qanastek/EMEA-V3 huggingface dataset:
229 pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition (see section 4.8).
Ciprofloxacin għandu jitwaqqaf f’ pazjenti li jkollhom esperjenza ta ’ sintomi ta ’ newropatija, ikluż uġigħ, ħruq, tingis, tnemnim, u/ jew debbulizza biex ikun evitat l - iżvilupp ta ’ kondizzjoni mhux riversibbli (ara sezzjoni 4. 8).
Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).
Għalhekk, pazjenti li qed jieħdu dawn is- sustanzi flimkien ma ’ ciprofloxacin għandhom jiġu sorveljati mill- viċin għall- sinjali kliniċi ta ’ doża eċċessiva, u jista ’ jkun hemm bżonn ta ’ determinazzjoni tal - konċentrazzjonijiet fis- serum, speċjalment (eż ta ’ theophylline) (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.
235 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.
230 NaCl Load In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.), the additional sodium load should be taken into account (for sodium chloride content, see section 2).
Kwantità ta ’ NaCl F’ pazjenti li għalihom it- teħid ta ’ sodium huwa t’ interess mediku (pazjenti b’ insuffiċjenza konġestiva tal- qalb, insuffiċjenza renali, sindrome nefrotiku, eċċ.), il- kwantità addizzjonali ta ’ sodium għandha tittieħed f’ kunsiderazzjoni (għal kontenut ta ’ sodium chloride, ara sezzjoni 2).
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 il - konċentrazzjonijiet ta ’ theophylline fis- serum għandhom jiġu ċċekkjati u d- doża ta ’ theophylline għandha tiġi mnaqqsa kif meħtieġ (ara sezzjoni 4. 4).
Phenytoin
236 Phenytoin
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).
Għalkemm 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).
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin.
Tqala It- tagħrif disponibbli dwar l- għoti ta ’ ciprofloxacin nisa tqal ma jindika l- ebda tossiċità malformattiva jew tossiċità għall- fetu/ tarbija tat- twelid ta ’ ciprofloxacin.
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
237 analiżi ta ’ frekwenza jieħu f’ kunsiderazzjoni tagħrif minn għoti orali kif ukoll minn għoti fil- vini ta ’ ciprofloxacin..
Uncommon ≥ 1/1 000 to <
≥ 1/ 100 sa
Rare ≥ 1/10 000 to <
≥ 1/ 1 000 sa ≥ 1/ 10 000 sa < 1/ 1
(cannot be estimated from available data)
magħrufa (ma tistax tittieħed
Infections and Infestations
stima mid - data disponibbli) Superinfezzjonij Kolite assoċjata Infezzjonijiet u Infestazzjoniji et
232
Disturbi tad -
System Organ Class
Esinofilja
Common ≥ 1/100 to <
Lewkopenija
Uncommon ≥ 1/1 000 to <
Anemija emolitika
Rare ≥ 1/10 000 to <
Demm u tas -
Frequency not known
Agranuloċitosi
1/100
Sistema
1/1 000
Newtropenija
(cannot be estimated from available data)
Panċitopenija (ta ’
Headache Dizziness Sleep disorders Taste disorders
Sturdament
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Disestesija
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Disturbi fil -
Peripheral neuropathy (see section 4.4)
periferali (ara
Eye Disorders Ear and Labyrinth Disorders
Disturbi ta ’ l -
Visual disturbances Tinnitus Hearing loss / Hearing impaired
koordinazzjoni
Visual colour distortions
sezzjoni 4. 4)
Cardiac Disorders
irqad Disturbi fit - togħma
Tachycardia
Tregħid Aċċessjonijiet (ara sezzjoni 4. 4) Vertigo
Ventricular arrhythmia, QT prolongation, torsades de pointes *
Disturb fil- mixja Disturbi fin- nerv tax- xamm Pressjoni intrakranjali għolja
Vascular Disorders
Disturbi fl - Għajnejn Disturbi fil -
Vasodilatation Hypotension Syncope
Disturbi fil- vista Żanżin fil- widnejn
Vasculitis
Disturbi fil- kuluri visivi
233 System Organ Class
238 Sistema tal -
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Eritima multiforme
Musculoskeletal, Connective Tissue and Bone Disorders
Tessuti ta ’ Taħt il- Ġilda
Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia
Urtikarja
Myalgia Arthritis Increased muscle tone and cramping
sezzjoni 4. 4)
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Eritima nodosum Sindrome Stevens - Johnson (b’ potenzjal ta ’ periklu għall- ħajja) Nekrolisi epidermika tossika (b’ potenzjal ta ’ periklu għall- ħajja)
Renal and Urinary Disorders
Disturbi
Renal impairment
Uġigħ muskolu -
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
skeltrali (e. ż.
234
Artrite
System Organ
239 Sistema tal -
≥ 1/ 100 to <
≥ 1/ 100 sa
≥ 1/1 000 to <
≥ 1/ 1 000 sa ≥ 1/ 10 000 sa < 1/ 1
General Disorders and Administration Site Conditions
tendon) (ara sezzjoni 4. 4) Rkadar tas- sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
Injection and infusion site reactions (only intravenous administration)
Ematurja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizjali
Asthenia Fever
et fis- sit ta ’ Deni l- injezzjoni u l - infużjoni (għoti fil - vini biss)
* 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).
phosphatase fid - normali
The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
demm
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
240 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.
235 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.
Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.
L- effikaċja tippendi l- aktar fuq ir- relazzjoni bejn il- konċentrazzjoni massima fis- serum (Cmax) u l - konċentrazzjoni ta ’ inibizzjoni minima (MIC ta ’ ciprofloxacin għal patoġenu batterju u r- relazzjoni bejn l- erja taħt il- kurva (AUC) u l- MIC.
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4) COMMONLY SUSCEPTIBLE SPECIES
Klassifikazzjoni ta ’ ispeċi rilevanti skond is- suxxettibilità għal ciprofloxacin (għall- ispeċi ta ’ Streptococcus ara sezzjoni 4. 4) SPEĊI SUXXETTIBLI B’ MOD KOMUNI Mikro- organiżmi aerobiċi Gram- positive Bacillus anthracis (1)
236 Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Mikro- organiżmi aerobiċi Gram- negative Aeromonas spp.
Yersinia pestis
(2)
Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. *(2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia +* Campylobacter spp.+* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
242 Mikro- organiżmi aerobiċi Gram- negative Acinetobacter baumannii+ Burkholderia cepacia+ * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
237 INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
Propionibacterium acnes ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
5.2 Pharmacokinetic properties
243 5. 2 Tagħrif farmakokinetiku
238 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.
1% of the dose is excreted via the biliary route.
244 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.
239 Articular tolerability:
Tollerabilità artikulari:
6.5 Nature and contents of container
245 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
240 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari.]
241 1.
246 1.
• Malignant external otitis
247 • Otite esterna malinna
242 • Infections of the bones and joints
• Infezzjonijiet ta ’ l- għadam u tal- ġogi
Infections of the lower respiratory tract
Infezzjonijiet ta ’ l- apparat respiratorju t’ isfel
243 Indications
248 Indikazzjonijiet
continued for longer than 21 days in some specific circumstances (such as abscesses)
7 sa 21 ġurnata, jista ’ jitkompla għal aktar minn 21 ġurnata f’ xi ċirkostanzi speċifiċi (bħal axxessi) 2sa 4 ġimgħat (akuta)
244 Indications
249 Indikazzjonijiet
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment Drug administration should begin as soon as possible after suspected or confirmed exposure.
Kura jew profilassi ta ’ nfezzjonijiet f’ pazjenti b’ newtropenija severa Ciprofloxacin għandu jingħata flimkien ma ’ sustanza( i) antibatterika xierqa.
400 mg twice daily
400 mg darbtejn kuljum sa 400 mg tlitt darbiet kuljum
Total duration of
Tul totali tal- kura (inkluż bidla għal
treatment (including switch to oral therapy as soon as possible) Cystic fibrosis
terapija orali malajr kemm jista ’ jkun) Fibrożi ċistika
10 to 14 days
10 sa14- il ġurnata
10 mg/kg body weight twice daily to 15 mg/kg body
10 mg/ kg ta ’ piż tal- ġisem sa 15 mg/ kg ta ’ piż tal -
weight twice daily with a maximum of 400 mg per dose.
ġisem darbtejn kuljum b’ massimu ta ’ 400 mg kull doża.
Renal and hepatic impairment
250 Indeboliment tal- kliewi u tal- fwied
245
Krejatinina fis- Serum
Creatinine Clearance [mL/min/1.73 m²]
Tneħħija tal- krejatinina [mL/ min / 1. 73 m²]
Serum Creatinine [µmol/L]
[µmol/ L]
200-400 mg every 12 h
Ara Doża tas- Soltu.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
251 Infezzjonijiet intra- addominali Hemm tagħrif limitat dwar l- effikaċja ta ’ ciprofloxacin fil- kura ta ’ infezzjonijiet intra- addominali ta ’ wara kirurġija.
246 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.
Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
252 organiżmu li qed jikkawża l- marda u valutazzjoni tal- bilanċ ta ’ riskju/ benefiċċju, ciprofloxacin jista ’ jiġi preskritt lil dawn il- pazjenti għall- kura ta ’ ċertu infezzjonijiet severi, speċjalment f’ każ ta ’ falliment tat- terapija stàndard jew reżistenza tal- batterja, fejn it- tagħrif mikrobijoloġiku jista ’ jiġġustifika l- użu ta ’ ciprofloxacin.
247 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Tendinite u tiċirit tat- tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b’ ciprofloxacin, anki fl- ewwle 48 siegħa ta ’ kura.
In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
F’ każijiet bħal dawn, ciprofloxacin għandu jitwaqqaf immedjatament tabib u għandha tinbeda terapija xierqa.
Anti-peristaltic drugs are contraindicated in this situation.
Mediċini kontra l- peristalsi huma kontra - indikati f’ din is- sitwazzjoni.
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.
253 Reżistenza Waqt jew wara kors ta ’ kura b’ ciprofloxacin jistgħu jiġu iżolati batterja li juru reżistenza għal ciprofloxacin, bi jew bla superinfezzjoni evidenti klinikament.
248 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, ropinirole, tizanidine).
Citokromju P450 Ciprofloxacin jinibixxi lil CYP1A2 u għalhekk jista ’ jikkawża żjieda fil- konċentrazzjoni fis- serum ta ’ sustanzi mogħtija fl- istess waqt metabolizzati minn din l- enżima (e. ż. theophylline, clozapine, ropinirole, tizanidine).
Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).
Għalhekk, pazjenti li qed jieħdu dawn is- sustanzi flimkien ma ’ ciprofloxacin għandhom jiġu sorveljati mill- viċin għall- sinjali kliniċi ta ’ doża eċċessiva, u jista ’ jkun hemm bżonn ta ’ determinazzjoni tal - konċentrazzjonijiet fis- serum( eż ta ’ theophylline) (ara sezzjoni 4. 5).
Methotrexate
254 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.
249 Other xanthine derivatives
Derivattivi oħra ta ’ xanthine
As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.
255 Bħala miżura ta ’ prekawzjoni, ikun aħjar li l- użu ta ’ ciprofloxacin ikun evitat waqt it- tqala.
250 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
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.
System Organ Class
Klassifika ta ’
Common ≥ 1/100 to <
≥ 1/ 100 sa
Uncommon ≥ 1/1 000 to <
≥ 1/ 1 000 sa
Infections and Infestations
stima mid - data disponibbli) Superinfezzjonijie Kolite assoċjata Infezzjonijiet u Infestazzjoniji et
Mycotic superinfections
tmill- moffa
Blood and Lymphatic System Disorders
Disturbi tad -
Eosinophilia
Lewkopenija
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
Anemija
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
emolitika
Allergic reaction Allergic oedema / angiooedema
Tromboċitopenija Tromboċitemija
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
(ta ’ periklu għall- ħajja) Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall - ħajja)
Hyperglycaemia
Edima allerġika
Psychomotor hyperactivity / agitation
/ anġjoedima
Psychotic reactions (see section 4.4)
Disturbi fil - Metaboliżmu
Nervous System Disorders
256 Sistema tal -
Headache Dizziness Sleep disorders Taste disorders
Komuni
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Mhux Komuni
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Rari
Peripheral neuropathy (see section 4.4)
Rari Ħafna
251
Frekwenza
Hepatobiliary Disorders
Gastro - intestinali
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
257 Sistema tal -
Skin and Subcutaneous Tissue Disorders
Komuni
Rash Pruritus Urticaria
Mhux Komuni
Photosensitivity reactions (see section 4.4)
Rari Ħafna
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Frekwenza
252 System Organ Class
Klassifika ta ’
Investigations
258 Sistema tal -
Increase in blood alkaline phosphatase
Klassifika ta ’
Prothrombin level abnormal Increased amylase
≥ 1/ 100 sa
* 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).
≥ 1/ 1 000 sa
The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
≥ 1/ 10 000 sa < 1/ 1
Common Uncommon
< 1/ 10 000
Vomiting, Transient increase in transaminases, Rash Thrombocytopenia, Thrombocytaemia, Confusion and disorientation, Hallucinations, Par- and dysaesthesia, Seizures, Vertigo, Visual disturbances, Hearing loss, Tachycardia, Vasodilatation, Hypotension, Transient hepatic impairment, Cholestatic icterus, Renal failure, Oedema
l- Organi
Rare
< 1/ 10
Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders, Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis, Petechiae, Tendon rupture
stima mid - data disponibbli) Investigazzjon
Paediatric patients
Żjieda fl- alkaline
253 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.
Mechanism of action:
259 Mekkaniżmu ta ’ azzjoni:
0.5 mg/L
S ≤ 0. 5 mg/ L
Pseudomonas
S ≤ 0. 5 mg/ L
S ≤ 1 mg/L S ≤ 1 mg/L
S ≤ 1 mg/ L
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
255 Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia +* Campylobacter spp.+* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
Mikro- organiżmi aerobiċi Gram- negative Acinetobacter baumannii+ Burkholderia cepacia+ * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
256 Comparison of the pharmacokinetic parameters for a twice a day and three times a day intravenous dose regimen indicated no evidence of drug accumulation for ciprofloxacin and its metabolites.
Paragun tal- parametri farmakokinetiċi għal kors ta ’ dożi fil- vini ta ’ darbtejn kuljum u tliet darbiet kuljum ma indika l- ebda evidenza ta ’ akkumulazzjoni tal- mediċina għal ciprofloxacin u l- metaboliti tiegħu.
Distribution
262 Distribuzzjoni
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.
257 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).
5.3 Preclinical safety data
263 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
258 For ease of use the infusion vial stopper should be penetrated in the central ring.
Biex jiġi faċilitat l- użu, it- tapp tal- kunjett ta ’ l- infużjoni għandu jittaqqab fiċ- ċirku ta ’ ġewwa.
259 LABELLING
265 TIKKETTA
260 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
266 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 261 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
{Name and Address} < {tel} > < {fax} > < {e-mail} >
{Isem u indirizz} < {tel} > < {fax} > < {e- mail} >
262 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
268 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
{Name}
{Isem}
263 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
269 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 264 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
265 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
271 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
266 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
272 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 500 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 267 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
268 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
274 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
269 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
275 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 750 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 270 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
271 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
277 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
272 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
278 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg ta ’ suspensjoni orali fi qratas b’ doża waħda [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
Oral use Shake before use applying slight pressure to the wall.
Użu orali Ħawwad qabel l- użu waqt li tagħfas il- ġnubijiet bil- mod.
Then tear the sachet open as indicated and take the contents directly.
Wara iftaħ il- qartas kif indikat u ħu l - kontenut direttament.
273 10.
279 10.
274 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
280 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SINGLE DOSE SACHETS 250 MG
QRATAS B’ DOŻA WAĦDA 250 mg
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin Oral use
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg suspensjoni orali fi qratas b’ doża waħda [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin Użu orali
Shake before use applying slight pressure to the wall.
Ħawwad qabel l- użu waqt li tagħfas il- ġnubijiet bil- mod.
275 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
281 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 500 mg ta ’ suspensjoni orali fi qratas b’ doża waħda [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
276 10.
282 10.
277 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
283 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SINGLE DOSE SACHETS 500 MG
QRATAS B’ DOŻA WAĦDA 500 mg
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin Oral use
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 500 mg suspensjoni orali fi qratas b’ doża waħda [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin Użu orali
278 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
284 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 50 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
KARTUNA TA ’ BARRA SUSPENSJONI ORALI TA ’ 50 mg/ mL (fiha l- flixkun (fliexken) għall- grani u l- flixkun (fliexken) għas- solvent)
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 50 mg/ mL grani u solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
Oral use Only after reconstitution Shake well before use.
Ħawwad sew qabel l- użu.
279 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
280 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
286 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
GLASS BOTTLE 50 mg/mL
FLIXKUN TAL- ĦĠIEĠ ta ’ 50 mg/ mL
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 50 mg/ mL grani għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
Oral use Only after reconstitution Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
281 10.
287 10.
282 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
288 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
HDPE BOTTLE 50 mg/mL
FLIXKUN TAL- HDPE ta ’ 50 mg/ mL
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 50 mg/ mL solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
283 10.
289 10.
284 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
290 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 100 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
KARTUNA TA ’ BARRA SUSPENSJONI ORALI TA ’ 100 mg/ mL (fiha l- flixkun (fliexken) għall- grani u l- flixkun (fliexken) għas- solvent)
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/ mL grani u solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
285 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
286 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
292 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
GLASS BOTTLE 100 mg/mL
FLIXKUN TAL- ĦĠIEĠ ta ’ 100 mg/ mL
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/ mL grani għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
Oral use Only after reconstitution.
Użu orali Wara r- rikostituzzjoni biss.
288 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
294 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
HDPE BOTTLE 100 mg/mL
FLIXKUN TAL- HDPE ta ’ 100 mg/ mL
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/ mL solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
289 10.
295 10.
290 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
296 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing wraps with bags of 100 mL solution for infusion)
KARTUNA TA ’ BARRA (fiha pakketti b’ boroż ta ’ 100 mL soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
For intravenous use Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 291 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
292 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER WRAP (containing 1 infusion bag of 200 mg / 100 mL solution for infusion)
PAKKETT TA ’ BARRA (fih borża għall- infużjoni waħda ta ’ 200 mg / 100 mL ta ’ soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għall - infużjoni
2.
298 2.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 293 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
12.
299 12.
294 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
300 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
FLEXIBLE PO/PVC BAG (200 mg / 100 mL solution for infusion)
BORŻA FLESSIBBLI TAL- PO/ PVC (200 mg / 100 mL soluzzjoni għall- infużjoni)
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 295 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
[To be completed nationally.]
[Biex timtela mill- pajjiż partikolari]
296 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
302 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing wraps with bags of 200 mL solution for infusion)
KARTUNA TA ’ BARRA (fiha pakketti b’ boroż ta ’ 200 mL soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg / 200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 200 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 297 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
298 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
304 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER WRAP (containing 1 infusion bag of 400 mg / 200 mL solution for infusion)
PAKKETT TA ’ BARRA (fih borża għall- infużjoni waħda ta ’ 400 mg / 200 mL ta ’ soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg / 200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 400 mL soluzzjoni għall - infużjoni
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 299 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
300 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
306 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
FLEXIBLE PO/PVC BAG (400 mg / 200 mL solution for infusion)
BORŻA FLESSIBBLI TAL- PO/ PVC (400 mg / 200 mL soluzzjoni għall- infużjoni)
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 301 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
302 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
308 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing 5 boxes with bottles of 50 mL solution for infusion)
KARTUNA TA ’ BARRA (fiha 5 kaxxi bi fliexken ta ’ 50 mL soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg / 50 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 303 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
304 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
310 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing 1 bottle of 100 mg / 50 mL solution for infusion)
KARTUNA BARRA (fiha flixkun wieħed ta ’ 100 mg / 50 mL ta ’ soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg / 50 mL soluzzjoni għall - infużjoni
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 305 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
306 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
COLOURLESS TYPE-2 GLASS BOTTLE WITH GREY SILICONISED BROMOBUTYL STOPPER OR CHLOROBUTYL STOPPER
FLIXKUN BLA KULUR TAL- ĦĠIEĠ TAT- TIP 2 B’ TAPP GRIŻ SILIKONIZZAT TA ’ BROMOBUTYL JEW CHLOROBUTYL
[To be completed nationally]
312 [Biex timtela mill- pajjiż partikolari]
[To be completed nationally]
313 [Biex timtela mill- pajjiż partikolari]
308 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
314 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing 5 or 40 boxes with bottles of 100 mL solution for infusion)
KARTUNA TA ’ BARRA (fiha 5 jew 40 kaxxa bi fliexken ta ’ 100 mL soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 309 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
310 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
316 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing 1 bottle of 200 mg / 100 mL solution for infusion)
KARTUNA BARRA (fiha flixkun wieħed ta ’ 200 mg / 100 mL ta ’ soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għall - infużjoni
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 311 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
312 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
318 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
313 10.
319 10.
314 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
320 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing 5 boxes with bottles of 200 mL solution for infusion)
KARTUNA TA ’ BARRA (fiha 5 kaxxi bi fliexken ta ’ 200 mL soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 200 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari] Ciprofloxacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 315 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
316 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
322 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (containing 1 bottle of 400 mg /200 mL solution for infusion)
KARTUNA BARRA (fiha flixkun wieħed ta ’ 400 mg / 200 mL ta ’ soluzzjoni għall- infużjoni)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 200 mL soluzzjoni għall - infużjoni
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 317 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
318 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT IMMEDJAT
COLOURLESS TYPE-2 GLASS BOTTLE WITH GREY SILICONISED BROMOBUTYL STOPPER OR CHLOROBUTYL STOPPER.
FLIXKUN BLA KULUR TAL- ĦĠIEĠ TAT- TIP 2 B’ TAPP GRIŻ SILIKONIZZAT TA ’ BROMOBUTYL JEW CHLOROBUTYL
[To be completed nationally]
324 [Biex timtela mill- pajjiż partikolari]
[To be completed nationally]
325 [Biex timtela mill- pajjiż partikolari]
320 PACKAGE LEAFLET
326 FULJETT TA ’ TAGĦRIF
321 PACKAGE LEAFLET:
327 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
What Ciprofloxacin Bayer is and what it is used for 2.
X’ inhu Ciprofloxacin Bayer u għalxiex jintuża 2.
Before you take Ciprofloxacin Bayer 3.
Qabel ma tieħu Ciprofloxacin Bayer 3.
How to take Ciprofloxacin Bayer 4.
Kif għandek tieħu Ciprofloxacin Bayer 4.
How to store Ciprofloxacin Bayer 6.
Kif taħżen Ciprofloxacin Bayer 6.
WHAT CIPROFLOXACIN BAYER IS AND WHAT IT IS USED FOR
X’ INHU CIPROFLOXACIN BAYER U GĦALXIEX JINTUŻA
Ciprofloxacin Bayer is an antibiotic belonging to the fluoroquinolone family.
Ciprofloxacin Bayer huwa antibijotiku li jagħmel parti mill- familja fluoroquinolone.
The active substance is ciprofloxacin.
Is- sustanza attiva hija ciprofloxacin.
Ciprofloxacin works by killing bacteria that cause infections.
Ciprofloxacin jaħdem billi joqtol il- batterja li tikkawża l- infezzjonijiet.
It only works with specific strains of bacteria.
Jaħdem biss fuq razez speċifiċi ta ’ batterja.
Ciprofloxacin Bayer is used in adults to treat the following bacterial infections:
Ciprofloxacin Bayer huwa wżat fl- adulti biex jikkura l- infezzjonijiet ikkawżati mill- batterja li ġejjin:
• respiratory tract infections • long lasting or recurring ear or sinus infections • urinary tract infections • infections of the testicles • genital organ infections in women • gastro-intestinal tract infections and intra-abdominal infections • skin and soft tissue infections • bone and joint infections • to treat infections in patients with a very low white blood cell count (neutropenia) • to prevent infections in patients with a very low white blood cell count (neutropenia) • to prevent infections due to the bacterium Neisseria meningitidis • anthrax inhalation exposure
• infezzjonijiet fl- apparat respiratorju • infezzjonijiet fil- widnejn jew fis- sinus fit- tul jew li jerġgħu jitfaċċaw • infezzjonijiet fl- apparat urinarju • infezzjonijiet fit- testikoli • infezzjonijiet fl- organi ġenitali fin- nisa • infezzjonijiet fl- apparat gastro- intestinali u intra- addominali • infezzjonijiet fil- ġilda u fit- tessut l- artab • infezzjonijiet fl- għadam u l- ġogi • biex jikkuraw infezzjonijiet f’ pazjenti b’ għadd ta ’ ċelluli bojod tad- demm baxx ħafna (newtropenija) • biex jipprevjenu infezzjonijiet f’ pazjenti b’ għadd ta ’ ċelluli bojod tad- demm baxx ħafna (newtropenija) • biex jipprevjenu infezzjonijiet ikkawżati mill- batterja Neisseria meningitidis • esponiment għal teħid man- nifs ta ’ antraċe
If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Bayer.
Jekk għandek infezzjoni severa jew infezzjoni kkawżata minn aktar minn tip wieħed ta ’ batterja, tista ’ tingħata kura b’ antibijotiku addizzjonali flimkien ma ’ Ciprofloxacin Bayer.
Children and adolescents
328 Tfal u adoloxxenti
Ciprofloxacin Bayer is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:
Ciprofloxacin Bayer jintuża fit- tfal u l- adoloxxenti taħt superviżjoni medika ta ’ speċjalista biex jikkura l- infezzjonijiet ikkawżati mill- batterja li ġejjin:
322 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• infezzjonijiet fil- pulmun u fil- bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika • infezzjonijiet kumplikati ta ’ l- apparat urinarju, ikluż infezzjonijiet li laħqu l- kliewi (pijelonefrite), • esponiment għal teħid man- nifs ta ’ antraċe
Ciprofloxacin Bayer may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.
Ciprofloxacin Bayer jista ’ jintuża wkoll għall- kura ta ’ infezzjonijet severi speċifiċi oħra fit- tfal u l - adoloxxenti meta t- tabib tiegħek jikkunsidra dan neċessarju.
BEFORE YOU TAKE CIPROFLOXACIN BAYER
QABEL MA TIEĦU CIPROFLOXACIN BAYER
Do not take Ciprofloxacin Bayer if you are:
Tieħux Ciprofloxacin Bayer jekk inti: