qanastek/EMEA-V3 huggingface dataset:
Antiperistaltics are contraindicated.
L- antiperistaltiċi huma kontra- indikati.
The transaminase or alkaline phosphatase concentrations may temporarily increase or cholestatic icterus might occur, especially in patients with previous liver damage.
Il- konċentrazzjonijiet tat- transaminase jew alkaline phosphatase jistgħu temporanjament jiżdiedu, jew jista ’ jseħħ ikterus kolestatiku, speċjalment f’ pazjenti li kellhom ħsara fil- fwied fil- passat.
Musculoskeletal system:
Is- sistema muskolo- skeletrika:
9 If there is any indication of tendinitis (e. g. painful swelling) the administration of ciprofloxacin or other fluoroquinolones must immediately be discontinued, the affected extremity should not be strained and a physician must be consulted.
Jekk ikun hemm kwalunkwe indikazzjoni ta ’ tendinite (eż. nefħa bl- uġigħ), l- għoti ta ’ ciprofloxacin jew ta ’ fluoroquinolones oħrajn, irid jitwaqqaf immedjatament, u l- parti affettwata m’ għandhiex tiġi 10 sfurzata, u għandu jiġi kkonsultat tabib.
Very rarely, a partial or total rupture (in particular of the Achilles tendon) has been reported, especially in elderly patients who were previously treated systemically with glucocorticoids.
B’ mod rari ħafna, ftuq parzjali jew totali (b’ mod partikulari tat- tendine ta ’ Achilles) kien irrappurtat, speċjalment f’ pazjenti anzjani li kienu kkurati b’ mod sistemiku bil- glukokortikojdi fil- passat.
Ciprofloxacin may cause an exacerbation of Myastenia gravis symptoms.
Ciprofloxacin jista ’ jikkawża aggravament tas- sintomi ta ’ Myastenia gravis.
Therefore, in case of any symptom indicating an exacerbation of Myastenia gravis a physician must be consulted.
Għalhekk, f’ każ ta ’ kwalunkwe sintomu li jindika aggravament ta ’ Myastenia gravis, għandu jiġi kkonsultat tabib.
Photosensibility:
Sensittività għad- dawl:
Ciprofloxacin and other fluoroquinolones may cause photosensibility.
Ciprofloxacin u fluoroquinolones oħrajn jistgħu jikkawżaw sensittività għad- dawl.
Therefore, it is recommended to avoid prolonged exposure to sunlight or UV light during treatment with ciprofloxacin.
Għalhekk, hu rakkomandat li tevita espożizzjoni fit- tul għad- dawl tax- xemx jew għad- dawl matul il- kura b’ ciprofloxacin.
However, if this is not possible the patient is recommended to use a sun-protection cream.
Madankollu, jekk dan mhuwiex possibbli, hu rakkomandat li l- pazjent juża krema li tipproteġih/ a mix- xemx.
When photosensibility occurs the treatment must be discontinued.
Meta sseħħ sensittività għad- dawl, il- kura trid titwaqqaf.
Hypersensitivity reactions and allergic reactions occurred in some cases after the first administration of ciprofloxacin.
Reazzjonijiet ta ’ sensittività eċċessiva u reazzjonijiet allerġiċi seħħew f’ xi każijiet wara l- ewwel l- għoti ta ’ ciprofloxacin.
If such reactions occur, a physician must immediately be consulted.
Jekk reazzjonijiet bħal dawn iseħħu, it- tabib għandu jiġi kkonsultat immedjatament.
Anaphylactic/ anaphylactoid reactions can in very rare cases develop into life-threatening shock, sometimes even after the first administration of ciprofloxacin.
F’ każijiet rari ħafna, ir- reazzjonijiet anafilattiċi/ anafilattojdi jistgħu jiżviluppaw f’ xokk li jkun ta ’ periklu għall- ħajja, xi kultant anki wara l- ewwel l- għoti ta ’ ciprofloxacin.
In that case, the ciprofloxacin treatment must be discontinued, and medical treatment for shock should be given.
F’ dak il- każ, il- kura b’ ciprofloxacin trid titwaqqaf, u għandha tingħata kura medika għal xokk.
Local reaction:
Reazzjoni lokali:
Local reactions have been reported after intravenous administration of ciprofloxacin.
Reazzjonijiet lokali kienu rrappurtati wara l- għoti ġol- vina ta ’ ciprofloxacin.
These reactions occur more frequently when the infusion time is 30 minutes or less.
Dawn ir- reazzjonijiet iseħħu b’ mod iktar frekwenti meta l- ħin ta ’ l- infużjoni jkun ta ’ 30 minuta jew inqas.
These may be manifested as local skin reactions, which rapidly disappear after the infusion has been completed.
Dawn jistgħu jidhru bħala reazzjonijiet lokali tal- ġilda, li jgħibu malajr wara li l- infużjoni tkun tlestiet.
Further intravenous administration is not contraindicated unless the reactions reoccur or worsen.
L- għoti addizzjonali ġol- vina mhuwiex kontra- indikat, ħlief jekk ir- reazzjonijiet iseħħu mill- ġdid jew jiħraxu.
Because ciprofloxacin has some activity against Mycobacterium tuberculosis, false-negative cultures may occur when the specimens are obtained during ciprofloxacin treatment.
Minħabba li ciprofloxacin għandu xi attività kontra Mycobacterium tuberculosis, kulturi foloz- negattivi jistgħu jseħħu meta l- kampjuni jinkisbu waqt il- kura b’ ciprofloxacin.
Ciprofloxacin Hikma contains 15.4 mmol (354 mg) sodium per 100 ml of solution for infusion.
Ciprofloxacin Hikma fiha 15. 4 mmol (354 mg) ta ’ sodium f’ kull 100 ml ta ’ soluzzjoni għall- infużjoni.
This has to be taken into consideration for patients on a controlled sodium diet.
Dan għandu jiġi kkunsidrat għal pazjenti li qegħdin fuq dieta kkontrollata tas- sodium.
Probenecid Probenecid inhibits the renal excretion of ciprofloxacin resulting in an increase in the plasma concentration of ciprofloxacin.
Probenecid Probenecid jinibixxi t- tneħħija mil- kliewi ta ’ ciprofloxacin, li tirriżulta f’ żieda fil- konċentrazzjoni ta ’ ciprofloxacin fil- plażma.
CYP1A2 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, tacrine, ropinirol, tizanidine).
CYP1A2 Ciprofloxacin jinibixxi CYP1A2 u għaldaqstant jista ’ jikkawża żieda fil- konċentrazzjoni fis- serum ta ’ sustanzi li jingħataw fl- istess ħin li jkunu metabolati minn din l- enzima (eż. theophylline, clozapine, tacrine, ropinirol, tizanidine).
Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose.
Għalhekk, pazjenti li jkunu qed jieħdu dawn is- sustanzi fl- istess ħin ma ’ ciprofloxacin, għandhom jiġu mmonitorjati mill- qrib għal sinjali kliniċi ta ’ doża eċċessiva.
Determination of serum concentrations, especially of theophylline, and dose adjustments may be necessary.
Id- determinazzjoni tal- konċentrazzjonijiet fis- serum, speċjalment ta ’ theophylline, u aġġustamenti fid- doża jistgħu jkunu meħtieġa.
The interaction between theophylline and ciprofloxacin is potentially life-threatening.
L- interazzjoni bejn theophylline u ciprofloxacin hi potenzjalment ta ’ periklu għall- ħajja.
Other xanthine derivatives On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Derivattivi oħrajn ta ’ xanthine Wara l- għoti fl- istess ħin ta ’ ciprofloxacin u caffeine jew pentoxifylline (oxpentifylline), kienu rrappurtati żiediet fil- konċentrazzjonijiet ta ’ dawn id- derivattivi ta ’ xanthine fis- serum.
10 Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Phenytoin L- għoti fl- istess ħin ta ’ ciprofloxacin u phenytoin jista ’ jirriżulta f’ żieda jew tnaqqis fil- livelli ta ’ phenytoin fis- serum b’ tali mod li l- monitoraġġ tal- livelli tal- mediċina hu rakkomandat.
Methotrexate Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate.
11 Methotrexate It- trasport tubulari tal- kliewi ta ’ methotrexate jista ’ jkun inibit mill- għoti fl- istess ħin ta ’ ciprofloxacin, li potenzjalment jista ’ jwassal għal żieda fil- livelli ta ’ methotrexate fil- plażma.
This may increase the risk of methotrexate associated toxic reactions.
Dan jista ’ jżid ir- riskju ta ’ methotrexate marbut ma ’ reazzjonijiet tossiċi.
Therefore, patients receiving methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.
Għalhekk, il- pazjenti li jkunu qed jirċievu terapija b’ methotrexate, għandhom ikunu mmonitorjati bl- attenzjoni meta t- terapija b’ ciprofloxacin fl- istess ħin tkun indikata.
Cyclosporine Following concomitant administration of ciprofloxacin and cyclosporine a transient increase of the serum creatinine concentration has been observed in separate cases.
Cyclosporine Wara l- għoti fl- istess ħin ta ’ ciprofloxacin u cyclosporine, żieda temporanja tal- konċentrazzjoni tal- creatine fis- serum kienet osservata f’ każijiet separati.
Therefore, the serum creatinine concentration must be checked regularly (twice per week) in these patients.
Għalhekk, il- konċentrazzjoni tal- kreatinina fis- serum trid tkun iċċekkjata regolarment (darbtejn kull ġimgħa) f’ dawn il- pazjenti.
Oral anticoagulants (e. g. warfarin) Ciprofloxacin, like other quinolones, may enhance the effect of coumarin derivates including warfarin.
Mediċini kontra l- koagulazzjoni tad- demm (eż. warfarin) Ciprofloxacin, bħal quinolones oħrajn, jista ’ jkabbar l- effett tad- derivattivi ta ’ coumarin li jinkludu warfarin.
In the case of concomitant administration of these products, prothrombin time (PT) or other suitable coagulation tests should be monitored.
Fil- każ ta ’ l- għoti fl- istess ħin ta ’ dawn il- prodotti, il- ħin tal- protrombin (PT) jew testijiet adattati oħrajn tal- koagulazzjoni, għandhom ikunu mmonitorjati.
If necessary, the oral anticoagulant dose should be adjusted as appropriate.
Jekk ikun meħtieġ, id- doża tal- mediċini orali li jraqqu d- demm għandha tkun aġġustata kif suppost.
Glibenclamide When used simultaneously, ciprofloxacin may, in certain cases, increase the effect of glibenclamide (hypoglycaemia).
Glibenclamide Meta jintuża fl- istess ħin, ciprofloxacin jista, f’ ċerti każijiet, jżid l- effett ta ’ glibenclamide (ipogliċemija).
NSAIDs Animal trials have shown that the concurrent administration of very high doses of fluoroquinolones and certain NSAIDs (but not acetylsalicylic acid) may provoke convulsions.
NSAIDs Provi fuq l- annimali wrew li l- għoti fl- istess ħin ta ’ dożi qawwija ħafna ta ’ fluoroquinolones u ċerti NSAIDs (iżda mhux acetylsalicylic acid) jistgħu jikkawżaw konvulżjonijiet.
Mexiletine Simultaneous administration of ciprofloxacin and mexiletine can lead to increased plasma concentrations of mexiletine.
Mexiletine L- għoti fl- istess ħin ta ’ ciprofloxacin u ta ’ mexiletine jista ’ jwassal għal żieda fil- konċentrazzjonijiet ta ’ mexiletine fil- plażma.
Premedicants It is recommended that opiate premedicants, (e. g. papaveretum) or opiate premedicants used with anticholinergic premedicants, (e. g. atropine or hyoscine) are not used concomitantly with ciprofloxacin, as the serum levels of ciprofloxacin are reduced.
Pre- medikanti Hu rakkomandat li l- pre- medikanti ta ’ l- opiate (eż. papaveretum) jew pre- medikanti ta ’ l- opiate li jintużaw ma ’ pre- medikanti antikolinerġiċi (eż. atropine jew hyoscine) ma jintużawx fl- istess ħin ma ’ ciprofloxacin, għax il- livelli ta ’ ciprofloxacin fis- serum jonqsu.
Co-administration of ciprofloxacin and benzodiazepine premedicants has been shown not to affect ciprofloxacin plasma levels.
Ma ntweriex li l- għoti flimkien ta ’ pre- medikanti ta ’ ciprofloxacin u benzodiazepine jaffettwa l- livelli ta ’ ciprofloxacin fil- plażma.
However, since decreased clearance of diazepam, with a prolonged half-life have been reported during co-administration of ciprofloxacin and diazepam, and in very rare cases with midazolam, careful monitoring of benzodiazepine therapy is recommended.
Madankollu, minħabba li kien irrappurtat tnaqqis fit- tneħħija ta ’ diazepam, b’ titwil tal- half- life matul l- għoti flimkien ta ’ ciprofloxacin u diazepam, u f’ każijiet rari ħafna ma ’ midazolam, monitoraġġ bl - attenzjoni tat- terapija b’ benzodiazepine hu rakkomandat.
Pregnancy Use during pregnancy is contraindicated.
Tqala L- użu matul it- tqala hu kontra- indikat.
There are limited data on the use of ciprofloxacin during pregnancy.
Hemm data limitata dwar l- użu ta ’ ciprofloxacin matul it- tqala.
Up to now, no evidence has been found of an increased risk of congenital abnormalities or other undesirable effects following use of ciprofloxacin or other quinolones during the first trimester.
S’ issa, ma nstabet l- ebda evidenza ta ’ żieda fir- riskju ta ’ anormalitajiet konġenitali jew effetti oħrajn mhux mixtieqa wara l- użu ta ’ ciprofloxacin jew quinolones oħrajn matul l- ewwel tliet xhur.
Teratogenic effects have not been observed in animal experimental research.
Effetti teratoġeniċi ma kienux osservati matul riċerka sperimentali fuq l- annimali.
In juvenile and prenatal animals exposed to quinolones effects on immature cartilage have been observed (see section 5.3).
F’ annimali żgħar u ta ’ qabel it- twelid esposti għall- effetti ta ’ quinolones, kienu osservati effetti fuq il- kartilaġni immatura (ara sezzjoni 5. 3).
Since the risks for humans are unknown Ciprofloxacin Hikma must not be administered during pregnancy (see section 4.3).
Minħabba li r- riskju għall- bnedmin mhuwiex magħruf, Ciprofloxacin Hikma m’ għandux jingħata matul it- tqala (ara sezzjoni 4. 3).
11 Lactation:
Treddigħ:
Ciprofloxacin is excreted in breast milk.
Ciprofloxacin jitneħħa fil- ħalib tas- sider.
Due to the risk of arthropathy and other potentially severe toxicity in the infant, ciprofloxacin is contraindicated during lactation (see section 4.3).
Minħabba r- riskju ta ’ artropatija u tossiċità potenzjalment severa oħra fit- tarbija, ciprofloxacin hu kontra- indikat matul it- treddigħ (ara sezzjoni 4. 3).
Ciprofloxacin Hikma has minor or moderate influence on the ability to drive and use machines.
12 Ciprofloxacin Hikma għandu influwenza żgħira jew moderata fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
When undesirable effects on the central nervous system, like dizziness, occur, it is prohibited to drive a vehicle or to operate machines.
Meta l- effetti mhux mixtieqa jseħħu fuq is- sistema nervuża ċentrali, bħal l- isturdament, hu pprojbit li ssuq vettura jew li tħaddem il- magni.
Adverse reactions have been reported in 5-14% of patients receiving ciprofloxacin.
Reazzjonijiet avversi kienu irrappurtat f’ 5- 14% tal- pazjenti li kienu qed jirċievu ciprofloxacin.
Most frequent adverse effects involve the gastro-intestinal tract and the central nervous system.
Il- biċċa l- kbira ta ’ l- effetti avversi frekwenti jinvolvu l- passaġġ gastro- intestinali u s- sistema nervuża ċentrali.
The following undesirable reactions have been observed:
Ir- reazzjonijiet mhux mixtieqa li ġejjin kienu osservati:
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1 000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 sa < 1/ 10) Mhux komuni (≥1/ 1 000 sa < 1/ 100) Rari (≥1/ 10, 000 sa < 1/ 1, 000) Rari ħafna (< 1/ 10, 000), (mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Uncommon: moniliasis
Mhux komuni: moniliasi
Uncommon: eosinophilia, leukopenia.
Disturbi tad- demm u tas- sistema limfatika Mhux komuni: eosinofilja, lewkopenja.
Rare: leukopenia (granulocytopenia), anaemia, leukocytosis, thrombocytopenia, thrombocytemia (thrombocytosis).
Rari: lewkopenja (granuloċitopenja), anemija, lewkoċitosi, valuri mibdulin tal- prothrombin, tromboċitopenja, tromboċitemija (tromboċitosi).
Very rare: haemolytic anaemia, pancytopenia, agranulocytosis.
Rari ħafna: anemija emolitika, panċitopenja, agranuloċitosi.
Immune system disorders:
Disturbi tas- sistema immuni:
Very rare: pulmonary oedema in case of shock (anaphylactic; life-threatening), itching rash, serum sickness-like symptoms.
Rari: edema (periferali, anġjo, tal- wiċċ), reazzjoni allerġika, deni minħabba l- mediċina, reazzjoni anafilattojdi (anafilattika) Rari ħafna: edema pulmonari f’ każ ta ’ xokk (anafilattiku; ta ’ periklu għall- ħajja), raxx bil- ħakk, sintomi tas- serum sickness.
Metabolism and nutrition disorders:
Disturbi marbut mal- metaboliżmu u n- nutrizzjoni:
Rare: hyperglycaemia.
Rari: ipergliċemija.
Rare: anxiety, nightmares, depression, hallucinations.
Rari: ansjetà, ħmar il- lejl, dipressjoni, alluċinazzjonijiet.
Very rare: psychotic reactions (which may progress to self-endangering behaviour).
Rari ħafna: reazzjonijiet psikotiċi (li jistgħu jaggravaw għal imġiba li tipperikola lil dak li jkun).
Common: perverted sensation of taste (usually reversible upon discontinuation of treatment), dizziness, headache, insomnia, agitation, confusion.
Komuni: sensazzjoni ta ’ togħma mibdula (normalment riversibbli mat- twaqqif tal- kura), sturdament, uġigħ ta ’ ras, nuqqas ta ’ rqad, aġitazzjoni, konfużjoni.
Rare: taste loss (reduced taste), paraesthesia (peripheral paralgesia), tremor (shaking), convulsions, migraine.
Rari: telf ta’ togħma (nuqqas ta ’ togħma), parestesija (paralġesija periferali), rogħda (titriegħed), konvulżjonijiet, emigranja.
Very rare: parosmia (impaired smell), anosmia (usually reversible after interruption), grand mal convulsion, abnormal (unstable) gait, intracranial hypertension, ataxia, hyperesthesia, hypertonia.
Rari ħafna: parosmija (indeboliment fix- xamm), anosmija (normalment riversibbli wara l - interruzzjoni), konvulżjoni grand mal, mod anormali ta ’ kif timxi (mixi instabbli), pressjoni tad- demm intrakranjali għolja, atassja, iperestesija, ipertonija.
Eye disorders:
Disturbi ta ’ l- għajnejn:
Rare: disturbed vision, diplopia, chromatopsia.
Rari: disturb fil- vista, diplopja, kromatopsija.
12 Ear and labyrinth disorders:
Disturbi tal- widnejn u tas- sistema labirintika:
Rare: tinnitus, transient hearing loss (particularly high frequencies).
Rari: żanżin fil- widnejn, ma tibqax tisma ’ temporanjament (partikularment il- frekwenzi għoljin).
Rare: tachycardia.
Rari: takikardija.
In very rare cases ventricular arrhythmia, QT interval prolongation and torsades de pointes have been reported.
13 F’ każijiet rari ħafna, arritmija ventrikulari, titwil fl- intervall tal- QT u torsades de pointes kienu rrappurtati.
These events were observed predominantly among patients with further risk factors for QTc prolongation.
Dawn l- avvenimenti kienu osservati l- biċċa l- kbira fost pazjenti b’ fatturi ta ’ riskju addizzjonali għat- titwil tal- QTc.
Rare: syncope (fainting), vasodilation (heat stress).
Rari: sinkope (ħass ħażin), vasodilatazzjoni (stress minħabba s- sħana).
Very rare: vasculitis (petechiae, hemorrhagic bullae, papules, crust formation).
Rari ħafna: vaskulite (tbenġil, infafet emorraġiċi, bżieżaq żgħar, formazzjoni ta ’ qoxra).
Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorju, toraċiku u medjastinali:
Rare: dyspnoea, laryngeal oedema.
Rari: dispnea, edema larinġeali.
Uncommon: vomiting, dyspepsia, flatulence, anorexia, abdominal pain.
Komuni: dardir, dijarea Mhux komuni: rimettar, dispepsja, gass, anoreksja, uġigħ addominali.
Rare: pseudomembranous colitis, moniliasis (oral).
Rari: kolite psewdomembranuża, moniliasi (orali).
Very rare: moniliasis (gastro-intestinal), pancreatitis.
Rari ħafna: moniliasi (gastro- intestinali), pankreatite.
Hepato-biliary disorders:
Disturbi tal- fwied u tal- marrara:
Rare: icterus, cholestatic icterus, liver cell necrosis.
Rari: ikterus, ikterus kolestatiku, nekrosi taċ- ċelluli tal- fwied.
Very rare: hepatitis, liver cell necrosis (very rarely resulting in life-threatening liver function failure).
Rari ħafna: epatite, nekrosi taċ- ċelluli tal- fwied (li b’ mod rari ħafna tirriżulta f’ kollass tal- funzjoni tal - fwied li jkun ta ’ periklu għall- ħajja).
Common: rash.
Komuni: raxx.
Uncommon: pruritis, papillo-macular rash, urticaria.
Mhux komuni: ħakk, raxx papillo- makulari, urtikarja.
Rare: photosensibility, erythema multiforme and erythema nodusum.
Rari: sensittività għad- dawl, eritema multiforme u eritema nodusum.
Very rare: erythema nodosum, erythema multiforme (minor), Stevens-Johnson syndrome, epidermal necrolysis (Lyell Syndrome), petechia.
Rari ħafna: eritema nodosum, eritema multiforme (minuri), sindrome ta ’ Stevens- Johnson, nekrolisi epidermali (sindrome ta ’ Lyell), tbenġil.
Uncommon: arthralgia (joint pain).
Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni: artralġja (uġigħ fil- gogi).
Rare: myalgia (muscular pain), joint disorder (swollen joints).
Rari: mijalġja (uġigħ fil- muskoli), mard tal- ġogi (ġogi minfuħin).
Very rare: tendinitis (in particular of the Achilles tendon), partial or total tendon ruptures (in particular of the Achilles tendon), worsening of the symptoms of myasthenia, muscular pains, inflammation of tendon sheaths (tenosynovitis).
Rari ħafna: tendinite (b’ mod partikulari t- tendine ta ’ Achilles), ftuq parzjali jew tat- tendini (b’ mod partikulari tat- tendine ta ’ Achilles), sintomi ta ’ mijastenja li jmorru għall- agħar, uġigħ fil- muskoli, infjammazzjoni ta ’ l- għantijiet tat- tendini (tenosinovite).
Rare: acute renal failure, impaired renal function, vaginal moniliasis, haematuria, crystalluria, interstitial nephritis.
Rari: kollass akut tal- kliewi, indeboliment fil- funzjoni tal- kliewi, moniliasi vaġinali, ematurja, kristallurja, nefrite interstizjali.
General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet tas- sit mnejn jingħata:
Uncommon: asthenia (general sensation of weakness, fatigue), injection site reactions.
Mhux komuni: astenja (sensazzjoni ġenerali ta ’ dgħjufija, għeja kbira), reazzjonijiet fis- sit ta ’ l- injezzjoni.
Rare: transpiration.
Rari: transpirazzjoni.
Uncommon: increase of blood creatinine levels, increased blood urea; abnormal liver function test results (increased SGOT and SGPT), bilirubinemia and increased alkaline phosphatase.
Mhux komuni: żieda fil- livelli tal- creatine fid- demm, żieda fl- urea fid- demm; testijiet tal- funzjoni tal- fwied b’ riżultat anormali (żieda fl- SGOT u SGPT), bilirubinemija u żieda fl- alkaline phosphatase.
13 Very rare: increment of amylase/ lipase levels.
Rari ħafna: żieda fil- livelli ta ’ amylase/ lipase.
Uncommon: pulmonary embolism, dyspnoea, pulmonary oedema, epistaxis, haemoptysis and hiccough.
Mhux komuni: emboliżmu pulmonari, dispnea, edema pulmonari, tinfaraġ, emoptisi u sulluzzu.
Very rare: asthenia, a transient impairment of kidney function to transient renal failure, photosensitivity (see Section 4.4).
Rari ħafna: astenja, indeboliment temporanju tal- funzjoni tal- kliewi sa kollass temporanju tal- kliewi, sensittività għad- dawl (ara sezzjoni 4. 4).
In acute and extreme overdosage, reversible kidney damage is seen.
14 F’ każ ta ’ doża eċċessiva akuta u estrema, dehret ħsara riversibbli tal- kliewi.
An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Doża eċċessiva ta ’ 12 g kienet irrappurtata li twassal għal sintomi ħfief ta ’ tossiċità.
Symptoms of overdose may include dizziness, tremor, headaches, tiredness, seizures, hallucinations, confusion, gastrointestinal upset, liver and kidney abnormalities, crystalluria, haematuria.
Sintomi ta ’ doża eċċessiva jistgħu jinkludu sturdament, rogħda, uġigħ ta ’ ras, għeja, puplesiji, alluċinazzjonijiet, konfużjoni, problemi gastrointestinali, anormalitajiet fil- fwied u fil- kliewi, kristallurja, ematurja.
The patient should be monitored closely and treated symptomatically with supportive measures.
Il- pazjent għandu jkun immonitorjat mill- qrib u kkurat b’ mod sintomatiku b’ miżuri ta ’ sapport.
Adequate hydration must be ensured.
Idratazzjoni adegwata għandha tkun aċċertata.
At haemodialysis or peritoneal dialysis only a modest amount of ciprofloxacin (less than 10%) is eliminated.
Waqt emodijaliżi jew dijaliżi peritoneali, jitneħħa biss ammont żgħir ta ’ ciprofloxacin (inqas minn 10%).
Antibacterial quinolones, ATC code:
Kategorija farmakoterapewtika: quinolones anti- batteriċi, Kodiċi ATC:
Mode of action:
Mod ta ’ azzjoni:
Ciprofloxacin has a rapid bactericidal effect, both in the growth phase and in the rest phase.
Ciprofloxacin għandu effett batteriċidjali mgħaġġel, kemm fil- fażi tat- tkabbir kif ukoll fil- fażi tas- serħan.
During the growth phase of bacteria, a partial rolling up and unfolding of chromosomes takes place.
Matul il- fażi tat- tkabbir tal- batterji, iseħħ rolling up u unfolding parzjali tal- kromosomi.
The enzyme DNA-gyrase plays a crucial role in this process.
L- enzima DNA- gyrase għandha rwol kruċjali f’ dan il- proċess.
Ciprofloxacin inhibits DNA-gyrase, resulting in inhibition of DNA synthesis.
Ciprofloxacin jinibixxi DNA- gyrase, li jirriżulta f’ inibizzjoni tas- sintesi tad- DNA.
Ciprofloxacin is effective in vitro against a large number of Gram-negative aerobic bacteria including P. aeruginosa.
Ciprofloxacin hu effettiv in vitro kontra numru kbir ta ’ batterji aerobiċi Gram- negattivi li jinkludu P. aeruginosa.
It is also effective against Gram-positive organisms, such as staphylococci and streptococci.
Hu effettiv ukoll kontra organiżmi Gram- pożittivi bħal staphylococci u streptococci.
Anaerobes are generally less sensitive.
Ġeneralment, l- anerobi huma inqas sensittivi.
Mechanism of resistance:
Mekkaniżmu tar- reżistenza:
Resistance to ciprofloxacin develops in stages through genomic mutations (multiple-step type).
Ir- reżistenza għal ciprofloxacin tiżviluppa fi stadji permezz ta ’ mutazzjonijiet ġenomiċi (tat- tip multiple- step).
Transferable plasmid-mediated quinolone resistance associated with qnr has been detected in quinolone-resistant clinical strains of E. coli and Klebsiella spp.
Reżistenza trasferibbli għal quinolone medjata mill- plasmid, assoċjata ma ’ qnr kienet osservata f’ razez ta ’ E. coli u Klebsiella spp. li kienu klinikament reżistenti għal quinolone.
As a result of its mechanism of action, ciprofloxacin does not show cross-resistance with other important, chemically different groups of substances such as beta-lactam antibiotics, aminoglycosides, tetracyclines, macrolides and polypeptides, sulphonamides, trimethoprim and nitrofurantoine.
Bħala riżultat tal- mekkaniżmu ta ’ l- azzjoni tiegħu, ciprofloxacin ma jurix reżistenza inkroċjata ma ’ gruppi oħrajn ta ’ sustanzi importanti li huma kimikament differenti, bħal antibijotiċi beta- lactam, aminoglycosides, tetracyclines, macrolides u polypeptides, sulphonamides, trimethoprim u nitrofurantoine.
Within the class of quinolones cross-resistance has been observed.
Fi ħdan il- klassi ta ’ quinolones, ir- reżistenza inkroċjata kienet osservata.
Development of resistance to ciprofloxacin and other fluoroquinolones has been observed in staphylococci, especially methicillin- resistant S. aureus, P. aeruginosa, E. coli and E. faecalis (see the sensitivity table).
L- iżvilupp tar- reżistenza għal ciprofloxacin u fluoroquinolones oħrajn kien osservat fi staphylococci, speċjalment f’ S. aureus li hu reżistenti għal methicillin, P. aeruginosa, E. coli u E. faecalis (ara t- tabella tas- sensittività).
Especially patients undergoing long-term treatment (e. g. in cystic fibrosis, osteomyelitis), or patients who are extremely susceptible to infections (e. g. in selective prophylaxis in certain groups of neutropenic patients, artificial ventilation) show the highest risk.
B’ mod speċjali, pazjenti li jkunu qed jirċievu kura fit- tul (eż. li għandhom fibrożi ċistika, osteomjelite), jew pazjenti li huma estremament suxxettibbli għall- infezzjonijiet (eż. fi profilassi selettiva f’ ċerti gruppi ta ’ pazjenti newtropeniċi, ventilazzjoni artifiċjali), juru l- ogħla riskju.
The percentage of resistant strains can be subject to great local variation.
Il- perċentwali ta ’ razez reżistenti jista ’ jkun suġġett għal varjazzjoni lokali kbira.
Regular determination of resistance is therefore recommended.
Għalhekk, id- determinazzjoni regolari tar- reżistenza hi rakkomandati.
According to EUCAST the following breakpoints for aerobic bacteria have been defined for ciprofloxacin:
Skond l- EUCAST il- breakpoints li ġejjin għal batterji aerobiċi kienu definiti għal ciprofloxacin:
- Enterobacteriaceae: ≤ 0.5 µg/ ml for susceptible, > 1 µg/ ml for resistant;
Enterobacteriaceae: ≤ 0. 5 µg/ ml għas- suxxettibbli, > 1 µg/ ml għar- reżistenti;
- Pseudomonas spp. ≤ 0.5 µg/ ml for susceptible, > 1 µg/ ml for resistant;
Pseudomonas spp. ≤ 0. 5 µg/ ml għas- suxxettibbli, > 1 µg/ ml għar- reżistenti;
- Acinetobacter spp. ≤ 1 µg/ ml for susceptible, > 1 µg/ ml for resistant;
Acinetobacter spp. ≤ 1 µg/ ml għas- suxxettibbli, > 1 µg/ ml għar- reżistenti;
- S. pneumonia ≤ 0.125 µg/ ml for susceptible, > 2 µg/ ml for resistant;
S. pneumonia ≤ 0. 125 µg/ ml għas- suxxettibbli, > 2 µg/ ml għar- reżistenti;
- Staphylococcus spp. ≤ 1 µg/ ml for susceptible, > 1 µg/ ml for resistant;
Staphylococcus spp. ≤ 1 µg/ ml għas- suxxettibbli, > 1 µg/ ml għar- reżistenti;
- H. influenza and M. catarrhalis ≤ 0.5 µg/ ml for susceptible, > 0.5 µg/ ml for resistant.
H. influenza u M. catarrhalis ≤ 0. 5 µg/ ml għas- suxxettibbli, > 0. 5 µg/ ml għar- reżistenti.
Non-species related breakpoints are ≤ 0,5 µg/ ml for susceptible, and > 1 µg/ ml for resistant organisms.
Il- breakpoints assoċjati mhux ta ’ l- ispeċi huma ta ’ ≤ 0, 5 µg/ ml għal organiżmi suxxettibbli, u ta ’ > 1 µg/ ml għal organiżmi reżistenti.
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.
15 Il- prevalenza tar- reżistenza miksuba tista ’ tvarja ġeografikament u maż- żmien għal speċi magħżula, u informazzjoni lokali dwar ir- reżistenza hi mixtieqa, partikularment meta tkun qed tikkura 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.
Parir espert għandu jinkiseb fejn ikun hemm bżonn meta l- prevalenza lokali tar - reżistenza hi tali li l- utilità tal- mediċina hi dubjuża f’ mill- inqas xi tipi ta infezzjonijiet.
Commonly susceptible species Gram-negative aerobe species Citrobacter spp.
Speċi li huma suxxettibbli b’ mod komuni Speċi ta ’ aerobi Gram- negattivi Citrobacter spp.
Proteus mirabilis Proteus vulgaris Serratia liquefaciens Serratia marcescens Species for which acquired resistance may be a problem Gram-positive aerobes Coagulase-negative Staphylococcus Enterococcous faecalis MRSA* Staphylococcus aureus Staphylococcus aureus (methicillin susceptible) Streptococcus spp.
Aerobi Gram- pożittivi Coagulase- negative Staphylococcus Enterococcous faecalis MRSA * Staphylococcus aureus Staphylococcus aureus (methicillin susceptible) Streptococcus spp.
Streptoococus agalactiae Streptococcus pneumoniae S. pneumoniae PEN-R Streptococcus pyogenes Gram-negative aerobes Acinetobacter spp.
Streptoococus agalactiae Streptococcus pneumoniae S. pneumoniae PEN- R Streptococcus pyogenes Aerobi Gram- negattivi Acinetobacter spp.
Amp-C producing Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Pseudomonas aeruginosa Inherently resistant organisms Gram-positive aerobes Enterococcus faecium Staphylococcus epidermidis Staphylococcus haemolyticus Gram-negative aerobes
Amp- C producing Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Pseudomonas aeruginosa Organiżmi reżistenti b’ mod inerenti:
15 E. coli multi-resistant Providencia spp.
Aerobi Gram- pożittivi Enterococcus faecium Staphylococcus epidermidis Staphylococcus haemolyticus Aerobi Gram- negattivi E. coli multi- reżistenti Providencia spp.
* MRSA are very likely to be resistant to ciprofloxacin and ciprofloxacin should not be used to treat presumed or known MRSA infections unless the organism is known to be susceptible.
* Hemm possibbilità kbira li l- MRSAs jkunu reżistenti ħafna għal ciprofloxacin, u għalhekk ciprofloxacin m’ għandux jintuża għall- kura ta ’ infezzjonijiet issoponuti jew magħrufa bl- MRSA ħlief jekk l- organiżmu hu magħruf li jkun suxxettibbli.
Abbreviations:
16 Taqsiriet:
Ciprofloxacin is rapidly and effectively absorbed after oral administration.
Ciprofloxacin jkun assorbit malajr u b’ mod effettiv wara l- għoti mill- ħalq.
The peak plasma concentration is reached 0.5 - 2 hours after taking 50 - 1000 mg p. o. and varies from 0.3 - 5.9 mg/ l.
Il- konċentrazzjoni massima fil- plażma tintlaħaq wara 30 minuta sa sagħtejn wara t- teħid ta ’ 50- 1000 mg p. o. u tvarja bejn 0. 3- 5. 9 mg/ l.
There is a linear correlation between dose on the one hand and plasma concentration and AUC on the other.
Hemm korrelazzjoni lineari bejn id- doża fuq naħa, u l- konċentrazzjoni fil- plażma u l- AUC fuq in- naħa l- oħra.
The bioavailability of ciprofloxacin after oral administration is between 70% and 85%.
Il- bijodisponibilità ta ’ ciprofloxacin wara l- għoti mill- ħalq hi bejn 70% u 85%.
The bioavailability is lower if antacids that contain aluminium and/ or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Il- bijodisponibilità hi iktar baxxa jekk l- antacids ikun fihom l- aluminium u/ jew magnesium hydroxide, u jekk il- calcium u iron salts jintużaw fl- istess ħin.
No accumulation occurs on repeated administration (twice daily).
L- ebda akkumulazzjoni ma sseħħ meta jkun hemm għoti ripetut (darbtejn kuljum).
Twelve hours after i. v. administration of 200 mg the plasma concentration is still higher than the MIC values of the majority of clinically relevant pathogens (approximately 0.1 µg/ ml).
Tnax- il siegħa wara l- għoti minn ġol- vina ta ’ 200 mg, il- konċentrazzjoni fil- plażma tibqa ’ ogħla mill- valuri MIC tal- maġġoranza ta ’ patoġeni li huma klinikament rilevanti (madwar 0. 1 µg/ ml).
In steady-state conditions the apparent distribution volume of ciprofloxacin is situated between 1,7 and 2,7 l/ kg.
Fil- kundizzjonijiet ta ’ l- istat fiss, il- volum apparenti tad- distribuzzjoni ta ’ ciprofloxacin ikun bejn 1. 7 u 2. 7 l/ kg.
This relatively high distribution volume indicates an effective tissue and fluid penetration.
Dan il- volum tad- distribuzzjoni relattivament għoli jindika penetrazzjoni effettiva tal- fluwidu fit- tessut.
This applies to gall, kidney, gall bladder and liver tissue.
Dan japplika għall- marrara, il- kliewi, il- bużżieqa tal- marrara u t- tessut tal- fwied.
Concentrations in pulmonary tissue, gynaecological tissue and prostate tissue and fluid were also significantly higher than the serum concentration.
Konċentrazzjonijiet fit- tessut pulmonari, fit- tessut ġinekoloġiku u fit- tessut u fil- fluwidu tal- prostata kienu wkoll ogħla b’ mod sinifikanti mill- konċentrazzjoni fis- serum.
The ciprofloxacin concentration in blister fluid, lymph, nasal secretion, peritoneal fluid, saliva and fatty tissue is approximately half of the serum concentration.
Il- konċentrazzjoni ta ’ ciprofloxacin fil- fluwidu ta ’ l- infafet, fil- limfa, fit- tnixxija nażali, fil- fluwidu peritoneali, fil- bżieq u fit- tessut tax- xaħam hi ta ’ madwar nofs il- konċentrazzjoni fis- serum.
The ciprofloxacin concentration in the sputum consists of 50-70% of the serum concentration.
Il- konċentrazzjoni ta ’ ciprofloxacin fl- isputum tikkonsisti f’ 50- 70% tal- konċentrazzjoni fis- serum.
Animal experiments have shown that ciprofloxacin passes the placenta and is excreted in breast milk.
Esperimenti fuq l- annimali wrew li ciprofloxacin jgħaddi minn ġol- plaċenta u jitneħħa fil- ħalib tas- sider.
The plasma protein binding of ciprofloxacin is situated between 16% and 28% and is not dependent on the concentration and pH (determined by means of ultrafiltration).
It- twaħħil ta ’ ciprofloxacin mal- proteini fil- plażma hu ta ’ bejn 16% u 28%, u ma jiddependix fuq il- konċentrazzjoni u fuq il- pH (ikun stabbilit permezz ta ’ ultrafiltrazzjoni).
Ciprofloxacin is mainly excreted unchanged.
Ciprofloxacin jitneħħa primarjament mhux mibdul.
Part of it is converted into desethylene-, sulpho-, oxo- and formylciprofloxacin.
Parti minnu tinbidel f’ desethylene -, sulpho -, oxo - u formylciprofloxacin.
All metabolites are active, but in a lesser degree than ciprofloxacin.
Il- metaboliti kollha huma attivi, iżda fi grad inqas minn ciprofloxacin.
77%.
Wara l- għoti mill- ħalq, madwar 70% ta ’ ciprofloxacin jitneħħa mhux mibdul, u madwar 77% jitneħħa wara l- għoti minn ġol- vina.
After oral administration 45% is excreted unchanged in the urine and 25% is excreted in the faeces.
Wara l- għoti mill- ħalq, 45% jitneħħa mhux mibdul fl- awrina u 25% jitneħħa fl- ippurgar.
After i. v. administration 62% is excreted unchanged in the urine and 15% is excreted in the faeces.
Wara l- għoti minn ġol- vina, 62% jitneħħa mhux mibdul fl- awrina u 15% jitneħħa fl- ippurgar.
After oral administration 19% and after i. v. administration 12% of ciprofloxacin is excreted in the urine and faeces in the form of metabolites.
Wara l- għoti mill- ħalq, 19%, u wara l- għoti minn ġol- vina, 12% ta ’ ciprofloxacin jitneħħa fl- awrina u fl- ippurgar taħt is- sura ta ’ metaboliti.
A larger number of metabolites after oral administration indicates some degree of first-pass metabolism, mainly forming sulphociprofloxacin.
Numru ikbar ta ’ metaboliti wara l- għoti mill- ħalq jindika xi grad ta ’ metaboliżmu first- pass, u primarjament jiffurmaw sulphociprofloxacin.
The total body clearance of ciprofloxacin is independent of the dose and remains unchanged in case of multiple administrations.
It- tneħħija totali ta ’ ciprofloxacin mill- ġisem hi indipendenti mid- doża u tibqa ’ mhux mibdul f’ każ ta ’ għoti multiplu.
The renal clearance constitutes 60%-70% of the total body clearance and is approximately 3 times higher than the creatinine clearance.
It- tneħħija mill- kliewi tikkostitwixxi 60% - 70% tat- tneħħija totali mill- ġisem u hi ta ’ madwar 3 darbiet ogħla mit- tneħħija tal- creatine.
The renal clearance occurs through glomerular filtration and active tubular secretion.
It- tneħħija mill- kliewi sseħħ permezz tal- filtrazzjoni glomerulari u tnixxija tubulari attiva.
The elimination half-life of ciprofloxacin after single or multiple oral dosage is between 3.4 and 6.9 hours.
Il- half- life ta ’ l- eliminazzjoni ta ’ ciprofloxacin wara doża waħda jew dożi multipli hi ta ’ bejn 3. 4 u 6. 9 sigħat.
After single and multiple i. v. dosage the elimination half-life is between 3 – 4.6 hours.
Wara doża waħda jew dożi multipli minn ġol- vina, il- half- life ta ’ l- eliminazzjoni hi ta ’ bejn 3 u 4. 6 sigħat.
16 Characteristics in patients:
Karatteristiċi fil- pazjenti:
In patients with severely impaired renal function (creatinine clearance < 30 ml/ min) the elimination half-life may be prolonged by a factor of 2.
F’ pazjenti b’ indeboliment sever fil- funzjoni tal- kliewi (tneħħija tal- creatine ta ’ < 30 ml/ min), il- half- life ta ’ l- eliminazzjoni tista ’ titwal b’ fattur ta ’ 2.
The elimination half-life of ciprofloxacin does not change with age.
Il- half- life ta ’ l- eliminazzjoni ta ’ ciprofloxacin ma tinbidilx ma ’ l- età.
The pharmacokinetics of ciprofloxacin in children with cystic fibrosis differs from that in children without cystic fibrosis, and dosing recommendations are only applicable for children with cystic fibrosis.
17 Il- farmakokinetiċi ta ’ ciprofloxacin fit- tfal b’ fibrożi ċistika huma differenti minn dawk fi tfal mingħajr fibrożi ċistika, u r- rakkomandazzjonijiet tad- dożaġġ huma applikabbli biss għal tfal b’ fibrożi ċistika.
Oral administration of 20 mg/ kg twice daily to children with cystic fibrosis gives an exposure that is comparable to that in adults following an oral dose of 750 mg twice daily.
L- għoti mill- ħalq ta ’ 20 mg/ kg darbtejn kuljum lil tfal b’ fibrożi ċistika tagħti espożizzjoni li hi komparabbli għal dik fl- adulti wara doża mill- ħalq ta ’ 750 mg darbtejn kuljum.
Like with other gyrase inhibitors, ciprofloxacin may induce joint damage during the growth phase of juvenile animals.
Bħal fil- każ ta ’ inibituri oħrajn ta ’ gyrase, ciprofloxacin jista ’ jikkaġuna ħsara fil- ġogi matul il- fażi ta ’ tkabbir ta ’ annimali żgħar.
Ciprofloxacin is potentially neurotoxic and causes reversible defects of the testes in case of higher dosage.
Ciprofloxacin hu potenzjalment newrotossiku u jikkawża difetti riversibbli fit- testikoli f’ każ ta ’ dożaġġ ogħla.
Mutagenicity of ciprofloxacin has not been indicated in mutagenicity studies.
Il- mutaġeniċità ta ’ ciprofloxacin ma kinitx indikata fi studji dwar il- mutaġeniċità.
However, like a number of other quinolones ciprofloxacin is phototoxic in animals in exposure values relevant to humans.
Madankollu, bħal numru ta ’ quinolones oħrajn, ciprofloxacin hu fototossiku f’ annimali f’ valuri ta ’ espożizzjoni li huma rilevanti għall- bnedmin.
The phototoxic, photomutagenic and photocarcinogenic potential of ciprofloxacin is comparable to that of other gyrase inhibitors.
Il- potenzjal fototossiku, fotomutaġeniku u fotokarċinoġeniku ta ’ ciprofloxacin hu komparabbli għal dak ta ’ inibituri oħrajn ta ’ gyrase.
Other preclinical effects were observed only at exposures that were sufficiently in excess of the maximum human exposure so that concern for human safety is negligible.
Effetti oħrajn ta ’ qabel l- użu kliniku kienu osservati biss f’ espożizzjonijiet li kienu suffiċjentement ‘ il fuq mill- espożizzjoni massima fil- bniedem, u għalhekk it- tħassib għas- sigurtà fil- bniedem hu negliġibbli.
Lactic acid (E 270) Sodium chloride Hydrochloric acid (E 507) for pH adjustment Water for injections
Lactic acid (E 270) Sodium chloride Hydrochloric acid (E 507) għal aġġustament tal- pH Water for injections
Ciprofloxacin Hikma cannot be mixed with solutions that are not stable at a pH of approximately 4.
Ciprofloxacin Hikma ma jistax jitħallat ma ’ soluzzjonijiet li ma jkunux stabbli f’ pH ta ’ madwar 4.
Keep the vial in the outer carton until time of use in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra sakemm tiġi biex tużah sabiex tilqa ’ mid- dawl.
Type I, clear glass vial, fitted with a chlorobutyl rubber stopper and aluminium flip-off caps.
Kunjett magħmul minn ħġieġ ċar ta ’ tip I, mgħammar b’ tapp tal- chlorobutyl tal- lastku u għatjien flip- off ta ’ l- aluminju.
1.5 10 or 20 vials.
1, 5, 10 jew 20 kunjetti
17 Use only clear solutions and undamaged containers.
Użu biss b’ soluzzjonijiet ċari u kontenituri mingħajr ħsara.
Any unused solution and the vial should be adequately disposed of, in accordance with local requirements.
Kwalunkwe soluzzjoni mhux użata u l- kunjett għandhom jintremew b’ mod adegwat skond il- ħtiġijiet lokali.
To be used immediately after the vial is opened.
Il- mediċina trid tintuża immedjatament wara li l- kunjett ikun infetaħ.
Ciprofloxacin Hikma is compatible with physiological sodium chloride solution, Ringer’ s solution, Ringer’ s lactate solution, 50 mg/ ml (5%) or 100 mg/ ml (10%) glucose solution and 50 mg/ ml (5%) glucose solution with 2.25 mg/ ml (0.225%) or 4.5 mg/ ml (0.45%) sodium chloride solution and 10% fructose solution.
Ciprofloxacin Hikma hu kompatibbli ma ’ soluzzjoni fiżjoloġika ta ’ sodium chloride, soluzzjoni ta ’ Ringer, soluzzjoni lactate ta ’ Ringer, soluzzjoni ta ’ 50 mg/ ml (5%) jew 100 mg/ ml (10%) glucose u 18 soluzzjoni ta ’ 50 mg/ ml (5%) glucose ma ’ 2. 25 mg/ ml (0. 225%) jew soluzzjoni ta ’ 4. 5 mg/ ml (0. 45%) ta ’ sodium chloride u soluzzjoni ta ’ 10% fructose.
Compatibility with these solutions has been proven in ciprofloxacin concentrations of 1 mg/ ml.
Il- kompatibilità ma ’ dawn is- soluzzjonijiet kienet ippruvata f’ konċentrazzjonijiet ta ’ ciprofloxacin ta ’ 1 mg/ ml.
Chemical and physical in-use stability has been demonstrated immediately after dilution, after 24 hours at 2-8°C and after 24 hours at room temperature.
L- istabbiltà kimika u fiżika waqt l- użu ntweriet immedjatament wara d- dilwizzjoni, wara 24 siegħa f’ temperatura ta ’ 2- 8°C u wara 24 siegħa fit- temperatura tal- kamra.
Unless compatibility is proven, the solution for infusion should always be administered separately.
Ħlief jekk il- kompatibilità tkun ippruvata, is- soluzzjoni għall- infużjoni għandha dejjem tingħata separatament.
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration.
Is- soluzzjoni rikostitwita għandha tiġi eżaminata viżwalment għal materjal f’ sura ta ’ partikuli u tibdil fil- kulur qabel ma tingħata.
The reconstituted solution is clear.
Is- soluzzjoni rikostitwita hi ċara.
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705-906 Terrugem SNT Portugal Tel.: +351 219 608 410 Fax: +351 219 615 102 e-mail: geral@hikma. pt
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705- 906 Terrugem SNT Portugall Tel.: +351 219 608 410 Fax: +351 219 615 102 e- mail: geral@ hikma. pt
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
19 TIKKETTA
Carton box
Kaxxa tal- kartun
Ciprofloxacin Hikma 200 mg/ 100 ml, solution for infusion [To be completed nationally] ciprofloxacin
Ciprofloxacin Hikma 200 mg/ 100 ml, soluzzjoni għall- infużjoni [Biex timtela nazzjonalment] ciprofloxacin
Lactic acid (E270), sodium chloride, hydrochloric acid (E507) and water for injection.
Lactic acid (E270), sodium chloride, hydrochloric acid (E507) u ilma għall- injezzjonijiet.
See enclosed leaflet.
Ara l- fuljett fil- pakkett.
Keep the vial in the outer carton until time of use in order to protect from light.
21 Żomm il- kunjett fil- kartuna ta ’ barra sakemm tiġi biex tużah sabiex tilqa ’ mid- dawl.
Any unused solution and the vial should be adequately disposed of in accordance with local requirements.
Kwalunkwe soluzzjoni mhux użata u l- kunjett għandhom jintremew b’ mod adegwat skond il- ħtiġijiet lokali.
Estrada do Rio da Mó, 8, 8A e 8B - Fervença 2705-906 Terrugem SNT Portugal Tel.: +351 219 608 410 Fax: +351 219 615 102 geral@hikma. pt
Estrada do Rio da Mó, 8, 8A e 8B - Fervença 2705- 906 Terrugem SNT Portugall Tel.: +351 219 608 410 Fax: +351 219 615 102 geral@ hikma. pt
Batch nr. {xxxxxx}
{xxxxxx}
Ciprofloxacin Hikma 200 mg/ 100 ml, solution for infusion [To be completed nationally] ciprofloxacin Intravenous use
Ciprofloxacin Hikma 200 mg/ 100 ml, soluzzjoni għall- infużjoni [Biex timtela nazzjonalment] ciprofloxacin Użu għal ġol- vini
EXP {MM/ YYY}
JIS {XX/ SSSS}
Batch nr.
Lott nru.
Presentation of 200 mg/ 100 ml:
Preżentazzjoni ta ’ 200 mg/ 100 ml:
23 PACKAGE LEAFLET:
23 FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
24 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Hikma 200 mg/ 100 ml, solution for infusion [To be completed nationally]
Ciprofloxacin Hikma 200 mg/ 100 ml, soluzzjoni għall- infużjon [Biex timtela nazzjonalment]
their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bhal tiegħek.
What Ciprofloxacin Hikma is and what it is used for 2.
X’ inhu Ciprofloxacin Hikma u għalxiex jintuża 2.
Before you use Ciprofloxacin Hikma 3.
Qabel ma tuża Ciprofloxacin Hikma 3.
How to use Ciprofloxacin Hikma 4.
Kif għandek tuża Ciprofloxacin Hikma 4.
How to store Ciprofloxacin Hikma 6.
Kif taħżen Ciprofloxacin Hikma 6.
WHAT CIPROFLOXACIN HIKMA IS AND WHAT IT IS USED FOR
X’ INHU CIPROFLOXACIN HIKMA U GĦALXIEX JINTUŻA
Ciprofloxacin Hikma is an antibiotic.
Ciprofloxacin Hikma hu antibijotiku.
Ciprofloxacin Hikma is used for the treatment of severe and/ or life-threatening infections caused by ciprofloxacin-sensitive microorganisms.
Ciprofloxacin Hikma hu indikat għall- kura ta ’ infezzjonijiet serji u/ jew ta ’ periklu għall- ħajja kkawżati minn mikroorganiżmi li huma sensittivi għal ciprofloxacin.
The following infections may be treated intravenously (via the blood) with Ciprofloxacin Hikma: • complicated urinary tract infections • certain lower respiratory tract infections including pneumonia • complicated skin and soft tissue infections • bone infections.
L- infezzjonijiet li ġejjin jistgħu jkunu kkurati minn ġol- vina (permezz tad- demm) b’ Ciprofloxacin Hikma: • infezzjonijiet kumplikati tal- passaġġ urinarju • ċerti infezzjonijiet tal- passaġġ respiratorju t’ isfel li jinkludu pnewmonja • infezzjonijiet kumplikati tal- ġilda u tat- tessut artab • infezzjonijiet fl- għadam.
Children and Adolescents Ciprofloxacin Hikma can also be used for the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa bacteria in children and adolescents aged 5-17 years with cystic fibrosis (also called mucoviscidosis), a hereditary disease of specific glands.
Tfal u adoloxxenti Ciprofloxacin Hikma jista ’ wkoll jintuża għall- kura ta ’ infezzjonijiet akuti tal- passaġġ respiratorju t’ isfel ikkawżati minn batterji Pseudomonas aeruginosa fit- tfal u fl- adolexxenti li għandhom minn 5 sa 17- il sena b’ fibrożi ċistika (imsejħa wkoll mucoviscidosis), marda ereditarja ta ’ glandoli speċifiċi.