qanastek/EMEA-V3 huggingface dataset:
Oral ant-icoagulants
Sustanzi orali kontra il- koagulazzjoni tad- demm
There have been many reports of increases in oral anti-coagulant activity in patients receiving antibacterial agents, including fluoroquinolones.
Kien hemm ħafna rapporti ta ’ żjidiet fl- attività orali kontra l- koagulazzjoni f’ pazjenti li kienu qed jirċievu sustanzi kontra l- batterja, inkluż fluoroquinolones.
It is recommended that the INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anti-coagulant agent.
Huwa rrakkomandat li l - INR jiġi sorveljat b’ mod frekwenti waqt u ftit wara l- għoti ta ’ ciprofloxacin flimkien ma ’ sustanza orali kontra l- koagulazzjoni tad- demm.
Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively.
Waqt u eżatt wara
Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co- administration with ciprofloxacin are advised (see section 4.4).
103 għoti flimkien ma ’ ciprofloxacin, huma rrakkomandati sorveljanza klinika u aġġustament xieraq tad - dożaġġ ta ’ clozapine (ara sezzjoni 4. 4).
101 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
≥ 1/ 1 000 to <
≥ 1/ 1 000 sa <
(cannot be estimated from available data)
tittieħed stima mid- data disponibbli) Infezzjonijiet u
Infections and Infestations
Kolite assoċjata
Mycotic superinfections
etmill- moffa
Blood and Lymphatic System Disorders
Disturbi tad- Demm
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
Lewkopenija
Immune System Disorders
u tas- Sistema
Allergic reaction Allergic oedema / angiooedema
Anemija
Metabolism and Nutrition Disorders
emolitika
Anorexia
Limfatika
Hyperglycaemia
Newtropenija
Psychiatric Disorders
Agranuloċitosi
Psychomotor hyperactivity / agitation
Lewkoċitosi Tromboċitopenija Tromboċitemija
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Panċitopenija (ta ’ periklu għall- ħajja) Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall - ħajja)
Psychotic reactions (see section 4.4)
Disturbi fis -
102 System Organ
Sistema tal -
(cannot be estimated from available data)
magħrufa (ma tistax
Nervous System Disorders
tittieħed stima mid- data disponibbli) Sistema Immuni
Headache Dizziness Sleep disorders Taste disorders
Edima allerġika / anġjoedima
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Xokk anafilattiku (ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4) Reazzjoni bħall- marda tas- serum
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Disturbi fil - Metaboliżmu u n - Nutrizzjoni
Peripheral neuropathy (see section 4.4)
Ipergliċemija
Eye Disorders Ear and Labyrinth Disorders
Disturbi Psikjatriċi
Visual disturbances Tinnitus Hearing loss / Hearing impaired
psikomotorja / aġitazzjoni
Visual colour distortions
psikotiċi (ara sezzjoni 4. 4)
Cardiac Disorders
Disturbi fis -
Tachycardia
Parastesja u
Ventricular arrhythmia, QT prolongation, torsades de pointes *
Emigranja Newropatija
Vascular Disorders
Sistema Nervuża
Vasodilatation Hypotension Syncope
Sturdament
Vasculitis
Disestesija
Respiratory, Thoracic and Mediastinal Disorders
Disturbi ta ’ l - irqad Disturbi fit - togħma
Dyspnoea (including asthmatic condition)
Ipoestesija Tregħid Aċċessjonijiet (ara sezzjoni 4. 4) Vertigo
Gastrointestinal Disorders
koordinazzjoni sezzjoni 4. 4) Disturb fil - mixja Disturbi fin - nerv tax- xamm Pressjoni intrakranjali għolja
Nausea Diarrhoea
Disturbi fl - Għajnejn Disturbi fil - Widnejn u fis -
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Disturbi fil- vista Żanżin fil - widnejn
Pancreatitis
Disturbi fil - kuluri visivi
Hepatobiliary Disorders
Sistema Labirintika Disturbi fil- Qalb
Increase in transaminases Increased bilirubin
Telf ta ’ smigħ / Nuqqas fis- smigħ Takikardija
Hepatic impairment Cholestatic icterus Hepatitis
Arritmija ventrikulari, titwil tal- QT, torsades de pointes *
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
Disturbi Vaskulari
Skin and Subcutaneous Tissue Disorders
Vasodilatazzjoni Pressjoni baxxa Sinkope
Rash Pruritus Urticaria
Vaskulite
Photosensitivity reactions (see section 4.4)
Disturbi Respiratorji, Toraċiċi u Medjastinali
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening)
Qtugħ ta ’ nifs (inkluż kondizzjoni ażmatika)
103 System Organ
105 Sistema tal -
Toxic epidermal necrolysis (potentially life- threatening)
ħafna tavvanza għall - insuffiċjenza tal- fwied ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4)
Musculoskeletal, Musculoskeletal
fit- Tessuti ta ’ Taħt
Myalgia
Artrite
Muscular
muskolari
Connective Tissue and Bone Disorders
Connective Tissue
pain (e. g. extremity pain, back pain, chest pain) Arthralgia
estremitajiet, uġigħ fid- dahar, uġigħ fis- sider) Artralġja
Arthritis Increased muscle tone and cramping
tal- muskoli u bugħawwieġ
weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Tiċrit tat - tendon (l- aktar Achilles tendon) (ara sezzjoni 4. 4) Rkadar tas - sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
Renal and Urinary Disorders
renali
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
tittieħed stima mid- data disponibbli) Ematurja Urinarja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizjali Disturbi Ġenerali u
Increase in blood alkaline phosphatase
Żjieda fl- alkaline Livell ta ’ Investigazzjonijiet phosphatase fid - prothrombin
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.
PK/ PD relationship:
107 Relazzjoni PK/ PD:
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 mill- batterja u r - relazzjoni bejn l- erja taħt il- kurva (AUC) u l- MIC.
Plasmid- mediated resistance encoded by qnr-genes has been reported.
Kienet irrapportata resistenza medjata minn plasmid b’ kowd minn ġeni qnr.
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/ PD data and are independent of MIC distributions of specific species.
Staphylococcus spp. - punti kritiċi għal ciprofloxacin huma konnessi ma ’ terapija b’ doża għolja. * Punti kritiċi li mhumiex konnessi ma ’ speċi ġew determinati primarjament fuq il- bażi ta ’ tagħrif PK/ PD u huma indipendenti mid- distribuzzjonijiet ta ’ MIC għall- ispeċi speċifiċi.
They are for use only for species that have not been given a species-specific breakpoint and not for those species
Huma għall- użu biss għall- ispeċi li ma ngħatawx punt kritiku speċifiku għall- ispeċji u mhux għal dawk l- ispeċi fejn ittestjar għas- suxxettibilità mhux irrakkomandata.
106 COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
108 Mikro- organiżmi aerobiċi Gram- negative Aeromonas spp.
Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($)
(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.
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.
Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens*
Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens * Mikro- organiżmi anaerobiċi Peptostreptococcus spp.
Propionibacterium acnes
Propionibacterium acnes ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia
107 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 ($):
109 Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
The treating physician should refer to national and / or international consensus documents regarding treatment of anthrax.
It- tabib li qed jikkura għandu jirreferi għad- dokumenti ta ’ konsensus nazzjonali u / jew internazzjonali dwar il- kura ta ’ antraċe.
The pharmacokinetics of ciprofloxacin 250 mg and 500 mg oral suspension in single-dose sachets are similar to those of tablets.
Il- farmakokinetika ta ’ ciprofloxacin 250 mg u 500 mg suspensjoni orali fi qratas b’ doża waħda hija simili għal dik tal- pilloli.
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 bħal pulmun (fluwidu ta ’ l- epitelju, makrofaġi alveolari, tessut tal- bijopsija), sinuses, feriti infjammati (fluwidu fin - nuffata kantaridin), u l- pparat uroġenitali (awrina, prostata, endometriju) fejn jintlaħqu konċentrazzjonijiet totali li jaqabżu dawk tal- konċentrazzjonijiet fil- plażma.
108 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).
Elimination
110 Eliminazzjoni
6.1 List of excipients
111 6. 1 Lista ta ’ sustanzi mhux attivi
Take the prescribed amount of sachets.
Ħu l- ammont ta ’ qratas preskritti.
Shake the sachet applying slight pressure to the walls.
Ħawwad il- qartas waqt li tagħfas il- ġnubijiet bil- mod.
Then tear the sachet open as indicated and take the contents directly.
Wara, iftaħ il - qartas kif indikat u ħu l- kontenut direttament.
110 1.
112 1.
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 500 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]
Suspensjoni orali (fi qratas b’ doża waħda) [Biex timtela mill- pajjiż partikolari]
The Ciprofloxacin Bayer 500 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 500 mg suspensjoni orali fi qratas b’ doża waħda huwa ndikat għall- kura ta ’ l - infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
exacerbations of chronic obstructive pulmonary disease broncho-pulmonary infections in cystic fibrosis or in bronchiectasis pneumonia
irkadar tal- marda pulmonari ostruttiva kronika infezzjonijiet bronko- pulmonari f’ fibrożi ċistika jew f’ bronkjektasi pnewmonja
• Chronic suppurative otitis media
medja kronika b’ suppurazzjoni
• Infections of the skin and soft tissue caused by Gram-negative bacteria
113 • Infezzjonijiet tal- ġilda u tat- tessut artab ikkawżati minn batterja Gram- negative
111 • Malignant external otitis
• Otite esterna malinna
weeks (acute) to 4 to6 weeks (chronic)
2 sa 4 ġimgħat (akuta) sa 4 sa 6 ġimgħat (kronika)
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
(potenzjalment inkluż bidu ta ’ kura parenterali b ’ ciprofloxacin)
500 mg twice daily 500 mg twice daily to 750 mg twice daily
500 mg darbtejn kuljum sa 750 mg darbtejn kuljum
7 days 5 to 14 days
5 sa 14- il ġurnata
Therapy should be continued over the entire period of neutropenia
Terapija għandha titkompla tul
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
Infezzjonijiet komplikati ta ’ l - 10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum apparat ta ’ l- awrina u sa 20 mg/ kg ta ’ piż tal- ġisem darbtejn pijelonefrite kuljum b’ massimu ta ’ 750 mg kull doża.
post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Profilassi wara esponiment jew 10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum 60 ġurnata mill- konferma 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.
body weight twice daily with a maximum of 500 mg per dose.
sa 15 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 500 mg kull doża.
confirmation of Bacillus anthracis exposure
ta ’ esponiment għal Bacillus anthracis
Geriatric patients should receive a dose selected according to the severity of the infection and the patient’ s creatinine clearance.
116 Pazjenti anzjani Pazjenti anzjani għandhom jirċievu doża magħzula skond is- severità tal- infezzjoni u t- tneħħija tal - krejatinina tal- pazjent.
114
Dosa Orali
30-60
Ara
250-500 mg every 12 h
Doża tas- Soltu.
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.
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.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
117 Infezzjonijiet intra- addominali Hemm tagħrif limitat dwar l- effikaċja ta ’ ciprofloxacin fil- kura ta ’ infezzjonijiet intra- addominali ta ’ wara kirurġija.
115 Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
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.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
L- użu ta ’ ciprofloxacin fi tfal u adoloxxenti għandu jsegwi l- gwida uffiċjali disponibbli.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/ disorder related to quinolone treatment.
118 Sistema Muskolu- skeletrali Ciprofloxacin ġeneralment m’ għandux jintuża f’ pazjenti b’ passat ta ’ marda/ disturb tat- tendon relatata ma ’ kura b’ quinolone.
116 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.
If seizures occur ciprofloxacin should be discontinued (see section 4.8).
Jekk iseħħu aċċessjonijiet ciprofloxacingħandu jitwaqqaf (ara sezzjoni 4. 8).
Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk.
F’ dawn il- pazjenti ciprofloxacin għandu jiġi evitat sakemm il- benefiċċju
117 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).
6 to 24-fold) when given concomitantly with ciprofloxacin.
6 sa 24 darba) meta mogħti flimkien
118 Theophylline
Theophylline
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).
121 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).
119 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Infections and Infestations
tittieħed stima mid- data disponibbli) Superinfezzjonij Kolite assoċjata Infezzjonijiet u Infestazzjoniji et
Psychiatric Disorders
Disturbi
Psychomotor hyperactivity / agitation
Attività
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Konfużjoni u
Psychotic reactions (see section 4.4)
Reazzjonijiet
120 System Organ
Sistema tal -
(cannot be estimated from available data)
tittieħed stima mid- data disponibbli) Psikjatriċi
Headache Dizziness Sleep disorders Taste disorders
Disturbi fil -
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
periferali (ara
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
irqad Disturbi fit - togħma
Peripheral neuropathy (see section 4.4)
Tregħid Aċċessjonijiet (ara sezzjoni 4. 4) Vertigo
121 System Organ
123 Sistema tal -
(cannot be estimated from available data)
tittieħed stima mid- data disponibbli) Ġilda u fit -
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)
tendon) (ara sezzjoni 4. 4) Rkadar tas- sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
122 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.
124 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.
124 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($) Staphylococcus spp. *(2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+* Campylobacter spp. +* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
(2)
Propionibacterium acnes
Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens * Mikro- organiżmi anaerobiċi Peptostreptococcus spp.
125 INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications. + Resistance rate ≥ 50% in one or more EU countries ($):
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
127 5. 2 Tagħrif farmakokinetiku
Pprotein binding of ciprofloxacin is low (20-30%).
It- twaħħil mal- proteini ta ’ ciprofloxacin huwa baxx (20- 30%).
126 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).
In a study in children Cmax and AUC were not age-dependent (above one year of age).
128 Fi studju fit- tfal Cmax u AUC ma kienux dipendenti mill- età (’ l fuq minn età ta ’ sena).
Take the prescribed amount of sachets.
129 Ħu l- ammont ta ’ qratas preskritti.
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/ mL granules and solvent for oral suspension [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 50 mg/ mL grani (granules) u solvent għal suspensjoni orali [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Granules and solvent for oral suspension [To be completed nationally]
Grani u solvent għal suspensjoni orali
The Ciprofloxacin Bayer 50 mg/ mL oral suspension is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 50 mg/ mL suspensjoni orali huwa ndikat għall- kura ta ’ l- infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
• Lower respiratory tract infections due to Gram-negative bacteria
• Infezzjonijiet ta ’ l- apparat respiratorju ta ’ isfel ikkawżati minn batterja Gram- negative irkadar tal- marda pulmonari ostruttiva kronika infezzjonijiet bronko- pulmonari f’ fibrożi ċistika jew f’ bronkjektasi pnewmonja
- exacerbations of chronic obstructive pulmonary disease
• Otite medja kronika b’ suppurazzjoni
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
• Rkadar akut ta ’ sinusite kronika, speċjalment jekk dawn huma kkawżati minn batterja Gram - negative aeruginosa
- pneumonia
• Infezzjonijiet fl- apparat ta ’ l- awrina
• Chronic suppurative otitis media
• Uretrite u ċerviċite kkawżati minn gonococci
• Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
• Epididimo- orkite inkluż każijiet ikkawżati minn Neisseria gonorrhoeae
• Epididymo-orchitis including cases due to Neisseria gonorrhoeae
• Marda infjammatorja tal- pelvi inkluż każijiet ikkawżati minn Neisseria gonorrhoeae
• Intra-abdominal infections
131 • Infezzjonijet intra- addominali
129 • Malignant external otitis
• Otite esterna malinna
Daily dose in mg
Doża ta ’
Daily dose in mL (Number of 5-mL
Doża ta ’ kuljum
Total duration of treatment
Tul totali tal -
measuring spoonfuls)
mgħaref tal- kejl ta ’ 5- mL)
(potentially
t inkluż bidu ta ’ kura
including initial parenteral treatment with ciprofloxacin) Infections of the lower
parenterali b ’ ciprofloxacin)
10 mL twice daily to
10 mL darbtejn
7 to 14 days
7 sa 14- il
daily to 750 mg
darbtejn kuljum sa 750 mg darbtejn kuljum 132
15 mL twice daily
kuljum sa 15 mL darbtejn kuljum (żewġ mgħaref
twice daily
Doża ta ’
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
Doża ta ’ kuljum
130
Tul totali tal -
Indications
kuljum f’ mg
Daily dose in mg
f ’ mL
Daily dose in mL (Number of 5-mL
(Ammont ta ’
Total duration of treatment
(potenzjalmen
including initial parenteral treatment with ciprofloxacin) Infections of
parenterali b ’ ciprofloxacin) tal- kejl ta ’ 5- mL darbtejn kuljum sa tliet mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum) Infezzjonijiet ta ’ l -
Acute
Irkadar akut ta ’
exacerbation of
apparat respiratorju ta ’ fuq
chronic sinusitis
sinusite kronika
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
darbtejn kuljum kuljum sa 15 mL sa 750 mg darbtejn kuljum darbtejn kuljum (żewġ mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum sa tliet mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum)
Chronic
Otite medja kronika
15 mL twice daily
b’ suppurazzjoni
Malignant
Otite esterna malinna
15 mL twice daily
15 mL darbtejn
28 days up to 3
28 ġurnata sa 3
external otitis
darbtejn
daily
kuljum
(three 5-mL measuring spoonfuls twice daily)
kuljum (tliet mgħaref tal - kejl ta ’ 5- mL darbtejn kuljum)
Urinary tract
Infezzjonijiet ta ’ l -
Uncomplicated
Ċistite mhux
5-mL twice daily to
5 mL darbtejn
infections
apparat ta ’ l- awrina
cystitis
komplikata
daily to 500 mg
Ċistite komplikata, Pijelonefrite mhux komplikata
10 mL twice daily
500 mg 10 mL darbtejn 7 ġranet darbtejn kuljum kuljum (żewġ mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum)
twice daily
133 Indikazzjonijiet
(one 5-mL measuring
Doża ta ’
spoonful twice daily up to two 5-mL measuring spoonfuls twice daily) In pre-menopausal women, 500 mg single dose may be used corresponding to 10 mL single dose = two 5-mL measuring spoonfuls as a single dose
Doża ta ’ kuljum
Complicated
Tul totali tal -
500 mg twice
kuljum f’ mg
10 mL twice daily
f ’ mL
7 days
kura
cystitis, Uncomplicated pyelonephritis
(Ammont ta ’
daily
(potenzjalmen
(two 5-mL measuring spoonfuls twice daily)
mgħaref tal- kejl ta ’ 5- mL)
at least 10 days, it
ta ’ l- inqas 10
pyelonephritis
darbtejn kuljum
daily to 750 mg
sa 750 mg
15-mL twice daily
darbtejn kuljum
can be continued
jitkompla għal
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
(żewġ mgħaref
for longer than 21 days in some specific circumstances (such as abscesses)
aktar minn 21
2 to 4 weeks
4 ġimgħat
daily to 750 mg
darbtejn kuljum sa 750 mg darbtejn kuljum
15-mL twice daily
kuljum sa 15 mL darbtejn kuljum (żewġ mgħaref
(acute) to 4 to 6
(akuta) sa 4 sa 6 ġimgħat
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
tal- kejl ta ’ 5- mL darbtejn kuljum sa tliet mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum)
weeks (chronic)
(kronika)
Total duration of treatment
Infezzjonijiet ta ’ l - apparat ġenitali
Gonococcal
Uretrite u ċerviċite kkawżata minn gonococci
500 mg as a
500 mg bħala doża waħda
corresponding to two 5- mL measuring spoonfuls as a single dose
10 mL bħala doża waħda li jikkorrispondu għal żewġ mgħaref tal- kejl ta ’ 5- mL bħala doża waħda
dose)
ġurnata (doża waħda)
Epididymo-
Epididimo- orkite u
at least 14 days
ta ’ l- inqas 14- il
orchitis and
mard infjammatorju tal- pelvi
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
kuljum sa 15 mL darbtejn kuljum (żewġ mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum sa tliet mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum)
Infections of
Infezzjonijiet ta ’ l -
Diarrhoea
Dijarea kkawżata
10 mL twice daily
darbtejn kuljum
1 day
kuljum
the gastro- intestinal tract and intra- abdominal infections
infezzjonijiet intra - addominali
caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea
Shigella spp. minbarra Shigella dysenteriae tip 1 u kura emperika ta ’ dijarea severa tal - vjaġġaturi
(two 5-mL measuring spoonfuls twice daily)
tal- kejl ta ’ 5- mL darbtejn kuljum)
10 mL twice daily
10 mL darbtejn
caused by Shigella dysenteriae type 1
minn Shigella
Diarrhoea caused by Vibrio cholerae
parenterali b ’ ciprofloxacin)
mg twice daily
10 mL darbtejn
Typhoid fever
Typhoid fever
Intra-abdominal
darbtejn kuljum
5 to 14 days
5 sa 14- il
infections due to
addominali kkawżati minn batterja Gram - negative
(potentially
ġurnata
including initial parenteral treatment with ciprofloxacin) Infections of the skin and soft
Infezzjonijiet tal- ġilda u tat- tessut artab
Bone and joint infections
ġurnata
max. of 3 months
Massimu ta ’ 3
15-mL twice daily
kuljum sa 15 mL darbtejn kuljum (żewġ mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum sa tliet mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum)
twice daily
500 mg darbtejn kuljum sa 750 mg darbtejn kuljum
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
10 mL darbtejn kuljum sa 15 mL darbtejn kuljum (żewġ mgħaref tal- kejl ta ’ 5- mL
Treatment of infections or
Terapija għandha titkompla tul il- perijodu
500 mg twice
gwida uffiċjali.
10 mL twice daily to
darbtejn kuljum sa tliet mgħaref tal- kejl ta ’ 5- mL darbtejn kuljum)
Therapy should
kollu tan - newtropenija
prophylaxis of infections in
135 Indikazzjonijiet
daily to 750 mg
Doża ta ’
15-mL twice daily
Doża ta ’ kuljum
be continued over
Tul totali tal -
twice daily
kuljum f’ mg
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
f ’ mL
the entire period of neutropenia
kura
Prophylaxis of invasive
(Ammont ta ’
500 mg as a
(potenzjalmen
10 mL as a single dose
mgħaref tal- kejl ta ’ 5- mL)
1 day (single
t inkluż bidu ta ’ kura
infections due to Neisseria meningitidis
parenterali b ’ ciprofloxacin) Profilassi ta ’ l- infezzjonijiet invażivi kkawżati minn Neisseria meningitides
single dose
500 mg bħala doża waħda
Inhalation anthrax post-exposure
Profilassi wara esponiment u kura li tfejjaq
60 days from the
60 ġurnata
prophylaxis and curative
ta ’ antraċe meħud man- nifs għall- persuni li jistgħu jirċievu kura mill- ħalq meta xieraq
(two 5-mL measuring
kuljum (żewġ mgħaref
confirmation of
mill- konferma ta ’ esponiment
treatment for persons able to receive treatment by oral route when clinically appropriate.
klinikament.
spoonfuls twice daily)
darbtejn kuljum)
Daily dose in mg and in mL
Doża ta ’ kuljum f’ mg u f’ mL
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.4 mL/ kg body weight twice daily with a maximum of 15-mL per dose
20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża, li jikkorrispondu għal 0. 4 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 15 mL kull doża.
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/ kg body weight twice daily to 0.4 mL/ kg body weight twice daily with a maximum of 15-mL per dose
Infezzjonijiet komplikati 10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa ta ’ l- apparat ta ’ l- awrina 20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum u pijelonefrite b’ massimu ta ’ 750 mg kull doża, li jikkorrispondu għal 0. 2 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum sa 0. 4 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 15 mL kull doża.
Inhalation anthrax
Profilassi wara esponiment jew kura li
10 mg/ kg body weight twice daily to 15 mg/ kg body
10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa 15 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum
days from the
ġurnata mill- konferma ta ’ esponiment għal
post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
tfejjaq ta ’ antraċe meħud b’ massimu ta ’ 500 mg kull doża, li man- nifs għall- persuni li jikkorrispondu għal 0. 2 mL/ kg ta ’ piż tal- ġisem jistgħu jirċievu kura mill - darbtejn kuljum sa 0. 3 mL/ kg ta ’ piż tal- ġisem ħalq meta xieraq darbtejn kuljum b’ massimu ta ’ 10 mL kull doża. klinikament.
confirmation of Bacillus anthracis exposure
Bacillus anthracis
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.4 mL/ kg body weight twice daily with a maximum of 15-mL per dose
Infezzjonijiet severi oħra 20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża, li jikkorrispondu għal 0. 4 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 15 mL kull doża.
Geriatric patients
136 Pazjenti anzjani
134 Method of administration
Metodu ta ’ l- għoti
Oral suspension can be taken independent of mealtimes.
Is- suspensjoni orali 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).
Appearance of the reconstituted product:
Dehra tal- prodott rikostitwit:
The reconstituted product is a white to slightly yellowish suspension with strawberry odour.
Il- prodott rikostitwit huwa suspensjoni bajda sa kemmxejn fl- isfar b’ riħa ta ’ frawli.
Occasionally the suspension may contain yellow-orange droplets and globular particles.
Xi kultant is - suspensjoni jista ’ jkun fiha qtar sofor- oranġjo u frak tondi.
250 mg ciprofloxacin.
½ mgħarfa tal- kejl waħda (madwar 2. 5 mL ta ’ suspensjoni) tipprovdi madwar 125 mg ta ’ ciprofloxacin Mgħarfa tal- kejl waħda (madwar 5. 0 mL ta ’ suspensjoni) tipprovdi madwar 250 mg ta ’ ciprofloxacin.
Always use the graduated measuring spoon to obtain the exact dose for administering the suspension.
Dejjem uża l- mgħarfa bil- marki tal- kejl biex tikseb id- doża eżatta biex tagħti s- suspensjoni.
No additions should be made to the mixed final ciprofloxacin suspension.
M’ għandu jiżdied xejn mas- suspensjoni rikostitwita finali ta ’ ciprofloxacin.
Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
Infezzjonijiet severi u infezzjonijiet imħalta b’ patoġeni Gram- positive u anaerobiċi
Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
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.
135 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.
Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
138 Infezzjonijiet severi oħra skond il- gwida uffiċjali, jew wara valutazzjoni b’ attenzjoni tal- benefiċċju - riskju meta kura oħra ma tistax tiġi wżata, jew wara falliment ta ’ terapija konvenzjonali u meta d - dokumentazzjoni mikrobijoloġika tista ’ tiġġustifika l- użu ta ’ Ciprofloxacin Bayer.
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.
136 At any sign of tendinitis (e. g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
Ma ’ xi sinjal ta ’ tedinite (e. ż. nefħa bl- uġigħ, infjammazzjoni), kura b’ ciprofloxacin għandha titwaqqaf.
In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
F’ każijiet bħal dawn, ciprofloxacin għandu jitwaqqaf immedjatament, għandu jiġi kkonsultat tabib u għandha tinbeda terapija xierqa.
Anti-peristaltic drugs are contraindicated in this situation.
Mediċini kontra l - peristalsi huma kontra- indikati f’ din is- sitwazzjoni.
Renal and urinary system Crystalluria related to the use of ciprofloxacin has been reported (see section 4.8).
139 Sistema renali u ta ’ l- awrina Kienet irrapportata kristallurja relata ma ’ l- użu ta ’ ciprofloxacin (ara sezzjoni 4. 8).
137 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).
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, speċjalment (e. ż. ta ’ theophylline) (ara sezzjoni 4. 5).
Sucrose Load As the oral suspension contains sucrose, it should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.
Peress li s- suspensjoni orali fiha sucrose, m’ għandhiex tintuża għall- pazjenti b’ intolleranza għal fructose, assorbiment ħażin ta ’ glucose- galactose jew nuqqas ta ’ sucrose- isomaltase.
As Ciprofloxacin Bayer 50 mg/ mL suspension contains 1.4 g sucrose per 5-mL measuring spoonful, this has to be taken into consideration in terms of daily intake.
Minħabba li ciprofloxacin 50 mg/ mL suspensjoni orali fih 1. 4 g sucrose f’ kull mgħarfa tal- kelj ta ’ 5 mL, dan għandu jiġi kkunsidrat f’ termini ta ’ teħid ta ’ kuljum.
The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e. g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e. g. sevelamer), sucralfate or antacids, and highly buffered drugs (e. g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin.
Għalhekk, ciprofloxacin
Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations.
140 għandu jingħata siegħa sa sagħtejn qabel jew ta ’ l- inqas 4 sigħat wara dawn il- preparazzjonijiet.
138 Methotrexate
Methotrexate
Oral anti-coagulants
Sustanzi orali kontra il- koagulazzjoni tad- demm
The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the fluoroquinolone to the increase in INR (international normalised ratio) is difficult to assess.
Huwa rrakkomandat li l -
It is recommended that the INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anti-coagulant agent.
141 INR jiġi sorveljat b’ mod frekwenti waqt u ftit wara l- għoti ta ’ ciprofloxacin flimkien ma ’ sustanza orali kontra l- koagulazzjoni tad- demm.
139 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).
System Organ
142 Sistema tal -
Class
Klassifika ta ’ ≥
≥ 1/ 100
1/ 100 sa ≥ 1/ 1 000 sa < < 1/ 10 1/ 100
< 1/ 10 000
l- Organi
to < 1/ 10
Esinofilja
1/ 100
Demm u tas -
1/ 1 000
Anemija
(cannot be estimated from available data)
Agranuloċitosi
Infections and Infestations
Sistema
Mycotic superinfections
Newtropenija
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
Panċitopenija (ta ’
Blood and Lymphatic System Disorders
Limfatika
140 System Organ
psikotiċi (ara
Common
sezzjoni 4. 4)
Uncommon
Disturbi fis -
Rare
Parastesja u
Very Rare
Emigranja
Frequency
Newropatija
Class
Sistema
≥ 1/ 100
Sturdament
≥ 1/ 1 000 to <
Disestesija
≥ 1/ 10 000 to <
Disturbi fil -
< 1/ 10 000
periferali (ara
not known
Nervuża
to < 1/ 10
Disturbi ta ’ l -
1/ 100
Ipoestesija
1/ 1 000
koordinazzjoni
(cannot be estimated from available data)
sezzjoni 4. 4)
Psychiatric Disorders
irqad Disturbi fit - togħma
Psychomotor hyperactivity / agitation
Tregħid Aċċessjonijiet (ara sezzjoni 4. 4) Vertigo
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Disturb fil- mixja Disturbi fin- nerv tax- xamm Pressjoni intrakranjali għolja
Psychotic reactions (see section 4.4)
Disturbi fil- vista Żanżin fil - widnejn
Nervous System Disorders
Disturbi fil- kuluri visivi
Headache Dizziness Sleep disorders Taste disorders
fis- Sistema Labirintika
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Telf ta ’ smigħ / Nuqqas fis- smigħ
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Sistema tal -
Peripheral neuropathy (see section 4.4)
Komuni Mhux Komuni
Eye Disorders Ear and Labyrinth Disorders
Klassifika ta ’ ≥
Visual disturbances Tinnitus Hearing loss / Hearing impaired
1/ 100 sa ≥ 1/ 1 000 sa < < 1/ 10 1/ 100
Visual colour distortions
≥ 1/ 10 000 sa < 1/ 1 000
Cardiac Disorders
tittieħed stima mid- data disponibbli) Disturbi fil - Qalb
141 System Organ
Disturbi fil -
Common
Petekja
Uncommon
Ġilda u fit -
Rare
Ħakk
Very Rare
Rari
to < 1/ 10
Uġigħ
1/ 100
muskolu -
1/ 1 000
Artrite
(cannot be estimated from available data)
skeltrali (e. ż.
Skin and Subcutaneous Tissue Disorders
Żjieda fit- tensjoni
Rash Pruritus Urticaria
uġigħ fl -
Photosensitivity reactions (see section 4.4)
tal- muskoli u
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Tiċrit tat- tendon
Myalgia Arthritis Increased muscle tone and cramping
dahar, uġigħ fis- sider) Artralġja
General Disorders and Administration Site Conditions
Ġenerali u Kondizzjonijie t ta 'Mnejn Jingħata
Investigations
Investigazzjo
4.9 Overdose 142 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.
Plasmid-mediated resistance encoded by qnr-genes has been reported.
Kienet irrapportata reżistenza medjata minn plasmid b’ kowd minn ġeni qnr.
S ≤ 0.5 mg/ L S ≤ 0.5 mg/ L S ≤ 1 mg/ L
S ≤ 0. 5 mg/ L
Staphylococcus spp.1
S ≤ 0. 5 mg/ L
S ≤ 1 mg/ L
R > 1 mg/ L
R
R > 1 mg/ L
1 Staphylococcus spp. – breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/ PD data and are independent of MIC distributions of specific species.
Staphylococcus spp. – punti kritiċi għal ciprofloxacin huma konnessi ma ’ terapija b’ doża għolja. * Punti kritiċi li mhumiex konnessi ma ’ speċi ġew determinati primarjament fuq il- bażi ta ’ tagħrif PK/ PD u huma indipendenti mid- distribuzzjonijiet ta ’ MIC għall- ispeċi speċifiċi.
They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.
Huma għall- użu biss għall- ispeċi li ma ngħatawx punt kritiku speċifiku għall- ispeċji u mhux għal dawk l- ispeċi
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)
COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
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)
(2)
144 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.
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 *