxime per tablet
Cefuroximaxetil 250 fih 300. 72 mg ta ’ cefuroxime axetil li hu ekwivalenti għal 250 mg ta ’ cefuroxime f’ kull pillola
Cefuroxime axetil 250 mg coated tablets contain 0.3 mg aspartame.
Cefuroxime axetil 250 mg pilloli miksija fihom 0. 3 mg ta ’ aspartame.
Cefuroximaxetil 250:
Cefuroximaxetil 250: fuq iż- żewġ naħat.
white to slightly yellowish, biconvex, oblong tablets, scored on both sides
pilloli ta ’ kulur li hu minn abjad sa ftit isfar, bikonvessi, oblungi, li fihom ferq
Dosage schedule for tablets:
Skeda tad- dożaġġ għall- pilloli:
16 Adults and children over 12 years of age
17 Adulti u adolexxenti fuq it- 12- il sena
A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase.
18 Il- kura ta ’ 20 jum tal- marda ta ’ Lyme tista ’ tikkawża l- frekwenza li tiżviluppa d- dijarea biex tiżdied.
17 Long term use of cefuroxime axetil may lead to an excess of pathogens resistant to cefuroxime axetil.
L- użu fit- tul ta ’ cefuroxime axetil jista ’ jwassal għal eċċess ta ’ patoġeni reżistenti għal cefuroxime axetil.
Cefuroximaxetil 250 contains 0,3 mg aspartame per tablet
Cefuroximaxetil 250 fih 0. 3 mg ta ’ aspartame f’ kull pillola
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics, aminoglycosides, or amphotericin as these combinations increases the risk of nephrotoxicity.
19 L- antibijotiċi cephalosporin f’ dożaġġ qawwi għandhom jingħataw bl- attenzjoni lil pazjenti li jkunu qed jirċievu dijuretiċi qawwija, aminoglycosides, jew amphotericin, għax dawn il- kumbinazzjonijiet iżidu r - riskju ta ’ nefrotossiċità.
18 Use in pregnancy There are not sufficient data on the use of cefuroxime axetil during pregnancy to assess its possible harmfulness.
L- użu waqt it- tqala M’ hemmx informazzjoni biżżejjed dwar l- użu ta ’ cefuroxime axetil matul it- tqala, biex tkun evalwata l- ħsara possibbli li jista ’ jagħmel.
Gastrointestinal disorders:
20 Disturbi gastro- intestinali:
19 Hepato-biliary disorders:
Disturbi fil- fwied u fil- marrara:
Mechanism of resistance Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms: • hydrolysis by beta-lactamases.
21 Mekkaniżmu tar- reżistenza Ir- reżistenza batterjali għal cefuroxime tista ’ tkun minħabba wieħed jew aktar mill- mekkaniżmi li ġejjin: • idrolisi minn beta- lactamases.
Escherichia coli Haemophilus influenzae Klebsiella species Moraxella catarrhalis Proteus mirabilis Proteus rettgeri Anaerobes, Peptococcus species Peptostreptococcus species Other organisms:
Escherichia coli Haemophilus influenzae Speċi Klebsiella Moraxella catarrhalis Proteus mirabilis Proteus rettgeri Anerobi, Speċi Peptococcus Speċi Peptostreptococcus Organiżmi oħrajn:
22 Coat: mannitol (E421), soluble starch (potato), talc (E553B), titanium dioxide (E171), aspartame (E951)
Kisja: mannitol (E421), soluble starch (potato), talc (E553B), titanium dioxide (E171), aspartame (E951)
Cefuroximaxetil 500, coated tablets 500 mg
Cefuroximaxetil 500, pilloli miksija 500 mg
Cefuroximaxetil 500 contain 601.44 mg cefuroxime axetil which is equivalent to 500 mg cefuroxime per tablet
Cefuroximaxetil 500 fih 601. 44 mg ta ’ cefuroxime axetil li hu ekwivalenti għal 500 mg ta ’ cefuroxime f’ kull pillola
Cefuroxime axetil 500 mg coated tablets contain 0.4 mg aspartame.
Cefuroxime axetil 500 mg pilloli miksija fihom 0. 4 mg ta ’ aspartame.
Where appropriate cefuroxime axetil is effective when used following initial parenteral cefuroxime sodium in the treatment of pneumonia and acute exacerbations of chronic bronchitis.
26 cefuroxime sodium parenterali inizjali fil- kura tal- pnewmonja u l- aggravament akut ta ’ bronkite kronika.
24 Adults and children over 12 years of age
Adulti u adolexxenti fuq it- 12- il sena
In patients who develop severe diarrhoea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account.
27 F’ pazjenti li jiżviluppaw dijarea severa matul jew wara l- użu ta ’ cefuroxime axetil, ir- riskju ta ’ kolite psewdomembranuża li tkun ta ’ periklu għall- ħajja, għandu jkun ikkunsidrat.
A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase.
Il- kura ta ’ 20 jum tal- marda ta ’ Lyme tista ’ tikkawża l- frekwenza li tiżviluppa d- dijarea biex tiżdied.
25 Long term use of cefuroxime axetil may lead to an excess of pathogens resistant to cefuroxime axetil.
L- użu fit- tul ta ’ cefuroxime axetil jista ’ jwassal għal eċċess ta ’ patoġeni reżistenti għal cefuroxime axetil.
Cefuroximaxetil 500 contains 0,4 mg aspartame per tablet
Cefuroximaxetil 500 fih 0. 4 mg ta ’ aspartame f’ kull pillola
The use of cefuroxime axetil may be accompanied by a false positive Coombs test.
28 L- użu ta ’ cefuroxime axetil jista ’ jkun akkompanjat minn test ta ’ Coombs li jagħti riżultat pożittiv falz.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics, aminoglycosides, or amphotericin as these combinations increases the risk of nephrotoxicity.
L- antibijotiċi cephalosporin f’ dożaġġ qawwi għandhom jingħataw bl- attenzjoni lil pazjenti li jkunu qed jirċievu dijuretiċi qawwija, aminoglycosides, jew amphotericin, għax dawn il- kumbinazzjonijiet iżidu r - riskju ta ’ nefrotossiċità.
26 Use in pregnancy There are not sufficient data on the use of cefuroxime axetil during pregnancy to assess its possible harmfulness.
L- użu waqt it- tqala M’ hemmx informazzjoni biżżejjed dwar l- użu ta ’ cefuroxime axetil matul it- tqala, biex tkun evalwata l- ħsara possibbli li jista ’ jagħmel.
Nervous system disorders Uncommon Headache, dizziness Very rare Restlessness, nervousness, confusion
29 Mhux Komuni Uġigħ ta ’ ras, sturdament Rari ħafna Nuqqas ta ’ kwiet f’ ġismek, nervożità, konfużjoni
27 Hepato-biliary disorders:
Disturbi fil- fwied u fil- marrara:
All cephalosporins (β -lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis.
30 Ic- cephalosporins kollha (antibijotiċi β- lactam) jinibixxu l- produzzjoni tal- ħajt taċ- ċelluli u huma inibituri selettivi tas- sintesi ta ’ peptidoglycan.
Mechanism of resistance Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms: • hydrolysis by beta-lactamases.
Mekkaniżmu tar- reżistenza Ir- reżistenza batterjali għal cefuroxime tista ’ tkun minħabba wieħed jew aktar mill- mekkaniżmi li ġejjin: • idrolisi minn beta- lactamases.
Aerobes, Gram positive:
Staphylococcus aureus (suxxettibbli għal methicillin)
Staphylococcus aureus (methicillin-susceptible) Coagulase-negative staphylococci (methicillin- susceptible) Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Aerobes, Gram negative:
31 Staphylococci negattivi għal coagulase (suxxettibbli għal methicillin) Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Aerobi, Gram- negattivi:
5.3 Preclinical safety data
32 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
30 Coat: mannitol (E421), soluble starch (potato), talc (E553B), titanium dioxide (E171), aspartame (E951)
Kisja: mannitol (E421), soluble starch (potato), talc (E553B), titanium dioxide (E171), aspartame (E951)
8, 10, 12, 14, 20, 24 tablets
8, 10, 12, 14, 20, 24 pillola
31 LABELLING
34 TIKKETTA
CARTON / BOX
KAXXA TAL- KARTUN
1 coated tablet contains cefuroxime axetil equivalent to 125 mg cefuroxime
1 pillola miksija fiha cefuroxime axetil ekwivalenti għal 125 mg ta ’ cefuroxime
See the package leaflet for further information
Ara l- fuljett fil- pakkett għal aktar tagħrif
8 tablets 10 tablets 12 tablets 14 tablets 24 tablets
8 pilloli 10 pilloli 12- il pillola 14- il pillola 24 pillola
[See Annex I - To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
To be completed nationally
Biex timtela mill- pajjiż partikolari
1 coated tablet contains cefuroxime axetil equivalent to 250 mg cefuroxime
1 pillola miksija fiha cefuroxime axetil ekwivalenti għal 250 mg ta ’ cefuroxime
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 coated tablet contains cefuroxime axetil equivalent to 500 mg cefuroxime
1 pillola miksija fiha cefuroxime axetil ekwivalenti għal 500 mg ta ’ cefuroxime
8 tablets 10 tablets 12 tablets 14 tablets 20 tablets 24 tablets
8 pilloli 10 pilloli 12- il pillola 14- il pillola 20 pillola 24 pillola
38 PACKAGE LEAFLET
41 FULJETT TA ’ TAGĦRIF
What Cefuroxime axetil is and what is it used used for Before you take Cefuroxime axetil How to take Cefuroxime axetil Possible side effects How to store Cefuroxime axetil Further information
X’ inhu Cefuroxime axetil u għalxiex jintuża Qabel ma tieħu Cefuroxime axetil Kif għandek tieħu Cefuroxime axetil Effetti sekondarji li jista ’ jkollu Kif għandek taħżen Cefuroxime axetil Aktar tagħrif
WHAT CEFUROXIME AXETIL IS AND WHAT IT IS USED FOR
X’ INHU CEFUROXIME AXETIL U GĦALXIEX JINTUŻA
Cefuroxime axetil is an antibiotic.
Cefuroxime axetil hu antibijotiku.
It belongs to a group of antibiotics that are called cephalosporins.
Jappartieni għall- grupp ta ’ antibijotiċi msejħa cephalosporins.
These types of antibiotics are similar to penicillin.
Dawn it- dawn tipi ta ’ antibijotiċi huma simili għal penicillin.
Cefuroxime axetil kills bacteria and it can be used against various sorts of infections.
Cefuroxime axetil joqtol il- batterji u jista ’ jintuża kontra diversi tipi ta ’ infezzjonijiet.
Like all antibiotics Cefuroxime axetil is only effective against some types of bacteria.
Bħall- antibijotiċi kollha Cefuroxime axetil hu effettiv biss kontra xi tipi ta ’ batterji.
So, it is only suitable for treating some types of infection.
Għalhekk, hu adattat biss biex jikkura xi tipi ta ’ infezzjoni.
Cefuroxime axetil can be used to treat: • ear, sinus and throat infections • chest infections such as bronchitis • infections of the bladder • infections in the skin and the layers just under the skin (such as furuncles, impetigo-an infection on the surface of the skin) • early Lyme disease (from a tick bite) and to prevent late complications in adults and children above the age of 12.
Cefuroxime axetil jista ’ jintuża biex jikkura: • infezzjonijiet fil- widnejn, fis- sinus u u fil- gerżuma • infezzjonijiet fis- sider bħal bronkite • infezzjonijiet tal- bużżieqa ta ’ l- awrina • infezzjonijiet fil- ġilda u fis- saffi kemm kemm taħt il- ġilda (bħal furunkli, impetigo - infezzjoni fuq wiċċ il- ġilda) • marda ta ’ Lyme fl- istadju bikri (minn gidma ta ’ qurdiena) u biex jiġu evitati kumplikazzjonijiet aktar tard fl- adulti u fi tfal li għandom aktar minn 12- il sena.
BEFORE YOU TAKE CEFUROXIME AXETIL
QABEL MA TIEĦU CEFUROXIME AXETIL
Do not take this medicine if:
Tiħux din il- mediċina jekk:
- You are allergic (hypersensitive) to Cefuroxime axetil or to any of the other ingredients of this
- Inti allerġiku/ a (tbati minn sensittività eċċessiva) għal Cefuroxime axetil jew għal xi sustanzi oħra
medicine (See “ Further Information”).
ta ’ din il- mediċina (ara “ Tagħrif addizzjonali ”).
- You are allergic (hypersensitive) to any other cephalosporin type of antibiotic
- Inti allerġiku/ a (tbati minn sensittività eċċessiva) għal kwalunkwe tipi antibijotiċi oħrajn ta ’
- You have ever had a severe allergic reaction to any sort of penicillin antibiotic
- Xi darba kellek reazzjoni allerġika severa għal kwalunkwe tip ta ’ antibijotiku tal- penicillin
Not all people who are allergic to penicillins are also allergic to cephalosporins.
43 Mhux in- nies kollha li huma allerġiċi għal penicillins huma allerġiċi wkoll għal cephalosporins.
However, you should not take this medicine if you have ever had a severe allergic
Madankollu, m’ għandekx tieħu din il- mediċina jekk xi darba kellek reazzjoni allerġika severa għal kwalunkwe penicillin.
This is because you might also be allergic to this medicine.
Dan hu minħabba l- fatt li tista ’ tkun allerġiku/ a għal din il- mediċina.
If you are not sure about anything, ask your doctor or pharmacist.
Jekk m’ intix ċert/ a dwar xi ħaġa, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Take special care with this medicine if:
Oqgħod attent/ a ħafna b’ din il- mediċina jekk:
- You have ever had an allergic reaction to penicillins, tell your doctor or pharmacist before
- Xi darba kellek reazzjoni allerġika għal penicillins, għid it- tabib jew lill- ispiżjar tiegħek
you take this medicine.
qabel ma tieħu din il- mediċina.
- If you have severe and persistant diarrhea while using or after using cefuroxime axetil –
- Jekk ikollok dijarea severa u persistenti waqt li tkun qed tuża, jew wara li tuża cefuroxime
contact your doctor and use no medicines for diarrhea that inhibit peristalsis;
axetil – ikkuntattja lit- tabib tiegħek u tuża l- ebda mediċini kontra d- dijarea li jinibixxu l - peristalsi;
- if you have abdominal complaints such as vomiting and diarrhoea.
- jekk ikollok disturbi fiż- żaqq, bħal rimettar u dijarea.
It is possible that insufficient
Hu possibbli li ammont insuffiċjenti ta ’
cefuroxime axetil will be absorbed by the body, your doctor will recommend an injection of cefuroxime;
cefuroxime axetil ser ikun assorbit mill- ġisem, u t- tabib tiegħek ser jirrakkomanda injezzjoni ta ’ cefuroxime;
- if you get fever and feel ill a short time after using cefuroxime axetil for the treatment of
- jekk ikollok id- deni u tħossok marid/ a ftit wara li tuża cefuroxime axetil għall- kura tal -
Lyme disease (this is a sign of a disease called Jarisch Herxheimer disease)
marda ta ’ Lyme (dan hu sinjal ta ’ marda msejħa l- marda ta ’ Jarisch Herxheimer)
- if you are also using medicines that decrease stomach acidity.
- jekk qed tuża wkoll mediċini li jnaqqsu l- aċidità fl- istonku.
It is possible that insufficient
Hu possibbli li Cefuroximaxetil
Cefuroximaxetil will be absorbed by the body (see: “ Using other medicines”);
insuffiċjenti ser ikun assorbit mill- ġisem (ara: “ Meta tuża mediċini oħra ”);
- some children have experienced mild to moderate hearing loss during treatment with
- xi t- tfal kellhom telf fis- sens tas- smigħ li kien minn ħafif sa moderat matul il- kura b’ cefuroxime
cefuroxime sodium
sodium
- Having a course of cefuroximeaxetil can temporarily increase the chance that you can get
- Li tieħu kors ta ’ cefuroximeaxetil jista ’ jżid temporanjament iċ- ċans li jkollok infezzjonijiet
infections caused by other sorts of germs.
ikkawżati minn tipi oħrajn ta ’ mikrobi.
For example, thrush may occur.
Pereżempju, jisgħu jseħħu tbajja ’ bojod.
Talk to your doctor or pharmacist if any of the above apply to you.
Kellem lit- tabib jew lill- ispiżjar tiegħek qabel jekk xi waħda minn dawn t’ hawn fuq japplikaw għalik:
In some cases, medicines can affect the way other medicines work.
F’ xi każijiet, il- mediċini jistgħu jaffettwaw il- mod li mediċini oħrajn jaħdmu.
This may be the case when Cefuroximaxetil is used together with:
Dan jista ’ jkun il- każ meta Cefuroximaxetil jintuża flimkien ma ’:
- medicines that decrease stomach acidity (medicines for heartburn);
- mediċini li jnaqqsu l- aċidità fl- istonku (mediċini għal qrusa fl- istonku);
- certain other medicines for the prevention or control of infections (antibiotics), such as
- ċerti mediċini oħrajn għall- prevenzjoni jew il- kontroll ta ’ infezzjonijiet (antibijotiċi), bħal
tetracyclines, macrolides, chloramphenicol, aminoglycosids;
tetracyclines, macrolides, chloramphenicol, aminoglycosids;
- probenecid (a medicine for gout and other ailments).
- probenecid (mediċina għall- gotta u mard ieħor).
Taking this medicine with cefuroxime
Li tieħu din il- mediċina ma ’ cefuroxime axetil
axetil can cause higher and more persistent levels of cefuroxime in the blood and bile;
jista ’ jikkawża livelli ogħla u aktar persistenti ta ’ cefuroxime fid- demm u fil- bila;
- Water tablets or injections (diuretics)
- Pilloli jew injezzjonijiet ta ’ l- ilma (dijuretiċi)
- Certain medicines against fungal infections (Amphotericin)
- Ċerti mediċini kontra l- infezzjonijiet fungali (Amphotericin)
- certain tests, such as tests for determining the amount of glucose (sugar) in the blood or urine
- ċerti testijiet, bħal testijiet biex jiġi stabbilit l- ammont ta ’ glucose (zokkor) fid- demm jew fl -
- certain tests, such as tests for determining some substances in your blood (Coombs test)
- ċerti testijiet, bħal testijiet biex jiġu stabbiliti xi sustanzi fid- demm tiegħek (test ta ’ Coombs)
Taking Cefuroxime axetil coated tablets with food and drink
Kif tieħu l- pilloli miksija Cefuroxime axetil ma ’ l- ikel u max- xorb
Take this medicine after meals.
Ħu din il- mediċina wara l- ikel.