natgillin/translations-raw huggingface dataset:
8 The following text shall be included in the Summary of Product Characteristics:
8 V Povzetek glavnih značilnost zdravila bo vključeno naslednje besedilo:
Treatment of the following infections in adults when caused by ciprofloxacin susceptible organisms, when oral therapy is not possible or not reliable:
Zdravljenje naslednjih okužb pri odraslih, ki jih povzročajo organizmi, dovzetni za ciprofloksacin, kadar peroralno zdravljenje ni mogoče ali ni zanesljivo:
- Pneumonia caused by aerobe gram-negative bacteria.
- pljučnica, ki jo povzročajo aerobne gramnegativne bakterije.
Ciprofloxacin is not the active substance
Ciprofloksacin ni zdravilna
of choice for the treatment of pneumonia caused by S. pneumoniae.
učinkovina izbere za zdravljenje pljučnice, ki jo povzroča S. pneumoniae;
- Complicated urinary tract infections
- zapletene okužbe sečil;
- Prostatitis
- prostatitis;
- Bacterial enteritis
- bakterijski enteritis;
- Skin and soft tissue infections caused by gram-negative bacteria
- okužbe kože in mehkih tkiv, ki jih povzročajo gramnegativne bakterije;
- Osteomyelitis
- osteomielitis;
- Intra-abdominal infections (the anaerobic component should be covered by an appropriate
intraabdominalne okužbe (anaerobno komponento je treba obravnavati z ustreznim
antibacterial agent)
antibiotikom);
- Infections in immune-suppressed patients
- okužbe pri bolnikih z oslabljenim imunskim sistemom.
Children and adolescents Acute pulmonary exacerbation of cystic fibrosis in children and adolescents (5-17 years) caused by Pseudomonas aeruginosa.
Otroci in mladostniki Akutna pljučna eksacerbacija cistične fibroze pri otrocih in mladostnikih (starih od 5 do 17 let), ki jo povzroča Pseudomonas aeruginosa.
Ciprofloxacin Nycomed is not indicated for other infections in this age group.
Zdravilo Ciprofloksacin Nycomed za druge okužbe v tej starostni skupini ni indicirano.
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.
Intravenski odmerek ciprofloksacina je odvisen od resnosti in vrste okužbe, občutljivosti povzročitelja (povzročiteljev) in bolnikove starosti, telesne mase ter delovanja ledvic.
The recommended dosage range for adults in different types of infection is given in the table below.
Priporočeni interval odmerjanja za odrasle pri različnih vrstah okužb je naveden v preglednici spodaj.
The usual dosage range for adults is 200-400mg twice daily.
Običajni interval odmerkov za odrasle je 200– 400 miligramov dvakrat na dan.
In very serious or life threatening infections, the dosage can be increased to 400 mg three times daily.
Pri zelo resnih, smrtno nevarnih okužbah se odmerek lahko poveča na 400 mg trikrat na dan.
The product may be infused directly and administered by short-term infusion over periods of 30-60 minutes.
Zdravilo se lahko infundira neposredno in daje s kratkotrajno 30 - do 60- minutno infuzijo.
The 400mg dose should be administered over a period of 60 minutes.
400- miligramski odmerek je treba infundirati 60 minut.
Initial intravenous administration may be followed by oral treatment.
Začetnemu infundiranju lahko sledi peroralno zdravljenje.
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).
Zdravilo se ne sme mešati z drugimi zdravili, ki so kemijsko ali fizikalno nestabilna pri vrednosti pH 3, 9– 4, 5 (glejte poglavje 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.
Vendar so dokazali, da je zdravilo Ciprofloksacin 2 mg/ ml raztopina za infundiranje združljivo z Ringerjevo raztopino, 0, 9- odstotno raztopino natrijevega klorida, 5 - in 10- odstotno raztopino glukoze, raztopino glukoze in fiziološke raztopine ter 10- odstotno raztopino fruktoze.
Unless compatibility is proven, the infusion solution should always be administered separately.
Če kompatibilnost ni dokazana, je treba raztopino za infundiranje vedno dajati ločeno.
In addition, discard any unused portion of product immediately after use.
Poleg tega je treba neuporabljeno zdravilo zavreči takoj po uporabi.
Adults The following dosages for specific types of infection are recommended:
Indikacija
Indication Pneumonia caused by aerobe gram-negative bacteria Complicated urinary tract infections
Zapletene okužbe sečil Okužbe zgornjih in spodnjih dihal (glede na resnost okužbe in občutljivost povzročitelja)
Dose intravenous (mg ciprofloxacin) 200-400 mg twice daily 200-400mg twice daily
200– 400 mg dvakrat na dan 200– 400 mg dvakrat na dan 200– 400 mg dvakrat na dan
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)
Bolniki s cistično fibrozo z okužbo spodnjih dihal, katere povzročitelj je psevdomonas * Druge okužbe (navedene v poglavju 4. 1)
400mg twice daily 200-400mg twice daily.
400 mg dvakrat na dan 200– 400 mg dvakrat na dan
* 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.
* Čeprav pri odraslih bolnikih s cistično fibrozo ostane farmakokinetika ciprofloksacina nespremenjena, je treba pri odmerjanju upoštevati majhno telesno maso teh bolnikov.
9 Impaired Renal function The following dose adjustments are recommended:
9 Okvarjeno delovanje ledvic Priporočene so naslednje prilagoditve odmerkov:
Creatinine clearance ml/ min 31-60 creatinine clearance (serum creatinine 120-170 µmol/ l) ≤ 30 creatinine clearance (serum creatinine > 175 µmol/ l)
Kreatininski očistek 31– 60 (koncentracija kreatinina v serumu 120– 170 µmol/ l) Kreatininski očistek ≤ 30 (koncentracija kreatinina v serumu > 175 µmol/ l)
Recommended dose adjustment Maximum daily dose intravenous 800 mg, divided in two doses Maximum daily dose intravenous, 400 mg*
Največji dnevni intravenski odmerek 800 mg, razdeljen v dva odmerka Največji dnevni intravenski odmerek 400 mg *
*Patients in haemodialysis:
* Bolniki na hemodializi:
On the day of dialysis the dose of Ciprofloxacin Nycomed should be given intravenously after dialysis.
Na dan dialize je treba odmerek zdravila Ciprofloksacin Nycomed dati intravensko po dializi.
Monitoring of drug serum levels provides the most reliable basis for dose adjustment.
Spremljanje ravni zdravila v serumu je najzanesljivejša osnova za prilagajanje odmerka.
Impaired hepatic function No adjustment of dosage is necessary.
Okvarjeno delovanje jeter Prilagajanje odmerkov ni potrebno.
Elderly Although higher ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary.
Starejši bolniki Čeprav so pri starejših bolnikih našli višje koncentracije ciprofloksacina v serumu, prilagajanje odmerka ni potrebno.
Adolescents and children Ciprofloxacin Nycomed is not recommended for use in children below 18 years of age.
Mladostniki in otroci Uporaba zdravila Ciprofloxacin Nycomed pri otrocih, mlajših od 18 let, ni priporočena.
As with other medicinal products in its class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals.
Kot pri drugih zdravilih iz te skupine so tudi o ciprofloksacinu poročali, da povzroča artropatijo nosilnih sklepov živali, pri katerih razvoj še ni končan.
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,.
Vendar analiza razpoložljivih podatkov o varnosti uporabe ciprofloksacina pri bolnikih, mlajših od 18 let, od katerih je večina imela cistično fibrozo, ne kaže na z zdravilom povezane okvare hrustanca ali sklepov.
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.
Klinični in farmakokinetični podatki podpirajo uporabo ciprofloksacina pri pediatričnih bolnikih s cistično fibrozo (starih od 5 do 17 let), z akutno pljučno eksacerbacijo, povezano z okužbo s P. aeruginosa, pri intravenskem odmerku 10 mg/ kg trikrat na dan (največji dnevni odmerek 1. 200 mg).
The infusion should be administered over 60 minutes.
Infundiranje mora trajati 60 minut.
10 LABELLING
10 OZNAČEVANJE
OUTER CARTON {50 ml vial, 100 ml and 200 ml vial}
ZUNANJA ŠKATLA {50- mililitrska viala, 100- mililitrska in 200- mililitrska viala}
Ciprofloxacin lactate corresponding to 2 mg of ciprofloxacin
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Hydrochloric acid, lactic acid, sodium chloride, water for injection
Pomožne snovi: klorovodikova kislina, mlečna kislina, natrijev klorid, voda za injekcije.
Solution for Infusion 50 ml vial 100 ml vial 200 ml vial
Raztopina za infundiranje 50- mililitrska viala 100- mililitrska viala 200- mililitrska viala
Intravenoususe.
Intravenska uporaba
Do not use if crystals are present.
Ne uporabljajte, če so v raztopini kristali.
Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji škatli, za zagotovitev zaščite pred svetlobo.
Discard any unused portion of the product immediately after use.
Neuporabljeno zdravilo zavrzite takoj po uporabi.
LABEL {50 ml vial, 100 ml vial and 200 ml vial}
NALEPKA {50- mililitrska viala, 100- mililitrska in 200- mililitrska viala}
Ciprofloxacin Nycomed 2mg/ ml Solution for Infusion [See Annex I - To be completed nationally]
Ciprofloxacin Nycomed 2 mg/ ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica]
intravenous
intravenska uporaba
14 PACKAGE LEAFLET
14 NAVODILO ZA UPORABO
15 The following text shall be included in the Package Leaflet:
15 V Navodilo za uporabo bo vključeno naslednje besedilo:
WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CIPROFLOKSACIN IN ZA KAJ GA UPORABLJAMO
Ciprofloxacin is an antibiotic agent belonging to the group called quinolones.
Zdravilo Ciprofloksacin je antibiotik, ki spada v skupino zdravil, imenovanih kinoloni.
It acts by killing bacteria that can cause infections.
Deluje tako, da ubija bakterije, ki lahko povzročajo okužbe.
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.
Zdravilo Ciprofloksacin Nycomed se uporablja za zdravljenje več vrst okužb pri odraslih, kot so pljučnica, nekatere vrste okužb sečil, okužbe prostate, okužbe v trebuhu in okrog črevesa, nekatere okužbe kože, okužbe kosti in okužbe pri bolnikih z oslabljenim imunskim sistemom.
In children and teenagers (age 5-17) who have cystic fibrosis, Ciprofloxacin Nycomed may also be used for treating certain types of lung infections.
Pri otrocih in mladostnikih (starih od 5 do 17 let) s cistično fibrozo se lahko zdravilo Ciprofloksacin Nycomed uporablja tudi za zdravljenje nekaterih vrst pljučnih okužb.
HOW TO USE CIPROFLOXACIN
KAKO UPORABLJATI ZDRAVILO CIPROFLOKSACIN
Ciprofloxacin Nycomed will be administered by your doctor or a specialist.
Zdravilo Ciprofloksacin Nycomed vam bo dal osebni zdravnik ali specialist.
The dose and the duration of the treatment are depending upon the severity and type of your infection.
Odmerek in trajanje zdravljenja sta odvisna od resnosti in vrste okužbe.
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.
Vendar je pomembno, da končate celoten cikel zdravljenja, tudi če se po nekaj dneh počutite bolje, sicer se simptomi lahko pojavijo znova.
Adults Complicated urinary tract infections, Respiratory tract infections, Pneumonia and other infections 200 – 400 mg twice daily.
Odrasli Zapletene okužbe sečil, okužbe dihal, pljučnica in druge okužbe 200– 400 mg dvakrat na dan.
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
Največji dnevni odmerek pri zelo resnih ali smrtno nevarnih okužbah je lahko do 1200 mg na dan, ki se daje trikrat na dan po 400 mg.
Adolescents and Children (age 5 – 17 years) Acute pulmonary exacerbation in paediatric cystic fibrosis patients:
Otroci in mladostniki (stari od 5 do 17 let) Akutno pljučno poslabšanje pri otrocih s cistično fibrozo:
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)
10 mg/ kg trikrat na dan (največ 1200 mg na dan) ali 10 mg/ kg intravensko trikrat na dan (največ 1200 mg na dan), nato 20 mg/ kg peroralno dvakrat na dan (največ 1500 mg na dan).
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.
Trajanje zdravljenja Odrasli Zdravljenje navadno traja 5 do 7 dni, vendar pa je pri vztrajnejših ali hujših okužbah lahko daljše.
The duration of treatment for certain lung infections in children and adolescents with cystic fibrosis is 10 – 14 days.
Otroci in mladostniki (stari od 5 do 17 let) Zdravljenje nekaterih okužb pljuč pri otrocih in mladostnikih s cistično fibrozo traja od 10 do 14 dni.
London, 23 January 2008 EMEA/ CHMP/ 350278/ 2007
London, 23. januar 2008 EMEA/ CHMP/ 350278/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Nycomed and associated names International Non-Proprietary Name (INN):
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA Ciprofloxacin Nycomed in z njim povezana imena Mednarodno nelastniško ime (INN):
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.
OSNOVNE INFORMACIJE Ciprofloxacin Nycomed in z njim povezana imena, 2 mg/ ml raztopina za infundiranje, je antibiotik iz družine kinolonov, ki so in vitro učinkoviti proti mnogim po Gramu negativnim aerobnim bakterijam kot tudi nekaterim po Gramu pozitivnim organizmom.
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.
Družba Nycomed Danmark ApS je predložila vloge za medsebojno priznavanje zdravila Ciprofloxacin Nycomed in z njim povezanih imen, 2 mg/ ml raztopine za infundiranje, na osnovi dovoljenja za promet z zdravilom, ki ga je izdalo Združeno kraljestvo dne 23. marca 2005.
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.
Predlagani režim odmerjanja pri zapletenih okužbah sečil (100 mg bid) je domnevno prenizek in bi ga bilo treba spremeniti v 200- 400 mg dvakrat dnevno.
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.
Med svojim zasedanjem od 13. do 16. novembra 2006 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru odbora zaključil, da je razmerje med koristmi in tveganji za zdravilo Ciprofloxacin Nycomed in z njim povezana imena ugodno, ter da ugovori, ki sta jih imeli Norveška in Švedska, ne bi smeli preprečiti izdaje dovoljenja za promet z zdravilom in da je treba dopolniti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo.
The list of the product names concerned is given in Annex I.
Seznam zadevnih imen zdravil je podan v dodatku I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so na voljo v dodatku II, povzetek glavnih značilnosti zdravila pa v dodatku III.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Člen 29 (4) direktive 2001/ 83/ ES, z vsemi spremembami.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE NA PODLAGI NAPOTITVE IZ ČLENA 6( 12)
Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), currently indicated for the treatment of hypertension and symptomatic heart failure.
Coversyl in povezana imena vsebujejo perindopril, zelo znan, močan inhibitor angiotenzinske konvertaze (ACE- I), ki je trenutno indiciran za zdravljenje hipertenzije in simptomatske odpovedi srca.
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the “ reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
Ta napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi z variacijo tipa II za novo indikacijo pri “ zmanjšanju tveganj kardiovaskularnih dogodkov pri bolnikih s stabilno koronarno arterijsko boleznijo ”.
At the end of the MRP procedure there was a discrepancy between different MS regarding the wording of the indication that adequately reflects the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/ 2003, as amended, was notified by the Netherlands to the CHMP on 17.03.2005.
1084/ 2003, kot je bila spremenjena, je Nizozemska obvestila CHMP dne 17. 3. 2005.
The arbitration procedure was discussed and initiated by the CHMP at its plenary meeting in April 2005, and a Rapporteur (Dr Gonzalo Calvo Rojas) and Co-Rapporteur (Dr.
Gonzalo Calvo Rojas) in soporočevalec (dr.
Based on the evaluation of the currently available data and the (Co-)Rapporteurs’ assessment reports, the CHMP adopted an opinion on 27 July 2005 recommending the variation of the Marketing Authorisations for the addition of the following new indication:
Na podlagi vrednotenja trenutno dosegljivih podatkov ter poročevalčevega in soporočevalčevega poročila o oceni, je CHMP dne 27. julija 2005 sprejel mnenje, s katerim je priporočil dopolnitev dovoljenja za promet z zdravilom za vključitev nove indikacije:
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/ or revascularisation.
Zmanjšanje tveganj kardioloških zapletov pri bolnikih, ki so doživeli miokardni infarkt in/ ali revaskularizacijo.
The scientific conclusions are provided in Annex II and the amended Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II, in dopolnjen Povzetek glavnih značilnosti zdravila v Dodatku III.
The information given in this document and Annexes reflect only the CHMP Opinion dated 27 July 2005.
Informacije, podane v tem dokumentu in v Dodatkih odražajo samo mnenje CHMP z dne 27. julija 2005.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINA UPORABE, IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Holder
Imetnik dovoljenja za promet
Luxembourg
Lukesemburg
United Kingdom United Kingdom
Les Laboratoires Servier
2 mg 4 mg
4 mg
Tablets Tablets
Tableta
Oral use Oral use
Peroralna uporaba
3  EMEA 2005 ANNEX II
3 EMEA 2005 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EMEA
Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), marketed in France as Coversyl 2 and 4 mg since 1988, the entire European Union, and world-wide in more than 10 countries including USA and Japan.
Zdravilo Coversyl in z njim povezana imena vsebujejo perindopril, dobro znan, učinkovit zaviralec angiotenzinske konvertaze (ACE- I), ki ga tržijo v Franciji kot Coversyl 2 in 4 mg od leta 1988, v celotni Evropski uniji ter po vsem svetu v več kot 10 državah, vključno z ZDA in Japonsko.
Background information on the type II variation through the MRP In the initial type II variation dossier submitted by MRP (FR/ H/ 246/ 01-02/ 001), the applicant claimed the following indication: “ Stable coronary artery disease:
Osnovne informacije v zvezi s spremembo tipa II v okviru postopka medsebojnega priznavanja (MRP) V prvotni dokumentaciji spremembe tipa II, predloženi po postopku medsebojnega priznavanja (FR/ H/ 246/ 01- 02/ 001), je vlagatelj predložil zahtevo za naslednjo indikacijo: » Stabilna koronarna arterijska bolezen:
Reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
Zmanjševanje tveganja kardiovaskularnih dogodkov pri bolnikih s stabilno koronarno arterijsko boleznijo «.
This wording was based on a significant relative risk reduction (RRR) of 20% (95% CI [9.4; 28.6] p=0.0003) in the primary combined endpoint of cardiovascular mortality, non-fatal myocardial infarction (MI) or cardiac arrest with successful resuscitation observed in the EUROPA study.
Besedilo je temeljilo na pomembnem relativnem zmanjšanju tveganja (RRR) za kombiniran primarni klinični izid, kamor spadajo kardiovaskularna smrt, nesmrtni miokardni infarkt (MI) ali zaustavitev srca z uspešnim oživljanjem, in sicer za 20% (95% interval zaupanja [9. 4; 28. 6] p=0. 0003), kot so ugotovili v okviru študije EUROPA.
A beneficial effect of perindopril was observed for all individual subcomponents of the primary combined endpoint, although only the risk reduction in “ non-fatal MI” reached statistical significance.
Koristnost perindoprila so ugotovili pri vseh posameznih elementih kombiniranega primarnega kliničnega izida, čeprav je bilo zmanjšanje tveganja statistično značilno le pri » nesmrtnem MI «.
In the Final Assessment report (dated on 14.02.2005), the indication proposed by the RMS was restricted to “ Reduction of risk of recurrent MI in patients with a history of MI” considering that the risk reduction was only demonstrated on the “ non fatal MI” component of the primary endpoint and that the effect of perindopril was only clearly established in patients with previous MI.
V Končnem poročilu o oceni (z dne 14. 02. 2005), je bila indikacija, ki jo je predlagana referenčna država članica, omejena na » Zmanjševanje tveganja za ponavljajoči se MI pri bolnikih, ki so v preteklosti že imeli MI «, upoštevaje, da je bilo zmanjšanje tveganja dokazano zgolj pri elementu kombiniranega primarnega izida » nesmrtni MI « ter da je bila učinkovitost perindoprila nedvoumno ugotovljena le pri bolnikih, ki so v preteklosti že imeli MI.
The applicant subsequently sent on 23.02.2005 a Position Paper to all MS stating that the indication proposed by the RMS was not acceptable, and that a broader indication reflecting the study population should be approved, namely: “ Stable coronary artery disease:
Zatem je vlagatelj 23. 02. 2005 poslal vsem državam članicam dokument o stališču, v katerem trdi, da indikacija, ki jo je predlagala referenčna država članica, ni sprejemljiva, ter da bi bilo potrebno odobriti širšo indikacijo, ki se je odražala v raziskovani populaciji, in sicer: » Stabilna koronarna arterijska bolezen: