qanastek/EMEA-V3 huggingface dataset:
Propionibacterium acnes INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications. + Resistance rate ≥ 50% in one or more EU countries.
Propionibacterium acnes ORGANIŻMI REŻISTENTI MINNHOM INFUSHOM Mikro- organiżmi aerobiċi Gram- positive Actinomyces Enteroccus faecium Listeria monocytogenes Mikro- organiżmi aerobiċi Gram- negative Stenotrophomonas maltophilia Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
145 Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Wara għoti orali ta ’ doża waħda ta ’ 250 mg, 500 mg, u 750 mg ta ’ pilloli ciprofloxacin, dan jiġi assorbit malajr u b’ mod estensiv, fil- biċċa l- kbira mill- musrana ż- żgħira, u konċentrazzjonijiet massima fis- serum jintlaħqu minn siegħa sa sagħtejn wara.
The pharmacokinetics of ciprofloxacin oral suspension 50 mg/ mL and 100 mg/ mL are similar to those of tablets.
Il- farmakokinetika ta ’ ciprofloxacin 50 mg/ mL u 100 mg/ mL suspensjoni orali hija simili għal dik tal - pilloli.
Distribution
148 Distribuzzjoni
Ciprofloxacin is present in plasma largely in a non- ionized form and has a large steady state distribution volume of 2-3 L/ kg body weight.
Ciprofloxacin huwa preżenti fil- plażma fil- biċċa l- kbira fil- forma mhux jonizzata u għandha volum ta ’ distribuzzjoni fi stat fiss kbir ta ’ 2- 3 L/ kg piż tal- ġisem.
146 In 10 children with severe sepsis Cmax was 6.1 mg/ L (range 4.6-8.3 mg/ L) after a 1-hour intravenous infusion of 10 mg/ kg in children aged less than 1 year compared to 7.2 mg/ L (range 4.7-11.8 mg/ L) for children between 1 and 5 years of age.
F’ għaxart itfal b’ sepsis severa, Cmax kienet 6. 1 mg/ L (firxa 4. 6- 8. 3 mg/ L) wara infużjoni ta ’ 10 mg/ kg ġol- vini ta ’ siegħa fi tfal b’ età ta ’ inqas minn sena meta mqabbel ma ’ 7. 2 mg/ L (firxa 4. 7- 11. 8 mg/ L) għal tfal b’ età bejn sena u 5 snin.
5.3 Preclinical safety data
149 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
The small bottle contains the active substance and the large bottle contains the solvent.
Il- flixkun iż- żgħir fih is- sustanza attiva u l- flixkun il- kbir fih is- solvent.
Open both bottles.
Iftaħ iż- żewġ fliexken.
147 Press down according to instructions on the cap while turning to the left.
Waqt li ddawwar lejn ix- xellug, għafas l- isfel skond l- istruzzjonijiet fuq l- għatu.
Pour the granules completely into the large bottle with the suspension fluid.
Ferragħ il- grani kompletament fil- flixkun il- kbir bil- fluwidu għas- suspensjoni.
Do not pour water into the suspension!
Tfergħax ilma ġewwa s- suspensjoni!
Reclose the large bottle properly according to the instructions on the cap and shake vigorously for about 15 seconds.
Erġa ’ għalaq il- flixkun il- kbir sew skond l- istruzzjonijiet fuq l- għatu u ħawwad sew għal madwar 15- il sekonda.
The ready-to-use suspension is now finished.
Is- suspensjoni lesta għall- użu hija rikostitwita.
Taking the Ready-to-Use Suspension
Meta Tieħu s- Suspensjoni Lesta għall- Użu
Take the prescribed amount of suspension by using the measuring spoon.
Ħu l- ammont preskritt ta ’ suspensjoni bl- użu tal- mgħarfa tal- kejl.
Do not chew the granules present in the suspension, simply swallow them.
Togħmodx il- grani preżenti fis - suspensjoni, sempliċiment iblagħhom.
A drink of water may be taken afterwards.
Wara tista ’ tittieħed xarba ilma.
Reclose the bottle properly after use according to the instructions on the cap.
Erġa ’ għalaq il- flixkun sew wara l- użu, skond l- istruzzjonijiet fuq l- għatu.
The ready-to-use suspension is stable for 14 days when stored in a refrigerator or at ambient temperatures below 30°C.
150 ġurnata meta maħżuna fil- friġġ jew f’ temperaturi tal- kamra taħt 30°C.
After treatment has been completed, it should not be reused.
Wara li tispiċċa l- kura, m’ għandhiex terġa ’ tintuża.
Shake vigorously each time before use for approximately 15 seconds.
Ħawwad sew għal madwar 15- il sekonda kull darba qabel l- użu.
The graduated measuring spoon with the markings 1/ 2 is equivalent to 2.6 mL containing 2.5-mL of final suspension and 1/ 1 is equivalent to 5.2 mL containing 5.0 mL of final suspension.
Il- mgħarfa b’ marki tal- kejl bil- marki 1/ 2 li hija ekwivalenti għal 2. 6 mL u fiha 2. 5 mL ta ’ suspensjoni finali u 1/ 1 li hija ekwivalenti għal 5. 2 mL u fiha 5. 0 mL ta ’ suspensjoni finali.
The graduated measuring spoon must be used for measuring the required prescribed amount of Ciprofloxacin oral suspension 50 mg/ mL.
Il- mgħarfa b’ marki tal - kejl għandha tintuża għall- kejl ta ’ l- ammont preskritt meħtieġ tas- suspensjoni ta ’ Ciprofloxacin 50 mg/ mL.
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 Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/ mL grani (granules) u solvent għal suspensjoni orali [Ara Anness I – Biex timtela mill- pajjiż partikolari]
The Ciprofloxacin Bayer 100 mg/ mL oral suspension is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 100 mg/ mL suspensjoni orali huwa ndikat għall- kura ta ’ l- infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
irkadar tal- marda pulmonari ostruttiva kronika infezzjonijiet bronko- pulmonari f’ fibrożi ċistika jew f’ bronkjektasi pnewmonja
• Intra-abdominal infections
152 • Infezzjonijet intra- addominali
149 • Malignant external otitis
• Otite esterna malinna
Daily dose in mg
Doża ta ’ Doża ta ’
Daily dose in mL
Tul totali tal- kura
Total duration of
kuljum f’ mg
(Number of 5-mL
kuljum f ’ mL
treatment
(potenzjalment
measuring spoonfuls)
(Ammont ta ’ mgħaref tal - kejl ta ’ 5- mL)
(potentially
inkluż bidu ta ’ kura parenterali b ’ ciprofloxacin)
including initial parenteral treatment with ciprofloxacin) Infections of the lower
Infezzjonijiet ta ’ l- apparat respiratorju
5 mL twice daily to
5 mL darbtejn
respiratory tract
t’ isfel
7.5 mL twice daily
kuljum sa 7. 5 mL darbtejn kuljum (mgħarfa
twice daily
Indikazzjonijiet
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
Doża ta ’ Doża ta ’
Indications
Tul totali tal- kura
Daily dose in mg
kuljum f’ mg
Daily dose in mL
kuljum f ’ mL
Total duration of
(potenzjalment
(Number of 5-mL
(Ammont ta ’ mgħaref tal -
treatment
inkluż bidu ta ’ kura parenterali b ’
measuring spoonfuls)
kejl ta ’ 5- mL) waħda tal- kejl ta ’ 5- mL darbtejn kuljum sa mgħarfa u nofs tal- kejl ta ’ 5- mL darbtejn kuljum)
(potentially
ciprofloxacin)
including initial parenteral treatment with ciprofloxacin) Infections of
Infezzjonijiet ta ’ l -
the
apparat respiratorju ta ’ fuq
exacerbation of
sinusite kronika
(one 5-mL measuring spoonful twice daily
kuljum sa 7. 5 mL darbtejn kuljum (mgħarfa waħda tal- kejl ta ’ 5- mL
tract up to one and a half 5- mL measuring spoonfuls twice daily)
darbtejn kuljum sa mgħarfa u nofs tal- kejl ta ’ 5- mL darbtejn kuljum)
Chronic
Otite medja
suppurative
kronika b’ suppurazzjoni
up to one and a half 5- mL measuring spoonfuls twice daily)
darbtejn kuljum sa mgħarfa u nofs tal- kejl ta ’ 5- mL darbtejn kuljum)
Malignant
Otite esterna
7.5 mL twice daily
7. 5 mL
28 days up to 3
28 ġurnata sa 3 xhur
external otitis
malinna
daily
darbtejn kuljum
(one and a half 5-mL measuring spoonfuls twice daily)
darbtejn kuljum (mgħarfa u nofs tal- kejl ta ’ 5- mL darbtejn kuljum)
Urinary tract
Infezzjonijiet ta ’ l - apparat ta ’ l- awrina
Uncomplicated
Ċistite mhux komplikata
250 mg twice
250 mg darbtejn kuljum sa 500 mg darbtejn kuljum
2.5 mL twice daily to
2. 5 mL darbtejn kuljum sa 5 mL darbtejn kuljum (nofs mgħarfa tal- kejl ta ’ 5 - mL darbtejn kuljum sa mgħarfa tal- kejl ta ’ 5- mL darbtejn kuljum)
infections
Doża ta ’ Doża ta ’
cystitis
Tul totali tal- kura
daily to 500 mg
kuljum f’ mg
5 mL twice daily
kuljum f ’ mL
twice daily
(potenzjalment
(half 5-mL measuring spoonful twice daily up to one 5-mL measuring spoonful twice daily)
kejl ta ’ 5- mL)
In pre-menopausal women, 500 mg single dose may be used corresponding to 5 mL single dose = one 5-mL measuring spoonful as a single dose
F’ nisa qabel il- menopawża, tista ’ tiġi wżata doża waħda ta ’ 500 mg li tikkorrispondi għal doża waħda ta ’ 5 mL = mgħaref waħda tal- kejl ta ’ 5- mL bħala doża waħda
Complicated
Ċistite
5 mL twice daily
5 mL darbtejn
cystitis, Uncomplicated pyelonephritis
komplikata,
(one 5-mL measuring spoonful twice daily)
waħda tal- kejl ta ’ 5- mL darbtejn kuljum)
at least 10 days, it can
ta ’ l- inqas 10 ġranet,
7.5 mL twice daily
mL darbtejn
be continued for
aktar minn 21 ġurnata
twice daily
kuljum
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
kuljum (mgħarfa
longer than 21 days in some specific circumstances (such as abscesses)
f’ xi ċirkostanzi speċifiċi (bħal
2 to 4 weeks (acute)
(akuta) sa 4 sa6
to 4 to 6 weeks
darbtejn kuljum
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
(mgħarfa waħda tal- kejl ta ’ 5- mL darbtejn kuljum sa mgħarfa u nofs tal- kejl ta ’ 5- mL darbtejn kuljum) Infezzjonijiet ta ’ l - apparat ġenitali
(chronic)
ġurnata (doża waħda)
151 Indications
gonococci suxxettibli għal fluoroquinolone
Daily dose in mg
jikkorrispondu għal mgħarfa waħda tal- kejl ta ’ 5- mL bħala doża waħda
Daily dose in mL
155 Indikazzjonijiet
Total duration of
Doża ta ’ Doża ta ’
(Number of 5-mL
Tul totali tal- kura
treatment
kuljum f’ mg
measuring spoonfuls)
kuljum f ’ mL
(potentially
(potenzjalment
including initial parenteral treatment with ciprofloxacin) Genital tract infections
(Ammont ta ’ mgħaref tal -
Gonococcal uretritis and cervicitis
inkluż bidu ta ’ kura parenterali b ’
500 mg as a single dose
kejl ta ’ 5- mL)
1 day (single dose)
ciprofloxacin)
Epididymo-
Epididimo- orkite
orchitis and
u mard infjammatorju tal- pelvi
7.5 mL twice daily
kuljum sa 7. 5 mL darbtejn kuljum (mgħarfa waħda tal- kejl ta ’ 5- mL
twice daily
ġurnata
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
darbtejn kuljum sa mgħaref u nofs tal- kejl ta ’ 5- mL darbtejn kuljum) Infezzjonijiet ta ’ l -
Infections of
Dijarea kkawżata
the gastro- intestinal tract and intra- abdominal infections
apparat gastro -
caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea
darbtejn kuljum
(one 5-mL measuring spoonful twice daily)
(mgħarfa
Diarrhoea caused by Shigella dysenteriae type 1
Shigella spp. minbarra Shigella dysenteriae tip 1 u kura emperika ta ’ dijarea severa tal- vjaġġaturi
5 mL twice daily (one 5-mL measuring spoonful twice daily)
5 mL darbtejn
Diarrhoea caused by Vibrio cholerae
minn Shigella
Intra-abdominal
Infezzjonijiet
5 to 14 days
5 sa 14- il ġurnata
infections due to
intra- addominali kkawżati minn batterja Gram - negative
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
darbtejn kuljum sa mgħaref u nofs tal- kejl ta ’ 5- mL darbtejn kuljum) Infezzjonijiet tal- ġilda u tat- tessut artab
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
darbtejn kuljum sa mgħaref u nofs tal- kejl ta ’ 5- mL darbtejn kuljum) Infezzjonijiet ta ’ l- għadam u l- ġogi
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
darbtejn kuljum sa mgħaref u nofs tal- kejl ta ’ 5- mL darbtejn kuljum) Kura ta ’ infezzjonijiet jew profilassi ta ’
Therapy should be
Terapija għandha
prophylaxis of infections in
infezzjonijiet f’ pazjenti b’ newtropenija
daily to 750 mg
darbtejn kuljum sa 750 mg
7.5 mL twice daily
kuljum sa 7. 5 mL darbtejn
continued over the
titkompla tul il -
neutropenic patients Ciprofloxacin should be co- administered with appropriate antibacterial agent(s) in accordance to official guidance.
Ciprofloxacin Bayer għandu jingħata flimkien ma ’ sustanza( i) antibatterika
(one 5-mL measuring spoonful twice daily up to one and a half 5- mL measuring spoonfuls twice daily)
(mgħarfa xierqa skond il- gwida uffiċjali. waħda tal- kejl ta ’ 5- mL darbtejn kuljum sa mgħaref u nofs tal- kejl ta ’ 5- mL darbtejn kuljum)
entire period of neutropenia
(Ammont ta ’ mgħaref tal -
Prophylaxis of invasive infections due to Neisseria meningitidis
Profilassi ta ’ l- infezzjonijiet invażivi
500 mg as a single dose
500 mg bħala
5 mL as a single dose corresponding to one 5-mL measuring spoonful as a single dose
doża waħda
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
kkawżati minn Neisseria meningitides
Drug administration should begin as soon as possible after suspected or confirmed exposure.
jikkorrispondu għal mgħarfa waħda tal- kejl ta ’ 5- mL bħala doża waħda Profilassi wara esponiment u kura li
60 days from the confirmation of Bacillus anthracis exposure
60 ġurnata mill -
Children and adolescents
tfejjaq ta ’ antraċe meħud man- nifs għall -
Indications
darbtejn
Daily dose in mg and in mL
kuljum kuljum
Total duration of
konferma ta ’
treatment (potentially including initial parenteral treatment with ciprofloxacin) Cystic fibrosis
L- għoti tal- mediċina għandha tinbeda malajr kemm jista ’ jkun wara esponiment suspettat jew ikkonfermat
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/ kg body weight twice daily with a maximum of 7.5 mL per dose
waħda tal- kejl ta ’ 5- mL darbtejn kuljum)
10 to 14 days
Tfal u adoloxxenti
153 Indications
Indikazzjonijiet
treatment (potentially including initial parenteral treatment with ciprofloxacin) Complicated urinary tract infections and pyelonephritis
(potenzjalment inkluż bidu ta ’ kura parenterali b’ ciprofloxacin) Fibrożi ċistika
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.1 mL/ kg body weight twice daily to 0.2 mL/ kg body weight twice daily with a maximum of 7.5 mL per dose
Infezzjonijiet komplikati 10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa ta ’ l- apparat ta ’ l- awrina 20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum u pijelonefrite b’ massimu ta ’ 750 mg kull doża, li jikkorrispondu għal 0. 1 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum sa 0. 2 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 7. 5 mL kull doża.
post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
tfejjaq ta ’ antraċe meħud b’ massimu ta ’ 500 mg kull doża, li man- nifs għall- persuni li jikkorrispondu għal 0. 1 mL/ kg ta ’ piż tal- ġisem jistgħu jirċievu kura mill - darbtejn kuljum sa 0. 15 mL/ kg ta ’ piż tal- ġisem ħalq meta xieraq darbtejn kuljum b’ massimu ta ’ 5 mL kull doża. klinikament.
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/ kg body weight twice daily with a maximum of 7.5 mL per dose
Infezzjonijiet severi oħra 20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża, li jikkorrispondu għal 0. 2 mL/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 7. 5 mL kull doża.
Geriatric patients
158 Pazjenti anzjani
154 Method of administration
Metodu ta ’ l- għoti
500 mg ciprofloxacin.
½ mgħarfa tal- kejl waħda (madwar 2. 5 mL ta ’ suspensjoni) tipprovdi madwar 250 mg ta ’ ciprofloxacin Mgħarfa tal- kejl waħda (madwar 5. 0 mL ta ’ suspensjoni) tipprovdi madwar 500 mg ta ’ ciprofloxacin.
4.4 Special warnings and precautions for use
159 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Ciprofloxacin should be co-administered with another appropriate antibacterial agent unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.
Ciprofloxacin għandu jingħata flimkien ma ’ sustanza xierqa oħra kontra l- batterja sakemm Neisseria gonorrhoeae reżistenti għal ciprofloxacin tista ’ tkun eskluda.
155 Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Infezzjonijiet ta ’ l- għadam u l- ġogi Ciprofloxacin għandu jintuża flimkien ma ’ sustanzi kontra l- mikrobi oħra skond ir- riżultati tad - dokumentazzjoni mikrobijoloġika.
Complicated urinary tract infections and pyelonephritis Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.
160 Infezzjonijiet komplikati ta ’ l- apparat ta ’ l- awrina u pijelonefrite Kura b’ Ciprofloxacin ta ’ infezzjonijiet ta ’ l- apparat ta ’ l- awrina għandha tiġi kkunsidrata meta kura oħra ma tistax tiġi wżata, u għandha tiġi bbażata fuq ir- riżultati tad- dokumentazzjoni mikrobijoloġika.
Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
Infezzjonijiet severi speċifiċi oħra Infezzjonijiet severi oħra skond il- gwida uffiċjali, jew wara valutazzjoni b’ attenzjoni tal- benefiċċju - riskju meta kura oħra ma tistax tiġi wżata, jew wara falliment ta ’ terapija konvenzjonali u meta d - dokumentazzjoni mikrobijoloġika tista ’ tiġġustifika l- użu ta ’ Ciprofloxacin Bayer.
156 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Tendinite u tiċirit tat- tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b’ ciprofloxacin, anki fl- ewwle 48 siegħa ta ’ kura.
At any sign of tendinitis (e. g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
Ma ’ xi sinjal ta ’ tedinite (e. ż. nefħa bl- uġigħ, infjammazzjoni), kura ciprofloxacin għandha titwaqqaf.
Gastrointestinal System The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8).
Sistema Gastro- intestinali L- okkorrenza ta ’ dijarea severa u persistenti waqt jew wara l- kura (inkluż bosta ġimgħat wara l- kura) tista ’ tindika kolite assoċjata ma ’ antibijotiku (ta 'periklu għall- ħajja b’ possibilità ta ’ riżultat fatali), li
Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk.
Defiċjenza ta ’ glucose- 6- phosphate dehydrogenase F’ pazjenti b’ defiċjenza ta ’ glucose- 6- phosphate dehydrogenase, kienu rrapportati reazzjonijiet emolitiċi b’ ciprofloxacin F’ dawn il- pazjenti ciprofloxacin għandu jiġi evitat sakemm il- benefiċċju potenzjali ma jkunx ikkunsidrat bħala akbar mir- riskju possibli.
157 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).
As Ciprofloxacin Bayer 100 mg/ mL suspension contains 1.3 g sucrose per 5-mL measuring spoonful, this has to be taken into consideration in terms of daily intake.
Peress li ciprofloxacin 100 mg/ mL suspensjoni orali fih 1. 3 g sucrose f’ kull mgħarfa tal- kelj ta ’ 5 mL, dan għandu jiġi kkunsidrat f’ termini ta ’ teħid ta ’ kuljum.
4.5 Interaction with other medicinal products and other forms of interaction
162 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
158 Methotrexate
Methotrexate
Phenytoin
163 Phenytoin
It is recommended that the INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anti- coagulant agent.
Huwa rrakkomandat li l - INR jiġi sorveljat b’ mod frekwenti waqt u ftit wara l- għoti ta ’ ciprofloxacin flimkien ma ’ sustanza orali kontra l- koagulazzjoni tad- demm.
In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the 159 drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).
F’ bhejjem b’ età żgħira u mhux imwielda esposti għal quinolones, kienu osservati effetti fuq il- qarquċa mhux matura, għalhekk, ma jistax jiġi eskluż li l- mediċina tista ’ tikkawża ħsara lill- qarquċa tal- ġogi u l- għekiesi fl- organiżmu immatur / fetu uman (ara sezzjoni 5. 3).
System Organ
164 Sistema tal -
≥ 1/ 10 000 to <
1/ 10 000 sa
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
Tromboċitopenij a Tromboċitemija
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
(ta ’ periklu għall- ħajja) Depressjoni tal - mudullun ta ’ l - għadam (ta ’ periklu għall - ħajja)
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
anafilattiku (ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4) Reazzjoni bħall - marda tas- serum
160 System Organ
Sistema
Psychiatric Disorders
l- Organi
Psychomotor hyperactivity / agitation
magħrufa (ma tistax
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
tittieħed stima mid- data disponibbli) għolja Disturbi fil- vista Disturbi fil - Disturbi fl - kuluri visivi Għajnejn Żanżin fil - Disturbi fil - widnejn Widnejn u fis - Sistema Labirintika
Psychotic reactions (see section 4.4)
Telf ta ’ smigħ / Nuqqas fis - smigħ
Nervous System Disorders
Disturbi fil - Qalb Disturbi Vaskulari
Headache Dizziness Sleep disorders Taste disorders
Takikardija Vasodilatazzjoni Vaskulite Pressjoni baxxa Sinkope
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Arritmija ventrikulari, titwil tal- QT, torsades de pointes *
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Disturbi Respiratorji, Toraċiċi u Medjastinali
Peripheral neuropathy (see section 4.4)
Qtugħ ta ’ nifs (inkluż kondizzjoni ażmatika)
Eye Disorders Ear and Labyrinth Disorders
Disturbi
Visual colour distortions
Tqalligħ
Cardiac Disorders
Rimettar
Tachycardia
Pankrejatite
Ventricular arrhythmia, QT prolongation, torsades de pointes *
Gastro - intestinali
Vascular Disorders
Dijarea
Vasodilatation Hypotension Syncope
Weġgħat gastro - intestinali u addominali Dispepsja Gass
Vasculitis
Disturbi fil - Fwied u fil - Marrara
Respiratory, Thoracic and Mediastinal Disorders
Żjieda fit - transaminases Żjieda fil - bilirubin
Dyspnoea (including asthmatic condition)
Indeboliment Nekrożi tal - tal- fwied fwied (rari Ikterus ħafna tavvanza kolestatiku għall - Epatite insuffiċjenza tal - fwied ta ’ periklu għall- ħajja) (ara sezzjoni 4. 4)
Gastrointestinal Disorders
Disturbi fil -
Nausea Diarrhoea
Raxx
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Reazzjonijet ta ’ Petekja
Pancreatitis
Ġilda u fit -
Hepatobiliary Disorders
fotosensittività Eritima
Increase in transaminases Increased bilirubin
Tessuti ta ’ Taħt il- Ġilda
Hepatic impairment Cholestatic icterus Hepatitis
Urtikarja
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
(ara sezzjoni multiforme 4. 4) Eritima nodosum Sindrome Stevens- Johnson (b’ potenzjal ta ’ periklu għall - ħajja) Nekrolisi epidermika tossika (b’ potenzjal ta ’
161 System Organ
166 Sistema tal -
(cannot be estimated from available data)
tittieħed stima mid- data disponibbli) periklu għall - ħajja)
Skin and Subcutaneous Tissue Disorders
Disturbi
Rash Pruritus Urticaria
Uġigħ muskolu -
Photosensitivity reactions (see section 4.4)
skeltrali (e. ż.
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Tendinite
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
renali Ematurja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizjal i
Prothrombin level abnormal Increased amylase
mhux normali Żjieda fl - amylase
162 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.
Apart from routine emergency measures, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria.
167 Minbarra miżuri ta ’ emerġenza ta ’ rutina, huwa rrakkomandat li tiġi sorveljata l- funzjoni tal- kliewi, inkluż il- pH ta ’ l- awrina u jekk meħtieġ din għandha tiġi aċidifikata biex tiġi evitata kristallurja.
S ≤ S ≤
S ≤ 0. 5 mg/ L
R > 1 mg/ L R > 1 mg/ L
S ≤ 0. 5 mg/ L
S ≤ 0.03 mg/ L S ≤ 0.03 mg/ L S ≤ 0.5 mg/ L
R > 0. 06 mg/ L
R > 0.06 mg/ L R > 0.06 mg/ L R > 1 mg/ L
R > 0. 06 mg/ L
COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Mikro- organiżmi aerobiċi Gram- negative Aeromonas spp.
164 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.
169 Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
165 Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Wara għoti orali ta ’ doża waħda ta ’ 250 mg, 500 mg, u 750 mg ta ’ pilloli ciprofloxacin, dan jiġi assorbit malajr u b’ mod estensiv, fil- biċċa l- kbira mill- musrana ż- żgħira, u konċentrazzjonijiet massima fis- serum jintlaħqu minn siegħa sa sagħtejn wara.
The pharmacokinetics of ciprofloxacin oral suspension 50 mg/ mL and 100 mg/ mL are similar to those of tablets.
170 Il- farmakokinetika ta ’ ciprofloxacin 50 mg/ mL u 100 mg/ mL suspensjoni orali hija simili għal dik tal - pilloli.
166 In 10 children with severe sepsis Cmax was 6.1 mg/ L (range 4.6-8.3 mg/ L) after a 1-hour intravenous infusion of 10 mg/ kg in children aged less than 1 year compared to 7.2 mg/ L (range 4.7-11.8 mg/ L) for children between 1 and 5 years of age.
F’ għaxart itfal b’ sepsis severa, Cmax kienet 6. 1 mg/ L (firxa 4. 6- 8. 3 mg/ L) wara infużjoni ta ’ 10 mg/ kg ġol- vini ta ’ siegħa fi tfal b’ età ta ’ inqas minn sena meta mqabbel ma ’ 7. 2 mg/ L (firxa 4. 7- 11. 8 mg/ L) għal tfal b’ età bejn sena u 5 snin.
5.3 Preclinical safety data
171 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
Tagħrif dwar il- fotomutaġeniċità / fotokarċinoġeniċità wera effett fotomutaġeniku jew fototumuroġeniku dgħajjef ta ’ ciprofloxacin in - vitro u f’ esperimenti fuq il - bhejjem.
167 Press down according to instructions on the cap while turning to the left.
Waqt li ddawwar lejn ix- xellug, għafas l- isfel skond l- istruzzjonijiet fuq l- għatu.
The ready-to-use suspension is stable for 14 days when stored in a refrigerator or at ambient temperatures below 30°C.
172 ġurnata meta maħżuna fil- friġġ jew f’ temperaturi tal- kamra taħt 30°C.
The graduated measuring spoon with the markings 1/ 2 is equivalent to 2.6 mL containing 2.5 mL of final suspension and 1/ 1 is equivalent to 5.2 mL containing 5.0 mL of final suspension.
Il- mgħarfa b’ marki tal- kejl bil- marki 1/ 2 li hija ekwivalenti għal 2. 6 mL u fiha 2. 5 mL ta ’ suspensjoni finali u 1/ 1 li hija ekwivalenti għal 5. 2 mL u fiha 5. 0 mL ta ’ suspensjoni finali.
The graduated measuring spoon must be used for measuring the required prescribed amount of Ciprofloxacin oral suspension 100 mg/ mL.
Il- mgħarfa b’ marki tal - kejl għandha tintuża għall- kejl ta ’ l- ammont preskritt meħtieġ tas- suspensjoni ta ’ Ciprofloxacin 100 mg/ mL.
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/ 100 mL solution for infusion [See Annex I - To be completed nationally]
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 Bayer 200 mg/ 100 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 200 mg/ 100 mL soluzzjoni għall- infużjoni huwa ndikat għall- kura ta ’ l - infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
• Chronic suppurative otitis media
Otite medja kronika b’ suppurazzjoni
• Infections of the gastro-intestinal tract (e. g. travellers ` diarrhoea)
• Infezzjonijiet ta ’ l- apparat gastro- intestinali (e. ż. dijarea tal- vjaġġaturi)
• Malignant external otitis
174 • Otite esterna malinna
169 • Infections of the bones and joints
• Infezzjonijiet ta ’ l- għadam u tal- ġogi
After intravenous initiation of treatment, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated at the discretion of the physician.
Wara bidu ta ’ kura fil- vini, il- kura tista ’ tinqaleb għall- kura orali b’ pilloli jew suspensjoni jekk indikat klinikament skond l- opinjoni tat- tabib.
IV treatment should be followed by oral route as soon as possible.
Kura IV għandha tiġi segwita b’ kura mir- rotta orali malajr kemm jista ’ jkun.
Total duration of treatment (including switch to oral therapy as soon as possible)
Tul totali tal- kura (inkluż bidla għal terapija orali malajr kemm jista ’ jkun)
400 mg twice daily to 400 mg three times a day
400 mg darbtejn kuljum sa 400 mg tlitt darbiet kuljum
Infections of the upper respiratory tract
Infezzjonijiet ta ’ l - apparat respiratorju ta ’ fuq
400 mg twice daily to 400 mg three times a day
400 mg darbtejn kuljum to 400 mg tlitt darbiet kuljum
400 mg three times a day
400 mg tlitt darbiet kuljum
Complicated and
Infezzjonijiet ta ’ l - apparat ta ’ l- awrina
uncomplicated pyelonephritis
Pijelonefrite komplikata u mhux komplikata
400 mg three times a day
400 mg darbtejn kuljum sa 400 mg tlitt darbiet kuljum
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) 2 sa 4 ġimgħat (akuta)
Genital tract infections
Infezzjonijiet ta ’ l - organi ġenitali
400 mg twice daily
mg darbtejn kuljum
400 mg twice daily 400 mg twice daily to 400 mg three times a day
mg darbtejn kuljum
Infections of the skin and soft tissue
Infezzjonijiet tal- ġilda
400 mg twice daily to 400 mg three times a day
400 mg darbtejn
max. of 3 months
massimu ta ’ 3 xhur
Treatment of infections or prophylaxis of infections in neutropenic patients Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
kuljum sa 400 mg tlitt darbiet kuljum Kura jew profilassi ta ’ nfezzjonijiet f’ pazjenti
400 mg twice daily to 400 mg three times a day
Doża ta ’ kuljum f’ mg
Therapy should be continued over the entire period of neutropenia
Tul totali tal- kura (inkluż bidla għal terapija orali malajr kemm jista ’ jkun)
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.
b’ newtropenija severa Ciprofloxacin għandu jingħata flimkien ma ’ sustanza( i) antibatterika xierqa.
400 mg twice daily
kuljum sa 400 mg tlitt darbiet kuljum
60 days from the confirmation of Bacillus anthracis exposure
60 ġurnata mill- konferma ta ’
Children and adolescents
L- għoti tal- mediċina għandu jinbeda mill - aktar fis possibli wara suspett jew konferma ta ’ esponiment.
171
kuljum
Indication
Tfal u adoloxxenti
Daily dose in mg
Indikazzjoni
Total duration of
Doża ta ’ kuljum f ’ mg
treatment (including switch to oral therapy as soon as possible) Cystic fibrosis
Tul totali tal- kura (inkluż bidla għal terapija orali malajr kemm jista ’ jkun)
10 mg/ kg body weight three times a day with a maximum of 400 mg per dose.
10 mg/ kg ta ’ piż tal- ġisem tlitt darbiet kuljum b’ massimu ta ’ 400 mg kull doża.
10 to 14 days
sa 14- il ġurnata
6 mg/ kg body weight three times a day to 10 mg/ kg body weight three times a day with a maximum of 400 mg per dose.
6 mg/ kg ta ’ piż tal- ġisem sa 10 mg/ kg ta ’ piż tal- ġisem tlitt darbiet kuljum b’ massimu ta ’ 400 mg kull doża.
10 mg/ kg body weight twice daily to 15 mg/ kg body
10 mg/ kg ta ’ piż tal- ġisem sa 2 x 15 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 400 mg kull doża.
10 mg/ kg body weight three times a day with a maximum of 400 mg per dose.
10 mg/ kg ta ’ piż tal- ġisem tlitt darbiet kuljum b’ massimu ta ’ 400 mg kull doża
Geriatric patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.
Pazjenti anzjani għandhom jirċievu doża magħzula skond is- severità tal- infezzjoni u t- tneħħija tal - krejatinina tal- pazjent.
Creatinine Clearance [mL/ min/ 1.73 m²]
Tneħħija tal- krejatinina [mL/ min / 1. 73 m²]
Intravenous Dose [mg]
Dosa Fil- Vini [mg]
200-400 mg every 24 h (after dialysis)
200- 400 mg kull 12 h 200- 400 mg kull 24 h 200- 400 mg kull 24 h (wara dijalisi)
200-400 mg every 24 h
200- 400 mg kull 24 h
Method of administration
177 Metodu ta ’ l- għoti
Ciprofloxacin Bayer should be checked visually prior to use.
Ciprofloxacin għandu jiġi ċċekkjat viżwalment qabel l- użu.
It must not be used if cloudy.
M’ għandhux jintuża jekk imċajpar.
172 Ciprofloxacin should be administered by intravenous infusion.
Ciprofloxacin għandu jingħata permezz ta ’ infużjoni fil- vini.
For children, the infusion duration is 60 minutes.
Għat- tfal, it- tul ta ’ l- infużjoni huwa 60 minuta.
In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin Bayer and 30 minutes for 200 mg Ciprofloxacin Bayer.
F’ pazjenti adulti, il- ħin ta ’ l- infużjoni huwa 60 minuta għal 400 mg Ciprofloxacin Bayer u 30 minuta għal 200 mg Ciprofloxacin Bayer.
Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
Infużjoni bil- mod ġo vina kbira tnaqqas l- iskomdu għall- pazjent u r- riskju ta ’ irritazzjoni tal- vina.
The infusion solution can be infused either directly or after mixing with other compatible infusion solutions (see section 6.2).
Is- soluzzjoni għall- infużjoni tista ’ tiġi nfuża direttament jew wara li titħallat ma ’ soluzzjonijiet għall - infużjoni kompatibbli oħra (ara sezzjoni 6. 2).
Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1).
• Sensittività eċċessiva għas- sustanza attiva, għal quinolones oħra jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1).
Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).
• L- għoti flimkien ta ’ ciprofloxacin u tizanidine (ara sezzjoni 4. 5).
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.
Treating physicians should refer to national and /or international consensus documents regarding the treatment of anthrax.
Tobba li qed jikkuraw għandhom jirreferu għad - dokumenti ta ’ kunsens nazzjonali u/ jew internazzjonali dwar il- kura ta ’ l- antraċe.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
178 Tfal u adoloxxenti L- użu ta ’ ciprofloxacin fi tfal u adoloxxenti għandu jsegwi l- gwida uffiċjali disponibbli.
Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Kura b’ ciprofloxacin għandha tinbeda biss minn tobba li għandhom esperjenza fil- kura ta ’ fibrosi ċistika u/ jew infezzjonijiet severi fit- tfal u l- adoloxxenti.
173 n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%.
Tagħrif dwar is- sigurtà minn studju randomised double- blind dwar l- użu ta ’ ciprofloxacin fit- tfal (ciprofloxacin: n=335, età medja = 6. 3 snin; komparaturi: n=349, età medja = 6. 2 snin; firxa ta ’ l- età = 1 sa 17- il sena) wera inċidenza ta ’ artropatija suspettata relatata mal- mediċina (misjuba minn sinjali u sintomi kliniċi relatati mal- ġogi) mal- Ġurnata +42 ta ’ 7. 2% u 4. 6%.
Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue.
Il - kura għandha tinbeda biss wara valutazzjoni b’ attenzjoni tal- benefiċċju/ riskju, minħabba l- possibiltà ta ’ avvenimenti avversi relatati mal- ġogi u/ jew mat- tessut tal- madwar.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
Sistema Muskolu- skeletrali Ciprofloxacin ġeneralment m’ għandux jintuża f’ pazjenti b’ passat ta ’ marda/ disturb tat- tendon relatata ma ’ kura b’ quinolone.
Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Madankollu, f’ każijiet rari ħafna, wara dokumentazzjoni mikrobijoloġika ta ’ l - organiżmu li qed jikkawża l- marda u valutazzjoni tal- bilanċ ta ’ riskju/ benefiċċju, ciprofloxacin jista ’ jiġi preskritt lil dawn il- pazjenti għall- kura ta ’ ċertu infezzjonijiet severi, speċjalment f’ każ ta ’ falliment tat- terapija stàndard jew reżistenza tal- batterja, fejn it- tagħrif mikrobijoloġiku jista ’ jiġġustifika l- użu ta ’ ciprofloxacin.
At any sign of tendinitis (e.g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
Ma ’ xi sinjal ta ’ tedinite (e. ż. nefħa bl- uġigħ, infjammazzjoni), kura b’ ciprofloxacin għandha titwaqqaf.
Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).
Pazjenti li qed jieħdu ciprofloxacin għandhom jiġu avżati biex jevitaw esponiment dirett għal dawl tax- xemx estensiv jew irradjazzjoni UV waqt kura b’ ciprofloxacin (ara sezzjoni 4. 8).
Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
179 Sistema Nervuż Ċentrali Quinolones huma magħrufa li jikkawżaw aċċessjonijiet jew ibaxxu l- limitu għal aċċessjoni.
Psychiatric reactions may occur even after the first administration of ciprofloxacin.
Reazzjonijiet psikjatriċi jistgħu jseħħu anki wara l- ewwel għoti ta ’ Ciprofloxacin Bayer.
174 Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including 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).
There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Jista ’ jkun hemm riskju partikolari ta ’ selezzjoni għall- batterja reżistenti għal ciprofloxacin waqt kura fit- tul u meta jiġu kkurati infezzjonijiet li jittieħdu minn sptar u/ jew infezzjonijiet ikkawżati mill- ispeċi Staphylococcus u Pseudomonas.
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 (e. ż. 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.
180 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.
Injection Site Reaction Local intravenous site reactions have been reported with the intravenous administration of ciprofloxacin.
Reazzjoni fis- Sit ta ’ l- Injezzjoni Reazzjonijiet lokali fis- sit għal ġol- vini ġew irrapportati b’ għoti fil- vini ta ’ ciprofloxacin.
These reactions are more frequent if the infusion time is 30 minutes or less.
Dawn ir - reazzjonijiet huma aktar frekwenti jekk il- ħin ta ’ l- infużjoni huwa 30 minuta jew inqas.
These may appear as local skin reactions which resolve rapidly upon completion of the infusion.
Dawn jistgħu jidrhu bħala reazzjonijiet lokali tal- ġilda li jgħaddu malajr wara li titlesta l- infużjoni.
Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
Għoti sussegwenti fil- vini mhux kontra- indikat sakemm ir- reazzjonijiet ma jerġgħux jidrhu jew imorru għall - agħar.
175 Glucose Load Ciprofloxacin Bayer solution for infusion contains 5 g glucose in 100 mL solution for infusion.
Kwantità ta ’ Glucose Soluzzjoni għall- infużjoni ta ’ ciprofloxacin fiha 5 g ta ’ glucose f’ 100 mL ta ’ soluzzjoni għall - infużjoni.
This should be taken into account in patients with diabetes mellitus.
Dan għandu jittieħed f’ konsiderazzjoni f’ pazjenti b’ dijabete mellitus.
Effects of other medicinal products on ciprofloxacin:
Effetti ta ’ prodotti mediċinali oħra fuq ciprofloxacin:
Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.
L- għoti flimkien ta ’ probenecid u Ciprofloxacin iżid il- konċentrazzjonijiet ta ’ ciprofloxacin fis- serum.
Phenytoin
181 Phenytoin
It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively.
Fi studju kliniku intwera li l- użu ta ’ ropinirole flimkien ma ’ ciprofloxacin, inibitur moderat ta ’ l - isożima CYP450 1A2, iwassal għal żjieda f ’ Cmax u l- AUC ta ’ ropinirole ta ’ 60% u 84%, rispettivament.
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin.
Tqala It- tagħrif disponibbli dwar l- għoti ta ’ ciprofloxacin lil nisa tqal ma jindika l- ebda tossiċità malformattiva jew tossiċità għall- fetu/ tarbija tat- twelid ta ’ ciprofloxacin.
The most commonly reported adverse drug reactions (ADRs) are nausea, diarrhoea, vomiting, transient increase in transaminases, rash, and injection and infusion site reactions.
L- aktar reazzjonijiet avversi tal- mediċina (ADRs) irrapportati b’ mod komuni huma tqalligħ, dijarea, rimettar, żjieda temporanja fit- transaminases, raxx u reazzjonijiet fis- sit ta ’ l- injezzjoni u l- infużjoni..
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.
L -
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
182 analiżi ta ’ frekwenza jieħu f’ kunsiderazzjoni tagħrif minn għoti orali kif ukoll minn għoti fil- vini ta ’ ciprofloxacin.
Common ≥ 1/100 to <
Komuni
Uncommon ≥ 1/1 000 to <
Mhux Komuni
Rare ≥ 1/10 000 to <
Rari
Very Rare < 1/ 10 000
Rari Ħafna
Frequency not known
Frekwenza
1/ 10
Klassifika ta ’ ≥ 1/ 100 sa < ≥ 1/ 1 000 sa <
1/100
≥ 1/ 10 000 sa <
(cannot be estimated from available data)
mhux
Infections and Infestations
l- Organi
Mycotic superinfections
1/ 10
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
1/ 100
177
1/ 1 000
System Organ Class
magħrufa (ma tistax
Common ≥ 1/100 to <
tittieħed stima mid- data disponibbli) Superinfezzjoni Kolite assoċjata Infezzjonijiet jietmill- moffa ma ’ antibijotiċi u (rari ħafna Infestazzjonij b’ possibiltà ta ’ iet riżultat fatali) (ara sezzjoni 4. 4) Disturbi tad -
Uncommon ≥ 1/1 000 to <
Esinofilja
Rare ≥ 1/10 000 to <
Lewkopenija
Very Rare < 1/ 10 000
Anemija
Frequency not known
Demm u tas -
1/ 10
Anemija
1/100
emolitika
1/1 000
Sistema
(cannot be estimated from available data)
Newtropenija
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
Reazzjoni ta ’ ansjetà Ħolm mhux normali Depressjoni Alluċinazzjonijiet
Nervous System Disorders
Disturbi fis -
Headache Dizziness Sleep disorders Taste disorders
Uġigħ ta ’ ras
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Sistema
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Sturdament
Peripheral neuropathy (see section 4.4)
Disestesija
Eye Disorders Ear and Labyrinth Disorders
Disturbi fil -
Visual disturbances Tinnitus Hearing loss / Hearing impaired
periferali (ara
Visual colour distortions
Nervuża
Cardiac Disorders
Disturbi ta ’ l -
Tachycardia
Ipoestesija
Ventricular arrhythmia, QT prolongation, torsades de pointes *
koordinazzjoni sezzjoni 4. 4)
Vascular Disorders
irqad Disturbi fit - togħma
Vasodilatation Hypotension Syncope
Disturb fil- mixja Disturbi fin- nerv tax- xamm Pressjoni intrakranjali għolja
Vasculitis
183
178 System Organ Class
Sistema tal -
Respiratory, Thoracic and Mediastinal Disorders
tittieħed stima mid- data disponibbli) Disturbi fl - Għajnejn Disturbi fil - Widnejn u
Dyspnoea (including asthmatic condition)
Disturbi fil- vista Żanżin fil - widnejn
Gastrointestinal Disorders
Disturbi fil - kuluri visivi
Nausea Diarrhoea
fis- Sistema Labirintika Disturbi fil - Qalb
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Telf ta ’ smigħ / Nuqqas fis- smigħ Takikardija
Pancreatitis
Arritmija ventrikulari, titwil tal- QT, torsades de pointes *