qanastek/EMEA-V3 huggingface dataset:
To support the recommended posology of 200-400 mg ciprofloxacin twice daily in the treatment of complicated urinary tract infections, the applicant/ MAH provided substantial scientific evidence.
Biex isostni l- pożoloġija rakkomandata ta ’ 200- 400 mg ciprofloxacin darbtejn kuljum fit- trattament ta ’ infezzjonijiet ikkumplikati tas- sistema awrinarja, l- applikant/ MAH ipprovda evidenza xjentifika sostanzjali.
A large number of published studies have demonstrated the efficacy and safety of ciprofloxacin, using the intravenous dose 200-400 mg twice daily and the corresponding oral dosage 250-500 mg bid in the treatment of urinary tract infections.
Numru kbir ta ’ studji ippubblikati wrew l- effikaċja u s- sigurtà ta ’ ciprofloxacin, bl- użu tad- doża fil- vini ta ’ 200- 400 mg darbtejn kuljum u d- doża orali korrispondenti ta ’ 250- 500 mg bid fit - trattament ta ’ infezzjonijiet tas- sistema awrinarja.
Martindale indicates that the usual adult intravenous dose is 100 mg to 400 mg twice daily, but the dosages is not related specifically to treatment of urinary tract infections.
Aktar tiftixiet fil- letteratura wrew li minoranza biss tal- letteratura ippubblikata ssemmi l- użu ta ’ 100 mg ciprofloxacin fil- vina darbtejn kuljum, pereżempju Martindale jindika li d- doża normali fil- vina għall- adulti hija 100 mg sa 400 mg darbtejn kuljum, iżda d- doża mhix relatata speċifikament mat- trattament ta ’ infezzjonijiet tas- sistema awrinarja.
No clinical study using 100 mg intravenous twice daily for the treatment of complicated urinary tract infections, was identified.
L- ebda studju kliniku fejn intużaw 100 mg fil- vini darbtejn kuljum għat- trattament ta ’ infezzjonijiet ikkumplikati tas- sistema awrinarja, ma ġie identifikat.
Medical practice in the treatment of UTI’ s with ciprofloxacin has changed and developed since the time of first licensing in 1987.
Il- prattika medika fit- trattament ta ’ UTIs b’ ciprofloxacin inbidlet u żviluppat miż- żmien ta ’ l- ewwel liċenzja fl- 1987.
The recommended posology of 200-400 mg ciprofloxacin twice daily is in line with current medical practice, supported by the published literature presented from the mid 1990’ s to date.
Il- pożoloġija rakkomandata ta ’ 200- 400 mg ciprofloxacin darbtejn kuljum hija konformi mal- prattika medika attwali, sostnuta mil- letteratura ippubblikata minn nofs l- 1990s sal- lum.
In addition a dose-dependent clinical response of fluoroquinolones in the treatment of complicated UTI has been demonstrated in a clinical trial by Frankenschmidt et al (1).
Barraminhekk fi prova klinika minn Frankenschmidt et al (1) ġie muri rispons kliniku dipendenti fuq id- doża ta ’ fluoroquinolones fit- trattament ta ’ UTI kumplikata.
According to pharmacodynamic studies, ciprofloxacin, like other fluoroquinolones, exhibits concentration dependent killing.
Skond studji farmakodinamiċi, ciprofloxacin, bħal fluoroquinolones oħra, juri qtil dipendenti fuq il- konċentrazzjoni.
Thus AUC over MIC is determinative for efficacy and it is therefore crucial that substantial concentrations are achieved at the site of the target pathogens.
Għalhekk l- AUC fuq il- MIC hija determinattiva għall- effikaċja u għalhekk huwa kruċjali li jinkisbu konċentrazzjonijiet sostanzjali fis- sit tal- patoġeni fil- mira.
The antimicrobial activity of fluoroquinolones in urine is reduced depending on pH and various solubles, mainly cations.
L- attività antimikrobika tal- fluoroquinoloes fl- awrina tonqos skond il- pH u diversi solubbli, l- aktar ketajins.
In addition, in complicated UTI, biofilm formation may play an important role where susceptibility of the pathogens is several folds reduced compared with planctonic or pure culture cells.
Barraminhekk, f’ UTI kumplikata, il- formazzjoni ta ’
100 mg bid, may be
4 bijorita tista ’ tilgħab rwol importanti fejn is- suxxettibilità tal- patoġeni tkun diversi drabi mnaqqsa meta mqabbla ma ’ ċelloli planktoniċi jew ta ’ kultura pura.
4 sufficient for the treatment of uncomplicated UTI, while for the treatment of complicated UTI due to Pseudomonas aeruginosa at least a dose of 500 mg bid of ciprofloxacin is needed (equivalent to 400 mg intravenous twice daily).
Naber et al (2) stabbilew it- tajters batteriċi urinarji (UBT) ex vivo ta ’ diversi fluoroquinolones u kkonkludew li għal razza suxxettibbli ħafna ta ’ E. coli, doża baxxa ta ’ ciprofloxacin, pereżempju 100 mg bid, tista ’ tkun biżżejjed għat- trattament ta ’ UTI mhux kumplikata, filwaqt li għat- trattament ta ’ UTI kumplikata minħabba Pseudomonas aeruginosa hija meħtieġa talanqas doża ta ’ 500 mg bid ta ’ ciprofloxacin (ekwivalenti għal 400 mg fil - vini darbtejn kuljum).
It has been shown that exposure to quinolones at subinhibitory concentrations significantly increase the mutation rate in E. coli, staphylococci, pneumococci and Mycobacterium spp., as well as selecting for resistance per se (3).
Ġie muri li l- esponiment għall- quinolones f’ konċentrazzjonijiet subinibitorji jżid b’ mod sinifikanti r - rata ta ’ tibdil fl- E. coli, stafilokokki, pnewmokokki u Mycobacterium spp., kif ukoll jagħżel għar - reżistenza per se (3).
The importance of using dosage regimens of fluoroquinolones leading to in vivo concentrations exceeding the mutant prevention concentrations, thus avoiding first-step mutants, is currently stressed by leading experts within the field.
L- importanza li jintużaw reġimi ta ’ dożaġġ ta ’ fluoroquinolones li jwasslu għal konċentrazzjonijiet in vivo li jaqbżu l- konċentrazzjonijiet ta ’ prevenzjoni tal- mutanti, biex hekk jiġu evitati l- mutanti ta ’ l- ewwel fażi, attwalment hija enfasizzata minn esperti ewlenin f’ dan il- kamp.
An adequate dosing, in order to achieve optimal clinical efficacy and to prevent emergence of antimicrobial resistance, is therefore crucial both for the individual patient and for the society, especially in light of the current increase of resistant uropathogens.
Dożaġġ adegwat, bil- għan li tinkiseb effikaċja klinika ottimali u biex jiġi impedit it- tfaċċar ta ’ reżistenza antimikrobika, huwa għalhekk kruċjali kemm għall- pazjent individwali kif ukoll għas - soċjetà, speċjalment fid- dawl taż- żieda attwali ta ’ uropatoġeni reżistenti.
To support the proposed maximum dose of 1200 mg (400 mg three times daily) instead of 800 mg, the applicant/ MAH referred to the published literature.
Biex isostni d- doża massima proposta ta ’ 1200 mg (400 mg tliet darbiet kuljum) minflok ta ’ 800 mg, l - applikant/ MAH irrefera għal- letteratura ippubblikata.
No clinical studies in the treatment of complicated or life-threatening urinary tract infections with the high 1200 mg intravenous [or 1500 mg peroral] maximum dose proposed, were included or reviewed.
L- ebda studji kliniċi dwar it- trattament ta ’ infezzjonijiet ikkumplikati fl- apparat urinarju jew ta ’ theddida għall- ħajja bid- doża massima għolja proposta ta ’ 1200 mg fil- vini [jew 1500 mg mill- ħalq], ma kienu inklużi jew evalwati.
However the published data presented demonstrated the safety and efficacy of thus high-dose ciprofloxacin (daily dose of with or without an option to oral switch, in various serious and life threatening infections (severe pneumonia, neutropenia, acute bacterial exacerbations of chronic bronchitis, complicated, community-acquired skin and skin structure infections, infections in cancer patients and bacteraemia).
Madankollu l- informazzjoni ippubblikata li ġiet ippreżentata wriet is - sigurtà u l- effikaċja ta ’ ciprofloxacin f’ doża hekk għolja (doża kuljum bi jew mingħajr opzjoni għal qalba orali, f’ diversi infezzjonijiet serji u ta ’ theddida għall- ħajja (pulmonite severa, newtropenja, aggravazzjonijiet batteriċi akuti ta ’ bronkite kronika, infezzjonijiet ikkumplikati tal- ġilda jew ta ’ l - istruttura tal- ġilda, akkwiżiti mill- komunità, infezzjonijiet f’ pazjenti morda bil- kanċer u batterimja).
The treatment was well tolerated, the most commonly occurring adverse event were gastrointestinal disorders.
It - trattament kien ittollerat tajjeb, l- aktar episodju avvers li seħħ b’ mod komuni kienu disturbi gastro - intestinali.
The frequencies of probably and/ or possibly drug-related adverse events did not differ significantly between ciprofloxacin-treated patients and the comparator groups.
Il- frekwenzi ta ’ l- episodji avversi probabbli jew possibbilment relatati mal- mediċina ma varjawx b’ mod sinifikanti bejn il- pazjenti trattati b’ ciprofloxacin u l- gruppi ta ’ tqabbil.
In light of the increasing rate of quinolone resistance in urinary pathogens in Europe, an optimal dosage regimen is therefore considered important, because underdosing may lead to an impaired clinical response and pose a risk for emergence of resistant strains.
Fid- dawl tar- rata li qiegħda tiżdied ta ’ reżistenza għall- quinolone f’ patoġeni urinarji fl- Ewropa, reġim ta ’ dożaġġ ottimali għalhekk huwa meqjus importanti, minħabba li doża baxxa tista ’ twassal għal rispons kliniku indebolit u toħloq riskju għat- tfaċċar ta ’ forom reżistenti.
Resistance development is beside absolute quantitative use of quinolone agents also driven by pharmacokinetic and pharmacodynamic (PK/ PD) factors.
L- iżvilupp tar- reżistenza huwa apparti mill- użu kwantitattiv assolut misjuq minn fatturi farmakokinetiċi u farmakodinamiċi (PK/ PD).
Current PK/ PD data stress the importance of adequate dosing in order to circumscribe emergence of resistance.
L- informazzjoni PK/ PD attwali tenfasizza l- importanza ta ’ dożaġġ adegwat biex jiġi limitat it- tfaċċar mill- ġdid ta ’ reżistenza.
These recommendations are also in line with current treatment guidelines, with clinical practice in most European countries and with the recommendations of previously approved European original and generic ciprofloxacin products.
Dawn ir- rakkomandazzjonijiet huma wkoll konformi mal- linji gwida kurrenti dwar it- trattament, mal - metodi kliniċi fil- maġġoranza tal- pajjiżi Ewropej u mar- rakkomandazzjonijiet ta ’ prodotti ciprofloxacin oriġinali u ġenerali Ewropej approvati qabel.
The daily dose of 1200 mg should not however be exceeded.
Id- doża ta ’ 1200 mg fil- ġurnata madankollu m’ għandhiex tinqabeż.
References (not all submitted are listed)
Referenzi (mhumiex elenkati dawk kollha li ġew sottomessi)
Once-Daily Fleroxacin Versus Twice-Daily Ciprofloxacin in the Treatment of Complicated Urinary Tract InfectionsJ Urol 1997; 158:
Fleroxacin Once- Daily Fleroxacin Versus Twice- Daily Ciprofloxacin in the Treatment of Complicated Urinary Tract InfectionsJ Urol 1997; 158:
5 GROUNDS FOR AMENDMENT OF THE PRODUCT INFORMATION
5 RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJU( I) TAL- KARATTERISTIĊI TAL - PRODOTT
- The body of published literature and resistance data presented provide adequate justification, both
- Il- korp tal- letteratura ippubblikata u l- informazzjoni dwar ir- reżistenza li ġiet ippreżentata jipprovdu
from an efficacy and safety viewpoint, for the dosing regimen of 200-400 mg ciprofloxacin twice daily for the treatment of complicated UTI.
ġustifikazzjoni adegwata, kemm mill- aspett ta ’ l- effikaċja kif ukoll tas- sigurtà, għar- reġim ta ’ dożaġġ ta ’ 200- 400 mg ciprofloxacin darbtejn kuljum għat- trattament ta ’ UTI ikkumplikata.
- This product being a solution intended for intravenous infusion, should be restricted to the treatment
- Dan il- prodott peress li huwa soluzzjoni intiża għal infużjoni fil- vini, għandu jkun limitat għat -
of complicated UTI’ s.
trattament ta ’ UTIs ikkumplikati.
- From the published data, which have demonstrated for the proposed maximum dose 400 mg
- Mill- informazzjoni ippubblikata, li għad- doża massima proposta ta ’ 400 mg fil- vini tliet darbiet
intravenous three times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is no reason to conclude that this favourable risk/ benefit profile would differ significantly in the treatment of complicated UTIs.
kuljum bħala doża massima, uriet prevenzjoni superjuri tar- reżistenza antibijotika mingħajr żieda sinifikanti fir- reazzjonijiet avversi f’ infezzjonijiet serji u ta ’ periklu għall- ħajja ta ’ sistemi ta ’ organi oħra, ma hemm l- ebda raġuni biex wieħed jikkonkludi li dan il- profil favorevoli tar- riskju/ benefiċċju se jvarja b’ mod sinifikanti fit- trattament ta ’ UTIs ikkumplikati.
The CHMP has recommended the granting of the Marketing Authorisation(s), as well as the text to be included in the Summary of Product Characteristics, Package Leaflet and Labelling.
Il- CHMP irrakkomanda l- għoti ta ’ l- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq u l- bidliet fis - Sommarju tal- Karatteristiċi tal- Prodott tar- RMS.
These are set out in Annex III for Ciprofloxacin Nycomed and associated names (see Annex I).
Dawn huma spjegati fl- Anness III għal Ciprofloxacin Nycomed u ismijiet assoċjati (ara Anness I).
6 ANNEX III
6 ANNESS III
AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET AND LABELLING
EMENDI GĦAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
7 SUMMARY OF PRODUCT CHARACTERISTICS
7 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
8 The following text shall be included in the Summary of Product Characteristics:
8 It test li ġej għandu jiġi inkluż fis- Sommarju tal- Karatteristiċi tal- Prodott:
Treatment of the following infections in adults when caused by ciprofloxacin susceptible organisms, when oral therapy is not possible or not reliable:
Trattament għall- infezzjonijiet li ġejjin f’ adulti meta dawn jiġu kkaġunati minn organiżmi suxxetibbli għal ciproflaxacin meta terapija orali mhix possibbli jew mhix afidabbli:
- Pneumonia caused by aerobe gram-negative bacteria.
- Pnewmonja kkaġunata minn batterja gramm- negattiva.
Ciprofloxacin is not the active substance
Ciproflaxin mhux is- sustanza attiva ta ’ l -
of choice for the treatment of pneumonia caused by S. pneumoniae.
għażla għal trattament ta ’ pnewmonja kkaġunata minn S. pneumoniae.
- Complicated urinary tract infections
- Infezzjonijiet kumplikati ta ’ l- apparat urinarju
- Bacterial enteritis
- Enterite batterika
- Skin and soft tissue infections caused by gram-negative bacteria
- Infezzjonijiet tal- ġilda u tat- tessut artab ikkaġunati minn batterja gramm- negattiva
- Osteomyelitis
- Osteomajlite
- Intra-abdominal infections (the anaerobic component should be covered by an appropriate
- Infezzjonijiet intra- addominali (il- komponent anerobiku jista ’ jiġi kopert minn sustanza
antibacterial agent)
antibatterika adattata)
- Infections in immune-suppressed patients
- Infezzjonijiet f’ pazjenti imuno- kompromessi.
Children and adolescents Acute pulmonary exacerbation of cystic fibrosis in children and adolescents (5-17 years) caused by Pseudomonas aeruginosa.
Tfal u adoloxxenti Tħarriex pulmonari akut ta ’ fibrożi ċistika fi tfal u adoloxxenti (5- 17- il sena) ikkaġunati minn Pseudomonas aeruginosa.
Ciprofloxacin Nycomed is not indicated for other infections in this age group.
Ciprofloxacin Nycomed mhux indikat għal infezzjonijiet oħra f’ dan il- grupp ta ’ etajiet.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata konsiderazzjoni għal gwida uffiċjali dwar l- użu xieraq ta ’ sustanzi antibatteriċi.
The dosage of intravenous ciprofloxacin is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight and renal function of the patient.
Id- doża ta ’ ciprofloxacin fil- vini hija stabbilita mis- severità u t- tip ta ’ l- infezzjoni, is- sensittività ta ’ l - organiżmu( i) kawżattivi u l- età, il- piż u l- funzjoni renali tal- pazjent.
The usual dosage range for adults is 200-400mg twice daily.
Il- medda ta ’ dożi rakkomandata għall- adulti f’ tipi differenti ta ’ infezzjonijiet hija mogħtija fit- tabella hawn isfel.
In very serious or life threatening infections, the dosage can be increased to 400 mg three times daily.
Il- medda normali tad- dożi għall- adulti hija 200- 400 mg darbtejn kuljum.
The product may be infused directly and administered by short-term infusion over periods of 30-60 minutes.
F’ infezzjonijiet serji ħafna jew ta ’ periklu għall- ħajja, id- doża tista ’ tiżdied għal 400 mg tliet darbiet kuljum.
The 400mg dose should be administered over a period of 60 minutes.
Il- prodott jista ’ jiġi infuż direttament u jingħata b’ infużjoni qasira fuq perjodi ta ’ 30- 60 minuta.
Initial intravenous administration may be followed by oral treatment.
Id- doża ta ’ 400 mg għandha tingħata fuq perjodu ta ’ 60 minuta.
The product should not be mixed with other drug products that are chemically or physically unstable at its pH of 3.9-4.5 (see section 6.2).
Il- prodott m’ għandux jitħallat ma ’ prodotti tal- mediċina oħrajn li huma kimikament jew fiżikament instabbli fil- pH tiegħu ta ’ 3. 9- 4. 5 (ara sezzjoni 6. 2).
However, Ciprofloxacin 2mg/ ml Solution for Infusion has been shown to be compatible with Ringer's solution, 0.9% sodium chloride solution, 5% and 10% glucose solutions, glucose/ saline and fructose 10% solution.
Madankollu, Ciprofloxacin 2 mg/ ml Soluzzjoni għal Infużjoni ntwera li huwa kompatibbli mas- soluzzjoni ta ’ Ringer, soluzzjoni ta ’ 0. 9% sodium chloride, soluzzjonijiet ta ’ 5% u 10% glucose, u soluzzjoni ta’ glucose/ saline u fructose 10%.
Unless compatibility is proven, the infusion solution should always be administered separately.
Sakemm ma tiġix ippruvata l- kompatibilità, is- soluzzjoni għal infużjoni għandha dejjem tingħata għaliha.
In addition, discard any unused portion of product immediately after use.
Barra minnhekk, kull fdal mhux użat tal- prodott għandu jintrema immedjatament wara l- użu.
Adults The following dosages for specific types of infection are recommended:
Adulti Huma rakkomandati d- dożi li ġejjin għal tipi speċifiċi ta ’ infezzjonijiet:
Indication Pneumonia caused by aerobe gram-negative bacteria Complicated urinary tract infections
Indikazzjoni Pnewmonja kkawżata minn batterji aerobji gram- negattivi Infezzjonijiet kumplikati ta ’ l- apparat urinarju Infezzjoni fil- partijiet ta ’ fuq u ta ’ isfel ta ’ l- apparat respiratorju (tiddependi fuq is- severità u s- sensittività ta ’ l - organiżmu kawżattiv)
Dose intravenous (mg ciprofloxacin) 200-400 mg twice daily 200-400mg twice daily
Doża fil- vina (mg ciprofloxacin) 200- 400 mg darbtejn kuljum 200- 400 mg darbtejn kuljum 200- 400 mg darbtejn kuljum
Upper and lower respiratory tract infection (depending on 200-400mg twice daily severity and sensitivity of causative organism) Cystic fibrosis patients with pseudomonal lower RTI* Other infections (as detailed under 4.1)
Pazjenti b’ fibrożi ċistika b’ RTI psewdomonali aktar baxx * Infezzjonijiet oħra (kif dettaljati taħt 4. 1)
400mg twice daily 200-400mg twice daily.
400 mg darbtejn kuljum 200- 400 mg darbtejn kuljum.
* Although the pharmacokinetics of ciprofloxacin remains unchanged in adult patients with cystic fibrosis, the low bodyweight of these patients should be taken into consideration when determining dosage.
ċistika, il- piż tal- ġisem baxx ta ’ dawn il- pazjenti għandu jiġi kkunsidrat meta tiġi stabbilita d- doża.
9 Impaired Renal function The following dose adjustments are recommended:
9 Funzjoni tal- kliewi indebolita Huma rakkomandati l- aġġustamenti li ġejjin fid- doża:
Creatinine clearance ml/ min 31-60 creatinine clearance (serum creatinine 120-170 µmol/ l) ≤ 30 creatinine clearance (serum creatinine > 175 µmol/ l)
31- 60 tneħħija tal- krejatinina (krejatinina fis- serum 120- 170 µmol/ l) ≤ 30 tneħħija tal- krejatinina (krejatinina fis- serum > 175 µmol/ l)
Recommended dose adjustment Maximum daily dose intravenous 800 mg, divided in two doses Maximum daily dose intravenous, 400 mg*
Doża massima ta ’ kuljum fil- vini 800 mg, maqsuma f’ żewġ dożi Doża massima ta ’ kuljum fil- vini, 400 mg *
*Patients in haemodialysis:
* Pazjenti f’ dijalisi tad- demm:
On the day of dialysis the dose of Ciprofloxacin Nycomed should be given intravenously after dialysis.
Dakinhar tad- dijalisi d- doża ta ’ Ciprofloxacin Nycomed għandha tingħata fil- vini wara d- dijalisi.
Monitoring of drug serum levels provides the most reliable basis for dose adjustment.
Il- monitoraġġ tal- livelli tal- mediċina fis- serum jipprovdi l- aktar bażi affidabbli għall- aġġustament fid - doża.
Impaired hepatic function No adjustment of dosage is necessary.
Funzjoni tal- fwied indebolita M’ hemmx bżonn ta ’ aġġustament fid- doża.
Elderly Although higher ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary.
Anzjani Għalkemm wieħed isib livelli aktar għoljin ta ’ ciprofloxacin fis- serum fl- anzjani, m’ hemmx bżonn ta ’ aġġustament fid- doża.
Adolescents and children Ciprofloxacin Nycomed is not recommended for use in children below 18 years of age.
Adoloxxenti u tfal Ciprofloxacin Nycomed mhux rakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena.
As with other medicinal products in its class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals.
Bħal prodotti mediċinali oħra fil- kategorija tiegħu, ciprofloxacin ġie muri li jikkawża artropatija fil - ġogi li jġorru l- piż ta ’ annimali mhux żviluppati.
However analysis of available safety data from ciprofloxacin used in patients below 18 years for which the majority had cystic fibrosis, did not disclose any evidence of drug related cartilage or articular damage,.
Madankollu l- analiżi ta ’ l- informazzjoni disponibbli dwar is- sigurtà tal- mediċina minn ciprofloxacin użat f’ pazjenti ta ’ taħt it- 18- il sena li l- maġġoranza tagħhom kellhom fibrożi ċistika, ma wriet l- ebda evidenza ta ’ kartilaġini marbuta mal- mediċina jew ħsara artikulari.
Clinical and pharmacokinetic data support the use of ciprofloxacin in paediatric cystic fibrosis patients (aged 5-17 years) with acute pulmonary exacerbation associated with P. aeruginosa infection, at a dose of 10mg/ kg intravenous three times daily (maximum daily dose 1200mg), see section 4.4 and 5.2.
Informazzjoni klinika u farmakokinetika ssostni l- użu ta ’ ciprofloxacin f’ pazjenti pedjatriċi (età 5- 17 - il sena) li għandhom fibrożi ċistika b’ aggravament pulmonari assoċjat ma ’ infezzjoni ta ’ P. aeruginosa, f’ doża ta ’ 10 mg/ kg fil- vini tliet darbiet kuljum (doża massima ta ’ kuljum ta ’ 1200 mg), ara sezzjoni 4. 4 u 5. 2.
The infusion should be administered over 60 minutes.
L- infużjoni għandha tingħata fuq 60 minuta.
10 LABELLING
10 TIKKETTA
OUTER CARTON {50 ml vial, 100 ml and 200 ml vial}
KARTUNA TA ’ BARRA {Kunjett ta ’ 50 ml, kunjett ta ’ 100 ml u kunjett ta ’ 200}
Ciprofloxacin Nycomed 2mg/ ml solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloxacin Nycomed 2 mg/ ml soluzzjoni għall- infużjoni [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Ciprofloxacin lactate corresponding to 2 mg of ciprofloxacin
Ciprofloxacin lactate li jikkorispondi għal 2 mg ta ’ ciprofloxacin
Excipents:
Sustanzi mhux attivi:
Hydrochloric acid, lactic acid, sodium chloride, water for injection
Hydrochloric acid, lactic acid, sodium chloride, ilma għall- injezzjoni
Solution for Infusion 50 ml vial 100 ml vial 200 ml vial
Soluzzjoni għall- infużjoni Kunjett ta ’ 50 ml Kunjett ta ’ 100 ml Kunjett ta ’ 200 ml
Intravenoususe.
Użu ġol- vina.
Do not use if crystals are present.
Tużax jekk hemm kristalli preżenti.
EXP.
JIS.
Discard any unused portion of the product immediately after use.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
12 11.
12 Kull fdal tal- prodott li ma jkunx intuża għandu jintrema mill- ewwel wara l- użu.
LABEL {50 ml vial, 100 ml vial and 200 ml vial}
TIKKETTA {Kunjett ta ’ 50 ml, kunjett ta ’ 100 ml u kunjett ta ’ 200}
Ciprofloxacin Nycomed 2mg/ ml Solution for Infusion [See Annex I - To be completed nationally]
Ciprofloxacin Nycomed 2 mg/ ml Soluzzjoni għall- Infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
intravenous
Użu ġol- vina
14 PACKAGE LEAFLET
14 FULJETT TA ’ TAGĦRIF
15 The following text shall be included in the Package Leaflet:
15 It- test li ġej għandu jiġi inkluż fil- Fuljett ta ’ Tagħrif:
WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
X’ INHU CIPROFLOXACIN U GĦALXIEX JINTUŻA
Ciprofloxacin is an antibiotic agent belonging to the group called quinolones.
Ciprofloxacin huwa sustanza antibijotika li tappartjeni għall- grupp imsejjaħ quinolones.
It acts by killing bacteria that can cause infections.
Dan jaġixxi billi joqtol batterji li jikkaġunaw infezzjonijiet.
Ciprofloxacin Nycomed is used for the treatment of several types of infections in adults such as pneumonia, certain types of urinary tract infections, infections in the prostate, infections in the abdomen and around the gut, certain skin infections, infections in the bones and of infections in patients with poor immune system.
Ciprofloxacin Nycomed jintuża għat- trattament ta ’ diversi tipi ta ’ infezzjonijiet f’ adulti bħal pnewmonja, ċertu tipi ta ’ infezzjonijiet ta ’ l- apparat urinarju, infezzjonijiet tal- prostata, infezzjonijiet ta ’ l- addome u madwar l- imsaren, ċertu tipi ta ’ infezzjonijiet tal- ġilda, infezzjonijiet ta ’ l- għadam u ta ’ infezzjonijiet għal pazjenti li għandhom sistema immunitarja dgħajfa.
In children and teenagers (age 5-17) who have cystic fibrosis, Ciprofloxacin Nycomed may also be used for treating certain types of lung infections.
Fi tfal u teenagers (etajiet ta ’ bejn 5- 17- il sena) li għandhom fibrożi ċistika, Ciprofloxacin Nycomed jista ’ jintuża biex jikkura ċertu tipi ta ’ infezzjonijiet tal- pulmun.
HOW TO USE CIPROFLOXACIN
KIF GĦANDEK TIEĦU CIPROFLOXACIN
Ciprofloxacin Nycomed will be administered by your doctor or a specialist.
Ciprofloxacin Nycomed ser jingħata lilek mit- tabib jew speċjalista tiegħek.
The dose and the duration of the treatment are depending upon the severity and type of your infection.
Id- doża u ż- żmien ta ’ kemm idum it- trattament jiddependu mis- severità u t- tip ta ’ infezzjoni li għandek.
However it is important that you are given a complete course of the treatment, even if you begin to feel better after a few days, otherwise your symptoms may return.
Madankollu hu importanti li tingħata kors sħiħ tat- trattament, anke jekk tibda tħossok aħjar wara ftit jiem, inkella s- sintomi tiegħek jistgħu jirritornaw.
Adults Complicated urinary tract infections, Respiratory tract infections, Pneumonia and other infections 200 – 400 mg twice daily.
Adulti Infezzjonijiet kumplikati ta ’ l- apparat urinarju, infezzjonijiet tal- passaġġ respiratorju, Pnewmonja u infezzjonijiet oħra 200- 400 mg darbtejn kuljum
The maximum daily dose in very serious or life-threatening infections can be up to 1200 mg daily, administered as 400 mg three times daily
Id- doża massima ta ’ kuljum għal infezzjonijiet serji jew li huma ta ’ periklu għal ħajja tista ’ tkun sa 1200 mg kuljum, li tingħata bħala 400 mg tliet darbiet kuljum.
Adolescents and Children (age 5 – 17 years) Acute pulmonary exacerbation in paediatric cystic fibrosis patients:
Adoloxxenti u Tfal (etajiet ta ’ bejn 5 - 17- il sena) Tħarriex pulmonari akut f’ pazjenti tfal b’ fibrożi ċistika:
10 mg/ kg three times daily (maximum 1200 mg daily), or 10 mg/ kg intravenous three times daily (maximum 1200 mg daily) followed by 20 mg/ kg orally twice daily (maximum 1500 mg daily)
Doża ta ’ 10 mg/ kg tliet darbiet kuljum (massimu ta ’ 1200 mg kuljum), jew 10 mg/ kg ġol vina tliet darbiet kuljum (massimu ta ’ 1200 mg kuljum) segwita b’ doża ta ’ 20 mg/ kg darbtejn kuljum mill- ħalq (massimu ta ’ 1500 mg kuljum)
Duration of treatment Adults The usual duration of treatment is between 5 -7 days, but it may be longer if your infection is more persistent or severe.
Kemm jieħu żmien it- trattament Adulti Ġeneralment it- trattament idum sejjer għal bejn 5- 7 ijiem, imma jista ’ idum aktar jekk l- infezzjoni tiegħek hija aktar persistenti jew severa.
Children and adolescent (aged 5 – 17 years):
Tfal u adoloxxenti (ta ’ etajiet bejn 5- 17- il sena):
The duration of treatment for certain lung infections in children and adolescents with cystic fibrosis is 10 – 14 days.
Iż- żmien ta ’ trattament fi tfal u adoloxxenti b’ fibrożi ċistika li għandhom ċertu infezzjonijiet tal - pulmun hu ta ’ bejn 10- 14- il jum.
London, 23 January 2008 EMEA/ CHMP/ 350278/ 2007
Londra, 23 ta ’ Jannar 2008 EMEA/ CHMP/ 350278/ 2007
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦAL UŻU MILL- BNIEDEM (CHMP)
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Nycomed and associated names International Non-Proprietary Name (INN):
OPINJONI WARA REFERENZA TA ’ L- ARTIKOLU 29( 4) 1 GĦAL Ciprofloxacin Nycomed u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI):
BACKGROUND INFORMATION Ciprofloxacin Nycomed and associated names, 2 mg/ ml Solution for Infusion, is an antibiotic belonging to the quinolone family effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Ciprofloxacin Nycomed u d- denominazzjonijiet assoċjati, 2 mg/ ml Soluzzjoni għal Infużjoni, huwa antibijotiku li jappartjeni għall- familja tal- kinoloni (quinolones), effikaċi in vitro, kontra numru kbir ta ’ batterji aerobiċi Gram- negattivi kif ukoll kontra xi organiżmi Gram- pożittivi.
Nycomed Danmark ApS submitted applications for mutual recognition of Ciprofloxacin Nycomed and associated names, 2 mg/ ml Solution for Infusion, on the basis of the marketing authorisation granted by United Kingdom on 23 March 2005.
Nycomed Danmark ApS ressqet applikazzjonijiet għar- rikonoxximent reċiproku ta ’ Ciprofloxacin Nycomed u ismijiet assoċjati, 2 mg/ ml Soluzzjoni għal Infużjoni, fuq il- bażi ta ’ l- awtorizzazzjoni għat - tqegħid fis- suq mogħtija mir- Renju Unit fit- 23 ta ’ Marzu 2005.
The Mutual Recognition Procedure started on 15 November 2005.
Il- Proċedura ta ’ Rikonoxximent Reċiproku bdiet fil- 15 ta ’ Novembru 2005.
The Reference Member State was United Kingdom and the Concerned Member States were Denmark, Finland, Norway and Sweden.
L- Istat Membru ta ’ Referenza kien ir- Renju Unit u l- Istati Membri Konċernati kienu d- Danimarka, il- Finlandja, in- Norveġja u l- Iżvezja.
These Member States were not able to reach an agreement with respect to the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma setgħux jilħqu ftehim fir- rigward tar- Rikonoxximent Reċiproku ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- suq mogħtija mill- Istat Membru ta ’ Referenza.
United Kingdom referred the reasons for disagreement to the EMEA on 5 May 2006.
Ir- Renju Unit irrefera r- raġunijiet għan- nuqqas ta ’ ftehim lill- EMEA fil- 5 ta ’ Mejju 2006.
Significant differences were identified with regards to the approved posology for complicated urinary tract infections and the maximum daily dose for this generic intravenous ciprofloxacin product.
Ġew identifikati differenzi sinifikanti fir- rigward tal- pożoloġija approvata għal infezzjonijiet ikkumplikati fl - apparat urinarju u d- doża massima ta ’ kuljum għal dan il- prodott ġeneriku abbażi ta 'ciprofloxacin għall- użu intravenuż (fil- vina).
These issues were considered to be of serious public health concern.
Dawn il- kwistjonijiet ġew ikkunsidrati bħala ta ’ tħassib serju għas- saħħa pubblika.
The proposed dosage regimen for complicated urinary tract infections (100 mg bid) was considered too low and should be changed to 200-400 mg twice daily.
Ir - reġim propost tad- doża għal infezzjonijiet ikkumplikati fl- apparat urinarju (100 mg darbtejn kuljum) kien baxx wisq u għandu jinbidel għal 200- 400 mg darbtejn kuljum.
Further, as patients referred to parenteral treatment often are seriously ill, it was felt of importance that a maximum dosage of 1200 mg (400 mg three times daily) instead of 800 mg be permitted.
Barra minn hekk, minħabba li pazjenti li ġew sottoposti għal trattament parenterali ta ’ spiss ikunu ma jifilħux serjament, inħass importanti li tkun permessa doża massima ta ’ 1200 mg (400 mg tliet darbiet kuljum) minflok 800 mg.
The arbitration procedure started on 1 June 2006 with the adoption of a list of questions.
Il- proċedura ta ’ arbitraġġ bdiet fl- 1 ta ’ Ġunju 2006 bl- adozzjoni tal- lista ta ’ mistoqsijiet.
The Rapporteur was Dr Hudson and Co-Rapporteur(s) was Dr Ljungberg.
Ir- Rapporteur kien id- Dr Hudson u l- Korapporteur( s) kien id- Dr Ljungberg.
The Marketing Authorisation Holder provided written explanations on 21 September 2006.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq ta spjegazzjonijiet bil- miktub fil- 21 ta ’ Settembru 2006.
During their 13-16 November 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Ciprofloxacin Nycomed and associated names, that the objections raised by Norway and Sweden should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Matul il- laqgħa tagħhom tat- 13- 16 ta ’ Novembru 2006, is- CHMP, fid- dawl tad- dejta kollha ppreżentata u fid- dawl tad- diskussjoni xejntifika fi ħdan il- Kumitat, kien ta 'l- opinjoni li l- proporzjon bejn il- benefiċċju u r - riskju kien wieħed favorevoli għal Ciprofloxacin Nycomed u denominazzjonijiet assoċjati, li l - objezzjonijiet imqajma min- Norveġja u mill- Iżvezja ma għandhomx jimpedixxu l- għoti ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif ta ’ l- Istat Membru ta ’ Referenza għandhom jiġu emendati.
A positive opinion was adopted by consensus on 16 November 2006.
Ġiet adottata opinjoni pożittiva, b’ konsensus, fis- 16 ta ’ Novembru 2006.
On 21 June 2007 the CHMP, in order to focus and facilitate the translations of the specific amendments in the Summary of Product Characteristics, adopted a revised opinion with amended Annex II and Annex III, which was further reconsidered in October 2007.
Fil- 21 ta ’ Ġunju 2007, is- CHMP, sabiex jiffoka u jiffaċilita t- traduzzjonijiet ta ’ l- emendi speċifiċi fis- Sommarju tal- Karatteristiċi tal- Prodott, adotta opinjoni riveduta b’ Anness II u b’ Anness III emendati, li ġiet rikunsidrata aktar f’ Ottubru 2007.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA ’ L- ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L - APPLIKANT( S), ID- DETENTUR( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ FL- ISTATI MEMBRI
Marketing Authorisation Holder
Isem Ivvintat losartan potassium
Invented name
Qawwa
Strength
Għamla
Route of administration
għat- tqegħid fis- suq
Merck Sharp & Dohme GmbH Donau-City-Straße 6 1220 Wien Austria
Merck Sharp & Dohme GmbH Donau- City- Straße 6, 1220 Wien L- Awstrija
Belgium
100 mg losartan potassium - 25 mg hydrochlorothiazide
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels Belgium
Pillola miksija b’ rita
COZAAR PLUS FORTE 100 MG/ 25 MG
Jittieħed mill- ħalq
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Il- Belġju
Oral use
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B- 1180 Brussels Il- Belġju
Belgium
COZAAR PLUS FORTE 100 100 mg losartan MG/ 25 MG potassium - 25 mg hydrochlorothiazide
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels Belgium
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B- 1180 Brussels Il- Belġju
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Pillola miksija b’ rita
Belgium
Therabel Pharma S. A. - Rue Egide LOORTAN PLUS FORTE 100 100 mg losartan Van Ophem 108 - B- 1180 Brussels, MG/ 25 MG potassium - Il- Belġju 25 mg hydrochlorothiazide
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Pillola miksija b’ rita
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Therabel Pharma S. A. - Rue Egide LOORTAN PLUS 50 MG/ 12, 5 50 mg losartan Van Ophem 108 - B- 1180 Brussels, MG potassium - Il- Belġju 12, 5 mg hydrochlorothiazide
Bulgaria
2 Il- Bulgarja
1407 Sofia Bulgaria
1407 Sofia Il- Bulgarja
Pharmaceutical Form
Pillola miksija b’ rita
Route of administration
Jittieħed mill- ħalq
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Merck Sharp & Dohme BV, Postbus FORTZAAR 581, 2003 PC, Haarlem, L- Olanda
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Merck Sharp & Dohme BV, Postbus HYZAAR 581, 2003 PC, Haarlem, L- Olanda
HYZAAR
50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
581, 2003 PC, Haarlem, L- Olanda
Cozaar Comp.
50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Forte 581, 2003 PC, Haarlem, L- Olanda
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
100 mg / 12, 5 581, 2003 PC, Haarlem, L- Olanda mg
100 mg / 12,5 mg
100 mg losartan potassium - 12, 5 mg hydrochlorothiazide
100 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Pillola miksija b’ rita
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Merck Sharp & Dohme BV, Fortzaar Postbus 581, 2003 PC, Haarlem, L- Olanda
100 mg losartan potassium – Film-coated tablets Oral use 25 mg hydrochlorothiazide
Pillola miksija b’ ritas
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia
Merck Sharp & Dohme OÜ HYZAAR Peterburi tee 46, Tallinn 11415, L- Estonja
50 mg losartan potassium - Film-coated tablet Oral use 12.5 mg hydrochlorothiazide
Pillola miksija b’ rita
Estonia
3 L- Estonja
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, L- Estonja
Waarderweg 39 P. O. Box 581 2031 BN Haarlem The Netherlands
Waarderweg 39 P. O. Box 581 2031 BN Haarlem L- Olanda
50 mg losartan potassium - Film-coated tablet Oral use 12.5 mg hydrochlorothiazide
50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
Hoche 75114 Paris Cedex 08 France
Hoche 75114 Paris Cedex 08 Franza
4 Member State
4 Franza
Pharmaceutical Form
Pillola miksija
MSD Chibropharm GmbH Postfach
100 mg/ 12, 5 mg film- coated potassium - tablets 12, 5 mg hydrochlorothiazide
LORZAAR PLUS 50/ 12,5 50 mg
b’ rita
losartan potassium -
Il- Ġermanja
1202 D-85530 Haar Germany
50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
mg Filmtabletten
Pillola miksija b’ rita
12.5 mg hydrochlorothiazide
Jittieħed mill- ħalq
MSD Chibropharm GmbH Postfach
MSD Chibropharm GmbH Postfach CARDOPAL PLUS 50/ 12, 5 1202 D- 85530 Haar, Il- Ġermanja mg Filmtabletten
1202 D-85530 Haar Germany
Pillola miksija b’ rita
50/ 12,5 mg Filmtabletten
Jittieħed mill- ħalq
VARIPHARM ARZNEIMITTEL GMBH Lindenplatz 1 85540, Haar Germany
VARIPHARM ARZNEIMITTEL LORZAAR VARIPHARM GMBH PLUS 50/ 12, 5 mg Lindenplatz 1 85540, Haar Filmtabletten Il- Ġermanja
MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Germany
MSD Chibropharm GmbH Postfach FORTZAAR 100/ 25 mg 1202 D- 85530 Haar, Il- Ġermanja Filmtabletten
FORTZAAR 100/ 25 mg Filmtabletten
100 mg losartan potassium - 25 mg hydrochlorothiazide
VARIPHARM ARZNEIMITTEL
VARIPHARM ARZNEIMITTEL FORTZAAR VARIPHARM
FORTZAAR
100 mg losartan
losartan potassium - Film-coated tablet
Pillola miksija
GMBH Lindenplatz 1 85540, Haar, Germany
GMBH Lindenplatz 1 85540, Haar, Il- Ġermanja
hydrochlorothiazide
potassium - 25 mg hydrochlorothiazide
MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Germany
MSD Chibropharm GmbH Postfach LORZAAR PLUS forte 1202 D- 85530 Haar, Il- Ġermanja 100/ 12, 5 mg Filmtabletten
LORZAAR PLUS forte 100/ 12,5 mg Filmtabletten
100 mg losartan potassium - 12, 5 mg hydrochlorothiazide
Tatoiou Street, Nea Erythraia 14671, Greece
HYZAAR Tatoiou Street, Nea Erythraia 14671, il- Greċja
HYZAAR
Jittieħed mill- ħalq
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
5 Il- Greċja
Tatoiou Street, Nea Erythraia 14671, Greece
Tatoiou Street, Nea Erythraia 14671, Il- Greċja
H-1123 Budapest Hungary
H- 1123 Budapest, L- Ungerija
5 Member State
Hyzaar 50/ 12. 5 mg
Iceland
L- Irlanda
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU Ir- Renju Unit
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
‘ Cozaar ’ Comp 50mg/ 12. 5mg film- coated tablets
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, Ir- Renju Unit
Cozaar’ Comp 100mg/ 25mg film-coated tablets
Pillola miksija b’ rita
Merck Sharp & Dohme Italia S. p. A. via G Fabbroni 6, 00191 Rome Italy
Fabbroni 6, 00191 Rome, L - Italja
Via G Fabbroni 6, 00191 Rome Italy
Via G Fabbroni 6, 00191 Rome, L - Italja
losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
100 mg losartan potassium - 25 mg hydrochlorothiazide
Italy
6 L- Italja
Fabbroni, 6 00191 Rome, Italy
Fabbroni, 6 00191 Rome, L- Italja
Sigma-Tau Industrie Farmaceutiche Riunite S. p. A. - viale Shakespeare 47, 00144 Rome, Italy
Sigma- Tau Industrie Farmaceutiche Riunite S. p. A. - viale Shakespeare 47, 00144 Rome, L- Italja
LOSAZID 50 mg + 12,5 mg compresse rivestite con film
LOSAZID 50 mg + 12, 5 mg 50 mg losartan compresse rivestite con film potassium - 12, 5 mg hydrochlorothiazide
oral use
Jittieħed mill- ħalq
Latvia
Il- Latvija
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga, Latvia
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV- 1013, Riga, Il- Latvija
HYZAAR 50 mg/ 12,5 mg
HYZAAR 50 mg/ 12, 5 mg; 50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga, Latvia
SIA Merck Sharp & Dohme Latvia, Fortzaar 100 mg/ 25 mg Latvija; Skanstes street 13, LV- 1013, Riga, Il- Latvija
UAB Merck Sharp & Dohme, Gelež inio Vilko 18A, LT- 01112 Vilnius Lithuania
UAB Merck Sharp & Dohme, FORTZAAR
FORTZAAR (Losartan/ Hydrochlorothia zide)
100 mg losartan
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Pillola miksija
Marketing Authorisation Holder
Geležinio Vilko 18A, LT - 01112 Vilnius, il- Litwanja
Invented name
(Losartan/ Hydrochlorothiazide)
Pharmaceutical Form
potassium - 25 mg hydrochlorothiazide
Route of administration
b’ rita
UAB Merck Sharp & Dohme, Gelež inio Vilko 18A, LT- 01112 Vilnius Lithuania
UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT - 01112 Vilnius, Il- Litwanja
Luxembourg
7 Il- Lussemburgu
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B- 1180 Brussels, Il- Belġju
Therabel Pharma S. A. - Rue Egide
Therabel Pharma S. A. - Rue Egide LOORTAN PLUS FORTE 100 100 Van Ophem 108 - B- 1180 Brussels, mg/ 25 mg Il- Belġju
LOORTAN PLUS FORTE 100 mg
mg losartan potassium - 25 mg hydrochlorothiazide
losartan potassium - Film-coated tablet
Pillola miksija b’ rita
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Therabel Pharma S. A. - Rue Egide LOORTAN PLUS 50 mg/ 12, 5 50 Van Ophem 108 - B- 1180 Brussels, mg Il- Belġju
LOORTAN PLUS 50 mg/ 12,5 mg
mg losartan potassium - 12, 5 mg hydrochlorothiazide
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Merck Sharp & Dohme Ltd., "Cozaar Comp" 50/ 12. 5 mg Hertfordshire Road, Hoddesdon, pilloli miksija b’ rita Hertfordshire, EN11 9BU, Ir- Renju Unit
Hertfordshire, EN11 9BU United Kingdom
50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
pilloli miksija b’ rita
Pillola miksija b’ rita
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
Merck Sharp & Dohme Ltd., "Cozaar Comp" Hertfordshire Road, Hoddesdon, 100/ 25 mg Hertfordshire, EN11 9BU, Ir- Renju pilloli miksija b’ rita Unit
"Cozaar Comp" 100/ 12,5 mg pilloli miksija b’ rita
100 mg losartan potassium - 25 mg hydrochlorothiazide
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom
Merck Sharp & Dohme Ltd., "Cozaar Comp" Hertfordshire Road, Hoddesdon, 100/ 12, 5 mg Hertfordshire, EN11 9BU, Ir- Renju pilloli miksija b’ rita Unit
"Cozaar Comp" 100/ 25 mg pilloli miksija b’ rita
100 mg losartan potassium - 12, 5 mg hydrochlorothiazide
The Netherlands
L- Olanda
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme Cozaar Plus 100/ 12, 5 PO Box 581 2003 PC Haarlem L- Olanda
Cozaar Plus 100/ 12,5
100 mg losartan potassium - 12, 5 mg hydrochlorothiazide
8 Member State
8 L- Olanda
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem L- Olanda
Cozaar Comp
Il- Polonja
Chł odna 51 00-867 Warsaw Poland
Chłodna 51 00- 867 Warsaw, Il- Polonja
9 Member State
Il- Portugall
Invented name
COZAAR Plus
Strength
50 mg losartan
Box 214 2770-192 Paço d 'Arcos Portugal
Box 214 2770- 192 Paço d 'Arcos, Il- Portugall
Oral use
b’ rita
Portugal
9 Il- Portugall
Box 214 2770-192 Paço d 'Arcos, Portugal
Box 214 2770- 192 Paço d 'Arcos, Il- Portugall
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova 2700-547 Amadora, Portugal
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1- 1° Venda Nova 2700- 547 Amadora, Il- Portugall
BOX 214 Porto Salvo 2780-730 Paço d´Arcos Portugal
BOX 214 Porto Salvo 2780- 730 Paço d´Arcos, Il- Portugall
1A, Clă direa C1, Etaj 3 Sector 1, Bucureş ti Romania
1A, Clădirea C1, Etaj 3 Sector 1, Bucureşti, Ir- Rumanija
Romania
10 FORTZAAR® 100 / 25 mg,, Ir- Rumanija
Merck Sharp & Dohme, inovativna zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana Slovenia
Merck Sharp & Dohme, inovativna HYZAAR zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana, Is- Slovenja
Merck Sharp & Dohme, inovativna zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana Slovenia
Merck Sharp & Dohme, inovativna zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana, Is- Slovenja
C/ Josefa Valcárcel, 38 28027 MADRID Spain
C / Josefa Valcárcel, 38 28027 MADRID, Spanja
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The L- Olanda
Sweden
11 L- Iżvezja
12 Member State
Ir- Renju Unit
Marketing Authorisation Holder
Pillola miksija b’ rita
Invented name
Jittieħed mill- ħalq
Strength
Ir- Renju Unit
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Ir- Renju Unit
COZAAR-COMP 50/ 12.5MG FILM COATED TABLETS
COZAAR- COMP 50/ 12. 5MG 50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
50 mg losartan potassium - 12.5 mg hydrochlorothiazide
COZAAR- COMP Forte 100 mg losartan potassium - 25 mg hydrochlorothiazide
United Kingdom
L- Iżlanda
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem L- Olanda
COZAAR-COMP 100/ 25MG FILM COATED TABLETS
COZAAR- COMP 100/ 12. 5MG 100 mg losartan potassium - 12, 5 mg hydrochlorothiazide
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Cozaar Comp 50 mg losartan potassium - 12, 5 mg hydrochlorothiazide
United Kingdom
12 In- Norveġja
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
100 mg losartan potassium - 12, 5 mg hydrochlorothiazide
COZAAR-Comp 100 mg/ 12.5 mg Film- coated tablets
Pillola miksija b’ rita
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦAL EMENDA TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
14 SCIENTIFIC CONCLUSIONS
14 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR COMP.
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ COZAAR COMP.
AND ASSOCIATED NAMES (SEE ANNEX I)
U ISMIJIET ASSOĊJATI (ARA ANNESS I)