qanastek/EMEA-V3 huggingface dataset:
Posology in the treatment of upper respiratory tract infections The CHMP asked the applicant/ MAH to further substantiate the efficacy/ risk of the lower dosage proposed (500 mg BID) in the treatment of upper respiratory tract infection, especially with regard to malignant external otitis.
Pożoloġija fit- trattament ta ’ infezzjonijiet fil- parti ta ’ fuq tal- passaġġi respiratorji Is- CHMP staqsa lill- applikant/ MAH biex jissostanzja l- effikaċja/ riskju tad- dożaġġ l- iktar baxx propost (500 mg BID) fit- trattament ta ’ infezzjonijiet fil- parti ta ’ fuq tal- passaġġi respiratorji, speċjalment fir - rigward ta ’ otite esterna malinna.
From the data submitted the CHMP considered that 500 mg bid could be used in the oral treatment of upper respiratory tract infections such as acute exacerbations of chronic sinusitis and chronic suppurative otitis media.
Mid- dejta sottomessa, is- CHMP ikkunsidra li 500 mg bid jista ’ jintuża f’ trattament orali ta ’ infezzjonijiet fil- parti ta ’ fuq tal- passaġġi respiratorji bħalma huma taħrixiet akuti ta ’ sinożite kronika u otite tan- nofs kronika ta ’ appoġġ.
The recommended dosage can be higher (750 mg bid) depending on the severity and the microorganism.
Id- dożaġġ irrakkomandat jista ’ jkun ogħla (750 mg bid) li jiddependi fuq is- severità u l- mikroorganiżmu.
However, 500 mg bid PO was considered inadequate for the treatment of malignant external otitis, and a dose of 750 mg bid PO was recommended for oral administration.
Madankollu, 500 mg bid PO kienu ikkunsidrati mhux adegwati għat- trattament ta ’ otite esterna malinna, u doża ta ’ 750 mg bid PO kienet irrakkomandata għal għoti orali.
Long-term safety profile of ciprofloxacin to treat upper-respiratory tract infections The CHMP requested that applicant/ MAH provide the rationale for a 3-month treatment duration of upper respiratory tract infections and substantiate the long-term safety of the drug in such a prolonged use.
Profil ta ’ sigurtà fuq tul ta ’ żmien ta ’ ciprofloxacin għat- trattament ta ’ infezzjonijiet fil- parti ta ’ fuq tal- passaġġi respiratorji Is- CHMP talab lill- applikant/ MAH jagħti r- raġuni fondamentali għall- infezzjonijiet fil- parti ta ’ fuq tal - passaġġi respiratorji fuq perjodu ta ’ trattament ta ’ 3 xhur u biex jissostanzja s- sigurtà fuq tul ta ’ żmien tal- mediċina f’ użu fit- tul bħal dan.
In general, treatment of upper respiratory tract infections requires short courses of antibiotic therapy.
Trattament ta ’ infezzjonijiet fil- parti ta ’ fuq tal- passaġġi respiratorji teħtieġ korsijiet qosra ta ’ terapija antibijotika, b’ mod ġenerali.
In studies supporting the use of oral ciprofloxacin in acute exacerbation of chronic sinusitis and exacerbation of chronic otitis media, the treatment duration was 10 days and efficacy results have shown that this duration was sufficient.
Fi studji li jappoġġjaw l- użu orali ta ’ ciprofloxacin f’ taħrixa akuta ta ’ sinożite kronika u f’ taħrixa ta ’ otite kronika medja, it- tul ta ’ żmien tat - trattament kien ta ’ 10 ijiem u r- riżultati tal- effikaċja wrew li dan it- tul ta ’ żmien kien biżżejjed.
However, for infections such as malignant external otitis (MEO), the scenario is different.
17 Madankollu, għall- infezzjonijiet bħal otite esterna malinna (MEO), ix- xenarju huwa wieħed differenti.
It is an often intractable bacterial infection of the ear, mastoid and skull base caused by Pseudomonas aeruginosa.
Hija infezzjoni batterika ta ’ spiss intrattabbli tal- widna, mastojde u bbażata fil- kranju kkaġunata minn Pseudomonas aeruginosa.
The infection typically occurs in elderly diabetic patient and is thought to arise at the osseous-cartilaginous junction.
L- infezzjoni tipikament isseħħ f’ pazjent dijabetiku anzjan u hija maħsuba li tfeġġ fit- twaħħila tal- għadma mal- qarquċa.
Typically, the infection spreads to the basis of the skull and mastoid, resulting in cranial neuropathies, and rarely, brain abscess, sphenoidal sinusitis.
Tipikament, l- infezzjoni tinfirex għall- bażijiet tal- kranju u l- mastojde, li tirriżulta f’ newropatiji kraniċi u rarament, f’ axxessi tal- moħħ, sinożite sfenojdali.
Additional studies
It- tul ta ’ żmien medju tat- trattament b’ ciprofloxacin għall- MEO kif irrappurtata fil- meta- analiżi ta ’ 13- il pubblikazzjoni, ippubblikati minn Gehanno (1993) kien ta ’ 3 xhur (6 xhur fi 3 studji, xahrejn fi studju wieħed).
16 submitted also considered that the optimal duration of antibiotic administration may be as long as 8 to 12 weeks in view of the recalcitrant nature of the infection.
Studji addizzjonali sottomessi ikkunsidraw ukoll li t- tul ta ’ żmien ottimu għall- għoti ta ’ antibijotiċi jista ’ jkun twil mill- inqas bejn 8 u 12- il ġimgħa minħabba n- natura mhux konformi tal - infezzjoni.
Therefore, the CHMP and the Applicant/ MAH were in agreement that a duration up to 3 months with ciprofloxacin was justified for the treatment of malignant external otitis.
Għaldaqstant, is- CHMP u l- Applikant/ MAH kienu fi qbil li tul ta ’ żmien b’ ciprofloxacin sa 3 xhur kien iġġustifkat għat- trattament ta ’ otite esterna malinna.
The CHMP also considers that the safety data do not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
Is- CHMP ikkunsidra wkoll li d- dejta ta ’ sigurtà ma wriet l- ebda evidenza li l- profil ta ’ sigurtà ta ’ ciprofloxacin huwa affettwat minn tul ta ’ żmien itwil minn 3 xhur.
Posology for the treatment of infections due to Vibrio cholerae The CHMP asked the Applicant/ MAH to justify the suggested dosage regimen for the treatment of infections caused by Vibrio cholerae (oral and iv formulations).
Pożoloġija għat- trattament ta ’ infezzjonijet dovuti għal Vibrio cholerae Is- CHMP talab lill- Applikant/ MAH biex jiġġustifika r- reġimen tad- dożaġġ issuġġerit għal trattament ta ’ infezzjonijiet ikkaġunati minn Vibrio cholerae (formulazzjonijiet orali u iv).
In its original document the applicant/ MAH proposed an oral posology of 500 mg QD and an IV posology of 200 mgx2.
Fid- dokument oriġinali tiegħu l- applikant/ MAH ippropona pożoloġija orali ta ’ 500 mg QD u pożoloġija IV ta ’ 200 mgx2.
However, these proposals were not in line with the bioequivalence data.
Madankollu, dawn il- proposti ma kinux konformi mad- dejta ta ’ bijoekwivalenza.
The Applicant/ MAH subsequently proposed to follow the same proposal for other diarrhoea indications, taking into account data supporting oral 500 mg bid daily dose and considering bioavailability purposes, the corresponding IV dosage should be 400 mg bid.
L - Applikant/ MAH sussegwentement ippropona li jsegwi l- istess proposta għall- kundizzjonijiet ta ’ dijarrea oħrajn, filwaqt li qies dejta li tappoġġja doża orali ta ’ 500 mg bid kuljum u kkunsidra skopijiet ta ’ bijodisponibbilità, id- dożaġġ IV li jikkorrispondi għandu jkun 400 mg bid.
The CHMP agreed with this last Applicant/ MAH proposal which is in line with the bioequivalence data.
Is- CHMP qabel ma ’ din l- aħħar proposta tal- Applikant/ MAH li hija konformi mad- dejta ta ’ bijoekwivalenza.
Posology for the treatment of uncomplicated cystitis The CHMP asked the applicant/ MAH to provide reassurance that a 100 mg BID dose for 3 days (currently validated in some EU countries) is adequate for treating uncomplicated cystitis in young women with regards to the epidemiological figure pertaining to the bacteria potentially involved and with regards to the treatment response as compared to the proposed higher dose of 250 mg- 500 mg BID.
Pożoloġija għat- trattament ta ’ ċistite mhux ikkumplikata Is- CHMP talab lill- applikant/ MAH biex jagħti serħan il- moħħ li doża ta ’ 100 mg BID għal 3 ijiem (ivvalidata bħalissa f’ xi pajjiżi tal- UE) hija adegwata biex tittratta ċistite mhux ikkumplikata f’ nisa li għadhom żgħar fir- rigward tal- figura epidemjoloġika li tappartjeni għall- batterji potenzjalment involuti u fir- rigward tar- reazzjoni tat- trattament meta mqabbla ma ’ doża ogħla proposta ta ’ 250 mg - 500 mg BID.
After careful evaluation, the CHMP agreed with the Applicant/ MAH to delete the dose regimen “ 100 mg bid for 3 days” allocated to the treatment of uncomplicated cystitis.
Wara evalwazzjoni bir- reqqa, is- CHMP qabel mal- Applikant/ MAH biex jitħassar ir- reġimen ta ’ doża “ 100 mg bid għal 3 ijem ” allokat għat- trattament ta ’ ċistite mhux ikkumplikata.
Considering risk of failures and taking into account epidemiological concerns due to this sub-optimal schedule, this posology could not be recommended
Meta jiġi kkunsidrat i r- riskju ta ’ fallimenti u jiġi kkunsidrat it- tħassib epidemjoloġiku minħabba din l- iskeda sotto- ottima, din il- pożoloġija ma tistax tkun irrakkomandata.
Dose adjustments for patients with impaired renal function The CHMP reviewed the Applicant/ MAH’ s initial proposal for dose adjustment in case of renal impairment and considered it incomplete and poorly substantiated.
Aġġustamenti ta ’ doża għal pazjenti b’ funzjoni renali indebolita Is- CHMP irreveda l- proposta inizjali tal- Applikant/ MAH għal aġġustament fid- doża f’ każ ta ’ indeboliment renali u kkunsidraha bħala waħda mhux kompluta u ssostanzjata b’ mod debboli.
Therefore, the CHMP requested a revised proposal with specific documentation in support.
Għaldaqstant, is- CHMP talab għall- proposta irreveduta b’ dokumentazzjoni speċifika bħala appoġġ.
Subsequently, the CHMP reached an agreement with the Applicant/ MAH concerning the new proposals for dose adjustments in case of renal impairment.
Sussegwentement, is- CHMP laħaq qbil mal- Applikant/ MAH dwar il- proposti l- ġodda għall - aġġustamenti fid- doża f’ każ ta ’ indeboliment renali.
Other Sections of the SPC The following sections of the SPC were also subject to extensive harmonisation during this referral procedure, namely sections 4.4 Special warnings and precautions, 4.5 Interactions, 4.6 Pregnancy and lactation, 4.8 Undesirable effects, 4.9 Overdose, 5.1 Pharmacodynamic properties, and 5.2 Pharmacokinetic properties.
Sezzjonijet oħrajn tal- SPC Is- sezzjonijiet li ġejjin tal- SPC kienu wkoll soġġetti għall- armonizzazzjoni estensiva matul din il - proċedura ta ’ referenza, b’ mod partikolari s- sezzjonijiet 4. 4 Twissijiet speċjali u prekawzjonijiet għall - użu, 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l - effett farmaċewtiku tal- prodott, 4. 6 Tqala u Treddigħ, 4. 8 Effetti mhux mixtieqa, 4. 9 Doża eċċessiva, 5. 1 Tagħrif farmakodinamiku, u 5. 2 Tagħrif farmakokinetiku.
Package Leaflet and Labelling The changes to the SPC have been taken into account in the amendments to the Package Leaflet and Labelling.
Fuljett ta ’ Tagħrif u Tikketta Il- bidliet fl- SPC ġew ikkunsidrati fl- emendi tal- Fuljett ta ’ Tagħrif u Tikketta.
Modified Release Tablets Formulation Regarding the modified release tablet SPC, no proposal for a harmonised SPC was provided.
18 Formulazzjoni ta ’ Pilloli Ta ’ Rilaxx Immodifikat Rigward l- SPC tal- pillola ta ’ rilaxx immodifikat, ma ngħatat l- ebda proposta għal SPC armonizzat.
The Applicant/ MAH proposed to take the Ciprofloxacin Modified Release Tablets out of this Referral procedure to significantly simplify the exercise of harmonisation.
L - Applikant/ MAH ippropona li jneħħi l- Pilloli Ciprofloxacin Ta ’ Rilaxx Immodifikat minn din il - proċedura ta ’ Referenza biex jissimplifika l- eżerċizzju ta ’ armonizzazzjoni b’ mod sinjifikanti.
Given the fact that several EU member states have rejected the MR tablet Marketing Authorisations due to a negative benefit/ risk, and taking into consideration that only 5 countries approved this pharmaceutical formulation, no consensual recommendation on the SPC wording could be provided at a European level on the basis of this present Article 30 Referral procedure.
Minħabba l- fatt li diversi Stati Membri tal- UE warrbu l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għall- pillola MR minħabba benefiċċju/ riskju negattiv, u meta jiġi kkunsidrat li 5 pajjiżi biss approvaw din il- formolazzjoni farmaċewtika, l- ebda rakkomandazzjoni ta ’ kunsens dwar il- kitba tal- SPC ma setgħet tingħata f’ livell Ewropew abbażi ta ’ din il- proċedura ta ’ Referenza tal- Artikolu 30.
17 Therefore, the CHMP and the Applicant/ MAH were in agreement with the proposal to adapt the national SPCs of Ciprofloxacin MR tablets in those European Member States where the product is approved, to the outcome of the referral procedure for the other Ciprofloxacin Bayer formulations by submitting adequate national variations.
Għaldaqstant, is- CHMP u l- Applikant/ MAH qablu dwar il- proposta biex jaddattaw l- SPCs nazzjonali ta ’ pilloli Ciprofloxacin MR f’ dawk l- Istati Membri Ewropej fejn il- prodott huwa approvat, skont il - proċedura ta ’ referenza għall- formulazzjonijet l- oħrajn ta ’ Ciprofloxacin Bayer billi ssottomettew varjazzjonijiet adegwati nazzjonali.
Importantly, the MR tablet formulation would not gain any new indications.
Huwa importanti l- fatt li, il- formulazzjoni tal- pillola MR mhux sejra tigwadanja xi indikazzjonijiet ġodda.
Only those indications already present in the current MR tablets SPC would be subsequently harmonised to the individually agreed wording of each corresponding indication as per the outcome of the Article 30 Referral.
Dawk l- indikazzjonijiet diġà preżenti biss fl- SPC attwali tal- pilloli MR sejrin ikunu armonizzati skont il- kitba li sar qbil fuqha individwalment ta ’ kull indikazzjoni korrespondenti bħal fir- riżultat tal- Artikolu 30 tar- Referenza.
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJU( I) TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTTA U FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- referenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, tikketta u
labelling and package leaflet.
fuljett ta ’ tagħrif.
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif proposti mid- Detenturi tal -
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Awtorizzazzjoni għat- Tqegħid fis- Suq ġew ivvalutati abbażi tad- dokumentazzjoni sottomessa u d - diskussjoni xjentifika fi ħdan il- Kumitat,
- the CHMP concluded that the Marketing Authorisation could be harmonised on the following
- is- CHMP ikkonkluda li l- Awtorizzazzjoni għat- Tqegħid fis- Suq tista ’ tkun armonizzata fuq l -
indications for oral and intravenous formulations in adults: • Lower respiratory tract infections due to Gram-negative bacteria: o Exacerbations of chronic obstructive pulmonary disease o Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis o Pneumonia • Chronic suppurative otitis media • Acute exacerbations of chronic sinusitis, especially if these are caused by Gram-negative bacteria • Urinary tract infections • Gonococcal urethritis and cervicitis (only for oral formulations) • Epididymo-orchitis, including cases due to Neisseria gonorrhoeae • Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae • Infections of the gastro-intestinal tract (e. g. travellers’ diarrhoea) • Intra-abdominal infections • Infections of the skin and soft tissue caused by Gram-negative bacteria • Malignant external otitis • Infections of the bone and joints • Treatment of infections in neutropenic patients • Prophylaxis of infections in neutropenic patients • Prophylaxis of invasive infections due to Neisseria meningitides (only for oral formulations) • Inhalation anthrax (post-exposure prophylaxis and curative intent)
indikazzjonijiet li ġejjin għall- formulazzjonijiet orali u intravenużi fl- adulti: • Infezzjonijiet fil- parti t’ isfel tal- passaġġi respiratorji minħabba batterji Gram negattivi: o Taħrixiet ta ’ mard kroniku pulmonari okklussiv o Infezzjonijiet bronko- pulmonari f’ fibrożi ċistika jew fi bronkjektażi o Pulmonite • Otite medja kronika ta ’ appoġġ • Taħrixiet akuti ta ’ sinożite kronika, speċjalment dawk ikkaġunati minn batterji Gram- negattivi • Infezzjonijiet tal- passaġġi awrinarji • Uretrite u ċerviċite gonokokkali (għall- formulazzjonijiet orali biss) • Epididimo- orkite, inklużi każijiet minn Neisseria gonorrhoeae • Mard pelviku infjammatorju inklużi każijiet ikkaġunati minn Neisseria gonorrhoeae • Infezzjonijiet tal- passaġġ gastro- intestinali (eż., dijarrea tal- vjaġġaturi) • Infezzjonijiet intra- addominali • Infezzjonijiet tal- ġilda u tat- tessut morbidu kkaġunati minn batterji Gram- negattivi • Otite esterna malinna • Infezzjonijiet tal- għadam u tal- ġogi • Trattament ta ’ infezzjonijiet f’ pazjenti newtropeniċi • Profilassi ta ’ infezzjonijiet f’ pazjenti newtropeniċi • Profilassi ta ’ infezzjonijiet invażivi minħabba Neisseria meningitides (għall- formulazzjonijiet orali biss) • Anthrax li jittieħed man- nifs (profilassi wara l- esponiment u intenzjoni kurattiva)
indications for oral and intravenous formulations in children and adolescents: • Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa. • Complicated urinary tract infections and pyelonephritis • Inhalation anthrax (post-exposure prophylaxis and curative intent)
19 • Infezzjonijiet bronko- pulmonari f’ fibrożi ċistika ikkaġunata minn Pseudomonas aeruginosa. • Infezzjonijiet tal- passaġġi awrinarji ikkumplikati u pjelonefrite • Anthrax li jittieħed man- nifs (profilassi wara l- esponiment u intenzjoni kurattiva)
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Ciprofloxacin Bayer and associated names (see Annex I).
is- CHMP irrakkomanda l- emenda tal- Awtorizzazzjoni għat- Tqegħid fis- Suq għal liema s- Sommarju tal- Karatteristiċi tal- Prodott, Tikketta u Fuljett ta ’ Tagħrif huma stabbiliti fl- Anness III għal Ciprofloxacin Bayer u ismijiet assoċjati (ara l- Anness I).
19 SUMMARY OF PRODUCT CHARACTERISTICS
21 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg pilloli miksija b’ rita [Ara Anness I – Biex timtela mill- pajjiż partikolari]
[To be completed nationally] For a full list of excipients, see section 6.1.
[Biex timtela mill- pajjiż partikolari] Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Film-coated tablet [To be completed nationally]
Pillola miksija b’ rita [Biex timtela mill- pajjiż partikolari]
Ciprofloxacin Bayer 100 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Ciprofloxacin Bayer 100 mg pilloli miksija b’ rita huma ndikati għall- kura ta ’ l- infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1).
Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Għandha tingħata attenzjoni speċjali lil tagħrif disponibbli dwar ir - reżistenza għal ciprofloxacin qabel tinbeda t- terapija.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata konsiderazzjoni lill- gwida uffiċjali dwar l- użu xieraq ta ’ sustanzi kontra l- batterja.
• Lower respiratory tract infections due to Gram-negative bacteria
• Infezzjonijiet ta ’ l- apparat respiratorju ta ’ isfel ikkawżati minn batterja Gram- negative
- - -
- irkadar tal- marda pulmonari ostruttiva kronika
exacerbations of chronic obstructive pulmonary disease broncho-pulmonary infections in cystic fibrosis or in bronchiectasis pneumonia
- infezzjonijiet bronko- pulmonari f’ fibrożi ċistika
• Chronic suppurative otitis media
• Otite medja kronika b’ suppurazzjoni
• Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
• Rkadar akut ta ’ sinusite kronika, speċjalment jekk dawn huma kkawżati minn batterja Gram - negative
• Urinary tract infections
• Infezzjonijiet fl- apparat ta ’ l- awrina
• Gonococcal uretritis and cervicitis
• Uretrite u ċerviċite kkawżati minn gonococci
• Epididymo-orchitis including cases due to Neisseria gonorrhoeae
• Epididimo- orkite inkluż każijiet ikkawżati minn Neisseria gonorrhoeae
• Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae In the above genital tract infections when thought or known to be due to Neisseria gonorrhoeae it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.
Fl- infezzjonijiet ta ’ l- apparat ġenitali msemmija fuq meta jkun maħsub jew magħruf li huma kkawżati minn Neisseria gonorrhoeae huwa importanti ħafna li jinkiseb tagħrif lokali dwar il- prevalenza ta ’ reżistenza għal ciprofloxacin u li tiġi kkonfermata suxxettibilità bbażata fuq analiżi ta ’ laboratorju.
• Infections of the gastro-intestinal tract (e. g. travellers’ diarrhoea)
• Infezzjonijiet ta ’ l- apparat gastro- intestinali (e. ż. dijarea tal- vjaġġaturi)
• Intra-abdominal infections
• Infezzjonijet intra- addominali
• Infections of the skin and soft tissue caused by Gram-negative bacteria
23 • Infezzjonijiet tal- ġilda u tat- tessut artab ikkawżati minn batterja Gram- negative
21 • Malignant external otitis
• Otite esterna malinna
• Infections of the bones and joints
• Infezzjonijiet ta ’ l- għadam u tal- ġogi
• Treatment of infections in neutropenic patients
• Kura ta ’ infezzjonijiet f’ pazjenti b’ newtopenija
• Prophylaxis of infections in neutropenic patients
• Profilassi ta ’ infezzjonijiet f’ pazjenti b’ newtopenija
• Prophylaxis of invasive infections due to Neisseria meningitidis
• Profilassi ta ’ infezzjonijiet invażivi kkawżati minn Neisseria meningitidis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
• Antraċe meħud man- nifs (profilassi wara esponiment u kura ta ’ fejqan)
• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa • Complicated urinary tract infections and pyelonephritis • Inhalation anthrax (post-exposure prophylaxis and curative treatment)
• Infezzjonijiet bronko- pulmonari f’ fibrożi ċistika kkawżata minn Pseudomonas aeruginosa • Infezzjonijiet ikkumplikati fl- apparat ta ’ l- awrina u pijelonefrite • Antraċe meħud man- nifs (profilassi wara esponiment u kura ta ’ fejqan)
Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Ciprofloxacin jista ’ jintuża wkoll biex jikkura infezzjonijiet severi fit- tfal u adoloxxenti fejn dan huwa kkunsidrat li huwa neċessarju.
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).
The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
Id- dożaġġ huwa determinat mill- indikazzjoni, is- severità u s- sit ta ’ l- infezzjoni, s- suxxettibilità ta ’ l - organiżmu( i) li qed jikkawża/ jikkawżaw l- infezzjoni għal ciprofloxacin, il- funzjoni renali tal- pazjent u, fit- tfal u l- adoloxxenti l- piż tal- ġisem.
The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.
It- tul tal- kura jiddependi mis- severità tal- marda u l- progress kliniku u batterjoloġiku.
Treatment of infections due to certain bacteria (e. g.
Il- kura ta ’ infezzjonijiet ikkawżati minn ċertu batterja (e. ż.
Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Pseudomonas aeruginosa, Acinetobacter jew Staphylococci) għandu mnejn tkun tinħtieġ dożi ogħla ta ’ ciprofloxacin u għoti flimkien ma 'sustanzi kontra l- batterja xierqa oħra.
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.
Indications
Indikazzjonijiet
Daily dose in mg
Doża ta ’ kuljum f’ mg
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
(potenzjalment inkluż bidu ta ’ kura parenterali b ’ ciprofloxacin)
Infections of the lower
Infezzjonijiet ta ’ l- apparat respiratorju t’ isfel
500 mg twice daily to 750 mg twice daily
500 mg darbtejn kuljum sa 750 mg darbtejn kuljum
to 14 days
sa 14- il ġurnata
Infections of the upper respiratory
Infezzjonijiet ta ’ l - Irkadar akut ta ’ sinusite apparat respiratorju kronika ta ’ fuq
7 to 14 days
7 sa 14- il ġurnata
tract
Tul totali tal- kura
Chronic suppurative otitis media
Otite medja kronika b’ suppurazzjoni
Malignant external otitis
Otite esterna malinna
750 mg twice daily
750 mg darbtejn kuljum
28 days up to 3 months
28 ġurnata sa 3 xhur
Urinary tract infections
Infezzjonijiet ta ’ l - apparat ta ’ l- awrina
Uncomplicated cystitis
Ċistite mhux komplikata
250 mg twice daily to 500 mg twice daily
250 mg darbtejn kuljum sa 500 mg darbtejn kuljum
3 days
3 ġranet
In pre-menopausal women, 500 mg single dose may be used
F’ nisa qabel il- menopawża, tista ’ tiġi wżata doża waħda ta ’ 500 mg
Complicated cystitis, Uncomplicated pyelonephritis
Ċistite komplikata, Pijelonefrite mhux komplikata
7 days
7 ġranet
at least 10 days, it can be
Pijelonefrite komplikata
750 mg twice daily
500 mg darbtejn kuljum sa 750 mg darbtejn kuljum
continued for longer than 21 days in some specific circumstances (such as abscesses)
ta ’ l- inqas 10 ġranet, jista ’ jitkompla għal aktar minn 21 ġurnata f’ xi ċirkostanzi speċifiċi (bħal axxessi)
2 to 4 weeks (acute) to 4 to 6 weeks (chronic)
2 sa 4 ġimgħat (akuta) sa 4 sa 6 ġimgħat (kronika)
Genital tract infections
Infezzjonijiet ta ’ l - apparat ġenitali
Gonococcal uretritis and cervicitis
Uretrite u ċerviċite kkawżata minn gonococci
500 mg as a single dose
500 mg bħala doża waħda
1 day (single dose)
ġurnata (doża waħda)
Epididymo-orchitis and pelvic inflammatory diseases
Epididimo- orkite u mard infjammatorju tal- pelvi
at least 14 days
ta ’ l- inqas 14- il ġurnata
Infections of the gastro-intestinal tract and intra- abdominal infections
Infezzjonijiet ta ’ l - apparat gastro - intestinali u infezzjonijiet intra - addominali
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea
Dijarea kkawżata minn patoġeni batteriċi inkluż Shigella spp. minbarra Shigella dysenteriae tip 1 u kura emperika ta ’ dijarea severa tal- vjaġġaturi
1 day
ġurnata
Diarrhoea caused by Shigella dysenteriae type 1
Dijarea kkawżata minn Shigella dysenteriae tip 1
5 days
5 ġranet
Diarrhoea caused by Vibrio cholerae
Dijarea kkawżata minn Vibrio cholerae
Typhoid fever Intra-abdominal infections due to Gram-negative bacteria
Typhoid fever Infezzjonijiet intra - addominali kkawżati minn batterja Gram - negative
500 mg twice daily 500 mg twice daily to 750 mg twice daily
500 mg darbtejn kuljum 500 mg darbtejn kuljum sa 750 mg darbtejn kuljum
7 days 5 to 14 days
7 ġranet 5 sa 14- il ġurnata
Infections of the skin
Infezzjonijiet tal- ġilda u tat- tessut artab
Bone and joint infections
Doża ta ’ kuljum f’ mg
500 mg twice daily to 750 mg twice daily
sa 750 mg darbtejn kuljum
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.
500 mg darbtejn kuljum Kura ta ’ infezzjonijiet jew profilassi ta ’
500 mg twice daily to 750 mg twice daily
kuljum
Therapy should be continued over the entire period of neutropenia
titkompla tul il- perijodu
Prophylaxis of invasive infections due to Neisseria meningitidis
Profilassi ta ’ l- infezzjonijiet invażivi kkawżati minn Neisseria meningitides
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Profilassi wara esponiment u kura li tfejjaq ta ’ antraċe meħud man- nifs għall- persuni li jistgħu jirċievu kura mill- ħalq meta xieraq klinikament.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
L- għoti tal- mediċina għandha tinbeda malajr kemm jista ’ jkun wara esponiment suspettat jew ikkonfermat
Total duration of
Tul totali tal- kura
treatment (potentially including initial parenteral treatment with ciprofloxacin) Cystic fibrosis
(potenzjalment inkluż bidu ta ’ kura parenterali b’ ciprofloxacin) Fibrożi ċistika
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża.
10 to 14 days
10 sa 14- il ġurnata
Complicated urinary tract infections and pyelonephritis
Infezzjonijiet komplikati ta ’ l- apparat ta ’ l- awrina u pijelonefrite
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa 20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża.
10 to 21 days
10 sa 21 ġurnata
Inhalation anthrax
L- għoti tal- mediċina għandu jinbeda mill- aktar fis possibli wara suspett jew konferma ta ’ esponiment.
10 mg/ kg body weight twice daily to 15 mg/ kg body
10 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum sa 15 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 500 mg kull doża.
confirmation of Bacillus anthracis exposure
ġurnata mill- konferma ta ’ esponiment għal Bacillus anthracis
Other severe infections
Infezzjonijiet severi oħra
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose.
20 mg/ kg ta ’ piż tal- ġisem darbtejn kuljum b’ massimu ta ’ 750 mg kull doża
According to the type of infections
Skond it- tip ta ’ infezzjoni
Geriatric patients
Pazjenti anzjani
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.
Renal and hepatic impairment
26 Indeboliment tal- kliewi u tal- fwied
Recommended starting and maintenance doses for patients with impaired renal function:
Dożi rrakkomandati tal- bidu u ta ’ manteniment għall- pazjenti b’ funzjoni tal- kliewi indebolita:
24
Dosa Orali
Creatinine Clearance [mL/ min/ 1.73 m²]
[mL/ min / 1. 73 m²]
Serum Creatinine [µmol/ L]
[µmol/ L]
See Usual Dosage.
Ara Doża tas- Soltu.
30-60 < 30 Patients on haemodialysis
30- 60 < 30 Pazjenti fuq emodijalisi
124 to 168 > 169 > 169
124 to 168 > 169 > 169
250-500 mg every 12 h 250-500 mg every 24 h 250-500 mg every 24 h (after dialysis)
250- 500 mg kull 12 h 250- 500 mg kull 24 h 250- 500 mg kull 24 h (wara dijalisi)
Patients on peritoneal dialysis
Pazjenti fuq dijalisi tal- peritonew
250-500 mg every 24 h
250- 500 mg kull 24 h
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.
Tablets are to be swallowed unchewed with fluid.
Il- pilloli għandhom jinbelgħu sħaħ ma ’ fluwidu.
They can be taken independent of mealtimes.
Jistgħu jittieħdu b’ mod indipendenti mill- ħinijiet ta ’ l- ikel.
If taken on an empty stomach, the active substance is absorbed more rapidly.
Jekk jittieħdu fuq stonku vojt, is- sustanz attiva hija assorbita aktar malajr.
Ciprofloxacin tablets should not be taken with dairy products (e. g. milk, yoghurt) or mineral-fortified fruit-juice (e. g. calcium-fortified orange juice) (see section 4.5).
Pilloli ciprofloxacin m’ għandhomx jittieħdu ma ’ prodotti mill- ħalib (e. ż. ħalib, jogurt) jew meraq tal- frott imsaħħaħ bil - minerali (e. ż. meraq tal- larinġ imsaħħaħ bil- kalċju) (ara sezzjoni 4. 5).
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.
• 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).
Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
Infezzjonijiet severi u infezzjonijiet imħalta b’ patoġeni Gram- positive u anaerobiċi Ciprofloxacin bħala monoterapija mhux adattat għall- kura ta ’ infezzjonijiet severi u ta ’ infezzjonijiet imħalta li jistgħu jkunu kkawżati minn patoġeni Gram- positive jew anaerobiċi.
In such infections ciprofloxacin must be co- administered with other appropriate antibacterial agents.
F’ infezzjonijiet bħal dawn ciprofloxacin għandu jingħata flimkien ma ’ sustanzi xierqa oħra kontra l- batterja.
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Infezzjonijiet ikkawżati minn Streptococci (inkluż Streptococcus pneumoniae) Ciprofloxacin Bayer mhux irrakkomandat għall- kura ta ’ infezzjonijiet ikkawżati minn streptococci minħabba effikaċja mhux adegwata.
Genital tract infections Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae.
Infezzjonijiet fl- apparat ġenitali Epididimo- orkite u mard infjammatorju tal- pelvi jistgħu jkunu kkawżati minn Neisseria gonorrhoeae reżistenti għal fluoroquinolone.
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.
If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Jekk titjib kliniku ma jintlaħaqx wara 3 ijiem ta ’ kura, it- terapija għandha tkun ikkunsidrata mill- ġdid.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Infezzjonijiet intra- addominali Hemm tagħrif limitat dwar l- effikaċja ta ’ ciprofloxacin fil- kura ta ’ infezzjonijiet intra- addominali ta ’ wara kirurġija.
Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
27 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.
25 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.
Inhalational anthrax Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data.
Antraċe meħud man- nifs L- użu fil- bnedmin huwa bbażat fuq tagħrif dwar is- suxxettibilità in- vitro u fuq tagħrif sperimentali fuq il- bhejjem flimkien ma ’ tagħrif limitat fil- bniedem.
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.
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.
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.
Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: 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%.
Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%.
Rispettivament, l- inċidenza ta ’ artropatija relatata mal- mediċina mal- vista ta ’ wara sena kienet ta ’ 9. 0% u 5. 7%.
The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups.
Iż- żjieda fil- każijiet ta ’ artropatija suspettata relatata mal- mediċina tul iż- żmien ma kienetx statistikament sinifikanti bejn il- gruppi.
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.
Broncho-pulmonary infections in cystic fibrosis Clinical trials have included children and adolescents aged 5-17 years.
Infezzjonijiet bronko- pulmonari f’ fibrożi ċistika Provi kliniċi inkludew tfal u adoloxxenti b’ età ta ’ 5- 17- il sena.
More limited experience is available in treating children between 1 and 5 years of age.
Esperjenza aktar limitata hija disponibbli dwar il- kura ta ’ tfal b’ età bejn sena u 5 snin.
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.
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.
Clinical trials have included children and adolescents aged 1-17 years.
Provi kliniċi inkludew tfal u adoloxxenti b’ età ta ’ 1- 17- il sena.
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.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited.
L- użu ta ’ ciprofloxacin għall- infezzjonijiet severi speċifiċi minbarra dawk imsemmijin fuq ma ġiex ivvalutat fi provi kliniċi u l- esperjenza klinika hija limitata.
Consequently, caution is advised when treating patients with these infections.
Bħala konsegwenza, kawtela hija rrakkomandata meta jiġu kkurati pazjenti b’ dawn l- infezzjonijiet.
Hypersensitivity Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose (see section 4.8) and may be life-threatening.
Sensittività eċċessiva Sensittività eċċessiva u reazzjonijiet allerġiċi, inkluż anafilassi u reazzjonijiet anafilattojdi, jistgħu jseħħu wara doża waħda (ara sezzjoni 4. 8) u jistgħu jkunu ta ’ periklu għall- ħajja.
If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.
Jekk isseħħ reazzjoni bħal din, ciprofloxacin għandu jitwaqqaf u hija meħtieġa kura medika xierqa.
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 ’
26 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.
The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids (see section 4.8).
Ir- riskju ta ’ tendinopatija jista ’ jiżdied f’ pazjenti anzjani jew f’ pazjenti kkurati fl- istess waqt b’ kortikosterojdi (ara sezzjoni 4. 8).
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.
Care should be taken to keep the affected limb at rest.
Wieħed għandu joqgħod attent biex isserraħ id- drigħ jew riġel affettwat.
Ciprofloxacin should be used with caution in patients with myasthenia gravis (see section 4.8).
Ciprofloxacin Bayer għandu jintuża b’ kawtela f’ pazjenti b’ myasthenia gravis (ara sezzjoni 4. 8).
Photosensitivity Ciprofloxacin has been shown to cause photosensitivity reactions.
Fotosensittività Ciprofloxacin intwera li jikkawża reazzjonijiet ta ’ fotosensittività.
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 il- kura (ara sezzjoni 4. 8).
Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
Sistema Nervuż Ċentrali Quinolones huma magħrufa li jikkawżaw aċċessjonijiet jew ibaxxu l- limitu għal aċċessjoni.
Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure.
Ciprofloxacin għandu jintuża b’ kawtela f’ pazjenti b’ disturbi tas- CNS li jista ’ jkollhom predispożizzjoni għal aċċessjonijiet.
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 first administration of ciprofloxacin.
Reazzjonijiet psikjatriċi jistgħu jseħħu anki wara l- ewwel għoti ta ’ ciprofloxacin.
In rare cases, depression or psychosis can progress to self- endangering behaviour.
F’ każijiet rari, depressjoni jew psikosi jistgħu javvanzaw għall- imġieba ta ’ periklu għall- pazjent innifsu.
In these cases, ciprofloxacin should be discontinued.
F’ dawn il- każijiet, ciprofloxacin għandu jitwaqqaf.
Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients receiving ciprofloxacin.
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.
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).
Cardiac disorders Since ciprofloxacin is associated with cases of QT prolongation (see section 4.8), caution should be exercised when treating patients at risk for torsades de pointes arrhythmia.
Disturbi fil- qalb Peress li ciprofloxacin huwa assoċjat ma ’ każijiet ta ’ titwil fil- QT (ara sezzjoni 4. 8), għandu jkun hemm kawtela meta jiġu kkurati pazjenti b’ riskju ta ’ arritmija torsades de pointes.
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 teħtieġ kura immedjata (ara sezzjoni 4. 8).
In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
F’ każijiet bħal dawn, Ciprofloxacin Bayer għandu jitwaqqaf immedjatament, u għandha tinbeda terapija xierqa.
Anti-peristaltic drugs are contraindicated in this situation.
Mediċini kontra l- peristalsi huma kontra- indikati f’ din is- sitwazzjoni.
Renal and urinary system Crystalluria related to the use of ciprofloxacin has been reported (see section 4.8).
Sistema renali u ta ’ l- awrina Kienet irrapportata kristallurja relata ma ’ l- użu ta ’ ciprofloxacin (ara sezzjoni 4. 8).