natgillin/translations-raw huggingface dataset:
In a total of 1810 patients with advanced COPD (mean post bronchodilatory screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Elebrato Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Među ukupno 1810 bolesnika s uznapredovalim KOPB-om (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru: 45% predviđene vrijednosti; standardno odstupanje: 13%), od kojih je njih 65% doživjelo umjerenu/tešku egzacerbaciju KOPB-a unutar godinu dana prije uključivanja u ispitivanje (ispitivanje CTT116853), prijavljena je viša incidencija događaja pneumonije tijekom najviše 24 tjedna u bolesnika koji su primali Elebrato Ellipta (20 bolesnika, 2%) nego u onih koji su primali budezonid/formoterol (7 bolesnika, < 1%).
In Study 200812, Elebrato Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
U ispitivanju 200812, Elebrato Ellipta bio je neinferioran flutikazonfuroatu/vilanterolu (FF/VI) + umeklidiniju (UMEK), primijenjenima istodobno dvama inhalatorima, s obzirom na poboljšanje najniže vrijednosti FEV1 od početka ispitivanja do 24. tjedna.
• pain in the back of the mouth and throat
• bol u stražnjem dijelu usta i grlu • upala sinusa
What Elebrato Ellipta is and what it is used for
Što je Elebrato Ellipta i za što se koristi
Therefore, Elebrato Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Stoga Elebrato Ellipta treba primjenjivati uz oprez u bolesnika s nestabilnom ili po život opasnom kardiovaskularnom bolešću.
Elebrato Ellipta contains lactose
Elebrato Ellipta sadrži laktozu
Elebrato Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Elebrato Ellipta treba primjenjivati uz oprez u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika s neuobičajeno dobrim odgovorom na beta2-adrenergičke agoniste.
INFORMATION IN BRAILLE elebrato ellipta
16. PODACI NA BRAILLEOVOM PISMU elebrato ellipta
Elebrato Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Elebrato Ellipta treba primjenjivati uz oprez u bolesnika s tuberkulozom pluća te u bolesnika s kroničnim ili neliječenim infekcijama.
Treatment with Elebrato Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Liječenje lijekom Elebrato Ellipta značajno je smanjilo godišnju stopu teških egzacerbacija za 34% u odnosu na UMEK/VI (95% CI: 22; 44; p < 0,001).
In IMPACT, Elebrato Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
U ispitivanju IMPACT, Elebrato Ellipta značajno je poboljšao (p < 0,001) plućnu funkciju u usporedbi s kombinacijama FF/VI i UMEK/VI tijekom 52-tjednog razdoblja (vidjeti Tablicu 2).
In FULFIL, Elebrato Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
U ispitivanju FULFIL, Elebrato Ellipta značajno je smanjio rizik od umjerene/teške egzacerbacije u odnosu na BUD/FOR tijekom 24 tjedna (33%; 95% CI: 12; 48; p = 0,004).
The most frequently reported adverse reactions with Elebrato Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Najčešće prijavljene nuspojave kod primjene lijeka Elebrato Ellipta bile su nazofaringitis (7%),
Elebrato Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Elebrato Ellipta ne smije se primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
In IMPACT, treatment with Elebrato Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
U ispitivanju IMPACT, liječenje lijekom Elebrato Ellipta smanjilo je godišnju stopu teških egzacerbacija (tj. onih koje su zahtijevale hospitalizaciju ili imale smrtni ishod) za 13% u odnosu na FF/VI (95% CI: -1; 24; p = 0,064).
The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
Učinci dobi na farmakokinetiku flutikazonfuroata, umeklidinija ivilanterola ocjenjivali su se u populacijskoj farmakokinetičkoj analizi.
There was no effect of race on pharmacokinetic parameters of umeclidinium or vilanterol in subjects with COPD.
Rasa ispitanika nije utjecala na farmakokinetičke parametre umeklidinija ili vilanterola u ispitanika s KOPB-om.
If you stop using Elebrato Ellipta
Ako prestanete primjenjivati Elebrato Ellipta
Česká republika GlaxoSmithKline, s.r.o.
Slovenská republika GlaxoSmithKline Slovakia s. r. o.
In FULFIL, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
U ispitivanju FULFIL, Elebrato Ellipta značajno je smanjio (p < 0,001) uporabu lijekova za hitno ublažavanje simptoma između 1. i 24. tjedna u odnosu na BUD/FOR (razlika između liječenja: -0,2 primjene na dan; 95% CI: -0,3; -0,1).
Contents of the pack and other information Step-by-step instructions
Kako čuvati Elebrato Ellipta Sadržaj pakiranja i druge informacije Upute za primjenu korak po korak
In IMPACT, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
U ispitivanju IMPACT, Elebrato Ellipta značajno je smanjio (p < 0,001) uporabu lijekova za hitno ublažavanje simptoma (broj primjena na dan) u svakom 4-tjednom razdoblju u odnosu na FF/VI i UMEK/VI.
If you forget to use Elebrato Ellipta
Ako ste zaboravili primijeniti Elebrato Ellipta
In FULFIL, based upon data up to 24 weeks, Elebrato Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Prema podacima prikupljenima do 24. tjedna u ispitivanju FULFIL, Elebrato Ellipta je značajno smanjio (p = 0,002) godišnju stopu umjerenih/teških egzacerbacija za 35% (95% CI: 14; 51) u odnosu na BUD/FOR.
14 doses 30 doses
14 doza
In FULFIL, Elebrato Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Evaluating Respiratory Symptoms in COPD, E-RS:COPD) u odnosu na BUD/FOR (smanjenje početnog rezultata za ≥ 2 jedinice).
In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Elebrato Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
udio bolesnika s odgovorom također je bio značajno veći (p < 0,001) uz Elebrato Ellipta (36%) nego uz FF/VI (29%; OR 1,36; 95% CI: 1,19; 1,55) i UMEK/VI (30%; OR 1,33; 95% CI: 1,13; 1,57).
Other long acting antimuscarinics and long acting beta2- adrenergic agonists
Drugi dugodjelujući antimuskarinici i dugodjelujući beta2-adrenergički agonisti
In IMPACT, over 52 weeks, Elebrato Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
U ispitivanju IMPACT, Elebrato Ellipta je tijekom 52 tjedna značajno smanjio (p < 0,001) godišnju stopu umjerenih/teških egzacerbacija za 15% (95% CI: 10; 20) u odnosu na FF/VI (stopa: 0,91 naspram 1,07 događaja po bolesnik-godini) te za 25% (95% CI: 19; 30) u odnosu na UMEK/VI (stopa: 0,91 naspram 1,21 događaj po bolesnik-godini).
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation.
Nakon inhalacije ponovljenih doza flutikazonfuroata/vilanterola, stanje dinamičke ravnoteže postignuto je unutar 6 dana, s kumulacijom do 1,6 puta.
Elebrato Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Elebrato Ellipta treba primjenjivati uz oprez u bolesnika s glaukomom uskog kuta ili retencijom mokraće.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1237/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1237/001
In IMPACT, Elebrato Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
U ispitivanju IMPACT, Elebrato Ellipta produljio je vrijeme do prve umjerene/teške egzacerbacije te je značajno smanjio (p < 0,001) rizik od umjerene/teške egzacerbacije, mjeren vremenom do prve egzacerbacije, i u odnosu na FF/VI (14,8%; 95% CI: 9,3; 19,9) i u odnosu na UMEK/VI (16,0%; 95% CI: 9,4; 22,1).
FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Elebrato Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Ispitivanje FULFIL (CTT116853) bilo je 24-tjedno ispitivanje (N = 1810) koje je u jednoj podskupini ispitanika (n = 430) bilo produženo do 52 tjedna i u kojem se Elebrato Ellipta (92/55/22 mikrograma) uspoređivao se s budezonidom/formoterolom u dozi od 400/12 mikrograma (BUD/FOR) primijenjenim dvaput na dan.
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Elebrato Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Ispitivanje IMPACT (CTT116855) bilo je 52-tjedno ispitivanje (N = 10 355) u kojem se Elebrato Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom u dozi od 92/22 mikrograma (FF/VI) i umeklidinijem/vilanterolom u dozi od 55/22 mikrograma (UMEK/VI).
The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Elebrato Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Udio bolesnika s odgovorom tijekom razdoblja od 21. do 24. tjedna bio je značajno veći (p < 0,001) uz Elebrato Ellipta nego uz BUD/FOR (47% odnosno 37%; OR 1,59; 95% CI: 1,30; 1,94).
Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Najniža vrijednost FEV1 (l) u 24. tjednu, srednja vrijednost promjene (LS) od početne vrijednosti
NAME OF THE MEDICINAL PRODUCT Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
NAZIV LIJEKA Elebrato Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani
In IMPACT, Elebrato Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Buđenje noću U ispitivanju IMPACT, Elebrato Ellipta statistički je značajno smanjio srednju vrijednost broja buđenja noću zbog KOPB-a u odnosu na FF/VI (-0,05; 95% CI: -0,08; -0,01; p = 0,005) i UMEK/VI (-0,10; 95% CI: -0,14; -0,05; p < 0,001) između 49. i 52. tjedna.
Elebrato Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
St. George's Respiratory Questionnaire, SGRQ]) i u ispitivanju FULFIL (24. tjedan) u usporedbi s kombinacijom BUD/FOR (-2,2 jedinice; 95% CI: -3,5; -1,0) i u ispitivanju IMPACT (52. tjedan) u usporedbi s kombinacijom FF/VI (-1,8 jedinica; 95% CI: -2,4; -1,1) i UMEK/VI (-1,8 jedinica; 95% CI: -2,6; -1,0).
In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Elebrato Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
U ispitivanju FULFIL, udio bolesnika koji su postigli odgovor prema TDI rezultatu (koji se definirao kao najmanje 1 jedinica) bio je značajno veći (p < 0,001) uz Elebrato Ellipta nego uz BUD/FOR (61% naspram 51%; OR 1,61; 95% CI: 1,33; 1,95).
There is no relevant use of Elebrato Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Nema relevantne primjene lijeka Elebrato Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Elebrato Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1237/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1237/003
NAME OF THE MEDICINAL PRODUCT Elebrato Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Elebrato Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
What Elebrato Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Djelatne tvari su flutikazonfuroat, umeklidinijev bromid i vilanterol.
What Elebrato Ellipta is
Što je Elebrato Ellipta
What Elebrato Ellipta is used for
Za što se Elebrato Ellipta koristi
Tel: +39 (0)55 56801
Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39 (0)55 56801
Elebrato Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Elebrato Ellipta značajno je poboljšao (p < 0,001) plućnu funkciju (definirano srednjom vrijednošću promjene najniže vrijednosti FEV1 od početka ispitivanja do 24. tjedna) (vidjeti
Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Umeklidinij se nije pokazao genotoksičnim u standardnom skupu ispitivanja niti kancerogenim u ispitivanjima cjeloživotne inhalacije na miševima odnosno štakorima pri razinama izloženosti ≥ 20
Package leaflet: Information for the patient Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Uputa o lijeku: Informacije za bolesnika Elebrato Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
Comparison Elebrato vs.
Elebrato u odnosu na UMEK/VI
How to store Elebrato Ellipta
Kako primjenjivati Elebrato Ellipta
Following repeat dosing of inhaled umeclidinium/vilanterol, steady state was achieved within 6 days with up to 1.5-fold accumulation.
Nakon inhalacije ponovljenih doza umeklidinija/vilanterola, stanje dinamičke ravnoteže postignuto je unutar 6 dana, s kumulacijom do
medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir or cobicistat, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets)
- ritonavir ili kobicistat, koji se koriste za liječenje HIV infekcije - lijekove koji smanjuju količinu kalija u krvi, poput nekih diuretika (tableta za izmokravanje) - druge dugodjelujuće lijekove slične ovom lijeku koji se koriste za liječenje dišnih tegoba, npr.
In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
U ispitivanjima inhalacijske primjene na kunićima vilanterol je izazvao učinke slične učincima zabilježenima kod ostalih beta2-adrenergičkih agonista (rascjep nepca,
Once the tray is opened Elebrato Ellipta is ready to use.
Elebrato Ellipta spreman je za uporabu odmah nakon otvaranja podloška.
Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Ne smijete primjenjivati ovaj lijek ako ste trudni,
Treatment with Elebrato Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
U slučaju paradoksalnog bronhospazma potrebno je odmah prekinuti liječenje lijekom
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Elebrato Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Elebrato Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
What Elebrato Ellipta looks like and contents of the pack The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter.
Inhalator Ellipta sastoji se od svijetlosivog plastičnog tijela, bež poklopca nastavka za usta i brojača doza.
Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or beta2-adrenergic receptor agonists.
5.3 Neklinički podaci o sigurnosti primjene Farmakološki i toksikološki učinci zabilježeni kod primjene flutikazonfuroata, umeklidinija ili vilanterola u nekliničkim ispitivanjima bili su oni koji se tipično povezuju s glukokortikoidima,
No clinically relevant effects of hypokalaemia were observed in clinical studies with Elebrato Ellipta at the recommended therapeutic dose.
U kliničkim ispitivanjima nisu primijećeni klinički značajni učinci hipokalijemije kod primjene lijeka
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Elebrato Ellipta inhaler:
Ako se neposredno nakon primjene lijeka Elebrato Ellipta jave stezanje u prsnom košu, kašalj, piskanje pri disanju ili nedostatak zraka:
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Elebrato Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
CTT116855), incidencija pneumonije iznosila je 8% (317 bolesnika) uz Elebrato Ellipta (n = 4151), 7% (292 ispitanika) uz flutikazonfuroat/vilanterol (n = 4134) te 5% (97 ispitanika) uz umeklidinij/vilanterol (n = 2070).
Talk to your doctor before using Elebrato Ellipta - if you have asthma (Don't use Elebrato Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
- ako imate astmu (ne smijete primjenjivati Elebrato Ellipta za liječenje astme) - ako imate srčane tegobe ili visok krvni tlak - ako imate tegoba s jetrom
Nasopharyngitis Candidiasis of mouth and throat Urinary tract infection
- klaritromicin ili telitromicin, koji se koriste za liječenje bakterijskih infekcija
STATEMENT OF ACTIVE SUBSTANCE(S)
(naveden u dijelu 6.)
Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Elebrato Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Ispitivanje 200812 bilo je 24-tjedno ispitivanje neinferiornosti (N = 1055) u kojem se Elebrato Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom (92/22 mikrograma) +
Desiccant
Podložak
Nighttime awakenings
Prijavljivanje nuspojava
DE-23812 Wahlstedt GERMANY
DE-23812 Wahlstedt
ATCvet code: QP53AG30
ATCvet kod: QP53AG30
Threshold for first treatment
Granični prag za prvi tretman
This might be associated with insufficient access to drinking water.
To se može povezati s nedostatnim pristupom vodi za piće.
Sachets are perforated for opening.
Vrećice su perforirane za otvaranje.
Darkness facilitates distribution of the product between the bees.
Tama olakšava distribuciju proizvoda među pčelama.
The acaricidal effect may be due mainly to the low pH of the formulation.
Akaricidni učinak moguć je uglavnom zbog niske vrijednosti pH formulacije.
Autumn
Jesen
Winter (broodless)
Zima (bez legla)
− Do not eat, drink or smoke while using the product.
Prilikom uporabe proizvoda ne jesti, piti niti pušiti.
− Children should not come into contact with this veterinary medicinal product.
Djeca ne bi smjela doći u kontakt s ovim veterinarsko-medicinskim proizvodom.
Before use, the product should be 25 to 35 °C warm, and then shaken well.
Prije uporabe proizvod mora imati temperaturu od 25 od 35 °C te se mora dobro protresti.
N/A All food producing species
Sve vrste koje proizvode hranu
Excipients: Caramel colour (E150d)
Boja karamel (E150d)
All colonies placed at the same location should be treated at the same time to minimize the risk of reinfestation.
Sve kolonije koje se nalaze na istom mjestu potrebno je istodobno tretirati kako bi se rizik od ponovne infestacije smanjio na najmanju moguću razinu.
The bottle has a graduated dosing scale.
Boca ima stupnjevitu doznu ljestvicu.
Determine the colony size and number of occupied bee spaces to be treated, and select the correct amount of product required.
Odredite veličinu kolonije i broj zauzetih prostora za pčele koje je potrebno tretirati i odaberite potrebnu količinu proizvoda.
Do not lift the frames during administration and for approximately one week after the last treatment.
Ne podižite okvire tijekom primjene i otprilike tjedan dana nakon posljednjeg tretmana.
Interaction with other medicinal products and other forms of interaction None known.
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Nisu poznate.
The dose should carefully be adjusted to the colony size (see dosing table).
Dozu je potrebno pažljivo prilagoditi veličini kolonije (vidi tablicu doziranja).
The active substances in VarroMed, oxalic acid dihydrate and formic acid, are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Djelatne tvari u VarroMedu, dihidrat oksalne kiseline i mravlja kiselina, dozvoljene su tvari kako je navedeno u tablici 1. Dodatka Uredbi Komisije (EU) br. 37/2010:
Box containing 1 bottle of 555 ml dispersion.
Kutija sadrži 1 bocu koja sadrži 555 ml disperzije.
DE-97708 Bad Bocklet-Grossenbrach GERMANY
DE-97708 Bad Bocklet-Grossenbrach
The pharmacokinetics of VarroMed have not been studied.
Farmakokinetička svojstva VarroMeda nisu ispitana.
Avoid contact with the skin, eyes and mucous membranes.
Izbjegavajte kontakt s kožom, očima i sluznicom.
Ensure, therefore, that treated bees have sufficient access to drinking water.
Stoga osigurajte da tretirane pčele imaju dostatan pristup vodi za piće.
Multi-dose container (bottle)
Višedozni spremnik (boca)
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Pitajte svojeg veterinara ili farmaceuta kako odlagati veterinarsko-medicinski proizvodi koji vam više nisu potrebni.