qanastek/EMEA-V3 huggingface dataset:
film-coated tablets film-coated tablets solution for infusion
pilloli miksija b’ rita pilloli miksija b’ rita soluzzjoni għall- infużjoni
oral use oral use intravenous use
użu orali użu orali użu għal ġol- vini
film-coated tablets film-coated tablets film-coated tablets film-coated tablets
pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita
oral use oral use oral use oral use
użu orali użu orali użu orali użu orali
film-coated tablets solution for infusion solution for infusion oral suspension oral suspension
pilloli miksija b’ rita soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni suspensjoni orali suspensjoni orali
oral use intravenous use intravenous use oral use oral use
użu orali użu għal ġol- vini użu għal ġol- vini użu orali użu orali
film-coated tablets film-coated tablets
pilloli miksija b’ rita pilloli miksija b’ rita
Germany Ciproxin Ciproxin
Il- Ġermanja
solution for infusion solution for infusion
soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
intravenous use intravenous use
użu għal ġol- vini użu għal ġol- vini
Bayer HealthCare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer HealthCare AG 51368 Leverkusen, Il- Ġermanja Bayer Santé
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion
pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
Bayer Santé Ciflox 13, rue Jean Jaurès Ciflox 92807 Puteaux Cedex Uniflox France
13, rue Jean Jaurès 92807 Puteaux Cedex Franza
film-coated tablets film-coated tablets film-coated tablets
pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita
oral use oral use oral use
użu orali użu orali użu orali
film-coated tablets oral suspension oral suspension solution for infusion solution for infusion
pilloli miksija b’ rita suspensjoni orali suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
solution for infusion solution for infusion solution for infusion film-coated tablets film-coated tablets film-coated tablets film-coated tablets oral suspension oral suspension film-coated tablets
soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita suspensjoni orali suspensjoni orali
intravenous use intravenous use intravenous use oral use oral use oral use oral use oral use oral use oral use
użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini użu orali użu orali użu orali użu orali użu orali użu orali
15125 Marousi, Athens, CIPROXIN Greece
15125 Marousi, Athens, Il- Greċja
400 mg/ 200 ml 500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml
400 mg/ 200 ml 500 mg 750 mg 250 mg/ 5 ml 500 mg/ 5 ml
solution for infusion film-coated tablets film-coated tablets oral suspension oral suspension
soluzzjoni għall- infużjoni pilloli miksija b’ rita pilloli miksija b’ rita suspensjoni orali suspensjoni orali
intravenous use oral use oral use oral use oral use
użu għal ġol- vini użu orali użu orali użu orali użu orali
2 mg / ml 500 mg 750 mg 50 mg/ ml 100 mg/ ml
2 mg / ml 500 mg 750 mg 50 mg/ ml 100 mg / ml
Ciprobay Hungary
L- Ungerija
Iceland
L- Islanda
Bayer Healthcare AG Ciproxin 51368 Leverkusen, Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer Healthcare AG 51368 Leverkusen, Il- Ġermanja
oral use use oral use use
użu orali użu orali
Dublin 18, Ireland Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Dublin 18, L- Irlanda
film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
pilloli miksija b’ rita pilloli miksija b’ rita suspensjoni orali suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use use oral use use oral use use oral use use intravenous use intravenous use intravenous use
użu orali użu orali użu orali użu orali użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini
Bayer HealthCare AG CIFLOX D-51368 Leverkusen, CIFLOX Germany
Bayer HealthCare AG D- 51368 Leverkusen, Il - Ġermanja
film-coated tablets
użu orali użu orali użu orali
oral use
250 mg 500 mg 750 mg
250 mg
CIPROXIN
6 Member State
500 mg
Marketing Authorisation Invented name Holder
pilloli li jerħu l- mediċina b' mod modifikat
Strength
użu orali
Pharmaceutical Form
CIPROXIN
Route of administration
pilloli li jerħu l- mediċina b' mod modifikat
Content (concentratio n)
Il- Latvja Il- Litwanja
Latvia Lithuania
Mhux awtorizzat Mhux awtorizzat
film-coated tablets film-coated tablets modified release tablets modified release tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
suspensjoni orali suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use oral use oral use oral use oral use intravenous use intravenous use intravenous use
użu orali użu orali użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini
solution for infusion film-coated tablets film-coated tablets
soluzzjoni għall- infużjoni pilloli miksija b’ rita pilloli miksija b’ rita
intravenous use oral use oral use
użu għal ġol- vini użu orali użu orali
film-coated tablets oral suspension solution for infusion solution for infusion
pilloli miksija b’ rita suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use intravenous use intravenous use
użu orali użu orali użu għal ġol- vini użu għal ġol- vini
Trading as:
7 Stat Membru
Bayer plc, Ciproxin Bayer Schering Pharma
Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
400 mg/ 200 ml
Isem Ivvintat
solution for infusion
Qawwa
intravenous use
Għamla Farmaċewtika
2 mg/ ml
Mnjen jingħata
Netherlands
Kontenut (konċentrazzjoni)
Bayer BV Ciproxin
Bayer plc, Bayer Schering Pharma
100 mg
Ciproxin
film-coated tablets
soluzzjoni għall- infużjoni
oral use
użu għal ġol- vini
100 mg
2 mg/ ml
7 Member State
L- Olanda
Marketing Authorisation Invented name Holder
Bayer BV Energieweg 1 3641 RT Mijdrecht L- Olanda
Pharmaceutical Form
100 mg 250 mg 500 mg
Route of administration
użu orali użu orali użu orali
film-coated tablets film-coated tablets film-coated tablets oral suspension oral suspension solution for infusion solution for infusion solution for infusion
pilloli miksija b’ rita suspensjoni orali suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use oral use oral use oral use intravenous use intravenous use intravenous use
użu orali użu orali użu orali użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini
Bayer HealthCare AG Ciproxin D-513 68 Leverkusen Ciproxin Germany Ciproxin Ciproxin Ciproxin
Bayer HealthCare AG D- 513 68 Leverkusen Il- Ġermanja
Bayer HealthCare AG Ciprobay Uro D-51368 Leverkusen Ciprobay Germany Ciprobay Ciprobay Ciprobay Ciprobay
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
film-coated tablet film-coated tablet film-coated tablet solution for infusion solution for infusion solution for infusion
pillola miksija b’ rita pillola miksija b’ rita pillola miksija b’ rita soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use oral use intravenous use intravenous use intravenous use
użu orali użu orali użu orali użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini
Ciproxina Rua Quinta do Ciproxina Pinheiro 5 Ciproxina 2794-003 Carnaxide
Rua Quinta do Pinheiro 5
film-coated tablets film-coated tablets film-coated tablets
pilloli miksija b’ rita pilloli miksija b’ rita
oral use oral use oral use
użu orali użu orali
modified release tablets oral suspension oral suspension solution for infusion
pilloli li jerħu l- mediċina b' mod modifikat
oral use oral use oral use intravenous use
użu orali
8 Member State
Ciproxina Ciproxina
Strength
10 g/ 100 ml 5 g/ 100 ml
Pharmaceutical Form
suspensjoni orali suspensjoni orali
Route of administration
użu orali użu orali
solution for infusion
soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
intravenous use
użu għal ġol- vini użu għal ġol- vini
Romania
Ir- Rumanija
Bayer HealthCare AG Ciprobay D-51368 Leverkusen Ciprobay Germany Ciprobay Ciprobay XR Ciprobay XR Ciproxin Ciproxin
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
film-coated tablets solution for infusion solution for infusion modified release tablets modified release tablets oral suspension oral suspension
pilloli miksija b’ rita soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni pilloli li jerħu l- mediċina b' mod modifikat
oral use intravenous use intravenous use oral use oral use oral use oral use
użu orali użu għal ġol- vini użu għal ġol- vini użu orali
film-coated tablet
pillola miksija b’ rita
Bayer Pharma, d. o. o., Bravnič arjeva 13 SI-1000 Ljubljana Slovenia
Bayer Pharma, d. o. o.,
Ciprobay Ciprobay Ciprobay Ciprobay Ciprobay
Bravničarjeva 13 SI- 1000 Ljubljana Is- Slovenja
film-coated tablet film-coated tablet film-coated tablet solution for infusion solution for infusion
pillola miksija b’ rita pillola miksija b’ rita soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use oral use intravenous use intravenous use
użu orali użu orali użu għal ġol- vini użu għal ġol- vini
Pharmaceutical Form
Barcelona Spanja
oral suspension (in single dose sachets)
suspensjoni orali (fi qratas b’ doża waħda)
oral suspension
suspensjoni orali
Germany Ciproxin
Il- Ġermanja
film-coated tablet oral suspension oral suspension solution for infusion solution for infusion
pillola miksija b’ rita suspensjoni orali suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
film-coated tablet film-coated tablet film-coated tablet
pillola miksija b’ rita pillola miksija b’ rita pillola miksija b’ rita
Trading as:
Għall- kummerċ bħala:
Bayer plc, Bayer Schering Pharma
Bayer plc, Bayer Schering
Ciproxin Ciproxin Ciproxin Ciproxin Ciproxin
Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
oral suspension oral suspension solution for infusion solution for infusion solution for infusion
soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use intravenous use intravenous use intravenous use
użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini
11 SCIENTIFIC CONCLUSIONS
11 ANNESS II
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN BAYER AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ CIPROFLOXACIN BAYER U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Ciprofloxacin is a broad spectrum antibacterial agent that belongs to the fluoroquinolone family.
Ciprofloxacin huwa mediċina antibatterika ta ’ spettru wiesa ’ li tappartjeni għall- familja ta ’ fluoroquinolone.
It has a long history of known safety and efficacy in adults, children and adolescents.
Hija għandha storja twila ta ’ sigurtà u effikaċja fl- adulti, it- tfal u l- adolexxenti.
Ciprofloxacin is approved for the treatment of uncomplicated and complicated infections caused by ciprofloxacin- susceptible bacteria and thus a broad variety of infections in adults.
Ciprofloxacin huwa approvat għat- trattament ta ’ infezzjonijiet kumplikati u mhux ikkumplikati kkaġunati minn batterji suxxettibbli għal ciprofloxacin u għalhekk għal varjetà kbira ta ’ infezzjonijiet fl- adulti.
Indications approved for children and adolescents in most European countries include acute pulmonary exacerbations of patients with cystic fibrosis caused by Pseudomonas aeruginosa, complicated urinary tract infections, pyelonephritis, and post-exposure prophylaxis of inhalational anthrax.
Indikazzjonijiet approvati għat- tfal u għall- adolexxenti fil- maġġoranza tal- pajjiżi Ewropej jinkludu taħrixiet pulmonari akuti f’ pazjenti b’ fibrożi ċistika kkaġunata minn Pseudomonas aeruginosa, infezzjonijiet ikkumplikati tal- passaġġi awrinarji, pjelonefrite u profilassi ta ’ wara l - esponiment għal anthrax li jittieħed man- nifs.
To date, ciprofloxacin has been the fluoroquinolone that has been used most extensively in adolescents.
S’ issa, ciprofloxacin kien il- fluoroquinolone li ntuża bl - iktar mod estensiv fl- adolexxenti.
The following oral and intravenous formulations are currently approved and marketed in different EU countries:
Bħalissa, il- formulazzjonijiet orali u intravenużi li ġejjin huma approvati u mqiegħda fis- suq f’ pajjiżi tal- UE differenti:
- Immediate release film-coated tablets:
- Pilloli miksijin b’ rita ta ’ rilaxx immedjat:
- Granules and solvent for oral suspension:
- Granuli u solvent għal sospensjoni orali:
- Solution for infusion (glass bottles and flexibags):
- Soluzzjoni għall- infużjoni (fliexken tal- ħġieġ u boroż flessibbli):
100 mg/ 50 ml, 200 mg/ 100 ml and 400 mg/ 200 ml
100 mg/ 50 ml, 200 mg/ 100 ml u
- Modified release film-coated tablets:
- Pilloli miksijin b’ rita ta ’ rilaxx modifikat:
- Sachets:
- Qratas:
The following sections of the Product Information were addressed during this harmonisation procedure.
Is- sezzjonijiet li ġejjin tal- Fuljett ta ’ Tagħrif kienu indirizzati waqt din il- proċedura ta ’ armonizzazzjoni.
SPC Section 4.1 Therapeutic Indications Overall, the CHMP harmonised this section, providing particular attention to the available information on resistance to ciprofloxacin for each indication.
SPC Sezzjoni 4. 1 Indikazzjonijiet terapewtiċi Ġeneralment, is- CHMP armonizza din is- sezzjoni, b’ attenzjoni partikolari għat- tagħrif disponibbli fuq ir- reżistenza għal ciprofloxacin għal kull indikazzjoni.
Withdrawn Indications Overall, the CHMP considered that the therapeutic indication “ acute sinusitis” could not be accepted, as the most commonly involved pathogen in this infection, Streptococcus pneumoniae, is only intermediately susceptible to ciprofloxacin and its efficacy in this indication is poorly substantiated by the submitted data.
Indikazzjonijet irtirati B’ kollox, is- CHMP ikkunsidra li l- indikazzjoni terapewtika “ sinożite akuta ” ma tistax tiġi aċċettata, għaliex il- patoġen involut bl- iktar mod komuni f’ din l- infezzjoni, Streptococcus pneumoniae, huwa suxxettibbli biss b’ mod intermedju għal ciprofloxacin u l- effikaċja tiegħu f’ din l- indikazzjoni hija ssostanzjata b’ mod limitat permezz tad- dejta sottomessa.
The CHMP considered that the therapeutic indication “ septicaemia due to Gram negative bacteria” could not be accepted as the Applicant/ MAH did not provide reassurance on the fact that ciprofloxacin could be viewed as an adequate option in this severe situation with regards its level of activity and the available therapeutic alternatives.
Is- CHMP ikkunsidra li l- indikazzjoni terapewtika “ settiċemija dovuta għal batterji Gram negattivi ” ma tistax tiġi aċċettata minħabba li l- Applikant/ MAH ma pprovdiex serħan il- moħħ dwar il- fatt li ciprofloxacin jista ’ jidher bħala għażla adegwata f’ din is- sitwazzjoni severa fir- rigward tal- livell ta ’ attività tagħha u l- alternattivi terapewtiċi disponibbli.
The CHMP was of the opinion that the therapeutic indication “ selective digestive decontamination in immuno-suppressed patients” could not be accepted, as there is an absence of specific data submitted by the Applicant/ MAH to support such therapeutic use and there is no consensus in the scientific community on the use ciprofloxacin in such indication.
Is- CHMP kien tal- opinjoni li l- indikazzjoni terapewtika “ dekontaminazzjoni diġestiva selettiva f’ pazjenti immuno- soppressati ” ma setgħetx tiġi aċċettata, minħabba li ma hemm l- ebda dejta speċifika sottomessa mill- Applikant/ MAH biex tappoġġja użu terapewtiku bħal dan u ma hemm l - ebda qbil fil- komunità xjentifika dwar l- użu ta ’ ciprofloxacin f’ indikazzjoni bħal din.
Single-dose treatment of uncomplicated UTI:
Trattament ta ’ doża waħda f’ UTI mhux ikkumplikata:
The CHMP had concerns with regards to the therapeutic indication “ single dose treatment of uncomplicated UTI”.
Is- CHMP kien imħasseb fir- rigward tal- indikazzjoni terapewtika “ trattament ta ’ doża waħda f’ UTI mhux ikkumplikata ”.
The single dose treatment of uncomplicated UTI should not be approved unless scientifically justified (comparative benefit/ risk assessment with the 3 day treatment regimen is provided).
It- trattament b’ doża waħda f’ UTI mhux ikkumplikata m’ għandhiex tkun approvata sakemm din ma tkunx iġġustifikata xjentifikament (mogħtija valutazzjoni benefiċċju/ riskju komparabbli ma ’ reġimen ta ’ trattament ta ’ 3 ijiem).
The Applicant/ MAH did not provide any data or scientific discussion to support the single dose oral ciprofloxacin treatment of uncomplicated cystitis.
L- Applikant/ MAH ma ta l- ebda dejta jew diskussjoni xjentifika biex jappoġġja l- użu ta ’ doża waħda ta ’ trattament ta ’ ciprofloxacin orali f’ ċistite mhux ikkumplikata.
In particular, the Applicant/ MAH did not discuss its benefit-risk ratio in comparison to the other longer treatment duration (3 day treatment).
B’ mod partikolari, l- Applikant/ MAH ma ddiskutiex il- proporzjon ta ’ benefiċċju- riskju meta mqabbel ma ’ tul ta ’ żmien itwal (trattament ta ’ 3 ijiem).
However, after extensive discussions, the CHMP considered that ciprofloxacin still remains a useful therapeutic option in uncomplicated cystitis.
13 Madankollu, wara diskussjonijiet estensivi, is- CHMP ikkunsidra li ciprofloxacin jibqa ’ għażla terapewtika bżonnjuża f’ ċistite mhux ikkumplikata.
Even if a 3-day treatment has some advantages in efficacy, the 500 mg single-dose therapy still has a place in the strategy provided its use is adequately 12 guided by the clinical status of the patients and diagnostic tools.
Anke jekk trattament ta ’ 3 ijiem għandu xi vantaġġi fl- effikaċja, it- terapija b’ doża waħda ta ’ 500 mg għad għandha post fl- istrateġija diment li l - użu tagħha jkun iggwidat adegwatament mill- istejtus kliniku tal- pazjenti u għodod dijanjostiċi.
Therefore, both strategies in the treatment of uncomplicated cystitis were considered noteworthy in the oral ciprofloxacin MAA.
Għaldaqstant, iż- żewġ strateġiji fit- trattament ta ’ ċistite mhux ikkumplikata kienu ikkunsidrati li ħaqqhom ikunu magħrufin fl- MAA ta ’ ciprofloxacin orali.
After a long discussion, an agreement was achieved to using precautionary statements for downgrading the recommendation of the single dose regimen as compared to the 3-day regimen and by restricting this possible option to uncomplicated cystitis in pre-menopausal women.
Wara diskussjoni twila, intlaħaq qbil biex jintużaw stqarrijiet ta ’ prekawzjoni li jnaqqsu l- importanza tar- rakkomandazzjoni ta ’ reġimen ta ’ doża waħda meta mqabbla ma ’ reġimen ta ’ 3 jiem u billi din l- għażla possibbli tiġi ristretta għal ċistite mhux ikkumplikata f’ nisa qabel il- menopawża.
Treatment of Shigellosis:
Trattament ta ’ Shigellożi:
The CHMP raised concerns on the potential uncontrolled use of ciprofloxacin in the empirical treatment of shigellosis or traveller’ s diarrhoea and questioned its effectiveness, especially in the mild form, pointing out the high risk of resistance induction.
Is- CHMP qajjem tħassib dwar l- użu potenzjali mhux ikkontrollat ta ’ ciprofloxacin fit- trattament empiriku ta ’ shigellożi jew dijarrea tal- vjaġġaturi u fisser dubju dwar l- effikaċja tiegħu, speċjalment f’ forma ħafifa, u wera r- riskju għoli ta ’ induzzjoni ta ’ reżistenza.
After evaluating the data presented by the Applicant/ MAH, the CHMP considered that the therapeutic indication related to the empiric ciprofloxacin treatment of Shigellosis or the traveller’ s diarrhoea was acceptable with the wording “ infections of the gastro-intestinal tract (e. g. travellers’ diarrhoea )” and restricted its use in “ severe” cases in section 4.2, with the following schedule regimens:
Wara li evalwa d- dejta ippreżentata mill- Applikant/ MAH, is- CHMP ikkunsidra li l- indikazzjoni terapewtika relatata mat- trattament b’ ciprofloxacin ta ’ Shigellożi jew dijarrea tal- vjaġġaturi kienet aċċettabbli bit- test“ infezzjonijiet tal - passaġġ gastro- intestinali (eż., dijarrea tal- vjaġġaturi) ” u llimita l- użu tiegħu f’ każijiet “ severi ” f’ sezzjoni 4. 2, bl- iskeda tar- reġimen li ġejja:
-Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteria type 1and empirical treatment of traveller’ s diarrhoea (per os:
Barra minn Shigella dysenteria tip 1 u trattament empiriku ta ’ dijarrea tal- vjaġġaturi (per os:
2 x 500 mg/ d - 1 day, i. v:
2 x 500 mg/ kuljum – jum 1, i. v:
2 x 400 mg/ d – 1 day) -Diarrhoea caused by Shigella dysenteriae type 1 (per os:
- Dijarrea ikkaġunata minn Shigella dysenteriae tip 1 (per os:
2 x 500 mg/ d - 5 days, i. v:
2 x 500 mg/ kuljum – 5 ijiem, i. v:
2x400 mg/ d- 5 days)
2x400 mg/ kuljum - 5 ijiem)
Additionally, the following statement was recommended in section 4.4:
Barra minn hekk, kienet irrakkomandata l- istqarrija li ġejja f’ sezzjoni 4. 4:
Caution is advised when treating traveller’ s diarrhea especially if the travel concerns countries a high rate of ciprofloxacin resistant Shigella is observed.
Huwa rrakkomandat li tintuża l- kawtela waqt it- trattament ta ’ dijarrea tal- vjaġġaturi speċjalment meta l- vjaġġ jikkonċerna pajjiżi fejn hija osservata rata għolja ta ’ Shigella reżistenti għal ciprofloxacin.
Infection of bone and joint infections due to Gram-positive bacteria:
Infezzjoni tal- għadam u infezzjonijiet tal- ġogi minħabba batterji Gram- pożittivi:
The CHMP asked the applicant/ MAH to discuss the extent to which ciprofloxacin could be viewed as an acceptable option for treating bone and joints infections due to Gram-positive bacteria (in particular Staphyloccocus species).
Is- CHMP talab lill- applikant/ MAH biex jiddiskuti l- medda li ciprofloxacin jista ’ jidher fiha bħala għażla aċċettabbli biex jittratta infezzjonijiet tal- għadam u tal- ġoġi minħabba batterji Gram- pożittivi (b’ mod partikolari speċi ta ’ Staphyloccocus).
The response document included a review of clinical data (published data, medical research reports) and microbiological data.
Id- dokument ta ’ reazzjoni inkluda reviżjoni ta ’ dejta klinika (dejta, rapporti ta ’ riċerka medika ppubblikati) u dejta mikrobijoloġika.
From the data presented, ciprofloxacin prescriptions in “ bone and joint infections” were supported by several clinical studies and an extensive use in clinical practice.
Mid- dejta ppreżentata, riċetti għal ciprofloxacin f ’ “ infezzjonijiet tal- għadam u l- ġoġi ” kienu appoġġjati minn diversi studji kliniċi u użu estensiv fil- prattika klinika.
Nevertheless the CHMP noted that consideration should be given to the precautions of use in ciprofloxacin treatment of such infections.
Madankollu s- CHMP innota li għandha tingħata kunsiderazzjoni għal- prekawzjonijiet ta ’ użu fit- trattament ta ’ infezzjonijiet bħal dawn b’ ciprofloxacin.
Staphylococci or Pseudomonas aeruginosa are the main bacteria involved in these infections and ciprofloxacin bacterial activity had to be taken into account regarding these targeted species.
Staphylococci jew Pseudomonas aeruginosa huma l- batterji ewlenin involuti f’ dawn l- infezzjonijiet u kellha tiġi kkunsidrata l- attività batterika ta ’ ciprofloxacin fir- rigward ta ’ dawn l- ispeċi fil- mira.
Consequently ciprofloxacin should be used only after microbiological documentation and empirical treatment was not recommended.
Konsegwentement ciprofloxacin għandu jintuża biss wara dokumentazzjoni mikrobijoloġika u wara li t- trattament empiriku ma jkunx ġie rrakkomandat.
Ciprofloxacin should be used in combination with other antimicrobial agents, such as rifampicin in infections due to Staphylococci, and beta-lactams or aminoglycosides in infections due to Pseudomonas aeruginosa.
Ciprofloxacin għandu jintuża ma ’ mediċini antimikrobiċi oħrajn bħalma huwa rifampicin f’ infezzjonijiet minħabba Staphylococci, u beta- lactams jew aminoglycosides f’ infezzjonijiet minħabba Pseudomonas aeruginosa.
Therefore, the CHMP considered that the data provided was sufficient to include the therapeutic indication “ Infections of the bones and joints” in Ciprofloxacin Marketing Authorisations, and noted that the SPC should give a clear message on the need for co-administration with appropriate antibacterial agent(s).
Għaldaqstant, is- CHMP ikkunsidra li d- dejta pprovduta kienet biżżejjed biex l- indikazzjoni terapewtika “ Infezzjonijiet tal- għadam u tal- ġogi ” tiġi inkluża f’ Awtorizzazzjonijiet għat- Tqegħid fis - Suq ta ’ Ciprofloxacin, u nnota li l- SPC għandu jagħti messaġġ ċar dwar il- ħtieġa għal għoti konkomittanti ma ’ mediċina( i) antibatterika( ċi) addattata( i).
Treatment or prophylaxis in patients with severe neutropenia:
Trattament jew profilassi f’ pazjenti b’ newtropenija severa:
The CHMP asked the applicant/ MAH to discuss the extent to which ciprofloxacin could be viewed as an acceptable option in the treatment or prophylaxis in patients with severe neutropenia.
Is- CHMP talab lill- applikant/ MAH biex jiddiskuti kemm ciprofloxacin tista ’ tidher bħala għażla aċċettabbli fit- trattament jew profilassi f’ pazjenti b’ newtropenija severa.
The applicant/ MAH provided documentation to support the use of ciprofloxacin as a valuable therapeutic option both prophylaxis and treatment of febrile neutropenic patients.
L- applikant/ MAH ipprovda dokumentazzjoni biex tappoġġja l- użu ta ’ ciprofloxacin bħala għażla terapewtika ta ’ valur kemm fil - profilassi kif ukoll fit- trattament ta ’ pazjenti newtropeniċi bid- deni.
In summary, for prophylaxis in neutropenic patients, a 500 mg bid ciprofloxacin dosage regimen was recommended.
Fil- qosor, għall- profilassi 14 f’ pazjenti newtropeniċi, kien irrakkomandat reġimen ta ’ dożaġġ ta ’ 500 mg bid.
For treatment of febrile neutropenic patients, when an intravenous antibiotic administration is necessary, ciprofloxacin should be administered at a 400 mg bid or tid regimen.
Għat- trattament ta ’ pazjenti newtropeniċi meta huwa meħtieġ għoti ta ’ antibijotiku intravenuż, ciproflaxacin għandu jingħata f’ reġimen ta ’ 400 mg bid jew tid.
In patients with low-risk neutropenic
Meta bidla għal terapija orali tkun possibbli, huwa rrakkomandat reġimen ta ’ ciprofloxacin 750 mg bid.
13 fever, a 750 mg bid ciprofloxacin regimen can also be used.
F’ pazjenti b’ deni newtropeniku ta ’ riskju baxx, jista ’ wkoll jintuża reġimen ta ’ ciprofloxacin 750 mg bid.
In most cases, ciprofloxacin should be administered in combination with another appropriate (beta-lactam) antibiotic.
Fil- maġġoranza tal- każijiet, ciprofloxacin għandu jingħata f’ kombinazzjoni ma ’ antibijotiku (beta- lactam) ieħor addattat.
With regards to the treatment of febrile patients with neutropenia, the CHMP considered that, despite the lack of robustness of the available data (limited number of patients included in these studies), the use of ciprofloxacin remained well admitted in the scientific community and had become part of the clinical practice.
Fir- rigward tat- trattament ta ’ pazjenti b’ newtropenija bid- deni, is- CHMP ikkunsidra li, minkejja n - nuqqas ta ’ robustezza tad- dejta disponibbli (numru limitat ta ’ pazjenti inklużi f’ dawn l- istudji), l- użu ta ’ ciprofloxacin baqa ’ jidħol sewwa fil- komunità xjentifika u kien sar parti mill- prattika klinika.
The combination with other antibiotics, or its use as monotherapy could be considered adequate.
Il - kombinazzjoni ma ’ antibijotiċi oħrajn, jew l- użu tagħha bħala monoterapija jista ’ jkun ikkunsidrat adegwat.
The resort to combination therapy, however, should be envisaged according to specific factors (including severe neutropenia).
Madankollu, ir- rikors għal terapija ta ’ kombinazzjoni għandu jkun previst skont fatturi speċifiċi (inkluża newtropenija severa).
The adequacy of the therapeutic strategy between monotherapy and combination therapy should be re-considered as soon as microbiological results become available and local guidelines should allow to adequately adapt the ciprofloxacin use.
L- adegwatezza tal- istrateġija terapewtika bejn monoterapija u terapija ta ’ kombinazzjoni għandha tkun ikkunsidrata mill- ġdid hekk kif isiru disponibbli r- riżultati mikrobijoloġiċi u l- linji gwida lokali għandhom jippermettu li l- użu ta ’ ciprofloxacin jiġi addattat adegwatement.
Therefore, the following statement was recommended in Section 4.2 of the SPC: “ ciprofloxacin should be co-administered with appropriate antibacterial agents in accordance to official guidance”.
Għaldaqstant, l- istqarrija li ġejja kienet irrakkomandata fis- Sezzjoni 4. 2 tal- SPC: “ ciprofloxacin għandu jingħata flimkien ma ’ mediċini antibatteriċi xierqa skont il- gwida uffiċjali ”.
With regards to the prophylaxis in neutropenic patients, the studies submitted by the Applicant/ MAH showed comparable results between treatment groups.
Fir- rigward tal- profilassi f’ pazjenti newtropeniċi, l- istudji sottomessi mill- Applikant/ MAH urew riżultati komparabbli bejn il- gruppi ta ’ trattament.
Additionally, the use of ciprofloxacin in prophylaxis of neutropenia was further supported by a recent trial with other fluoroquinolones (levofloxacin).
Barra minn hekk, l- użu ta ’ ciprofloxacin fil - profilassi ta ’ newtropenija kien appoġġjat aktar permezz ta ’ prova riċenti bi fluoroquinolones (levofloxacin) oħrajn.
Such a prescription should be handled by specialists in the field and local and national guidelines are available to promote the good use of ciprofloxacin in such situation.
Riċetta bħal din għandha tingħata minn speċjalisti fil- qasam u linji gwidi lokali u nazzjonali huma disponibbli biex jippromwovu l- użu tajjeb ta ’ ciprofloxacin f’ sitwazzjoni bħal din.
In summary, the CHMP considers that both indications (curative treatment and prophylaxis) were acceptable.
Fil- qosor, is- CHMP ikkunsidra li ż- żewġ indikazzjonijiet (trattament kurattiv u profilassi) kienu aċċettabbli.
In line with the data submitted, the benefit/ risk in prophylaxis was regarded as favourable in patients with neutrophil count less than 1000/ mm3.
B’ mod konformi mad- dejta sottomessa, il- benefiċċju/ riskju fil- profilassi kien meqjus bħala favorevoli f’ pazjenti b’ għadd ta ’ newtrofili inqas minn 1000/ mm3.
The CHMP therefore recommended the following wording to distinguish, by specific indications, the prophylactic and curative uses of ciprofloxacin in neutropenic patients with the following wording: -treatment of infections in neutropenic patients, -prophylaxis of infections in neutropenic patients.
Għaldaqstant, is- CHMP irrakkomanda l- formolazzjoni ta ’ kliem li ġejja biex jagħmel distinzjoni, skont indikazzjonijiet speċifiċi, bejn l- użu profilattiku u kurattiv ta ’ ciprofloxacin f’ pazjenti newtropeniċi bil- kitba li ġejja: - trattament ta ’ infezzjonijiet f’ pazjenti newtropeniċi, - profilassi ta ’ infezzjonijiet f’ pazjenti newtropeniċi.
Treatment of infections caused by Bacillus Anthracis The CHMP asked the Applicant/ MAH to provide an updated review of the non clinical data (including animal data) and on the clinical experience gained up to now in the use of ciprofloxacin in inhalation anthrax.
Trattament ta ’ infezzjonijiet ikkaġunati minn Bacillus Anthracis Is- CHMP talab lill- Applikant/ MAH biex jagħti reviżjoni aġġornata tad- dejta mhux klinika (inkluża dejta minn annimali) u fuq l- esperjenza klinika miksuba s’ issa fl- użu tal- anthrax li jittieħed man- nifs.
The Applicant/ MAH provided reports summarizing the results of a literature search from 2001 to 2006, including animal model and clinical articles.
L- Applikant/ MAH ta rapporti li jagħtu fil- qosor ir- riżultati ta ’ tfittxija fil- letteratura mill- 2001 sal - 2006, inklużi mudelli tal- annimali u artikoli kliniċi.
Referring to the lack of clinical data to support the use of ciprofloxacin in anthrax, the applicant/ MAH proposed a statement in section 5.1.
B’ referenza għan- nuqqas ta ’ dejta klinika li tappoġġja l- użu ta ’ ciprofloxacin f’ anthrax, l- applikant/ MAH ippropona stqarrija f’ sezzjoni 5. 1.
However, the CHMP considered that the particular context of anthrax (i. e. bioterrorism) required deviation from the usual requirement of clinical data and the benefit assessment.
Madankollu, is- CHMP ikkunsidra li l- kuntest partikolari tal- anthrax (jiġifieri bijoterroriżmu) ħtieġ devjazzjoni mir- rekwiżit tas- soltu ta ’ dejta klinika u valutazzjoni tal- benefiċċju.
Indeed, ciprofloxacin is part of the drugs recommended in the European strategy targeted on treatments and prophylaxis when biological agents are used as weapons of bioterrorism.
Ċertament, ciprofloxacin hija waħda mill- mediċini rrakkomandati fl- istrateġija Ewropea mmirata lejn trattamenti u profilassi meta mikrobi bijoloġiċi jintużaw bħala armi tal- bijoterroriżmu.
With regards to inhalation, intestinal and cutaneous anthrax, EMEA proposed guidelines in 2002 including the recommended use of ciprofloxacin in a first line treatment.
Fir- rigward tal- anthrax li jittieħed man- nifs, intestinali u tal- ġilda, fl- 2002, l- EMEA ipproponiet linji gwidi inkluż l- użu rrakkomandat ta ’ ciprofloxacin f’ trattament tal- ewwel linja.
In summary, the CHMP was of the opinion that anthrax should remain part of the indications to avoid any confusion for prescribers and to be consistent with EU and international guidelines including a recommendation on ciprofloxacin as a first line treatment.
Fil- qosor, is- CHMP kien tal- opinjoni li l- anthrax għandu jibqa ’ parti mill- indikazzjonijiet sabiex tkun evitata kwalunkwe konfużjoni għat- tobba li jagħtuh b’ riċetta u għal raġunijiet ta ’ konsistenza mal- linji gwida tal- UE u internazzjonali inkluż ir- rakkomandazzjoni fuq ciprofloxacin bħala trattament tal - ewwel linja.
The proposed wording of the therapeutic indications was as follows: “ Inhalation anthrax (post exposure prophylaxis and curative treatment )” for oral and IV pharmaceutical presentations.
Anthrax li jittieħed man - nifs (profilassi wara l- esponiment u trattament kurattiv) ” għall- preżentazzjonijiet farmaċewtiċi orali u IV.
A statement in section 5.1 referring to this indication was also recommended as follows:
Stqarrija f’ sezzjoni 5. 1 li tirreferi għal din l- indikazzjoni kienet ukoll irrakkomandata kif ġej:
Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition, avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose.
Saru studji f’ infezzjonijiet esperimentali tal- annimali minħabba teħid man- nifs ta ’ spori ta ’ Bacillus anthracis; dawn l- istudji juru li antibijotiċi mibdijin kmieni wara l- esponiment, jevitaw is- seħħ tal -
The recommended use in human subjects is based primarily on in vitro susceptibility and on animal experimental data together with limited human data.
L- użu rrakkomandat f’ suġġetti umani huwa bbażat primarjament fuq suxxettibilità in vitro u fuq dejta esperimentali tal- annimali flimkien ma ’ dejta limitata fuq il- bnedmin.
Two -month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent 14 anthrax infection in humans.
Trattament ta ’ xahrejn fl- adulti b’ ciprofloxacin orali mogħtija fid- doża li ġejja, 500 mg bid, hija kkunsidrata ugwalment effettiva biex timpedixxi infezzjoni b’ anthrax fil- bnedmin.
The treating physician is referred to national and / or international consensus documents regarding treatment of anthrax
It- tabib li jkun qiegħed jagħti t- trattament huwa rreferut għal dokumenti ta ’ kunsens nazzjonali u/ jew internazzjonali rigward it- trattament tal- anthrax
Prophylaxis of invasive infections of adults due to Neisseria meningitides Ciprofloxacin is used in clinical practice in prophylaxis of invasive infections of adults due to Neisseria meningitidis when rifampicin is contra-indicated or after microbiologically documentation when Neisseria meningitidis is resistant to rifampicin, in line with some therapeutic guidelines.
Profilassi ta ’ infezzjonijiet invażivi ta ’ adulti minħabba Neisseria meningitides Ciprofloxacin jintuża fil- prattika klinika fil- profilassi ta ’ infezzjonijiet invażivi ta ’ adulti minħabba Neisseria meningitidis meta rifampicin huwa kontraindikat jew wara dokumentazzjoni mikrobijoloġika meta Neisseria meningitidis hija reżistenti għal rifampicin, b’ mod konformi ma ’ xi linji gwidi terapewtiċi.
Such a use is supported by publications and clinical experience.
Użu bħal dan huwa appoġġjat permezz ta ’ pubblikazzjonijiet u esperjenza klinika.
The CHMP asked the applicant/ MAH to provide a substantiated discussion on the use of ciprofloxacin in prophylaxis of invasive infections of adults, to harmonize the therapeutic management of patients.
Is- CHMP talab lill- applikant/ MAH biex jagħti diskussjoni ssostanzjata dwar l- użu ta ’ ciprofloxacin fi profilassi ta ’ infezzjonijiet invażivi tal- adulti, biex is- sistema terapewtika tal- pazjenti tkun armonizzata.
After a careful review of the data submitted the CHMP considered that the therapeutic indication of ciprofloxacin in prophylaxis of invasive infections due to Neisseria meningitidis in adults was well substantiated by publications and corresponded to the current practice.
Wara reviżjoni bir- reqqa tad- dejta sottomessa, is- CHMP ikkunsidra li l- indikazzjoni terapewtika ta ’ ciprofloxacin fil- profilassi ta ’ infezzjonijiet invażivi minħabba Neisseria meningitidis fl- adulti kienet appoġġjata tajjeb minn pubblikazzjonijiet u kkorrispondiet mal- prattika attwali.
Ciprofloxacin should be used only when the resort to rifampcicin is not possible.
Ciprofloxacin għandha tintuża meta r- rikors għal rifampicin ma jkunx possibbli.
As it is not compulsory to specify the recommended antibiotic strategy in the wording of the therapeutic indication in the Marketing Authorisation, the CHMP recommended that the proposed 4.1 SPC wording “ prophylaxis of invasive infections due to Neisseria meningitidis” remain, and accepted the adult posology:
Minħabba li m’ huwiex obbligatorju li l - istrateġija ta ’ antibijotiċi rrakkomandata fil- kitba tal- indikazzjoni terapewtika fl- Aworizzazzjoni għat - Tqegħid fis- Suq tkun speċifikata, is- CHMP irrakkomanda li l- kitba proposta tas- sezzjoni 4. 1 tal- SPC “ profilassi ta ’ infezzjonijiet invażivi minħabba Neisseria meningitidis ” tibqa ’, u aċċetta l- pożoloġija tal- adulti:
1 x 500 mg/ d (single dose).
1 x 500 mg/ kuljum (doża waħda).
However, this indication was not considered acceptable for the IV ciprofloxacin formulation.
Madankollu, din l- indikazzjoni ma kinitx ikkunsidrata aċċettabbli għall- formulazzjoni ta ’ ciprofloxacin IV.
Restriction of the indication “ Infections of the lower respiratory tract” The CHMP noted that ciprofloxacin was not suited for therapy of pneumococci and its efficacy against chlamydia was worse compared to other fluoroquinolones such as levofloxacin or moxifloxacin.
Restrizzjoni tal- indikazzjoni “ Infezzjonijiet fil- parti t’ isfel tal- passaġġi respiratorji ” Is- CHMP innota li ciprofloxacin ma kienx addattat għat- terapija ta ’ pnewmokokki u li l- effikaċja tagħha kontra klamidija kienet agħar meta mqabbla ma ’ fluoroquinolones oħrajn bħalma huma levofloxacin jew moxifloxacin.
Therefore, the CHMP requested that an appropriate restriction of the indication be made.
Għaldaqstant, is- CHMP talab li ssir restrizzjoni xierqa tal - indikazzjoni.
The indication was reworded to state ciprofloxacin's utility in Gram negative bacterial infections of the lower respiratory track causing exacerbations of chronic obstructive pulmonary disease, bronchopulmonary infections in cystic fibrosis or in bronchiectasis and pneumonia.
L- indikazzjoni nkitbet mill- ġdid biex tistqarr l- utilità ta ’ ciprofloxacin f’ infezzjonijiet batteriċi Gram negattivi fil- parti t’ isfel tal- passaġġi respiratorji li jikkaġunaw taħrixiet ta ’ mard kroniku pulmonari okklussiv, infezzjonijiet bronkopulmonari f’ fibrożi ċistika jew fi bronkjektażi u pulmonite.
Therefore the following wording was recommended: “ Lower respiratory tract infections due to Gram negative bacteria:
Għaldaqstant kienet rrakkomandata l- kitba li ġejja: “ Infezzjonijiet fil- parti t’ isfel tal- passaġġi respiratorji minħabba batterji Gram negattivi:
- exacerbations of chronic obstructive pulmonary disease
- taħrixiet ta ’ mard kroniku pulmonari okklussiv
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- infezzjonijiet bronko- pulmonari f’ fibrożi ċistika jew fi bronkjektażi
- pneumonia”
- pulmonite ”
Other Indications The CHMP agreed to simplify the wording for other indications and adapt them to the current epidemiological concerns.
Indikazzjonijiet oħrajn Is- CHMP aċċetta li jissimplifika l- kitba għall- indikazzjonijiet l- oħrajn u li jaddattahom għat- tħassib epidemjoloġiku kurrenti.
Consequently, the following wording was recommended in section 4.1, and subsequently section 4.2 was amended accordingly:
Konsegwentement, il- kitba li ġejja ġiet irrakkomandata fis- sezzjoni 4. 1, u għalhekk, sussegwentement is- sezzjoni 4. 2 ġiet emendata:
- acute exacerbations of chronic sinusistis especially if these are caused by Gram-negative bacteria
- taħrixiet ta ’ sinożite kronika speċjalment jekk dawn huma kkaġunati minn batterji Gram negattivi
- gonococcal urethritis and cervicitis
- uretrite u ċerviċite gonokokkali
- epididymo-orchitis including cases due to Neisseria gonorrhoeae
- epididimo- orkite inklużi każijiet minħabba Neisseria gonorrhoeae
- pelvic inflammatory disease including cases due to Neisseria gonorrhoeae
- mard pelviku infjammatorju inklużi każijiet minħabba Neisseria gonorrhoeae
- malignant external otitis
- otite esterna malinna
Use of Ciprofloxacin in Children and Adolescents The CHMP raised concerns on the following wording in Section 4.1 of the SPC: “ Other severe infections in accordance with Official guidance, 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 .” It was deemed to describe clinical situations in which the use of ciprofloxacin may be considered in spite of a missing indication, in children and adolescents.
Infezzjonijiet severi oħrajn skont gwida Uffiċjali, wara evalwazzjoni bir- reqqa ta ’ benefiċċju- riskju meta kuri oħrajn ma jkunux jistgħu jintużaw, jew wara li terapija konvenzjonali ma tkunx irnexxiet u meta d- dokumentazzjoni mikrobijoloġika tista ’ tiġġustifika l- użu ta ’ ciprofloxacin. ” Fit- tfal u l- adolexxenti kien meqjus li jiġu deskritti sitwazzjonijiet kliniċi fejn jista ’ jiġi kkunsidrat l- użu ta ’ ciprofloxacin minkejja indikazzjoni 16 nieqsa.
The CHMP initially proposed to put this information in section 4.4 under the subheading “ Children and adolescents”.
Inizjalment, is- CHMP ippropona li jpoġġi dan it- tagħrif f’ sezzjoni 4. 4 taħt is- sottotitlu “ Tfal u adolexxenti.
However, after careful deliberations, an agreement was reach to include a statement in section 4.1 to cover the possible resort of ciprofloxacin in severe infections with a cross reference in section 4.4 that details such situations.
Madankollu, wara deliberazzjonijiet bir- reqqa, intlaħaq qbil biex tkun inkluża stqarrija f ’ sezzjoni 4. 1 biex tkopri r- rikors possibbli għal ciprofloxacin f’ infezzjonijiet severi b’ referenza oħra f’ sezzjoni 4. 4 li tiddeskrivi fid- dettall sitwazzjonijiet bħal dawn.
Therefore, the following wording was proposed for section 4.1:
Għaldaqstant, ġiet proposta l- kitba li ġejja għal sezzjoni 4. 1:
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 jittratta infezzjonijiet severi fi tfal u adolexxenti meta dan ikun meqjus meħtieġ.
Treatment should be initiated only by physicians who are 15 experienced in the treatment of cystic fibrosis and/ or severe infections in children and adolescents (see sections 4.4 and 5.1).
It- trattament għandu jinbeda biss minn tobba li għandhom l- esperjenza fit- trattament ta ’ fibrożi ċistika u/ jew infezzjonijiet severi fi tfal u adolexxenti (ara sezzjonijiet 4. 4 u 5. 1).
SPC Section 4.2 Posology and method of administration
SPC Sezzjoni 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Posology for severe respiratory tract infections, severe bone and joint infections In severe respiratory tract infections as well as in severe bone and joint infections, higher doses than that currently recommended (such as 750 mg x 3/ day or 1000 mg x 2/ day) for oral route are currently used in clinical practice given the known decreased susceptibility of the main pathogens involved (including Pseudomonas aeruginosa, Acinetobacter, Staphylococcus aureus) and the severity of the disease (as well as the difficulties in reaching optimal concentration at the bone level).
Pożoloġija għall- infezzjonijiet tal- passaġġi respiratorji, infezzjonijiet tal- għadam u tal- ġogi F’ infezzjonijiet severi tal- passaġġi respiratorji kif ukoll f’ infezzjonijiet severi tal- għadam u tal- ġogi, fil- preżent, fil- prattika klinika, qegħdin jintużaw dożi ogħla minn dawk rakkomandati (bħalma huma 750 mg x 3/ kuljum jew 1000 mg x 2/ kuljum) għar- rotta orali minħabba s- suxxettibbilità mnaqqsa magħrufa tal- patoġeni involuti (inklużi Pseudomonas aeruginosa, Acinetobacter, Staphylococcus aureus) u s- severità tal- marda (kif ukoll id- diffikultajiet biex tintlaħaq konċentrazzjoni ottima fil- livell tal- għadam).
Therefore, the CHMP asked the applicant/ MAH to discuss (PK/ PD rational) and make a proposal in this field.
Għaldaqstant, is- CHMP talab lill- applikant/ MAH biex jiddiskuti (PK/ PD razzjonali) u jagħmel proposta f’ dan il- qasam.
However, the recommendation of the administration of 750 mg tid and 1g bid by oral route in severe infections (respiratory tract infections, bone and joint infections) was not supported by the data submitted and the CHMP considered that none of the proposed posologies could be included in the Marketing Authorisation.
Madankollu, ir- rakkomandazzjoni tal- għoti ta ’ 750 mg tid u 1g bid bir- rotta orali f’ infezzjonijiet severi (infezzjoni tal- passaġġ respiratorju, infezzjonijiet tal- għadam u tal - ġogi) ma kinitx appoġġjata minn dejta sottomessa u s- CHMP ikkunsidra li l- ebda waħda mill - pożoloġiji proposti ma setgħet tkun inkluża fl- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Long-term safety profile of ciprofloxacin to treat bone and joint infections Since a treatment duration of up to 3 months may be required in clinical practice to treat bone and joints infections, the CHMP requested that the applicant/ MAH provide long term safety data to substantiate the safety profile of the drug in such a prolonged use.
Profil ta ’ sigurtà ta ’ ciprofloxacin fuq tul ta ’ żmien biex jittratta infezzjonijiet tal- għadam u tal- goġi Minħabba li fil- prattika klinika jista ’ jkun meħtieġ perjodu ta ’ trattament sa 3 xhur biex jittratta infezzjonijiet tal- għadam u tal- ġogi, is- CHMP talab li l- applikant/ MAH jagħti dejta ta ’ sigurtà fuq tul ta ’ żmien biex jissostanzja l- profil tas- sigurtà tal- mediċina f’ użu fit- tul bħal dan.
The applicant/ MAH submitted 11 studies (8 published clinical studies and 3 medical study reports) in which treatment duration for ciprofloxacin ranged from 2 and 476 days.
L- applikant/ MAH issottometta 11- il studju (8 studji kliniċi ppubblikati u 3 rapporti ta ’ studji mediċi) għal liema t- tul ta ’ żmien ta ’ trattament għal ciprofloxacin varja minn jumejn sa 476 jum.
No new safety concerns arose from these data.
Ma tqajjem l- ebda tħassib ġdid dwar is- sigurtà minn din id- dejta.
Most reported adverse events were not unexpected, mainly gastro-intestinal disorders or cutaneous disorders.
Il- maġġoranza tal- episodji avversi rapportati kienu mistennija, prinċipalment disturbi gastro- intestinali jew disturbi tal- ġilda.
In addition, taking into account the large use of ciprofloxacin in post-marketing, no safety signal was identified with long-term use of ciprofloxacin in PSURs.
Barra minn hekk, meta jitqies l- użu kbir ta ’ ciprofloxacin wara t- tqegħid fis- suq, ma kien identifikat l- ebda sinjal ta ’ sigurtà fil- PSURs b’ użu ta ’ ciprofloxacin fuq tul ta ’ żmien.
Therefore, the CHMP agreed that the safety data did not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
Għaldaqstant, is- CHMP qabel li d- dejta ta ’ sigurtà ma wriet l- ebda evidenza li l- profil ta ’ sigurtà ta ’ ciprofloxacin huwa affettwat minn tul ta ’ żmien ta ’ trattament sa 3 xhur.