natgillin/translations-raw huggingface dataset:
In cases of fluticasone propionate overdose Salmeterol/Fluticasone Pharos therapy may still be continued at a suitable dosage for symptom control.
U slučajevima predoziranja flutikazon propionatom, može se i dalje nastaviti liječenje dozama Salmeterol/Fluticasone Pharosa koje su prikladne za kontrolu simptoma.
5.1 Pharmacodynamic properties
5.1 Farmakodinamička svojstva
ATC Code:
ATC (anatomsko-terapijsko-kemijski razred, engl. Anatomical Therapeutic Chemical Class) šifra:
A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of Salmeterol/Fluticasone propionate versus inhaled corticosteroid, ICS (Fluticasone Propionate) alone to determine whether the goals of asthma management were achievable.
Ispitivanje u trajanju od dvanaest mjeseci (Postizanje optimalne kontrole astme, engl. GOAL, Gaining Optimal Asthma ControL) na 3416 odraslih i adolescentnih bolesnika s trajnom astmom uspoređivalo je podnošljivost i učinkovitost salmeterol/flutikazon propionata u odnosu na samostalan inhalacijski kortikosteroid, IKS (flutikazon propionat) kako bi se odredilo mogu li se postići ciljevi kontrole astme.
Treatment was stepped up every 12 weeks until **Total control was achieved or the highest dose of study drug was reached.
Liječenje se postupno pojačavalo svakih 12 tjedana sve dok **nije uspostavljena potpuno kontrola ili dosegnuta najveća doza ispitivanog lijeka.
GOAL showed more patients treated with salmeterol/fluticasone propionate achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose.
GOAL je pokazao da je više bolesnika liječeno salmeterol/flutikazon propionatom postiglo kontrolu astme od bolesnika liječenih samostalnim IKS-om i da je ta kontrola postignuta s nižom dozom kortikosteroida.
Well Controlled asthma was achieved more rapidly with salmeterol/fluticasone propionate than with ICS alone.
Dobra kontrola astme brže je postignuta sa salmeterol/flutikazon propionatom nego sa samostalnim IKS-om.
The time on treatment for 50% of subjects to achieve a first individual Well Controlled week was 16 days for salmeterol/fluticasone propionate compared to 37 days for the ICS group.
Vrijeme liječenja potrebno da 50% ispitanika postigne prvi pojedinačni Dobro kontrolirani tjedan bilo je 16 dana sa salmeterol/flutikazon propionatom u usporedbi s 37 dana za skupinu s IKS-om.
In the subset of steroid naive asthmatics the time to an individual Well Controlled week was 16 days in the salmeterol/fluticasone propionate treatment compared to 23 days following treatment with ICS.
U podskupini ispitanika s astmom koji ranije nisu koristili steroidne lijekove, vrijeme za postizanje pojedinačnog Dobro kontroliranog tjedna bilo je 16 dana u liječenju sa salmeterol/flutikazon propionatom u usporedbi s 23 dana u liječenju s IKS-om.
No ICS (SABA alone)
Bez IKS-a (samo KDBA - kratkodjelujući beta-agonisti)
Low dose ICS (≤500mcg BDP or equivalent/day)
Niska doza IKS-a (≤ 500mikrograma BDP-a (beklometazon dipropionat) ili ekvivalent/dan)
Medium dose ICS (500-1000 mcg
Srednja doza IKS-a (500 - 1000 mikrograma
Pooled results across the 3 treatment levels
Ukupni rezultati za sve 3 razine liječenja
*Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy
*Dobro kontrolirana astma; povremeni simptomi ili uporaba KDBA-a ili manje od 80% predviđene plućne funkcije bez noćnih buđenja, bez egzacerbacija i bez nuspojava koje zahtijevaju promjenu liječenja
The results of this study suggest that salmeterol/fluticasone propionate 50/100mcg bd may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Rezultati ovog ispitivanja pokazuju da se salmeterol/flutikazon propionat 50/100 mikrograma b.i.b. može uzeti u obzir kao početna terapija održavanja u bolesnika s umjerenom trajnom astmom za koje je presudna brza kontrola astme (vidi odlomak 4.2.).
A double-blind, randomised, parallel group study in 318 patients with persistent asthma aged 18 years evaluated the safety and tolerability of administering two inhalations twice daily (double dose) of salmeterol/fluticasone propionate for two weeks.
Dvostruko slijepo, randomizirano ispitivanje usporednih skupina s 318 ispitanika s trajnom astmom u dobi od 18 godina procijenilo je sigurnost i podnošljivost primjene dvije inhalacije dva puta dnevno (dvostruka doza) salmeterol/flutikazon propionata tijekom dva tjedna.
The study showed that doubling the inhalations of each strength of salmeterol/fluticasone propionate for up to 14 days resulted in a small increase in beta-agonist-related adverse events (tremor; 1 patient [1%] vs 0, palpitations; 6 [3%] vs 1 [<;1%], muscle cramps; 6[3%] vs 1 [<;1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis; 6 [6%] vs 16 [8%], hoarseness; 2 [2%] vs 4 [2%]) compared to one inhalation twice daily.
Ispitivanje je pokazalo da udvostručavanje inhalacija obje jačine salmeterol/flutikazon propionata tijekom 14 dana dovodi do malog povećanja štetnih događaja vezanih uz beta-agonist (tremor; 1 bolesnik [1%] u odnosu na 0, palpitacije; 6 [3%] u odnosu na 1 [<; 1%], mišični grčevi; 6 [3%] u odnosu na 1 [<; 1%]) i slična incindencija štetnih događaja vezanih uz kortikosteroid (npr. oralna kandidijaza 6 [6%] u odnosu na 16 [8%], promuklost; 2 [2%] u odnosu na 4 [2%] u usporedbi s jednom inhalacijom dva puta dnevno.
The small increase in beta-agonist-related adverse events should be taken into account if doubling the dose of salmeterol/fluticasone propionate is considered by the physician in adult patients requiring additional short-term (up to 14 days) inhaled corticosteroid therapy.
Malo povećanje učestalosti štetnih događaja vezanih uz beta-agonist mora se uzeti u obzir ako liječnik razmatra udvostručavanje doze salmeterol/flutikazon propionata u odraslih bolesnika koji zahtijevaju dodatno kratkotrajno (do 14 dana) liječenje inhalacijskim kortikosteroidima.
TORCH was a 3-year study to assess the effect of treatment with salmeterol/fluticasone propionate 50/500mcg bd, salmeterol 50mcg bd, fluticasone propionate (FP) 500mcg bd or placebo on all-cause mortality in patients with COPD.
TORCH je bilo 3-godišnje ispitivanje za procjenu učinka liječenja sa salmeterol/flutikazon propionatom 50/500 mikrograma b.i.d., salmeterolom 50 mikrograma b.i.d., flutikazon propionat (FP) 500 mikrograma ili placebo na sveukupnu smrtnost u bolesnika s KOPB-om.
COPD patients with a baseline (pre-bronchodilator) FEV1 <;60% of predicted normal were randomised to double-blind medication.
KOPB bolesnici s početnim (prije bronhodilatatora) FEV1-om <; 60% predviđene normale nasumično su raspoređeni u dvostruko slijepo liječenje.
During the study, patients were permitted usual COPD therapy with the exception of other inhaled corticosteroids, long acting bronchodilators and long-term systemic corticosteroids.
Tijekom ispitivanja ispitanicima je dozvoljeno uobičajeno liječenje KOPB-a, osim drugih inhalacijskih kortikosteroida, dugodjelujućih bronhodilatatora i duodjelujućih sustavnih kortikosteroida.
Survival status at 3 years was determined for all patients regardless of withdrawal from study medication.
Određeno je preživljavanje nakon 3 godine za sve ispitanike, neovisno o prekidu uzimanja ispitivanog lijeka.
The primary endpoint was reduction in all cause mortality at 3 years for salmeterol/fluticasone propionate vs Placebo.
Primarna krajnja točka bila je smanjenje ukupne smrtnosti u 3 godine za salmeterol/flutikazon propionat u odnosu na placebo.
There was a trend towards improved survival in subjects treated with salmeterol/fluticasone propionate compared with placebo over 3 years however this did not achieve the statistical significance level p≤0.05.
Postojao je trend prema povećanom preživljavanju u ispitanika liječenih sa salmeterol/flutikazon propionatom u usporedbi s placebom kroz 3 godine, međutim to nije dostiglo statistički značajnu razinu p ≤ 0,05.
The mean number of moderate to severe exacerbations per year was significantly reduced with salmeterol/fluticasone propionate as compared with treatment with salmeterol, FP and placebo (mean rate in the salmeterol/fluticasone propionate group 0.85 compared with 0.97 in the salmeterol group, 0.93 in the FP group and 1.13 in the placebo).
Srednji broj umjerenih do teških egzacerbacija po godini bio je značajno smanjen salmeterol/flutikazon propionatom u usporedbi s liječenjem salmeterolom, FP-om i placebom (srednja stopa u skupini sa salmeterol/flutikazon propionatom bila je 0,85 u uspredbi s 0,97 u skupini sa salmeterolom, 0,93 u FP skupini i 1,13 s placebom).
19% to 31%; p<;0.001) compared with placebo, 12% compared with salmeterol (95% CI:
19% do 31%; p <; 0,001) u usporedbi s placebom, 12% u usporedbi sa salmeterolom (95% CI:
5% to 19%, p=0.002) and 9% compared with FP (95% CI:
5% do19%, p = 0,002) i 9% u usporedbi s FP (95% CI:
1% to 16%, p=0.024).
1% do 16%, p = 0,024).
Salmeterol and FP significantly reduced exacerbation rates compared with placebo by 15% (95% CI:
Salmeterol i FP značajno su smanjili stope egzacerbacija u usporebi s placebom za 15% (95% CI:
7% to 22%; p<;0.001) and 18% (95% CI:
7% do 22%; p <; 0,001) i 18% (95% CI:
11% to 24%; p<;0.001) respectively.
11% do 24%; p <; 0,001) navedenim redom.
Health Related Quality of Life, as measured by the St George's Respiratory Questionnaire (SGRQ) was improved by all active treatments in comparison with placebo.
Kvaliteta života povezana sa zdravljem kako je izmjereno SGRQ-em (engl. St George's Respiratory Questionnaire, St. George Upitnik o disanju) povisila se pri svim aktivnim liječenjima u usporedbi s placebom.
-4.1 to -2.1; p<;0.001), compared with salmeterol was -2.2 units (p<;0.001) and compared with FP was 1.2 units (p=0.017).
-4,1 do -2,1; p <; 0,001), u usporedbi sa salmeterolom je bilo -2,2 jedinice (p <; 0,001) i u usporedbi s FP-om 1,2 jedinice (p = 0,017).
A 4-unit decrease is considered clinically relevant.
Klinički značajnim smatra se smanjenje od 4 jedinice.
The estimated 3-year probability of having pneumonia reported as an adverse event was 12.3% for placebo, 13.3% for salmeterol, 18.3% for FP and 19.6% for salmeterol/fluticasone propionate (Hazard ratio for salmeterol/fluticasone propionate vs placebo:
Procijenjena vjerojatnost dobivanja pneumonije kao štetnog događaja kroz 3 godine bila je 12,3% za placebo, 13,3% za salmeterol, 18,3% za FP i 19,6% za salmeterol/flutikazon propionat (omjer rizika za salmeterol/flutikazon propionat u odnosu na placebo:
1.33 to 2.01, p<;0.001).
1,33 do 2,01, p <; 0,001).
0.87 to 1.72, p=0.248.
0,87 do 1,72, p <; 0,248).
Placebo-controlled clinical trials, over 6 and 12 months, have shown that regular use of salmeterol/fluticasone propionate 50/500 micrograms improves lung function and reduces breathlessness and the use of relief medication.
Placebo kontrolirana ispitivanja tijekom 6 i 12 mjeseci pokazala su da redovna uporaba salmeterol/flutikazon propionat 50/500 mikrograma poboljšava plućnu funkciju i smanjuje zaduhu te uporabu lijekova za olakšanje simptoma.
The Salmeterol Multi-center Asthma Research Trial (SMART)
Multicentrično ispitivanje salmeterola u astmi, SMART (engl. The Salmeterol Multi-center Asthma Research Trial )
SMART was a multi-centre, randomised, double-blind, placebo-controlled, parallel group 28-week study in the US which randomised 13,176 patients to salmeterol (50μg twice daily) and 13,179 patients to placebo in addition to the patients' usual asthma therapy.
SMART je bilo multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje usporednih skupina u trajanju od 28 tjedana u SAD-u koje je nasumično rasporedilo 13 176 ispitanika u skupinu sa salmeterolom (50μg dva puta dnevno) i 13 179 ispitanika u skupinu s placebom uz dodatnu uobičajenu terapiju ispitanika za astmu.
Patients were enrolled if 12 years of age, with asthma and if currently using asthma medication (but not a LABA).
Ispitanici su uključeni ako su bili stari 12 godina, imali astmu i ako su trenutačno koristili lijekove za astmu (ali ne DDBA, dugodjelujući beta-agonist).
Baseline ICS use at study entry was recorded, but not required in the study.
Zabilježena je početna uporaba IKS-a na ulasku u ispitivanje, ali nije bila potrebna za uključivanje u ispitivanje.
African-American patients
Afroamerički ispitanici
(Risk in bold is statistically significant at the 95% level.)
(Podebljani rizik statistički je značajan pri razini CI-a od 95%.)
(*=could not be calculated because of no events in placebo group.
(* = nije se moglo izračunati jer nije bilo pojava u skupini s placebom.
Risk in bold figures is statistically significant at the 95% level.
Podebljani je rizik statistički značajan pri razini CI-a od 95%.
The secondary endpoints in the table above reached statistical significance in the whole population.)
Sekundarne krajnje točke u prethodnoj tablici dostigle su statističku značajnost u cjelokupnoj populaciji.)
The secondary endpoints of combined all-cause death or life-threatening experience, all cause death, or all cause hospitalisation did not reach statistical significance in the whole population.
Sekundarne krajnje točke kombiniranih smrti od svih uzroka ili stanja opasnih po život, smrti od svih uzroka ili svih uzroka hospitalizacije nisu dostigle statističku značajnost u cjelokupnoj populaciji.
Salmeterol/Fluticasone Pharos contains salmeterol and fluticasone propionate which have differing modes of action.
Salmeterol/Fluticasone Pharos sadržava salmeterol i flutikazon propionat koji imaju različite načine djelovanja.
The respective mechanisms of action of both drugs are discussed below:
Ti su mehanizmi djelovanja oba lijeka opisani u nastavku:
Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting beta-2-agonists.
Salmeterol dovodi do dužeg djelovanja bronhodilatacije, koje traje najmanje 12 sati, od preporučenih doza konvencionalnih kratkodjelujućih beta-2-agonista.
Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Flutikazon propionat koji se primjenjuje inhalacijom pri preporučenim dozama ima glukokortikoidno protutupalno djelovanje u plućima koje dovodi do ublažavanja simptoma i egzacerbacija astme, bez uočenih štetnih učinaka koji se javljaju kod sustavne primjene kortikosteroida.
5.2 Pharmacokinetic properties
5.2. Farmakokinetska svojstva
When salmeterol and fluticasone propionate were administered in combination by the inhaled route, the pharmacokinetics of each component were similar to those observed when the drugs were administered separately.
Kad se salmeterol i flutikazon propionat primjenjuju u kombinaciji inhalacijskim putem, farmakokinetika svake od sastavnica slična je onima koje su uočene kad se lijekovi primjenjuju odvojeno.
In addition there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram /ml or less) achieved after inhaled dosing.
Nadalje, postoje samo ograničeni podaci o farmakokinetici salmeterola zbog tehničkih poteškoća za testiranje lijeka u plazmi uslijed niskih koncentracija u plazmi pri terapijskim dozama (približno 200 pikograma /ml ili manje) koje se postižu nakon inhalacije.
The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 5-11% of the nominal dose depending on the inhalation device used.
Apsolutna bioraspoloživost jedinstvene doze inhaliranog flutikazon propionata u zdravih dobrovoljaca mijenja se između približno 5 - 11% nominalne doze ovisno o uređaju za inhalaciju koji se upotrebljava.
In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
U bolesnika s astmom ili KOPB-om uočena je niža sustavna izloženost inhaliranom flutikazon propionatu.
Systemic absorption occurs mainly through the lungs and is initially rapid then prolonged.
Sustavna apsorpcija uglavnom se javlja kroz pluća i u početku je brza, a potom produžena.
The remainder of the inhaled dose may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and pre-systemic metabolism, resulting in oral availability of less than 1%.
Ostatak inhalirane doze može se progutati, no minimalno doprinosi sustavnoj izloženosti uslijed niske topivosti u vodi i presustavnom metabolizmu koji dovodi do oralne raspoloživosti manje od 1%.
The disposition of fluticasone propionate is characterised by high plasma clearance (1150ml/min), a large volume of distribution at steady-state (approximately 300l) and a terminal half-life of approximately 8 hours.
Raspodjela flutikazon propionata karakterizirana je visokim klirensom plazme (1150 ml/min), velikim volumenom raspodjele pri ravnotežnom stanju (približno 300 l) i krajnjem poluživotu od približno 8 sati.
Fluticasone propionate is cleared very rapidly from the systemic circulation.
Flutikazon propionat vrlo se brzo uklanja iz sustavne cirkulacije.
The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Glavni je put metaboliziranje u neaktivni metabolit karboksilnu kiselinu putem citokrom P450 enzima CYP3A4.
Other unidentified metabolites are also found in the faeces.
U stolici su također nađeni drugi neidentificirani metaboliti.
Less than 5% of the dose is excreted in urine, mainly as metabolites.
Manje od 5% doze izlučuje se urinom, uglavnom u obliku metabolita.
The main part of the dose is excreted in faeces as metabolites and unchanged drug.
Glavnina doze izlučuje se stolicom kao metaboliti i nepromijenjeni lijek.
The only safety concerns for human use derived from animal studies of salmeterol xinafoate and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.
Jedine brige o sigurnosti za ljude proizlaze iz ispitivanja salmeterol ksinafoata i flutikazon propionata odvojeno primijenjenih na životinjama gdje su učinci povezani s pretjeranim farmakološkim djelovanjem.
In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
U reproduktivnim ispitivanjima životinja pokazalo se da glukokortikosteroidi induciraju malformacije (rascjep nepca, malformacije kostura).
Animal studies with salmeterol xinafoate have shown embryofoetal toxicity only at high exposure levels.
Ispitivanja na životinjama sa salmeterol ksinafoatom pokazala su embriofetalnu toksičnost samo pri visokim razinama izloženosti.
Following co-administration, increased incidences of transposed umbilical artery and incomplete ossification of occipital bone were found in rats at doses associated with known glucocorticoid-induced abnormalities.
Nakon istovremene primjene, u štakora je uočena povišena incidencija transpozicije umbilikalne arterije i nepotpune osifikacije zatiljne kosti pri dozama s poznatim abnormalnostima koje su inducirane glukokortikoidima.
6.1 List of excipients
6.1. Popis pomoćnih tvari
6.2 Incompatibilities
6.2. Inkompatibilnosti
6.3 Shelf life
6.3. Rok valjanosti
6.4 Special precautions for storage
6.4. Posebne mjere pri čuvanju lijeka
6.5 Nature and contents of container
6.5. Narav i sastav spremnika
Salmeterol/Fluticasone Pharos contains two medicines packed in the two alu-alu blisters of the single dose foil strips (double-blister strips), which are stored in the inhalation device Elpenhaler®.
Salmeterol/Fluticasone Pharos sadržava dva lijeka pakirana u dva blistera u dvoslojnicama za jedinstvenu dozu koje se drže u uređaju za inhalaciju Elpenhaler®.
Each carton box contains one inhalation device Elpenhaler® with 30 alu-alu double blister strips and one spare canister with 30 additional alu-alu double blister strips.
Svaka kartonska kutija sadržava jedan uređaj za inhalaciju Elpenhaler® s 30 dvoslojnica s dva blistera i jednim rezervnim spremnikom s 30 dodatnih alu-alu dvoslojnica s dva blistera.
60 doses per pack.
60 doza po pakovanju.
6.6 Special precautions for disposal and other handling
6.6. Posebne mjere opreza za odlaganje i rukovanje
To ensure proper administration of the drug, the patient should be shown how to use the inhaler by a physician or other health professional.
Da bi se osigurala ispravna primjena lijeka, liječnik ili drugi zdravstveni radnici moraju pokazati bolesniku kako koristiti inhalator.
The double-blister strip contains one (1) dose of the medicinal combination.
Dvoslojnica sadržava jednu (1) dozu kombinacije lijekova.
The three parts are connected to each other and can be
Tri su dijela međusobno povezana i mogu
The supporting surface contains:
Potporna površina sadržava:
-An attachment point (2A) where the double-blister strip is
-pričvrsnu točku (2A) za namještanje dvoslojnice
-Two cavities (2B) which accommodate the two blisters
-dvije udubine (2B) u kojima se nalaze dva blistera
-Two strip guides (2C) which firmly secure the
-dvije vodilice dvoslojnice (2C) koje čvrsto osiguravaju
The double blister strip contains:
Dvoslojnica s dva blistera sadržava:
- Two sheets (4).
- dva sloja (4).
- Two blisters (5), one containing salmeterol and
- dva blistera (5), jedan sadrži salmeterol, a
- A hole (6).
- rupa (6).
-Uncover the mouthpiece completely from its protective cover.
-Potpuno uklonite zaštitni poklopac s usnika.
-Unlock and push the mouthpiece backwards as to reveal the supporting surface.
-Otključajte usnik i gurnite unatrag da biste otkrili potpornu površinu.
-Hold the double-blister strip with its shiny surface upwards.
-Primite dvoslojnicu s dva blistera s njezinom sjajnom površinom prema gore.
By applying light pressure make sure the strip is securely attached on the attachment point.
Laganim pritiskom provjerite je li dvoslojnica sigurno pričvršćena za pričvrsnu točku.
-The two blisters of the strip will fit in the cavities of the supporting surface, and the guides will secure the strip in the correct position.
-Dva će blistera dvoslojnice pristajati u udubine potporne površine i vodilice će držati dvoslojnicu u ispravnom položaju.
The dose is now ready to be inhaled.
Doza je sada spremna za udisanje.
Be careful not to exhale on the
Pazite da ne izdišete na
from your nose) until your lungs are full.
na nos) dok vam se pluća ne ispune.
-Remove the empty strip, and proceed to step C.
-Uklonite praznu dvoslojnicu i prijeđite na korak C.
C. Cleaning the device
C. Čišćenje uređaja
- Following each use, wipe the mouthpiece and the supporting surface with a dry cloth or dry paper tissue.
- Nakon svake uporabe usnik i potpornu površinu obrišite suhom tkaninom ili suhim papirnatim rupčićem.
MARKETING AUTHORISATION HOLDER
NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET GOTOVOG LIJEKA
THE REPUBLIC OF CROATIADocument:
REPUBLIKA HRVATSKADokument:
Page:
Stranica:
1 of 1
1 od 1
Mr. Jose Manuel Silva Rodriguez
G. Jose Manuel Silva Rodriguez
REPUBLIC OF CROATIA
REPUBLIKA HRVATSKA
MINISTRY OF FINANCE
MINISTARSTVO FINANCIJA
REF.NO:
REF. BROJ:
Zagreb, 28 February 2012
Zagreb, 28. veljače 2012.
Statement of Assurance
Izjava o jamstvu
for the IPA Component V-Rural Development
za komponentu instrumenta IPA V-Ruralni razvoj
of the National Authorizing Officer of Republic of Croatia
nacionalnog dužnosnika za ovjeravanje u Republici Hrvatskoj
On the spot checks
Provjere na licu mjesta
Ex- post checks
Ex-post provjere
(art 19 of the Sectoral agreement)
(članak 19 Sektorskog sporazuma)
Measure/Axis
Mjera/Os
Short name
Skraćeno ime
Administrative checks
Administrativne provjere
Amounts
Iznosi
Checked
Provjereno
101 Investments in agricultural holdings
101 Ulaganja u poljoprivredna gospodarstva