qanastek/EMEA-V3 huggingface dataset:
Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/ benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Madankollu, f’ każijiet rari ħafna, wara dokumentazzjoni mikrobijoloġika ta ’ l - organiżmu li qed jikkawża l- marda u valutazzjoni tal- bilanċ ta ’ riskju/ benefiċċju, ciprofloxacin jista ’ jiġi preskritt lil dawn il- pazjenti għall- kura ta ’ ċertu infezzjonijiet severi, speċjalment f’ każ ta ’ falliment tat- terapija stàndard jew reżistenza tal- batterja, fejn it- tagħrif mikrobijoloġiku jista ’ jiġġustifika l- użu ta ’ ciprofloxacin.
44 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Tendinite u tiċirit tat- tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b’ ciprofloxacin, anki fl- ewwle 48 siegħa ta ’ kura.
At any sign of tendinitis (e. g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
46 Ma ’ xi sinjal ta ’ tedinite (e. ż. nefħa bl- uġigħ, infjammazzjoni), kura b’ ciprofloxacin għandha titwaqqaf.
Ciprofloxacin should be used with caution in patients with myasthenia gravis (see section 4.8).
Ciprofloxacin għandu jintuża b’ kawtela f’ pazjenti b’ myasthenia gravis (ara sezzjoni 4. 8).
In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
F’ każijiet bħal dawn, ciprofloxacin għandu jitwaqqaf immedjatament, u għandha tinbeda terapija xierqa.
Resistance During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.
Reżistenza Waqt jew wara kors ta ’ kura b’ ciprofloxacin jistgħu jiġu iżolati batterja li juru reżistenza għal ciprofloxacin, bi jew bla superinfezzjoni evidenti klinikament.
There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/ or infections caused by Staphylococcus and Pseudomonas species.
Jista ’ jkun hemm riskju partikolari ta ’ selezzjoni għall- batterja reżistenti għal ciprofloxacin waqt kura fit- tul u meta jiġu kkurati infezzjonijiet li jittieħdu minn sptar u/ jew infezzjonijiet ikkawżati mill- ispeċi Staphylococcus u Pseudomonas.
45 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, ropinirole, tizanidine).
47 Citokromju P450 Ciprofloxacin jinibixxi lil CYP1A2 u għalhekk jista ’ jikkawża żjieda fil- konċentrazzjoni fis- serum ta ’ sustanzi mogħtija fl- istess waqt metabolizzati minn din l- enżima (e. ż. theophylline, clozapine, ropinirole, tizanidine).
Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e. g. of theophylline) may be necessary (see section 4.5).
Għalhekk, pazjenti li qed jieħdu dawn is- sustanzi flimkien ma ’ ciprofloxacin għandhom jiġu sorveljati mill- viċin għall- sinjali kliniċi ta ’ doża eċċessiva, u jista ’ jkun hemm bżonn ta ’ determinazzjoni tal - konċentrazzjonijiet fis- serum, (e. z. ta ’ theophylline) (ara sezzjoni 4. 5).
Effects of ciprofloxacin on other medicinal products:
Effetti ta ’ ciprofloxacin fuq prodotti mediċinali oħra:
46 Theophylline
48 Theophylline
Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration.
L- għoti fl- istess waqt ta ’ ciprofloxacin u theophylline jista ’ jikkawża żjieda mhux mixtieqa fil - konċentrazzjoni ta ’ theophylline fis- serum.
During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).
Waqt l- użu fl- istess waqt il - konċentrazzjonijiet ta ’ theophylline fis- serum għandhom jiġu ċċekkjati u d- doża ta ’ theophylline għandha tiġi mnaqqsa kif meħtieġ (ara sezzjoni 4. 4).
As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.
Bħala miżura ta ’ prekawzjoni, ikun aħjar li l- użu ta ’ ciprofloxacin ikun evitat waqt it- tqala.
47 4.7 Effects on ability to drive and use machines
49 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Due to its neurological effects, ciprofloxacin may affect reaction time.
Minħabba l- effetti newroloġiċi tiegħu, ciprofloxacin jista ’ jaffettwa l- ħin ta ’ reazzjoni.
≥ 1/ 100
≥
≥ 1/ 1 000 to <
1/ 100 sa < 1/ 10
≥ 1/ 10 000 to <
≥ 1/ 1 000 sa < ≥ 1/ 10 000 sa < 1/ 1 1/ 100 000
not known
mhux
to < 1/ 10
Organi
(cannot be estimated from available data)
magħrufa (ma tistax tittieħed stima mid - data
Infections and Infestations
disponibbli) Superinfezzjonij Kolite assoċjata Infezzjonijiet u Infestazzjonijie t
Mycotic superinfections
ietmill- moffa
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
ma ’ antibijotiċi (rari ħafna b’ possibiltà ta ’ riżultat fatali) (ara sezzjoni 4. 4)
Blood and Lymphatic System Disorders
Agranuloċitosi
Eosinophilia
Lewkoċitosi
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
Tromboċitopenija Tromboċitemija
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
periklu għall - ħajja) Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall - ħajja)
Immune System Disorders
Sistema
Allergic reaction Allergic oedema / angiooedema
/ anġjoedima
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
Xokk anafilattiku (ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4) Reazzjoni bħall - marda tas- serum
Metabolism and Nutrition Disorders
Disturbi fil - Metaboliżmu u n- Nutrizzjoni
Hyperglycaemia
Reazzjonijiet
Psychiatric Disorders
diżorjentament
Psychomotor hyperactivity / agitation
psikomotorja / aġitazzjoni
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Reazzjoni ta ’ ansjetà Ħolm mhux normali
Psychotic reactions (see section 4.4)
sezzjoni 4. 4)
48 System Organ
Sistema tal -
≥ 1/ 100
1/ 100 sa < 1/ 10
≥ 1/ 1 000 to <
≥ 1/ 1 000 sa < ≥ 1/ 10 000 sa < 1/ 1 1/ 100 000
not known
magħrufa (ma tistax tittieħed stima mid - data
to < 1/ 10
Uġigħ ta ’ ras
1/ 100
Emigranja
1/ 1 000
Sistema
(cannot be estimated from available data)
Disturbi fil -
Nervous System Disorders
Disturbi ta ’ l -
Headache Dizziness Sleep disorders Taste disorders
irqad Disturbi fit - togħma
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Tregħid Aċċessjonijiet (ara sezzjoni 4. 4) Vertigo
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Disturb fil- mixja Disturbi fin- nerv tax- xamm Pressjoni intrakranjali għolja
Eye Disorders Ear and Labyrinth Disorders
Disturbi fl - Għajnejn Disturbi fil -
Visual disturbances Tinnitus Hearing loss / Hearing impaired
Disturbi fil- vista Żanżin fil- widnejn
Visual colour distortions
Disturbi fil- kuluri visivi
Cardiac Disorders
Disturbi fil - Qalb
Ventricular arrhythmia, QT prolongation, torsades de pointes *
Arritmija ventrikulari, titwil tal - QT, torsades de pointes *
Vasodilatation Hypotension Syncope
Vasodilatazzjoni Pressjoni baxxa Sinkope
Vasculitis
Vaskulite
Gastrointestinal Disorders
Disturbi
Nausea Diarrhoea
Gastro - intestinali
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Weġgħat gastro - intestinali u addominali Dispepsja Gass
Pancreatitis
Disturbi fil - Fwied u fil - Marrara
Hepatobiliary Disorders
Żjieda fit - transaminases Żjieda fil -
Increase in transaminases Increased bilirubin
Indeboliment tal - fwied Ikterus kolestatiku
Hepatic impairment Cholestatic icterus Hepatitis
Nekrożi tal- fwied (rari ħafna tavvanza għall -
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
insuffiċjenza tal - fwied ta ’ periklu għall- ħajja) (ara sezzjoni 4. 4)
49 System Organ
51 Sistema tal -
1/ 100
disponibbli) Ġilda u fit -
1/ 1 000
Ħakk
(cannot be estimated from available data)
fotosensittività (ara
Skin and Subcutaneous Tissue Disorders
Tessuti ta ’ Taħt il- Ġilda
Rash Pruritus Urticaria
Urtikarja
Photosensitivity reactions (see section 4.4)
sezzjoni 4. 4)
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
multiforme Eritima nodosum Sindrome Stevens- Johnson (b’ potenzjal ta ’ periklu għall - ħajja) Nekrolisi epidermika tossika (b’ potenzjal ta ’ periklu għall - ħajja)
Musculoskeletal, Connective Tissue and Bone Disorders
Connective
Musculoskeletal pain (e. g. extremity pain, back pain, chest pain) Arthralgia
estremitajiet,
Myalgia Arthritis Increased muscle tone and cramping
uġigħ fis- sider) Artralġja
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
tendon) (ara sezzjoni 4. 4) Rkadar tas - sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
Renal and Urinary Disorders
Insuffiċjenza renali
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
Ematurja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizjali
General Disorders and Administration Site Conditions
u Kondizzjonijiet ta 'Mnejn Jingħata
Investigations
Investigazzjonij
Increase in blood alkaline phosphatase
alkaline
Prothrombin level abnormal Increased amylase
Żjieda fl- amylase
4.9 Overdose
52 4. 9 Doża eċċessiva
50 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Doża eċċessiva ta ’ 12 g ġiet irrapportata li twassal għall- sintomi ħfief ta ’ tossiċità.
Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.
L- effikaċja tippendi l- aktar fuq ir- relazzjoni bejn il- konċentrazzjoni massima fis- serum (Cmax) u l - konċentrazzjoni ta ’ inibizzjoni minima (MIC) ta ’ ciprofloxacin għal patoġenu batterju u r- relazzjoni bejn l- erja taħt il- kurva (AUC) u l- MIC.
The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable.
L- ammont ta ’ cross- resistance bejn ciprofloxacin u floroquinolones oħra li jirriżulta huwa varjabbli.
EUCAST Recommendations
53 Rakkomandazzjonijiet EUCAST
Haemophilus influenzae and Moraxella catarrhalis
Haemophilus influenzae u Moraxella catarrhalis
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4) COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Klassifikazzjoni ta ’ ispeċi rilevanti skond is- suxxettibilità għal ciprofloxacin (għall- ispeċi ta ’ Streptococcus ara sezzjoni 4. 4) SPEĊI SUXXETTIBLI B’ MOD KOMUNI Mikro- organiżmi aerobiċi Gram- positive Bacillus anthracis (1)
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. *(2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+* Campylobacter spp. +* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca
Yersinia pestis Mikro- organiżmi anaerobiċi Mobiluncus Mikro- organiżmi oħrajn Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPEĊI LI GĦALIHOM REŻISTENZA MIKSUBA TISTA ’ TKUN PROBLEMA Mikro- organiżmi aerobiċi Gram- positive Enterococcus faecalis ($)
52 Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
Mikro- organiżmi aerobiċi Gram- negative Acinetobacter baumannii+ Burkholderia cepacia+ * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
Propionibacterium acnes INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
Propionibacterium acnes ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
5.2 Pharmacokinetic properties
55 5. 2 Tagħrif farmakokinetiku
53 Protein binding of ciprofloxacin is low (20-30%).
It- twaħħil mal- proteini ta ’ ciprofloxacin huwa baxx (20- 30%).
Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4).
Kienu irrapportati konċentrazzjonijiet baxxi ta ’ erba ’ metaboliti, li kienu identifikati bħala: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) u formylciprofloxacin (M 4).
Excretion of ciprofloxacin (% of dose) Oral Administration
Tneħħija ta ’ ciprofloxacin (% tad- doża) Għoti Orali
In a study in children Cmax and AUC were not age-dependent (above one year of age).
56 Fi studju fit- tfal Cmax u AUC ma kienux dipendenti mill- età (’ l fuq minn età ta ’ sena).
Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or
Bħal numru ta ’ quinolones oħra, ciprofloxacin huwa fototossiku fil- bhejjem f’ livelli ta ’ esponiment klinikament rilevanti.
54 phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
Tagħrif dwar il- fotomutaġeniċità / fotokarċinoġeniċità wera effett fotomutaġeniku jew fototumuroġeniku dgħajjef ta ’ ciprofloxacin in- vitro u f’ esperimenti fuq il - bhejjem.
Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions.
Studji b’ bhejjem maturi (far, kelb) ma wrew l- ebda evidenza ta ’ feriti fil- qarquċa.
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 500 mg pilloli miksija b’ rita [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Ciprofloxacin Bayer 500 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 500 mg pilloli miksija b’ rita huma ndikati għall- kura ta ’ l- infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
• Infections of the skin and soft tissue caused by Gram-negative bacteria
59 • Infezzjonijiet tal- ġilda u tat- tessut artab ikkawżati minn batterja Gram- negative
57 • Malignant external otitis
• Otite esterna malinna
• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa • Complicated urinary tract infections and pyelonephritis • Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Infezzjonijiet bronko- pulmonari f’ fibrożi ċistika kkawżata minn Pseudomonas aeruginosa Infezzjonijiet ikkumplikati fl- apparat ta ’ l- awrina u pijelonefrite Antraċe meħud man- nifs (profilassi wara esponiment u kura ta ’ fejqan)
The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
Id- dożaġġ huwa determinat mill- indikazzjoni, is- severità u s- sit ta ’ l- infezzjoni, s- suxxettibilità ta ’ l - organiżmu( i) li qed jikkawża/ jikkawżaw għal ciprofloxacin, il- funzjoni renali tal- pazjent u, fit- tfal u l - adoloxxenti l- piż tal- ġisem..
Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Pseudomonas aeruginosa, Acinetobacter, jew Staphylococci) għandu mnejn tkun tinħtieġ dożi ogħla ta ’ ciprofloxacin u għoti flimkien ma 'sustanzi kontra l- batterja xierqa oħra.
Complicated
Pijelonefrite
500 mg twice daily to
500 mg darbtejn kuljum
at least 10 days, it can be
ta ’ l- inqas 10 ġranet, jista ’
pyelonephritis
komplikata
750 mg twice daily
sa 750 mg darbtejn kuljum
continued for longer than 21 days in some specific circumstances (such as abscesses)
jitkompla għal aktar minn 21 ġurnata f’ xi ċirkostanzi speċifiċi (bħal axxessi)
2 to 4 weeks (acute) to 4 to 6 weeks (chronic)
2- 4 ġimgħat (akuta) sa 4- 6 ġimgħat (kronika)
60 days from the confirmation of Bacillus anthracis exposure
60 ġurnata mill- konferma ta ’ esponiment għal Bacillus anthracis
Complicated urinary tract infections and pyelonephritis
Infezzjonijiet komplikati ta ’ l - apparat ta ’ l- awrina u pijelonefrite
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Profilassi wara esponiment jew kura li tfejjaq ta ’ antraċe meħud man- nifs għall- persuni li jistgħu jirċievu kura mill- ħalq meta xieraq klinikament.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
L- għoti tal- mediċina għandu jinbeda mill - aktar fis possibli wara suspett jew konferma ta ’ esponiment.
10 mg/ kg body weight twice daily to 15 mg/ kg body weight twice daily with a maximum of 500 mg per dose.
10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa 15 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 500 mg kull doża.
Renal and hepatic impairment
62 Indeboliment tal- kliewi u tal- fwied
60
Dosa Orali
• Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1).
Sensittività eċċessiva għas- sustanza attiva, għal quinolones oħra jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1).
• Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).
L- għoti flimkien ta ’ ciprofloxacin u tizanidine (ara sezzjoni 4. 5).
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Infezzjonijiet ikkawżati minn Streptococci (inkluż Streptococcus pneumoniae) Ciprofloxacin mhux irrakkomandat għall- kura ta ’ infezzjonijiet ikkawżati minn streptococci minħabba effikaċja mhux adegwata
61 Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
63 Dijarea tal- vjaġġaturi L- għażla ta ’ ciprofloxacin għandha tieħu f’ kunsiderazzjoni tagħrif dwar ir- reżistenza għal ciprofloxacin f’ patoġeni rilevanti fil- pajjiżi fejn sar il- vjaġġ.
Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Infezzjonijiet ta ’ l- għadam u l- ġogi Ciprofloxacin għandu jintuża flimkien ma ’ sustanzi kontra l- mikrobi oħra skond ir- riżultati tad - dokumentazzjoni mikrobijoloġika.
62 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Tendinite u tiċirit tat- tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b’ ciprofloxacin, anki fl- ewwle 48 siegħa ta ’ kura.
In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
F’ każijiet bħal dawn, ciprofloxacin għandu jitwaqqaf immedjatament u għandha tinbeda terapija xierqa.
There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/ or infections caused by Staphylococcus and Pseudomonas species.
65 selezzjoni għall- batterja reżistenti għal ciprofloxacin waqt kura fit- tul u meta jiġu kkurati infezzjonijiet li jittieħdu minn sptar u/ jew infezzjonijiet ikkawżati mill- ispeċi Staphylococcus u Pseudomonas.
63 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, ropinirole, tizanidine).
Citokromju P450 Ciprofloxacin jinibixxi lil CYP1A2 u għalhekk jista ’ jikkawża żjieda fil- konċentrazzjoni fis- serum ta ’ sustanzi mogħtija fl- istess waqt metabolizzati minn din l- enżima (e. ż. theophylline, clozapine, ropinirole, tizanidine).
Methotrexate
66 Methotrexate
64 Theophylline
Theophylline
Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co-administration with ciprofloxacin (see section 4.4).
Waqt u eżatt wara l- għoti flimkien ma ’ ciprofloxacin, huma rrakkomandatii sorveljanza ta ’ effetti sekondarji relatati ma ’ ropinirole u aġġustament xieraq fid- doża (ara sezzjoni 4. 4).
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/ neonatal toxicity of ciprofloxacin.
Tqala It- tagħrif disponibbli dwar l- għoti ta ’ ciprofloxacin nisa tqal ma jindika l- ebda tossiċità malformattiva jew tossiċità għall- fetu/ tarbija tat- twelid ta ’ ciprofloxacin.
In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).
F’ bhejjem b’ età żgħira u mhux imwielda esposti għal quinolones, kienu osservati effetti fuq il- qarquċa mhux matura, għalhekk, ma jistax jiġi eskluż li l - mediċina tista ’ tikkawża ħsara lill- qarquċa tal- ġogi u l- għekiesi fl- organiżmu immatur / fetu uman (ara sezzjoni 5. 3).
As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.
67 Bħala miżura ta ’ prekawzjoni, ikun aħjar li l- użu ta ’ ciprofloxacin ikun evitat waqt it- tqala.
65 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Class
Klassifika ta ’
≥ 1/ 100
1/ 100 sa
≥ 1/ 1 000 to <
1/ 1 000 sa
≥ 1/ 10 000 to <
≥ 1/ 10 000 sa <
Infections and Infestations
disponibbli) Superinfezzjonij Kolite assoċjata Infezzjonijiet u Infestazzjoniji et
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall- ħajja)
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
(ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4) Reazzjoni bħall - marda tas- serum
Psychomotor hyperactivity / agitation
psikomotorja /
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Reazzjoni ta ’
66 System Organ
Sistema tal -
(cannot be estimated from available data)
disponibbli)
Nervous System Disorders
Sistema
Cardiac Disorders
Sistema Labirintika Disturbi fil - Qalb
Tachycardia
Telf ta ’ smigħ / Nuqqas fis- smigħ Takikardija
Increase in transaminases Increased bilirubin
Indeboliment tal - fwied Ikterus
Hepatic impairment Cholestatic icterus Hepatitis
Nekrożi tal- fwied (rari ħafna tavvanza għall- insuffiċjenza
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
tal- fwied ta ’ periklu għall- ħajja) (ara sezzjoni 4. 4)
67 System Organ
69 Sistema tal -
(cannot be estimated from available data)
disponibbli) Disturbi fil -
Skin and Subcutaneous Tissue Disorders
Reazzjonijet ta ’
Rash Pruritus Urticaria
Eritima multiforme
Photosensitivity reactions (see section 4.4)
(ara sezzjoni 4. 4)
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Eritima nodosum Sindrome Stevens - Johnson (b’ potenzjal ta ’ periklu għall - ħajja) Nekrolisi epidermika tossika (b’ potenzjal ta ’ periklu għall- ħajja)
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
sezzjoni 4. 4) Rkadar tas- sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
Renal and Urinary Disorders
Disturbi fil -
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
renali Ematurja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizjali
General Disorders and Administration Site Conditions
Ġenerali u Kondizzjonijiet ta 'Mnejn Jingħata
Investigations
Investigazzjon
4.9 Overdose
70 4. 9 Doża eċċessiva
68 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Doża eċċessiva ta ’ 12 g ġiet irrapportata li twassal għall- sintomi ħfief ta ’ tossiċità.
EUCAST Recommendations
71 Rakkomandazzjonijiet EUCAST
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4)
Klassifikazzjoni ta ’ ispeċi rilevanti skond is- suxxettibilità għal ciprofloxacin (għall- ispeċi ta ’ Streptococcus ara sezzjoni 4. 4) SPEĊI SUXXETTIBLI B’ MOD KOMUNI Mikro- organiżmi aerobiċi Gram- positive Bacillus anthracis (1)
70 COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Mikro- organiżmi aerobiċi Gram- negative Aeromonas spp.
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. * (2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+* Campylobacter spp. +* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
Yersinia pestis Mikro- organiżmi anaerobiċi Mobiluncus Mikro- organiżmi oħrajn Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPEĊI LI GĦALIHOM REŻISTENZA MIKSUBA TISTA ’ TKUN PROBLEMA Mikro- organiżmi aerobiċi Gram- positive Enterococcus faecalis ($)
71 Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
Propionibacterium acnes ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.
Ir- rata ta ’ reżistenza għal methicillin hija madwar 20 sa 50% fost l- ispeċi ta ’ staphylococci kollha u ġeneralment hija ogħla f’ iżolati minn infezzjonijiet li jittieħdu minn sptar..
5.2 Pharmacokinetic properties
73 5. 2 Tagħrif farmakokinetiku
Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
Ciprofloxacin jilħaq konċentrazzjonijiet għolja f’ varjetà ta ’ tessuti bħall- pulmun (fluwidu ta ’ l- epitelju, makrofaġi alveolari, tessut tal- bijopsija), sinuses, feriti infjammati (fluwidu fin - nuffata kantaridin), u l - apparat uroġenitali (awrina, prostata, endometriju) fejn jintlaħqu konċentrazzjonijiet totali li jaqabżu dawk tal- konċentrazzjonijiet fil- plażma.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
Ciprofloxacin huwa magħruf li huwa inibitur moderat ta ’ isoenżimi CYP 450 1A2.
72 Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.
Ciprofloxacin jitneħħa fil- biċċa l- kbira mhux mibdul kemm mill- kliewi kif ukoll, fi kwantità inqas, fl - ippurgar.
In a study in children Cmax and AUC were not age-dependent (above one year of age).
74 Fi studju fit- tfal Cmax u AUC ma kienux dipendenti mill- età (’ l fuq minn età ta ’ sena).
73 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
74 1.
76 1.
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 750 mg pilloli miksija b’ rita [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Ciprofloxacin Bayer 750 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 750 mg pilloli miksija b’ rita huma ndikati għall- kura ta ’ l- infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
• Infections of the skin and soft tissue caused by Gram-negative bacteria
77 • Infezzjonijiet tal- ġilda u tat- tessut artab ikkawżati minn batterja Gram- negative
75 • Malignant external otitis
• Otite esterna malinna
Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Pseudomonas aeruginosa, Acinetobacter jew Staphylococci) għandu mnejn tkun tinħtieġ dożi ogħla ta ’ ciprofloxacin u għoti flimkien ma 'sustanzikontra l- batterja xierqa oħra.
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
Tul totali tal- kura (potenzjalment inkluż bidu ta ’ kura parenterali b ’ ciprofloxacin)
Infections of the upper respiratory
Infezzjonijiet ta ’ Irkadar akut ta ’ sinusite l- apparat kronika respiratorju ta ’
Chronic suppurative otitis media
fuq Otite medja kronika b’ suppurazzjoni
Urinary tract infections
Infezzjonijiet ta ’ l- apparat ta ’ l -
250 mg twice daily to 500 mg twice daily
250 mg darbtejn kuljum sa 500 mg
Genital tract infections
Infezzjonijiet ta ’ l- apparat ġenitali
Epididymo-orchitis and pelvic inflammatory diseases
Epididimo- orkite u mard infjammatorju tal - pelvi
Infections of the gastro-intestinal tract and intra- abdominal infections
Infezzjonijiet ta ’ l- apparat gastro - intestinali u infezzjonijiet intra- addominali
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea
Dijarea kkawżata minn patoġeni batteriċi inkluż Shigella spp. minbarra Shigella dysenteriae tip 1 u kura emperika ta ’ dijarea severa tal - vjaġġaturi
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
Typhoid fever Infezzjonijiet intra - addominali kkawżati minn batterja Gram - negative (skond is - severità u l- organiżmu) Ciprofloxacin Bayer għandu jingħata flimkien ma ’ sustanza anti- anaerobika
Infections of the skin and soft tissue
Infezzjonijiet tal- ġilda u tat- tessut artab
Treatment of infections or prophylaxis of infections in neutropenic patients Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
Kura ta ’ infezzjonijiet jew profilassi ta ’ infezzjonijiet f’ pazjenti b’ newtropenija Ciprofloxacin għandu jingħata flimkien ma ’ sustanza( i) antibatterika xierqa skond il - gwida uffiċjali.
Therapy should be continued over the entire period of neutropenia
Terapija għandha titkompla tul il- perijodu kollu tan - newtropenija
10 mg/ kg body weight twice daily to 15 mg/ kg body
Profilassi wara esponiment 10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa jew kura li tfejjaq ta ’ 15 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum antraċe meħud man- nifs b’ massimu ta ’ 500 mg kull doża. għall- persuni li jistgħu jirċievu kura mill- ħalq meta xieraq klinikament.
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
Infezzjonijiet severi oħra 20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża
According to the type of infections
Għandha tkun adattata għat- tip ta ’ infezzjoni
Geriatric patients should receive a dose selected according to the severity of the infection and the patient’ s creatinine clearance.
Geriatric patients should receive a dose selected according to as low as possible depending on the severity of their infection illness and their the patient’ s creatinine clearance.
Renal and hepatic impairment
80 Indeboliment tal- kliewi u tal- fwied
78
Dosa Orali
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Infezzjonijiet ikkawżati minn Streptococci (inkluż Streptococcus pneumoniae) Ciprofloxacin mhux irrakkomandat għall- kura ta ’ infezzjonijiet ikkawżati minn streptococci ta ’ minħabba effikaċja mhux adegwata.
79 Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
81 Dijarea tal - vjaġġaturi L- għażla ta ’ ciprofloxacin għandha tieħu f’ kunsiderazzjoni tagħrif dwar ir- reżistenza għal ciprofloxacin f’ patoġeni rilevanti fil- pajjiżi fejn sar il- vjaġġ.
80 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Tendinite u tiċirit tat- tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b’ ciprofloxacin, anki fl- ewwle 48 siegħa ta ’ kura.
Hepatobiliary system Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8).
Sistema tal- fwied u tal- marrara Każijiet ta ’ nekrożi tal- fwied u insuffiċjenza tal- fwied ta ’ periklu għall- ħajja ġew irrapportati b ’ ciprofloxacin (ara sezzjoni 4. 8).
There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/ or infections caused by Staphylococcus and Pseudomonas species.
83 selezzjoni għall- batterja reżistenti għal ciprofloxacin waqt kura fit- tul u meta jiġu kkurati infezzjonijiet li jittieħdu minn sptar u/ jew infezzjonijiet ikkawżati mill- ispeċi Staphylococcus u Pseudomonas.
81 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, ropinirole, tizanidine).
Citokromju P450 Ciprofloxacin jinibixxi lil CYP1A2 u għalhekk jista ’ jikkawża żjieda fil- konċentrazzjoni fis- serum ta ’ sustanzi mogħtija fl- istess waqt metabolizzati minn din l- enżima (e. ż. theophylline, clozapine, ropinirole, tizanidine).
Methotrexate
84 Methotrexate
82 Theophylline
Theophylline
. Simultaneous administration of ciprofloxacin with warfarin may augment its anti-coagulant effects.
L- għoti ta ’ ciprofloxacin flimkien ma ’ warfarin jista ’ jqawwi l- effetti tiegħu kontra l- koagulazzjoni tad- demm.
As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.
85 Bħala miżura ta ’ prekawzjoni, ikun aħjar li l- użu ta ’ ciprofloxacin ikun evitat waqt it- tqala.
83 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
L - analiżi ta ’ frekwenza jieħu f’ kunsiderazzjoni tagħrif minn għoti orali kif ukoll minn għoti fil- vini ta ’ ciprofloxacin..
Frequency
Frekwenza mhux
≥ 1/ 100
≥ 1/ 100 sa <
≥ 1/ 1 000 to <
Komuni
not known
magħrufa
1/ 1 000
Superinfezzjo
(cannot be estimated from available data)
Infestazzjonijiet
Infections and Infestations
ma ’ antibijotiċi
Mycotic superinfections
moffa
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
(rari ħafna b’ possibiltà ta ’ riżultat fatali) (ara sezzjoni 4. 4)
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
ħajja) Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall - ħajja)
Immune System Disorders
Sistema Immuni
Allergic reaction Allergic oedema / angiooedema
Edima allerġika / anġjoedima
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Reazzjoni ta ’ ansjetà Ħolm mhux
84 System Organ
86 Sistema tal -
1/ 1 000
normali Depressjoni Alluċinazzjonijiet
(cannot be estimated from available data)
stima mid- data disponibbli)
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
koordinazzjoni Disturb fil- mixja Disturbi fin- nerv tax- xamm Pressjoni intrakranjali għolja
Gastrointestinal Disorders
intestinali
85 System Organ
87 Sistema tal -
Skin and Subcutaneous Tissue Disorders
u fit- Tessuti ta ’
Musculoskeletal pain (e. g. extremity pain, back pain, chest pain) Arthralgia
Tiċrit tat- tendon
Myalgia Arthritis Increased muscle tone and cramping
estremitajiet, uġigħ fid - dahar, uġigħ fis- sider) Artralġja
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
(l- aktar Achilles tendon) (ara sezzjoni 4. 4) Rkadar tas - sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
Investigations
Livell ta ’
Prothrombin level abnormal Increased amylase
mhux normali Żjieda fl- amylase
86 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Doża eċċessiva ta ’ 12 g ġiet irrapportata li twassal għall- sintomi ħfief ta ’ tossiċità.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
88 Sintomi ta ’ doża eċċessiva jikkonsistu minn sturdment, tregħid, uġigħ ta 'ras, għeja, aċċessjonijiet, alluċinazzjonijiet, konfużjoni, skomdu addominali, indeboliment tal- kliewi u tal- fwied kif ukoll kristallurja u ematuria.
88 COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Mikro- organiżmi aerobiċi Gram- negative Aeromonas spp.
89 Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
Propionibacterium acnes ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
5.2 Pharmacokinetic properties
91 5. 2 Tagħrif farmakokinetiku
90 Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.
Ciprofloxacin jitneħħa fil- biċċa l- kbira mhux mibdul kemm mill- kliewi kif ukoll, fi kwantità inqas, fl - ippurgar.
In a study in children Cmax and AUC were not age-dependent (above one year of age).
92 Fi studju fit- tfal Cmax u AUC ma kienux dipendenti mill- età (’ l fuq minn età ta ’ sena).
91 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg suspensjoni orali fi qratas b’ doża waħda [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Oral suspension (in single-dose sachets) [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
The Ciprofloxacin Bayer 250 mg oral suspension in single-dose sachets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 250 mg suspensjoni orali fi qratas b’ doża waħda huwa ndikat għall- kura ta ’ l - infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Għandha tingħata attenzjoni speċjali lil tagħrif disponibbli dwar ir- reżistenza għal ciprofloxacin qabel tinbeda t- terapija.
• Intra-abdominal infections
95 • Infezzjonijet intra- addominali
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Infezzjonijiet tal- ġilda u tat- tessut artab ikkawżati minn batterja Gram- negative
93 • Malignant external otitis
• Otite esterna malinna
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/ or severe infections in children and adolescents (see sections 4.4 and 5.1).
Il- kura għandha tinbeda biss minn tobba li għandhom esperjenza fil- kura ta ’ fibrożi ċistika jew/ u infezzjonijiet severi fit- tfal u l- adoloxxenti (ara sezzjonijiet 4. 4 u 5. 1).
to 14 days
Doża ta ’ kuljum f’ mg
Infections of the upper respiratory
(potenzjalment inkluż bidu ta ’ kura parenterali b ’ ciprofloxacin) Infezzjonijiet ta ’ l - apparat respiratorju ta ’ fuq
Acute exacerbation of chronic sinusitis
Irkadar akut ta ’ sinusite kronika
2-4 weeks (acute) to 4-6 weeks (chronic)
2- 4 ġimgħat (akuta) sa 4- 6 ġimgħat (kronika)
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
Typhoid fever
500 mg twice daily 500 mg twice daily to 750 mg twice daily
500 mg darbtejn kuljum
7 days 5 to 14 days
7 ġranet
Infections of the skin
Doża ta ’ kuljum f’ mg
and soft tissue
Infezzjonijiet tal- ġilda u tat- tessut artab
Treatment of infections or prophylaxis of infections in neutropenic patients Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
500 mg darbtejn kuljum Kura ta ’ infezzjonijiet jew profilassi ta ’ infezzjonijiet f’ pazjenti b’ newtropenija
500 mg twice daily to 750 mg twice daily
750 mg darbtejn kuljum
Therapy should be continued over the entire period of neutropenia
Terapija għandha titkompla tul il- perijodu kollu tan -
Inhalation anthrax
L- għoti tal- mediċina għandu jinbeda mill - aktar fis possibli
10 mg/ kg body weight twice daily to 15 mg/ kg
10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 500 mg kull doża.
post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
ġurnata mill- konferma ta ’ esponiment għal Bacillus anthracis
body weight twice daily with a maximum of 500 mg per dose.
wara suspett jew konferma ta ’ esponiment.
confirmation of Bacillus anthracis exposure
98
96
Dosa Orali
250-500 mg every 12 h
Ara Doża tas- Soltu.
Oral suspension in single-dose sachets can be taken independent of mealtimes.
Is- suspensjoni orali fi qratas b’ doża waħda tista ’ tittieħed b’ mod indipendenti mill- ħinijiet ta ’ l- ikel.
Ciprofloxacin should not be taken with dairy products (e. g. milk, yoghurt) or mineral-fortified fruit juice (e. g. calcium-fortified orange juice) (see section 4.5).
Ciprofloxacin m’ għandux jittieħed ma ’ prodotti mill- ħalib (e. ż. ħalib, jogurt) jew meraq tal- frott imsaħħaħ bil- minerali (e. ż. meraq tal- larinġ imsaħħaħ bil- kalċju) (ara sezzjoni 4. 5).
In severe cases or if the patient is unable to take oral suspension (e. g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
F’ każijiet severi jew jekk il- pazjent ma jistax jieħu s- suspensjoni orali (e. ż. pazjenti fuq nutrizzjoni enterali), huwa rrakkomandat li t- terapija tinbeda b’ ciprofloxacin ġol- vini sakemm tkun possibli bidla għall- għoti orali..
In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.
F’ infezzjonijiet bħal dawn ciprofloxacin għandu jingħata flimkien ma ’ sustanzi xierqa oħra kontra l- batterja.
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
99 Infezzjonijiet ikkawżati minn Streptococci (inkluż Streptococcus pneumoniae) Ciprofloxacin mhux irrakkomandat għall- kura ta ’ infezzjonijiet ikkawżati minn streptococci minħabba effikaċja mhux adegwata.
97 The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
Dijarea tal- vjaġġatur i L- għażla ta ’ ciprofloxacin għandha tieħu f’ kunsiderazzjoni tagħrif dwar ir- reżistenza għal ciprofloxacin f’ patoġeni rilevanti fil- pajjiżi fejn sar il- vjaġġ.
Treating physicians should refer to national and / or international consensus documents regarding the treatment of anthrax.
Tobba li qed jikkuraw għandhom jirreferu għad - dokumenti ta ’ kunsens nazzjonali u/ jew internazzjonali dwar il- kura ta ’ l- antraċe.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited.
100 L- użu ta ’ ciprofloxacin għall- infezzjonijiet severi speċifiċi minbarra dawk imsemmijin fuq ma ġiex ivvalutat fi provi kliniċi u l- esperjenza klinika hija limitata.
If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.
Jekk isseħħ reazzjoni bħal din, ciprofloxacin għandu jitwaqqaf immedjatament u hija meħtieġa kura medika xierqa.
98 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Tendinite u tiċirit tat- tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b’ ciprofloxacin, anki fl- ewwle 48 siegħa ta ’ kura.
Hepatobiliary system Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8).
101 Sistema tal- fwied u tal- marrara Każijiet ta ’ nekrożi tal- fwied u insuffiċjenza tal- fwied ta ’ periklu għall- ħajja ġew irrapportati b’ ciprofloxacin (ara sezzjoni 4. 8).
99 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, ropinirole, tizanidine).
Citokromju P450 Ciprofloxacin jinibixxi lil CYP1A2 u għalhekk jista ’ jikkawża żjieda fil- konċentrazzjoni fis- serum ta ’ sustanzi mogħtija fl- istess waqt metabolizzati minn din l- enżima (e. ż. theophylline, clozapine, ropinirole, tizanidine).
Effects of ciprofloxacin on other medicinal products:
102 Effetti ta ’ ciprofloxacin fuq prodotti mediċinali oħra:
100 Theophylline
Theophylline