qanastek/EMEA-V3 huggingface dataset:
Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Pazjenti li qed jirċievu ciprofloxacin għandhom ikunu idratati sew u alkalinità eċċessiva ta ’ l- awrina għandha tiġi evitata.
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).
In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
F’ każ ta ’ xi sinjali u sintomi ta ’ marda tal- fwied (bħal anoressija, suffejra, awrina skura, ħakk, jew addome teneru), il- kura għandha titwaqqaf.
Glucose-6-phosphate dehydrogenase deficiency Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency.
Defiċjenza ta ’ glucose- 6- phosphate dehydrogenase F’ pazjenti b’ defiċjenza ta ’ glucose- 6- phosphate dehydrogenase, kienu rrapportati reazzjonijiet emolitiċi b’ ciprofloxacin.
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 potenzjali ma jkunx ikkunsidrat bħala akbar mir- riskju possibli.
In this case, potential occurrence of haemolysis should be monitored.
F’ dan il- każ l- okkorrenza potenzjali ta ’ emolisi għandha tiġi sorveljata.
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.
Jista ’ jkun hemm riskju partikolari ta ’
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.
29 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.
27 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).
Co-administration of ciprofloxacin and tizanidine is contra-indicated.
L- għoti ta ’ ciprofloxacin flimkien ma ’ tizanidine hija kontra- indikata.
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. ż. ta ’ theophylline) (ara sezzjoni 4. 5).
Methotrexate The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).
Methotrexate L- użu ta ’ ciprofloxacin flimkien ma ’ methotrexate mhux irrakkomandat (ara sezzjoni 4. 5).
Interaction with tests The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
Interazzjoni mat- testijiet L- attività in- vitro ta ’ ciprofloxacin kontra Mycobacterium tuberculosis tista ’ tagħti riżultati negattivi foloz tat- testijiet batterjoloġiċi f’ kampjuni minn pazjenti li jkunu qed jieħdu ciprofloxacin.
Effects of other products on ciprofloxacin:
Effetti ta ’ prodotti oħra fuq ciprofloxacin:
Chelation Complex Formation
Formazzjoni ta ’ Kumpless ta ’ Kelazzjoni
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.
L- għoti ta ’ ciprofloxacin (orali) flimkien ma ’ mediċini multivalenti li fihom il- cations u supplimenti ta ’ minerali (e. ż. kalċju, manjesju, aluminju, ħadid), sustanzi polimeriċi li jeħlu mal- fosfat (e. ż. sevelamer), sucralfate jew antaċidi, u mediċini buffered ħafna (e. ż. pilloli didanosine) li fihom manjesju, aluminju, jew kalċju jnaqqas l- assorbiment ta ’ ciprofloxacin.
Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations.
Għalhekk, ciprofloxacin għandu jingħata siegħa sa sagħtejn qabel jew ta ’ l- inqas 4 sigħat wara dawn il- preparazzjonijiet.
The restriction does not apply to antacids belonging to the class of H2 receptor blockers.
Ir - restrizzjoni ma tapplikax għall- antaċidi li jagħmlu parti mill- klassi ta ’ imblukkaturi tar- riċetturi H2.
Food and Dairy Products
Ikel u Prodotti mill- Ħalib
Dietary calcium as part of a meal does not significantly affect absorption.
Kalċju fid- dieta bħala parti minn ikla ma jaffettwax l- assorbiment b’ mod sinifikanti.
However, the concurrent administration of dairy products or mineral-fortified drinks alone (e. g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.
Madankollu l - għoti ta ’ prodotti mill- ħalib jew xarbiet imsaħħa b’ minerali waħedhom (e. ż. ħalib, jogurt, meraq tal - larinġ imsaħħaħ bil- kalċju) flimkien ma ’ ciprofloxacin għandu jiġi evitat peress li l- assorbiment ta ’ ciprofloxacin jista ’ jkun imnaqqas.
Probenecid interferes with renal secretion of ciprofloxacin.
Probenecid jinterferixxi mas- sekrezzjoni renali ta ’ ciprofloxacin.
Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.
L- għoti flimkien ta ’ probenecid u ciprofloxacin iżid il- konċentrazzjonijiet ta ’ ciprofloxacin fis- serum.
Effects of ciprofloxacin on other medicinal products:
Effetti ta ’ ciprofloxacin fuq prodotti mediċinali oħra
Tizanidine must not be administered together with ciprofloxacin (see section 4.3).
Tizanidine m’ għandux jingħata flimkien ma ’ ciprofloxacin (ara sezzjoni 4. 3).
In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase:
Fi studju kliniku b’ individwi b’ saħħithom, kien hemm żjieda fil- konċentrazzjoni ta ’ tizanidine fis- serum (żjieda f’ Cmax:
7-fold, range:
7 darbiet, firxa:
4 to 21-fold; AUC increase:
4 sa 21 darba; żjieda fl- AUC:
10-fold, range:
10 darbiet, firxa:
6 to 24-fold) when given concomitantly with ciprofloxacin.
6 sa 24 darba) meta mogħti flimkien ma ’ ciprofloxacin.
Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.
Konċentrazzjoni ta ’ tizanidine fis- serum miżjuda hija assoċjata ma ’ effett ipotensiv u sedattiv imsaħħaħ.
Methotrexate
30 Methotrexate
Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions.
Trasport fit- tubi renali ta ’ methotrexate jista ’ jiġi inibit mill- għoti flimkien ta ’ ciprofloxacin, u dan jista ’ jwassal għal- livelli ta ’ methotrexate fil- plażma miżjuda u żjieda fir- riskju ta ’ reazzjonijiet tossiċi assoċjati ma ’ methotrexate.
The concomitant use is not recommended (see section 4.4).
L- użu flimkien mhux irrakkomandat (ara sezzjoni 4. 4).
Theophylline
Theophylline
28 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.
This can lead to theophylline-induced side effects that may rarely be life threatening or fatal.
Din tista ’ twassl għall- effetti sekondarji indotti minn theophylline li rarament jistgħu jkunu ta ’ periklu għall- ħajja jew fatali.
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).
Other xanthine derivatives
Derivattivi oħra ta ’ xanthine
On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Wara għoti fl- istess waqt ta ’ ciprofloxacin u kafeina jew pentoxifylline (oxpentifylline), kienu rrapportati konċentrazzjonijiet fis- serum ta ’ dawn id- derivati ta ’ xanthine miżjuda.
Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
L- għoti flimkien ta ’ ciprofloxacin u phenytoin tista ’ twassal għal- livelli fis- serum ta ’ phenytoin miżjuda jew imnaqqsa, għalhekk sorveljanza tal- livelli tal- mediċina hija rrakkomandata.
Oral anticoagulants
Sustanzi orali kontra il- koagulazzjoni tad- demm
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.
There have been many reports of increases in oral anticoagulant 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.
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.
Ir- riskju jista ’ jvarja skond l - infezzjoni preżenti, l- età u l- istat ġenerali tal- pazjent biex il- kontribut tal- fluoroquinolone għaż- żjieda fl- INR (Proporzjon Normalizzat Internazzjonali) ikun diffiċli biex jiġi stmat.
It is recommended that the INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anticoagulant 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.
It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively.
Fi studju kliniku intwera li l- użu ta ’ ropinirole flimkien ma ’ ciprofloxacin, inibitur moderat ta ’ l - isożima CYP450 1A2, iwassal għal żjieda f’ Cmax u l- AUC ta ’ ropinirole ta ’ 60% u 84%, rispettivament.
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 rrakkomandati sorveljanza ta ’ effetti sekondarji relatati ma ’ ropinirole u aġġustament xieraq fid- doża (ara sezzjoni 4. 4).
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.
Wara għoti ta ’ 250 mg ciprofloxacin flimkien ma ’ clozapine għal 7 ġranet, konċentrazzjonijiet fis - serum ta ’ clozapine u N- desmethylclozapine żdiedu b’ 29% u 31%, rispettivament.
Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co- administration with ciprofloxacin are advised (see section 4.4).
Waqt u eżatt wara għoti flimkien ma ’ ciprofloxacin, huma rrakkomandati sorveljanza klinika u aġġustament xieraq tad - dożaġġ ta ’ clozapine (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 lil nisa tqal ma jindika l- ebda tossiċità malformattiva jew tossiċità għall- fetu/ tarbija tat- twelid ta ’ ciprofloxacin.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti rigward tossiċità riproduttiva.
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.
31 Bħala miżura ta ’ prekawzjoni, ikun aħjar li l- użu ta ’ ciprofloxacin ikun evitat waqt it- tqala.
Lactation Ciprofloxacin is excreted in breast milk.
Treddigħ Ciprofloxacin jitneħħa fil- ħalib tas- sider.
Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.
Minħabba l- potenzjal għal riskju ta ’ ħsara fil- ġogi u l - għekiesi, ciprofloxacin m’ għandux jintuża waqt it- treddigħ.
29 Due to its neurological effects, ciprofloxacin may affect reaction time.
Minħabba l- effetti newroloġiċi tiegħu, ciprofloxacin jista ’ jaffettwa l- ħin ta ’ reazzjoni.
Thus, the ability to drive or to operate machinery may be impaired.
Għalhekk, jista ’ jnaqqas il- ħila biex issuq jew tħaddem magni.
The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.
L- aktar reazzjonijiet avversi tal- mediċina (ADRs) irrapportati b’ mod komuni huma tqalligħ u dijarea.
ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin Bayer (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below.
ADRs derivati mill- istudji kliniċi u minn sorveljanza ta ’ wara t- tqegħid fis- suq ta ’ Ciprofloxacin Bayer (terapija orali, ġol- vini u sekwenzjali) rranġati skond il- kategoriji ta ’ frekwenza huma mniżżla isfel.
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.
Class
Klassifika ta ’ l -
≥ 1/ 100
≥ 1/ 100 sa < ≥ 1/ 1 000 sa < 1/ 10 1/ 100
≥ 1/ 1 000 to <
≥ 1/ 10 000 sa < 1/ 1 000
≥ 1/ 10 000 to <
< 1/ 10 000
< 1/ 10 000
Organi
not known
magħrufa (ma tistax
to < 1/ 10
tittieħed stima mid- data disponibbli) Superinfezzjonij Kolite assoċjata Infezzjonijiet u Infestazzjonijiet
1/ 1 000
ietmill- moffa
(cannot be estimated from available data)
ma ’ antibijotiċi (rari ħafna b’ possibiltà ta ’ riżultat fatali) (ara sezzjoni 4. 4)
Infections and Infestations
Disturbi tad- Demm
Mycotic superinfections
Lewkopenija
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
Anemija
Blood and Lymphatic System Disorders
u tas- Sistema
Eosinophilia
emolitika
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
Limfatika
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
Newtropenija
Immune System Disorders
Agranuloċitosi
Allergic reaction Allergic oedema / angiooedema
Lewkoċitosi Tromboċitopenij a Tromboċitemija
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
Panċitopenija (ta ’ periklu għall- ħajja) Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall - ħajja)
Metabolism and Nutrition Disorders
Disturbi fis -
Anorexia
Reazzjoni
Hyperglycaemia
Sistema Immuni
Psychiatric Disorders
anafilattika
Psychomotor hyperactivity / agitation
Edima allerġika / anġjoedima
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Xokk anafilattiku (ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4) Reazzjoni bħall - marda tas- serum
Psychotic reactions (see section 4.4)
Disturbi fil - Metaboliżmu u n - Nutrizzjoni
30 System Organ
Sistema tal -
to < 1/ 10
Attività
1/ 100
Konfużjoni u
1/ 1 000
Reazzjonijiet
(cannot be estimated from available data)
psikotiċi (ara sezzjoni 4. 4)
Nervous System Disorders
Sistema Nervuża
Headache Dizziness Sleep disorders Taste disorders
Disturbi ta ’ l - irqad Disturbi fit - togħma
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Ipoestesija Tregħid Aċċessjonijiet (ara sezzjoni 4. 4) Vertigo
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
koordinazzjoni Disturb fil - mixja Disturbi fin - nerv tax- xamm Pressjoni intrakranjali għolja
Peripheral neuropathy (see section 4.4)
sezzjoni 4. 4)
Eye Disorders Ear and Labyrinth Disorders
Disturbi fl - Għajnejn Disturbi fil - Widnejn u fis -
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 *
Respiratory, Thoracic and Mediastinal Disorders
Vasodilatazzjoni Vaskulite Disturbi Vaskulari Pressjoni baxxa Sinkope Disturbi Respiratorji, Toraċiċi u Medjastinali
Dyspnoea (including asthmatic condition)
Qtugħ ta ’ nifs (inkluż kondizzjoni ażmatika)
Gastrointestinal Disorders
Disturbi Gastro -
Nausea Diarrhoea
Tqalligħ
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Rimettar
Pancreatitis
Pankrejatite
Hepatobiliary Disorders
intestinali
Increase in transaminases Increased bilirubin
Dijarea
Hepatic impairment Cholestatic icterus Hepatitis
Weġgħat gastro - intestinali u addominali Dispepsja Gass
31 System Organ
33 Sistema tal -
to < 1/ 10
Żjieda fil - bilirubin
1/ 100
Disturbi fil- Ġilda u
1/ 1 000
Raxx
(cannot be estimated from available data)
Reazzjonijet ta ’
Skin and Subcutaneous Tissue Disorders
fit- Tessuti ta ’ Taħt
Rash Pruritus Urticaria
fotosensittività
Photosensitivity reactions (see section 4.4)
(ara sezzjoni
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)
Musculoskeletal, Connective Tissue and Bone Disorders
Connective Tissue
Musculoskeletal pain (e. g. extremity pain, back pain, chest pain) Arthralgia
estremitajiet, uġigħ fid- dahar, uġigħ fis- sider) Artralġja
Myalgia Arthritis Increased muscle tone and cramping
tensjoni tal - muskoli u bugħawwieġ
Muscular 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
Disturbi fil- Kliewi
Renal impairment
renali
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
renali Ematurja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizja li
General Disorders and Administration Site Conditions
Kondizzjonijiet ta 'Mnejn Jingħata
Asthenia Fever
Deni
Oedema Sweating (hyperhidrosis)
Għaraq (iperidrosi)
Investigations
34 Sistema tal -
Increase in blood alkaline phosphatase
alkaline phosphatase fid - demm
Prothrombin level abnormal Increased amylase
prothrombin mhux normali Żjieda fl - amylase
* These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see section 4.4).
* Dawn l- avvenimenti kienu rrapportati waqt il- perijodu ta ’ wara t- tqegħid fis- suq u kienu osservati l- aktar f’ pazjenti b’ aktar fatturi ta ’ riskju għal titwil tal- QT (ara sezzjoni 4. 4).
Paediatric patients The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
Pazjenti pedjatriċi L- inċidenza ta ’ artopatija, msemmija fuq, tirreferi għal tagħrif miġbur minn studji bl- adulti.
In children, arthropathy is reported to occur commonly (see section 4.4).
Fit- tfal, artropatija hija rrapportata li sseħħ b’ mod komuni (ara sezzjoni 4. 4).
32 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.
An acute overdose of 16 g has been reported to cause acute renal failure.
Doża eċċessiva akuta ta ’ 16 g ġiet irrapportata li tikkawża insuffiċjenza akuta tal- kliewi.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
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.
Reversible renal toxicity has been reported.
Kienet irrapportata tossiċità renali riversibbli.
Apart from routine emergency measures, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria.
Minbarra miżuri ta ’ emerġenza ta ’ rutina, huwa rrakkomandat li tiġi sorveljata l- funzjoni tal- kliewi, inkluż il- pH ta ’ l- awrina u jekk meħtieġ din għandha tiġi aċidifikata biex tiġi evitata kristallurja.
Patients should be kept well hydrated.
Il - pazjenti għandhom jinżammu idratati sew.
Only a small quantity of ciprofloxacin (< 10%) is eliminated by haemodialysis or peritoneal dialysis.
Kwantità żgħira biss ta ’ ciprofloxacin (< 10%) hija eliminata permezz ta ’ emodijalisi jew dijalisi tal - peritonew.
Fluoroquinolones, ATC code:
Fluoroquinolones, Kodiċi ATC:
As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
Bħala sustanza fluoroquinolone kontra l- batterja, l- azzjoni batteriċida ta ’ ciprofloxacin tirriżulta mill - inibizzjoni taż- żewġ topoisomerase tat- tipi II (DNA- gyrase) u ta ’ topoisomerase IV, li huma meħtieġa għar- replikazzjoni, transkrizzjoni, tiswija u rikombinazzjoni tad- DNA tal- batterja.
PK/ PD relationship:
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 tal- batterja u r - relazzjoni bejn l- erja taħt il- kurva (AUC) u l- MIC.
Mechanism of resistance:
Mekkaniżmu ta ’ reżistenza:
In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV.
Reżistenza in- vitro għal ciprofloxacin tista ’ tinkiseb permeżż ta ’ proċess ta ’ pass wara pass b’ mutazzjonijiet fis- sit immirat f’ DNA gyrase u f’ topoisomerase IV.
The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable.
L- ammont ta ’ cross- resistance
Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.
Mutazzjoni waħda biss tista ’ ma tirriżultax f’ reżistenza klinika, iżda mutazzjonijiet multipli jirriżultaw f’ reżistenza klinika għal ħafna jew għas- sustanzi attivi kollha fil- klassi.
Impermeability and/ or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance.
Impermeabilità u/ jew mekkaniżmi ta ’ reżistenza tal- pompa ta ’ effluss tas- sustanza attiva jista ’ jkollhom effett varjabbli fuq is- suxxettibilità għal fluoroquinolones, li tiddependi fuq il- karatteristiċi fisjokimiċi ta ’ diversi sustanzi attivi fil- klassi u l- affinità tas- sistemi ta ’ transport għal kull sustanza attiva.
All in-vitro mechanisms of resistance are commonly observed in clinical isolates.
Il- mekkaniżmi ta ’ reżistenza in- vitro kollha huma osservati b’ mod komuni f’ iżolati kliniċi.
Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.
Mekkaniżmi ta ’ reżistenza li jinattivaw antibijotiċi oħra bħall- barrieri ta ’ permeazzjoni (komuni f’ Pseudomonas aeruginosa) u mekkaniżmi ta ’ effluss jistgħu jaffettwaw is- suxxettibilità għal ciprofloxacin.
Plasmid-mediated resistance encoded by qnr-genes has been reported.
Kienet irrapportata resistenza medjata minn plasmid b’ kowd minn ġeni qnr.
Spectrum of antibacterial activity:
Firxa ta ’ l- attività antibatterika:
Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:
Punti kritiċi jisseparaw razez suxxettibli minn razez b’ suxxettibilità intermedja u dawn ta ’ l- aħħar minn razez reżistenti:
EUCAST Recommendations
Rakkomandazzjonijiet EUCAST
Microorganisms
Mikro- organiżmi
Susceptible
Suxxettibli
Resistant
Reżistenti
S ≤ 0.5 mg/ L S ≤ 0.5 mg/ L S ≤ 1 mg/ L S ≤ 1 mg/ L
R > 1 mg/ L
33 Haemophilus influenzae and Moraxella catarrhalis
Haemophilus influenzae u Moraxella catarrhalis
S ≤ 0.5 mg/ L
S ≤ 0. 5 mg/ L
S ≤ 0.03 mg/ L S ≤ 0.03 mg/ L S ≤ 0.5 mg/ L
> 0. 06 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 fejn ittestjar għas- suxxettibilità mhux irrakkomandata.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Il- prevalenza ta ’ reżistenza miksuba tista ’ tvarja ġeografikament u maż- żmien għall- speċi magħżula u informazzjoni lokali dwar ir- reżistenza hija mixtieqa, speċjalment meta jiġu kkurati infezzjonijiet severi.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Għandu jinkiseb parir minn espert skond il- bżonn meta l- prevalenza lokali ta ’ reżistenza hija tali li l- utilità tas- sustanza hija dubjuża ta ’ l- inqas f’ xi tipi ta ’ infezzjonijiet.
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.
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 ($) SPEĊI LI GĦALIHOM REŻISTENZA MIKSUBA TISTA ’ TKUN PROBLEMA Mikro- organiżmi aerobiċi Gram- positive Enterococcus faecalis ($) Staphylococcus spp.
34 Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
(2) 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* Anaerobic micro-organisms Peptostreptococcus spp.
Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens * Mikro- organiżmi anaerobiċi Peptostreptococcus spp.
35 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 ($):
37 ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
Natural intermediate susceptibility in the absence of acquired mechanism of resistance (1):
Suxxettibilità intermedja naturali fin- nuqqas ta ’ mekkaniżmu ta ’ reżistenza miksub (1):
Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose.
Twettqu studji dwar infezzjonijiet f’ bhejjem sperimentali ikkawżati minn teħid man- nifs ta ’ spori ta ’ Bacillus anthracis; dawn l- istudji wrew li antibijotiċi mibdija kmieni wara l - esponiment, jevitaw l- okkorrenza tal- marda jekk il- kura ssir għat- tnaqqis tan- numru ta ’ spori fl- organiżmu taħt id- doża infettiva.
The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data.
L- użu rrakkomandat f’ individwi umani huwa bbażat primarjament fuq is- suxxettibilità in- vitro u fuq tagħrif sperimentali dwar il- bhejjem flimkien ma ’ tagħrif limitat fil- bniedem.
Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans.
Fl- adulti tul ta ’ kura ta ’ xahrejn b’ ciprofloxacin orali mogħti b’ doża ta ’ 500 mg bid, hija kkunsidrata bħala effettiva biex tipprevjeni infezzjoni ta ’ antraċe fil- bnedmin.
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.
Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones.
S. aureus reżistenti għal methicillin spiss ħafna juru reżistenza għal fluoroquinolones ukoll.
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.
Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Wara għoti orali ta ’ doża waħda ta ’ 250 mg, 500 mg, u 750 mg ta ’ pilloli ciprofloxacin, dan jiġi assorbit malajr u b’ mod estensiv, fil- biċċa l- kbira mill- musrana ż- żgħira, u konċentrazzjonijiet massima fis- serum jintlaħqu minn siegħa sa sagħtejn wara.
Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/ L.
Dożi waħedhom ta ’ 100- 750 mg ipproduċew konċentrazzjonijiet massimi fis- serum (Cmax) bejn 0. 56 u 3. 7 mg/ L dipendenti mid- doża.
Serum concentrations increase proportionately with doses up to 1000 mg.
Konċentrazzjonijiet fis- serum jiżdiedu b’ mod proporzjonali mad- doża b’ dożi sa 1000 mg.
The absolute bioavailability is approximately 70-80%.
Il- bijodisponibiltà assoluta hija madwar 70- 80%.
A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours.
Doża orali ta ’ 500 mg mogħtija kull 12- il siegħa intweriet li tipproduċi erja taħt il- kurva tal - konċentrazzjoni fis- serum kontra l- ħin (AUC) ekwivalenti għal dik prodotta minn infużjoni ġol- vini ta ’ 400 mg ciprofloxacin mogħtija fuq medda ta ’ 60 minuta kull 12- il siegħa.
Protein binding of ciprofloxacin is low (20-30%).
It- twaħħil mal- proteini ta ’ ciprofloxacin huwa baxx (20- 30%).
Ciprofloxacin is present in plasma largely in a non- ionised form and has a large steady state distribution volume of 2-3 L/ kg body weight.
Ciprofloxacin huwa preżenti fil- plażma fil- biċċa l- kbira fil- forma mhux jonizzata u għandha volum ta ’ distribuzzjoni fi stat fiss kbir ta ’ 2- 3 L/ kg piż tal- ġisem.
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- apparat uroġenitali (awrina, prostata, endometriju) fejn jintlaħqu konċentrazzjonijiet totali li jaqabżu dawk tal- konċentrazzjonijiet fil- plażma.
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 38 formylciprofloxacin (M 4).
The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.
Il- metaboliti juru attività in- vitro kontra l- mikrobi iżda fi grad inqas mis - sustanza oriġinali.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
Ciprofloxacin huwa magħruf li huwa inibitur moderat ta ’ iso- enżimi CYP 450 1A2.
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.
The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.
Il- half- life tal- eliminazzjoni fis- serum f’ individwi b’ funzjoni renali normali hija madwar 4- 7 sigħat.
36 Excretion of ciprofloxacin (% of dose) Oral Administration
Tneħħija ta ’ ciprofloxacin (% tad- doża) Għoti Orali
Urine
Awrina
Faeces
Purgar
Ciprofloxacin Metabolites (M1-M4)
Ciprofloxacin Metaboliti (M1- M4)
44.7 11.3
44. 7 11. 3
25.0 7.5
25. 0 7. 5
Renal clearance is between 180-300 mL/ kg/ h and the total body clearance is between 480-600 mL/ kg/ h.
It- tneħħija renali hija bejn 180- 300 mL/ kg/ h u t- tneħħija totali mill- ġisem hija bejn 480- 600 mL/ kg/ h.
Ciprofloxacin undergoes both glomerular filtration and tubular secretion.
Ciprofloxacin jgħaddi kemm minn filtrazzjoni glomerulari kif ukoll minn sekrezzjoni tubulari.
Severely impaired renal function leads to increased half lives of ciprofloxacin of up to 12 h.
Funzjoni renali indebolita b’ mod sever twassal għal żjieda fil- half- lives ta ’ ciprofloxacin sa 12 h.
1% of the dose is excreted via the biliary route.
Tneħħija mhux renali ta ’ ciprofloxacin fil- biċċa l- kbira hija minħabba sekrezzjoni trans- intestinali attiva, u metaboliżmu 1% tad- doża titneħħa permezz tar- rotta tal- bili.
Ciprofloxacin is present in the bile in high concentrations.
Ciprofloxacin huwa preżenti fil - bili f’ konċentrazzjonijiet għolja.
The pharmacokinetic data in paediatric patients are limited.
It- tagħrif farmakokinetiku f’ pazjenti pedjatriċi huwa limitat.
In a study in children Cmax and AUC were not age-dependent (above one year of age).
Fi studju fit- tfal Cmax u AUC ma kienux dipendenti mill- età (’ l fuq minn età ta ’ sena).
No notable increase in Cmax and AUC upon multiple dosing (10 mg/ kg three times daily) was observed.
Ma ġietx ossrvata żjieda notabbli Cmax u l- AUC b’ dożaġġ multiplu (10 mg/ kg tliet darbiet kuljum).
In 10 children with severe sepsis Cmax was 6.1 mg/ L (range 4.6-8.3 mg/ L) after a 1-hour intravenous infusion of 10 mg/ kg in children aged less than 1 year compared to 7.2 mg/ L (range 4.7-11.8 mg/ L) for children between 1 and 5 years of age.
F’ għaxart itfal b’ sepsis severa, Cmax kienet 6. 1 mg/ L (firxa 4. 6- 8. 3 mg/ L) wara infużjoni ta ’ 10 mg/ kg ġol- vini ta ’ siegħa fi tfal b’ età ta ’ inqas minn sena meta mqabbel ma ’ 7. 2 mg/ L (firxa 4. 7- 11. 8 mg/ L) għal tfal b’ età bejn sena u 5 snin.
The AUC values were 17.4 mg*h/ L (range 11.8-32.0 mg*h/ L) and 16.5 mg*h/ L (range 11.0-23.8 mg*h/ L) in the respective age groups.
Il- valuri ta ’ l- AUC kienu 17. 4 mg* h/ L (firxa 11. 8- 32. 0 mg* h/ L) u 16. 5 mg* h/ L (firxa 11. 0- 23. 8 mg* h/ L) fil- gruppi ta ’ età rispettiva.
These values are within the range reported for adults at therapeutic doses.
Dawn il- valuri huma fil- firxa rrapportata għall- adulti b’ dożi terapewtiċi.
4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.
Ibbażat fuq analiżi farmakokinetika tal- popolazzjoni għall- pazjenti pedjatriċi b’ diversi infezzjonijiet, il- half- life medja mbassra fit- tfal hija madwar 4- 5 sigħat u l- bijodisponibiltà tas- suspensjoni orali tvarja minn 50 sa 80%.
Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ effett tossiku minn doża waħda, effett tossiku minn dożi ripetuti, potenzjal karċinoġeniku, jew effett tossiku fuq is- sistema riproduttiva ma turi l- ebda periklu speċjali għall- bnedmin.
Like a number of other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels.
Bħal numru ta ’ quinolones oħra, ciprofloxacin huwa fototossiku fil- bhejjem f’ livelli ta ’ esponiment klinikament rilevanti.
Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or 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.
This effect was comparable to that of other gyrase inhibitors.
Dan l- effett kien komparabbli għal dak ta ’ inibituri ta ’ gyrase oħra.
Articular tolerability:
Tollerabilità artikulari:
As reported for other gyrase inhibitors, ciprofloxacin causes damage to the large weight-bearing joints in immature animals.
Kif irrapportat għall- inibituri ta ’ gyrase oħra, ciprofloxacin jikkawża ħsara lill- ġogi l- kbar li jġorru piż f’ bhejjem mhux maturi.
The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints.
L- estensjoni ta ’ ħsara lill- qarquċa tvarja skond l- età, speċi u doża; il- ħsara tista ’ titnaqqas billi jitneħħa l- piż minn fuq il- ġogi.
Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions.
Studji b’ bhejjem maturi (far, kelb) ma wrew l- ebda
In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
Fi studju bi klieb tal- beagle żgħar, ciprofloxacin ikkawża tibdiliet artikulari severi b’ dożi terapewtiċi wara ġimagħtejn ta ’ kura, li baqgħu jiġu osservati wara 5 xhur.
37 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
[See Annex I - To be completed nationally.]
[Ara Anness I - Biex timtela mill- pajjiż partikolari.]
{Name and address }< {tel }> < {fax }> < {e-mail }>
{Isem u indirizz} < {tel} > < {fax} > < {e- mail} >
[To be completed nationally.]
[Biex timtela mill- pajjiż partikolari.]
[To be completed nationally]
[Biex timtela mill- pajjiż partikolari.]
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg pilloli miksija b’ rita [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Ciprofloxacin Bayer 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 250 mg pilloli miksija b’ rita huma ndikati 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
- infezzjonijiet bronko- pulmonari f’ fibrożi ċistika jew f’ bronkjektasi
• Infections of the skin and soft tissue caused by Gram-negative bacteria
41 • Infezzjonijiet tal- ġilda u tat- tessut artab ikkawżati minn batterja Gram- negative
39 • Malignant external otitis
• Otite esterna malinna
Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Ciprofloxacin jista ’ jintuża wkoll biex jikkura infezzjonijiet severi fit- tfal u adoloxxenti fejn dan huwa kkunsidrat li huwa neċessarju
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/ tikkawża l- infezzjoni 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.
Il- kura ta ’ infezzjonijiet ikkawżati minn ċertu batterja (e. ż Pseudomonas aeruginosa, Acinetobacter, jew Staphylococci) għandu mnejn tkun tinħtieġ dożi ogħla ta ’ ciprofloxacin u għoti flimkien ma 'sustanza kontra l- batterja xierqa oħra.
7
7 sa 14- il ġurnata
Infections of the upper respiratory
Infezzjonijiet ta ’ l - Irkadar akut ta ’ apparat respiratorju sinusite kronika ta ’ fuq
Complicated
Pijelonefrite komplikata
500 mg twice daily to
500 mg darbtejn kuljum sa 750 mg darbtejn
at least 10 days, it can be
ta ’ l- inqas 10 ġranet, jista ’ jitkompla għal aktar minn
750 mg twice daily
kuljum
continued for longer than 21 days in some specific circumstances (such as abscesses)
21
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
Bone and joint infections
Infezzjonijiet ta ’ l- għadam u l- ġogi
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.
(potenzjalment inkluż bidu ta ’ kura parenterali b ’ ciprofloxacin) 500 mg darbtejn kuljum Kura ta ’ infezzjonijiet jew profilassi ta ’
500 mg twice daily to 750 mg twice daily
sa 750 mg darbtejn
Therapy should be continued over the entire period of neutropenia
Terapija għandha titkompla
Inhalation anthrax
L- għoti tal- mediċina għandu jinbeda mill - aktar fis possibli wara suspett jew konferma ta ’ esponiment.
42
Dosa Orali
< 30
30- 60 < 30 Pazjenti fuq emodijalisi
250-500 mg every 24 h (after dialysis)
250- 500 mg kull 12 h 250- 500 mg kull 24 h 250- 500 mg kull 24 h (wara dijalisi)
• 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).
43 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.
Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
45 Infezzjonijiet ta ’ l- għadam u l- ġogi Ciprofloxacin għandu jintuża flimkien ma ’ sustanzi kontra l- mikrobi oħra skond ir- riżultati tad - dokumentazzjoni mikrobijoloġika.
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.
L- użu ta ’ ciprofloxacin għall- infezzjonijiet severi speċifiċi minbarra dawk imsemmijin fuq, ma ġiex ivvalutat fi provi kliniċi u l- esperjenza klinika hija limitata.