qanastek/EMEA-V3 huggingface dataset:
Hepatobiliary Disorders
Disturbi Vaskulari
Increase in transaminases Increased bilirubin
Vasodilatazzjoni Pressjoni baxxa Sinkope
Hepatic impairment Cholestatic icterus Hepatitis
Disturbi Respiratorji, Toraċiċi u Medjastinali
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
Qtugħ ta ’ nifs (inkluż kondizzjoni ażmatika)
Rash Pruritus Urticaria
Pankrejatite
Photosensitivity reactions (see section 4.4)
Gastro - intestinali
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Weġgħat gastro - intestinali u addominali Dispepsja Gass
Musculoskeletal, Connective Tissue and Bone Disorders
Disturbi fil - Fwied u fil - Marrara
Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia
Żjieda fit - transaminases Żjieda fil -
Myalgia Arthritis Increased muscle tone and cramping
Indeboliment tal - fwied Ikterus
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Nekrożi tal - fwied (rari ħafna tavvanza
Renal and Urinary Disorders
bilirubin
Renal impairment
kolestatiku Epatite
Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
għall - insuffiċjenza tal - fwied ta ’ periklu għall- ħajja) (ara sezzjoni 4. 4)
System Organ
184 Sistema tal -
Frequency
Rari Ħafna
Class
Frekwenza
≥ 1/ 100 to <
Klassifika ta ’ ≥ 1/ 100 sa < ≥ 1/ 1 000 sa <
≥ 1/1 000 to <
≥ 1/ 10 000 sa <
≥ 1/10 000 to <
< 1/ 10 000
< 1/ 10 000
mhux
not known
l- Organi
1/100
1/ 100
1/1 000
1/ 1 000
General Disorders and Administration Site Conditions
tittieħed stima mid- data disponibbli) Disturbi fil -
Injection and infusion site reactions (only intravenous administration)
Reazzjonijet ta ’
Asthenia Fever
Ġilda u fit -
Oedema Sweating (hyperhidrosis)
fotosensittività
Investigations
Eritima
Increase in blood alkaline phosphatase
Tessuti ta ’ Taħt il- Ġilda
Prothrombin level abnormal Increased amylase
Żjieda fit- tensjoni
* 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).
sezzjoni 4. 4) Rkadar tas - sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
renali Ematurja Kristallurja (ara sezzjoni 4. 4) Nefrite tubulointerstizjali
Common Uncommon
Reazzjonijiet
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
fis- sit ta ’ l -
Rare
Deni
Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders, Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis, Petechiae, Tendon rupture
prothrombin
Paediatric patients
phosphatase fid- demm
The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
Pazjenti pedjatriċi L- inċidenza ta ’ artopatija, msemmija fuq, tirreferi għal tagħrif miġbur minn studji bl- adulti.
180 As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
Bħala sustanza fluoroquinolone kontra l- batterja, l- azzjoni batteriċida ta ’ ciprofloxacin tirriżulta mill - inibizzjoni taż- żewġ topoisomerase tat- tipi II (DNA- gyrase) u ta ’ topoisomerase IV, li huma meħtieġa għar- replikazzjoni, transkrizzjoni, tiswija u rikombinazzjoni tad- DNA tal- batterja.
PK/PD relationship:
Relazzjoni PK/ PD:
Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.
186 tirriżultax f’ reżistenza klinika, iżda mutazzjonijiet multipli jirriżultaw f’ reżistenza klinika għal ħafna jew għas- sustanzi attivi kollha fil- klassi.
Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance.
Impermeabilità u/ jew mekkaniżmi ta ’ reżistenza tal- pompa ta ’ effluss tas- sustanza attiva jista ’ jkollhom effett varjabbli fuq is- suxxettibilità għal fluoroquinolones, li tiddependi fuq il- karatteristiċi fisjokimiċi ta ’ diversi sustanzi attivi fil- klassi u l- affinità tas- sistemi ta ’ transport għal kull sustanza attiva.
S ≤ 0.5 mg/L S ≤ 0.5 mg/L S ≤ 1 mg/L S ≤ 1 mg/L
R > 1 mg/ L
S ≤ 0.5 mg/L
S ≤ 0. 5 mg/ L
R > 0.5 mg/L
R > 0. 5 mg/ L
S ≤ 0.03 mg/L S ≤ 0.03 mg/L S ≤ 0.5 mg/L
> 0. 06 mg/ L
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Staphylococcus spp. – punti kritiċi għal ciprofloxacin huma konnessi ma ’ terapija b’ doża għolja. * Punti kritiċi li mhumiex konnessi ma ’ speċi ġew determinati primarjament fuq il- bażi ta ’ tagħrif PK/ PD u huma indipendenti mid- distribuzzjonijiet ta ’ MIC għall- ispeċi speċifiċi.
181 COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
187 Mikro- organiżmi aerobiċi Gram- negative Aeromonas spp.
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. *(2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia +* Campylobacter spp.+* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
(2)
182 INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
188 Mikro- organiżmi anaerobiċi Excepted kif msemmi hawn fuq Mikro- organiżmi oħra Mycoplasma genitalium Ureaplasma urealitycum * Effikaċja klinika ġiet dimostrata għal iżolati suxxettibli f’ indikazzjonijiet kliniċi approvati + Rata ta ’ reżistenza ≥ 50% f’ wieħed jew aktar mill- pajjiżi ta ’ l- EU ($):
The treating physician should refer to national and /or international consensus documents regarding treatment of anthrax.
It- tabib li qed jikkura għandu jirreferi għad- dokumenti ta ’ konsensus nazzjonali u / jew internazzjonali dwar il- kura ta ’ antraċe.
Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
Wara infużjoni fil- vini ta ’ ciprofloxacin il- medja tal- konċentrazzjonijiet massimi fis- serum intlaħqu fl - aħħar ta ’ l- infużjoni.
Pharmacokinetics of ciprofloxacin were linear over the dose range up to 400 mg administered intravenously.
Il- farmakokinetika ta ’ ciprofloxacin kienet lineari tul il- firxa tad- doża sa 400 mg mogħtija fil- vini.
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.
A 60-minute intravenous infusion of 200 mg ciprofloxacin or the oral administration of 250 mg ciprofloxacin, both given every 12 hours, produced an equivalent area under the serum concentration time curve (AUC).
Infużjoni fil- vini ta ’ 60 minuta ta ’ 200 mg ciprofloxacin jew l- għoti orali ta ’ 250 mg ciprofloxacin, it - tnejn mogħtija kull 12- il siegħa, ipproduċew erja taħt il- kurva (AUC) tal- konċentrazzjoni fis- serum kontra l- ħin ekwivalenti.
A 60-minute intravenous infusion of 400 mg ciprofloxacin every 12 hours was bioequivalent to a 500 mg oral dose every 12 hours with regard to AUC.
Infużjoni fil- vini ta ’ 60 minuta ta ’ 400 mg ciprofloxacin kull 12- il siegħa kienet bijoekwivalenti għal doża orali ta ’ 500 mg kull 12- il siegħa rigward l- AUC.
The 400 mg intravenous dose administered over 60 minutes every 12 hours resulted in a Cmax similar to that observed with a 750 mg oral dose.
Id- doża fil- vini ta ’ 400 mg mogħtija fuq medda ta ’ 60 minuta kull 12- il siegħa wasslet għal Cmax simili għal dik osservata b’ doża orali ta ’ 750 mg.
A 60-minute infusion of 400 mg ciprofloxacin every 8 hours is equivalent with respect to AUC to 750 mg oral regimen given every 12 hours.
Infużjoni fil- vini ta ’ 60 minuta ta ’ 400 mg ciprofloxacin kull 8 sigħat hija ekwivalenti għal kors orali ta ’ 750 mg mogħti kull 12- il siegħa rigward l- AUC.
Ciprofloxacin
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.
183 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.
Metabolism
189 Metaboliżmu
Excretion of ciprofloxacin (% of dose) Intravenous Administration
Tneħħija ta ’ ciprofloxacin (% tad- doża) Għoti fil- Vini
61.5 9.5
61. 5 9. 5
15.2 2.6
15. 2 2. 6
Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h.
It- tneħħija renali hija bejn 180- 300 mL/ kg/ h u t- tneħħija totali mill- ġisem hija bejn 480- 600 mL/ kg/ h.
No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.
Ma ġietx ossrvata żjieda notabbli Cmax u l- AUC b’ dożaġġ multiplu (10 mg/ kg tliet darbiet kuljum).
In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age.
F’ għaxart itfal b’ sepsis severa, Cmax kienet 6. 1 mg/ L (firxa 4. 6- 8. 3 mg/ L) wara infużjoni ta ’ 10 mg/ kg ġol- vini ta ’ siegħa fi tfal b’ età ta ’ inqas minn sena meta mqabbel ma ’ 7. 2 mg/ L (firxa 4. 7- 11. 8 mg/ L) għal tfal b’ età bejn sena u 5 snin.
The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.
Il- valuri ta ’ l- AUC kienu 17. 4 mg* h/ L (firxa 11. 8- 32. 0 mg* h/ L) u 16. 5 mg* h/ L (firxa 11. 0- 23. 8 mg* h/ L) fil- gruppi ta ’ età rispettiva.
184 Articular tolerability:
190 Tollerabilità artikulari:
Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use.
Peress li s- soluzzjoni għall- infużjoni hija sensittiva għad- dawl, il- boroż għall- infużjoni għandhom jitneħħew mill- kaxxa eżatt qabel l- użu biss.
In daylight conditions complete efficacy is guaranteed for a period of three days.
Fid- dawl, effikaċja kompleta hija garantita għall- perijodu ta ’ tlett ijiem.
Any unused solution should be disposed off.
Kull soluzzjoni mhux użata għandha tintrema.
{Name and address} < {tel} > < {fax} > < {e-mail} >
{Isem u indirizz} < {tel} > < {fax} > < {e- mail} >
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
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 Bayer 400 mg/200 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 400 mg/ 200 mL soluzzjoni għall- infużjoni huwa ndikat għall- kura ta ’ l - infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
• Infections of the gastro-intestinal tract (e.g. travellers` diarrhoea)
• Infezzjonijiet ta ’ l- apparat gastro- intestinali (e. ż. dijarea tal- vjaġġaturi)
• Malignant external otitis
193 • Otite esterna malinna
187 • Infections of the bones and joints
• Infezzjonijiet ta ’ l- għadam u tal- ġogi
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
Il- kura għandha tinbeda biss minn tobba li għandhom esperjenza fil- kura ta ’ fibrożi ċistika u/ jew infezzjonijiet severi fit- tfal u l- adoloxxenti (ara sezzjonijiet 4. 4 u 5. 1).
In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
F’ każijiet severi jew jekk il- pazjent ma jistax jieħu l- pilloli (e. ż. pazjenti fuq nutrizzjoni enterali), huwa rrakkomandat li t- terapija tinbeda b’ ciprofloxacin ġol- vini sakemm tkun possibli bidla għall - għoti orali.
Treatment of infections due to certain bacteria (e.g.
Il- kura ta ’ infezzjonijiet ikkawżati minn ċertu batterja (e. ż.
Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
Il- kura ta ’ xi infezzjonijiet (e. ż. marda infjammatorja tal- pelvi, infezzjonijiet intra- addominali, infezzjonijiet f’ pazjenti newtropeniċi u infezzjonijiet ta ’ l- għadam u tal- ġogi) jistgħu jinħtieġu l- għoti flimkien ma ’ sustanzi kontra l- batterja xierqa skond il- patoġeni nvoluti.
Epididymo-orchitis and pelvic inflamm atory diseases
Epididimo- orkite u mard infjammatorju tal- pelvi
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.
Kura jew profilassi ta ’ nfezzjonijiet f’ pazjenti b’ newtropenija severa Ciprofloxacin għandu jingħata flimkien ma ’ sustanza( i) antibatterika xierqa.
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.
Profilassi wara esponiment u kura li tfejjaq ta ’
400 mg twice daily
400 mg darbtejn
189
kuljum
Total duration of
Doża ta ’ kuljum f’ mg
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.
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.
60
60 ġurnata mill- konferma ta ’ esponiment għal Bacillus anthracis
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
Creatinine Clearance [mL/min/1.73 m²]
Krejatinina fis- Serum
Serum Creatinine [µmol/L]
Tneħħija tal- krejatinina [mL/ min / 1. 73 m²]
Dosing in children with impaired renal and/or hepatic function has not been studied.
196 Id- dożaġġ fi tfal b’ funzjoni tal- kliewi u/ jew tal- fwied indebolita ma ġiex studjat.
190 Method of administration
Metodu ta ’ l- għoti
Ciprofloxacin should be administered by intravenous infusion.
Ciprofloxacin għandu jingħata permezz ta ’ infużjoni fil- vini.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
197 Tfal u adoloxxenti L- użu ta ’ ciprofloxacin fi tfal u adoloxxenti għandu jsegwi l- gwida uffiċjali disponibbli.
191 Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals.
Ciprofloxacin intwera li jikkawża artropatija fil- ġogi li jġorru l- piż ta ’ bhejjem immaturi.
Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
198 Sistema Nervuż Ċentrali Quinolones huma magħrufa li jikkawżaw aċċessjonijiet jew ibaxxu l- limitu għal aċċessjoni.
If seizures occur Ciprofloxacin should be discontinued (see section 4.8).
Jekk iseħħu aċċessjonijiet ciprofloxacin għandu jitwaqqaf (ara sezzjoni 4. 8).
Psychiatric reactions may occur even after the
Reazzjonijiet psikjatriċi jistgħu jseħħu anki wara l- ewwel għoti ta ’ Ciprofloxacin Bayer.
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).
In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
F’ każijiet bħal dawn, ciprofloxacin għandu jitwaqqaf immedjatament għandha tinbeda terapija xierqa.
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).
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.
199 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.
193 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.
Glucose Load Ciprofloxacin Bayer solution for infusion contains 10 g glucose in 200 mL solution for infusion.
Kwantità ta ’ Glucose Soluzzjoni għall- infużjoni ta ’ ciprofloxacin fiha 10 g glucose f’ 200 mL ta ’ soluzzjoni għall- infużjoni.
Phenytoin
200 Phenytoin
The risk may vary with the underlying infection, age
Kien hemm ħafna rapporti ta ’ żjidiet fl- attività orali kontra l- koagulazzjoni f’ pazjenti li kienu qed jirċievu sustanzi kontra l- batterja, inkluż fluoroquinolones.
194 and general status of the patient so that the contribution of the fluoroquinolone to the increase in INR (international normalised ratio) is difficult to assess.
Ir- riskju jista ’ jvarja skond l - infezzjoni preżenti, l- età u l- istat ġenerali tal- pazjent biex il- kontribut tal- fluoroquinolone għaż- żjieda fl- INR (Proporzjon Normalizzat Internazzjonali) ikun diffiċli biex jiġi stmat.
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
201 analiżi ta ’ frekwenza jieħu f’ kunsiderazzjoni tagħrif minn għoti orali kif ukoll minn għoti fil- vini ta ’ ciprofloxacin.
195 System Organ Class
Sistema tal -
Common ≥ 1/100 to <
Komuni Mhux Komuni
Uncommon ≥ 1/1 000 to <
≥ 1/ 100 sa ≥ 1/ 1 000 sa
Rare ≥ 1/10 000 to <
≥ 1/ 10 000 sa < 1/ 1
Frequency not known
l- Organi
Infections and Infestations
tittieħed stima mid- data disponibbli) Superinfezzjoni Kolite assoċjata ma ’ Infezzjonijiet jietmill- moffa antibijotiċi (rari ħafna u b’ possibiltà ta ’ Infestazzjonij riżultat fatali) (ara iet sezzjoni 4. 4) Disturbi tad -
Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
Newtropenija
Eye Disorders Ear and Labyrinth Disorders
Disturbi fl - Għajnejn Disturbi fil - Widnejn u
Visual disturbances Tinnitus Hearing loss / Hearing impaired
Disturbi fil- vista Żanżin fil- widnejn 202
196 System Organ Class
Sistema tal -
Cardiac Disorders
tittieħed stima mid- data disponibbli) fis- Sistema Labirintika Disturbi fil - Qalb
Vasodilation Hypotension Syncope
Vasodilatazzjoni Pressjoni baxxa Sinkope
Rash Pruritus Urticaria
Ġilda u fit -
Photosensitivity reactions (see section 4.4)
fotosensittività (ara
197 System Organ Class
Sistema tal -
Musculoskeletal, Connective Tissue and Bone Disorders
tittieħed stima mid- data disponibbli) Connective
Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia
estremitajiet,
Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
sezzjoni 4. 4) Rkadar tas - sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
General Disorders and Administration Site Conditions
Disturbi
Injection and infusion site reactions (only intravenous administration)
et fis- sit ta ’
Prothrombin level abnormal Increased amylase
normali Żjieda fl- amylase
* These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see section 4.4).
* Dawn l- avvenimenti kienu rrapportati waqt il- perijodu ta ’ wara t- tqegħid fis- suq u kienu
Common Uncommon
osservati l -
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
aktar f’ pazjenti b’ aktar fatturi ta ’ riskju għal titwil tal- QT (ara sezzjoni 4. 4).
Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders, Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis, Petechiae, Tendon rupture
L- effetti mhux mixtieqa li ġejjin għandhom kategorija ta ’ frekwenza ogħla fis- sottogruppi ta ’ pazjenti li rċevew kura fil- vini jew sekwenzjali (fil- vini għal orali):
Paediatric patients
Rimettar, Żjieda temporanja fit- transaminases, Raxx Komuni Tromboċitopenija, Tromboċitemija, Konfużjoni u diżorjentazzjoni, Mhux komuni Alluċinazzjonijiet, Par - u disestesija, Aċċessjonijiet, Vertigo, Disturbi fil - vista, Telf ta ’ smigħ, Takikardija, Vasodilatazzjoni, Pressjoni baxxa, Indeboliment temporanju tal- fwied, Ikterus kolestatiku, Insuffiċjenza renali, Edima Panċitopenija, Depressjoni tal- mudullun ta 'l- għadam, Xokk anafilattiku, Rari Reazzjonijiet psikotiċi, Emigranja, Disturbi fix- xamm, Smigħ imnaqqas, Vaskulite, Pankreatite, Nekrosi tal- fwied, Petekja, Tiċrit tat- tendon
198 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Doża eċċessiva ta ’ 12 g ġiet irrapportata li twassal għall- sintomi ħfief ta ’ tossiċità.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
204 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.
199 Haemophilus influenzae and Moraxella catarrhalis
Haemophilus influenzae u Moraxella catarrhalis
200 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.
206 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.
5.2 Pharmacokinetic properties
207 5. 2 Tagħrif farmakokinetiku
201 Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
Wara infużjoni fil- vini ta ’ ciprofloxacin il- medja tal- konċentrazzjonijiet massimi fis- serum intlaħqu fl - aħħar ta ’ l- infużjoni.
Ciprofloxacin is present in plasma largely in a non- ionised form and has a large steady state distribution volume of 2-3 L/kg body weight.
Ciprofloxacin huwa preżenti fil- plażma fil- biċċa l- kbira fil- forma mhux jonizzata u għandha volum ta ’ distribuzzjoni fi stat fiss kbir ta ’ 2- 3 L/ kg piż tal- ġisem.
1% of the dose is excreted via the biliary route.
208 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.
202 The pharmacokinetic data in paediatric patients are limited.
It- tagħrif farmakokinetiku f’ pazjenti pedjatriċi huwa limitat.
[To be completed nationally]
209 [Biex timtela mill- pajjiż partikolari]
203 Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use.
Peress li s- soluzzjoni għall- infużjoni hija sensittiva għad- dawl, il- boroż għall- infużjoni għandhom jitneħħew mill- kaxxa eżatt qabel l- użu biss.
204 1.
210 1.
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/50 mL solution for infusion [See Annex I - To be completed nationally]
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 Bayer 100 mg/50 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 100 mg/ 50 mL soluzzjoni għall- infużjoni huwa ndikat għall- kura ta ’ l - infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
• Malignant external otitis
211 • Otite esterna malinna
205 • Infections of the bones and joints
• Infezzjonijiet ta ’ l- għadam u tal- ġogi
Infections of the lower respiratory tract
Infezzjonijiet ta ’ l - Irkadar akut ta ’ apparat respiratorju sinusite kronika ta ’ fuq
206 Indications
Indikazzjonijiet
Acute exacerbation of chronic sinusitis
Otite medja kronika b’ suppurazzjoni
Chronic suppurative otitis media
400 mg tlitt darbiet kuljum
400 mg twice daily to 400 mg three times a day
Infezzjonijiet ta ’ l -
28 days up to 3 months
sa 21 ġurnata, jista ’ jitkompla
Urinary tract infections
apparat ta ’ l- awrina
Complicated and uncomplicated pyelonephritis
komplikata u mhux komplikata
400 mg twice daily to 400 mg three times a day
kuljum sa 400 mg tlitt darbiet kuljum
7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
għal aktar minn 21 ġurnata f’ xi ċirkostanzi speċifiċi (bħal axxessi) 2 sa 4 ġimgħat (akuta)
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment Drug administration should begin as soon
b’ newtropenija severa Ciprofloxacin għandu jingħata flimkien ma ’ sustanza( i) antibatterika xierqa.
400
213
mg twice daily
Doża ta ’ kuljum f’ mg
Indications as possible after suspected or confirmed exposure.
antraċe meħud man- nifs għall- persuni li jinħtieġu kura parenterali.
Daily dose in mg
kuljum
Total duration of treatment (including switch to oral therapy as soon as possible)
esponiment għal Bacillus anthracis
Total duration of
Tul totali tal- kura (inkluż bidla għal terapija orali malajr kemm jista ’ jkun)
treatment (including switch to oral therapy as soon as possible) Cystic fibrosis
Fibrożi ċistika
Creatinine Clearance [mL/min/ 1.73 m²]
Krejatinina fis- Serum
208 In patients with impaired liver function no dose adjustment is required.
F’ pazjenti b’ funzjoni indebolita tal- fwied m’ hemmx bżonn ta ’ aġġustament fid- doża.
Dosing in children with impaired renal and/or hepatic function has not been studied.
Id- dożaġġ fi tfal b’ funzjoni tal- kliewi u/ jew tal- fwied indebolita ma ġiex studjat.
Method of administration
214 Metodu ta ’ l- għoti
209 Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
215 Tfal u adoloxxenti L- użu ta ’ ciprofloxacin fi tfal u adoloxxenti għandu jsegwi l- gwida uffiċjali disponibbli.
210 Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
216 Sistema Nervuż Ċentrali Quinolones huma magħrufa li jikkawżaw aċċessjonijiet jew ibaxxu l- limitu għal aċċessjoni.
211 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.
217 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.
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).
Effects of other medicinal products on Ciprofloxacin:
Effetti ta ’ prodotti mediċinali oħra fuq ciprofloxacin:
Effects of Ciprofloxacin on other medicinal products:
Effetti ta ’ ciprofloxacin fuq prodotti mediċinali oħra:
Tizanidine must not be administered together with Ciprofloxacin (see section 4.3).
Tizanidine m’ għandux jingħata flimkien ma ’ ciprofloxacin (ara sezzjoni 4. 3).
6 to 24-fold) when given concomitantly with Ciprofloxacin.
6 sa 24 darba) meta mogħti flimkien ma ’ ciprofloxacin.
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.
Concurrent administration of Ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration.
L- għoti fl- istess waqt ta ’ ciprofloxacin u theophylline jista ’ jikkawża żjieda mhux mixtieqa fil - konċentrazzjoni ta ’ theophylline fis- serum.
On concurrent administration of Ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Wara għoti fl- istess waqt ta ’ ciprofloxacin u kafeina jew pentoxifylline (oxpentifylline), kienu rrapportati konċentrazzjonijiet fis- serum ta ’ dawn id- derivati ta ’ xanthine miżjuda.
Phenytoin
218 Phenytoin
Simultaneous administration of Ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
L- għoti flimkien ta ’ ciprofloxacin u phenytoin tista ’ twassal għal- livelli fis- serum ta ’ phenytoin miżjuda jew imnaqqsa, għalhekk sorveljanza tal- livelli tal- mediċina hija rrakkomandata.
212 Oral anticoagulants
Sustanzi orali kontra il- koagulazzjoni tad- demm
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
219 analiżi ta ’ frekwenza jieħu f’ kunsiderazzjoni tagħrif minn għoti orali kif ukoll minn għoti fil- vini ta ’ ciprofloxacin..
213 System Organ Class
Klassifika ta ’ l -
Common ≥ 1/100 to < 1/10
Komuni
Uncommon ≥ 1/1 000 to < 1/100
≥ 1/ 10 000 sa < 1/ 1
Rare ≥ 1/10 000 to < 1/1 000
000 sa 000
Very Rare < 1/10 000
< 1/ 100
Frequency not known (cannot be estimated from available data)
(ma tistax tittieħed
Infections and Infestations
stima mid - data disponibbli) Superinfezzj Kolite assoċjata Infezzjonijiet u onijietmill - ma ’ antibijotiċi Infestazzjonijiet
Mycotic superinfection s
moffa
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopen ia Thrombocytaemi a
Tromboċitopenija Tromboċitemija
Haemolytic anaemia Agranulocyt osis Pancytopeni a (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
Xokk anafilattiku (ta ’ periklu għall - ħajja) (ara sezzjoni 4. 4) Reazzjoni bħall - marda tas- serum
Psychomotor hyperactivity / agitation
psikomotorja
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
/ aġitazzjoni ansjetà Ħolm mhux normali Depressjoni Alluċinazzjonijiet Disturbi fis -
Psychotic reactions (see section 4.4)
Uġigħ ta ’ ras Parastesja u
Headache Dizziness Sleep disorders Taste disorders
Sturdament Disestesija
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Disturbi ta ’ Ipoestesija l- irqad Tregħid Disturbi fit - Aċċessjonijiet (ara togħma sezzjoni 4. 4) Vertigo
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
koordinazzjoni sezzjoni 4. 4) Disturb fil- mixja Disturbi fin- nerv tax- xamm Pressjoni intrakranjali għolja
Peripheral neuropathy (see section 4.4)
Rari Ħafna Frekwenza
214 System Organ Class
Klassifika ta ’ l -
Eye Disorders
stima mid - data disponibbli) Disturbi fl - Għajnejn Disturbi fil -
Visual disturbances
Disturbi fil- vista Żanżin fil- widnejn
Ear and Labyrinth Disorders
Widnejn u fis - Sistema Labirintika
Tinnitus Hearing loss / Hearing impaired
Telf ta ’ smigħ / Nuqqas fis- smigħ
Gastrointestin al Disorders
Disturbi Gastro - intestinali
Nausea Diarrhoea
Tqalligħ Dijarea
Vomiting Gastrointestin al and abdominal pains Dyspepsia Flatulence
Rimettar Weġgħat gastro - intestinali u addominali Dispepsja Gass
Hepatobiliary Disorders
Żjieda fit - transaminase s
Hepatic impairment Cholestatic icterus Hepatitis
Nekrożi tal - fwied (rari ħafna tavvanza
Liver necrosis (very rarely progressing to life- threatening hepatic failure) (see section 4.4)
għall - insuffiċjenza tal - fwied ta ’ periklu għall- ħajja) (ara sezzjoni 4. 4)
215 System Organ Class
Klassifika ta ’ l -
Rash Pruritus Urticaria
skeltrali (e. ż.
Photosensitivity reactions (see section 4.4)
Żjieda fit- tensjoni
Musculoskelet al, Connective Tissue and Bone Disorders
Connective
Musculoskelet al pain (e.g. extremity pain, back pain, chest pain) Arthralgia
estremitajiet,
Myalgia Arthritis Increased muscle tone and cramping
uġigħ fid - dahar, uġigħ fis- sider) Artralġja
Muscular weakness Tendinitis Tendon rupture (predominan tly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
tendon) (ara sezzjoni 4. 4) Rkadar tas - sintomi ta ’ myasthenia gravis (ara sezzjoni 4. 4)
Renal and Urinary Disorders
Indeboliment Insuffiċjenza renali Disturbi fil - Kliewi u fis - Sistema Urinarja
Injection and infusion site reactions (only intravenous administration)
fis- sit ta ’ l - injezzjoni u l - infużjoni (għoti fil- vini biss)
Prothrombin level abnormal Increased amylase
prothrombin mhux
* 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 normali
216 The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
fid- demm
Common Uncommon
Żjieda fl- amylase
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
* Dawn l- avvenimenti kienu rrapportati waqt il- perijodu ta ’ wara t- tqegħid fis- suq u kienu osservati l- aktar f’ pazjenti b’ aktar fatturi ta ’ riskju għal titwil tal- QT (ara sezzjoni 4. 4).
The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
222 Pazjenti pedjatriċi L- inċidenza ta ’ artopatija, msemmija fuq, tirreferi għal tagħrif miġbur minn studji bl- adulti.
217 Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance.
Impermeabilità u/ jew mekkaniżmi ta ’ reżistenza tal- pompa ta ’ effluss tas- sustanza attiva jista ’ jkollhom effett varjabbli fuq is- suxxettibilità għal fluoroquinolones, li tiddependi fuq il- karatteristiċi fisjokimiċi ta ’ diversi sustanzi attivi fil- klassi u l- affinità tas- sistemi ta ’ transport għal kull sustanza attiva.
Spectrum of antibacterial activity:
223 Firxa ta ’ l- attività antibatterika:
1 Staphylococcus spp. – breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Staphylococcus spp. – punti kritiċi għal ciprofloxacin huma konnessi ma ’ terapija b’ doża għolja. * Punti kritiċi li mhumiex konnessi ma ’ speċi ġew determinati primarjament fuq il- bażi ta ’ tagħrif PK/ PD u huma indipendenti mid- distribuzzjonijiet ta ’ MIC għall- ispeċi speċifiċi.
218 Yersinia pestis
Yersinia pestis Mikro- organiżmi anaerobiċi Mobiluncus Mikro- organiżmi oħrajn
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.
219 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 ($):
Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones.
S. aureus reżistenti għal methicillin spiss ħafna ġeneralment juru reżistenza għal
The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.
Ir- rata ta ’ reżistenza għal methicillin hija madwar 20 sa 50% fost l - ispeċi ta ’ staphylococci kollha u ġeneralment hija ogħla f’ iżolati minn infezzjonijiet li jittieħdu minn sptar.
Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages,
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.
Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.–
Ciprofloxacin jitneħħa fil- biċċa l- kbira mhux mibdul kemm mill- kliewi kif ukoll, fi kwantità inqas, fl - ippurgar.
Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h.
226 It- tneħħija renali hija bejn 180- 300 mL/ kg/ h u t- tneħħija totali mill- ġisem hija bejn 480- 600 mL/ kg/ h.
221 Articular tolerability:
Tollerabilità artikulari:
6.4 Special precautions for storage
227 6. 4 Prekawzjonijiet speċjali għall- ħażna
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.
Penetration of the outer ring may result in damage to the vial stopper.
Penetrazzjoni taċ- ċirku ta ’ barra jista ’ jwassal għal ħsara lit- tapp tal- kunjett.
222 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari.]
223 1.
228 1.
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).
• Malignant external otitis
229 • Otite esterna malinna
224 • Infections of the bones and joints
• Infezzjonijiet ta ’ l- għadam u tal- ġogi
Infections of the upper respiratory tract
Infezzjonijiet ta ’ l - Irkadar akut ta ’ apparat respiratorju sinusite kronika ta ’ fuq
400 mg three times a day
400 mg TID
Complicated and
230 Indikazzjonijiet
400 mg twice daily to
Doża ta ’ kuljum f’ mg
7 to 21 days, it can be
Tul totali tal- kura (inkluż bidla għal terapija orali malajr kemm jista ’ jkun)
infections
Infezzjonijiet ta ’ l - apparat ta ’ l- awrina
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.
b’ newtropenija severa Ciprofloxacin għandu jingħata flimkien ma ’ sustanza( i) antibatterika xierqa.
Therapy should be continued over the entire period of neutropenia
il- perijodu kollu tan - newtropenija
Children and adolescents
Profilassi wara esponiment u kura li tfejjaq ta ’
400 mg twice daily 226
mg darbtejn
Indication
kuljum
treatment (including switch to oral therapy as soon as possible) Cystic fibrosis
Tul totali tal- kura (inkluż bidla għal
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 to 21 days
10sa 21 ġurnata
Inhalation anthrax
Kura li tfejjaq ta ’
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
60
60 ġurnata mill -
post-exposure curative treatment for persons requiring parenteral treatment Drug administration should begin as soon as possible after suspected or confirmed exposure.
L- għoti tal - mediċina għandu jinbeda mill- aktar fis possibli wara suspett jew konferma ta ’ esponiment.
weight twice daily with a maximum of 400 mg per dose.
tal- ġisem darbtejn kuljum b’ massimu ta ’ 400 mg kull doża.
confirmation of Bacillus anthracis exposure
konferma ta ’ esponiment għal Bacillus anthracis
Creatinine Clearance [mL/min/1.73 m²]
Krejatinina fis -
Dosing in children with impaired renal and/or hepatic function has not been studied.
232 Id- dożaġġ fi tfal b’ funzjoni tal- kliewi u/ jew tal- fwied indebolita ma ġiex studjat.
Ciprofloxacin Bayer should be checked visually prior to use.
Ciprofloxacin Bayer għandu jiġi ċċekkjat viżwalment qabel l- użu.
227 Ciprofloxacin should be administered by intravenous infusion.
Ciprofloxacin għandu jingħata permezz ta ’ infużjoni fil- vini.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
233 Tfal u adoloxxenti L- użu ta ’ ciprofloxacin fi tfal u adoloxxenti għandu jsegwi l- gwida uffiċjali disponibbli.
228 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%.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited.
L- użu ta ’ ciprofloxacin għall- infezzjonijiet severi speċifiċi minbarra dawk imsemmijin fuqma ġiex ivvalutat fi provi kliniċi u l- esperjenza klinika hija limitata.
Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
234 Sistema Nervuż Ċentrali Quinolones huma magħrufa li jikkawżaw aċċessjonijiet jew ibaxxu l- limitu għal aċċessjoni.
Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including
Kienu rrapportati każijiet ta ’ polinewropatija (bbażat fuq sintomi newroloġiċi bħal uġigħ, ħruq, disturbi tas- sensi jew debbulizza fil- muskoli, waħedhom jew flimkien ma ’ oħrajn) f’ pazjenti li kienu qed jirċievu ciprofloxacin.